id
int64 3
7.01k
| topic_id
int64 1
50
| statement_medical
stringclasses 50
values | statement_pol
stringclasses 50
values | premise
stringlengths 111
17k
| NCT_title
stringlengths 18
299
| NCT_id
stringlengths 11
11
| label
stringclasses 2
values |
|---|---|---|---|---|---|---|---|
1,417 | 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:
- Asymptomatic adult volunteer with previously determined normal esophagus and stomach
who understands the risks of the procedure.
Exclusion Criteria:
- Known strictures in the intestine,
- Crohn's disease,
- Swallowing difficulty,
- Age less than 21,
- Age over 75 or have a pacemaker,
- Presence of implanted metal devices,
- Presence of esophageal or bowel disease or conditions that may preclude study
participation as a matter of clinical judgment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Remote Manipulation of a Capsule Endoscope | NCT01044797 | Contradiction |
2,100 | 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:
For all patients
- history of clinically significant chronic cough for > 3 months
- For COPD patients
- >40 years of age
- 20-pack-year history of smoking
- GOLD classification of Stage 1 or higher
- For IPF patients
- > 50 years of age
- history of unexplained dyspnea on exertion of > 3 months
- exhibits coughing and bilateral, basilar, inspiratory crackles on physical exam
- presents as being in a stable phase of IPF
- lung biopsy or HRCT indicative of IPF
Exclusion Criteria:
- ACE inhibitor use
- GERD
- current cancer or history of lung cancer
- non-ambulatory
- hospitalized in the previous 12 months for heart failure
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.
| Interferon-alpha Treatment of Chronic Cough in Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis | NCT00690885 | Entailment |
6,006 | 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:
- Had Gastro Esophageal Reflux disease with or without oesophagitis.
- Had a history of heartburn at least for 5 days per week during the past 6 months or
was receiving long-term treatment with a proton pump inhibitor and during two weeks
(without proton pump inhibitor treatment) prior to enrolment.
Exclusion Criteria:
- History of surgery of stomach or oesophagus.
- Gastric ulcer (can be included after healing of gastric ulcer).
- Duodenal ulcer (can be included after healing of duodenal ulcer).
- Bleeding (melena, hematemesis).
- Severe concomitant disease (cancer, cardiovascular, renal, hepatic diseases).
- Barrett oesophagus with dysplasia.
- Complicated esophagitis (oesophageal strictures or ulcers).
- Treatment with proton pump inhibitor or Histamine receptor 2 (H2)antagonists within
the previous two weeks.
- Pregnancy, wish to become pregnant, breast feeding.
- Treatment with non steroidal anti-inflammatory drugs, treatment with acetylsalicylic
acid (aspirin) > 100 mg/day.
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 | Safety and Efficacy of Lansoprazole in Patients With Reflux Disease | NCT01135368 | Entailment |
5,669 | 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:
- Children has completed all visits and therapy in previous phase IV study;
- Investigators evaluate subjects could continue growth hormone therapy;
- Subjects is willing and able to cooperate to complete scheduled visits, treatment
plans and laboratory tests and other procedures, to sign informed consent.
Exclusion Criteria:
- Children with epiphyseal closure;
- Children is near the adule final height, that is, growth rate≤ 2 cm / year or bone age
≥ 14 years old for girls, bone age ≥ 16 years old for boys;
- Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper
limit of normal);
- Patients with known hypersensitivity to PEG-Somatropin or Somatropin or any other
components of the study product;
- Patients with severe cardiopulmonary or hematological diseases, a current or past
history of malignant tumors, immunodeficiency diseases, or mental diseases;
- Patients with diabetics;
- Patients with congenital bone dysplasia or scoliosis;
- Patients took drugs that would influence the efficacy and safety of PEG-Somatropin
after phase IV study and before screening for this extension study;
- Other conditions in which the investigator preclude enrollment into 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 42 Months old.
Subject must be at most 15 Years | Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children | NCT03290235 | Contradiction |
1,989 | 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:
1. An individual, or their family members, with any of the following:
- Fulfills clinical criteria for Hereditary Diffuse Gastric Cancer (HGDC) syndrome
or Gastric Adenocarcinoma and Proximal Polyposis of the Stomach (GAPPS) syndrome
- Clinically suspicious personal or family medical history of gastric cancer or
gastric cancer syndrome that warrants genetics evaluation
- Current diagnosis of gastric cancer and a germline mutation associated with a
known cancer syndrome or an associated family history of gastric cancer
- Harbors a pathogenic germline mutation known to predispose to gastric cancer
- First-degree relatives, regardless of family history or personal history of
cancer, with a documented deleterious germline mutation (including but not
limited to CDH1, CTNNA1, SDH) known to predispose to gastric tumors
- Diagnosis or suspicion of a premalignant or malignant stomach lesion of suspected
hereditary etiology
2. Age greater than or equal to 18 years; patients under 18 years of age and greater than
or equal to the age of 2 may participate if the tissue acquisition is performed during
a clinically indicated surgical procedure, and the sampling of tissue, blood and urine
collection does not add risk to the clinically indicated procedures.
3. Ability of subject or legally authorized representative (LAR) to understand and the
willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
-None
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
| Hereditary Gastric Cancer Syndromes: An Integrated Genomic and Clinicopathologic Study of the Predisposition to Gastric Cancer | NCT03030404 | Entailment |
1,627 | 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:
- right handed adults
- no known physical or neurological abnormalities
Exclusion Criteria:
- patients with:
- cardiac pacemaker
- surgical clips or values on the heart
- implants
- metal or metallic fragments in any part of the body
- pregnancy
- claustrophobia
- a personal or family history of epilepsy
- currently taking antipsychotic drugs
- currently taking antidepressant drugs
- currently taking antianxiety drugs
- history of concussion.
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 40 Years | Sensory Memory in Speech Motor Learning | NCT04818268 | Contradiction |
6,182 | 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:
- Patients with Covid-19
- non-opposition of the patient to participate
Exclusion Criteria:
- Non-Covid-19 acute respiratory distress syndrome
- Non-Covid septicemia
- Pregnant women
- Breastfeeding women
- Protected vulnerable adults
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.
| Thrombosis and Covid-19 | NCT04366778 | Contradiction |
2,560 | 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 3 months to 16 years
- hospitalization for expiratory wheezing
- written informed consent from the parents
Exclusion Criteria:
- Any chronic disease (other than allergy or asthma), e.g. heart disease, immune
deficiency, or diabetes
- varicella and exposure to varicella if not previously have had it
- Systemic glucocorticoid 4 weeks prios to the study
- Severe disease that needs treatment in the intensive care unit or oxygen saturation
below 92% despite of additional oxygen and frequent salbutamol inhalations
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 15 Years | Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children | NCT00494624 | Entailment |
3,921 | 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:
- Knee pain
- Failure to understand the pain with more conventional diagnosis
- Symptoms and retrotrochanteric pain with examination
- Pain relief with retro trochanteric local anaesthetic injection
Exclusion Criteria:
- Mental illness
- Failure to cooperate
- Not adequate Norwegian language skills
- Other well known disease explaining symptoms
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 70 Years | The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain | NCT02560259 | Entailment |
4,504 | 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:
- Male or female Caucasian participants aged 45-70 years;
- Body Mass Index (BMI) between 18 and 30 kilograms per square meter (extremes
included);
- Participants must be in good health as determined by medical history, physical
examination, 12-lead electrocardiogram (ECG), electroencephalogram (EEG), vital signs
and clinical laboratory parameters (haematology, sedimentation rate, clotting,
clinical chemistry, urinalysis and virus serology). Minor deviations of laboratory
values and ECG parameters from the normal range may be accepted, if judged by the
investigator to have no clinical relevance and if not considered to interfere with the
study objectives;
- Adequate contraception. For females of childbearing potential (i.e., all females
except surgically sterilized or at least 2 years postmenopausal) this was defined as
follows: any form of hormonal contraception or intra-uterine device had to be used, at
least from 4 weeks prior to the first dosing up to 4 weeks after the last dosing and
an additional barrier contraception (condom or diaphragm) had to be used from 2 weeks
prior to the first dosing up to 4 weeks after the last dosing;
- Participants must give written informed consent to participate within this study;
- Negative human immunodeficiency virus-1/2-antibodies, surface antigen of the hepatitis
B virus (HBs-antigen), hepatitis B core (HBc)-antibodies, hepatitis C virus
(HCV)-antibodies determined at screening examination;
- Negative drug abuse screening test determined at screening examination and prior to
first dose administration in each period (the test will include screening for
amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids and opiates);
- Negative blood beta-human chorionic gonadotropin (beta-HCG) test for females of
childbearing potential determined at screening examination and prior to first dose
administration in each period (the test is not necessary in females who are in
post-menopausal state for at least 2 years or in females with status after surgical
sterilisation).
Exclusion Criteria:
- Pulse rate below 50 or above 100 beats per minute. The measurement must be performed
in supine position after a resting period of at least 5 minutes
- Systolic blood pressure below 100 or above 160 millimeters Mercury (mmHg), diastolic
blood pressure below 50 or above 100 mmHg. The measurement must be performed in supine
position after a resting period of at least 5 minutes;
- Participants with history or presence of diseases or functional disorders of the
central nervous system, endocrinological system, gastrointestinal tract, connective
tissue, hepatobiliary system, renal system, respiratory system or cardiovascular
system or other conditions known to interfere with the absorption, distribution,
metabolism or excretion of drugs;
- Marked repolarisation abnormality (e.g., suspicious or definite congenital long QT
syndrome) or co-medication that is known to influence cardiac repolarisation
substantially;
- History of seizures or at risk (i.e. head trauma, epilepsy in family anamnesis,
unclear loss of consciousness); abnormal, clinically relevant EEG findings at
screening;
- History of orthostatic hypotension;
- Bronchial asthma;
- Definite or suspected history of drug allergy or hypersensitivity;
- History of Raynaud´s disease or phenomenon;
- Malignancy;
- Participation in another clinical study within the last 3 month prior to the start of
this study (exception: characterisation of metaboliser status);
- Blood donation (above 100 milliliters [mL]) or comparable blood losses within three
month prior to the start of this study;
- Excessive consumption of food or beverages containing caffeine or other xanthines
(more than 1000 mL coffee or equivalent per day) within 2 weeks before administration
of the investigational products or during the study;
- Drinking of alcohol containing beverages within 48 hours before administration of the
investigational products or during the study;
- Evidence of alcohol, medication or drug abuse;
- Smoking of more than 3 cigarettes per day. Smokers who are not able to abstain from
smoking for 24 hours prior to the administration of any cold pressor test, and during
the period of hospitalisation must be excluded;
- Intake of drugs that are substrates to cytochrome P2D6 (CYP2D6) isoenzyme within the
last 4 weeks prior to the start of this study. Intake of more than 1000 mg paracetamol
within 3 days prior to administration of the investigational products. Use of any
other medication within 4 weeks prior to the start of the study (self-medication or
prescription), if not on a stable basis;
- Neurotic personality, psychiatric illness or suicide risk;
- Known or suspected of not being able to comply with the study protocol or of not being
able to communicate meaningfully with the investigator and staff;
- Participants who in the opinion of the investigator should not participate in the
study;
- Not able to perform the Cold Pressor Test reproducibly, i.e., the difference in the
area under the pain-time curves (AUC) is above 20 percent during the 2 tests performed
to evaluate the reproducibility at screening;
- Not able to perform the Vienna Test System (Determination Test, Visual Pursuit Test,
Tachistoscopic Traffic Test Mannheim for Screen or equivalent subtests);
- Pregnant or breastfeeding women.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 70 Years | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GRT9906 Prolonged Release Tablets After Dose Escalation in Healthy Subjects | NCT03776110 | Contradiction |
1,295 | 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:
- Adults: between 18 and 70 years old; obesity present as defined by body mass index
(BMI) ≥30 kg/m2 and by abdominal circumference ≥84 cm (women), and ≥90 cm (men);
dyslipidemia present as defined by: serum Cholesterol ≥200 mg/dl, HDLc ≤50 mg/dl
(women) or ≤40 mg/dl (men), serum Triglycerides ≥150 mg/dl, or present treatment for
dyslipidemia (e.g. statins, fibrates, omega-3 fatty acids, cholestyramine, ezetimibe).
- Children: age between 7 and 18 years old; BMI >+2SD WHO reference
Exclusion Criteria:
- Adults: diagnosed for any type of cancer, or medical history of cancer; any
auto-immune disease; any psychiatric disorder; blood coagulation disorders; history of
drug abuse; alcohol abuse evaluated using AUDIT-C.
- Children: the above exclusion criteria for adults; familial hypercholesterolemia;
endocrine-induced obesity (Cushing syndrome, hypothyroidism, growth hormone deficit),
hypothalamus-induced obesity (Babinski-Fröhlich syndrome), genetic syndromes
(Prader-Willi, achondroplasia, Bardet-Biedl, Fanconi, Turner, etc.); deposition
diseases (glycogenosis, lipomatosis); personal history for: convulsive disorders,
nephrotic syndrome, or asthma that necessitated corticoid treatment.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 70 Years | Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People | NCT02837367 | Contradiction |
2,445 | 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:
- • Males or females, of any race, between 18 and 80 years of age, inclusive;
- Able to speak, read, and understand English;
- Able to provide written informed consent;
- Able to communicate effectively with the Investigator and other study centre
personnel and agree to comply with the study procedures and restrictions.
- Clinician diagnosis of pulmonary sarcoidosis;
- If a female of child-bearing potential (i.e., have not undergone a hysterectomy
or bilateral oophorectomy) or not post-menopausal (defined as no menses for at
least 12 months), agree to use acceptable birth control (defined in Section 6.3)
from screening through to the follow up visit;
Exclusion Criteria:
- • Hypersensitivity to azithromycin or another macrolide antibiotic (e.g. erythromycin,
clarithromycin) or excipients (see 7.4)
- History of signficant cardiac arrhythmia
- Personal or family history of congenital long QT syndrome;
- Prolonged QTc interval on 12-lead ECG
- Signficant liver disease
- Evidence of acute bacterial infection
- Clinically significant bronchiectasis
- Requiring concomitant therapy with prohibited medications (see Section 7.5)
- Pregnant or breastfeeding;
- Treatment with an investigational drug or biologic within 30 days preceding the
first dose of study medication or plans to take another investigational drug or
biologic within 30 days of study completion;
- Other severe, acute, or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with trial participation or
investigational product administration or may interfere with the interpretation
of trial results and, in the judgment of the Investigator or Sponsor, would make
the subject inappropriate for entry into this trial.
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 80 Years | Azithromycin a Treatment for Pulmonary Sarcoidosis | NCT04020380 | Entailment |
5,848 | 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:
- Symptoms indicating dyspepsia, including:
- Epigastric pain or epigastric discomfort
- Bothersome postprandial fullness
- Early satiation
- Epigastric burning
- Access to internet
Exclusion Criteria:
- Daily use of PPI or H2-receptor antagonists in more than 28 days within the last 120
days OR more than two days within the last 28 days OR more than five non-consecutive
days within the last 28 days.
- Mild heartburn or regurgitation more than once per week
- Moderate or severe heartburn or regurgitation at least once per week
- Complications to GERD (esophagitis, stricture or Barrett's esophagus) prior to
enrolment or at screening
- Abnormal findings at upper endoscopy necessitating treatment
- Abnormal pH-monitoring prior to enrolment or at screening (pH <4 in ≥5.5 % of the time
on "worst day" of 48-h monitoring)
- Excludes data from analysis regarding primary endpoint (see summary)
- Previous surgery on esophagus, stomach or duodenum
- Regular use of NSAIDs through the last six months
- Potential language problems in understanding information and registering symptoms
- Pregnancy or breast feeding
- Other diseases which can interfere with the symptom registration (severe congestive
heart disease, malignant disease, schizophrenia ect.)
- Abuse of alcohol/narcotics
- Allergy/intolerance to gelatine or lactose used in placebo
- Patients with pacemaker, Implantable Cardioverter Defibrillator or Implantable
Neurostimulator
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 Clinical Significance of Acid Rebound in Functional Dyspepsia | NCT01373970 | Contradiction |
5,306 | 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:
- women 55-80 years of age;
- post-menopausal for >= 5 years;
- ambulatory.
