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3,482 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
Patients > 18 years old Referred to ENT clinic at Rikshospitalet for evaluation and
treatment of OME, tympanic membrane peroration or tympanic membrane retraction Dysfunction
of the ET is suspected by the ENT surgeon The patient is a candidate for balloon dilation
of the ET
Exclusion Criteria:
Previous serious allergic reaction to iodine based contrast medium Increased risk of
bleeding Serious heart disease Diabetes I Previous ENT-surgery (t-tubes excluded) Middle
ear disease, which requires other type of treatment Chronic rhino sinusitis or nasal
polyposis Pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Novel Imaging of the Eustachian Tube; Patient Study | NCT02282540 | Entailment |
2,092 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- Patients who will undergo pleuroscopy with biopsy
Exclusion Criteria:
- Patients with known malignant pleural effusion
- Inability or unwillingness to give informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Rapid On Site Evaluation of Pleural Touch Preparations in Diagnosing Malignant Pleural Effusion in Patients Undergoing Pleuroscopy | NCT03868579 | Entailment |
5,863 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. Males and females aged 12 to 16 years with a clinical diagnosis of symptomatic GERD or
suspected or endoscopically proven GERD.
2. Patients who have ever been treated with, or are currently receiving proton pump
inhibitors (PPIs),histamine receptor (H2) blockers, or antacids are eligible (as long
as they can go off PPIs and H2 blockers for three days prior to dosing, except for
cimetidine, which must be discontinued for at least seven days prior to dosing;
exclusion criteria 5 and 6). Also, patients should be able to go off PPI therapy for
two weeks at the end active drug treatment.
3. Children with stable asthma/reactive airways disease on stable treatment regimens are
eligible.
4. Children on stable doses of allergy, antiepileptic, antidepressant, and attention
deficit disorder medicines are eligible.
5. Patients must be able and willing to swallow the test drug tablet intact. The ability
of the child to swallow an intact tablet must be confirmed by the site at Screening.
6. The patient is willing and able to give assent to participate.
7. The patient's parent or guardian gives written informed consent.
8. Post-pubertal females will be required to be abstinent during the course of the study.
9. Clinically insignificant laboratory findings.
Exclusion Criteria:
1. Evidence of significant hepatic, renal, respiratory, endocrine, immune, infectious,
hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that
would interfere with the conduct of the study, the interpretation of study results, or
the health of the patient during the study.
2. History of primary esophageal motility disorders or systemic condition affecting the
esophagus (eg, scleroderma, esophageal infections).
3. History of eosinophilic esophagitis, persistent milk protein allergy, or allergic
gastroenteropathy. History or current presence of peptic ulcers; current presence of
Helicobacter pylori.
4. History of definitive acid-lowering surgery, previous esophageal surgery, or
esophageal stricture is disallowed. History of fundoplication or feeding tube
insertion is allowed.
5. Treatment with full therapeutic doses of H2-receptor antagonists or sucralfate within
three days prior to dosing (or a shorter washout if agreed to by Investigator and
Sponsor), except for cimetidine, which must be discontinued for at least seven days
prior to dosing.
6. Treatment with a proton pump inhibitor within three days prior to dosing (or a shorter
washout if agreed to by Investigator and Sponsor).
7. Inability to have 2-week PPI therapy-free period at end of active drug treatment.
8. Pregnancy or lactation.
9. Known or suspected drug addiction or alcohol abuse and/or a positive urine drug screen
not explained by medication list; occasional alcohol or tobacco use is not an
exclusion criterion.
10. Unwilling or unable to abide by the requirements of the study or violating the
prohibitions and restrictions of the study defined in Section 9.4.
11. Any condition which would make the patient, in the opinion of the Investigator or
Sponsor, unsuitable for the study.
12. Participation in another investigational drug study within one month prior to dosing.
13. A history of allergy/sensitivity to proton pump inhibitors or to their inactive
ingredients.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 16 Years | Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole | NCT00132496 | Contradiction |
6,284 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Adults with a SARS-CoV-2 positive molecular swab carried out in the previous 48 hours
before the enrollement
- Adults with mild infection
- Adults with symptoms such as fever above 37 ° C, feeling bad, cold symptoms (cough,
pharyngodynia, nasal congestion), headache, myalgia, diarrhea, anosmia, dysgeusia
- Adults without the above symptoms
Exclusion Criteria:
- Adults with dyspnea and/or dehydration and/or alterations in consciousness and/or
sepsis.
- Subjects with severe asthma
- Subjects and with contraindications to treatment with steam inhalations
- Multi-allergic subjects
- Subjects unable to complete the protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Steam Inhalations in COVID-19 Patients | NCT04743349 | Entailment |
6,610 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Patients with severe haemophilia A (<2% FVIII baseline plasma levels) treated with
KOGENATE Bayer as their only source of recombinant FVIII
Exclusion Criteria:
- Exclusion criteria must be read in conjunction with the product information (SmPC)
Male
No healthy subjects accepted to join the trial.
| International PMS Study - KOGENATE Bayer | NCT00864552 | Contradiction |
85 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Men, age 18 years and older.
- Chronic non-cancer back pain.
- Use of opioid analgesics for at least 6 months.
- Serum total testosterone (measured by mass spectrometry) <348 ng/dL and/or free
testosterone <70 pg/mL.
- Ability and willingness to provide informed consent.
Exclusion Criteria:
- History of prostate cancer or breast cancer.
- Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or
testicular disease).
- Use of testosterone within the past 6 months.
- Baseline hematocrit >48%.
- Prostate-specific antigen (PSA) level >4 ng/mL in Caucasians or >3 ng/mL in
African-Americans.
- Presence of prostate nodule or induration on digital rectal examination.
- Uncontrolled congestive heart failure.
- Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke
within 3 months.
- Serum creatinine >2.5 mg/dL.
- Alanine aminotransferase (ALT) level 3 times above the upper limit of normal.
- Diagnosis of bipolar disorder or schizophrenia.
- Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the
patient from undergoing functional magnetic resonance imaging (MRI). In subjects who
are otherwise eligible and either do not qualify for MRI or are reluctant to undergo
imaging, the investigators may consider enrolling such participants on a case-by-case
basis.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism | NCT04798469 | Contradiction |
4,256 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- • Study sample will consist of individuals aged 18-60 with a diagnosis of acute or
chronic respiratory disorders or normal subjects with no pulmonary disease.
Healthy subjects may include:
1. Adult males or females age ≥ 18 and ≤ 60 years at time of enrollment
2. Non-smokers
3. Person with no history of asthma, chronic obstructive pulmonary disease (COPD), or
other chronic lung disease
4. Person with no history of severe allergic/atopic disease requiring immunotherapy or
immunomodulators
Subjects with pulmonary disease may include:
1. Person with well-documented disease with objective diagnostics such a lung function or
genetic testing.
2. Person with FEV1 > 55% predicted on the day of study procedures.
3. Person who is clinically stable with no significant changes in health status within 4
weeks.
Exclusion Criteria:
- • Subjects that are mechanically ventilated.
- Subjects that are unable or unwilling to cooperate with specimen collection.
- Subjects with diagnosis of any medical condition that in the investigator's
opinion would make them unsuitable for study participation.
- Subjects who experienced a pulmonary exacerbation within the 4 weeks prior to
visit.
- Subjects requiring continuous oxygen therapy.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Determining Airway pH by Compartmental Exhaled Nitric Oxide Levels During Alkaline Buffer Challenge | NCT04738422 | Entailment |
5,519 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Diagnosis of giant cell arteritis (GCA) according to the following criteria:
- History of erythrocyte sedimentation rate (ESR) >= 50 mm/hour or high sensitivity
C-reactive protein (hsCRP)/CRP >=1.0 mg/dL
- Presence of at least one of the following: Unequivocal cranial symptoms of GCA or
Unequivocal symptoms of polymyalgia rheumatica (PMR)
- Presence of at least one of the following: Temporal artery biopsy revealing
features of GCA or evidence of large vessel vasculitis by angiography or
cross-sectional imaging such as ultrasound, magnetic resonance imaging (MRI),
computed tomography (CT) or positron emission tomography (PET).
- Active GCA, either new onset or relapsing, within 6 weeks of Baseline.
- Participants must have received treatment with >=40 mg prednisone (or equivalent) at
any time prior to Baseline and be receiving prednisone (or equivalent) >= 20 mg once
daily (QD) at Baseline.
- Participants must have GCA that, in the opinion of the investigator, is clinically
stable to allow the participant to safely initiate the protocol-defined corticosteroid
(CS) taper regimen.
- Females must either be postmenopausal or permanently surgically sterile or, practicing
at least 1 specified method of birth control through the study.
Exclusion Criteria:
- Prior exposure to any Janus Kinase (JAK) inhibitor.
- Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or
prior treatment with an IL-6 inhibitor and experienced a disease flare during
treatment.
- Use of any of the following systemic immunosuppressant treatments within the specified
timeframe prior to study start:
- Anakinra within 1 week of study start.
- Methotrexate, hydroxychloroquine, cyclosporine, azathioprine, or mycophenolate
within 4 weeks of study start.
- Oral corticosteroid (CS) for conditions other than GCA within 4 week of study
start, or intravenous CS within 4 weeks of study start.
- Greater than or equal to 8 weeks for leflunomide if no elimination procedure was
followed, or adhere to an elimination procedure.
- Cell-depleting agents or alkylating agents including cyclophosphamide within 6
months of study start.
- Current or past history of infection including herpes zoster or herpes simplex, HIV,
active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
- Female who is pregnant, breastfeeding, or considering pregnancy during the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis | NCT03725202 | Entailment |
745 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion criteria are the following:
1. 60-79 years of age and diagnosed with KOA by a physician or meet the ACR criteria (95%
sensitivity, and 69% specificity) for KOA. The ACR criteria include experiencing
almost daily knee pain and having at least 3 of these 6 criteria: (1) Age more than 50
years old, (2) less than 30 minutes of morning stiffness, (3) increased warmth of the
knee, (4) crepitus with flexion or extension, (5) joints' bony enlargement , and (6)
tenderness of joint line with palpation, or subject must be diagnosed radiologically,
with grade II or more according to the Kellgren and Lawrence rating scale.
2. Frequent knee pain or aching on most of the preceding 30 days.
3. An average of mild to moderate pain intensity level (5 to 75 mm on the 100 mm VAS) in
the last 7 days
4. Sedentary lifestyle assessed using 2011 Compendium of Physical Activities
questionnaire. The subject is considered sedentary if engaging in exercise or physical
activity with metabolic equivalents of task (MET) less than 4, not more than two
times/week.
Exclusion criteria:
1. Unwilling to attend 3 sessions/week at Kirmayer Fitness Center
2. Having other types of arthritis such as rheumatoid arthritis or gout
3. Neurological disorders
4. CVD including hypertension that prevent them from engaging in walking exercise
5. Currently using beta blocker medication
6. Underwent any lower limb surgery during the past 6 months
7. A history of two or more incidents of fall during the last 6 months
8. Current hip or spine pain that prevents them from engaging in walking exercise.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 79 Years | Investigating the Effect of Interval Walking and Qigong on People With Knee Osteoarthritis: Pilot Study | NCT04528953 | Contradiction |
5,923 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Having undergone any anti-reflux surgery at Department of Surgery, Kolding Hospital, a
part of Hospital Lillebaelt, Denmark from January 1, 2002 to December 31, 2013
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Applying Long-term Follow-up to Improve Patient Selection in Laparoscopic Anti-reflux Surgery | NCT03959020 | Contradiction |
4,413 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Presence of pain in the elbow region at least for three months
- Flares with activity
- Tenderness at or within 2cm of the lateral humeral epicondyle on resisted extension of
the wrist and/or the third finger.
Exclusion Criteria:
- Participants who had constant or radicular pain
- Any previous surgery or acute trauma in the upper extremity.
- Elbow deformity
- Bilateral symptoms
- Clinical or electrophysiological findings referable to peripheral nerve (ulnar and
median) disease and
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Neuromodulation in Lateral Elbow Pain | NCT03433716 | Contradiction |
3,464 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
1. Type 2 diabetes
2. Metformin treatment
3. Haemoglobin A1c (HbA1c) I. > 59 mmol/mol in case the diabetes treatment is only
metformin II. 59-75 mmol/mol in case the diabetes treatment is metformin and add-on
therapy
4. Body Mass Index (BMI) > 25 kg/m2
5. Age > 18 years
6. Caucasian
7. Normal haemoglobin levels
Exclusion Criteria:
1. Treatment with insulin or GLP-1-receptor agonist
2. Any treatment that cannot be paused for 12 hours
3. Diabetes duration more than 20 years
4. Weekly alcohol intake of more than 14 units for men or 7 units for women of alcohol
(of 12 g) or narcotics abuse
5. Liver disease
6. Kidney disease (estimated glomerular filtration rate, eGFR < 60 ml/min/1,73 m2)
7. Unusual dietary preferences or planned weight loss within the duration of the study
8. Any other condition that in the opinion of the responsible investigators is
disqualifying.
9. For women I. Current or planned pregnancy for the duration of the study II. Positive
pregnancy test at the screening or any of the experimental days III. Women who are
currently breastfeeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Insulin Response to the Gut Hormone GIP After Near-normalisation of Plasma Glucose in Patients With Type 2 Diabetes | NCT04228484 | Entailment |
2,787 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
1. All patients undergoing elective laparoscopic inguinal hernia repair, unilateral or
bilateral.
2. ≥18 years of age.
3. Patients must leave the operating room without at indwelling urinary catheter.
Exclusion Criteria:
1. History of neurogenic bladder requiring routine intermittent catheterization
2. Emergent laparoscopic hernia repair.
3. Elective laparoscopic hernia repair in conjuncture with an additional operation (e.g.
nephrectomy, pelvic surgery) that requires the patient to have a planned, indwelling
urinary catheter in the postoperative period.
4. Pregnant women.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair | NCT04434378 | Entailment |
716 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- age 45-60
- female
- history of knee injury or surgery (except replacement surgery) or body mass index
(BMI) greater than or equal to 25.
Exclusion Criteria:
- diagnosis of knee osteoarthritis
- inflammatory arthritis such as rheumatoid or psoriatic arthritis
- knee replacement
- metallic implant or stent placement surgery or any implanted devices
- surgery or lower limb injury in the last 6 months that affects walking ability
- lower limb amputation (other than single ray)
- unable to walk without an assistive device
- wounds that contraindicate weight-bearing exercise
- acute infection or inflammation that contraindicates exercise
- acute disk related problems (new lower back pain in the last 3 months or severe enough
to affect walking)
- osteonecrosis
- currently pregnant or planning to become pregnant
- kidney, bladder or gallstones that have not been passed
- retinal detachment
- ever experienced deep vein thrombosis
- type 1 diabetes mellitus (insulin dependent)
- history of myocardial infarction or stroke in the last year
- medical conditions that affect walking ability or ability to take part in the study or
exercise such as; Alzheimer's disease, multiple sclerosis, Parkinson's disease, severe
cardiovascular disease, congestive heart failure, severe emphysema, severe asthma,
severe dysrhythmias or pacemaker
- Any type of implanted pump (e.g. Morphine, baclofen) or catheter (e.g. In kidney,
brain or spine)
- neuropathy (by Semmes-Weinstein Monofilament)
- uncontrolled epilepsy
- active cancer (< 5 years since remission) or other illness expected to be terminal
within 1 year
- concurrent participation in another research study
- Inability to follow protocol (e.g. lack of ability to attend visits or understand
instructions)
- frequent knee pain on most of the last 30 days
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 60 Years | Platform Exercise Training | NCT01239823 | Contradiction |
2,173 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
1. Known gout patients (per criteria of the American Rheumatism Association for the
classification of the acute arthritis of primary gout
1. Patients who have been taking at least 200 mg/day of allopurinol as the sole ULT
for at least two weeks with a sUA of ≥ 6.5 mg/dL and ≤ 12 mg/dL at screening and
≥ 6.0 mg/dL and ≤ 12 mg/dL at Week -1 (Visit 2) randomization visit.
-OR -
2. Patients who are not on ULT or are taking allopurinol < 200 mg/day must have a
sUA ≥ 8.0 mg/dL and ≤ 12 mg/dL at screening and ≥ 6.0 mg/dL and ≤ 12 mg/dL at
Week -1 (Visit 2) randomization visit.
2. Male or female, 18-75 years of age at screening
3. All female patients must be surgically sterile or post-menopausal (at least 45 years
of age with no history of menses for at least 2 years; or any age with no history of
menses for at least six months and serum FSH ≥ 40 mIU/mL) or have a partner who has
undergone vasectomy or must agree to use two medically accepted methods of
contraception including a barrier method (see the list in Appendix 4) for the entire
duration of the study unless she reports complete sexual abstinence.
4. Female patients must not be pregnant or lactating.
5. Male patients with a female partner of child-bearing potential must agree to use
condoms or the partner must use a medically acceptable method of contraception for the
entire duration of the study.
6. Estimated creatinine clearance (CrCl) by Cockcroft-Gault method ≥ 60 mL/min at
screening
7. Serum creatinine value ≤ 1.1 mg/dL in females and ≤ 1.3 mg/dL in males
8. Liver function tests ≤ 1.5X ULN for AST, ALT and T-bilirubin, ≤ 2X ULN for ALP, ≤ 3X
ULN for GGT; and ≤ 3X ULN for CK
9. All other clinical laboratory parameters must be within normal limits or considered
not clinically significant for participation in this study.
10. Electrocardiogram (ECG) must be normal, or if abnormal, considered not clinically
significant for participation in this study.
11. Systolic blood pressure ≤ 160 mm Hg and diastolic blood pressure ≤ 90 mm Hg; known
hypertensive patients controlled with medications other than thiazide diuretics (blood
pressure [BP] reading as above) may be included
Exclusion Criteria:
1. Treatment with any ULT other than allopurinol (e.g., probenecid, benzbromarone,
febuxostat, or pegloticase) within 30 days of the Screening Visit
2. Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder,
or organ transplant)
3. Diagnosis of xanthinuria
4. History of documented or suspected kidney stones
5. Known infection with HIV or history of viral hepatitis type B or C
6. History of illicit drug or alcohol abuse within 1 year of screening
7. History of significant pulmonary disease, upper GI bleeding, documented peptic ulcer
disease (unless known H. pylori infection treated successfully without recurrence), or
nephrotic syndrome within three years of screening
8. History of stroke, TIA, acute MI, congestive heart failure (NYHA Class II-IV), angina
pectoris, coronary intervention procedure (including but not limited to angioplasty,
stent placement, coronary revascularization), lower extremity bypass procedure,
systemic or intracoronary fibrinolytic therapy within five years of screening
9. Malignancy (except treated basal cell carcinoma) within five years of screening
10. BMI > 42 kg/m2
11. Current or expected requirement for anticoagulant therapy (except for aspirin ≤ 325
mg/day)
12. Rheumatoid arthritis or other autoimmune disease requiring ongoing treatment
13. Current or expected treatment with potent CYP3A4 inhibitors (See Appendix 6),
cytotoxic agents (azathioprine, mercaptopurine, cyclosporine, cyclophosphamide, etc.),
ranolazine, digoxin, theophylline, sulphonylureas, thiazolidinediones, diuretics,
atypical antipsychotic agents, ampicillin, amoxicillin or phenytoin
14. Chronic treatment with NSAIDs (use to treat acute flares are permitted).
15. Current or expected treatment with systemic corticosteroids (except topical,
ophthalmic, intra-articular, or inhaled at a dose < 1600 μg/day) other than to treat
acute flare
16. Known hypersensitivity to allopurinol, colchicine, or aspirin
17. Treatment with any other investigational therapy within the 30 days prior to
screening, or patients who received at least one dose of study drug while enrolled in
any previous or concomitant MBX-102 trial
18. Any other condition that compromises the ability of the patient to provide informed
consent or to comply with the objectives and procedures of this protocol, as judged by
the investigator and/or medical monitor.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients | NCT01399008 | Contradiction |
144 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Provide responses to standard questionnaires administered to subjects
- Written Informed Consent obtained
- Male sex at birth
- ≥ 40 and ≤ 75 years of age
- Presentation to the clinic with symptoms suggestive of low testosterone such as loss
of libido, erectile dysfunction, cognitive or mood disturbances, etc.
