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3,859 | 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:
- Have a physician confirmed diagnosis of knee osteoarthritis OR are both 1) over 50,
and 2) have experienced 4 weeks of pain, aching, or discomfort in or around the knee
during the last year (equal to or more than 28 separate or consecutive days).
- Have no previous diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis,
psoriatic arthritis, ankylosing spondylitis), connective tissue diseases, or gout.
- Have no history of using disease-modifying anti-rheumatic drugs, such as
hydroxychloroquine, sulfasalazine, methotrexate, biologic agents (e.g., Humira,
Enbrel), or gout medications.
- Have no prior knee arthroplasty, and not on a waiting list for total knee replacement
surgery.
- Have no history of acute injury to the knee in the past 6 months.
- Have not had surgery in the back, hip, knee, or ankle joints in the past 12 months.
- Have an email address and use online/mobile applications.
- Are able to attend one 1.5-hour education session.
Exclusion Criteria:
- Have received a hyaluronate injection in a knee in the last 6 months.
- Have received a steroid injection in a knee in the last 6 months.
- Are at risk when exercising, as identified by the Physical Activity Readiness
Questionnaire.
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.
| SuPRA: Using Wearable Activity Trackers With a New Application to Improve Physical Activity in Knee Osteoarthritis | NCT02585323 | Entailment |
6,277 | 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:
- major
- having given his or her written consent and being able to consent
- For the prospective COVID-19 (+) sub-population : Diagnosis of COVID-19 by RT-PCR
SARS-CoV-2 (+)
- For the retrospectiveCOVID-19 (+) sub-population : Serum stored as part of care in
patients diagnosed with COVID-19 (+) by an RT-PCR SARS-CoV-2 (+), and no patient
opposition obtained.
- For the prospective COVID-19 (-) sub-population :
No suggestive clinical picture associated with RT-PCR SARS-CoV-2 (-) or Evocative clinical
picture with RT-PCR SARS-CoV-2 (-) and negative chest CT scan
- For the retrospective COVID-19 (-) sub-population : Serum kept as part of the care
before the outbreak began, and no opposition from the subject obtained.
- For the staff hospital sub-population : The staff members included must be of legal
age, work at the Cornish Hospital Center and have given their written consent and be
able to consent.
Exclusion Criteria:
-Patients with RT-PCR SARS-CoV-2 (-) but with a chest CT suggestive of COVID-19.
And for all the patients in different sub-populations :
- incapable of consent
- refusal to participate
- not covered by a social security scheme
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.
| Serology COVID-19 From the Cornwall Hospital Union | NCT04363593 | Entailment |
806 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Male and female aged between 45 and 90 years
- Presence of activity-related joint pain
- Patients who have either no morning joint-related stiffness or morning stiffness that
lasts no longer than 30 minutes
- Patients who have not responded to previous treatments,
- Patients with a baseline pain intensity of 4 to 8 on a 10-cm VAS
- Patients who are not candidates for immediate surgery
- Signed statement of informed consent (approved by Ethics Committee)
Exclusion Criteria:
- Prior surgery or previous local treatment (infiltration, other) in the past 3 months
- Changes in medications used during the previous 2 months
- Intravenous drug use
- Corticosteroid use of more than 3 months within the preceding year
- Diagnosis of other rheumatologic disorders
- Trauma, fracture, or osteomyelitis of the investigated joints within the preceding
year
- Any neurological disease or disorders potentially affecting pain perception
- Fibromyalgia
- Pregnancy
- Patients with large scar at skin or deeper soft tissue potentially included in the
planned path of the ultrasound beam
- General contraindications to MRI and/or to anaesthesiological procedures planned for
the patient
- Presence of internal hardware or devices potentially affecting MR thermometry
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 90 Years | MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain | NCT03467165 | Entailment |
6,341 | 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 (18 -80 years) with mild to moderate COVID-19 cases consented to home or
hospital isolation to follow them.
Exclusion Criteria:
Severe cases not fulfilling the definition of mild and moderate cases.
Definition of mild cases according to The Egyptian Ministry Of Health: (MOH)