Exclusion Criteria:
- malignant disease diagnosed within the previous 10 years (except basal cell cancer
that has been successfully removed);
- breast cancer within the previous 20 years;
- allergy to bisphosphonates;
- previous treatment with an intravenous bisphosphonate at any time;
- previous treatment with an oral bisphosphonate within the last 6 months, >1 month of
treatment within the last year, or >3 months of treatment within the last 2 years.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 80 Years | MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis | NCT00048061 | Entailment |
2,163 | 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:
- Patients currently treated at the University of Mississippi Medical Center General
Internal Medicine/Hypertension or Family Medicine Clinics.
- Have a diagnosis of gout.
- Taking allopurinol at a stable dose for at least 2 months.
Exclusion Criteria:
- Less than 18 years old.
- Severe renal impairment defined as CrCl <30 mL/min.
- Previous diagnosis of severe hepatic impairment.
- Currently taking azathioprine, mercaptopurine, or theophylline.
- Pregnant, breastfeeding, or anticipating pregnancy or breastfeeding.
- Arm circumference greater than 50 cm.
- Change in antihypertensive medication within the previous 2 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 80 Years | The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study | NCT01701622 | Contradiction |
6,011 | 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. Subject age ≥ 18 years old
2. Subject received an explanation about the nature of the study and agrees to provide
written informed consent.
Group A (healthy volunteers) Only
3. Subject is an healthy volunteer
Group B (symptomatic patients) Only 1. The subject was referred for pH monitoring procedure
to detect acid reflux for at least one of the following reasons:
- Burning substernal chest pain (heartburn)
- Regurgitation of food or stomach contents
- Dysphagia
- Epigastric pain
- Non-erosive reflux disease (NERD)
Exclusion Criteria:
Group A and B-
1. Subject has a cardiac pacemaker or other implanted electromedical device.
2. Subject has any condition, which precludes compliance with study and/or device
instructions.
3. Women who are either pregnant or nursing at the time of screening, or are of
child-bearing potential and do not practice medically acceptable methods of
contraception.
4. Subject suffers from life threatening conditions
5. Subject currently participating in another clinical study which may interfere with
study objectives, per physician discretion
Additional exclusion criteria for Group B only
6. Subject has prior abdominal surgery other than uncomplicated procedures that would be
unlikely to lead to bowel obstruction based on the clinical judgment of the
investigator
7. Subject is schedule to undergo MRI examination within 30 days from pH monitoring
procedure.
8. Subject has known bleeding diathesis, strictures, severe esophagitis, varices and or
obstructions -
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance | NCT01503476 | Entailment |
2,528 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- • Male or female between 2 and 12 years of age
- The subject suffers from moderate atopic dermatitis (SCORAD<40) that is amenable
to treatment
- Diagnosis of atopic dermatitis meets Hanifin's criteria (at least 3 basic
features and at least 3 minor features)
- Atopic dermatitis is, in the opinion of the investigator, stable for the past 7
days
- The subject's parents are able to apply the study product twice a day (each
morning and evening) for a consecutive period of 42 days
- The subject's parents agree that the subject will not change his/her lifestyle
during the study period (including: regular body hygiene product (soap), the
number of baths and showers per day, the laundry detergent and fabric softener
used to wash clothes)
- The subject's parents agree to use only the test product during the study period
- The subject's legal guardian is able and willing to sign the informed consent
form and to comply with the study regulations of this protocol
Exclusion Criteria:
- • The subject has another dermatological disease/condition that could interfere with
the clinical evaluation, including infected atopic dermatitis lesions
- The subject has a previous history of allergy to cosmetic products or to any of
the ingredients included in the tested formulations (Appendices 1 and 2)
- The subject received a topical or a systemic immune-modulator (such calcineurin
inhibitors or cortico-steroids) for the treatment of atopic dermatitis, within 14
days prior to day 0
- The subject underwent phototherapy within 28 days prior to day 0
- The subject is expected to be extensively exposed to the sun during the trial
- The subject underwent any experimental treatment within 14 days prior to day 0
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 12 Years | Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD) | NCT01781663 | Entailment |
4,002 | 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:
- Confirmed diagnosis of knee osteoarthritis (OA)
- OA ranging from grade 1 to grade 3 by Kellgren and Lawrence system
- Agree to participate into the study
Exclusion Criteria:
- OA ranging from grade 4 by Kellgren and Lawrence system
- Allergic or contradicted with oral NSAIDs (Meloxicam)
- Pregnant and breastfeeding women.
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.
| Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis | NCT03717714 | Entailment |
4,419 | 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:
- All patients with tennis elbows in our hospital
Exclusion Criteria:
- none
No condition on gender to be admitted to the trial.
| Tennis Elbow Patients Undergoing Closed Therapy Can Easily Cause Tendon Tear | NCT04457024 | Contradiction |
3,953 | 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:
- symptomatic knee OA
- Kellgren- Lawrence grades I - III OA
- no or minimal positive effects of previous conservative treatment (rehabilitation,
hyaluronic acid injections, steroid injections)
- VAS pain level minimum 4 in one knee, VAS pain < 2 in the contralateral knee
Exclusion Criteria:
- Use of local corticosteroids up to three months or hyaluronic acid injections up to
six months prior to the study
- Past or present joint infection
- Previous knee arthroscopy surgery up to one year prior to examination
- Peripheral inflammatory diseases (rheumatoid arthritis, spondyloarthropathies, etc.)
- Total arthroplasty and osteotomy
- Ankylosis of the joint
- Dermatitis or dermatological disease at the intended injection site
- Coexistence of degenerative changes in other limb joints (hip, foot)
- Cancer
- Oral corticosteroid therapy
- Use of medicines that affect blood clotting
- Pregnancy or breast-feeding
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 65 Years | Knee Arthritis Treatment With Autologous Fragmented Adipose Tissue and PRP - Comparison of Two Treatment Methods | NCT04321629 | Entailment |
699 | 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:
Written informed consent must be obtained prior to any screening procedures.
Patients eligible for inclusion must meet all following criteria prior to receiving study
treatment:
1. Male or female ≥ 18-years-old 2. Documented genotype testing confirming homozygous for
the C282Y mutation (C282Y/C282Y) 3. Transferrin saturation ≥ 45% (at either screening
visit) 4. Serum ferritin (SF) ≥ 500 μg/L (at either screening visit)
-
Exclusion Criteria:
1. Medical conditions that preclude inclusion:
- Iron overload not due to HH
- Condition which might significantly alter the absorption, distribution,
metabolism or excretion of oral deferasirox
- Systemic disease which prevents taking study treatment or any contraindication to
phlebotomy
- Inflammatory condition or immunological disease which may interfere with the SF
interpretation, such as an active infection, collagen vascular disorders,
irritable bowel syndrome, lupus, or immune thrombocytopenia
- Significantly impaired gastrointestinal function or disease that may
significantly alter the absorption of oral deferasirox, e.g. ulcerative diseases,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel
resection.
- Psychiatric or addictive disorder which prevent giving informed consent or
undergoing any of the treatment options or unwilling or unable to comply with the
protocol
- Uncontrolled or significant cardiac disease or symptomatic cardiac arrhythmias,
e.g., sustained ventricular tachycardia and clinically significant second or
third degree AV block without a pacemaker.
- Illicit drug use and/or alcohol use, defined as an average alcohol consumption
greater than one standard drink a day for women or two standard drinks a day for
men within the 12 months prior to enrolment. A standard drink is generally
considered to be 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of 80-proof
distilled spirits
- Cirrhosis, including Child-Pugh class A, B, and C, diagnosed by liver biopsy,
elastography, radiologic exams, or clinical criteria
- Active hepatitis B or C (hepatitis B carrier will be allowed)
- History of HIV seropositivity (ELISA or Western blot)
- Organ transplant recipient
- Malignancy of any organ system, treated or untreated, within the past 5 years
whether or not there is evidence of local recurrence or metastases, except
localized basal cell carcinoma of the skin, or any history of hepatocellular
carcinoma
2. Concomitant therapy that precludes enrollment:
- Prior iron chelation therapy
- Prohibited concomitant medications with deferasirox
3. Abnormal Laboratory Values:
- Significant anemia that contraindicates phlebotomy (males with hemoglobin <
130g/L, females with hemoglobin < 120g/L) in both screening visit samples
- Platelets ≤ 50 x 109/L in both screening visit samples
- Urine protein/urine creatinine ratio > 1.0 mg/mg in both non-first void urine
screening visit samples
- Creatinine clearance ≤ 40 ml/min, or use the locally approved contraindication
limit in prescribing information if it is stricter, in both screening visit
samples
- Serum creatinine > 1.5 x ULN in both screening visit samples
- ALT ≥ 5 x ULN in both screening visit samples
- Total bilirubin > 1.5 x ULN in both screening visit samples
4. Participation in an investigational study:
- Observational registry study is allowable
- Within 30 days prior to enrollment or within 5-half-lives of an investigational
product, whichever is longer
- Treatment with a systemic investigational drug within 4 weeks or topical
investigational drug within 7 days of starting the study
5. Pregnancy and contraception:
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless using basic methods of contraception, such as:
- Total abstinence Periodic abstinence (calendar, ovulation, symptothermal,
post-ovulation methods) and withdrawal are unacceptable methods.
- Female sterilization (bilateral oophorectomy with or without hysterectomy), total
hysterectomy, or tubal ligation at least six weeks before taking study treatment.
If oophorectomy alone, hormone levels must confirm menopause.
- Male sterilization (at least 6 months prior to screening). The vasectomized male
must be the sole partner.
- Barrier methods of contraception: condom or occlusive cap For UK: spermicidal
foam/gel/film/cream/vaginal suppository
- Placement of an intrauterine device or intrauterine system
- Women considered as post-menopausal and not of childbearing potential are allowed
to be enrolled in the trial if they have had 12 months of natural (spontaneous)
amenorrhea with an expected clinical profile, e.g., age appropriate and history
of vasomotor symptoms.
Other protocol-defined inclusion/exclusion may apply. -
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 Two-year Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis. | NCT03203850 | Entailment |
697 | 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. | Index subjects as well as male and female first and second degree family members, greater
than 5 years of age, of index subjects with iron overload.
In some cases, more distant family members will also be studied.
No patients less than or equal to 5 years old.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Iron Overload in African Americans | NCT00001455 | Entailment |
5,203 | 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:
- age: 50 and older
- vertebral fracture: 15-85% height loss
- level: thoracic vertebral body 5 (Th 5) or lower
- osteopenia (T-score < -1 SD)
- back pain for at least no longer than 6 weeks
- edema in the vertebrae on MR imaging
Exclusion criteria:
- complete loss of vertebral body height
- fracture through or destruction of the posterior vertebral wall
- pressure of bone fragments on the spinal cord
- osteomyelitis or spondylodiscitis
- vertebral column neoplasms
- uncorrectable coagulation disorder
- medical conditions that would make the patient ineligible for emergency decompressive
surgery should it be necessary to treat a complication of the procedure
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.
| VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Therapy | NCT00232466 | Entailment |
4,708 | 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:
- Willing and able to use OCs or DMPA
- General good health (by volunteer history and investigator assessment) without any
clinically significant systemic disease
- Currently having regular menstrual cycles of 25 to 35 days by volunteer report
- History of Pap smears and follow-up consistent with American Congress of Obstetricians
and Gynecologists (ACOG) practice bulletin #99 or #109 or willing to undergo a Pap
smear at Visit 1
- Willing to follow protocol requirements including abstinence, use of study condoms,
and prohibited use of intravaginal products
- Willing to follow post-biopsy restrictions for at least 5 days following genital
biopsies
- Meets one of the following criteria:
1. Sexually abstinent and planning to remain abstinent for the duration of the
study.
2. In a mutually monogamous relationship for at least the last 4 months with a male
partner who is at least 18 years of age, willing to use condoms, and has no known
HIV infection or risks for sexually transmitted infections (STIs)
3. In a mutually monogamous same-sex relationship for at least the last 4 months
with a partner who is at least 18 years of age and has no known HIV infection or
risks for STIs
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy genital tract sample collection
- Negative urine pregnancy test
- Willing to give voluntary consent, sign an informed consent form and comply with study
procedures, as required by the protocol
Exclusion Criteria:
- History of hysterectomy
- Currently pregnant or within 2 calendar months from the last pregnancy outcome. (Note:
If recently pregnant must have had at least 2 spontaneous menses since pregnancy
outcome.)
- Use of any hormonal contraceptive method in the last 30 days (oral, transdermal,
transvaginal, implant, or hormonal intrauterine contraceptive device)
- Injection of DMPA in the last 6 months
- Protection from pregnancy by presence of a copper IUD
- Currently breastfeeding or having breastfed an infant in the last 2 months, or
planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of the study product, or topical
anesthetic, or allergy to both silver nitrate and Monsel's solution
- Diagnosed with or treated for any STI or pelvic inflammatory disease in the last 6
months. (Note: Women with a history of genital herpes or condylomata who have been
asymptomatic for at least 6 months may be considered for eligibility.)
- Positive test for Trichomonas vaginalis, Neisseria gonorrhoeae or Chlamydia
trachomatis
- Symptomatic vulvovaginal candidiasis, Nugent score greater than or equal to 7 at
screening or bacterial vaginosis (BV) at Visit 2, or urinary tract infection (UTI)
- Deep epithelial genital findings such as abrasions, ulcerations, or lacerations, or
vesicles suspicious for STIs
- Positive test for HIV
- Positive test for Hepatitis B surface antigen (HBsAg)
- Known bleeding disorder that could lead to prolonged or continuous bleeding with
biopsy
- Chronic or acute vulvar or vaginal symptoms (e.g., pain, irritation, or spotting)
- Contraindications to the chosen contraceptive method
- Known current drug or alcohol abuse which could impact study compliance
- Grade 1 or higher laboratory abnormality, per the August 2009 update of the DAIDS
Table for Grading the Severity of Adverse Events
- Participation in any other investigational trial (device, drug, or vaginal trial) in
the last 30 days or planned participation in any other investigational trial during
the study
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix in the last 14 days
- Abnormal finding on laboratory or physical examination or a social or medical
condition which, in the opinion of the investigator, would make participation in the
study unsafe or would complicate interpretation of data
- Systemic use in the last two weeks or anticipated use during the study of any of the
following: corticosteroids, antibiotics, antifungals, antivirals or antiretrovirals
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use | NCT01421368 | Entailment |
6,785 | 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:
- Males aged 12 to 60 years
- Hemophilia A with plasma FVIII level less than 1% (severe hemophilia)
- No history of FVIII inhibitor antibody formation and no current evidence of inhibitor
antibody measured using the Nijmegen modified Bethesda assay (< 0.6 Nijmegen Bethesda
Units [N.B.U.]/mL)
- No signs or symptoms of an acute bleeding episode on the day of infusion
- Four or more days without treatment with FVIII prior to the day of infusion
- Subject (or the subject's legal representative) must provide written informed consent
and authorization of use and disclosure of Protected Health Information (PHI)
- Subjects must have been previously treated with FVIII concentrate for a total of at
least 200 exposure days, including 20 exposure days in the previous 12 months.
Previous treatment can have been with any type of rFVIII or plasma-derived FVIII
concentrate
Exclusion Criteria:
- Individuals with abnormal renal function (serum creatinine concentrations greater than
1.3 mg/dL) or active hepatic disease (persistent aspartate aminotransferase [AST] or
alanine aminotransferase [ALT] increases to greater than five times the upper limit of
normal).
- Individuals with anemia, as defined by hemoglobin level less than 12 g/dL
- Any individual with a past history of severe reaction(s) to FVIII products
- Any individual on interferon treatment or who has received interferon within the
previous 3 months
- Any individual with thrombocytopenia (platelets greater than or equal to 100,000
cells/mm3) or known hematologic/bleeding problems other than hemophilia A
- Any individual who is receiving or has received other experimental drugs within 3
months prior to study entry
- Any individual with known dislipidemic disease or actively taking cholesterol lowering
drugs for the treatment of hypercholesterolemia or hyperlipidemia (e.g., statins,
cholesterol absorption inhibitors, bile acid sequestrants, nicotinic acid or fibrates)
or individuals taking anaesthetic drugs
- Any individual who requires pre-medication for FVIII infusions (e.g., antihistamines)
- Any individual with high blood pressure (defined as diastolic blood pressure great
than or equal to 100 mm/Hg)
- Any patient who cannot forego FVIII treatment for at least 4 days prior to study entry
or between study infusions due to a need for more frequent prophylactic treatment
because of a pre-existing medical condition
- Any patient with known allergy or severe reactions to liposomes or PEG
- Individuals with any other known disease affecting hemostasis besides hemophilia A
- Any patient who is not suitable for participation in this trial for any reason,
according to the Investigator
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 60 Years | Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980 | NCT00629837 | Entailment |
2,523 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
1. Must be a new patient/parent dyad arrived at the main pediatric dermatology clinic
2. Patient must be under the age of 18.
3. Consenting parent or guardian must be present and able to speak English to
participate.