- Able and willing to provide blood specimens and follow study schedule
- A final diagnosis can be established (androgen deficient versus not androgen
deficient)
Exclusion Criteria:
- Previous exposure to exogenous T, DHEA, clomiphen citrate, or other Selective Estrogen
Receptor Modulators, or OTC or herbals (Treatment Naïve)
- Use of opioid medication within 3 months prior to enrollment
- Serious psychiatric disease or uncontrolled medical illness, as suspected from medical
history or clinical examination
- Use of any sex hormones or steroidal anabolic drug supplements (OTC or
prescribed)(Treatment Naïve)
- Incapable of giving informed consent or complying with protocol or unwilling to comply
with protocol requirements
- Diagnosis of prolactinoma
Male
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Evaluation of Prealbumin Levels in Men With Low-T | NCT03313635 | Contradiction |
5,983 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Signed informed consent
- Males and females ages 18-69 who are of Hispanic origin
- Symptoms of GERD, defined as heartburn at least 2 times a week on average over the
last 3 months
Exclusion Criteria:
- Female patients who are pregnant or breastfeeding
- Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium,
Prevacid, or Protonix
- Current or relevant history of non-healed ulcers, stomach surgery, or esophageal
surgery
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 69 Years | Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD | NCT00410592 | Entailment |
5,967 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Age 18-75 years
- GERD for > 1 year
- History of daily PPIs use for > 6 months
- Moderate to severe typical or atypical GERD symptoms off PPIs
- Complete (responders) or partial (nonresponders) symptom control on PPIs
- Deteriorated gastroesophageal junction (Hill grade II or III)
- Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow
testing
- Willingness to undergo pH/impedance testing, if required
- Willingness to cooperate with the postoperative diet for 6 weeks
- Availability for follow up visits at 6 months and 12 months
- Willingly and cognitively signed informed consent
Exclusion Criteria:
- BMI > 35
- Incompletely reducible hiatal hernia with residual of > 5 mm
- Esophagitis grade D
- Barrett's Esophagus > 2 cm
- Esophageal ulcer
- Fixed esophageal stricture or narrowing
- Portal hypertension and/or varices
- Active gastro-duodenal ulcer disease
- Gastric outlet obstruction or stenosis
- Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying
study, if patient complains of postprandial satiety during assessment
- Coagulation disorder
- History of any of the following: resective gastric or esophageal surgery, antireflux
surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical
spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia,
scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
- Pregnancy or plans of pregnancy in the next 12 months
- Enrollment in another device or drug study that may confound the results
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD) | NCT01118585 | Contradiction |
5,053 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Ambulatory Korean postmenopausal women with osteoporosis
- greater than 5 years postmenopausal
- aged 60 to 90 years old
- absolute bone mineral density value consistent with a T-score less than -2.5 and
greater than or equal to - 4.0 at the either the lumbar spine or total hip, as
measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0
are at very high risk for fracture and will be excluded.
Exclusion Criteria:
- previous or current metabolic bone disease, Paget's or Cushing's disease, or
hyperprolactinemia
- current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable
thyroid replacement therapy and TSH level meets criteria
- rheumatoid arthritis
- cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal
to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater
than or equal to 1.5 times the upper limit of normal
- medications used to treat osteoporosis, defined for type and duration of use, and
including IV and oral bisphosphonates
- medications that affect bone metabolism including parathyroid hormone or derivatives;
anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement
therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol
or vitamin D derivatives; other bone active drugs including anticonvulsives (but not
benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH,
cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and
gonadotropin-releasing hormone agonists
- malignancy within 5 years except certain resected types
- malabsorption syndrome or gastrointestinal disorders associated with malabsorption
- abnormal calcium level
- vitamin D deficiency
- any laboratory abnormality that will prevent the subject from completing the study or
interfere with interpretation of study results
- severe renal impairment or on dialysis
- impaired immune system or subject is taking immunosuppressants
- oral or dental conditions including current or past history of osteomyelitis or
osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery;
planned invasive dental procedure; un-healed dental or oral surgery
- any disorder that compromises the ability of the subject to give written informed
consent or to comply with study procedures
- any physical or psychiatric disorder that will prevent the subject from completing the
study or interferes with study results
- known to have tested positive for HIV
- less than two lumbar vertebrae evaluable for DXA measurements
- height, weight, or girth that may preclude accurate DXA measurements
- drug or alcohol abuse within 12 months that interferes with understanding or
completing the study
- known sensitivity to mammalian cell-derived drug products
- use of an investigational drug or device within 30 days of enrollment or currently
receiving other investigational agent(s)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 90 Years | A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab | NCT01457950 | Contradiction |
6,585 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male patients diagnosed with moderate to severe hemophilia A (≤ 5% FVIII:C (Factor
VIII Coagulant activity))
- Any age
- ≥ 50 exposure days (EDs) to any FVIII product
- Patients with or without history of inhibitors
- Patient with previous history of inhibitors, with at least 2 consecutive negative
inhibitor tests and on standard prophylaxis therapy for at least 1 year prior to
study entry
- No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
- Evidence of FVIII inhibitor as measured by the Nijmegen-modified Bethesda
assay [<0.6 Bethesda units (BU/mL)] or Bethesda assay [< 1.0 BU/mL] in 2 on
consecutives samples
- Documented or clinical suspicion of shortened FVIII half-life (< 6 hrs)
- Currently on or plan to start prophylaxis therapy with KOVALTRY
- Written informed consent
Exclusion Criteria:
- Patients participating in an investigational program with interventions outside of
routine clinical practice
- Patients with an additional diagnosis of any bleeding/coagulation disorder other than
hemophilia A
- Patients on Immune Tolerance Induction (ITI) treatment at the time of enrollment
Male
No healthy subjects accepted to join the trial.
| Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis | NCT02830477 | Contradiction |
4,729 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier
and have no other pathology of the uterus, regardless of clinical symptoms.
Exclusion Criteria:
- Postmenopausal women,
- Pregnant women,
- Gynaecological cancer,
- GnRH analog therapy or systemic hormone therapy in the last three months prior to
hysterectomy,
- Endometriosis,
- Uterine fibroids
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Norwegian Adenomyosis Study III: Peristalsis | NCT02197936 | Entailment |
6,764 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male subjects with severe or moderately severe hemophilia A
- A negative past medical history of a Factor VIII inhibitor
- Age greater than or equal to 12 years
Exclusion Criteria:
- A history of Factor VIII inhibitors
- Presence of a bleeding disorder in addition to hemophilia
- Known hypersensitivity to hamster protein
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A | NCT00141843 | Entailment |
1,191 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Malignant Pleural Effusion MPE (either cytology proven or recurrent exudative pleural
effusion in the context of histologically proven cancer)
- Presence of an indwelling pleural catheter (IPC)
- Nondraining IPC (defined as <50 mL of drainage on the past three drainage attempts)
not responding to routine saline flush to assure patency
- Residual pleural fluid remaining on chest x-ray (CXR) or ultrasound
- Dyspnea deemed attributable to the effusion (i.e. symptomatic loculations), as
assessed by the treating chest physician and using the modified Borg scale
- Presence of written informed consent from the patient or surrogate
Exclusion Criteria:
- Age <18
- Expected survival less than 14 days
- Known allergy or intolerance to tissue plasminogen activator
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| The Safety and Efficacy of Fibrinolysis in Patients With an Indwelling Pleural Catheter for Multi-loculated Malignant Pleural Effusion. | NCT03678090 | Entailment |
834 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Subject must provide written, informed consent before any study procedures occur. The
subject should be provided with a copy of the signed Informed Consent upon signature.
2. Subjects with symptomatic Kellgren-Lawrence (KL) Grade 2, 3, or 4 OA by radiograph (AP
tunnel view) within 30 days prior to day 0 visit, where the K-L grades are defined as:
- Grade 0: no radiographic features of OA are present
- Grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping
- Grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing
radiograph
- Grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity
- Grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony
deformity
3. Subject must have a normal tibiofemoral angle (0-8°) and a joint space width of ≥ 3mm
confirmed by radiograph.
4. Subjects who are between the ages of 21 - 85 years.
5. Subjects must have a visual analog pain (VAS) score of at least 4 cm on a 10 cm scale
for a nominated activity in the target knee at the time of screening.
6. For bilateral knee osteoarthritis subjects, the visual analog pain VAS score for a
nominated activity of the contralateral knee must be less than 4 cm on the VAS scale.
7. Subject has access to a smartphone or tablet (Android or iOS).
8. Subject must be ambulatory.
9. Subject must be willing to discontinue receiving knee intra-articular injections of
steroids, knee intra-articular injections of hyaluronic acid, opioids, and analgesics
(except for acetaminophen up to 3000 mg/day or an equivalent) for the duration of the
study.
10. Subject must be willing to take acetaminophen (up to 3000 mg/day) or an equivalent as
pain medication for the duration of the study.
11. Subject must be willing to stop taking any pain medications 24 hours prior any
scheduled study visit.
12. Subject must be willing to stop receiving knee physical therapy of the target knee for
the duration of the study.
13. Subject must be willing to stop wearing any knee unloader brace of the target knee for
the duration of the study.
14. Subjects must be proficient in English.
15. Subjects must be willing and able to comply with all study procedures for the duration
of the clinical study
Exclusion Criteria:
1. Subjects who have a body mass index ≥ 40 at the time of consent (at the discretion of
the PI).
2. Subjects with a diagnosis of inflammatory arthritis (knee rheumatoid arthritis, active
gout, knee joint infection, Lyme disease, SLE, etc.).
3. Subjects with a diagnosis of severe neuropathy condition for the past 6 months and
under medication for treatment of the condition.
4. Subjects with a diagnosis of fibromyalgia for the past year.
5. Subjects who have had an injury or an acute traumatic injury to the target knee within
6 months of screening.
6. Subject must NOT have had arthroscopy of the target knee within 8 weeks of
randomization.
7. Subjects who have had treatment of the target knee with intra-articular injections of
steroids within 8 weeks of screening.
8. Subjects who have had intra-articular injections of hyaluronic acid within 12 weeks of
screening.
9. Subjects who have had a scheduled surgery on the target knee within the study period.
(Note- Subjects who are scheduled to go under total knee replacement surgery within
the next 3 months at screening will not be enrolled. Subjects that are contemplating
the surgery can be included.)
10. Subjects who have used electrotherapy or acupuncture for OA of the target knee within
4 weeks of screening.
11. Subjects who have used Neuromuscular Electrical Stimulation (NMES) in the past year.
12. Subjects with significant and clinically evident mal-alignment of the target knee (> 5
degrees varus or valgus in the target knee).
13. Subjects with surgical metallic hardware in the target knee.
14. Subjects who have had implanted electrical devices (cardiac pacemakers, deep brain
stimulators, implantable cardiac defibrillators).
15. Subjects who have contraindications to X-rays.
16. Subjects with a current malignancy or who have received treatment for malignancy with
the last 5 years, with the exception of resected basal cell carcinoma and squamous
cell carcinoma of the skin.
17. Subjects who have an active substance abuse problem (drugs or alcohol) or a history of
chronic substance abuse (> 5 years).
18. Subjects with skin breakdown or infection in the area where the study device will be
placed (quadriceps of the target knee).
19. Subjects with any chronic conditions (e.g., diabetes, hypertension, congestive heart
failure, etc.) that have not been well-controlled for at least 3 months prior to
screening.
20. Subjects who have any ongoing litigation for worker's compensation.
21. Subjects with any condition, in the opinion of the Investigator that might interfere
with the evaluation of the study objectives.
22. Subjects who are pregnant.
23. Subject must not have participated in a clinical study within the past 12 weeks from
the last day of treatment that required the use of an investigational device, drug or
biologic
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 85 Years | Evaluation of a Home-based NMES Therapy for Knee Osteoarthritis Pain | NCT04128618 | Entailment |
3,158 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- age between 18 and 80 years,
- history of at least 3 months of dry eye symptoms referable to mild to moderate dry
eye.
Exclusion Criteria:
- presence of any ocular disease, present or past, other than dry eye;
- previous ocular surgery,
- use of contact lens or topic treatments other than tear substitutes;
- presence of systemic diseases requiring a treatment with systemic drugs potentially
interfering with tear productions;
- hypersensitivity to the active substance or to excipients;
- participation in a clinical trial during the 3 months prior to the beginning of the
study,
- pregnancy or breast-feeding.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Cross-linked Hyaluronic Acid and Coenzyme Q10 in the Treatment of Dry Eye | NCT03074344 | Contradiction |
327 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
Women 18-48 years of age who are scheduled for IVF or ICSI with a history of recurrent
spontaneous abortion (continous miscarriage occurred earlier than 20 weeks of gestation for
equal or greater than 2 times) in our IVF institute while meeting the following criteria:
1. regular menstrual cycles and normal level of E2, P, FSH, LH, T, RPL in the early
follicular phase;
2. no history of hormone medicine application in the last 3 months;
3. no history of poison contact;
4. normal uterine and adnexal ultrasonography;
5. TORCH(-), chlamydia(-), mycoplasma(-), normal leucorrhoea routine, anti-phospholipid
antibody (-), antinuclear antibody(-);
6. for the couple, no blood type incompatibility or ABO antibody IgG≤1：64 and normal
blood chromosome analysis.
Exclusion Criteria:
1. hydrosalpinx without operation; endometriosis; polycystic ovary syndrome; adenomyosis;
uterine leiomyomata(submucous myoma or non-submucous myoma which size was exceed 4cm
and/or with the compressed endometrium);uterine cavity lesions(such as uterine
malformation, intrauterine adhesions, the septate uterus, endometritis etc);
2. the former abortion is because of luteal phase defect without treatment;
3. thyroid dysfunction or increased CA125 level;
4. acute inflammation of genitourinary system or STD carriers;
5. unable to comply with the study procedures.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 48 Years | Effects of PGS in Infertile Female Patients With RPL | NCT02223221 | Contradiction |
1,309 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Signed informed consent of the subjects or the legal guardian.
- Subjects and guardian are willing and able to cooperate to complete scheduled
visits,treatment plans and laboratory tests and other procedures.
- Diagnosed as chronic kidney disease.
- Glomerular filtration rate (GFR) <75ml/per min/1.73m2.
- After the treatment and adjustment of hypertension, anemia, metabolic acidosis,
malnutrition, renal osteopathy, hypothyroidism, etc..
- Chronological age: ≥2years and ≤14years.
- Height Standard Deviation Score(HtSDS) ≤-2SD for chronological age.
- Bone age: girls≤10 years; boys≤11years.
- Pre-pubertal (Tanner Stage I ) patients.
- No history of growth hormone treatment.
Exclusion Criteria:
- Subjects with abnormal liver functions.
- Subjects positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests.
- After adjustment heart function,Cardiac ejection fraction(EF) <50%.
- Subjects with highly allergic constitution or allergy to proteins or investigational
product or its excipient.
- Subjects with systemic chronic disease or general infection or mental disease.
- Subjects with diabetes or impaired fasting glucose.
- Subjects with tumor or potential tumor.
- Subjects who are using glucocorticoid or immunosuppressant.
- Other causes for growth retardation.
- Inability to obtain accurate height measurements.
- Subjects who took part in other clinical trials within 3 months.
- Concomitant administration of other treatment that may have an effect on growth within
3 months.
- Other conditions which are unsuitable for this study in the opinion of the
investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 14 Years | A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation | NCT03535415 | Contradiction |
3,071 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Learning Disorder diagnosis
- Normal range IQ
- Regular class attendance
Exclusion Criteria:
- Suicidal ideation and psychosis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 11 Years old.
Subject must be at most 15 Years | Risk and Resilience Factors in Learning Disabilities Population | NCT01652651 | Entailment |
5,748 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Confirmation of the diagnosis of OELP by histological examination and a clinical score
superior to 3
Exclusion Criteria:
- Patients under 18 years
- Pregnancy or breast feeding
- Malignancy
- Severe or recurrent infections
- Uncontrolled chronic disorders
- Congenital or acquired immunosuppression and concomitant treatments potentially
effective on OELP such as antimalarials, oral retinoids, steroids or immunosuppressive
drugs
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Treatment of Oral Erosive Lichen Planus With Pimecrolimus Cream | NCT00321750 | Contradiction |
4,627 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Healthy women aged 40 to 60 years
2. Are still experiencing regular menstrual cycles.
3. They must be willing to be randomized to placebo or GnRHAG therapy for 24 weeks
4. Be physically able to be randomized to participate in a programmed exercise training
program.
The investigators will consent up to 132 subjects with the aim of enrolling 22 in each of
the 3 groups (placebo, GnRHAG, or GnRHAG+Exercise).