1. Age < 60
2. Temperature <38.5
3. SaO2 >92%
4. Heart Rate <110
5. Respiratory Rate <25 /min.
6. Neutrophil / lymphocyte ratio on CBC < 3.1
7. No co-morbidities that necessitates hospital admission: Pregnancy, severe uncontrolled
Diabetes, Chronic lung disease, Chronic kidney disease, Chronic liver disease, Serious
heart diseases (arrythmia, Ischemic heart disease, uncontrolled hypertension),
immunocompromised: prolonged use of corticosteroids and other immunosuppressive drugs/
organ transplantation/ HIV/ Immunodeficiency, Obesity (BMI > 40) Any patient not
fulfilling the above mild criteria is considered having moderate disease as well as
any positive pulmonary imaging findings
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 | Nutritional Habits, and Coronavirus Disease 2019 (COVID-19) Outcome | NCT04447144 | Entailment |
4,844 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Shows lack of cortisol suppression
- Suppressed or low early-morning ACTH levels
- A radiologically confirmed adrenal lesion
- Has IGT or DM
- Has uncontrolled hypertension
Exclusion Criteria:
- Has severe, uncontrolled hypertension
- Has poorly controlled DM
- Has significantly abnormal liver test results or severe renal insufficiency
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
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 | Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas | NCT04308590 | Contradiction |
3,937 | 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:
- Femorotibial knee OA (Uni- or bilateral)
- Responding to clinical and radiological criteria of American College of Rheumatology
(ACR)
- Symptomatic for more than 6 months in the most painful knee
- Radiological K&L grade II-III in radiographs from less than 12 months
- Moderate-to-severe knee pain: knee pain score evaluated on Visual Analogue Scale (VAS)
(0-100) ≥ 40 over the last 24 hours at the inclusion visit (the most painful knee is
considered)
- Able to follow the instructions of the study
- Having signed an informed consent
Exclusion Criteria:
Related to the OA pathology
- Recent trauma (< 1 month) of the knee responsible of the symptomatic knee
- Concurrent articular disease interfering with the evaluation of OA and/or pain such as
articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia,
hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative
spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis,
radiculalgia in the lower limbs, arteritis, etc.
- Radiological K&L grade I or IV
- Prosthesis in the target knee
Related to treatments
- Analgesics to manage OA knee pain 24h before inclusion visit
- Corticosteroids injection in the target knee in the month preceding inclusion
- Hyaluronan injection in the target knee in the last 6 months
- Oral corticotherapy ≥ 5mg/day in the last 3 months
- Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine,
soy and avocado unsaponifiables) in the last 3 months
- An anticipated need for any OA related medication for the duration of the trial
(Corticosteroids or hyaluronan injection, Oral corticotherapy, Arthroscopy, analgesics
other than the authorized rescue treatments) which are forbidden during the trial
- Arthroscopy in the last 6 months
- Patients with known allergy to CS, GH, or intolerance to rescue treatment (Paracetamol
and NSAIDs)
- Patients with allergy to shellfish
Related to associated diseases
- Severe and uncontrolled diseases (liver or renal failure, lung/heart severe disease,
tumor, HIV….)
- Anticipated need for any surgical or other invasive procedure during the trial
including prosthesis in the target knee Related to patients
- Artialis (study coordinator) or Bioiberica (Sponsor) 's employees
- Participation to a therapeutic clinical trial in the last 3 months
- Under guardianship or judicial protection
- Pregnancy, breastfeeding, planned conception
- Women without menopause or tubal ligation and without contraception
Related to MRI
- Unable to receive gadopentetate contrast agent injection because of contraindications:
- Acute or chronic severe renal insufficiency (a glomerular filtration rate < 30
mL/min/1.73m2); or
- Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the
peri-operative liver transplantation period.
- Known anaphylactic reactions to Gadolinium or related substances
- Risk groups for MRI scanning due to magnetic field or contrast agent: Metal in body:
Pacemaker / Automatic Implantable Cardioverter Defibrillators / Implantable
Cardioverter Defibrillators (coronary defibrillator), Nervus vagus stimulator,
Artificial heart valve (depending on type), Metal clips on cerebral arteries or veins,
Metal particles in eye, Port-a-cath, Metal stents, Hydrocephalic pump / insulin pump,
Metal implants; f/e screws, prostheses, piercings.
- Claustrophobia, or serious mobility problem (Parkinson, tremors)
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.
| Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN | NCT02821468 | Entailment |
1,736 | 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:
- Subjects must satisfy ALL of the following criteria to be eligible for enrollment into
the study:
1. Must understand and voluntarily sign a written Informed Consent (ICF) prior to any
study-related procedures being performed.
2. Must be able to communicate with the investigator, understand and comply with the
requirements of the study, and agree to adhere to restrictions and examination
schedules.
3. Male and female subjects of any race between 18 to 55 years of age (inclusive), and in
good health as determined by the Investigator at the time of signing the informed
consent document.
4. Have a Boday Mass Index (BMI) between 18 and 33 kg/m2 (inclusive).
5. No clinically significant laboratory test results as determined by the investigator.
6. At the screening visit, must be afebrile, with supine systolic BP: 90 to 140 mmHg,
supine diastolic BP: 50 to 90 mmHg, and pulse rate: 40 to 110 bpm. Eligibility
criteria for vital signs performed during check-in and/or predose on Day 1 will be at
the discretion of the Investigator.
7. Must have a normal or clinically acceptable 12-lead Electrocardiogram (ECG). Subjects
must have a QTcF value ≤ 450 msec.