4. Patients are either already enrolled in MyCHOP (MyChart) or are willing to enroll
during the encounter.
5. Parent or legal guardian has a mobile phone with the capability to download the free
MyChart app.
6. Parents have a data plan that allows them to download the MyChart app (if not already
downloaded) and upload pictures, and are willing to accept any potential data charges
incurred with these activities.
7. Patient has active skin lesion or rash that can be photographed during the clinic
visit.
Exclusion Criteria:
1. Patient is over the age of 18.
2. Parent or guardian is not present or not able to speak English.
3. Parent or guardian is not able to enroll in MyCHOP (MyChart).
4. Parent or guardian does not have a mobile phone capable of downloading the MyChart
app.
5. Photographs are not able to be taken (phone battery dies, phone/app does not work,
patient is not cooperative, participant does not have time).
6. If there are no active skin lesions to photograph the patient/parent will not be
enrolled (e.g. hives that are inactive, hyperhidrosis [excessive sweating], itching
without a rash, resolved skin lesions [e.g. warts, molluscum]).
7. Patients presenting for a general full body skin exam will be excluded, as this would
require full body photography, which is too time consuming. (Note: this does not
include evaluation of one individual mole [nevus], which can be included in the
study).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at most 17 Years | Photograph Quality Rating Scale Study ("PQRS Study") | NCT03246945 | Entailment |
6,876 | 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:
- 55 years of age or older
- Elevated dementia-related fear
- Able to read/write in English
- Willingness to be randomized to intervention group
- Willingness to complete three weeks of self-guided intervention, questionnaires, and
cognitive tests.
- Access to a reliable internet connection
Exclusion Criteria:
- Diagnosis of mild cognitive impairment, Alzheimer's Disease, or dementia by a
healthcare provider.
- Impaired cognitive or neurologic function
- Unstable medical condition
- Severe depression
- Current treatment for anxiety or depression
- Current participation in another psychotherapy
- Current use of psychiatric medication
- Current substance use disorder
- Inadequate vision or hearing to interact with study materials
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
| Memory and Fear Study (Fear of Memory Loss Study) | NCT04821960 | Contradiction |
2,781 | 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 a diagnosis of inguinal hernia undergoing laparoscopic repair
- Age 21-80 years
- Patients taking Aspirin
- BMI 18-30
Exclusion Criteria:
- Age <21 and >80years
- Recurrent inguinal hernia
- Coagulopathy
- Patients who can't stop Aspirin
- BMI <18 and >30
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years | Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair | NCT02604732 | Entailment |
6,574 | 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:
- Any age (newborn and older)
- Ability to comply with the study protocol, in the investigator's judgment
- Diagnosis of hemophilia A and current or history of an inhibitor (Bethesda titer ≥0.6
Bethesda units) and currently using bypassing agents (BPAs) for breakthrough bleeds
(for PwHA with inhibitors)
- Diagnosis of hemophilia A and no history of an inhibitor (Bethesda titer <0.6 Bethesda
units), or a history of an inhibitor that has been tolerized for >5 years and using
FVIII for breakthrough bleeds (for PwHA without inhibitors)
- Plan to receive at least 4 loading doses of emicizumab and been adherent to emicizumab
prophylaxis by the time of surgery
- Undergoing minor surgery within 60 days of study enrollment. Other minor surgical
procedures could be included upon consultation and approval of Medical Monitor, but
examples include central venous catheter insertion/removal/replacement, simple dental
extractions, colonoscopy, cystoscopy, or endoscopy with biopsy, excisional skin biopsy
- Must plan to continue emicizumab prophylaxis for at least 1 month after surgery
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods that result in a failure rate
of <1% per year during the study period
Exclusion Criteria:
- Diagnosis of a bleeding disorder other than hemophilia A
- Participants who have been tolerized to Factor VIII products (for PwHA with
inhibitors)
- Tolerized to FVIII products for <5 years (for PwHA without inhibitors)
- Using FVIII products to treat breakthrough bleeds (for PwHA with inhibitors)
- Treatment with BPAs or FVIII within 24 hours prior to surgical procedure
- Undergoing a major surgical procedure
- Previous (in the past 12 months) or current treatment for thromboembolic disease (with
the exception of previous catheter-associated thrombosis for which anti-thrombotic
treatment is not currently ongoing) or current signs of thromboembolic disease
- Other conditions (e.g., certain autoimmune diseases, including but not limited to
diseases such as systemic lupus erythematosus, inflammatory bowel disease, and
antiphospholipid syndrome) that may increase the risk of bleeding or thrombosis
- Patients who are at high risk for thrombotic microangiopathy (TMA), e.g., have a
previous medical or family history of TMA, in the investigator's judgment
- Would refuse treatment with blood or blood products, if necessary
- Any serious medical condition or abnormality in clinical laboratory tests that, in the
investigator's judgment, precludes the participant's safe participation in and
completion of the study
- Pregnant or lactating, or intending to become pregnant during the study; women of
childbearing potential must have a negative serum pregnancy test result within 7 days
before Study Day 1
- Treatment with any of the following: An investigational drug to treat or reduce the
risk of hemophilic bleeds within 5 half-lives of last drug administration before Study
Day 1; A non-hemophilia-related investigational drug within the last 30 days or 5
half-lives before Study Day 1 (whichever is longer); An investigational drug
concurrently
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapies or components of the emicizumab injection
- Known human immunodeficiency virus (HIV) infection with CD4 count < 200
cells/microlitre within 24 weeks prior to enrollment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Study of Emicizumab Prophylaxis in Participants With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures | NCT03361137 | Contradiction |
6,499 | 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:
- be at least 21 years old
- be in reasonably good health as defined by the study doctor
- have routine laboratory tests to evaluate your blood cell count, and kidney and liver
function
- for females of child-bearing age, not be pregnant or nursing and have a negative urine
pregnancy test (except if surgically sterile or at least 1 year menopausal)
- for females, agree to use medically acceptable forms of birth control throughout the
entire study (medically acceptable forms of birth control include oral contraceptive
["the pill"], implants such as Norplant®, injectable progesterone [Depo-provera®],
diaphragm and spermicide or condoms and spermicide)
- must have mild to moderate acne rosacea
- be willing to refrain from using non-approved lotions, moisturizer, cleansers or
lotions on affected facial areas during the treatment period
- be capable of understanding and giving written, voluntary informed consent before
study screening
- be willing to consent to facial photographs at baseline and each follow-up visit to
monitor treatment with the test product.
Exclusion Criteria:
- have a history or evidence of any chronic or reoccurring skin disease or disorder
(e.g., psoriasis, eczema, etc.) affecting the face
- have known or suspected hypersensitivity to study treatment or any of its ingredients
- have used systemic retinoids within 6 months prior to study entry (e.g., acitretin,
isotretinoin)
- have received treatment with systemic corticosteroids (e.g. prednisone) or antibiotics
within 1 month
- have used topical treatment to the face with retinoids (e.g. tretinoin, adapalene), or
antibiotics or corticosteroids, within 2 weeks prior to study entry
- are unwilling to use a sunscreen with an SPF of 30 during the study
- have participated in any clinical trial involving an investigational drug or cosmetic
product or procedure 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 21 Years old.
| Effects of PRK 124 Lotion in Acne Rosacea | NCT00580723 | Entailment |
1,282 | 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) due to lung cancer
Exclusion Criteria:
- workup of MPE (pleural fluid results, blood test results, or treatment history) not
available
- Patients unwilling to join study (for prospective recruitment)
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.
| Prognostic Factors on Malignant Pleural Effusion | NCT03276715 | Entailment |
6,906 | 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:
- Outpatients with a diagnosis of Alzheimer's disease according to the National
Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and
Related Disorders Association (NINCDS-ADRDA) criteria (including patients living
independently in residential homes for the elderly or day patients)
- have mild to moderate dementia, as evidenced by a Mini-Mental Status Examination
(MMSE) score of 11 - 24 and a score of at least 12 on the cognitive portion of the
Alzheimer's Disease Assessment scale (ADAS-cog)
- history of at least a 6 months of gradual and progressive cognitive decline
- have a consistent informant to accompany the patient on scheduled visits
Exclusion Criteria:
- Neurogenerative disorders such as Parkinson's disease
- dementia caused by small strokes or cerebrovascular disease
- cognitive impairment resulting from acute cerebral trauma, cerebral damage due to a
lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant
endocrine or metabolic disease, mental retardation or a brain tumor
- having epilepsy, significant psychiatric disease, active peptic ulcer, clinically
significant liver, kidney, or lung disorders, or heart disease
- Females of child bearing potential without adequate contraception
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 Study of the Safety and Effectiveness of Two Doses of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's Disease | NCT00253188 | Entailment |
5,840 | 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:
- Participant is of non-Asian origin.
- Female participants of reproductive potential must have a negative pregnancy test and
agree to use (and/or have their partner use) two acceptable methods of birth control
beginning at the screening visit, throughout the study, and until 2 weeks after the
last dose of study drug.
- Participant has a Body Mass Index (BMI) ≤35 kg/m2 at the screening visit.
- Participant is judged to be in good health.
- Participant has no clinically significant abnormality on electrocardiogram (ECG).
- Participant has been a nonsmoker and/or has not used nicotine or nicotine-containing
products for at least 6 months.
Exclusion Criteria:
- Participant is mentally or legally incapacitated, has significant emotional problems
at the time of screening visit or has a history of a clinically significant
psychiatric disorder over the last 5 to 10 years. Participants who have had
situational depression may be enrolled in the study at the discretion of the
investigator.
- Participant has a history of any illness that, in the opinion of the study
investigator, might confound the results of the study or poses an additional risk to
the participant by their participation in the study.
- Participant has taken any gastric antisecretory drugs (e.g., histamine receptor type-2
antagonists [H2RAs] or proton pump inhibitors [PPIs]), antacids, or any other
prescription or over- the-counter (OTC) medications within 14 days prior to Period 1
and during the trial.
- Participant has been treated with any trial drug or therapy, or participated in a
clinical trial in the 30 days prior to Period 1.
- Participant has any laboratory test result prior to dosing in Period 1 deviating from
the normal reference ranges established by the local laboratory by more than 20% that
the investigator judges to be of possible clinical significance.
- Participant has an estimated creatinine clearance of ≤80 mL/min based on the
Cockcroft-Gault equation.
- Participant has a history of stroke, chronic seizures, or major neurological disorder.
- Participant has a history of clinically significant endocrine, gastrointestinal,
cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
genitourinary abnormalities or diseases. Participants with a history of uncomplicated
kidney stones or childhood asthma may be enrolled in the study at the discretion of
the investigator.
- Participant has a history of neoplastic disease.
- Participant is a nursing mother.
- Participant has any history or serologic evidence of hepatitis B or C with abnormal
liver function tests (except for benign, self-limited hepatitis A >5 years prior to
randomization), hepatic or biliary tract disease, or a history of gastrointestinal
tract surgery.
- Participant has an allergy or hypersensitivity to any component/excipient of the study
drugs, has a history of significant multiple and/or severe allergies (including latex
allergy), or has had an anaphylactic reaction or significant intolerability to
prescription or non-prescription drugs or food.
- Participant is unable to refrain from or anticipates the use of any medication,
including prescription and non-prescription drugs or herbal remedies (such as St.
John's Wort [hypericum perforatum]) beginning approximately 2 weeks (or 5 half-lives)
prior to administration of the initial dose of study drug, throughout the study
(including washout intervals between treatment periods), until the telephone
follow-up. There may be certain medications that are permitted. Participants must be
explicitly warned of the potential risk of taking erythromycin, clarithromycin,
nefazodone, ketoconazole, itraconazole, cyclosporine, and human immunodeficiency virus
(HIV)protease inhibitors during the study.
- Participant consumes excessive amounts of alcohol, defined as greater than 3 glasses
per day of alcoholic beverages (1 glass is approximately equivalent to: 10 ounces of
beer, 4 ounces of wine, or 1 ounce of distilled spirits).
- Participant has consumed grapefruit juice, grapefruits and grapefruit products within
2 weeks prior to administration of the initial dose of study drug, and does not agree
to refrain from their consumption throughout the study (including the washout interval
between treatment periods) and until the telephone follow-up.
- Participant consumes excessive amounts, defined as greater than 6 servings (1 serving
is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, chocolate, or
other caffeinated beverages per day.
- Participant has had major surgery, donated or lost 1 unit of blood (approximately 500
mL) or participated in another investigational study within 30 days prior to Period 1.
The 4-week window will be derived from the date of the last study procedure (i.e.,
telephone follow-up) in the previous study to the screening visit of the current
study.
- Participant is currently a regular user (including "recreational use") of any illicit
drugs or has a history of drug (including alcohol) abuse within approximately 1 year.
- There is any concern by the investigator regarding the safe participation of the
participant in the study or for any other reason; the investigator considers the
participant inappropriate for participation in the study.
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 45 Years | A Study to Compare Omeprazole Administered as Zegerid® Powder and as Prilosec® Capsule in Healthy Participants (P08050)(CL2010-12) | NCT01337804 | Contradiction |
4,663 | 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:
- Females with BMI-18.5-34.99 and between 18-45 years, with normal menstrual cycle
defined as 28-30 days cycles +-3 days.
- Including higher BMI participants might alter the results as increased body fat has
been linked to changes in different hormonal levels (not only sex hormones) and that
might influence substrate utilization.
- Sedentary .or physically active for 2 days a week or less.
Exclusion Criteria:
- • Musculoskeletal injuries,
- cardio-respiratory conditions,
- metabolic conditions,
- irregular menstrual cycle,
- menstrual dysfunction or unusual sex hormone levels,
- on contraceptives,
- on medication that alter hormonal or cardio-respiratory responses,
- pre-menopausal symptoms,
- on moderate to high-intensity exercise regime more than 2d/week.
- All these exclusion criteria are chosen because any one of the listed criteria
above can alter the responses and/or affect the safety of the subject during
their participation in the study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Effects of Resistance Training on Substrate Metabolism During the Menstrual Cycle | NCT04024826 | Entailment |
4,124 | 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:
Common to both infertile and fertile couples:
- Couples where both members are over eighteen and at childbearing age (≤38 for women
and ≤ 45 for men)
- Couples where both members agreed to take part in the study
- Couples where both members completed a medical check-up and gave an informed consent.
Infertile couples could be included following a medical consultation for infertility
- Couples with none of its member facing any comprehension difficulty in oral or written
French language
- Couples where both members are affiliated to the French NHS [national health service]
(beneficiary or legal claimant)
Specific to fertile couples:
- fertile couples who naturally and spontaneously conceived a or many children with a time
to conceive shorter than 12 months.