Exclusion Criteria:
- irregular menstrual cycles defined as 2 or more missed cycles in the previous year
- serum FSH >25 mIU/mL measured during the first 5 days of the menstrual cycle
- on hormonal contraceptive or menopausal therapy
- positive pregnancy test
- intention to become pregnant or start hormonal contraceptive therapy during the period
of study
- lactation
- known hypersensitivity to GnRH or leuprolide acetate
- score >16 on the CESD((Center for Epidemiologic Studies Depression Scale )
- severe osteopenia or osteoporosis (i.e., proximal femur or lumbar spine t scores <
-2.0)
- abnormal vaginal bleeding
- thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers
with abnormal TSH values will be re-considered for participation in the study after
follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone
replacement
- uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP>90
mmHg; participants who do not meet these criteria at first screening will be
re-evaluated, including after follow-up evaluation by the PCP with initiation or
adjustment of anti-hypertensive medications
- cardiovascular disease; subjective or objective indicators of ischemic heart disease
(e.g., angina, ST segment depression) or serious arrhythmias at rest or during the
graded exercise test (GXT) without follow-up evaluation; follow-up evaluation must
include diagnostic testing (e.g., thallium stress test) with interpretation by a
cardiologist
- orthopedic or other problems that would interfere with participation in the exercise
program
- exercising at least 30 minutes per day at a moderate to vigorous intensity most days
of the week (defined as >4 d/wk) over the past 6 months
- BMI <40 kg/m2
Female
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 60 Years | Females, Aging, Metabolism, and Exercise | NCT01712230 | Entailment |
2,480 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- normal vision
- 18-65 years
Exclusion Criteria:
- blindness
- colorblind
- pregnant women
- prisoners
- decisionally challenged
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 66 Years | Evaluating Color Perception Under LED Red/Green and Green Dominant Light | NCT01927536 | Contradiction |
2,680 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- healthy volunteers(n:100)
- patients above age of 18(n:100)
- patients with groin hernia(n:100)
Exclusion Criteria:
- previous inguinal hernia surgery
- patients who did not accept the procedure
- patients under age of 18
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 78 Years | Relationship Between Constipation and Inguinal Hernia | NCT02749682 | Entailment |
1,099 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- All hypertrophic cardiomyopathy patients, inclusive of male and female and all
racial/ethnic origins, age 18 or older who are scheduled to receive a septal myectomy
with a preoperative transthoracic echocardiograph suggesting an interventricular
septal width of less than 2.0 cm.
Exclusion Criteria:
- Those hypertrophic cardiomyopathy patients who are scheduled to receive a septal
myectomy who are less than 18 years old or whose preoperative transthoracic
echocardiograph suggests an interventricular septal width of greater than 2.0 cm.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| OPIE in the Thin Interventricular Septum | NCT04050579 | Entailment |
4,312 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- All patients for whom an order was placed in the study period.
- All providers with the authority to place electronic orders and who placed electronic
orders during the study period.
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Evaluating the Impact of Patient Photographs for Preventing Wrong-Patient Errors | NCT03626766 | Entailment |
5,610 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Female
- Age 12-21 years
- 45,XO karyotype in >50% of cells tested with a diagnosis of Turner syndrome (TS)
- Tanner stage 2-5 for breast development
Exclusion Criteria:
- Growth hormone treatment within the past 3 months
- Diagnosis of type 1 or type 2 diabetes
- Untreated hypertension with blood pressure > 99%ile for sex, age and height or >140/90
- Weight > 300 lbs
- Height < 54"
- Aortic sinus of Valsalva or ascending aorta z-score > 2
- Other cognitive, psychiatric, or physical impairment resulting in inability to
tolerate the study procedures, including vigorous exercise
- Pregnancy
Female
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 21 Years | Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome | NCT03181230 | Contradiction |
5,233 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Over the age of 50 years
- Have been diagnosed with primary osteoporosis
- Have low vitamin D level (less than 75nmol/L) recently (within the previous month)
- Fluent in English
Exclusion Criteria:
- Cognitive diseases
- Mal-absorption syndromes that may interfere with vitamin D absorption.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| The Effect of Theory Menu-Based Intervention on Vitamin D Adherence in People With Osteoporosis-Pilot Study | NCT02358590 | Entailment |
6,126 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- • Covid 19 infected healthcare workers.
Exclusion Criteria:
- •Risky healthcare workers (diabetic, hypertensive and more than 50 years)
No condition on gender to be admitted to the trial.
| Diagnostic Value of New COVID-19 Antibodies Testing Among Laboratory Healthcare Workers | NCT04445415 | Contradiction |
2,278 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- DMD diagnoses was based on molecular methods and/or muscular protein expression.
- TD age-matched with DMD.
Exclusion Criteria:
- subjects with severely dilated myocardium.
- subjects with other associated diseases.
- individuals with inability to understand task instructions.
Male
Accepts Healthy Volunteers
Subject must be at least 9 Years old.
Subject must be at most 21 Years | Heart Rate Variability in Duchenne Muscular Dystrophy During Computer Task | NCT04607824 | Contradiction |
5,886 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
1. English-speaking male and female adults between the ages of 25 and 75, inclusive
2. Body mass index (BMI) <35 and >19
3. Either 3.a. or 3.b. or both, based on the Screening Phase ReQuest Short and Long
Version responses:
1. At least one incidence of (a) acid complaints; (b) upper abdominal/stomach
complaints and RQ Total score >3.37 or RQ-GI score >0.95
2. Four days or more of combined incidence of (a) acid complaints; (b) upper
abdominal/stomach complaints.
4. History (minimum of three months) of GERD symptoms as defined in #3 above
5. Must be on stable doses of medications, if any, prescribed for chronic conditions
other than GERD
6. If female, must be on an active contraceptive measure or have male partner(s) with
suitable protective measures
7. Have access to a computer/tablet/phone with internet access and active e-mail account
in order to complete electronic surveys daily throughout study participation
8. Ability and willingness to give consent to participate in study
Exclusion Criteria:
1. Significant comorbidities that are not medically stable
2. History of scleroderma, diabetes, Barrett's esophagus, esophageal cancer, esophageal
stricture, or esophageal scarring (fibrosis)
3. Known hiatal hernia > 2cm
4. Positive diagnosis for Helicobacter pylori (HP) or has had an HP infection within 45
days of study entry
5. History of surgery or endoscopic treatment including fundoplication and dilation for
esophageal stricture
6. History of gastric surgery (except for endoscopic removal of benign polyps) or
bariatric surgery
7. BMI >=35, BMI <=19
8. History of diseases that have symptoms that may be confused with GERD, such as
eosinophilic esophagitis, angina, gastritis, esophageal spasm, rumination, or other
conditions involving the mouth, throat, chest or abdomen
9. Active history of nicotine use, cannabis use or alcohol abuse (as defined by: greater
than 14 drinks/week or 4 drinks/day for men, 7 drinks/week or 3 drinks/day for women).
Has used any tobacco, nicotine or cannabis products in the last 6 months or has abused
alcohol in the last 6 months
10. Taking any excluded medications listed in the protocol (e.g. metformin, antibiotics
within the prior 6 months.)
11. If female, is pregnant, lactating, or intending to become pregnant before, during or
within 4 weeks after participating in this study or intending to donate ova during
such time period
12. Primary sleep disorder including sleep apnea, restless leg syndrome, or insomnia
13. Colon prep within 30 days prior to study entry
14. Use of any investigational product within 90 days prior to study entry
15. Participation in another investigation (clinical trial) during the course of this
study
16. Participation in a rigorous weight loss program or have any planned changes in diet or
lifestyle, such as getting married, change in residence, change in job, or other
highly stressful event
17. Diagnosis of inflammatory bowel disease, irritable bowel syndrome, or chronic diarrhea
(mild chronic constipation is allowed)
18. Employment (or relative of an employee) or involvement in any way with ISOThrive Inc.
19. An investigator, key study personnel or first degree relative of anyone involved with
the study
20. Other conditions or situations that, in the investigator's opinion, may put the
subject at significant risk, may confound the study results, or may interfere
significantly with the subject's participation in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 75 Years | Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease | NCT04491734 | Contradiction |
6,501 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Healthy, male and non-pregnant female subjects, 18 years of age or older.
2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at
Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
3. Subjects with the presence of telangiectasia at Baseline.
4. Subjects with an erythema score of at least 2 on the Investigator Assessment of
Erythema scale at Baseline.
5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.
Exclusion Criteria:
1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
2. Subjects with nodular rosacea.
3. Standard exclusion criteria.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle | NCT02547441 | Entailment |
974 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration
requiring treatment with either an analgesic or anti-inflammatory agent on a regular
basis (greater than or equal to three days/week) for at least three months.
- A history of osteoarthritis of the knee characterized by pain of at least a moderate
intensity.
- Demonstrated radiographic evidence of mild to moderate osteoarthritis based on the
Kellgren and Lawrence radiographic entry criteria of grade 2 or 3 osteoarthritis.
- Subjects' physical ability was to be either American College of Rheumatology (ACR)
Function Class I or II
- At the baseline visit, subjects must have reported a maximum pain intensity
experienced over the previous 24 hours of at least moderate on a five-point scale of
none(0), mild(1), moderate(2), moderately severe(3), or severe(4) in order to be
enrolled in the study.
Exclusion Criteria:
- Medical history, physical examinations, or radiographs suggestive of other types of
arthritis, pseudogout, collagen vascular disease or fibromyalgia.
- Medical or psychiatric conditions that may influence absorption, metabolism, or
excretion of the study medications or interfere with interpretation of adverse
reactions to the study drug.
- History of allergy, sensitivity, contraindication or non-response to acetaminophen,
rofecoxib, or drugs classified as NSAIDs including aspirin.
- Use of concomitant medications that might interfere with study drug assessments,
including intra-articular corticosteroids.
- Signs of active knee inflammation, morning stiffness of greater than 30 minutes
duration.
- Rheumatoid factor quantitative value greater than or equal to 40 IU/mL or a Westergren
erythrocyte sedimentation rate greater than or equal to 40 mm/hour.
- ACR functional class III or IV, or unable to walk without assistive devices.
- Pregnancy, lactation, or expect to become pregnant within one month of study
completion.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee | NCT00568295 | Entailment |
3,035 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- He / she has been diagnosed with mild mental retardation Being between 5 and 18 years
of age Ability to adapt to exercises No epileptic epilepsy no cardiac or orthopedic
disturbance
Exclusion Criteria:
- Being healthy Not be between 5-18 years
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 18 Years | Effectiveness of Video Based Games on Upper Extremity Functions in Mild Mental Retardation Diagnosed Cases | NCT03503955 | Entailment |
3,358 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Subject has chronic tympanic membrane perforation (CTMP) documented as persisting
longer than 3 months.
- A female subject is eligible to participate if she is not pregnant and at least one of
the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- WOCBP who agrees to follow the contraceptive guidance starting at screening and
for at least 28 days after investigational product (IP) application on Day 1.
- Female subject must agree not to breastfeed starting at drug application on Day 1 and
for at least 28 days after IP application.
- Female subject must not donate ova starting on Day 1 and for at least 28 days after
investigational product (IP) application.
- A male subject with female partner(s) of child-bearing potential must agree to use
contraception starting on Day 1 and for at least 28 days after IP application.
- A male subject must not donate sperm starting on Day 1 and for at least 28 days after
IP application.
- Male subject with a pregnant or breastfeeding partner(s) must agree to remain
abstinent or use a condom from Day 1 and for at least 28 days after IP application.
- Subject must be willing and able to comply with the study requirements including
prohibited concomitant medication restrictions.
- Subject agrees not to participate in another interventional study while receiving IP.
Exclusion Criteria:
- Subject has one of following conditions that may affect the ipsilateral side of the
ear with chronic tympanic membrane perforation (CTMP):
- Perforation involving 3 or more quadrants.
- Pin hole perforation (only for the expansion cohort).
- Presence of tympanosclerosis adjacent to the perforation.
- Perforation involves malleus erosion.
- Absent malleus.
- Marginal perforation (i.e., involving the annulus or exposing the handle of
malleus).
- Tympanic membrane perforation (TMP) caused by electric/slag/blast/burn injury.
- Post radiated TMP.
- History of tympanic membrane repair by any type of live tissue.
- History of otorrhea or active treatment for otorrhea within the last 3 months
prior to Screening.
- Bellucci otorrhea grade 3 or above.
- Active external ear canal inflammation (otitis externa, dermatitis) or within the
last 3 months prior to Screening.
- Active diagnosis of Eustachian Tube dysfunction or diagnosis within 6 months
prior to Screening.
- Craniofacial abnormalities, History of head and neck surgery within the last 3
months prior to Screening, history of radiation to head and neck.
- Recent (within 2 weeks) diagnosis of upper respiratory tract infection.
- Presence or history of cholesteatoma.
- Presence of pars-flaccida or pars tensa retraction or adhesion.
- Presence or history of tumors of the middle or external ear.
- Contraindications to tympanic membrane closure.
- An audiometric finding indicates a characteristic of Carhart's notch which is an
increase in bone conduction threshold with a peak at 2,000 Hz.
- Only hearing or better hearing ear.
- Whole circumference of the tympanic membrane perforation is not visible by
endoscope.
- Presence/history of eosinophilic otitis media in either ear.
- Subject has a presence of adhesive otitis media in the contralateral ear.
- Subject has a presence of any wound healing systemic condition.
- Subject has Obstructive Sleep Apnea where the subject is required to use Continuous
Positive Airway Pressure (CPAP) during the study period.
- Subject is exposed in their daily life to high volume of water into the ear canal
(e.g., swimmer or surfer).
- Subject has health conditions that would prevent him/her from fulfilling the study
requirements on the basis of medical history and laboratory test (Serum Chemistries,
complete blood count [CBC] with Differential, Urinalysis) results at the screening
visit.
- Subject is receiving any other investigational agents during study participation.
- Subject has any form of substance abuse, or psychiatric illness/social situations that
would limit compliance with study requirements, or a condition that could invalidate
communication.
- Subject has a known or suspected hypersensitivity to ASP0598, or any components of the
formulation used.
- Subject has had previous exposure with ASP0598.
- Subject is unlikely to comply with the visits scheduled in the protocol.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP) | NCT04305184 | Contradiction |
3,180 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Subject is a male or a female aged ≥ 18 years
- Have given their written consent to participate in the study
- Use of artificial tears (AT), autologous serum or specific dry eye medications during
the last 6 months prior to the selection
- Willing to not use AT or autologous serum for the study duration
- VAS scale for Dry Eye Symptom Score ≥ 40
- Total CFS ≥ 5
- Schirmer's test with anesthesia < 10 mm/5min
- Patients with Sjögren Syndrome
Exclusion Criteria:
- Any concomitant treatment or prior ocular procedure or surgery, or alteration of the
dose of systemic medications at the time of entry into the study
- Use of contact lenses during the study
- Significant Eye diseases according to investigator's opinion
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome | NCT04819269 | Entailment |
6,523 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Diagnosis of congenital Hemophilia A and baseline FVIII ≤2%.
2. Weight ≥ 5 kg
3. History of FVIII inhibitor titer ≥5 BU
4. Current FVIII inhibitor titer ≥5 BU or ≥0.6 BU and failed ITI defined by FVIII
recovery <66% normal and half-life <6 hours
5. Adequate venous access for daily concentrate infusions
6. For participants <18 years, a parent or guardian willing and able to provide informed
consent with verbal or written assent from the child if require by the local
institution. For participants ≥18 years, a willingness and ability to provide informed
consent from the subject.
7. Ability to comply with study related treatments, evaluations, and follow-up.
Exclusion Criteria:
1. Acquired hemophilia
2. Congenital or acquired bleeding disorder in addition to Hemophilia A
3. ITI factor replacement regimen within the past one month unless there is clear
evidence of ITI failure with no reduction in inhibitor titer over the past two months
4. HIV positive with viral load ≥200 particles/μL or ≥400,000 copies/mL
5. Rituximab within the past 3 months
6. IVIG within the past 1 month
7. Treatment with other immunosuppressive drugs within the past 1 month (excluding
intermittent steroid use for asthma)
8. Concomitant experimental treatment
9. History of hypersensitivity to plasma-derived VWF- or FVIII-containing concentrates
10. Elective surgery planned in the next 6 months (excluding vascular access procedure)
11. Any condition or chronic illness, which in the opinion of the investigator makes
participation ill-advised
12. Inability or unwillingness to complete required screening, follow-up, and exit studies
Male
No healthy subjects accepted to join the trial.
| INdividualized ITI Based on Fviii(ATE) Protection by VWF | NCT03204539 | Contradiction |
946 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to participate in the study:
1. Be 35-75 years of age and in good general medical and psychological health.
2. Be able to speak, read, write, and understand English, understand the consent form,
complete study-related procedures, and communicate with the study staff.
3. Have OA of at least 1 knee (target knee) for at least 6 months and meet all the
following criteria:
- OA documented by standing X-rays anterior-posterior patella-femoral view taken
within 1 month of screening visit indicating Kellgren-Lawrence Grade 2 to
early-stage Grade 4 radiographic stage of the knee;
- Have pain associated with OA of the target knee for at least 25 of the last 30
days; c. Meet the American College of Rheumatology clinical classification
criteria, defined as having pain in the target knee and at least 3 of the
following 6 items:
- Age > 50;
- Morning stiffness <30 minutes;
- Crepitus on active motion;
- Bony tenderness;
- Bony enlargement;
- No palpable warmth of synovium.
4. Target knee does not have any type of orthopedic and/or prosthetic device.
5. Based on standard physical examination of the target knee, does not have any
neurovascular deficits, any skin abnormalities, any meniscal abnormalities, or any
ligament instability.
6. At treatment visit 2 prior to randomization, have a score of at least 20 on the WOMAC
pain subscale (questions 1-5) for the target knee and an in-clinic average pain
intensity score of at least 4/10 on the 0-10 NRS for the 24-hour recall.
7. Be willing to maintain any present stable treatment modalities (e.g., acupuncture or
physical therapy) and be willing to refrain from initiating any new treatment
modalities.
8. Be willing to stop taking nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids
for the duration of the study.
9. If female of child-bearing potential (ie, not medically or surgically sterilized or
not post-menopausal more than 1 year) or fertile male with sexual partner of
childbearing potential, be willing to use adequate and reliable contraception
throughout the study (eg, abstinence or barrier with additional spermicidal foam or
jelly, or the use of intrauterine device or hormonal contraception by female subjects
and partners of male subjects).
10. Not be enrolled in any other clinical trial and not have used any investigational drug
within 1 month.
Exclusion Criteria:
Subjects who meet any of the following criteria will not be eligible to participate:
1. Have a Kellgren-Lawrence Grade 1 radiographic stage of the knee or have
Kellgren-Lawrence Grade 4 radiographic end stage of the knee with bone on bone, ie,
less than 2 mm joint space.
2. Be a candidate for knee replacement within next 6 months.
3. Have a body mass index > 35 kg/m2.
4. Have a Hospital Anxiety and Depression Scale score >12 on either subscale or have an
established history of major depressive disorder not controlled with medication.
5. Have, in the Investigator's opinion, clinically significant abnormalities in clinical
laboratory tests (hematology, clinical labs, urinalysis).
6. Have a positive urine drug test for illegal drug substances at screening.
7. Have, in the Investigator's opinion, clinically significant abnormalities in
electrocardiogram readings
8. If a female of childbearing potential, have a positive pregnancy test at screening.
9. Have significant pain outside the target knee, including significant hip or back pain
(bilateral knee OA will be allowed as long as target knee pain can be distinguished
from contralateral knee pain and contralateral knee does not require treatment).
10. Have pain affecting the target knee that is due to any etiology other than OA.
11. Have documented history of inflammatory arthritis, including rheumatoid arthritis.
12. Have a meniscal tear in the target knee.
13. Have had viscosupplementation with hyaluronic acid products within 6 months prior to
screening.
14. Have failed to respond to prior treatment with viscosupplementation with hyaluronic
acid products.
15. Have had IA corticosteroid injections within 12 weeks or intramuscular or oral
steroids within 4 weeks prior to screening.