8. Contraception Requirements:
- Must comply with the following acceptable forms of contraception. All FCBP must
use one of the approved contraceptive options as described below while taking
apremilast and for at least 28 days after administration of the last dose of the
apremilast.
- At the time of study entry, and at any time during the study when a FCBP's
contraceptive measures or ability to become pregnant changes, the Investigator
will educate the subject regarding contraception options and the correct and
consistent use of effective contraceptive methods in order to successfully
prevent pregnancy
All FCBP must have a negative pregnancy test at Visits 1 and 2. All FCBP subjects who
engage in activity in which conception is possible must use one of the approved
contraceptive options described below:
Option 1: Any one of the following highly effective methods: hormonal contraception
(oral, injection, implant, transdermal patch, vaginal ring); intrauterine device
(IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom
(latex condom or non-latex condom NOT made out of natural [animal] membrane [for
example, polyurethane]); PLUS one of the following additional barrier methods: (a)
diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive
sponge with spermicide.
Male subjects (including those who have had a vasectomy) who engage in activity in
which conception is possible must use barrier contraception (latex or non-latex
condoms NOT made out of natural [animal] membrane [for example, polyurethane]) while
on IP and for at least 28 days after the last dose of IP.
9. Must agree to refrain from donating sperm, blood or plasma (other than for this study)
while participating in this study and for at least 28 days after the last dose of
investigational product.
10. Subject is willing and able to adhere to the study visit schedule and other protocol
requirements
Exclusion Criteria:
The presence of ANY of the following will exclude any healthy subject from enrollment into
the study:
1. History of any clinically significant and relevant neurological, psychiatric,
gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic,
endocrine, hematological, allergic disease, drug allergies, or other major disorders.
2. Any condition which places the subject at unacceptable risk if he were to participate
in the study, or confounds the ability to interpret data from the study.
3. Use of any prescribed systemic or topical medication within 30 days of the first dose
administration.
4. Use of any non-prescribed systemic or topical medication (including vitamin/mineral
supplements, and herbal medicines) within 14 days of the first dose administration,
Any surgical or medical condition possibly affecting drug absorption, distribution,
metabolism and excretion, eg, bariatric procedure, colon resection, irritable bowel
syndrome, Crohn's disease, etc. Subjects with cholecystectomy and appendectomy may be
included.
5. Exposure to an investigational drug (new chemical entity) within 30 days prior to the
first dose administration or 5 half-lives of that investigational drug, if known
(whichever is longer).
6. Donated blood or plasma within 8 weeks before the first dose administration to a blood
bank or blood donation center.
7. History of drug abuse (as defined by the current version of the Diagnostic and
Statistical Manual [DSM]) within 2 years before dosing, or a positive drug screen
reflecting consumption of illicit drugs.
8. History of alcohol abuse (as defined by the current version of the DSM) within 2 years
before dosing, or a positive alcohol screen.
9. Known to have hepatitis, or known to be a carrier of the HBsAg, or HCV Ab, or have a
positive result to the test for HBsAg, HCV Ab, or HIV antibodies at Screening.
-
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 55 Years | Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and a Study to Assess Effect of Food on the Pharmacokinetic (PK) of the Oral Suspension | NCT02641353 | Entailment |
5,919 | 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. Signed informed consent.
2. Head and neck cancer (HNC) Oropharynx cancer (OPC) patients who are adults > 18 years
of age, dispositioned to receive curative RT with bilateral neck (including) parotid
irradiation with or without chemotherapy.
3. Radiation Therapy (3D conformal or IMRT).
Exclusion Criteria:
1. Subjects unable to tolerate pH-probe in past.
2. Subjects currently on proton-pump inhibitor (PPI), daily antacids and daily H2
antagonists.
3. Prior history of esophago-gastric surgery.
4. Symptoms of active gastrointestinal bleeding (melena, hematemesis).
5. Known hepatic cirrhosis or esophageal varices.
6. Prior esophageal perforation.
7. Pregnant or lactating woman. Women of childbearing potential who have not undergone a
hysterectomy with either a positive or no pregnancy test at baseline. Women / men of
childbearing potential not using a reliable and appropriate contraceptive method
(oral, injectable, or implantable hormonal contraceptive; tubal ligation;
intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
8. Subjects with allergies or sensitivities to proton-pump inhibitors.
9. Patients who cannot complete study follow-up and compliance with study protocol.
10. Patients on Plavix (if medically appropriate)
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.
| Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy | NCT00928161 | Contradiction |
1,992 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy cStage
IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0）at preoperative evaluation according to the
American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- The tumor is on the upper or middle third stomach and expected to perform total
gastrectomy with D1+/D2-10 lymph node dissction to obtain R0 resection sugicall
results.