Specific to infertile couples:
- Infertile couples (primary, infertility, inability to conceive a child after 12 months
of unprotected sexual intercourse)
- Couples where the male partner has sperm parameters compatible with a natural
conception
- Couples where the female partner does not present anovulation, ovarian insufficiency
and or any uterus-tubal pathology
Exclusion Criteria:
Common to both infertile and fertile couples:
- couples where one of the members is under eighteen or not a childbearing age (>38 for
women an >45 for men)
- couples where at least one member refused to give written agreement for the study
- couples where at least one member shows any known cardiovascular risk (diabetes,
hypercholesterolemia, HBR)
- couples where at least one member shows any known cardiovascular pathology, digestive
pathology, no good absorptive pathology or a cancer
- couples where at least one member faces some difficulty in understanding French
language
- couples where at least one member is not affiliated with the French NHS (beneficiary
or legal claimant)
Specific to fertile couples:
•Couples where the woman had a miscarriage or medical termination of pregnancy with current
partner
Specific to infertile couples:
- Couples in which it is not the first pregnancy
- Couples with the male member showing either:
- severe oligozoospermia (<5 millions/ml) or a confirmed azoospermia (absence of
spermatozoid in the ejaculate)
- a moderate non idiopathic oligozoospermia (5-20 millions/ml), related to one more
of the following factors:
1. toxic (chemotherapy, radiotherapy, drugs with a demonstrated effect on
spermatogenesis)
2. infectious
3. anatomic: vasectomy, congenital anomaly (agenesis of vas deferens), long
post-traumatic ischemia
4. endocrine: hypogonadotropic, hypogonadism
5. cytogenetic: klinefelter syndrome, translocation
- couples whose male partner shows an abnormality of the male genital tractus :
VARICOCEME undescended,testis, testicular volume < 12ml
- couples whose female partner presents an anovulation, ovarian insufficiency or a
proven uterus-tubal pathology
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 | Diet and Its Relationship With Couple Infertility | NCT01093378 | Contradiction |
2,155 | 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. | - Low back pain duration of at least 3 months;
- Low back pain occurring in the past week;
- No numbness or tingling in the lower extremities;
- No pain that radiates to below the knee;
- No use of massage, chiropractic or acupuncture for any reason in the past year;
- Able to attend scheduled appointments;
- Able to hear, read, and understand English;
- No low back pain surgery in the past 3 years;
- No unexplained weight loss;
- No previous vertebral or spinal fractures;
- No previous non-traumatic bone fractures;
- No other spinal pathology, including scoliosis, spinal stenosis, osteoporosis, or
ankylosing spondylitis;
- No cancer (except simple skin cancers) in the past 5 years;
- No pacemakers;
- No bleeding problems or anticoagulant use;
- No major organ transplants;
- No oral corticosteroid use for more than 4 consecutive weeks during the past year;
- Cannot be pregnant;
- Must be able to get down to and up from the floor by yourself;
- Able to walk 2 flat city blocks unassisted;
- Willing to participate in periodic telephone interviews.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| Physical CAM Therapies for Chronic Low Back Pain | NCT00065975 | Contradiction |
5,066 | 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 meet the following inclusion criteria to be eligible for study entry:
- Post-menopausal female with diagnosed osteoporosis
- Age 40-90 years
- Completed 36 months of denosumab therapy (SQ; 60mg every 6 months) but not yet
received the 42 month injection
- Availability of DXA scans at the study-required time points, including the
willingness of subjects to undergo a DXA evaluation at 36 months, if required
- Provided written informed consent
Exclusion Criteria:
- Patients will be excluded from this study for any of the following reasons:
- Received denosumab injections for less than 36 months
- Patients who have missed more than 1 dose of denosumab in a 36 month period
- Contra-indicated for treatment with denosumab
- History of rheumatoid arthritis
- Current diagnosis of hyperparathyroidism; hyperthyroidism; osteomalacia, or other
known diseases that can affect bone
- In the opinion of the investigator, have any kind of disorder that may compromise
the ability of the subject to provide written informed consent
Female
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 90 Years | Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index | NCT02435147 | Contradiction |
5,663 | 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:
- • children of both sexes.
- Age range: 4-18 years.
- patients fulfilling criteria of short stature.
- height is 2 standard deviations below normal .
- initial height below the third percentile on Egyptian growth chart. • Number of
patients: will include 50 cases
Exclusion Criteria:
- Skeletal dysplasia.
- Chromosomal anomalies
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
Subject must be at most 18 Years | Zinc and Iron in Children With Short Stature | NCT03131349 | Contradiction |
4,568 | 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:
- Eighteen to 55 years of age, inclusive
- Pre-menopausal with a history of regular menstrual cycles every 21-35 days and without
intermenstrual bleeding heavier than spotting and staining.
- Females with adenomyosis confirmed on magnetic resonance imaging (MRI), - Females with
heavy menstrual bleeding .
- Willing and able to collect all menstrual cycle by-products for each cycle from
screening to follow up.
- Not pregnant as confirmed by a negative serum human chorionic gonadotropin
Exclusion Criteria:
- A female subject will not be eligible for inclusion in this study if any of the
following criteria apply:
- Abnormal gynecological examination other than adenomyosis and/or breast examination
requiring intervention within six months of study start
- Abnormal endometrial biopsy within six months of starting study treatment.
- History of an endometrial ablation within 12 months of starting study treatment.
- Uterine artery embolization within six months of starting study treatment.
- Prior major uterine procedures or any other significant uterine abnormalities on MRI
(previous caesarean section, dilation and curettage, and diagnostic hysteroscopy are
permitted).
- Confirmed rectovaginal endometriosis in women who have undergone a prior laparoscopy.
- Active pelvic infection or current use of an intrauterine device within three months
of screening.
- Women with a history of transfusion for heavy menstrual bleeding within the past 2
years or history of postpartum hemorrhage.
- Any uterine dimension >20 centimeter (cm).
- Other major causes of heavy menstrual bleeding -
- Use within 3 months or anticipated use of medications that modify reproductive
function
- Use or anticipated use of the following drugs: anticoagulants aminocaproic acid ,or
any other medications that affect menstrual bleeding such as tranexamic acid.
- Use of daily opioid pain medications other than with menses.
- Hemoglobin <8 grams (g)/deciliter.
- History of bleeding disorder or known presence of acquired or inherited thrombophilia,
(sickle cell trait individuals are not excluded).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis | NCT02794467 | Contradiction |
4,296 | 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:
- Male and females aged 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 monitoring.
- 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) and Body mass index (BMI) within the range 19 - 24.9
kilograms per square meter (kg/m^2) (inclusive).
- Male subject
- Female subject: is eligible to participate if she is not pregnant (as confirmed by a
negative serum human chorionic gonadotrophin [hCG] test), not lactating, and at least
one of the following conditions applies:
Non-reproductive potential defined as:
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) and whose menopausal status is
in doubt will be required to use one of the highly effective contraception methods if
they wish to continue their HRT during the study. Otherwise, they 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 OR until
any continuing pharmacologic effect has ended, whichever is longer] 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 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.
- Contraceptive subdermal implant that meets the standard operating procedure
(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 progestogen alone
- Injectable progestogen
- Contraceptive vaginal ring
- Percutaneous contraceptive patches
- Male partner sterilisation 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) only for the following 3 situations when there is a very low risk for
developmental toxicity: Vaccines; Monoclonal antibodies when there is no target
biology concern; Compounds that have a complete reproductive toxicology package and
have not shown any signal for developmental toxicity.
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 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.
- Vasectomy with documentation of azoospermia.
- 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 progestogen alone. Injectable progestogen
- 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 written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.
Exclusion Criteria:
- Alanine aminotransferase (ALT) and bilirubin >1.5 x 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)
- Corrected QT (QTC) > 450 milliseconds (msec)
- NOTES: The QTc is the QT interval corrected for heart rate according to Bazett's
formula (QTcB), Fridericia's formula (QTcF), and/or another method, machineread or
manually over-read.
- The specific formula that will be used to determine eligibility and discontinuation
for an individual subject should be determined prior to initiation of the study. In
other words, several different formulae cannot be used to calculate the QTc for an
individual subject and then the lowest QTc value used to include or discontinue the
subject from the trial.
- For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a
composite of available values of QTc will be used as specified in the Reporting and
Analysis Plan (RAP).
- No concomitant medications should be taken by the subject while participating in the
study. Refer to Study Protocol for further detail.
- History of regular alcohol consumption within 6 months of the study defined as: An
average weekly intake of >21 units for males or >14 units for females. One unit is
equivalent to 8 grams of alcohol: a half-pint (~240 milliliters [mL]) of beer, 1 glass
(125 mL) of wine or 1 (25 mL) measure of spirits.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco or
nicotine-containing products within 6 months prior to screening.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- 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.
- Subjects with phenylketonuria
- 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. For
potent immunosuppressive agents, subjects with presence of hepatitis B core
- A positive pre-study drug/alcohol screen.
- A positive test for Human Immunodeficiency Virus (HIV) antibody.
- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 90 day period.
- 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: 90 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.
- Gastrointestinal disease or with gastrointestinal surgical history which can affect
the absorption of the investigational drug.
- Any symptoms with a systolic Blood pressure (BP) <95 millimeters of mercury (mmHg)
- Pregnant females as determined by positive serum hCG test at screening or prior to
dosing
- Lactating females
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 Bioavailability Study of Two Montelukast Sodium (GW483100) 5 Milligrams (mg) Chewable Tablets and One Reference Montelukast Sodium 5 mg Chewable Tablet in Healthy Adult Subjects | NCT02322671 | Entailment |
4,228 | 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:
- Male Patient,
- Patient age ≥ 18 years,
- Infertile patient with isolated teratozoospermia or associated with asthenozoospermia
and / or oligozoospermia and / or necrozoospermia, defined according to WHO
recommendations (WHO guidelines, 2010) and the David amended classification (Auger et
al, 2001) for teratozoospermia
- Patient with normal constitutional karyotype (46, XY).
- Smoking tobacco,
- Drinking ≤ 20 g (2 units) / day,
- Patient exposed : Cannabis user for over 3 months and consuming at least weekly (≥ 1 /
week) [questionnaire and positive blood detection of Delta-9-Tetrahydrocannabinol
(THC) and / or its derivatives (11-hydroxy-THC and 11-nor-9-carboxy-THC)].
- Unexposed : No cannabis user (questionnaire and negative blood detection of
Delta-9-THC and its derivatives) matched for age (+/- 2.5 years) with exposed patients
included,
Exclusion Criteria:
- Patient age > 60 years
- Patient with azoospermia
- Patient previously exposed to gonadotoxic treatment (chemotherapy, radiotherapy,
androgen therapy and other gonadotoxic treatments),
- Patient with professional toxic exposure,
- Patient consuming other recreational drugs,
- Patient with severely impaired sperm parameters and sperm counts <1 million,
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men | NCT02932527 | Contradiction |
3,942 | 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:
- Symptomatic unilateral knee tibiofemoral OA
- Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both
knees on a recent 3 months time X-Ray
- Knee pain within the last 24 hours before assessment more than 40mm on VAS
- Pain on most days in the last month
Exclusion Criteria:
- Knee pain equal or more than 80mm on a 100mm VAS.
- Pain in the contra lateral knee; more than 30mm on a 100 VAS.
- Concomitant inflammatory joint disease (e.g. gout, rheumatoid arthritis, history of
Reiter's syndrome, psoriatic arthritis and ankylosing spondylitis.
- Any condition that may interfere with the measure of pain in the targeted knee
- Concomitant meaningful synovial fluid effusion
- Post trauma OA
- Gross ligamentous instability of the knee
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.
| Safety and Efficacy of an Injectable Medical Device to Treat Knee Osteoarthritis | NCT01365260 | Entailment |
203 | 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
1. Hypogonadal males
2. Screening testosterone <300 ng/dL
Exclusion Criteria
1. Smokers
2. Previous history of or current or suspected prostate or breast cancer
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males | NCT01133548 | Entailment |
4,664 | 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:
- Women aged 20-49;
- Having a regular menstrual cycle of which the menstrual period is between day 3-7, and
the period between day 25-35;
- Excluding internal and surgical disease (after having variety of physical examination
such as electrocardiogram/hepatic and renal function/blood routine and urine routine).
Exclusion Criteria:
- Having experienced severe allergies, trauma history and/or operation history within 3
months;
- With a history of mental illness and/or family history of mental illness;
- Limb disabled;
- Taking medicine within one month;
- Suffering major events or having mood swings.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 49 Years | Study About Lymphocytes Change During Menstrual Cycle in Women of Child-bearing Age | NCT02951832 | Entailment |
6,330 | 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:
1. Age ≥21 years
2. Positive laboratory test for COVID-19 by RT-PCR methods
3. Presenting with at least one symptom (symptoms include fever, dry cough, sore throat,
nasal congestion, malaise, headache, muscle pain, anosmia, and diarrhoea)
4. Length of time between date of onset of symptoms and the date of recruitment should
not exceed 5 days to ensure that trial participants are in the early stages of
infection
5. No clinical or radiographic evidence of pneumonia
6. Able to provide informed consent
Exclusion Criteria:
1. Individuals with underlying primary diseases such as cardiovascular, respiratory,
liver, renal, diabetes, hepatitis A/B/C, gout or endocrinological diseases and
neurological disorders which put them at a higher risk of developing severe disease
2. Individuals with compromised immune systems such as malignant tumors, organ or bone
marrow transplants, HIV, or have taken immunosuppressants in the past three months.
3. Women who are pregnant or on lactation.
4. Individuals with mental illness.
5. History of allergy to any drug or food, or herb ingredient observed in this trial.
6. Individuals who are deemed not able to comply with trial procedure or follow-up
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
| A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19 | NCT04433013 | Entailment |
3,519 | 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:
- primary Addison's disease in combination with long-standing Type 1 diabetes
Exclusion Criteria:
- cardiovascular disease
- active malignant disease
- pregnant women
- pharmacological treatment with glucocorticoids or drugs that interfere with cortisol
metabolism (antiepileptics, rifampicin, St. Johns war, estrogens)
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 70 Years | Continuous Subcutaneous Hydrocortisone Infusion In Addison's Disease and Type 1 Diabetes | NCT01840189 | Contradiction |
4,307 | 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: Infertile men with azoospermia on at least two semen analyses separated
by at least one week, and no pregnancy with partner with normal cycles and normal
hysterosalpingogram despite >1 year of unprotected intercourse.
-
Exclusion Criteria: hypogonadotropic hypogonadism (that might respond to gonadotropin
injections); use of anabolic steroids,illicit drugs, or consumption of more than 4
alcoholic beverages daily; current therapy with retinoic acid (eg Accutane) or vitamin A-
of use of isotretinoin within eight weeks of start of dosing;phenytoin, or medication
containing tetracycline; personal history of serious psychiatric disorders, score of
greater than 15 on the PHQ9 (mood) questionnaire; elevated serum serum triglycerides or
other abnormal serum chemistry values; history of inflammatory bowel disease or bone
disease; not living within catchment area; participation in another clinical trial
-
Male
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 60 Years | RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia | NCT03323801 | Entailment |
1,506 | 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:
- Diagnosis of Oropharyngeal Dysphagia.
- Patients who have primary caregiver.
- Agreeing to participate in the study.
Exclusion Criteria:
- Critically ill patients.
- Chronic kidney disease with Glomerular Filtration Rate <30 ml / min or in renal
replacement therapy
- Liver failure.
- Cancer with active radiotherapy or chemotherapy treatment.
- Patients who are participating in another 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.
Subject must be at most 99 Years | Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia | NCT02959450 | Entailment |
4,996 | 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:
1. Outpatients with essential tremor diagnosed by a movement disorder specialist.
2. Age 18 years to 80 years.
3. Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm
as measured by the FTM rating scale.
4. Women of child-bearing potential must use a reliable method of contraception and must
provide a negative pregnancy test at entry into the study.
5. Baseline EKG read as within normal limits (no clinically significant
abnormalities)obtained from primary care physician or cardiologist (performed within
the past year).
6. Serum creatine kinase, complete metabolic blood count, liver function tests, renal
function tests, and platelets are within normal limits (blood drawn within the past
year).
7. Stable doses of all medications for 30 days prior to study entry and for the duration
of the study.
Exclusion Criteria:
1. Any illness that in the investigator's opinion preclude participation in this study.
2. Pregnancy or lactation.
3. Concurrent participation in another clinical study.
4. Dementia or other psychiatric illness that prevents the patient from giving informed
consent (Mini Mental Status Exam score less than 24).
5. Legal incapacity or limited legal capacity.
6. Presence of severe renal disease (BUN 50% greater than normal or creatine clearance
<60 mL/min) or hepatic disease.
7. Presence of severe daytime sleepiness.
8. Abnormal creatine kinase and/or platelet count in the past year.
9. Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies,
cardiac abnormalities.
10. Previous lack of response to other ET therapies (propranolol AND primidone).
11. Patients who have had deep brain stimulation (DBS).
12. Concomitant treatment with gabapentin.
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 80 Years | Pregabalin (Lyrica) for the Treatment of Essential Tremor | NCT00584376 | Entailment |
6,708 | 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:
- The subject or the subject's legally authorized representative has provided signed
informed consent.
- The subject is within 18 to 70 years of age.
- The subject has severe or moderately severe hemophilia A, defined by a baseline factor
VIII level <= 2% of normal, as tested at screening. A subset of 15 subjects per group
must have baseline factor VIII levels < 1% of normal.
- The aPTT must be within the range of normal after administration of FVIII concentrate,
as determined in the preoperative pharmacokinetic evaluation, or as documented in the
medical history, if available.
- The subject is scheduled to undergo an elective unilateral major orthopedic surgery
that requires drain placement.