16. Have had surgery of the target knee within 6 months prior to screening.
17. Have used opioids 4 or more days per week during in the past month prior to screening.
18. Are allergic to, or intolerant of, acetaminophen.
19. Have used verapamil within the past 4 weeks or are allergic or intolerant to
verapamil.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 75 Years | Safety, Tolerability, and Efficacy of IA Verapamil in the Treatment of Joint Pain in Subjects With Osteoarthritis of the Knee | NCT01645709 | Entailment |
1,429 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
A. Men and women B. Accomplished age 30 to 60 years
C. Diagnosis of mixed dyslipidemia established to meet the following criteria:
- Total cholesterol> 200 mg / dL
- Triglycerides> 150 mg / dL 27 D. BMI of 25 kg / m2 to 39.9 kg / m2, weight stable over
the past three months, defined as a variability in the lower body weight of 5%.
E. No drug treatment for lipid profile 3 months prior to baseline. F. Women must ensure a
non-hormonal method to avoid pregnancy during the study period G. written information
consent
Exclusion Criteria:
A. Removal for informed consent letter B. Loss of monitoring C. Presence of serious adverse
event D. Adherence to treatment <80% E. Consumption of drugs known about lipid profile,
glucose metabolism, blood pressure and body weight during the intervention period influence
F. Intolerance or not tolerability or hypersensitivity to the compounds used in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 60 Years | Effect of Administration of the Combination Bezafibrate More Berberine on Lipid Profile in Patients With Dyslipidemia | NCT02548832 | Contradiction |
1,665 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
1. Men or women
2. Age 18-65 years old, both included
3. Diagnose of primary dorsal wrist syndrome, defined as:
3.1 Radiocarpal dorsal focal pain 3.2 Pain increases in hyperextension of the wrist
and in axial load 3.3 X-rays and MRI without significant findings 3.4 Watson test,
extension finger test, Kleinman shuck test, distal radio-ulnar ballottement test,
fovea sign all of them negatives and absence of tenosynovitis of the extensor tendons.
4. Refractory to conservative treatment consisting in at least 3 months of physical
therapy.
5. Presence of a hypertrophy of the dorsal synovial of the wrist diagnosed through direct
visualization in wrist arthroscopy.
6. Other diagnoses excluded through wrist arthroscopy
Exclusion Criteria:
1. Hand or wrist fractures
2. Arthritis
3. Carpal boss
4. Scapho-lunate ligament tears
5. Luno-triquetral ligament tears
6. Triangular fibrocartilage tears
7. Bone necrosis
8. Systemic arthritis as rheumatoid arthritis, psoriasic arthritis, gouty arthritis,
etc.)
9. Dorsal or volar ganglions
10. Distal radio-ulnar joint injury or instability
11. Hand or wrist infections or tumors
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Arthroscopic Diagnosis and Treatment of Dorsal Wrist Syndrome in Patients With Synovial Hypertrophy | NCT04648527 | Entailment |
3,720 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- patients over 18 year old
- patients with an acute arthritis defined by an evolution of less than 6 weeks
- patients benefiting from joint fluid puncture for diagnostic purposes in the
rheumatology hospitals participating in the study
- patients who received information about the protocol and have not expressed opposition
to participate
Exclusion Criteria:
- patients opposing the study
- protected major (safeguard justice, trusteeship and guardianship) and persons deprived
of liberty
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis | NCT04004962 | Contradiction |
3,124 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
1. Subjects age 18 years or older on the date of informed consent.
2. All subjects must provide signed written consent prior to participation in any
study-related procedures.
3. Patient-reported history of KCS for a period of at least 6 months.
4. Clinical diagnosis of bilateral KCS supported by OTX-101-2014-001 study assessments.
5. Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible
score of 12 (scoring excludes superior zones 2 and 4) in the same eye at Screening and
Baseline.
6. Global symptom score ≥ 40 at both Screening and Baseline.
7. Corrected Snellen VA of better than 20/200 in each eye.
8. Willing to discontinue use of current dry eye therapy (including artificial tears or
ocular lubricants) during the study as of the run-in period.
9. Female subjects of childbearing potential must have a negative urine pregnancy test at
Screening. Women of childbearing potential (ie, women who are not either
postmenopausal for one year or surgically sterile) must use an acceptable form of
contraception throughout the study.
Exclusion Criteria:
1. Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to
Screening.
2. Previous treatment failure (lack of efficacy) on cyclosporine ophthalmic emulsion
0.05% (Restasis).
3. Diagnosed with Sjögren's disease ˃5 years prior to Screening.
4. Clinical diagnosis of seasonal and perennial allergic conjunctivitis.
5. Use of systemic and topical medications that are known to cause dry eye within 7 days
prior to Screening and throughout the study period. These include the following
medications:
- Immunomodulators (permitted if dose is stable for 3 months prior to screening and
does not change during the study period)
- Antihistamines (including over-the counter (OTC))
- Cholinergics
- Antimuscarinics
- Tricyclic antidepressants
- Phenothiazines
- Retinoids
6. Oral omega-3 fatty acids (permitted if dose is stable for 3 months prior to Screening
and does not change during the study period)
7. Use of any topical ophthalmic medications, prescription (including antiglaucoma
medications) or OTC (including artificial tears), other than the assigned study
medication during the study period.
8. Current active eye disease other than KCS (i.e., any disease for which topical or
systemic ophthalmic medication is necessary).
9. History of herpes keratitis.
10. Unstable macular disease (e.g., age-related macular degeneration, diabetic
maculopathy). Stable macular disease is defined as no reduction in central VA within 6
months prior to Screening.
11. Diagnosis of chronic uveitis.
12. Corneal transplant (e.g., penetrating keratoplasty, lamellar keratoplasty, Descemet's
stripping endothelial keratoplasty (DSEK) ).
13. Corneal refractive surgery (e.g., laser-assisted in situ keratomileusis (LASIK]) photo
refractive keratectomy (PRK), limbal relaxing incision (LRI) ) within 6 months prior
to screening or postoperative refractive surgery symptoms of dryness that have not
resolved.
14. Cataract surgery within 3 months prior to Screening.
15. Non-laser glaucoma surgery at any time; glaucoma laser procedures within 3 months
prior to Screening.
16. Presence of punctal plugs or past history of permanent punctal occlusion (e.g.,
cautery).
17. Lagophthalmos or clinically significant eyelid margin irregularity of the study eye
whether congenital or acquired.
18. Presence of conjunctivochalasis (i.e., mechanical blockage of the lower lid punctum by
redundant conjunctiva).
19. Presence of pterygium in the study eye.
20. Unwilling to discontinue use of contact lenses during the duration of the study.
21. Preplanned elective surgery or hospitalization during the study period.
22. HIV-positive.
23. Unable to reliably report symptoms and history.
24. Has known hypersensitivity or contraindication to the study medication(s) or their
components.
25. Has a history or presence of chronic generalized systemic disease that the
Investigator feels might increase the risk to the subject or confound the result(s) of
the study.
26. Has a severe/serious ocular condition, or any other unstable medical condition that,
in the Investigator's opinion, may preclude study treatment or follow-up.
27. Women who are pregnant or breastfeeding.
28. Participation in any drug or device clinical investigation within 30 days prior to
entry into this study and/or during the period of study participation.
29. Previous randomization into this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca | NCT02254265 | Contradiction |
2,233 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
1. Male or female patients 18 years and older;
2. History of gout, flare free in the 4 weeks prior to study entry
3. History of crystal (joint liquid) proven diagnosis or anamnestic diagnosis of gout
according to Wallace at el. To be eligible, a subject had to present at least 6 of the
following 12 clinical, laboratory, and x-ray phenomena:
1. Maximum inflammation developed within 1 day, 2. More than one attack of acute arthritis,
3. Monoarticular arthritis attack, 4. Redness observed over joints, 5. First
metatarsophalangeal (MTP) pain or swelling, 6. Unilateral first MTP joint attack, 7.
Unilateral tarsal joint attack, 8. Suspected or proven tophus, 9. Hyperuricemia, 10.
Asymmetric swelling within a joint on a X ray, 11. Subcortical cysts without erosions on X
ray, 12. Negative organisms on culture of joint fluid; 4. Naive to ULT or previously
treated with ULT, but with no ULT treatment in the last 1 month prior to study entry and
only if reason for ULT interruption was not due to safety concerns.
5. Patients at study entry have elevated serum urate level >8 mg/dl. 6. Overall
Cardiovascular (CV) risk based on the scoring proposed by the Joint Task Force of the
European Society of Cardiology and other European Societies on cardiovascular disease
prevention in clinical practice between 5 and 15-% (inclusive). Patients with diabetes
mellitus type 2 could be included in the study if their CV risk score is calculated as ≤7%.
7. Allowed concomitant medications should be maintained stable during the last 2 weeks
before randomisation
Exclusion Criteria:
1. Severe chronic renal failure (creatinine clearance < 30 ml/min)
2. Hepatic failure
3. Active liver disease or hepatic dysfunction, defined as both alanine aminotransferase
(ALT) and aspartate aminotransferase (AST) >2 times the upper limit of normal.
4. Diabetes mellitus type1
5. Life-threatening co-morbidity or with a significant medical condition and/or
conditions that would interfere with the treatment, the safety or the compliance with
the protocol
6. Diagnosis of, or receiving treatment for malignancy (excluding basalioma skin cancer)
in the previous 5 years
7. Patients who have experienced either myocardial infarction or stroke
8. Patients with inflammatory based arthritis (e.g.: rheumatoid arthritis, etc.)
9. Patients with congestive heart failure, New York Heart Association (NYHA) Class III or
IV
10. Patients with untreated/uncontrolled thyroid function
11. Patients with clinically severe peripheral arterial disease
12. Concomitant administration of any of the following: azathioprine, mercaptopurine,
theophylline, meclofenamate, sulfinpyrazone, trimethoprim-sulfamethoxazole,
cyclophosphamide, benzbromarone, pyrazinamide, captopril and enalapril (for
Allopurinol), tegafur, pegloticase and tacrolimus.
13. Hypersensitivity to any one of the active substances or to any of the excipients
14. Any contraindication to febuxostat or allopurinol (with reference to the summary of
product characteristics).
15. Subject is unable to take either of the protocol-required gout flare prophylactic
medications (NSAID or colchicine) due to contraindications or intolerance, e.g.
hypersensitivity, active gastric ulcer disease, renal impairment and/or changes in
liver enzymes
16. Participation in another trial of an investigational drug or device within 30 days
prior to screening, or prior treatment with investigational product(s)
17. Women of childbearing potential (WOCBP), including peri-menopausal women who have had
a menstrual period within 1 year, not willing to use highly effective method of birth
control throughout the study period and for 4 weeks after study completion defined as
a method which results in a failure rate of less than 1% per year such as:
- combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation (oral, intravaginal, transdermal),
- progestogen-only hormonal contraception associated with inhibition of ovulation
(oral, injectable, implantable),
- intrauterine device (IUD),
- intrauterine hormone-releasing system (IUS),
- bilateral tubal occlusion,
- vasectomised partner (provided that partner is the sole sexual partner of the
trial participant and that the vasectomised partner has received medical
assessment of the surgical success),
- sexual abstinence;
18. Severe psychiatric disorders/neurological disorders
19. Severe concurrent pathology, including terminal illness (cancer, AIDS, etc)
20. Abuse of alcohol, analgesics, or psychotropic drugs
21. Inability or unwillingness, in the investigator's opinion, to follow study procedures
including, but not limited to the ability to obtain adequate PWV/Pulse Wave Analysis
(PWA) recordings. Special attention was made to any physical abnormalities which could
affect quality of PWV/PWA measurement:
- Neck region- neck flexibility and accessibility of carotid artery,
- Upper arm and thigh region- exclude any abnormalities which would prevent
adequate placement of the cuff;
22. Inability or unwillingness to issue the informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout | NCT02500641 | Entailment |
799 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- 40 years of age or older
- Meet the American College of Rheumatology (ACR) clinical criteria for a diagnosis of
knee OA. The ACR clinical criteria for knee OA includes knee pain plus 3 of the
following 6 criteria:
- age > 50 years,
- morning stiffness of < 30 minutes,
- crepitus on active movement,
- tenderness of the bony margins of the joint,
- bony enlargement of the joint noted on exam,
- lack of palpable warmth of the synovium. Based on this criteria, a subject who is less
than 50 years but has knee pain and 3 of the other 5 criteria would also be classified
as having knee OA.
Exclusion Criteria:
- do not meet the ACR clinical criteria for knee OA,
- are scheduled for total knee arthroplasty (TKA) surgery,
- have undergone TJA surgery on any lower extremity joint,
- exhibit uncontrolled hypertension (i.e. individuals not currently taking medication
for hypertension whose systolic blood pressure is greater than 140 mm Hg or diastolic
blood pressure greater than 90 mm Hg at rest),
- have complaints of low back pain or other lower extremity joint pain that affects
function at the time of recruitment,
- have a history of neurological disorders that would affect lower extremity function
(stroke, peripheral neuropathy, parkinson's disease, multiple sclerosis, etc.),
- are women who are pregnant.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Enhancing the Effectiveness of Physical Therapy for People With Knee Osteoarthritis | NCT01314183 | Entailment |
1,059 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
-Patients are eligible if they have:
- >1 syncopal spell within 1 year preceding enrollment, and
- bifascicular block on a 12-lead ECG, and
- Age > 50 years and
- written informed consent. Syncope will be defined based on history using a
standardized form.
Exclusion Criteria:
-Patients will be excluded if they have criteria related to study strategies, including:
1. previous pacemaker, ICD, or Implantable Loop Recorder in situ,
2. ACC/AHA/HRS Class I indication for permanent pacing or ICD implantation,
3. left ventricular ejection fraction < 35% mandating ICD therapy,
4. contra-indication to a transvenous pacemaker such as artificial tricuspid valve or
active sepsis.
-Patients will also be excluded if a potential competing cause of syncope poses a
threat to life, such as:
5. hypertrophic cardiomyopathy,
6. documented sustained ventricular tachycardia or
7. inducible, sustained monomorphic ventricular tachycardia on EP study.
-They will be excluded if they have:
8. a history of myocardial infarction within 3 months prior to enrollment, and
9. a major chronic co-morbid medical condition that would preclude 24 months of
follow-up.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Syncope: Pacing or Recording in the Later Years | NCT01423994 | Contradiction |
1,570 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
In order to participate, women must meet the following criteria:
1. Are non-pregnant and meet ASSIST criteria for at least moderate risk for alcohol (≥11)
or drug (≥4) abuse or dependence (tobacco or illicit drugs, including cocaine,
opiates, methamphetamine, marijuana or a prescription drug used in a medically
inappropriate manner).
2. Are pregnant and meet ASSIST criteria for at least mild to moderate risk for alcohol
(≥6) or drug (≥4) abuse or dependence (alcohol, tobacco, an illicit drug, or a
prescription drug in a medically inappropriate manner). We define pregnant women who
use alcohol or drugs at least monthly in the last 90 days as eligible because alcohol
and many of the other substances (eg. tobacco) are teratogens and use in pregnancy
would be consistent with a diagnosis of abuse ("recurrent use in situations in which
it is physically hazardous"). This level of use in pregnancy also indicates a greater
likelihood of problematic substance use.
3. Have used their primary substance at least once within the prior 28 days.
4. Are aged 18 or more. We include participants who are aged 18 or older because parents
may not be available at screening to provide consent for non-pregnant participants and
subjects may not wish to disclose drug or alcohol abuse to a parent.
Exclusion Criteria:
Women are ineligible if they have any of the following criteria:
1. Are unable to speak English.
2. Are incarcerated or at risk of incarceration. The YNHH Women's Center provides care to
incarcerated women. These individuals as well as those at risk of incarceration are
excluded because incarceration precludes their ability to seek specialty drug or
alcohol abuse treatment (a dependent measure).
3. Have a cognitive disorder that would impair their ability to provide informed consent
or provide accurate information.
4. Require immediate hospitalization because of general medical needs or due to active
suicidal or homicidal ideation or other behavioral health problems. We exclude
individuals who are in need of immediate hospitalization because hospitalization will
render it more difficult for them to immediately follow-up on a referral and because
providers, rather than subjects, may be making the decision to initiate treatment.
Hospitalization would also potentially force women who smoke to initiate treatment for
tobacco addiction.
5. Are currently participating or have participated in drug abuse treatment, including
self-help interventions (eg. 12 step facilitation, smoking cessation interventions),
within the last 3 months prior to screening.
6. Are planning to relocate out of the area in the following 6 months. Women who relocate
out of the area would be difficult to see for follow up assessments and it would be
difficult to confirm treatment attendance in local treatment centers.
7. Have previously participated in this protocol or
8. Are unwilling to participate or accept randomization.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Screening to Augment Referral to Treatment- Project START | NCT01539525 | Contradiction |
4,223 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- All inpatients in a hospital environment
Exclusion Criteria:
- Inability to give an informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Improving the Quality of Patient Care by Using a Clinical Expert System. | NCT00430755 | Contradiction |
6,841 | 49 | A 50-year-old woman comes to the clinic complaining of difficulty swallowing both liquids and solid foods, as well as occasional cough while eating. She also has difficulty lifting her arms above her head and getting up from a chair. The weakness seems to get worse gradually. The patient has no prior medical problems and takes no medications. Vital signs are normal. Physical examination shows an erythematous rash on the upper eyelids. There are some red papules over joints of her hands. The rest of the physical examination is unremarkable. Antinuclear antibodies, anti-Jo-1 antibodies and anti-MDA5 antibody are positive. Muscle biopsy shows perifascicular inflammation and atrophy of the fascicle and surrounding blood vessels. | I had to go to the clinic because of difficulty swallowing all kinds of food, liquid and solid. I also sometimes cough when I eat my dinner. At only 50 year old, I had some difficulties lifting up my arms and getting up from a chair! And it's only getting worse! I never had any medical issues in the past and I'm not under any medication, I just don't get it! My vitals were normal. The physical exam showed a red rash on my upper eyelids. I also have red papules on my hands' joints. After a blood test, they told me that my antinuclear antibodies, anti-Jo-1 antibodies, and anti-MDA5 antibodies were positive. I also did a muscle biopsy and it showed that I had an atrophy of my blood vessels around my muscle fibers and that I have an inflammation of these. | INCLUSION CRITERIA:
Any Clinical Center inpatients and outpatients with known or suspected dysphagia on any
other NIH institute protocol can be included for study as well as patients who are admitted
specifically for this protocol.
Those patients at risk for oropharyngeal dysfunction will be screened initially by
completing a self-assessment swallowing questionnaire, and by an interview with staff
and/or family members. Patients who demonstrate appropriate signs and symptoms of dysphagia
and oral motor impairment on the screening assessment will be considered for the protocol:
Difficulty swallowing food or pills.
Changed swallowing ability.
Coughing or choking when eating.
Shortness of breath during swallowing.
Food backing up into the mouth or nasal passage.
Fever or voice changes after swallowing.
Pain when swallowing.
Unexplained loss of weight.
EXCLUSION CRITERIA:
Patients who are severely demented or severely compromised will be excluded if they do not
have sufficient cognitive ability to follow directions.