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
Exclusion Criteria:
- cStage IIA or more advaned at preoperative evaluation according to the American Joint
Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- Multiple primary cancer
- History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal
Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Gastric multiple primary carcinoma
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative
imaging
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
- FEV1<50% of the predicted values
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 | Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer | NCT03524300 | Entailment |
4,718 | 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. Males and females 18-65 years of age, inclusive
2. BMI of 18-32.5 kg/m2, inclusive
3. Individuals with occupational (construction workers, manual labourers, athletes) and
non-occupational unresolved aches and discomfort for at least 2 weeks
4. Individuals on non-prescription, OTC medication for unresolved aches and discomfort
and are willing to undergo a washout determined by the QI based on dose and frequency
prior to enrollment
5. Female participants not of child bearing potential, defined as females who have had a
hysterectomy or bilateral oophorectomy, bilateral tubal ligation, total endometrial
ablation or are post-menopausal (natural or surgically with > 1 year since last
menstruation) or, Females of childbearing potential must agree to use a medically
approved method of birth control and have a negative urine pregnancy test result. All
hormonal birth control must have been in use for a minimum of three months. Acceptable
methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control
patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable
contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing
to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
6. Healthy as determined by laboratory results and medical history as assessed by the QI
7. Willingness to complete questionnaires, records, and diaries associated with the study
and to complete all clinic visits
8. Agrees to comply with study procedures
9. Has given voluntary, written, informed consent to participate in the study
Exclusion Criteria:
1. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
2. Anticipated problems or allergy to any ingredients in the investigational products
3. Allergy to rescue medication
4. Have chronic disease conditions causing chronic pain
5. Uncontrolled high and low blood pressure
6. Uncontrolled blood sugar levels
7. Clinically significant abnormal laboratory results at screening
8. Prescribed medications used to help with aches and discomfort (Section 7.3.1)
9. OTC medications and supplements taken to help with aches and discomfort (Section
7.3.2)
10. Autoimmune disease or if immune-compromised (i.e. HIV-positive, use of anti-rejection
medication, rheumatoid arthritis, Hepatitis B/C-positive)
11. Cancer, except skin cancers completely excised with no chemotherapy or radiation with
a follow-up that is negative. Volunteers with cancer in full remission for more than 5
years after diagnosis are acceptable after review by QI
12. History of mental illness that might impair the ability of participants to provide
written informed consent
13. Current or history of bleeding disorders
14. Current or history of liver or kidney disease as assessed by QI on a case by case
basis.
15. Current or pre-existing unstable thyroid condition. Treatment on a stable dose
medication for over one year will be reviewed on a case-by-base basis by the QI
16. Surgical procedures which may impact the study outcomes within the past 3 months to be
assessed by the QI
17. Medicinal marijuana
18. Recreational marijuana; dose and frequency to be assessed by QI
19. Alcohol intake >2 standard drinks per day or >10 standard drinks per week
20. Illicit drug use in the past 6 months as assessed by the QI
21. Participation in clinical trials within 30 days prior to screening visit
22. Blood donation during or within 30 days after conclusion of clinical trial
23. Any other active or unstable medical condition, that, in the opinion of the QI, may
adversely affect the participant's ability to complete the study or its measures or
pose significant risk to the participant.
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 | A Study to Investigate the Efficacy of Pain Bloc-R in Healthy Participants With Non-pathological Aches and Discomfort | NCT03965819 | Entailment |
5,732 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Both gender;
- Fitzpatrick phototypes I - IV;
- age between 40 and 75 years;
- photodamaged skin with at least 1 lesion of actinic keratosis
Exclusion Criteria:
- Pregnancy and lactation;
- photosensitivity;
- smoking;
- malignant neoplasms;
- infections;
- immunosuppression;
- collagenoses;
- any systemic disease or emotional/psychological disorder that could contraindicate the
procedure.
- any topical treatment or interventions for at least three months before the study
started
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Transepidermal Application of Metilaminolevulinate in Daylight PDT in the Treatment of Photodamaged Skin | NCT03963765 | Contradiction |
2,600 | 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:
- Age 18 or older
- Patients undergoing unilateral laparoscopic inguinal hernia repair, found to have a
contralateral occult inguinal hernia
Exclusion Criteria:
- Patient has life expectancy of less than 2 years
- Patients unlikely to follow-up (e.g. live out of state, unable to be reached by
phone/e-mail
- Non-English and Non-Spanish speakers
- Pregnant or breast-feeding patients
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Treatment of Occult Inguinal Hernias | NCT04815707 | Contradiction |
5,845 | 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:
- Males and non-pregnant females over the age of 18 years.
- Gastro-oesophageal symptoms in accordance with Montreal criteria49
- Patients who had oesophageal physiology testing at Guy's and St Thomas' NHS Foundation
Trust
- Oesophageal manometry based on Chicago classification
- 24-hour standard pH, impedance-pH and Bravo™
- Minimum 6 months post ARS and follow-up at GSTT
- Verbal consent over the phone
Exclusion Criteria:
- Patients less than 18 years of age.