- The subject was previously treated with factor VIII concentrate(s) for a minimum of at
least 150 exposure days (as estimated by the investigator) prior to study entry.
- Human immunodeficiency virus (HIV) positive subjects must be immunocompetent as
determined with a CD4 count >= 200 cells/mm³ (CD4 count at screening), but HIV
negative subjects with a CD4 count < 200 cells/mm³ qualify, if immunocompetency is
documented.
- The subject has a life expectancy of at least 28 days from the day of surgery.
Exclusion Criteria:
- The subject has a detectable factor VIII inhibitor at screening, with a titer >= 0.4
BU (Nijmegen modification of the Bethesda assay) in the central laboratory.
- The subject has a history of factor VIII inhibitors with a titer >= 0.4 BU (by
Nijmegen assay) or >= 0.5 BU (by Bethesda assay) at any time prior to screening.
- The subject is scheduled to undergo any other concurrent minor or major surgery during
the course of the study. The placement of central venous lines and the performance of
fine needle aspiration biopsies are permitted.
- Excluding hemophilia-related physical impairments, the subject is assigned to NYHA
class >= III according to the New York Heart Association (NYHA).
- The subject has an abnormal renal function (serum creatinine > 1.5 mg/dL).
- The subject has active hepatic disease (alanine aminotransferase [ALT] or aspartate
aminotransferase [AST] levels > 5 times the upper limit of normal).
- The subject has severe chronic liver disease as evidenced by, but not limited to, any
of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal
vein hypertension including presence of otherwise unexplained splenomegaly and history
of esophageal varices.
- The subject has clinical and/or laboratory evidence of abnormal hemostasis from causes
other than hemophilia A (e.g., late-stage chronic liver disease, immune
thrombocytopenia purpura).
- The subject is currently receiving, or is scheduled to receive during the course of
the study, an immunomodulating drug other than anti-retroviral chemotherapy (e.g.,
alpha-interferon, corticosteroid agents at a dose equivalent to hydrocortisone greater
than 10 mg/day).
- The subject has a known hypersensitivity to mouse or hamster proteins.
- The subject has received another investigational drug study within 30 days prior to
screening and/or is scheduled to receive additional investigational drug during the
course of the trial in the context of another investigational study.
- The subject is identified by the investigator as being unable or unwilling to
cooperate with study procedures.
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 70 Years | Phase 3/4 Study of a Recombinant Protein-Free Factor VIII (rAHF-PFM): Comparison of Continuous Infusion Versus Intermittent Bolus Infusion in Hemophilia A Subjects Undergoing Major Orthopedic Surgery | NCT00357656 | Contradiction |
4,255 | 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:
- Literacy must be in English (able to understand Informed Consent)
- In general good health
- Heterosexual, monogamous couples, of any race or ethnicity, who are sexually active
(as a couple)
- 18 - 50 years of age
- REALM-SF Test Results demonstrate 6th grade literacy or above
- Past experience with using condoms
- Trying to conceive or using a non-vaginal birth control with which they do not
normally use a condom.
- Signed Informed Consent
Exclusion Criteria:
- Vaginal prolapsed (female)
- Hysterectomy (female)
- Erectile Dysfunction (male)
- Colposcopy with biopsy surgery within the last three (3) months (female)
- Treatment for dysplasia surgery within the last three (3) months (female)
- Vaginal/cervical surgery within the last three (3) months (female)
- Current Pregnancy (female)
- Unable to read and understand English
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 50 Years | The Stork OTC: Collection, Placement & Delivery | NCT02038322 | Entailment |
4,436 | 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:
Any patient who:
- Has experienced more than 6 months of symptoms from tennis elbow (pain on the lateral
elbow that radiates down the forearm, point tenderness over the origin of the extensor
muscles or at its close proximity (within 2.5cm) and pain on resisted extension of the
Wrist).
- Patients must also have failed conservative treatment (a course of physiotherapy and
activity modification)
- Baseline elbow pain >3/10 on VAS during resisted elbow extension.
Exclusion Criteria:
- Presence of a full tendon tear on pre-intervention ultrasound
- Unfit for surgical intervention
- Have undergone previous elbow surgery,
- Have previously undergone PRP injection therapy
- Systemic autoimmune rheumatological disease
- Receiving immunosuppressive treatments
- Received local steroid injection within 3 months of randomization
- Unable to comply with follow-up.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Platelet Rich Plasma vs Open Surgery in the Treatment of Tennis Elbow | NCT02755727 | Contradiction |
1,128 | 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:
1. Symptomatic Hypertrophic Cardiomyopathy patients
2. Abnormal Peak VO2
3. No significant LVOT obstruction at rest (gradient < 30mmHg)
4. Sinus rhythm
Exclusion Criteria:
1. Abnormal LFT.
2. Concomitant use of amiodarone
3. Pre-existing evidence of peripheral neuropathy.
4. Women of childbearing potential.
5. Patients with ICD's will be excluded from the MR part of 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 18 Years old.
Subject must be at most 80 Years | Perhexiline Therapy in Patients With Hypertrophic Cardiomyopathy | NCT00500552 | Entailment |
5,612 | 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. | - Short stature and/or constitutional growth delay
- No epilepsy or risk of epilepsy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | Pilot Study of the Effect of Baclofen and Bromocriptine on Luteinizing Hormone Secretion in Pubertal Children | NCT00004793 | Contradiction |
4,029 | 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:
1. Males and females aged 18-80 years (both inclusive) at the time of recruitment.
2. Clinical diagnosis of osteoarthritis, rheumatoid arthritis, lower back pain or joint /
muscle pain.
3. Having non-malignant pain of moderate or severe intensity requiring an opioid for
adequate analgesia (according to local label of Norspan® or Sovenor®). This is to be
determined using BS-11 scores, where the cut-off point is ≥4.
4. Patients with chronic uncontrolled pain and is assessed to require opioid treatment
but have not been treated with opioids (including tramadol, morphine etc.) within 4
weeks or more before study entry.
Exclusion Criteria:
1. Pregnant and lactating females.
2. Patients with chronic condition(s), in addition to osteoarthritis, that require(s)
frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout).
3. Patients who are awaiting a scheduled operation or other surgical procedure during
study period or 3 months or less post-operative.
4. Prior history of being on opioids in the preceding 1 month prior to the study for the
management of chronic non-malignant pain.
5. Prior history of buprenorphine transdermal system use.
6. Patients with history of allergic reactions against paracetamol/ acetaminophen, NSAIDs
and/or opioids.
7. Patients with allergies or other contraindications to transdermal systems or patch
adhesives.
8. Patients with dermatological disorders who may have problems applying patch or
rotating patch placement area.
9. Patients with cancer (except for basal cell carcinoma) or history of cancer who have
been diagnosed within five years prior to the first study visit (except for treated
basal cell carcinoma).
10. Patients with conditions such as brain tumour, brain injury or raised intracranial
pressure.
11. Patients with history of psychiatric disorder, uncontrollable epilepsy, untreated
depression or other psychiatric disorders of a type that would make participation in
the study an unacceptable risk to the patient.
12. Patients with any conditions causing poor cognitive function as assessed by the
participating physician.
13. Patients with history of alcohol and drug abuse or patients who have demonstrated
behaviour that suggests a dependency or drug abuse.
14. Patients currently taking hypnotics or other central nervous system depressants that
may pose a risk of additional central nervous system depression with study medication.
15. Patients who are currently being administered monoamine oxidase inhibitors (MAOIs) or
have taken MAOIs within 2 weeks before screening.
16. Patients requiring dose titration of adjuvant analgesics i.e. antidepressants (e.g.
amitriptyline, amoxapine, clomipramine, selective serotonin re-uptake inhibitors
(SSRIs)) and anticonvulsants (e.g. gabapentin, pregabalin). Patients will be allowed
to enter the study as long as they are on the stable doses of adjuvant analgesics at
screening and do not have dose adjustments during the study.
17. Patients who have received steroid treatment (intra-articular, intramuscular, oral,
intravenous, epidural or other corticosteroid injections) within 6 weeks prior to
clinical study or planned steroid treatment during the clinical study period.
18. Patients who have to use heating facility (examples: heating lamp, electric blanket,
sauna, warm compresses, heated saline baths, etc.).
19. Patients who cannot or do not wish to remove hair growing at body surface where the
patch can be placed.
20. Patients who are currently on disability claims or in the process of applying for
disability claims.
21. Patients at child-bearing age who are planning to conceive a child during the study
period and are not practicing adequate contraception.
22. Patients with known severe hepatic impairment as determined by liver function test
within the past one year.
23. Patients who are currently in or have participated in other clinical trials within the
last 30 days prior to study recruitment.
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 80 Years | Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain | NCT01961271 | Entailment |
766 | 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:
- Participants diagnosed with osteoarthritis and chronic low back pain
- 3 months of persistent moderate to severe pain levels
- More than 3 times a week frequency or daily moderate to severe pain
- Moderate to severe pain at Baseline (at least a score of 4 in the 11-point numerical
pain scale) Exclusion Criteria
- History of allergy to fentanyl transdermal patch or its components and history of
illicit drug use for the past 3 months
- Active skin disease preventing application of the transdermal system
- Chronic pulmonary disease (lung disorder)
- Participants susceptible to intracranial (inside the skull) effects of carbon dioxide
retention
- Pregnant and breastfeeding mothers
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 | An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain | NCT01795898 | Contradiction |
6,905 | 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:
A participant is eligible for inclusion in the study if the individual meets all of the
following criteria:
1. Self-reported proficiency in English language.
2. Equal to or more than 8 years of education.
3. Normal or corrected to normal vision.
4. Able to provide informed consent.
5. Able to hold their breath for 20 seconds.
Normal cognition for healthy participant group inclusion criteria:
1. Preserved independence in functional abilities.
2. MoCA score no less than 26.
3. Males and non-lactating females of 18 to 85 years of age.
Alzheimer's disease group inclusion criteria:
1. Participants meet National Institute on Aging-Alzheimer's Association for probable or
possible Alzheimer's Disease dementia.
2. MoCA score no less than 16.
3. Males and non-lactating females of 60 to 85 years of age.
4. Have a family member, close friend, or LAR that can be present for the informed
consent process and study visits.
Exclusion Criteria:
A participant is ineligible for the study if the individual meets any of the following
criteria:
1. Serious underlying medical condition, other, then the condition being investigated,
which may affect cognitive function of the participant (in the opinion of the
investigator): substance abuse, psychotic or depressive disorder, advanced or poorly
controlled cardiac, pulmonary, hepatic, renal, neurological disorders in which the
patient has significant speech, visual, motor or cognitive deficit, seizure disorders,
endocrine or infectious disease or active malignancy.
2. MRI incompatibility as determined by MR Technologist during MRI screening.
3. Self-identifies as claustrophobic.
4. Female exclusion only: Are or may be pregnant; Planning on becoming pregnant.
5. Is a student currently enrolled in a course at Lakehead University where the Principal
Investigator (PI) is the instructor.
6. Is a student currently enrolled in a degree program at Lakehead University where the
PI is their direct thesis supervisor.
7. Is currently an employee of the PI at the Thunder Bay Regional Research Institute
(TBRRI) and/or Lakehead University.
Normal cognition group exclusion criteria:
1. History of diagnosed neurological disease or injury.
Alzheimer's disease group exclusion criteria:
1. Existing diagnosis of dementia of etiology other than Alzheimer's disease.
2. Acute Delirium on the day of scanning (CAM tool assessment)
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 85 Years | HP Xenon-129 fMRI of Healthy Volunteers and Participants With Alzheimer's Disease | NCT02638519 | Entailment |
1,153 | 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. | Key Inclusion Criteria:
- Age 18 and greater, body weight ≥ 45kg
- Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)
- Diagnosed with oHCM consistent with current American College of Cardiology
Foundation/American Heart Association and European Society of Cardiology guidelines
and satisfy both criteria:
- Has documented left ventricular ejection fraction (LVEF) ≥55%
- NYHA Class II or III
- Has documented oxygen saturation at rest ≥90% at Screening
- Is able to perform an upright CPET and has a respiratory exchange ratio (RER) ≥1.0 at
Screening per central reading
Key Exclusion Criteria:
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM,
such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6
months prior to Screening
- History of resuscitated sudden cardiac arrest (at any time) or known history of
appropriate implantable cardioverter defibrillator (ICD) discharge for
life-threatening ventricular arrhythmia within 6 months prior to Screening
- Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at
Screening
- Persistent or permanent atrial fibrillation not on anticoagulation for at least 4
weeks prior to Screening and/or not adequately rate controlled within 6 months prior
to Screening
- Treatment (within 14 days prior to Screening) or planned treatment during the study
with disopyramide or ranolazine
- Treatment (within 14 days prior to Screening) or planned treatment during the study
with a combination of β-blockers and calcium channel blockers
- LVOT gradient with Valsalva maneuver <30 mmHg at Screening
- Has been successfully treated with invasive septal reduction (surgical myectomy or
percutaneous alcohol septal ablation [ASA]) within 6 months prior to Screening or
plans to have either of these treatments during the study
- ICD placement within 2 months prior to Screening or planned ICD placement during the
study
- Has a history or evidence of any other clinically significant disorder, condition, or
disease that, in the opinion of the investigator, would pose a risk to participant
safety or interfere with the study evaluation, procedures, or completion
- Prior treatment with cardiotoxic agents such as doxorubicin or similar
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.
| Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy | NCT03470545 | Entailment |
1,615 | 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:
- Female, ages 13 to 17 years, committed to Columbia Training School, who provide
written informed assent.
Exclusion Criteria:
- Acute or chronic physically illness that would preclude participation as determined by
facility physician; placement in maximum security unit; study participation during a
prior commitment
Female
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
Subject must be at most 18 Years | Healthy Teen Girls: HIV Risk Reduction | NCT00787696 | Contradiction |
6,894 | 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:
Previous diagnosis of Dementia by neurologist, other medical care provider, or researcher
accompanied by sufficient clinical and/or laboratory evidence
Clinical confirmation of Dementia by the investigator and his associates either by exam
and/or review of medical records
Family member of diagnosed dementia patient
Healthy controls
EXCLUSION CRITERIA:
Individuals with any movement disorder secondary to a specific environmental exposure,
birth injury, metabolic disorder, or brain infection such as encephalitis.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| The Genetic Characterization of Dementia | NCT01867359 | Entailment |
1,055 | 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:
- Patient with a symptomatic severe aortic stenosis with a too high risk of surgical
valvular replacement. This patient will be selected for a TAVI. In this study, we only
randomized patient for a TAVI with an Edwards prosthesis
- male or female patient, older than eighteen years old
- who have given their written consent
- who are affiliated to the French social security system
- which has a too high risk of surgical valvular replacement (EuroSCORE logistic > 20%
or Society of Thoracic Surgeons Score > 10, or contre indicated to a cardiac surgery
by a heart team
- Severe Aortic stenosis with symptoms like dyspnea, heartache, syncope, heart failure
Exclusion Criteria:
- Patient who can't give his written consent because of his physical or mental status
- Adult patient protect by law (article L1121-8),
- Person deprived of liberty (article L1121-8),
- Pregnant women
- Patient in terminal phase of illness,
- Terminal kidney failure
- Allergy to iodine
- bicuspids ou unicuspid aortic,
- Diameter of the left ventricular outflow tract < 18mm or > 25mm,
- Diameter of the femoral artery < 7mm, tortuosity or calcifications
- Septal hypertrophy
- Apical thrombosis.
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.
| Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI | NCT01672268 | Contradiction |
4,958 | 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:
- Age ≥ 18 years and ≤ 65 years
- Important essential tremor (bilateral postural and/or action tremor since more than
one year)
- Normal physical and neurological examination, except for essential tremor
- Insufficient efficiency of usual essential tremor's treatment
- No treatment altering the cortical excitability
- Agreement to use a medically acceptable method of contraception throughout the study
for female of childbearing potential
- mini-mental status score >24
Exclusion Criteria:
- Age < 18 years and > 65 years
- Current neurological or psychiatric illness other than essential tremor
- Individual who is on medication which is known to lower seizure threshold
- Previous history of seizure, loss of conciousness or current active epilepsy
- Contraindication for MRI or TMS study
- Intake of antiepileptic medications for essential tremor (barbiturates, gabapentine,
topiramate, clonazepam), within the 7 days preceeding the first visit
- alcohol intake within the 24 hours preceeding the first visit
- Pregnancy, breast feeding women and women who are of childbearing age and not
practicing adequate birth control
- Individual who have MMS ≤ 24/30 or patients legally protected or inability to provide
an informed consent
- Simultaneous participation in another clinical trial
- Patients who are not enrolled at social security
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 | Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation | NCT02052271 | Entailment |
2,808 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Sporadic Amyotrophic Lateral Sclerosis (SALS) diagnosed as possible,
laboratory-supported probable, probable, or definite ALS as defined by revised El
Escorial criteria.