Patients who are non-ambulatory will be excluded if they can not be braced or supported
within the fluoroscopy unit.
Highly agitated individuals will also be excluded if they are unable to remain confined in
the equipment.
Infants and children under age 3 will be excluded due to radiation risk on the developing
visual system.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Ultrasound and Videofluoroscopy for Diagnosing Swallowing Disorders | NCT00001220 | Entailment |
2,338 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- In the opinion of the investigator, the subject is capable of understanding and
complying with protocol requirements.
- The subject or, when applicable, the subject's legally acceptable representative signs
and dates a written, informed consent form and any required privacy authorization
prior to the initiation of any study procedures.
- If above the age of 7, the subject signs and dates a written, informed assent form
(IAF) and any required privacy authorization prior to the initiation of any study
procedures.
- The subject must have confirmed diagnosis of Duchenne Muscular Dystrophy defined as
muscle biopsy and dystrophin analyses consistent with DMD or DNA mutation and analysis
by PCR or Southern blot techniques to detect gene deletions as well as:
1. onset of weakness before 5 years of age;
2. proximal muscle weakness;
3. increased serum creatine kinase more than 10 times the upper limit of normal
(ULN);
- The subject is male and aged 4 to 16 years, inclusive.
- The subject weighs at least 13 kg and has a Body Mass Index (BMI) of ≤ 40.
- Willingness and ability to comply with scheduled visits, oral drug administration, and
study procedures including blood sample draws (total blood volume collected not to
exceed 50 mL for the study duration or 25 mL on any single study day [≤ 3 mL/kg])
- The subject has a life expectancy of >1 year.
- Up to date on all childhood vaccinations, specifically varicella vaccine (chicken
pox).
- Baseline health is judged to be stable based on medical history, physical examination,
laboratory profiles, vital signs, or ECGs at screening, as deemed by the Investigator.
- Continuous non smoker who has not used nicotine containing products for at least 3
months prior to the first dose.
- The subject is able to take tablets.
Exclusion Criteria:
- The subject has received any investigational compound and/or has participated in
another clinical study within 90 days prior to study treatment with the exception of
observational cohort studies or non-interventional studies.
- The subject has received deflazacort within 30 days or previous discontinued
deflazacort due to an intolerable reaction.
- The subject is an immediate family member, study site employee, or is in a dependent
relationship with a study site employee who is involved in the conduct of this study
(e.g. spouse, parent, child, sibling) or may consent under duress.
- Any significant finding on the Columbia suicide severity rating scale (C SSRS) for
subjects (ages 12-16, inclusive), in the opinion of the PI, warrants exclusion from
this study.
- The subject has, in the judgment of the investigator, clinically significant abnormal
clinical chemistry laboratory parameters that may affect safety at Screening.
- The subject has, in the judgment of the investigator, a history or current medical
condition that could affect safety including, but not limited to:
1. Major renal or hepatic impairment
2. Immunosuppression or other contraindications for corticosteroid treatment
3. History of chronic systemic fungal or viral infections
4. Diabetes mellitus
5. Idiopathic hypocalcuria
6. Symptomatic cardiomyopathy at screening
- The subject has a history of hypersensitivity or allergic reaction to steroids or
their formulations including, but not limited to lactose, sucrose, etc.
- Inability to take tablets as assessed by site investigator.
- Unable to refrain from or anticipates the use of:
- Any medications at least 4 hours before and after dosing on PK Days 1 and 8.
- Any vitamins, vitamins with minerals, and/or meal supplementation (e.g., Ensure,
Boost, etc.) at least 4 hours before and after dosing on PK Days 1 and 8.
- Any drug, including prescription and non prescription medications, and herbal
remedies known to be significant inhibitors of CYP 3A4 enzymes and/or P gp for 14
days prior to the first dose of study drug and throughout the study. Appropriate
sources will be consulted by the PI or designee to confirm lack of
pharmacokinetic/pharmacodynamic interaction with study drug. Acetaminophen may be
permitted during the study (doses to be based upon appropriate age/weight ranges.
- Any drugs known to be significant inducers of CYP 3A4 enzymes and/or P gp for 28
days prior to the first dose of study drug and throughout the study. Appropriate
sources will be consulted by the PI or designee to confirm lack of
PK/pharmacodynamics interaction with study drug.
- Subject is mentally or legally incapacitated or has significant emotional problems at
the time of screening visit or expected during the conduct of the study.
- History of any illness that, in the opinion of the PI, might confound the results of
the study or poses an additional risk to the subject by their participation in the
study.
- Positive urine drug or alcohol results at screening or check in.
- Positive urine cotinine at screening.
- Positive results at screening for HIV, HBsAg, or HCV.
- Hemoglobin level below the lower limit of normal at screening.
- Donation of blood or significant blood loss within 56 days prior to the first dose of
study drug.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 16 Years | A Pharmacokinetic Study of Oral Deflazacort in Children and Adolescent Subjects With Duchenne Muscular Dystrophy | NCT02251600 | Entailment |
190 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Adult males aged ≥ 18 year of age with a documented diagnosis of hypogonadism
- Total testosterone levels < 300 ng/dL at two qualification visits
- Patients in good general health
Exclusion Criteria:
- Allergy to sesame or testosterone products
- BMI ≥ 40 kg/m2
- Hematocrit ≥ 52%
- History or current evidence of breast or prostate cancer
- Elevated PSA (Prostate-Specific Antigen) for age.
- Abnormal DRE (digital rectal examination)
- Obstructive uropathy of prostatic origin
- Poorly controlled diabetes
- Congestive heart failure
- Within 6 months of screening, MI (myocardial ischemia), unstable angina leading to
hospitalization, percutaneous coronary intervention, coronary artery bypass graft,
uncontrolled cardiac arrhythmia, stroke transient ischemia attack, ceratoid
revascularization, endovascular procedure, or surgical intervention for peripheral
vascular disease.
- History or current treatment of thromboembolic disease.
- Use of ACTH (adrenocorticotropic hormone) or oral/depot corticosteroids within 6 weeks
of screening.
- History of severe, untreated sleep apnea
- Subjects with any clinically significant medical condition which, in the opinion of
the investigator, would make the subject an unsuitable candidate for enrollment in the
study
- Positive serology for HIV, hepatitis B or hepatitis C
- Current evidence of drug or alcohol abuse.
- Skin conditions in injection site that could confound injection site assessments.
- Administration of other investigational compounds within one month of screening or 5
half-lives of the investigational compound, whichever is longer).
- Use of estrogen, GnRH (gonadotropin-releasing hormone) or growth hormone within 12
months of screening.
- Use of other androgens (DHEA(Dehydroepiandrosterone), anabolic steroids, other sex
hormones) or other substances/supplements know to affect the PK (pharmacokinetics) of
testosterone enanthate
- Considered or scheduled surgical or dental procedures associated with blood loss ≥500
mL during study.
- Donation of plasma or blood within 56 days of screening or history of donation of > 50
mL of blood or plasma within 3 months of screening.
- Donation of plasma or blood during study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism | NCT02159469 | Entailment |
685 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion criteria:
- Biological profile suggesting hepcidin deficiency:
- high serum iron (> 25μmol / l) checked at least 2 times.
- increased transferrin saturation coefficient (> 50 %) checked at least 2 times,
and calculated from transferrinemia.
- Proved hepatic iron overload: using a dosage of iron hepatic concentration either on
hepatic biopsy, or by MRI according to the method of iron overload quantification. A
threshold of 100 µmol / g is set.
- Patient's written consent for examination and collection of genetic data to set the
diagnosis.
Non inclusion criteria:
- HFE hemochromatosis: C282Y/C282Y homozygosity
- Treatment by iterative phlebotomies (more than 2 phlebotomies)
- Hematological diseases with dyserythropoiesis and/or repeated transfusions
- Low haptoglobin level, suggesting chronic hemolysis or myelodysplasia
- Long-term iron oral and/or parenteral supplementation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Rare Iron Overloads Except C282Y Homozygosity : Description and Characterization. | NCT01541813 | Entailment |
1,723 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Be currently enrolled either full time or part time as an undergraduate in a 2-year or
4-year college
- Be between the ages of 18-30
- Be a native English speaker
- ADHD Participants: Must report a prior diagnosis of ADHD and self-report five or more
inattention (IA) symptoms on the DSM-5 Symptom Checklist on the pre-screener.
- Healthy Participants: Must disavow ever being diagnosed with ADHD, report 3 or fewer
IA symptoms and 3 or fewer hyperactivity/impulsivity (HI) symptoms on the DSM-5 ADHD
Symptom Checklist in the pre-screener and are an age and sex match of an ADHD group
participant
Exclusion Criteria:
- Not meeting any of the above stated inclusion criteria
- Any contraindications for physical exercise placing the participant at moderate or
high-risk. This includes the following:
1. Participants will be excluded if they report having an acute or uncontrolled
disease (cardiovascular, pulmonary, neurological, endocrine, musculoskeletal,
immunological).
2. Participants will be excluded if they are non-ambulatory or rely on walking aids
for ambulation.
3. Participants will be excluded who chronically manage asthma or another
respiratory condition or require using an inhaler to complete exercise.
4. Participants will be excluded if they experience uncontrolled or current problems
with syncope (loss of consciousness or fainting) or postural hypotension.
5. Participants will be excluded if they have ever had a stroke, aneurysm, or
transient ischemic attack (TIA).
6. Participants will be excluded if they have exercise or physical activity
restrictions imposed by a health provider.
7. Participants will be excluded by the medical director due to possible underlying
disease/condition or risk.
8. Participants will be excluded if they are pregnant (determined by a urine
pregnancy test), are attempting to become pregnant, or are currently
breastfeeding will also be excluded (stated above).
9. Participants will be excluded for any current use of other psychotropic drugs
(e.g., SSRIs, SNRIs, sedatives; stated above).
- Any contraindications for stimulant medication use placing the participant at moderate
or high-risk. This includes the following:
1. Participants will be excluded if they have ever been diagnosed with seizure
disorder, high blood pressure, glaucoma, gastrointestinal hypermotility disorder
(e.g., IBS), diabetes, hypoglycemia, cardiac problems (e.g., heart disease), or
thyroid problems.
2. Participants will be excluded if they have ever been diagnosed with a bipolar
disorder (e.g., Bipolar I or Bipolar II), a psychotic disorder (e.g.,
schizophrenia), a sleep disorder (e.g., narcolepsy), an eating disorder (e.g.,
bulimia nervosa), or a severe substance use disorder (e.g., endorsing six or more
symptoms of a substance use disorder according to the DSM-5). Participants will
also be excluded if they report a past year diagnosis of major depressive
disorder, panic disorder, generalized anxiety disorder, or any substance use
disorder.
3. Participants will be excluded if they report any prior treatment for substance
use (e.g. rehabilitation for alcohol or other substance use). Additionally,
participants will be excluded if they do not agree to abstain from illicit or
addictive drugs and marijuana use for the duration of the study beginning with
the eligibility assessment.
4. Participants will be excluded if they experience uncontrolled or current problems
with syncope (e.g., loss of consciousness or fainting) or postural hypotension.
5. Participants will be excluded if they are pregnant (determined by a urine
pregnancy test), are attempting to become pregnant, or are currently
breastfeeding.
6. Non-ADHD participants will be excluded if they have ever engaged in
non-prescription stimulant use.
7. ADHD participants who are currently prescribed a prescription stimulant will be
asked not to take their medication the day prior to and day of any study visits.
They will be excluded if they are not comfortable with abstaining.
8. Participants will be excluded for any current use of other psychotropic drugs
(e.g., SSRIs, SNRIs, sedatives) or non-stimulant ADHD medication (i.e.,
Strattera).
9. Participants will be excluded for any current use of any other prescription
medication that could interact negatively with Adderall (e.g., neurological and
blood-pressure drugs, antihistamines).
10. They will also be excluded for current use of high levels of caffeine consumption
(e.g., daily use more than 600mg/day or about six 8-oz. cups of coffee). Daily
use is defined as 5 or more days per week for the last month.
11. Participants who are using other over-the-counter-substances that could interact
negatively with Adderall (e.g., dietary supplements, weight-loss pills, and
low-to-moderate levels of caffeine consumption, antihistamines) will be asked to
abstain from use for at least 12-hours prior to lab visits. They will be excluded
if they are not comfortable with abstaining.
12. Participants will be excluded if they report current nicotine use (i.e., 5 or
more cigarettes per day), daily vaping (i.e., e-cigarettes), smokeless tobacco
(i.e., chewing tobacco), nicotine gum, and/or nicotine patches use in the past
month.
13. Participants will be excluded if they experienced a concussion within the past 6
months, have experienced two or more concussions in their lifetime, or have a
history of traumatic brain injury.
14. Participants will be excluded if they have ever had a stroke, aneurysm, or
transient ischemic attack (TIA).
15. Participants will be excluded if they are unwilling to ingest a prescription
stimulant medication (Adderall) or placebo in the lab.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years | Acute Effects of Stimulant Medication in College Students With ADHD | NCT03935646 | Entailment |
2,613 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Children aged 1 - 3 years undergoing urologic surgery (circumcision, hydrocele repair,
orchidopexy, mild hypospadias) or inguinal hernia repair
- American Society of Anesthesiologist Physical Status (ASA-PS) I or II
- Eligible for caudal block
- Parental/legal guardian consents for study '
Exclusion Criteria:
- Allergy to remifentanil, dexmedetomidine or ropivacaine
- Family history of malignant hyperthermia
- Parental/legal guardian refusal
- ASA-PS ≥ 3
- Symptoms of upper respiratory infection (URI) within the 2 weeks prior to surgery
- Known spinal deformity, presence of sacral dimple, or signs of infection at the site
of the caudal block (e.g. diaper rash, skin redness or tenderness).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 3 Years | Remifentanil-dexmedetomidine Anesthesia With a Caudal for Elective Surgery. (Remi-dex) | NCT02799589 | Contradiction |
3,496 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
1. Participants will include community-dwelling, Spanish-speaking (monolingual or
bilingual) adults over age 50 who self-identify as Hispanic/Latino
2. Clinically-significant hearing loss defined as either greater than 25 decibels hearing
leve (dB HL) thresholds at 2 or more frequencies from 250 - 8000 hertz (Hz) and/or
significant self-reported hearing difficulties as defined by a score of greater than 8
on the Hearing Handicap Inventory - Screening measure for adults/elderly.
Exclusion Criteria:
- Individuals who are not fluent Spanish-speakers or who do not self-identify as
Hispanic/Latino are not eligible to participate in this study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| Development and Assessment of a Spanish-Language Hearing Loss Toolkit for Self-Management | NCT04534387 | Entailment |
5,065 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal womeen (≥60 and ≤90 years) with a diagnosis of osteoporosis
- Body weight ≥50 kg and ≤90 kg
- Bone Mineral Density (BMD) measurement T score of less than 2.5 but not less than 4.0
by dual-energy X-ray absorptiometry (DXA) at the lumbar spine at screening
- At least 3 vertebrae in the L1 L4 region that are evaluable by dual-energy X-ray
absorptiometry (DXA)
Exclusion Criteria:
- One severe or more than two moderate vertebral fractures
- History and/or presence of hip fracture or atypical femur fracture
- Any prior treatment with denosumab
- Ongoing use of any bone active drugs which can affect Bone Mineral Density (BMD)
- Vitamin D deficiency or hyper- or hypocalcemiacium at screening
- Hyperthyroidism, hypothyroidism, hypoparathyroidism or hyperparathyroidism
- Any medical condition that could jeopardize or would compromise the patient's safety
or ability to participate in this study
Other Inclusion/exclusion criteria may apply
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 90 Years | A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis | NCT04729621 | Contradiction |
4,104 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
1. Males and females age 18 and older (except when the age of majority for a state
differs from 18, including Delaware [19 years or older], Mississippi [21 years or
older], and Nebraska [19 years or older])
2. ICSD-3 criteria (8) for Narcolepsy (Type I or II)
3. Endorse current psychological distress based on a t-score ≥ 60 on the PROMIS
depression or anxiety scales
4. Established standard care for narcolepsy. Patients who have not been previously
diagnosed will be required to complete a clinical work-up through a sleep clinic
(i.e., nocturnal PSG followed by a next-day MSLT) before participating. Standard care
is managed outside of the study.
Exclusion Criteria:
1. Hypersomnia not of central origin (i.e., hypersomnia attributed to psychiatric
disorder, medical disorder, other sleep disorder such as circadian rhythm sleep
disorder, or insufficient sleep).
2. Current suicidal ideation or intent.
3. Uncontrolled medical conditions or physical limitations that require immediate medical
treatment that would prevent ability to engage in the treatment protocol.
4. Inability to engage in the treatment protocol due to a psychiatric (e.g., psychotic
disorder) or cognitive issue.
5. Untreated moderate-to-severe sleep-related breathing disorder, defined as an apnea
hypopnea index (AHI) ≥ 15. Those receiving treatment for a sleep-related breathing
disorder and can demonstrate adequate management (e.g., residual AHI < 5) will be
allowed to participate.
6. Previous participation in a formal MBI program, such as MBSR.
7. Unstable dose of medications at the time of screening (e.g., stimulants).
8. Unable to attend intervention sessions due to accessibility (i.e., reliable internet
connection) or availability (i.e., not available due to scheduling conflicts).
9. Currently living outside of the United States.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Awareness and Self-Compassion Enhancing Narcolepsy Treatment | NCT04306952 | Entailment |
6,332 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Clinical suspicion or evidence of SARS-CoV-2-infection on presentation in the ED
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Registry for Clinical Presentation and Management of Patients With COVID-19 in the Emergency Room | NCT04351854 | Entailment |
2,458 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
Sarcoidosis patients:
- Patients with relevant clinical, radiologic and histologic features of sarcoidosis
(all stages).
- Signed informed consent.
Exclusion Criteria:
- Organ failure (kidney, heart, liver).
- Collagen vascular diseases.
- Diabetes.
- Contraindications of vaccine (Egg allergy).
- Patients who receive high dose (> 60 mg/day) steroid therapy.
- Any acute disease.
- Conditions accompanied by immunosuppression (like organ transplantation, HIV).
- Any psychological disease that interferes with regular follow-up.