- Pregnancy at the time of interview
- Patients unable to comprehend or answer the questionnaires
- Oesophageal physiology tests performed in other centres
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.
| Physiological Predictors of Clinical Outcomes After Anti-reflux Surgery | NCT03390634 | Contradiction |
5,782 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- 20 pemphigus vulgaris patients
- healthy age and sex matched
Exclusion Criteria:
- - Patients with a history of topical or systemic treatment (corticosteroids,
intralesional steroid injection, immunosuppressive therapy, anticonvulsants and
anticancer medications, within 4 weeks of the study.
- Patients receiving phototherapy within 6 months of the study .
- Patients with a history of diabetes mellitus, anemia, thyroid or parathyroid
disorders, chronic liver or renal diseases, or atopy .
- Patients with known autoimmune diseases or cancer.
- Pregnant or lactating women were also excluded from the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Serum IL-21 Levels in Patients With Pemphigus Vulgaris | NCT03177213 | Contradiction |
1,893 | 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... | Key Inclusion Criteria:
1. Disease diagnosis and prior treatment:
1. Cohort 1 (the first-line breast cancer treatment cohort):
- Female participants with histologically or cytologically confirmed
unresectable, locally advanced, recurrent or metastatic adenocarcinoma of
the breast and candidate for chemotherapy. Locally recurrent disease must
not be amenable to resection with curative intent.
- Human epidermal growth factor receptor 2 (HER2) IHC 3+ or in situ
hybridization positive on the archival tumor tissue or fresh biopsy sample.
- Have not received previous systemic anticancer therapy for locally advanced
unresectable or metastatic disease.
2. Cohort 2 (the first-line gastric/gastroesophageal junction adenocarcinoma
treatment cohort):
- Histologically or cytologically confirmed unresectable, locally advanced,
recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal
junction
- HER2 IHC 3+ or HER2 IHC 2+ together with in situ hybridization positive on
the archival tumor tissue or fresh biopsy sample.
- Have not received previous systemic anticancer therapy for locally advanced
unresectable or metastatic disease, including any approved or
investigational estimated glomerular filtration rate (EGFR) or anti-HER2
agents or vaccines, cytotoxic chemotherapy or checkpoint inhibitors
2. At least 1 measurable lesion as defined per RECIST Version 1.1
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
4. Adequate organ function as indicated by the following laboratory values during
screening:
5. Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either
echocardiogram or multigated acquisition scan (MUGA) (echocardiogram is the preferred
method) within 28 days before the first dose of study drug
Key Exclusion Criteria:
1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug
specifically targeting T-cell co-stimulation or checkpoint pathways
2. History of approved or investigative tyrosine kinase/HER inhibitors in any treatment
setting
a. except trastuzumab with or without pertuzumab used in neoadjuvant or adjuvant
setting for Cohort 1
3. Active leptomeningeal disease or uncontrolled brain metastasis. Participants with
equivocal findings or with confirmed brain metastases are eligible for enrollment
provided that they are asymptomatic and radiologically stable without the need for
corticosteroid treatment for ≥ 4 weeks before the first dose of study drug
4. Any active malignancy ≤ 2 years before the first dose of study drug, except for the
specific cancer under investigation in this trial and any localized cancer that has
been treated curatively (eg, resected basal or squamous cell skin cancer, superficial
bladder cancer, carcinoma in situ of the cervix or breast)
5. Any condition that required systemic treatment with either corticosteroids (> 10 mg
daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days
before the first dose of study drug
Note: Participants who are currently or have previously been on any of the following
steroid regimens are not excluded:
1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal
systemic absorption
3. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for
contrast dye allergy) or for the treatment of a non-autoimmune condition (eg,
delayed-type hypersensitivity reaction caused by contact allergen)
NOTE: 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 18 Years old.
| Anti-HER2 Bispecific Antibody ZW25 Activity in Combination With Chemotherapy With/Without Tislelizumab | NCT04276493 | Entailment |
2,105 | 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:
- In order to be eligible to participate in this study, the patient must meet all of the
following criteria:
Diagnosis of either definite or possible IPF according to the American Thoracic Society
(ATS) and European Respiratory Society (ERS) criteria Signed informed consent DLCO ≥ 30%
predicted and FVC ≥ 50% predicted 6 minute walking test ≥ 150 m Adults ≥ 18 years Being
clinically stable Absolute decline in DLCO & FVC should be less than 10% in the past 6
months.
Exclusion Criteria:
- A potential patient who meets any of the following criteria will be excluded from
participation in this study if:
Participation in an official rehabilitation program < 4 months before start of the study
Musculoskeletal disorders Severe cardiac diseases (ejection fraction < 30%, daily angina,
or otherwise specified by treating cardiologist) Unable to understand informed consent
Other conditions that hamper the use of tele-rehabilitation Non-Danish speaking.