- Age 18 years or older.
- Disease duration ≤ 36 months from ALS symptom onset.
- Capable of providing informed consent and following trial procedures.
- Subjects must not have taken riluzole for at least 30 days or be on a 50 milligrams
twice daily dose of riluzole for at least 60 days prior to randomization
(riluzole-naïve subjects are permitted in the study).
- Subjects must not have taken medication for muscle cramping such as cyclobenzaprine,
baclofen, carisoprodol, or methocarbamol, for at least 30 days prior to randomization
or be on a stable dose for at least 60 days prior to randomization.
- Geographic accessibility to the site.
- Women must not become pregnant for the duration of the study and must be willing to
use two contraceptive therapies and have a negative pregnancy test throughout the
course of the study.
- Slow vital capacity (SVC) measure greater than or equal to 50% of predicted for
gender, height, and age at the screening visit.
- Subjects medically able to undergo lumbar puncture (LP) as determined by the
investigator (for example, no bleeding disorder, allergy to local anesthetics, a skin
infection at or near the LP site, or evidence of high intracranial pressure).
- Must be able to swallow capsules throughout the course of the study, according to
Principal Investigator (PI) judgment.
- Must have a caregiver assist with dispensing the study drug.
Exclusion Criteria:
- Invasive ventilator dependence, such as tracheostomy.
- Creatinine level greater than 1.5 milligram/deciliter.
- Serum glutamic oxaloacetic transaminase or (aspartate transaminase) / serum glutamic
pyruvic transaminase (alanine aminotransferase) greater than 3 times the upper limit
of normal at screening.
- History of known sensitivity or intolerability to mexiletine or lidocaine.
- Any history of either substance abuse within the past year, unstable psychiatric
disease, cognitive impairment, or dementia.
- Clinically significant conduction abnormalities on electrocardiogram or a known
history of cardiac arrhythmia.
- Known history of epilepsy.
- Known history of congestive heart failure (CHF) or history of myocardial infarction
within the past 24 months.
- Use of mexiletine for 60 days prior to Baseline Visit.
- Exposure to any other experimental agent (off-label use or investigational) including
high dose creatine (greater than 10 grams a day) within 30 days prior to Baseline
Visit.
- Use of amiodarone, flecainide, duloxetine, tizanidine, or clozapine.
- Pregnant women or women currently breastfeeding.
- Placement of Diaphragm Pacing System (DPS) device less than 60 days prior to Baseline
Visit.
- Planned DPS device implantation after Baseline Visit.
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.
| Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS) | NCT01849770 | Contradiction |
3,080 | 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:
- (a) 10 to 23 years of age (this age range was chosen to maximize the probability that
subjects will cooperate with the imaging procedures as well as benefit from the
interventions),
- (b) in good physical health,
- (c) able to participate in the imaging component of the project,
- (d) IQ between 50 and 80. We have found that individuals with IQ's less than 50 points
are generally unable to comply with the scanning procedures.
- (e) diagnosis of FXS (for FXS group) and non-specific developmental disorder (for
control group).
Exclusion Criteria:
Exclusion criteria include
- contraindications for MRI (e.g., pacemaker, braces),
- the presence of neurological or sensory problems not associated with the conditions of
interest (e.g., head trauma, blindness), or inability to discontinue psychotropic
medication for 4 weeks prior to the scan.
- Additional exclusion criteria for the control group include the presence of any known
identifiable syndrome (e.g., fragile X syndrome, Down syndrome, Prader-Willi syndrome,
Turner syndrome, PKU, fetal alcohol syndrome, Williams syndrome).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 23 Years | Teaching Math Skills to Individuals With Fragile X Syndrome | NCT01204151 | Entailment |
305 | 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:
- Infertile female patients aged 20-37 years old undergoing IVF
- Long protocol
- Embryo transfer of fresh cycles D3
Exclusion Criteria:
- Uterine abnormalities e.g. sub-mucous fibroid, or fibroids indenting the endometrium,
polyps, Ashermann, etc.
- Poor responders
- Female patients ˃35 years old
- Medical disorders e.g. DM, HTN
- Immunological disorders e.g. SLE, APS
- Cervical distortions
- Thyroid or adrenal dysfunction
- Endometriosis grade 3 or 4
Female
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 37 Years | Comparative Study Between ICSI Results in Transvaginal Ultrasound Guided Embryo Transfer and Transabdominal Ultrasound Guided Embryo Transfer | NCT03683043 | Contradiction |
2,632 | 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 inguinal hernia.
Exclusion Criteria:
- Patients with acute disease and severe chronic disorder.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Plasma Total Antioxidant Status and Thiobarbituric Acid-reacting Substances in Patients With Inguinal Hernia | NCT02336256 | Entailment |
1,293 | 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:
- Group1: Children with GH deficiency diagnosed by 2 provocative tests with peak GH less
than 10 ng/ml.
- Group 2:Children with height less than the 3rd centile without any etiology
- Group 3:children with failure to thrive until the age of 3 years.
- Group 4: children with obesity defined by BMI above the 90th centile for age and sex.
- Group 5: children with no endocrine diseases and without obesity or short stature.
Exclusion Criteria:
- Children with known pediatric or endocrine diseases.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | Study of the Molecular Basis in the Pathophysiology of Food Intake and Growth in Children | NCT00830141 | Contradiction |
4,616 | 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 30 - 50 years old
- scheduled for vaginal, abdominal or laparoscopic total hysterectomy
- one or more of the following clinical symptoms: bleeding disorders (menorrhagia,
irregular bleeding, hypermenorrhoea), chronic pelvic pain, dysmenorrhoea, or
dyspareunia
- junction zone definable
Exclusion Criteria:
- postmenopausal women,
- pregnancy
- gynecological cancer
- GnRH analog therapy or systemic hormone therapy in the last three months prior to
hysterectomy
- junctional zone not identifiable
Female
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 50 Years | Norwegian Adenomyosis Study I | NCT02201719 | Entailment |
4,677 | 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. 21 to 45 years of age, inclusive;
2. In good health, as evidenced by history and procedures at screening and enrollment
visits without any clinically significant systemic disease;
3. Not be at risk for pregnancy, due to surgical sterilization of participant and or her
sexual partner, abstinence for duration of study, consistent condom use, non-hormonal
IUD or same sex relationship. Note: If consistent condom user, must agree to use
condoms without spermicide for duration of study.;
4. Have had regular menstrual cycles (every 24-35 days) for the past two cycles;
5. Willing and able to comply with study procedures
Exclusion Criteria:
1. A clinically significant history of an abnormal pap smear (by written report) that has
not been evaluated and or treated, if indicated, according to standard guidelines;
2. It has been less than 9 months since the participant's last depot medroxyprogesterone
acetate (DMPA) injection and she has not had 2 normal, spontaneous menses (this can be
shortened to 6 months if the participant has had at least 2 normal spontaneous
menses);
3. Use of any other hormonal contraceptive method within past 3 months (oral,
transdermal, transvaginal, implant, or intrauterine device) without 2 subsequent,
normal menses;
4. Surgery or biopsy of the vulva, vagina, or cervix (including piercings) within 30
days;
5. Pregnancy within the past 3 months;
6. Currently breastfeeding;
7. Current STI or lower genital tract infection (including, but not limited to HIV-1,
HSV-2, Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Neisseria Protocol #
D11-119 Version 2.0 April 13, 2012 10 gonorrhea (NG), Hepatitis B, high risk HPV sub
types and or Syphilis), yeast vaginitis or bacterial vaginosis (BV);
8. Current use of chronic immunosuppressants (for example daily steroids or daily
non-steroidal anti-inflammatory drugs [NSAIDs]);
9. Current presence of vulvar, anal and or vaginal genital warts;
10. Current tobacco use of any amount;
11. Other conditions that, in the opinion of the investigator, would constitute
contraindications to participation in the study or would compromise the ability to
comply with study protocols, such as any major chronic illness including but not
limited to cancer, serious autoimmune disease, metabolic disorders or a major
psychiatric disorder (e.g., schizophrenia); and
12. Current participation in any other drug or device study, or any study which, in the
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 45 Years | Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation | NCT01593124 | Entailment |
6,784 | 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:
- Adult patients (≥ 18 years of age) suffering from severe haemophilia A or B
- No professional medical background
- Submitted written consent to participate in the study and to use their study related
pseudonymized data
Exclusion Criteria:
- Patients suffering from other bleeding diseases
- Participants < 18 years of age
- Participants without written consent
- Professional medical background
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Sonography and Haemophilia | NCT04550988 | Entailment |
1,769 | 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:
- Subjects will have either bothersome upper abdominal discomfort, bloating (feeling of
abdominal distention) or belching following meals for at least 12 month's duration.
Subjects must have had a normal upper gastrointestinal endoscopy and/or upper GI
series during the preceding three years.
Exclusion Criteria:
- Individuals with a history suggestive of organic disease such as recent weight loss,
nausea, vomiting, GERD, recent changes in bowel habits will be excluded from 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 18 Years old.
Subject must be at most 70 Years | Efficacy of Pancrelipase on Postprandial Belching and Bloating. | NCT00266721 | Contradiction |
657 | 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:
- phase 1: experts in the field of haemochromatosis (hepatologists, hematologists,
endocrinologists, general practitioner, nurses, ...)
- phase 2: patients with hereditary haemochromatosis, treatment with phlebotomy since 3
months, Dutch/English speaking
Exclusion Criteria:
- patients with secundary iron overload
- phlebotomy treatment less than 3 months
- language: no Dutch or 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.
| Implications for Quality of Life and Quality of Care in Patients With Hereditary Haemochromatosis | NCT01991925 | Contradiction |
6,483 | 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. Outpatient, male or female of any race, 18 years of age or older. Female subjects of
childbearing potential must have a negative UPT at Baseline and practice a reliable
method of contraception throughout the study.
2. Facial redness associated with rosacea.
3. Facial redness (IGA-R) score of 2 or 3 (i.e., mild or moderate).
4. Absence of any skin conditions that could interfere with the visual erythema
assessments.
5. Willing to forego any other topical or non-topical treatment on the study areas during
treatment (other than sun protection or the study specified face wash and
moisturizer).
6. Willing to use the provided skincare regimen (e.g., face wash and moisturizer) over
the duration of the study.
7. Sign the IRB-approved ICF (which includes HIPAA) prior to any study-related procedures
being performed.
Exclusion Criteria:
1. Known hypersensitivity or previous allergic reaction to any constituent of the
Investigational Products (i.e., essential oils, fragrance, choline,
phosphatidylcholine, etc.).
2. Any transient flushing syndrome.
3. History of basal cell carcinoma within 6 months of Visit 1.
4. History or presence of a skin condition/disease that is located in the treatment
area(s) and might interfere with the diagnosis or evaluation of study parameters
(i.e., atopic dermatitis, psoriasis, significant actinic damage, vitiligo, open
wounds, infection, etc.).
5. Diagnosis of severe rosacea, ocular rosacea, rhinophymatous rosacea, or acne fulminans
at Baseline.
6. Blepharitis/meibomianitis requiring systemic treatment by an ophthalmologist.
7. Uncontrolled systemic disease.
8. Foreseen unprotected and intense/excessive UV exposure during the course of the study.
9. Use of any of the following concomitant medications/procedures:
- Cosmetic and/or OTC products for redness reduction and/or skin clearing
- Topical medications for rosacea
- Systemic antibiotics or corticosteroids
- Topical antibiotics, corticosteroids, or antiparasitic agents
- Intense/excessive ultraviolet (UV) radiation
- Phototherapy, energy-based therapy, facials, chemical peels, microdermabrasion
10. Exposure to any other investigational drug/device within 30 days prior to study entry.
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.
| CGB-400 for the Reduction of Facial Redness | NCT04508660 | Entailment |
6,823 | 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:
- hemophilia A or B
- FVIII/FIX <1% to 25%
- informed consent
Exclusion Criteria:
- no consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | German Pediatric Hemophilia Research Database | NCT02912143 | Entailment |
4,722 | 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:
- Participants will be healthy women aged 18 to 55 years. Women will enter in studies at
the follicular phase of the menstrual cycle, in order to avoid the interference of
estrogens.
- Female subjects (if not postmenopausal) possessing regular menstrual cycle between 26
and 32 days and willing to use effective methods of contraception through the study
(sexual abstinence, vasectomized partner, sterilization, intrauterine device,
double-barrier method).
- Clinical history and physical examination demonstrating no organic or psychiatric
disorders.
- The ECG and general blood and urine laboratory tests performed before the study should
be within normal ranges. Minor or occasional changes from normal ranges are accepted
if, in the investigator's opinion, considering the current state of the art, they are
not clinically significant, are not life-threatening for the subjects and do not
interfere with the product assessment. These changes and their non-relevance will be
justified in writing specifically.
- The body mass index (BMI=weigh/height2) will range from 18.5 to 29.9 kg/m2, and the
weight from 50 to 100 kg.
- Understanding and accepting the study procedures and signing the informed consent.
- Agreeing to follow a diet free from ethanol in the 72 hours prior to the start of each
session and until the end of the study.
- Subjects with social or recreational alcohol consumption, at least 3 standard
drinks/week and subjects with experience in several drunkenness.
Exclusion Criteria:
- Not meeting the inclusion criteria.
- History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive
drugs.
- Having suffered any organic disease or major surgery in the three months prior to the
study start.
- History of psychiatric disorders.
- Women presenting amenorrhea or who suffer from moderate to intense premenstrual
syndrome. Female subjects using hormonal contraceptive hormones.
- Smokers of more than 20 cigarettes per day.
- Taking more than 30 g of alcohol a day
- Regular use of any drug in the month prior to the study sessions. The treatment with
single or limited doses of symptomatic medicinal products in the week prior to the
study sessions will not be a reason for exclusion if it is calculated that it has been
cleared completely the day of the experimental session.
- Ingestion of vitamin supplements or antioxidants or nonsteroidal anti-inflammatory
drugs in the two weeks preceding the study.
- Blood donation 8 weeks before or participation in other clinical trials with drugs in
the previous 12 weeks.
- Subjects with intolerance or adverse reactions to ethanol.
- Subjects who have suffered a hospitalization caused by alcohol intoxication or who
have received treatment for drunkenness
- History or clinical evidence of gastrointestinal, liver, renal or other disorders
which may lead to suspecting a disorder in drug absorption, distribution, metabolism
or excretion, or that suggest gastrointestinal irritation due to drugs.
- Subjects unable to understand the nature, consequences of the study and the procedures
requested to be followed.
- Subjects with positive serology to Hepatitis B, C or HIV.
- Subjects who follow a vegetarian diet.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Dose-response Effect of Alcohol Ingestion on Steroid Profile | NCT02869763 | Entailment |
1,581 | 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. Person is over the age of 20 but not older than age 45.
2. Person is willing to participate as evidenced by signing the written informed consent
form.
3. Suffers from known dominant severe symptom of breast swelling and tenderness (level
7-10 according to standard scale of PMS symptoms severity)
4. Other severe symptoms of Premenstrual syndrome (based on WHO and ACOG criteria). This
may include one or more of PMS symptoms with level 7-10 according to standard scale of
PMS symptoms severity.
5. At work, school, home, or in daily routine, at least one of the PMS symptoms caused
reduction of productivity or inefficiency
6. At least one of the PMS symptoms caused avoidance of or less participation in hobbies
or social activities
7. At least one of the PMS symptoms interfere with relationships with others:
i. Timing of PMS symptom(s): during the 14 days prior to onset of menstrual flow
(rather than spotting) and up to 5 days during the menstrual flow.
ii. Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days.
iii. For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by
daily monitoring of symptoms.
iv. Timing and length of asymptomatic phase: day 6 to at least day 10 of the menstrual
cycle.
v. Cyclicity - presentation of the 'off-on' phenomenon: there should be a clear shift from
no PMS symptoms to PMS symptoms.
vi. Reliable non hormonal contraception.