- Inoculation with influenza vaccine within the past 5 years.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 60 Years | Antibody Response to Influenza Vaccine in Patients With Sarcoidosis | NCT00828828 | Entailment |
2,043 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- histologically proven adenocarcinoma of the stomach or gastroesophageal junction
- stage IV
- patient receives chemotherapy
- signed informed consent
- Age > 18 years
Exclusion Criteria:
- Patient can not understand meaning and purpose of the study
- patient already received a chemotherapy treatment for advanced disease.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Gastric Cancer | NCT02305043 | Entailment |
5,474 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Healthy women aged 18-45 using the subdermal progestogen-only contraceptive implant
and experiencing frequent or prolonged vaginal bleeding Willing to keep a menstrual
diary for 6 months
Exclusion Criteria:
Women who have currently or previously had
- Heart attack or stroke
- Blood clot in a vein
- High blood pressure
- Severe liver or kidney disease
- Blood pressure > 135 mm systolic or >85 mm diastolic
- Migraine with aura
- Breast cancer or any genital cancer
- Severe chronic liver or kidney disease
- Women with known sensitivity to ethinyl oestradiol, progestogens
- Women taking phenytoin, carbamazepine or phenobarbitol
- Women who are pregnant
- Women who are lactating
- Women who are unwilling to keep a daily menstrual diary or otherwise unwilling to
follow the study criteria
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | New Treatments for Troublesome Bleeding in Implanon Users | NCT01384331 | Entailment |
26 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
Men with late-onset hypogonadism who are either on testosterone treatment or naïve of
treatment:
- have symptoms of androgen deficiency at screening (after wash-out if applicable) i.e.
with a positive score on the Androgen Deficiency in the Aging Male (ADAM)
Questionnaire (a "yes" answer to questions 1 or 7 or any three other questions).
- morning total T levels of <=3 ng/mL (<=300 ng/dL; <=10.4 nmol/l) on two separate days
prior to randomization (after appropriate wash-out, if applicable).
- calculated free T <=0.074 ng/mL.
- at least 50 and at most 75 years of age.
- BMI of at least 18 kg/m^2 or at most 32 kg/m^2
Inclusion Criteria for Normogonadal Men:
- morning total T levels <=3 ng/mL (<=300 ng/dL; <=10.4 nmol/L).
- calculated free T <=0.074 ng/mL.
- at least 50 and at most 75 years of age.
- BMI of at least 18 kg/m^2 or at most 32 kg/m^2
Exclusion Criteria:
- History or current diagnosis of prostate cancer or any clinically significant finding
on prostate examination
- Severe obstructive symptoms of benign prostate hypertrophy
- Prostate specific antigen (PSA) levels greater than 4 ng/mL at screening
- History or current diagnosis of carcinoma of the breast
- Known chronic polycythemia and/or hematocrit greater than 50% at screening
- Treatment-naïve subjects with hyperprolactinemia at screening (serum prolactin level
>=50 ng/mL)
- Hematological or biochemical values at screening outside the reference ranges
considered as clinically significant in the opinion of the investigator
- clinically significant abnormal physical finding prior to randomization
- sensitive to trial medication or its components
- History or presence of hepatic or renal disorder considered as clinically relevant in
the opinion of the investigator.
Exclusion Criteria for Normogonadal Men:
- Presence or previous diagnosis of androgen deficiency.
- Previous or present use of testosterone preparations
- Use of medication within the 12 weeks prior to the visit that may interfere with the
objectives of the trial: hypothalamic/pituitary hormones and analogues (e.g.,
gonadotropins, ACTH, STH, Gn-RH agonists and antagonists, etc.); sex steroid
- Any other disease that in the opinion of the investigator might compromise or confound
the subject's symptomatology (e.g., presence of clinically significant depression or
other psychiatric disorders, unstable endocrine disorder, sleep apnea, cardiovascular
and cerebrovascular diseases, etc.)
Male
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 75 Years | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two Period Cross Over Trial to Validate Patient-Reported Outcome Measures for Use in Men With Late Onset Hypogonadism | NCT00254553 | Contradiction |
4,687 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Age 18 years and over
- Regular menstrual cycles
Exclusion Criteria:
- Taking any hormonal medications
- Taking any medications that may affect heart rate
- Known heart condition or use of a pacemaker
- Skin condition where there is sensitivity to wearing a skin monitor
- Currently suffering with anxiety or panic attacks
- Pregnant or breastfeeding
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Investigation of Heart Rate Variability During the Menstrual Cycle | NCT04008277 | Entailment |
3,872 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Diagnosed with inflammatory osteoarthritis
- In good general health
- Stable pattern of anti-inflammatory or pain relieving drug use for 3 months prior to
study
- Ability and willingness to maintain consistent pattern of anti-inflammatory or pain
relieving drug use during the course of the study, and to not seek any other treatment
during the study
- Ability and willingness to consume juice or placebo drink for 21 consecutive days, and
to participate in screening measures, including a blood draw, before and after the
intervention period
Exclusion Criteria:
- Pregnancy
- Serious medical conditions such as recent heart attack or stroke, cancer, diabetes
(type 1 and type 2), or gastrointestinal ulcers
- Individuals who have not been on a stable dose of pain medications or pain modalities
for at least 3 months, including muscle relaxants, tender point anesthetic injections,
systemic or intrabursal or intraarticular steroids, or any investigational drug/device
in the prior 90 days
- Individuals who have used nonpharmacologic pain therapies including acupuncture,
ultrasound, or transcutaneous electrical nerve stimulation within the past 30 days
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 70 Years | Efficacy of Tart Cherry Juice to Reduce Pain and Inflammation Among Patients With Inflammatory Osteoarthritis | NCT01073982 | Entailment |
932 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Patient may have evidence of osteoarthritis (radiographic and/or by patient symptoms
report) in more than one joint, however, osteoarthritis of one knee has been the
patient's primary complaint and the focus of treatment.
- Radiographic evidence, within 6 months of enrollment, of osteoarthritis of the knee
receiving treatment.
- Kellgren and Lawrence osteoarthritis classification grade 1, 2 or 3 (i.e., indicative
of cartilage still remaining in joint).
- Average rating of pain associated with osteoarthritis of knee greater than or equal to
4 cm (on a 10 cm visual analog scale).
- Stiffness in knee(s) lasts less than 30 minutes (to demonstrate that stiffness is not
from a more serious condition)
- Agrees to follow their randomized treatment plan and use the device.
- At least 18 years old.
- Signed informed consent.
- Erythrocyte Sedimentation rate greater than 40 mm/hour (Higher rates may be indicative
of RA)
- Agrees to follow the randomized treatment plan and use of the stimulation device.
Exclusion Criteria:
- Hypersensitivity to electrical stimulation.
- Undergone within 3 months of enrollment, corticosteroid or viscosupplementation (i.e.,
hyaluronate) injections to the effected knee.
- If taking medications such as oral steroids, non-steroidal anti-inflammatories, or
acetaminophen, patient has been on a stable dose for at least 3 months prior to
enrollment. (The criteria should match the prior retrospective data studies.)
- If taking chondroprotective supplements (e.g., glucosamine and chondroitin sulfate),
patient has been on a stable dose for at least 3 months prior of enrollment.
- Pathologic process at the knee (congenital defect or blunt trauma leading to
structural defect such as torn anterior cruciate or meniscus ligaments).
- Problems due to mechanical/anatomical deformities (i.e., valgus greater than 5 degrees
or varus greater than 1.5 degrees)
- Women who are, or plan to become pregnant during the clinical investigation.
- Known malignancy or cancer.
- Morbid obesity (BMI > 40).
- Serious or uncontrolled systemic illness (e.g., autoimmune disease, rheumatoid
arthritis, diabetes mellitus or renal failure).
- Implanted devices such as a cardiac pacemaker or defibrillator
- Concurrent use of another electrical stimulation device for treatment of knee
symptoms.
- Ongoing enrollment, or discontinued enrollment within the last 30 days, in another
clinical trial for medical devices or biologic agents.
- Relationship other than medical (e.g., spouse or employee of investigator) with
principal investigator(s) and their staff which may bias patient reports.
- Relationship with another person enrolled in the clinical investigation.
- Unable to complete the study per the investigational plan or unable to complete the
case report forms.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Patterned Electrical Neuromuscular Stimulation and Therapeutic Exercise for Osteoarthritis of the Knee: Pilot Study | NCT00701506 | Entailment |
577 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Women who signed informed consent.
- Women who understand the Spanish language.
- Women under 40 years
Exclusion Criteria:
- Thrombopenia.
- Congenital or acquired uterine malformations that reduce embryo implantation or term
gestation.
- Ovarian tumors.
- Benign uterine tumors require surgical treatment
- Local acute inflammatory diseases
- Patients with malignant tumors requiring chemotherapy.
- Patients with acute or chronic infectious or inflammatory diseases requiring active
treatment with drugs that may interfere with implantation and gestation.
- Chronic treatment with NSAIDs (Nonsteroidal anti-inflammatory drugs)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Concentrate of Autologous Rich Plasma in Growth Factors in the Treatment of the Thin Endometrium | NCT03387501 | Entailment |
6,231 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- All hospitalized patients with cough, fever, myalgia - with confirmed COVID-19
infection • All patients with a positive SARS-CoV-2 PCR test
Exclusion Criteria:
- Patient refusal
- Uncertain tests results
- Children
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Investigating the Involvement of ACE and Angiotensinogen Genes' Polymorphism Along With Other Thrombophilic Genotypes in Severe Forms of COVID-19 With/Without Thrombotic Events | NCT04519398 | Contradiction |
4,268 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator or medically qualified designee based on a
medical evaluation including medical history, physical examination, laboratory tests
and cardiac evaluation (history, electrocardiogram [ECG]).
- A subject with a clinical abnormality or laboratory parameter(s) which is/are not
specifically listed in the inclusion or exclusion criteria, outside the reference
range for the population being studied may be included only if the investigator in
consultation with the medical monitor if required agree and document that the finding
is unlikely to introduce additional risk factors and will not interfere with the study
procedures.
- Body weight >=50 kilograms (kg) (110 pounds [lbs]) for men and >=45 kg (99 lbs) for
women and body mass index (BMI) within the range 18.5-31.0 kg/square meter (m^2)
(inclusive).
- Male or Female- Female: Female subject of non-reproductive potential : is eligible to
participate if she is not pregnant (as confirmed by a negative serum or urine human
chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following
conditions applies: Pre-menopausal females with one of the following: documented tubal
ligation, documented hysteroscopic tubal occlusion procedure with follow-up
confirmation of bilateral tubal occlusion, hysterectomy, documented bilateral
oophorectomy.
Postmenopausal defined as 12 months of spontaneous amenorrhea; in questionable cases a
blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels
consistent with menopause (refer to laboratory reference ranges for confirmatory levels).
Females on hormone replacement therapy (HRT) must discontinue HRT to allow confirmation of
post-menopausal status prior to study enrolment.
Reproductive potential and agrees to follow one of the options listed below in the
GlaxoSmithKline (GSK) modified list of highly effective methods for avoiding pregnancy in
females of reproductive potential (FRP) requirements from 30 days prior to the first dose
of study medication and until at least five terminal half-lives (10 days) after the last
dose of study medication and completion of the follow-up visit.
GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of
Reproductive Potential (FRP)
This list does not apply to FRP with same sex partners, when this is their preferred and
usual lifestyle or for subjects who are and will continue to be abstinent from
penile-vaginal intercourse on a long term and persistent basis.
- Intrauterine device that meets the standard operating procedure (SOP) effectiveness
criteria including a <1% rate of failure per year, as stated in the product label.
- Male partner sterilization with documentation of azoospermia prior to the female
subject's entry into the study, and this male is the sole partner for that subject.
- Male condom combined with a vaginal spermicide (foam, gel, film, cream, or
suppository).
These allowed methods of contraception are only effective when used consistently, correctly
and in accordance with the product label. The investigator is responsible for ensuring that
subjects understand how to properly use these methods of contraception.
Male:
- Male subjects with female partners of child bearing potential must comply with the
following contraception requirements from the time of first dose of study medication
until [at least five half-lives of study medication OR for a cycle of spermatogenesis
following five terminal half-lives] after the last dose of study medication.
1. Vasectomy with documentation of azoospermia.
2. Male condom plus partner use of one of the contraceptive options below:
- Contraceptive subdermal implant that meets the SOP effectiveness criteria including a
<1% rate of failure per year, as stated in the product label.
- Intrauterine device or intrauterine system that meets the SOP effectiveness criteria
including a <1% rate of failure per year, as stated in the product label.
- Oral Contraceptive, either combined or progestrogen alone.
- Injectable progestrogen.
- Contraceptive vaginal ring.
- Percutaneous contraceptive patches.
These allowed methods of contraception are only effective when used consistently, correctly
and in accordance with the product label. The investigator is responsible for ensuring that
subjects understand how to properly use these methods of contraception.
- Capable of giving signed informed consent as described in protocol which includes
compliance with the requirements and restrictions listed in the consent form and in
this protocol.
Exclusion Criteria:
- Alanine aminotransferase (ALT) and bilirubin >1.5x upper limit of normal (ULN)
(isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct
bilirubin <35%).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Unable to refrain from the use of prescription or non-prescription drugs, including
vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or
14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is
longer) prior to the first dose of study medication, unless in the opinion of the
Investigator and GSK medical monitor the medication will not interfere with the study
procedures or compromise subject safety.
- History of regular alcohol consumption within 6 months of the study defined as: An
average weekly intake of >14 drinks for males or >7 drinks for females. One drink is
equivalent to 12 grams (g) of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5
ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- History of sensitivity to any of the study medications, or components thereof or a
history of drug or other allergy that, in the opinion of the investigator or medical
monitor, contraindicates their participation.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test
result at screening or within 3 months prior to first dose of study treatment.
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- Where participation in the study would result in donation of blood or blood product in
excess of 500 mL within 56 days.
- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.
- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility
determination):
Heart Rate for males: <45 and >100 beats per minute (bpm), females: <50 and >100 bpm PR
Interval for males: <120 and >220 milliseconds (msec) QRS Interval for males: <70 and >120
msec QT duration corrected for heart rate (QTc) interval (Fridericia's) for males: >450
msec Note: A heart rate from 100 to 110 bpm can be rechecked by ECG or vitals within 30
minutes to verify eligibility.
Evidence of previous myocardial infarction (does not include ST segment changes associated
with repolarization).
Any conduction abnormality (including but not specific to left or right complete bundle
branch block, atrioventricular block (AV block) (2nd degree or higher), Wolf Parkinson
White [WPW] syndrome).
Sinus Pauses >3 seconds. Any significant arrhythmia which, in the opinion of the principal
investigator OR GSK medical monitor, will interfere with the safety for the individual
subject.
Non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic
beats).
- Employment with Janssen and GSK or with the Investigator or study site, with direct
involvement in the proposed study or other studies under the direction of that
Investigator or study site, as well as family members of the employees or the
Investigator.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects | NCT02373930 | Entailment |
5,125 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must
be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD
values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and
0.478 at the total hip. Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH
derivatives use within the last 12 months and administration of any of anti-osteoporotic
treatments within the last 3 months before initial administration of the investigational
product. - History of hypocalcemia. - More than two moderate vertebral fractures or any
severe vertebral fracture.
Female
No healthy subjects accepted to join the trial.
Subject must be at most 80 Years | A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects | NCT00306189 | Contradiction |
3,406 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
It will include 50 subjects whose:
- Age ranges from 10 to 40 years old.
- Body Mass Index more than the 85th percentile.
- male and female will be included
Exclusion Criteria:
- External or middle ear disease that causes conductive hearing loss such as otitis
media, otomycosis, perforated drum, tumors, dislocation of the ossicles.
- High environmental noise exposure which causes acoustic trauma such as exploration,
fire shots and noise in industries.
- ototoxic drug intake such as Aspirin, Aminoglycosides, Erythromycin, Vancomycin
Streptomycin, Kanamycin, Neomycin, Gentamycin, Tobramycin, Lasix, Cisplatin, Nitrogen
Mustard, and Vincristine, and Quinine.
- Major neurological or psychiatric diseases brain tumor, vestibular Schwannoma, stroke,
acoustic neuroma, encephalitis, meningitis, and depression.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
Subject must be at most 40 Years | Body Mass Index and Audiology Function | NCT03172663 | Contradiction |
4,287 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Subject must be male or female, aged 18 years (inclusive) or older (at the time of
consent).
2. Each subject must sign an informed consent form (ICF) indicating that he or she
understands the purpose and requirements of the study and is willing to participate.
3. Subject's diagnosis of moderate to severe asthma (GINA Step 3 or 4) made by a
respiratory physician and treated with an inhaled steroid or other chronic respiratory
disease.
1. For subjects with asthma, the diagnosis of asthma must be supported either by:
- i. Historical evidence of:
- 1. Increased airway hyper-responsiveness (methacholine PC20 <8 mg/ml).
- or
- 2. Airflow obstruction (FEV1/FVC ratio of less than 70%) and short-term
variations in FEV1 (>12%).
- or
- ii. Bronchodilator reversibility ≥12% or ≥200 mL improvement in FEV1 post
bronchodilator after administration of a short-acting beta agonist at
screening.
OR
2. Subjects with other chronic respiratory disease (such as COPD or bronchiectasis)
susceptible to fungal bronchitis.
4. Subject must have a positive sputum fungal culture with one or more colonies of A.
fumigatus complex / A. niger complex or 200 or more colonies of yeast measured using a
modified standard approach on one occasion obtained within the 28-day screening
period.
5. Subject must be able to produce a spontaneous sputum sample.
Exclusion Criteria:
1. Subjects who have received more than 2 weeks of intravenous (IV), oral or inhaled
antifungal therapy within 6 months prior to Visit 3 or any antifungal therapy (IV,
oral or inhaled) within 2 months of Visit 3.
2. Subjects taking medication that could significantly increase the risks of AEs with
triazoles.
3. Subjects who are receiving antiretroviral protease inhibitors.
4. Clinical or laboratory evidence of bacterial bronchitis at the point of screening.
5. Subjects who have used an experimental medical device or received an experimental drug
within 3 months or within a period less than five times the experimental drug's
half-life, whichever is longer, before the first dose of the study drug is scheduled.
6. Clinically significant screening abnormalities (including, but not limited to, vital
signs, ECG, laboratory tests, physical examination and spirometry) that, in the
Investigator's opinion, exclude the subject from participation in the study.
7. Positive test at screening for hepatitis B virus infection, or antibodies to hepatitis
C virus.
8. If female, the subject is pregnant (e.g. has a positive serum β human chorionic
gonadotropin at screening or a positive urinary pregnancy test pre-dose on Day 1),
lactating or breast feeding.
9. Subject is an employee or a first-degree relative of anyone employed by Pulmocide, a
participating clinical trial site, or any contract research organisation involved in
the study.
10. Any other reason that the Investigator considers makes the subject unsuitable to
participate.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Effect of PC945 on Aspergillus or Candida Lung Infections in Patients With Asthma or Chronic Respiratory Diseases | NCT03745196 | Entailment |
3,465 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
1. Subject is willing to give consent and comply with evaluation and treatment schedule
2. 18 to 65 years of age
3. Have a BMI > 30 with one or more significant co-morbid medical conditions which are
generally expected to be improved, reversed, or resolved by weight loss. these
conditions include but are not limited to:
- Hyperlipidemia
- Type 2 diabetes
- Mild Obstructive Sleep Apnea
- Hypertension
- Osteoarthritis of the hip or knee
4. Agree to refrain from any type of weight-loss drug ( prescription or OTC) or elective
procedure that would affect body weight for the duration of the trial
5. HbA1C < 11 %
6. For subjects who have Type 2 Diabetes, the anti-diabetic medication regimen is no more
complex than oral metformin plus one oral sulfonylurea plus once daily insulin
injection.