Unwillingness to implement the protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Feasibility & Effect of a Tele-rehabilitation Program in Idiopathic Pulmonary Fibrosis (IPF) | NCT03548181 | Entailment |
1,413 | 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:
- diagnosed with essential hypertension
- systolic blood pressure >140 mm Hg (130 if diabetic) OR diastolic blood pressure > 90
mm Hg (80 if diabetic)on at least 2 clinic visits prior to randomization
- BP at time of screening is > than systolic 140 (130 if diabetic) or diastolic 90 (80
if diabetic)
- patient is prescribed at least 1 antihypertensive medication
- Patient is fluent in English
- Patient is easily accessible by telephone
Exclusion Criteria:
- persons with stage 4 or 5 chronic kidney disease or end stage renal disease on
dialysis
- Patients with a terminal illness
- Patients with severe dementia or serious mental illness
- Inability to preform self blood pressure monitoring
- Patient lacks a functioning home phone or personal cellular phone
- Pregnant or planning to get pregnant
- Arm circumference exceeds the allowable limit on the largest home BP monitor cuff
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 | A Study in the Use of Home Blood Pressure Monitoring and Telephone Follow-up to Control Blood Pressure | NCT00662753 | Contradiction |
5,246 | 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:
- Clinical diagnosis of osteoporosis
- No other severe disabling conditions
- Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral
density T-score should be less than -2.5
- Ambulatory
- Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years)
Exclusion Criteria:
- History of a disease that affects bone metabolism
- History of treatment with any drug that may significantly affect bone metabolism
- History or presence of liver disease
- History or presence of kidney disease
- History of excessive alcohol drinking or drug abuse
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | A Study for Patients With Osteoporosis | NCT00414973 | Entailment |
4,667 | 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:
- HV aged between 18 - 60 years
Exclusion Criteria:
- history of psychiatric disease or a positive first degree psychiatric family history
- pregnancy or lactation
- concomitant administration of any centrally activating medication (anti-depressive
medication, hypnotics, sedatives, anxiolytics, …)
- medication affecting esophageal motility
- significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary,
endocrine, autoimmune, renal and hepatic)
- prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
- history of gastrointestinal disease
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers | NCT04355455 | Entailment |
5,878 | 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:
- Subject must have a Body Mass Index (BMI) from 19-30 kg/m2
- Subject does not present with abnormal clinical lab findings
- Subject is able to tolerate a nasogastric pH electrode.
Exclusion criteria:
- Subject is Helicobacter-positive on a C13 urea breath test
- Subject has a baseline median 24-hour gastric pH>3
- For Part B of the study, subjects are CYP 2C19 poor metabolizers.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine. | NCT00405119 | Contradiction |
6,560 | 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:
- Aged <12 years ;
- Male severe (central laboratory tested FVIII:C <1%) hemophilia A patients;
- Previously received FVIII treatment (prophylactic or bleeding treatment), have the
relevant records and are verified to have accumulated EDs ≥150 days（6≤age<12years
old）and EDs >50 days（age <6 years old）;
- The bleeding treatment records of at least 3 months before screening can be obtained;
- Negative FVIII inhibitor assay results (laboratory tested Nijmegen-Bethesda assay
result <0.6 BU/mL);
- HIV negative; if HIV positive, the viral load <200 particles/uL or <400,000 copies/mL,
and HIV patients must satisfy CD4+ count >200/μL;
- The patient or his guardian voluntarily signed the Informed Consent Form.
Exclusion Criteria:
- Known allergy to any coagulation factor VIII or any excipient; known allergy to
bovine, rodent or hamster bovine;
- Has a history or family history of blood coagulation factor VIII inhibitor;
- Platelet count <100 × 109/L;
- Clinical liver function test ((glutamic-pyruvic transaminase, glutamic-pyruvic
transaminase) ≥ five times the upper limit of normal (ULN) or clinical kidney function
test （creatinine) ≥ two times the ULN;
- International normalized ratio (INR) >1.5;
- Patients with other coagulation dysfunction diseases in addition to hemophilia A;
- Patients who used any anticoagulant or anti-platelet treatment (including
non-steroidal anti-inflammatory drugs [NSAIDs]) within 1 weeks before the first drug
administration or who regularly (e.g., daily, every other day) use anticoagulant or
anti-platelet treatment within the clinical trial period;
- Patients who used immunomodulator(e.g., immunoglobulin,
corticosteroids,alpha-interferon, prednisone [>10 mg/day and >7 days], or comparable
drugs, other than anti-retroviral chemotherapy) within two weeks before the first
administration of the study drug or during the clinical trial period;
- Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to
administration of study drug.
- Patients with other clinically significant diseases, alcoholism, drug abuse, mental
disorders or intellectual disabilities;
- Patients with other severe or clinical significant diseases verified by the
investigator to be unable to benefit from the clinical study;
- Patients who participated in other clinical studies within one month before the first
drug administration (except FVIII trials) and patients who participated in other FVIII
clinical trials after signing the Informed Consent Form;
Male
No healthy subjects accepted to join the trial.