Exclusion Criteria:
1. Pregnant or lactating woman
2. Oral contraceptives during last three months, including hormonal IUD (trade name
mirena).
3. Serious health problems.
4. Unexplained menstrual disorders.
5. Treated by hormones (estrogen and progesterone).
6. For healthy: Irregular or abnormal test results.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years | Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel | NCT00866437 | Contradiction |
2,436 | 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:
Consecutive patients presenting with clinicoradiological features suggestive of sarcoidosis
and an indication for transbronchial needle aspiration
Exclusion Criteria:
- Pregnancy
- Hypoxemia (SpO2 <90%) on room air
- Poor lung function (forced expiratory volume in first second [FEV1] <1L)
- Patients with deranged clotting profile (prothrombin time >3 seconds above control;
activated partial thromboplastin time >10 seconds above control, platelet count
<50000/µL)
- Patients already initiated on glucocorticoids
- Diagnosis of sarcoidosis possible on minimally invasive techniques such as skin biopsy
or peripheral lymph node biopsy and failure to provide 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 15 Years old.
Subject must be at most 75 Years | A Trial of EBUS-TBNA Versus Conventional TBNA in Diagnosis of Sarcoidosis | NCT01908868 | Contradiction |
4,771 | 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:
1. Subject is ≥ 18 years old
2. Subject understands the nature of the procedure and has signed the Subject Informed
Consent Form prior to the procedure
3. Subject is willing and able to comply with specified follow-up evaluations and
understands the audiological test procedures and use of the Esteem® System.
4. Subject has moderate to severe sensorineural hearing loss in the ear to be implanted
defined by pure tone average air-conduction threshold level.
5. Subject has an unaided maximum word recognition score of greater than or equal to 40%
with recorded delivery using a phonetically balanced word list at SRT + 40 decibels
(dB) or at maximum tolerable presentation level.
6. Subject is a current user of a properly functioning and appropriately fit hearing aid
for at least one (1) month in the ear to be implanted.
7. Subject has normally functioning eustachian tube
8. Subject has normal tympanic membrane
9. Subject has a normal middle ear anatomy
10. Subject has adequate space for Esteem® System implant determined via fine cut temporal
bone CT scan
11. Subject is a native speaker of the English language.
Exclusion Criteria:
1. Subject has a history of post-adolescent chronic middle ear infections, inner ear
disorders or recurring vertigo requiring treatment, disorders such as mastoiditis,
Hydrops or Meniere's syndrome or disease
2. Subject has a history of otitis externa or eczema for the outer ear canal and the
investigator believes this will affect the Esteem® System implantation
3. Subject has cholesteatoma or destructive middle ear disease
4. Subject has life expectancy of < two (2) years due to other medical conditions
5. Subject has retrocochlear or central auditory disorders
6. Subject is known to be suffering from any psychological, developmental, physical, or
emotional disorder that the investigator feels would interfere with the surgery or
follow-up testing
7. Subject has a known history of fluctuating air conduction and/or bone conduction
hearing loss over a one-year period of 15 dB in either direction at 2 or more
frequencies (from 500 - 4000 Hz)
8. Subject has sudden hearing loss due to unknown cause
9. Subject has a history of disabling tinnitus, defined as tinnitus which required
treatment.
10. Subject is unable to adequately perform audiological testing
11. Subject has a medical condition or undergoing a treatment that may affect healing and
the investigator does not believe the subject is a good candidate for the trial.
12. Subject has diabetes that is not well controlled with medication or diet and the
investigator does not believe in his best medical judgment that the subject would be a
good candidate for the trial
13. Subject is pregnant at the time of device implant
14. Subject has a history of keloid formation
15. Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel,
titanium and/or gold
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Esteem New Subject Enrollment Post Approval Study | NCT02689349 | Entailment |
1,772 | 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:
- Provision of signed written informed consent from the patient's guardian
- Patients aged ≥ 1 year to 14 years old
- Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or
Zollinger-Ellison syndrome.
Exclusion Criteria:
- Patients less than 10 kg in weight.
- Use of any other investigational compounds or participations in another clinical trial
within 4 weeks prior to the randomisation/registration.
- Significant clinical illness within 4 weeks prior to the registration
- Presence of hepatic diseases or other conditions that could interfere with evaluation
of the study as judged by the investigators.
- Positive for pregnancy test by urinary or lactation for post-menarchal females.
- Previous total gastrectomy
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 14 Years | A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases | NCT02153398 | Contradiction |
217 | 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:
- Males between 18 to 55 years of age
- In good general health based on normal screening evaluation (consisting of a medical
history, physical exam, normal serum chemistry, hematology, and baseline hormone
levels)
- Subject must agree not to participate in another research drug study for the duration
of the study
- Subject must agree to not donate blood during the study
- Subject must be willing to comply with the study protocol and procedures
Exclusion Criteria:
- Men in poor general health, with abnormal blood results (clinical laboratory tests or
hormone values)
- A known history of alcohol or drug abuse
- A history of testicular disease or severe testicular trauma,
- A history of bleeding disorders or current use of anti-coagulants
- A history of sleep apnea and/or major psychiatric disorders
- A body-mass index greater than 35,
- A history of or current use of testosterone
- Infertility
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Oral Androgens in Man-4: (Short Title: Oral T-4) | NCT00399165 | Entailment |
6,372 | 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:
1. Age ≥18 years at time of signing Informed Consent Form.
2. Laboratory (RT-PCR) confirmed infection with CoVID-19.
3. Hospitalised with Fever(≥36.7℃ -axilla or oral temperature ≥ 38.0 ℃ or ≥38.6°C
tympanic or rectal) and cough;
4. No difficulty swallowing oral medications.
5. Must agree not to enroll in another study of an investigational agent prior to
completion of Day 28 of study.
Exclusion Criteria:
1. Allergies, known to be allergic to research drugs or drug excipients;
2. Patient weight is less than 40 kg;
3. Respiratory distress-RR≥30 / min on room air,or SPO2≤ 93%, or PaO2/FiO2 ≤300mmHg
(1mmHg = 0.133kPa)
4. Shock;
5. The clinician judges that ICU monitoring treatment is needed;
6. Patients who have participated in other clinical trials within 1 month;
7. Known patients with impaired renal function (estimated creatinine clearance <60 mL /
min (male: Cr (ml / min) = (140-age) × body weight (kg) / 72 × blood creatinine
concentration (mg / dl); female: Cr (ml / min) = (140-age) × weight (kg) / 85 × blood
creatinine concentration (mg / dl));
8. During the screening or within 24 hours before screening, patients were found to have
any of the following laboratory parameter abnormalities (based on local laboratory
reference range):-ALT or AST level> 5 times the upper limit of normal range (ULN)
or-ALT or AST > 3 times ULN and total bilirubin levels> 2 times ULN;
9. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of
pre-dose inspection, or planning to become pregnant within 3 months of study
treatment.
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.
| Yinhu Qingwen Decoction for the Treatment of Mild / Common CoVID-19 | NCT04278963 | Entailment |
6,980 | 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:
- Diagnosis of Alzheimer Disease
- Living independently at home (not in a care home or similar aged care facility)
- Able to complete questionnaires in Norwegian
- Able to undergo MRI scans
- Able to attend interventions and assessments in the area of Bergen, Norway
- Has given informed consent
Exclusion Criteria:
- Hearing impairment that cannot be mended by hearing aids
- Conditions that hinder MRI scans, such as claustrophobia or metal objects in body
(e.g. pacemakers)
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.
| ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients | NCT03444181 | Entailment |
3,208 | 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:
- Be at least 18 years of age;
- Provide written informed consent;
- Have a subject reported history of dry eye;
- Have a history of use of eye drops for dry eye symptoms ;
- Ocular Discomfort;
- Schirmer's Test score;
- Have corneal fluorescein staining ;
- Have lissamine green conjunctival Staining ;
- Have a conjunctival redness;
Exclusion Criteria:
- Have participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;
- Have any clinically significant slit lamp findings at Visit 1;
- Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit
1;
- Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned
over the study period;
- Have an uncontrolled systemic disease;
- Be a woman who is pregnant, nursing or planning a pregnancy;
- Be a woman of childbearing potential who is not using an acceptable means of birth
control;
- Have a known allergy and/or sensitivity to the study drug or its components ;
- Have a condition or be in a situation which the investigator feels may put the subject
at significant risk, may confound the study results, or may interfere significantly
with the subject's participation in the study;
- Be currently enrolled in an investigational drug or device study or have used an
investigational drug or device within 30 days of Visit 1;
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.
| Study of SkQ1 as Treatment for Dry-eye Syndrome | NCT03764735 | Entailment |
5,572 | 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:
- Chronological Age ≥ 3.0 years and ≤ 9.0 years (girls) or ≤ 10.0 years (boys)
- Pre-pubertal status
- Diagnosis of GHD as documented by two or more GH stimulation test results
- Height SD score ≤ -2.0 at screening
- Weight for Stature ≥ 10th percentile
- IGF-I SD score ≤ -1.0 at screening
- Delayed bone age
Exclusion Criteria:
- Prior treatment with any growth promoting agent
- History of, or current, significant disease
- Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD)
or confirmed diagnosis of a named syndrome
- Birth weight and/or birth length less than 5th percentile for gestational age
- A diagnosis of Attention Deficit Hyperactivity Disorder
- Daily use of anti-inflammatory doses of glucocorticoid
- Prior history of leukemia, lymphoma, sarcoma or cancer
- Ocular findings suggestive of increased intracranial pressure and/or retinopathy at
screening
- Significant spinal abnormalities including scoliosis, kyphosis and spina bifida
variants
- Significant abnormality in screening laboratory studies
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 10 Years | Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317) | NCT02413138 | Contradiction |
237 | 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:
1. Post-menarcheal, pre-menopausal females up to 45 years of age at the time of informed
consent/assent and in good general health;
2. History of regular menstrual cycles defined as occurring every 21-35 days when not
using hormones or prior to recent pregnancy or spontaneous or induced abortion;
3. Sexually active with a male partner who has not had a vasectomy nor other known
fertility problems;
4. Reasonably expect to have coitus at least once monthly during the study period;
5. In a mutually monogamous relationship of at least 3 months duration at time of
consent;
6. Seeking to avoid pregnancy for the duration of the study;
7. Willing to use the study drug as the sole form of contraception;
8. Willing to accept a risk of pregnancy;
9. Subjects must be in compliance with cervical cancer screening guidelines per the
American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines without
evidence of disease. Subjects who are age 21 to 24 y/o, at time of informed consent,
must have a normal Papanicolaou test (Pap), atypical squamous cells of undetermined
significance (ASC-US), or low-grade squamous intraepithelial lesion (LSIL). Subjects
who are 25 or older at the time of informed consent must have a normal Pap test or an
ASC-US result with a negative high-risk human papilloma virus (HPV) test result within
the appropriate screen timeframe per ASCCP guidelines, and prior to the study IUD
insertion. Alternatively, the subject must have had a colposcopy performed within the
appropriate screen timeframe, and prior to the study IUD insertion that showed no
evidence of dysplasia requiring treatment per ASCCP guidelines, or treatment was
performed and follow-up at least 6 months after the treatment showed no evidence of
disease by clinical evaluation;
10. Able and willing to comply with all study tests, procedures, assessment tools
(including e-diary) and follow-up;
11. Able and willing to provide and document informed consent and Authorization for
Release of Protected Health Information (PHI). Unemancipated subjects under 18 years
old must provide assent and have written parental/legal guardian consent documented on
the consent form consistent with local legal requirements;
12. Plan to reside within a reasonable travel distance of a research site for the duration
of the study.
13. Subject agrees not to intentionally self-remove LevoCept
Exclusion Criteria:
1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse
earlier in current cycle;
2. Has had any procedure for or causing sterility (e.g. tubal ligation procedure);
3. Subject who anticipates separation from her partner for more than a 6-month period
during use of LevoCept;
4. A previously inserted IUD/IUS that has not been removed by the time the study IUS is
placed;
5. History of previous IUD/IUS complications, such as perforation, expulsion, or
pregnancy with IUD/IUS in place;
6. Pain with current IUD/IUS;
7. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months and
has not had 2 normal menstrual cycles since the last injection;
8. Subject is <4 weeks post-pregnancy (postpartum, spontaneous or induced abortion)
9. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time
during the 60 months of study participation;
10. Exclusively breastfeeding before return of menses; lactating women will be excluded
unless they have had 2 normal menstrual periods prior to enrollment;
11. Unexplained abnormal uterine bleeding (suspicious for a serious condition), including
bleeding 4 weeks post-septic abortion or puerperal sepsis;
12. Severely heavy or painful menstrual bleeding;
13. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically
significant abnormal Pap test requiring evaluation or treatment;
14. Any history of gestational trophoblastic disease with or without detectable elevated
ß-human chorionic gonadotropin (ß-hCG) levels, or related malignant disease;
15. Any congenital or acquired uterine anomaly that may complicate study drug placement,
such as:
- Submucosal uterine leiomyoma
- Asherman's syndromes
- Pedunculated polyps
- Bicornuate uterus
- Didelphus or uterine septa
16. Any distortions of the uterine cavity (e.g. fibroids), that, in the opinion of the
investigator, are likely to cause issues during insertion, retention or removal of the
IUS;
17. Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior
trachelectomy or extensive conization that, in the opinion of the investigator would
prevent cervical dilation and study drug placement;
18. Untreated or unresolved acute cervicitis or vaginitis;
19. Known or suspected breast cancer or other progestin-sensitive cancer now or in the
past;
20. Known acute liver disease or liver tumor;
21. Subjects who have an established immunodeficiency;
22. Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;
23. At high risk for sexually transmitted infections (e.g. multiple sexual partners);
24. Known intolerance or allergy to any components of LevoCept, including intolerance or
allergy to levonorgestrel, nickel, titanium, or silicone;
25. Currently participating or planning future participation in a research study of an
investigational drug or device during the course of this investigational study.
Subject must have waited at least 30 days from exiting their last study prior to
informed consent in this study;
26. Subject has previously been enrolled in a VeraCept or LevoCept study (including the
current study);
27. Known or suspected alcohol or drug abuse within 12 months prior to the screening
visit;
28. Any general health, mental health or behavioral condition that, in the opinion of the
investigator, could represent an increased risk for the subject or would render the
subject less likely to provide the needed study information;
29. Study staff or a member of the immediate family of study staff.
Female
Accepts Healthy Volunteers
Subject must be at most 45 Years | Evaluation of the Efficacy, Safety, and Tolerability of LevoCept | NCT04457076 | Contradiction |
4,269 | 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:
- Confirmed diagnosis of cystic fibrosis
- Male and female patients at least 6 years of age at the time of screening.
- Forced expiratory volume in one second (FEV1) at screening must be at least 25% and
less than or equal to 75% of normal predicted values for age, sex, and height based on
Knudson criteria.
- Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat
cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to
screening and in the sputum/ deep-throat cough swab culture at the screening visit.
- Able to comply with all protocol requirements.
- Clinically stable in the opinion of the investigator.
- Use of an effective means of contraception in females of childbearing potential.
- Provide written informed consent, Health Authority Portability and Accountability Act
(HIPAA) authorization (where applicable), and assent (as appropriate) prior to the
performance of any study-related procedure.
Exclusion Criteria:
- History of sputum culture or deep-throat cough swab (or BAL) culture yielding
Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to
screening and/or sputum culture yielding B cepacia at screening.
- Coughing up more than 60 cc of blood from the respiratory tract at any time within 30
days prior to study drug administration.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- Females who are pregnant (positive pregnancy test), lactating, or are planning to
become pregnant during the study.
- History of hearing loss or chronic ringing in the ears deemed clinically significant
by the investigator.
- Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study
drug administration.
- Use of loop diuretics within 7 days prior to study drug administration.
- Use of any investigational treatment within 28 days prior to study drug
administration.
- Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or
inhaled corticosteroids within 28 days prior to study drug administration (patients
may be taking these therapies at the time of enrollment, but they must have initiated
treatment more than 28 days prior to study drug administration).
Other protocol-defined inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
| Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis | NCT00388505 | Entailment |
3,781 | 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:
1. Subject is informed and has been given ample time and opportunity to think about
his/her participation and has given his/her written informed consent
2. Subject is ≥18 years of age
3. Subject's health status: individual is considered to be healthy (hypertension and
hypotension is permissible. Other stable diseases at the time of testing are also
permissible)
4. Subject is capable of undergoing controlled hypoxaemia to the levels called for the in
the protocol with minimal medical risk (unless only participating in the blood
pressure study).