7. Ability to self-pay for the procedure and follow up.
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Resolution of Comorbidities & Safety and Efficacy of Greater Curvature Plication in Obese Patients | NCT02315105 | Entailment |
2,566 | 19 | A 7-year-old girl is brought to the emergency department by her parents for generalized rash. The mother reports that she was playing outside wearing a skirt and felt a sharp pain in her arm while seating on a mat, plying with her doll. Her mother suspects that something had stung her. The patient's blood pressure is 75/55 mm Hg and her heart rate is 122/min. Physical examination shows erythematous, raised plaques over the trunk, extremities, and face. Lung auscultation reveals bilateral expiratory wheezes. | I just brought my seven-year-old girl to the ER because she just developed a terrible rash. My little girl was playing outside and she was wearing a lovely little skirt and all of a sudden. She felt like a really sharp pain in her arm. She was sitting on a mat playing with her doll. I think that something stung her. They took her blood pressure, and it turned out to be 75 out of 55. Her heart rate was 122. Then they did a physical examination, and it showed rashes all around her trunk, extremities, and face. Her breath test revealed some high-pitched breathing. | Inclusion Criteria:
- Age > 16, or < 16 and accompanied by a legal guardian
- Has one of 38 ED discharge diagnoses
- Fluent in English, or caregiver fluent
- Has access to a computer, with internet access, in the next 4 days
- Has access to a telephone
Exclusion Criteria:
- Age < 16 when unaccompanied by a legal guardian
- Decreased level of consciousness at ED discharge (eg palliative patient)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Using Online Videos to Supplement Emergency Department Discharge Instructions | NCT01361932 | Entailment |
5,129 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria
Subjects must:
- Have a bone mineral density T-score (at the lumbar spine or total hip) of less than or
equal to -2.5
- Be female
- Be at least 5 years post menopausal (more than 5 years since their last menstrual
period) but <85 years old.
- Be ambulatory
- Be able and willing to participate in the study and provide written informed consent
- Have a serum 25(OH)2 vitamin D3 >50 nmol/L (after vitamin D3 loading)
Exclusion Criteria
Patients will not be admitted to the study if they exhibit any of the following:
- Evidence of a clinically significant organic disease which could prevent the patient
from completing the study
- A body mass index less than 18 or greater than 35
- Abuse of alcohol or use illicit drugs (information obtained from medical history) or
who consumed more than 4 servings of any alcoholic beverage one day prior to the visit
(i.e., subjects who might be binge drinkers)
- Any history of cancer within the past 5 years excluding skin cancer non melanomas
- Any history of ongoing conditions or diseases known to cause abnormalities of calcium
metabolism or skeletal health including Paget's disease of bone
- Chronic renal disease (as defined by an estimated glomerular filtration rate of ≤
30mL/min)
- Acute or chronic hepatic disease
- Malabsorption syndromes
- Hyperthyroidism as manifested by TSH outside the lower limit of the normal range
- Hyperparathyroidism
- Hypocalcemia or hypercalcemia
- Osteomalacia
- Cushing's syndrome
- Current use of glucocorticoid therapy
- A corrected serum calcium less than 2.2 mmol/L and a PTH above 100 ng/L (that persists
after testing and treatment for vitamin D deficiency)
- A history of any known condition that would interfere with the assessment of DXA at
either lumbar spine or femoral neck
- Markedly abnormal clinical laboratory parameters that are assessed as clinically
significant by the investigator
- Any previous use of bisphosphonate
- Use any of the following medications within 12 months of starting study drug
- Any fluoride with the exception of use for oral hygiene
- Strontium Ranelate
- Other bone agents (e.g. SERM, isoflavones, HRT)
- Participation in another clinical trial involving active therapy 3 months prior to
enrolment
- Less than 5 years since menopause
- Bilateral fractures in the measurement regions (hip, tibia and forearm)
- Recent fracture within the last 12 months
- Prior radiation therapy which may involve the skeleton
- Hypersensitivity to teriparatide or any of its excipients
- Unexplained elevations of alkaline phosphatase
- Any known contraindication to the use of teriparatide
Female
No healthy subjects accepted to join the trial.
Subject must be at most 84 Years | Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action | NCT01293292 | Contradiction |
977 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Male or female participants between 40 and 80 years of age
- Diagnosis of moderate to moderately-severe osteoarthritis (OA) of either the knee or
hip with respect to the following:
- Pain in one knee/hip over 3 months immediately before screening visit
- Use of non steroidal anti-inflammatory drugs (NSAIDs), acetaminophen
(paracetamol) or any other analgesic for 3 or more days per week for at least 3
months prior to screening visit
- Clinical diagnosis of osteoarthritis of knee/hip for minimum 6 month duration
prior to screening visit
- Therapeutic benefit with acetaminophen use with a score of ≥ 1 on 5-point
categorical scale
- Radiological evidence of ≥ Grade 2 osteoarthritis according to Kellgren-Lawrence
radiographic criteria
- Increased WOMAC Pain Subscale score of at least 20 % following untreated run-in period
- Moderate to moderately-severe self-reported pain on a 5-point categorical scale
following untreated run-in period
- Historical self-reported positive therapeutic benefit with paracetamol use for
osteoarthritis pain relief
Exclusion Criteria:
- History of surgery or major trauma to the study joint
- Clinically significant signs or symptoms of inflammation upon completion of run-in
period
- Required ongoing use of analgesic therapy for other indications, anticoagulants,
psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class
hypolipidemic agents at doses that have not been stabilized, or other treatments know
to interfere with pain perception
- History of hepatic or renal or liver or biliary disease or gastrointestinal surgery
- Participants with alanine aminotransferase (ALT) >2 times Upper Limit Normal (2xULN)
and bilirubin > 1.5 times Upper Limit Normal (1.5xULN) (However, if direct bilirubin
is <35% and fractioned, isolated bilirubin >1.5xULN is acceptable)
- Other arthritis type, fibromyalgia or collagen vascular disease or secondary OA of
study joint or chronic pain condition
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis | NCT02311881 | Entailment |
483 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- First IVF cycle
- Normal ovarian reserve parameters (antral follicle count > 12, follicle stimulating
hormone (FSH) < 10 IU/L, AMH (if measured) > 15 pmol/L)
- Infertility cause due to tubal factor, male factor with ejaculated sperm or
unexplained
- 3 or more fresh transfer or cryopreservation-quality blastocysts on day 5
post-oocyte-retrieval
- GnRH antagonist or long GnRH agonist cycles
Exclusion Criteria:
- Evidence of (or evidence for significant risk of) ovarian hyperstimulation syndrome
(OHSS) on post-oocyte-retrieval day 5 (in which the standard protocol is not to
perform a fresh embryo transfer, but rather to freeze all blastocysts for future
frozen embryo transfers).
- Use of a gonadotropin releasing hormone (GnRH) agonist trigger for ovulation and
resulting intensive luteal phase support protocol.
- Women requiring automatic freeze-all approaches (such as for pre-implantation genetic
testing or cryopreservation for fertility preservation).
- Female infertility causes that may adversely affect implantation, such as severe
endometriosis, fibroids, mullerian abnormalities, or prior uterine procedures
resulting in a potentially compromised endometrial cavity.
- In-vitro maturation of oocytes
- Oocyte donation cycles
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Comparing Pregnancy Outcomes in Good Prognosis Patients Between Fresh and 'Freeze-All' Single Blastocyst Transfers | NCT02712840 | Contradiction |
6,874 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
1. Ability to give written informed consent
2. Age: 90≥ years ≥50
3. Gender: male and female
4. CDR ≤ 0.5
5. Complaints of memory loss reflected in such everyday problems as difficulty
remembering names of individuals following introduction, misplacing objects,
difficulty remembering multiple items to be purchased or multiple tasks to be
performed, difficulty remembering telephone numbers or zip codes, and difficulty
recalling information quickly or following distraction. Onset of memory loss must be
described as gradual, without sudden worsening in recent months. Complaints of memory
loss to be assessed by the MAC-Q scale.
6. Mini-Mental State Examination (MMSE) ≥27 for subjects with college education (BA) and
≥ 26 for all others
7. Memory test performance that is at least 1 SD below the mean established for young
adults on at least one neuropsychological subtest of NexAde.
8. Language: Subjects must be able to read, write and speak Hebrew.
9. Ability to perform tests and interviews
Exclusion Criteria:
1. Evidence of delirium, confusion, or other disturbances of consciousness
2. Any Neurological disorder that could produce cognitive deterioration. Such disorders
include AD, Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions
including tumors, and normal pressure hydrocephalus
3. History of any infective or inflammatory brain disease including those of viral,
fungal, or syphilitic etiologies
4. Evidence of significant cerebral vascular pathology
5. Head injury immediately preceding cognitive deterioration.
6. Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or
any other major psychiatric disorder
7. Current diagnosis or history of alcoholism or drug dependence.
8. Evidence of depression as determined by the Geriatric Depression Scale (short version)
score of 5 or more.
9. Any medical disorder that could produce cognitive deterioration including renal,
respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or
hematological disturbances unless well controlled, and malignancy not in remission for
more than two years
10. Use of psychotropic drug or any other drug or supplement that may significantly affect
cognitive functioning during the month prior to psychometric testing.
11. Use of any experimental medication within 1 month prior to screening or as concomitant
medications.
12. Subject has a history of hypersensitivity or allergy to fish or fish oil or soy.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 90 Years | The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment | NCT00437983 | Contradiction |
2,573 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Patients with persistent pain (< 6 mo) after open groin hernia repair
- Patients with maximal pain area 3 cm or less from the superficial inguinal ring
- Patients living in the Capital Region of Denmark (Region Hovedstaden) or the Region of
Zealand (Region Sjælland)
Exclusion Criteria:
- Known allergy to bupivacaine or other local anesthetics of amide-type
- Declared incapable of making his/hers own affairs
- Does not comprehend Danish in the written or spoken language
- Cognitive impairment to a degree influencing the testing reliability
- Known recurrence of the inguinal hernia
- Other surgical procedures performed in the groin or on the external genitals
- Neuropathy affecting the groin region caused by other conditions, e.g. post-stroke,
multiple sclerosis, herniated intervertebral disc
- Abuse of alcohol or drugs
- Unable to cooperate with the sensory examinations
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair | NCT02065219 | Contradiction |
3,691 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Present with Osteoarthritis (OA) of the knee based on: 1) Knee pain for at least 14
days per month for the last 3 months, 2) Osteophytes (bone spurs), 3) And at least 1
of the following: Over the age of 50, OR morning stiffness in knee for less than 30
minutes, OR crunching sensation as the knee bends back and forth (crepitus).
- Mean score of 4 or greater on the 24-hour average pain score from Visit 2 to Visit 3.
- Completion of electronic daily diaries with at least 70% complete between Visit 2 and
Visit 3.
- Taken non-steroidal anti-inflammatory drugs (NSAIDs) less than 15 days over the past
month AND not taken NSAIDs at least 1 week prior to Visit 3.
- Agree to maintain the same activity level throughout the study.
- Women who can become pregnant must test negative for pregnancy and agree to utilize
medically acceptable/reliable birth control during the study and 1 month following the
last dose of the study.
- Competent and freely able to give an informed consent.
- Ability to understanding and intelligibly communicate with the investigator.
- Judged to be reliable and agree to keep all appointments for clinic visits, tests, and
procedures required by the protocol.
Exclusion Criteria:
- Knee arthroscopy within past 3 months or any knee joint replacement.
- Surgery planned during the trial for the knee to be studied.
- Prior synovial fluid analysis showing a white blood cell of 2000 cubic millimeters
(mm^3) that is indicative of a diagnosis other than OA
- Are non-ambulatory or require the use of crutches or a walker. Use of a cane in the
hand opposite the index knee is acceptable.
- Body Mass Index over 40.
- Confounding painful condition that may interfere with assessment of the index knee.
(Knee pain should be the predominant pain. Mild OA of the hands is allowed, for
instance.)
- Diagnosis of inflammatory arthritis (rheumatoid arthritis) or an autoimmune disorder
(except inactive Hashimoto's thyroiditis).
- Received intra-articular hyaluronate or steroids, joint lavage, or other invasive
therapies to the knee in the past 3 months.
- Frequent falls that could result in hospitalization or could compromise response to
treatment.
- Current or previous (within the past 1 year) Axis 1 diagnosis of major depressive
disorder, mania, bipolar disorder, psychosis, dysthymia, anxiety disorder, alcohol or
eating disorders.
- Serious or unstable cardiovascular, hepatic, renal, respiratory, ophthalmologic,
gastrointestinal, or hematologic illness, symptomatic peripheral vascular disease, or
other medical condition that in the opinion of investigator would compromise
participation or be likely to lead to hospitalization during the course of the study.
- Alanine transaminase (ALT) > 2.0 times upper limit of normal at Visit 1, based on
reference ranges of the central lab.
- Prior renal transplant, current renal dialysis, or serum creatinine laboratory value
>1.5 times upper limit of normal based on the reference ranges of the central lab.
- Diagnosis or past history of glaucoma. Subjects with intraocular pressure >24
millimeters of mercury (mm Hg).
- Are taking any excluded medications that cannot be discontinued at Visit 1.
- History of substance abuse or dependence within the past year, excluding nicotine and
caffeine. Have a positive urine drug screen for any substance of abuse or excluded
medication.
- History of recurrent seizures other than febrile seizures.
- Are judged by the investigator to be at suicidal risk.
- History of frequent and/or severe allergic reactions with multiple medications.
- Pregnant or breast-feeding.
- Are unwilling/unable to comply with the use of a data collection devices.
- Received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry.
- Investigator site personnel directly affiliated with this study, and/or their
immediate families, or Lilly employees.
- History of severe delay in stomach emptying (gastroparesis).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | A Study in the Treatment of Osteoarthritis Knee Pain | NCT00790790 | Contradiction |
980 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
[Visit 1, 2 Inclusion Criteria]
1. Males or Females 40 years and older
2. According to the clinical diagnosis standard of the American College of Rheumatology
(ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to
over 3 conditions of followings.
1) Over 50 years of age 2) Less than 30 minutes of morning stiffness 3) Crepitus on active
motion 4) 4 bony tenderness 5) Bony enlargement 6) Nopalpable warmth of synvium 3. Within 6
months from screening visit, someone who diagnosed with Kellgren & Lawrence Grade I~III by
the radioactive examination.
4. By the Weight-bearing pain(100mm-VAS) examination, someone who has a outcome of the
single or both sides of the osteoarthritis is over 40mm 5. Patient (No-responder) who has
experienced steady pain in spite of dosing NSAIDs or other pain-killers in the past.
6. Patient who can walk by themselves without helper like cane or walker etc. (If the
patient who has used helper routinely from previous 6 months, evaluating the patient
including the helper is possible. In this case, patient needs to use same helper
continuously by end of the clinical trial test.) 7. Patient who agrees to participate in
this clinical trial by themselves.
[Visit 6, 7 Inclusion criteria] 1. According to the clinical diagnosis standard of the
American College of Rheumatology (ACR), someone, diagnosed as a single/both sides of
osteoarthritis, who corresponds to over 3 conditions of followings.
1. Over 50 years of age
2. Less than 30 minutes of morning stiffness
3. Crepitus on active motion
4. 4 bony tenderness
5. Bony enlargement
6. Nopalpable warmth of synvium 2. At Re-screening visit, someone who diagnosed with
Kellgren & Lawrence Grade I~III by the radioactive examination.
3. Patient who can walk by themselves without helper like cane or walker etc. (If the
patient who has used helper routinely from previous 6 months, evaluating the patient
including the helper is possible. In this case, patient needs to use same helper
continuously by end of the clinical trial test.) 4. Patient who are confirmed for Responder
by efficacy at visit 5.
Exclusion Criteria:
1. Someone who has BMI≥32kg/m² at the screening visit.
2. Patient who has an experience dosing psychoactive drug, narcotic analgesic which can
have an effect on pain sense over 3 months habitually.
3. Patient who has been administrated gastrointestinal drug(for example H₂-blockers,
misoprostol or proton pump inhibitors) regularly, who can't stop injecting for
clinical study period.
4. Patient has attended abnormal values from screening test(2 times excess at upper limit
of the normal values at ALT, AST, BUN, Serum Creatinine).
5. Patient who has rheumarthritis or other inflammatory metabolic arthritis.
6. Patients having serious gastrointestinal, liver, renal, heart disease.
7. When the inflammatory disease is occurred on joint area to patient like septic
arthritis.
8. Patients having skin ailment at the injecting site of the joint region.
9. Patients having secondary osteoarthritis according to the Ochronosis, Hemochromatosis
or systemic disease.
10. Patients who have severe pain like Sudek's atrophy, Paget's disease, Spinal disc
herniation.
11. Poly-articular patients who have suffered seriously by osteoarthritis at other parts
affect judge of the knee joint pain.
12. Patients who diagnosed clear interval disappearance at the knee joint by X-ray.
13. Patients who were administrated below drugs before baseline visit. 1) Patients who
were injected HA at the target knee joint or other parts of knee joint in recent 9
months.
2) Patients who were injected steroids into the intra-articular knee joint in recent 3
months 3) Patients who were administrated steroids systemically by the oral medication
(But, except inhalation) 4) Patients who were administerated Osteoarthritis nutrition such
as glucosamine/chondroichin sulfate or physical therapy or herbal remedy(acupuncture,
yellowish swelling, moxa cautery) for the purpose of pain relief in recent 2 weeks 5)
Patients who have administerated steroid/No-steriod NSAIDs or other pain relief drugs
(patch or other external medicine) in recents 2 weeks except Acetaminophen or below
300mg/day of Asprin 14. Patients who have joint effusion trouble were judged as a positive
by tests like Patella tap test.
15. Patients who have target knee joint gotten surgical operation history including
Arthroscopy within past one year (In case of having other side of knee joint or hip joint
gotten surgical operation history, excepting the patients if there is possibility which can
influence the target knee joint's appraisal.
16. Patients who have an operation history about target knee joint. 17. Patients who do the
height weight aerobic exercise or anaerobic exercise. 18. Patients who need to be
administrated anticoagulant agent together(But, except 300mg daily dose aspirin) 19.
Patients who have hypersensitivity history about Investigational Product. 20. In the midst
of women in their childbearing years, patients who disagree to do * contraception by
medically permitted method for 12 weeks from administrating investigational product.
- The contraception by medically permitted method: Condom, In case of using injection or
insertion, In case of installing a intrauterine contraception device etc.
21. Pregnant and lactating women 22. Patients who were injected other investigational
product over a time within 30 days before participated in this clinical trail.
23. Besides that, the patients who have difficulty to be participated in this clinical
trial continuously by Principle Investigator (PI)'s decision.