Subject must be at most 12 Years | Safety,Efficacy and Pharmacokinetics Evaluation of SCT800 in Previously Treated Paediatric Patients With Severe Haemophilia A. | NCT03947320 | Contradiction |
4,601 | 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:
- The study included 80 women with ASA I-II,
- Aged 18 to 45 years, who were accepted to participate in the study,
- were smoking,
- did not use oral contraceptives,
- had no menstrual irregularity (regular 28 ± 2 days menstrual cycle)
Exclusion Criteria:
- In preop evaluation patients had difficulties in communication,
- amenorrhea,
- pregnancy,
- delirium,
- psychological illness,
- major depressive disorder,
- patients with a history of acute illness (such as in intensive care unit follow-up),
- which may affect cognitive function and daily life activities in the last 6 months,
- malignancy,
- acute renal failure,
- substance abuse and patients older than 45 years and male sex will be excluded from
the study.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Menstrual Cycle Phases on Recovery and Cognitive Function | NCT03708692 | Entailment |
6,374 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- All emergency department patients with suspected or diagnosed COVID-19.
Exclusion Criteria:
- Negative screening for COVID-19
- recent negative COVID-19 test
- no indication for isolation in the Emergency Department
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 17 Years old.
| Ultrasonography in Norwegian Emergency Department Patients With Suspected Covid-19 Infection | NCT04422691 | Entailment |
880 | 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. | **Patients must be able to get care at Nellis Air Force Base (a military installation) in
order to participate in this study**
Inclusion Criteria:
- Male and Female Active Duty and DoD Beneficiaries aged 18 years or older
- Hand pain, aching, or stiffness
And at least 3 of the 4 following features:
- Hard tissue enlargement of 2 or more of 10 selected joints
- Hard tissue enlargement of 2 or more distal interphalangeal (DIP) joints
- Fewer than 3 swollen metacarpophalangeal (MCP) joints
- Deformity of at least 1 of 10 selected joints
(The 10 selected joints are the first carpometacarpal (CMC), second and third proximal
interphalangeal (PIP), second and third DIP joints of both hands.)
Exclusion Criteria:
- Known diagnosis of another type of arthritis: rheumatoid, psoriatic, crystalline,
inflammatory bowel associated arthritis
- History of treatment with LLLT in the past 12 weeks Surgery within the past 6 weeks
- Hand fracture within the past 6 weeks
- Pregnancy
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.
| Low Level Laser Therapy (LLLT) for the Treatment of Hand Osteoarthritis. | NCT04692597 | Entailment |
4,952 | 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:
A total of 20 subjects will be enrolled in the study. 10 normal subjects will be enrolled
in the study. All will have an 8-12 Hz component of physiologic tremor as determined by
neurophysiologic studies. Patients will have a prominent 8-12 Hz spike on accelerometry
recordings that is associated with an EMG spike at the same frequency.
5 patients with essential palatal tremor and 5 patients with symptomatic palatal tremor
will be included.
All participants must be a minimum of 21 years of age.
EXCLUSION CRITERIA:
The presence of any medical condition, such as liver disease, history or family history of
alcoholism, that can reasonably be expected to subject the patient to unwarranted risk or
compromise the value of the data.
Any patient with pathologic tremor, such as parkinsonian rest tremor, essential tremor, or
tremor secondary to medications or structural brain lesions.
Any clinically significant laboratory abnormalities.
Lack of effective contraception.
Patients who are pregnant.
Inability to understand the nature of the study or its procedures.
Persons under the age of 21, who are not of legal age to consume alcohol in Maryland.
Patients taking any psychoactive medications including certain cough or cold medicine
preparations.
No one will be excluded or discriminated against based on the grounds of race, creed,
gender, color, or national origin. Every attempt will be made to include women and
minorities in the study population.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Effect of Alcohol on Tremors | NCT00001925 | Entailment |
3,877 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Patients who have a diagnosis of knee Osteoarthritis according to the American Society
of Rheumatology (ACR) criteria,
- Between 45 to 75 years of age
- Can read and write in Turkish language
Exclusion Criteria:
- Active synovitis
- Taking any physical therapy section in the last 6 months
- Have a neurological problems that affect walking
- Have an arthritis problem in the ankle and hip joint
- Have a history of lower extremity surgery
- Intraarticular steroid injection in the last 6 months
- Use psychoactive drug
- Have a severe defect of vision and hearing, speech disorders
- Vestibular dysfunction
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 75 Years | Strengthening Exercises Versus Proprioception and Balance Exercises in the Treatment of Knee Osteoarthritis | NCT03893981 | Entailment |
4,023 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Patients:
1. A diagnosis of knee OA and suitable for the study as determined by a responsible
physician, based on a medical evaluation including medical history, physical
examination, laboratory tests and cardiac monitoring.