Exclusion Criteria:
1. Subject cannot expose their face fully for a reading to be taken
2. Subject is unable to give informed consent
3. Subject is outside of the specified age range
4. Subject has already taken part in the study (all 4 sub studies)
5. Subject with significant irregular heart rhythm or any disease that might affect the
results of the study
6. Subject is not capable of undergoing controlled hypoxia and would be placed at undue
medical risk if this occurred
7. Subject has any contraindications identified that would deem them unsuitable to take
part
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application | NCT03998098 | Entailment |
1,523 | 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:
Arm 1: healthy volunteers:
1. Male and female volunteers 18 years of age and older
2. No history of chronic or acute cough and throat clearing
3. Ability to read a 5th grade script written in English for approximately 20 minutes
Arm 2: patients:
1. Male and female volunteers 18 years of age and older
2. Cough as chief complaint
3. Referred to the GI clinic to evaluate if reflux is the cause of their chief complaint
4. pH testing for standard of care purposes
Exclusion Criteria:
- Subjects who are not able to give informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Cough Monitoring Study | NCT01263626 | Entailment |
3,563 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- Woman aged 18 to 65, consultant in general medicine. (Any patient meeting the
inclusion criteria may choose to answer the questionnaire in the waiting room of
general practitioners selected by lot.)
Exclusion Criteria:
-
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Prevention of Cystitis. | NCT03744338 | Entailment |
5,866 | 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:
- subjects who completed upper GI endoscopy and questionnaires about GERD symptoms
Exclusion Criteria:
- a history of gastrointestinal surgery
- Barrett's esophagus
- esophageal motility disorder
- duodenal ulcer
- benign gastric ulcer
- gastroduodenal cancer
- if he or she had any history of systemic disease requiring chronic medication (except
for hypertension and diabetes mellitus).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Nociceptors, Neurotrophic Factors and Cytokine Expression in Gastroesophageal Reflux Disease | NCT02114216 | Contradiction |
2,351 | 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:
- age group of 6 months and above
- muscular dystrophy diagnosed on the basis of clinical presentation
Exclusion Criteria:
- presence of respiratory distress
- presence of acute infections such as Human Immunodeficient Virus/Hepatitis B
Virus/Hepatitis C Virus
- malignancies
- acute medical conditions such as respiratory infection, fever, hemoglobin less than 8,
bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30%
- pregnancy or breastfeeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 60 Years | Stem Cell Therapy in Muscular Dystrophy | NCT02241928 | Entailment |
1,258 | 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 confirmed by cytological analysis of pleural fluid and/or
pleural biopsy;
- Recurrent pleural effusion with symptoms;
- Chest radiography with lung expansion after thoracocentesis;
- Karnofsky Performance Status > 70;
- Written informed patient consent were obtained.
Exclusion Criteria:
- Hemorrhagic diathesis;
- Active infection;
- Cutaneous infiltration;
- Patients unable to understand the questionnaires;
- Age: > 90 yo or < 18 yo.
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 90 Years | Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion | NCT00789087 | Entailment |
6,271 | 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:
In order to be eligible to participate in this study, all individuals must meet all of the
following criteria:
1. Stated willingness to comply with all study procedures and availability for the
duration of the study
2. Age 18 years or older.
3. Ability of participant to understand and the willingness to sign a written informed
consent document.
4. Hemoglobin of 9.0 gm/dl or higher
5. Willingness to give consent for the storage of blood samples for research.
6. Have a physician or clinic outside NIH to manage underlying medical conditions or
agreeing to establish care with an outside physician or clinic for any medical
conditions requiring treatment that may be diagnosed as a result of protocol
participation.
COVID-19 Survivor Group
1. Documented prior COVID-19 as evidenced by:
1. detection of SARS-CoV-2 RNA or antigen in nasopharyngeal swab, sputum or other
sample source with EUA/approval from the FDA; or
2. a positive antibody test using an assay that has received emergency use
authorization (EUA) from the Food and Drug Administration (FDA) and a history
clinical manifestation compatible with COVID-19.
2. Greater than 6 weeks since onset of COVID-19 symptoms and no fever for at least 1
week. For individuals with asymptomatic infection, screening will not occur until at
least 4 weeks after the last positive SARS-CoV-2 PCR or antigen test.
COVID-19 Close Contact
1. Living in the same household as a COVID-19 survivor during the time of illness or,
being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period
of time or having direct contact with infectious secretions of a COVID-19 case (e.g.,
being coughed on).
2. No diagnosis of COVID-19 or current symptoms suggestive of COVID-19
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation
in this study:
1. Current abuse of alcohol or other drugs that, in the judgement of the Principal
Investigator (PI) could interfere with patient compliance.
2. Inability to travel to the NIH Clinical Center for study visits
3. Any medical or mental health condition that, in the judgement of the PI, would make
the volunteer unable to participate in the study.
4. Positive SARS-CoV-2 PCR at screening visit.
5. History of any of the following in the past 14 days: fever > 38.2 degrees Celsius; new
or worsening respiratory symptoms (e.g. cough, dyspnea).
6. Pregnancy
INCLUSION OF VULNERABLE PARTICIPANTS:
Pregnant Women will not be enrolled in the protocol. If a woman is pregnant at the time of
screening she will not be enrolled until the end of her pregnancy because important
baseline research assessments (e.g. leukapheresis, chest x-ray, pulmonary function testing)
should not be done during pregnancy.
Children will not be included in this study. Due to the rarity of COVID-19 in children (as
of 4/11/2020 in Maryland, <2% of cases occurred in children), it would not be possible to
recruit enough children to address the protocol research objectives. In addition, pediatric
restrictions for the volume of blood permitted to be drawn for research purposes and the
more than minimal risk of apheresis in children would severely limit the ability to conduct
the immunologic studies described in this protocol.
Participation of Employees
NIH employees may be enrolled in this study as this population meets the study entry
criteria.
Neither participation nor refusal to participate as a participant in the research will have
an effect, either beneficial or adverse, on the participant s employment or position at
NIH.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Longitudinal Study of COVID-19 Sequelae and Immunity | NCT04411147 | Contradiction |
1,854 | 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:
inpatients or outpatients of either sex who require therapeutic upper gastrointestinal
endoscopy (EMR or ESD) and meet the criteria (1)-(4) below will be enrolled in the study.
Patients have to provide written informed consent for voluntary participation in the study.
The criteria (2) and (3) will be confirmed by the endoscopic observation just before
starting the intended treatment.
1. Patients with an early gastric cancer located in the lower third of the stomach, who
require therapeutic upper gastrointestinal endoscopy (EMR or ESD) (except for those
with an intended treatment by using a scope of <9 mm in diameter)
2. Differentiated -type intramucosal gastric cancer or the suspected lesion, ≤ 2 cm in
size, no ulcer finding
3. Patients with a single intended lesion for the treatment
4. Patients who are older than 20 years at the time of consent
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study beforehand.
The criteria (3) to (5) will be confirmed by the endoscopic observation just before
starting the intended treatment.
1. Patients with a history of surgery to the upper gastrointestinal tract
2. Patients who require emergency endoscopy
3. Patients with severe gastric stenosis or deformation which makes observation of
gastric peristalsis difficult
4. Patients who require emergency endoscopic treatment except for the intended lesion
5. Patients with a lesion extended to the pyloric ring
6. Patients with an ongoing cancer treatment (chemotherapy or radiotherapy)
7. Patients with pacemaker
8. Patients with known bleeding tendency or Patients with difficulty of antithrombogenic
agents withdrawal
9. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil
10. Patients with contraindications to glucagon
11. Patients with contraindications to benzodiazepines, pethidine hydrochloride, and
epinephrine
12. Pregnant or lactating women, women of childbearing potential, or women who plan to
become pregnant during the study
13. Patients who have received other investigational drugs within four months before
consent or who are participating in other clinical studies
14. Patients otherwise ineligible for participation in the study in the 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 20 Years old.
| Phase III Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy | NCT01411176 | Entailment |
1,130 | 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:
- Age 18-80 years
- Established diagnosis of HCM
Exclusion Criteria:
- Known history of coronary or peripheral artery disease
- History of myocardial infarction
- Pregnant or lactating females
- Hypersensitivity to any ultrasound contrast agent
- Evidence right-to-left or bi-directional intracardiac shunt
- Moderate or greater valve disease other than from HCM (systolic anterior motion of the
mitral valve)
- History of septal ablation or myectomy
- Hemodynamic instability
- Pacemaker dependent heart rhythm
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.
Subject must be at most 80 Years | Perfusion Imaging With Myocardial Contrast Echocardiography in HCM | NCT02560467 | Entailment |
3,381 | 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 of both sexes
- Between 35 and 65 years old
- Patients with type 2 diabetes within two years of diagnosis according to the ADA
criteria
- Overweight patients (BMI between 25.5 and 29.9 kg/m2) or with grade 1 obesity (BMI
between 30.0 and 34.9 kg/m2), according to WHO classification
- Low HDL levels: <50 in women and <40 mg/dL in men
- Hypertriglyceridemia: >150 and less than 300 mg/dL
- Patients who had not taken antidiabetes drug treatment or with diet and exercise
treatment, or with metformin or DPP4 inhibitor monotherapy
- HbA1c between 6.5 and 8.5%.
- Creatinine clearance >60 ml/min (calculated by Cockcroft and Gault)
- Informed consent form signed.
- Women using contraception.
Exclusion Criteria:
- Patients with other types of diabetes (type 1, LADA, MODY, etc.).
- Patients with primary dyslipidemia.
- Patients with poorly substituted hypothyroidism TSH > 5 mU/mL.
- Patients hospitalized in the last month.
- Patients with a disease of poor short-term prognosis
- Patients with autoimmune or rheumatic diseases.
- Patients with acute infection or febrile illness.
- History of chronic liver disease or ALT or AST ≥ 2.0 times the upper limit of normal,
or GGT ≥ 3 times the upper limit of normal.
- Patients with any other chronic disease, for example: HIV, rheumatic diseases.
- Pregnant or positive pregnancy test.
- Women who are breastfeeding.
- Patients in another research project.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 65 Years | Efficacy Study of Metformin Glycinate on Postprandial Lipemia | NCT02064881 | Contradiction |
441 | 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:
- increased levels of serum β-hCG and ultrasonography findings. The criteria for
diagnosis by ultrasonography was the presence of the following: (1) an empty uterine
cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac
embedded in the hysterectomy scar; (3) the presence of the gestation sac with or
without a fetal pole and with or without fetal cardiac activity (depending on the
gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm)
or absent myometrial layer between the gestational sac and the bladder(24). All
patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis .
Pregnancy tissues were identified by histopathology examinations of the surgical
tissues.
Exclusion Criteria:
- All enrolled patients had no contraindications for transvaginal surgery or UAE,
including renal failure, active pelvic infection, clotting disorders, or known allergy
to the contrast material.
Female
No healthy subjects accepted to join the trial.
| Fertility After Transvaginal Surgery or Uterine Artery Embolization Combined With Uterine Curettage in Patients With Cesarean Scar Pregnancy | NCT02933190 | Contradiction |
6,055 | 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. Individuals with reflux disease between the ages of 18 and 79 who have failed a trial of
daily PPI.
Exclusion Criteria:
1. Barrett's esophagus
2. Use of high dose proton pump inhibitor within 4 weeks of study entry
3. Esophageal varices
4. Coagulopathy
5. GI cancer or mass
6. Previous surgery involving the esophagus, stomach or duodenum
7. Pregnancy
8. Allergy to either sucralfate or proton pump inhibitors
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 79 Years | Confocal Endomicroscopy for Non-Erosive Reflux Disease (CE NERD) | NCT02039869 | Entailment |
5,512 | 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 GCA defined by the following Revised GCA Diagnosis Criteria:
Age >=50 years. History of ESR >=50 millimeter/hour (mm/hour) or CRP >=2.45
milligram/deciliter(mg/dL).
Presence of at least one of the following: Unequivocal cranial symptoms of GCA; Unequivocal
symptoms of polymyalgia rheumatic (PMR).
Presence of at least one of the following: Temporal artery biopsy revealing features of
GCA; Evidence of large-vessel vasculitis by angiography or cross-sectional imaging.
- Active GCA within 6 weeks of Randomization (Baseline) where active disease is defined
by an ESR >=30 mm/hr or CRP >=1 mg/dL AND the presence of at least one of the
following:
Unequivocal cranial symptoms of GCA; Unequivocal symptoms of PMR; Other features judged by
the clinician investigator to be consistent with GCA or PMR flares.
- At screening, receiving or able to receive prednisone 20-60 mg/day for the treatment
of active GCA.
- Clinically stable GCA disease at baseline such that the subject is able to safely
participate in the blinded prednisone taper regimen in the opinion of the
investigator.
- Practicing acceptable methods of birth control if a female of child-bearing potential.
- No evidence of active or latent infection with Mycobacterium tuberculosis (TB).
Exclusion Criteria:
- Are pregnant or breastfeeding.
- Recent (within the past 12 weeks) or planned major surgery that would impact on study
procedures or assessments.
- Organ transplantation recipients (except corneas within 3 months prior to baseline
visit).
- Had prior treatment with any of the following:
Systemic immunosuppressives) within 4 weeks of baseline; Biologic agents targeted at
reducing tumor necrosis factor-alpha (TNF-alpha) within 2-8 weeks of baseline, depending on
the agent; Any prior use of tocilizumab or other anti-IL-6 agents; B-cell depleting agents
(eg, rituximab) within 12 months prior to baseline or longer if B cell counts have not
returned to normal range or baseline levels; Cytotoxic drugs such as cyclophosphamide,
chlorambucil, nitrogen mustard, or other alkylating agents within 4 weeks of baseline;
Abatacept within 8 weeks of baseline; Tofacitinib within 4 weeks of baseline; Methotrexate
use within 2 weeks of baseline.
Methylprednisolone > 100 mg/day intravenous (IV) (or equivalent) within 8 weeks of
baseline.
- History of severe allergic reactions to monoclonal antibodies, human proteins, or
excipients.
- Evidence of serious concomitant disease, which in the opinion of the investigator
makes them unsuitable for participation in the study.
- Major ischemic event, unrelated to GCA, within 12 weeks of screening.
- Marked baseline prolongation of corrected QT (QTc) interval >= 450 milliseconds (msec)
(QTc by Bazett's formula [QTcB ]or QTc by Fridericia's formula [QTcF] ), history of
Torsade de Pointes, family history of long QT syndrome, history of second or third
degree heart block.
- Current liver disease that could interfere with the trial
- History of or current active diverticulitis, inflammatory bowel disease, or other
symptomatic gastrointestinal tract condition that might predispose to bowel
perforation.
- History of known demyelinating diseases such as multiple sclerosis or optic neuritis.
- Active infections, or history of recurrent infections or have required management of
acute or chronic infections, as follows:
Currently on any suppressive therapy for a chronic infection, history or suspicion of
chronic infection, hospitalization for treatment of infection within 60 days of the
baseline visit, or use of parenteral (IV) or intra-muscular [IM]) antimicrobials within 60
days of baseline or oral antimicrobials within 30 days of baseline
- Primary or secondary immunodeficiency or any other autoimmune disease.
- Human immunodeficiency virus (HIV) infection, hepatitis C or hepatitis B infection
- Live virus or bacterial vaccination within 3 months before the first administration of
study drug
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.
| Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis | NCT02531633 | Entailment |
811 | 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:
- Pain in the knee
- Osteophytes on knee x-ray
- Self-reported pain on the inner aspect of the study knee
- Osteophytes in the medial compartment of the knee joint and
- Medial joint space narrowing greater than lateral joint space narrowing on x-ray
Exclusion Criteria:
- Knee surgery within the previous 6 months
- History of lower limb joint replacements
- Systemic arthritic conditions such as rheumatic or psoriatic arthritis
- Valgus knee deformity (> 5º)
- Inability to walk without the use of walking aids
- Intending to start a lower limb strengthening program in the next 3 months
- Seeking or currently receiving physiotherapy for OA knee
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.
| Knee Malalignment and Thigh Muscle Strengthening in Individuals With Medial Knee Arthritis | NCT00414557 | Entailment |
Subsets and Splits
No saved queries yet
Save your SQL queries to embed, download, and access them later. Queries will appear here once saved.