- Exclusion criteria for Re-injection is except for 13-1) Re-injection date is followed
by visit 7.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Clinical Trial of YYD302 (Phase3) for Treatment of Osteoarthritis of the Knee | NCT03561779 | Entailment |
4,518 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Has a regular menstrual cycle (for women only)
2. Young adult (18-35 years)
3. Right-side dominant
4. At least 30 min of moderate-intensity, physical activity on at least 3 days of the
week for at least the last 3 months
5. Without chronic neurological, psychiatric, or medical conditions
6. Not taking any psychoactive medications.
Exclusion Criteria:
1. Pregnant
2. Known holes or fissures in the skull
3. Metallic objects or implanted devices in the skull (e.g., metal plate)
4. Women on hormonal contraceptives/supplements.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | tDCS and Sex Differences | NCT04471805 | Contradiction |
6,757 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male, aged 12 to 65 years
- Severe hemophilia A
- History of more than 150 exposure days (ED) with clotting factor concentrates
- Currently receiving episodic treatment with FVIII; no regular prophylaxis for more
than 6 consecutive months in the past 5 years
- No current Factor VIII inhibitor or history of inhibitor
- Willing to use electronic patient diary
Exclusion Criteria:
- Presence of another bleeding disease that is different from hemophilia A
- Thrombocytopenia
- Abnormal renal function
- Presence of active liver disease
- Known hypersensitivity to FVIII
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A | NCT01233258 | Entailment |
920 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Males or Females 40 years and older
2. According to the clinical diagnosis standard of the American College of Rheumatology
(ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to
over 3 conditions of followings.
- Over 50 years of age
- Less than 30 minutes of morning stiffness
- Crepitus on active motion
- 4 bony tenderness
- Bony enlargement
- Nopalpable warmth of synvium
3. Within 6 months from screening visit, someone who diagnosed with Kellgren & Lawrence
Grade I~III by the radioactive examination.
4. By the Weight-bearing pain(100mm-VAS) examination, someone who has a outcome of the
single or both sides of the osteoarthritis is over 40mm
5. Patient (No-responder) who has experienced steady pain in spite of dosing NSAIDs or
other pain-killers in the past.
6. Patient who can walk by themselves without helper like cane or walker etc. (If the
patient who has used helper routinely from previous 6 months, evaluating the patient
including the helper is possible. In this case, patient needs to use same helper
continuously by end of the clinical trial test.)
7. Patient who agrees to participate in this clinical trial by themselves.
Exclusion Criteria:
1. Someone who has BMI≥32kg/m² at the screening visit.
2. Patient who has an experience dosing psychoactive drug, narcotic analgesic which can
have an effect on pain sense over 3 months habitually.
3. Patient who has been administrated gastrointestinal drug(for example H₂-blockers,
misoprostol or proton pump inhibitors) regularly, who can't stop injecting for
clinical study period.
4. Patient has attended abnormal values from screening test(2 times excess at upper limit
of the normal values at ALT, AST, BUN, Serum Creatinine).
5. Patient who has rheumarthritis or other inflammatory metabolic arthritis.
6. Patients having serious gastrointestinal, liver, renal, heart disease.
7. When the inflammatory disease is occurred on joint area to patient like septic
arthritis.
8. Patients having skin ailment at the injecting site of the joint region.
9. Patients having secondary osteoarthritis according to the Ochronosis, Hemochromatosis
or systemic disease.
10. Patients who have severe pain like Sudek's atrophy, Paget's disease, Spinal disc
herniation.
11. Poly-articular patients who have suffered seriously by osteoarthritis at other parts
affect judge of the knee joint pain.
12. Patients who diagnosed clear interval disappearance at the knee joint by X-ray.
13. Patients who were administrated below drugs before baseline visit.
- Patients who were injected HA at the target knee joint in recent 9 months.
- Patients who were injected HA at other parts of the knee joint in recent 6
months.
- Patients who were injected steroids into the intra-articular knee joint.
- Patients who were administrated steroids systemically by the oral medication
(But, except inhalation)
14. Patients who have joint effusion trouble were judged as a positive by tests like
Patella tap test.
15. Patients who have target knee joint gotten surgical operation history including
Arthroscopy within past one year (In case of having other side of knee joint or hip
joint gotten surgical operation history, excepting the patients if there is
possibility which can influence the target knee joint's appraisal.
16. Patients who have an operation history about target knee joint.
17. Patients who do the height weight aerobic exercise or anaerobic exercise.
18. Patients who need to be administrated anticoagulant agent together(But, except 300mg
daily dose aspirin)
19. Patients who have hypersensitivity history about Investigational Product.
20. In the midst of women in their childbearing years, patients who disagree to do *
contraception by medically permitted method for 12 weeks from administrating
investigational product.
* The contraception by medically permitted method: Condom, In case of using injection
or insertion, In case of installing a intrauterine contraception device etc.
21. Patients who were injected other investigational product over a time within 30 days
before participated in this clinical trail.
22. Besides that, the patients who have difficulty to be participated in this clinical
trial continuously by Principle Investigator (PI)'s decision.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| Clinical Trial of YY1201 for Treatment of Osteoarthritis of the Knee | NCT02554552 | Entailment |
1,083 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Suspected or certain neurally-mediated syncope, based on the Guidelines of the ESC TF
on Syncope.
- 3 syncope episodes in the last 2 years.
- Severe clinical presentation of syncope requiring treatment initiation in the
judgement of the investigator.
- Age >30 years.
- Patients have undergone carotid sinus massage, and ILR implantation.
Exclusion Criteria:
- ILR not implanted for any reason; in this case, the patients are still followed in the
ILR-not implanted group.
- Carotid sinus syndrome.
- Suspected or certain cardiac syncope.
- Symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement.
- Loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic,
drop-attack, TIA, intoxication, cataplexy).
- Steal syndrome.
- Psychologically or physically (due to any other illness) unfit for participation in
the study according to the opinion of the investigator.
- Patient compliance doubtful.
- Patients who are geographically or otherwise inaccessible for follow-up.
- Patient unwilling or unable to give informed consent;
- Pregnancy.
- Life expectancy < 1 year due to non-cardiac cause
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
| International Study on Syncope of Uncertain Etiology | NCT00120094 | Contradiction |
817 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- male or female patients aged between 18 and 75 years
- everyday joint pain for the past three months
- global pain intensity in the involved joint (hip or knee) of "moderate" to "severe"
within the last 48 h
Exclusion Criteria:
- acute inflammation or ischaemic necrosis
- paget's disease, chondrocalcinosis, ochronosis of the hip/knee joint
- slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology
- hip/knee arthropathy due to diabetes mellitus
- Charcot's joint
- villous synovitis
- chondromatosis of the synovium
- patients with existing gastritis or existing ulcers or bleedings in the
gastrointestinal tract or patients with history of gastrointestinal ulcers or
gastrointestinal haemorrhage in the past 6 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee | NCT01066676 | Entailment |
4,997 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
Seleced for DBS of the VIM nucleus at Vanderbilt Medical center Diagnosis of essential
tremor
Exclusion Criteria:
Unable to use the patient handheld programmer
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Atlas Predicted DBS Settings in Essential Tremor | NCT02678429 | Entailment |
3,526 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Female,
- Adrenal insuficiency,
- Stable and safe anticonception,
- Stable hydrocortison substituation treatment.
Exclusion Criteria:
- Neoplastic and thromboembolic disease,
- Diabetes mellitus.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Six Months DHEA Treatment in Female Adrenal Failure | NCT00471900 | Entailment |
4,803 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Be 18 years or over
- Be registered with a participating GP
- Must have visited their GP for dizziness in the last 2 years
- Must complete the consent form, and baseline questionaire indicating they are still
suffering from dizziness and that quick head movements make them dizzy.
Exclusion Criteria:
- Non-Labyrinthe cause of dizziness identified by GP
- Medical contraindications from making normal head movements
- Serious co-morbidity
- Moved away from practice
- Recently deceased
- Non-English speakers, and unable to read/write in English.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Trial of Booklet Based Self Management of Dizziness | NCT00732797 | Entailment |
2,408 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Evidence of signed and dated informed consent/assent document(s) indicating that the
participant (and/or his parent/legal guardian) has been informed of all pertinent
aspects of the trial. Note: If the study candidate is considered a child under local
regulation, a parent or legal guardian must provide written consent prior to
initiation of study screening procedures and the study candidate may be required to
provide written assent. The rules of the responsible Institutional Review
Board/Independent Ethics Committee (IRB/IEC) regarding whether 1 or both parents must
provide consent and the appropriate ages for obtaining consent and assent from the
participant should be followed.
2. History of exposure to ataluren in a prior PTC study in nmDBMD. Note: Participants are
considered eligible only if they received ataluren during their participation in 1 or
more prior PTC-sponsored studies of ataluren in nmDBMD. Note: Participants who have
participated in a prior or ongoing PTC study with ataluren in nmDBMD at a trial site
in the US or Canada, but reside outside of the US and Canada, may be eligible for this
study (with the approval of the PTC Therapeutics Medical Monitor).
3. Male sex.
4. In participants who are sexually active, willingness to abstain from sexual
intercourse or employ a barrier or medical method of contraception during ataluren
administration and the 6-week follow-up period.
5. Willingness and ability to comply with scheduled visits, drug administration plan,
study procedures, laboratory tests, and study restrictions. Note: Psychological,
social, familial, or geographical factors that might preclude adequate study
participation should be considered.
Exclusion Criteria:
1. Exposure to another investigational drug within 1 month prior to start of study
treatment.
2. Eligibility for another ataluren clinical trial that is actively enrolling study
participants.
3. Known hypersensitivity to any of the ingredients or excipients of ataluren (Litesse®
UltraTM [refined polydextrose], polyethylene glycol 3350, Lutrol® micro F127
[poloxamer 407], mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, vanilla,
Cab-O-Sil® M5P [colloidal silica], magnesium stearate).
4. Ongoing use of the following medications:
1. Coumarin-based anticoagulants (for example, warfarin), phenytoin, tolbutamide, or
paclitaxel.
2. Systemic aminoglycoside therapy
5. Ongoing uncontrolled medical/surgical condition, electrocardiogram (ECG) findings, or
laboratory abnormality that, in the Investigator's opinion, could adversely affect the
safety of the participant or make it unlikely that follow-up would be completed.
Male
No healthy subjects accepted to join the trial.
| Study of Ataluren for Previously Treated Participants With Nonsense Mutation Duchenne/Becker Muscular Dystrophy (nmDBMD) in Europe, Israel, Australia, and Canada | NCT01557400 | Entailment |
5,783 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Male and non-pregnant, non-lactating female subjects aged 18 years or older
- Diagnosed with chronic idiopathic pruritus (CIP) with an NRS Itch Score of ≥ 7 at both
Screening and Baseline
- Diagnosis of CIP for at least 6 weeks prior to screening
- Willingness to avoid pregnancy or fathering of children
- Ability and willingness to provide written informed consent
- Willing and able to comply with all study requirements and restrictions
- Willing to not participate in any other interventional trial for the duration of their
participation
- Subjects must be in good health as determined by medical history, physical
examination, electrocardiogram, clinical laboratory tests and vital signs
- Failure of a course 2-week course of treatment with topical triamcinolone 0.1%
ointment BID
- Histopathological demonstration of skin dermal edema, eosinophils, mast cell
activation or lymphocytic infiltration
Exclusion Criteria:
1. Chronic pruritus due to a defined primary dermatologic disorder (e.g., atopic
dermatitis, psoriasis, etc.)
2. Patients with a prior diagnosis of excoriation disorder
3. Use of topical treatments for CIP (other than bland emollients) within 1 week of
baseline
4. Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable
corticosteroids, methotrexate, cyclosporine, mycophenolat mofetil, azathioprine)
within 4 weeks of baseline
5. Subjects with cytopenias at screening, defined as:
1. Leukocytes < 3 × 109/L
2. Neutrophils < lower limit of normal
3. Lymphocytes < 0.8 × 109/L
4. Hemoglobin < 10 g/dL
5. Platelets < 100 × 109/L
6. Unwilling or unable to follow medication restrictions or unwilling or unable to
sufficiently washout from use of restricted medication
7. Use of any prohibited medications (see Section 5.8) within 14 days or 5 half-lives
(whichever is longer) of the baseline visit
8. Current clinically significant cardiovascular, respiratory, neurologic, hepatic,
hematopoietic, renal gastrointestinal, endocrine or metabolic dysfunction unless
currently controlled and stable, including (but not limited to) the following:
1. Positive for hepatitis C antibody test (anti-HCAbF) with detectable RNA
2. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody
(HBcAb);
3. Positive for HIV (DUO test, p24 antigen)
9. Active malignancy
10. Subjects with a history of malignancy, except for the following adequately treated,
nonmetastatic malignancies: basal cell skin cancer, squamous cell carcinomas of the
skin, or in situ cervical cancer
11. History (including family history) or current evidence of congenital long QT syndrome
or known acquired QT prolongation
12. Exposure to any investigational medication, including placebo, within 60 days of the
Baseline Visit
13. History of intolerance and/or hypersensitivity to medications similar to INCB039110
(e.g., Xeljanz)
14. Participation in a previous INCB39110 trial
15. Subjects with severely impaired liver function (Child-Pugh Class C) or end-stage renal
disease on dialysis or at least 1 of the following:
1. Serum creatinine > 1.5 mg/dL;
2. Alanine aminotransferase or aspartate aminotransferase ≥ 1.5 × upper limit of
normal
16. Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
17. Any other sound medical reason as determined by the Investigator including any
condition which may lead to an unfavorable risk-benefit of study participation, may
interfere with study compliance or may confound study results
18. Subjects taking potent systemic CYP3A4 inhibitors or fluconazole within 2 weeks or 5
half-lives, whichever is longer, before the baseline visit
19. Subjects who have previously received JAK inhibitors, systemic or topical (e.g.
ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib and pacritinib)
20. Women who were pregnant or breastfeeding within 4 months before screening.
21. Current or recent history (< 30 days before screening and/or < 45 days before
randomization) of a clinically meaningful bacterial, fungal, parasitic, or
mycobacterial infection
22. Clinically significant or uncontrolled cardiac disease, including unstable angina,
acute myocardial infarction within 6 months from Day 1 of study drug administration,
New York Heart Association Class III or IV congestive heart failure, and arrhythmia
requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mmHg) unless
approved by medical monitor/sponsor
23. History of alcoholism or drug addiction within 1 year before screening, or current
alcohol or drug use that, in the opinion of the investigator, will interfere with the
subject's ability to comply with the administration schedule and study assessments
24. Subjects who have received systemic chemotherapy at any time
25. Subjects who anticipate receiving a live or live-attenuated vaccination from screening
through the final follow-up visit
26. Subjects who, in the opinion of the investigator, are unable or unlikely to comply
with the administration schedule and study evaluations
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Relieving Chronic Itch: Oral Medication | NCT02909569 | Contradiction |
3,014 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Male or female patients, 18 to 45 years of age.
- Diagnosis of Fragile X Syndrome.
- Females must demonstrate a negative pregnancy test at screening.
- Females of child-bearing potential must be using a medically accepted means of
contraception or must remain abstinent for the duration of the study.
- Each Legally Authorised Representative (LAR, usually parent or caregiver) must have a
level of understanding sufficient to provide written informed consent to all required
study tests and procedures.
- Each patient must consent/assent (depending on center-specific procedures) to all
required study tests and procedures.
- Permitted concomitant medications must be stable for at least 6 weeks prior to
enrollment. The following concomitant medications are permitted: psychostimulants,
SSRIs, atypical antipsychotics, anticonvulsants which do not have liver inducing
effects, clonidine.
- Each patient must be able to swallow the capsules (2, 3 or 4) to be provided in the
study.
Exclusion Criteria:
- Current treatment with anticonvulsants known to induce liver enzymes e.g. depakote
- Current treatment with N-methyl-D-aspartate (NMDA) antagonists
- Current treatment with tricyclic antidepressants
- Current treatment with typical antipsychotics
- Current treatment with lithium
- Patients planning to commence cognitive behaviour therapy during the period of the
study or those who have begun cognitive behavioural therapy within 6 weeks prior to
enrolment.
- History of, or current cardiovascular, renal, hepatic, respiratory and particularly
gastrointestinal disease which may interfere with the absorption, distribution,
metabolism or excretion of the study medication.
- History of, or current cerebrovascular disease or brain trauma.
- History of, or current significant endocrine disorder, e.g. hypo or hyperthyroidism.
- History of, or current malignancy.
- Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder,
or other psychotic disorder, as assessed by the Investigator.
- Current major depressive disorder (patients must be free of the disorder for 3 months
prior to enrolment).
- Judged clinically to be at risk of suicide (suicidal ideation, severe depression, or
other factors), as assessed by the Investigator.
- Tourette's Disorder.
- Female patients who are either pregnant or nursing.
- Current drug abuse or dependence disorder or dependency in the 3 months prior to
enrolment.
- Clinically significant abnormalities in safety laboratory tests, vital signs or EKG,
as measured at screening
- Patients with significant hearing and/or visual impairments that may affect their
ability to complete the test procedures
- Enrollment in another clinical trial within the previous 30 days
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Open Label Study Investigating Safety and Efficacy of NPL2009 50 mg - 150 mg on Prepulse Inhibition Tests and Continuous Performance Tasks, Adults With Fragile X Syndrome | NCT00637221 | Contradiction |
1,929 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Age >18 years old
- Disease progression after treatment with the DCF regimen
- Assessable target lesion(s) as defined by RECIST criteria
- ECOG performance status ≤ 1
- Estimated life expectancy more than 3 months
- Serum bilirubin less than 1.5 times the upper normal limit
- Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper
normal limit
- Creatinine Clearance ≥50 ml/min
- Neutrophil count more than 1.5x 109 /L
- Platelet count more than 100x 109 /L
- Hemoglobin more than 8g/dL
- Before patient enrollment, written informed consent must be given according to Good
Clinical Practice guidelines and national/local regulations.
Exclusion Criteria:
- Gastrointestinal bleeding
- Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's
discomfort
- CNS metastases
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months
after the end of treatment
- Subject (male or female) is not willing to use highly effective methods of
contraception (per institutional standard) during treatment and for 6 months (male or
female) after the end of treatment
- Known hypersensitivity reaction to the component of the treatment
- Active infection or malnutrition or bowel obstruction
- Legal incapacity or limited legal capacity
- Definite contraindications for the use of corticosteroids
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest CT scan
- Chronic inflammation of the bowel
- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) ≤ 1 year before enrollment
- Medical or psychological condition which in the opinion of the investigator would not
permit the subject to complete the study or sign meaningful informed consent
- Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer | NCT02251951 | Entailment |
2,616 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- physical status ASA: I-II BMI >18kg/m2<30kg/m2 written informed consent from the patient
scheduled for open unilateral inguinal hernia repair
Exclusion Criteria:
- uncooperative patient
- Allergy to local anesthetic drugs
- patients on chronic alcohol, opioid, tranquilizer or sedative use
- Pregnant females.
- Psychological, mental disorders, or depression.
- Patients receiving anticoagulants therapy or suspected coagulopathy.
- Patients with infection or previous surgery at sit of anesthetic procedures.
- Patients with significant cardiovascular, respiratory, renal, hepatic, or metabolic
disease
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Qudratus Lumborum Block Versus Unilateral Intrathecal Block for Inguinal Hernia Repair | NCT04805580 | Contradiction |
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