2. Have a radiological and clinical diagnosis of knee OA based upon American College
of Rheumatology (ACR) criteria (1986) affecting at least one knee of a minimum of
3 months in symptom duration prior to screening.
3. Subject is either male or female and at least 45 years of age.
4. A minimum of 4 out of 10 on the numerical rating scale (Brief Pain Inventory- BPI
item 5) at screening and/ or a requirement for the use of an analgesic for the
pain in the OA knee. In addition, baseline pain must be stable for at least 72
hours prior to fMRI assessment or fMRI assessment may be delayed.
5. A maximum of 8 out of 10 on the NRS at screening. Enrolment may be delayed if, in
the opinion of the investigator, the severity of pain represents an isolated
incident.
6. A female subject is eligible to participate if she is of non-childbearing
potential.
7. Body weight <120kg.
8. Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.
9. Subject demonstrates an understanding of the study and a willingness to
participate as evidenced by voluntary written informed consent.
- Controls:
1. Subject is either male or female and at least 45 years of age.
2. Absence of clinically relevant neurologic and psychiatric disease and history of
head trauma with loss of consciousness.
3. Absence of non-compensated medical diseases and pain disorders that may
relevantly affect brain function and pain perception.
4. No clinical evidence of knee OA.
5. A female subject is eligible to participate if she is of non-childbearing
potential.
6. Body weight <120kg.
7. Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.
8. Subject demonstrates an understanding of the study and a willingness to
participate as evidenced by voluntary written informed consent.
Exclusion Criteria:
1. - Subjects will not be permitted to heavily exercise for 12 hours prior to fMRI
assessment
2. - Subjects will be required to refrain from the following treatments: I.- Analgesic
and anti-inflammatory drugs for 3 days prior to fMRI assessment except for rescue
medication. Rescue medication will be based on paracetamol (dosed 1g/8h), which in any
case must be withdrawn for a minimum of 24 h prior to fMRI assessment or the fMRI
assessment may be delayed.
II.- Steroid injections into the joint or muscle for three months prior to fMRI assessment
III.- Hyaluronan injections into index knee within the previous 6 months prior fMRI
assessment IV.- Non-pharmacological treatments, such as heat wraps or massage for 24 hours
prior to fMRI assessment.
V.- Antidepressants not allowed: MAOIs, Tricyclic antidepressants, mixed 5HT & NE reuptake
inhibitors (eg. Duloxetine). SISR are not allowed as a recent prescription, moreover they
are allowed in case of chronic use (more than 6 weeks). If those drugs are used for less
than 6 weeks, patients could participate in the study after a washout period.
VI.- Anticonvulsant indicated as a pain killer are not allowed, but patients could
participate in the study after a washout period.
VII.- Patients can take low doses of hypnotic drugs (eg. Lorazepam 1mg/OD or Diazepam
5mg/OD) if they are used as a chronic prescription (more than 6 weeks). If they are used
for less than 6 weeks, patients could participate in the study after a washout period.
Subjects will be allowed to take their chronic (non-analgesic and non-anti-inflammatory)
medications if the treatments have been used continuously for at least six weeks prior to
assessment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
| fMRI Evaluation of Pain Central Sensitization Phenomena in Subjects With Knee Osteoarthritis | NCT01700634 | Entailment |
5,492 | 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 PMR by standard criteria. The Bird criteria will be used. 3 or more
features are required to make the diagnosis.
- Bilateral shoulder pain/stiffness
- Duration of symptoms <2/52
- Initial ESR >40 mm/h
- Stiffness >1 h
- Age >65 years
- Depression and/or weight loss
- Bilateral upper arm tenderness
- Are over 50 but less than 85 years old.
- No or stable NSAID or analgesic therapy for at least 7 days.
- Currently active disease defined by a CRP at least 10mg/L, ESR at least 29mm in one
hour or PV >1.72
Exclusion Criteria:
- Currently on oral glucocorticoid treatment or taken within 2 months
- Parenteral glucocorticoid treatment with the last 2 months
- Pregnancy and lactation
- Inflammatory diseases such as inflammatory bowel disease, colitis, asthma
- Co-existent giant cell arteritis
- Other auto-immune diseases
- Cancer
- Infections, treatment with antibiotics within the past 6 weeks
- Significant renal disease (creatinine >150 μmol/L)
- Significant hepatic impairment
- Participation in a clinical trial within the past 30 days
- Working shift employee
- Jet lag
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.
Subject must be at most 85 Years | Timed Release Tablet Prednisone in Polymyalgia Rheumatica | NCT00836810 | Contradiction |
2,483 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- Prior Visual Field
Exclusion Criteria:
- Scotopic pupil less than 3 mm
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| To Compare the Octopus 311 and the Humphrey Field Analyzer 700 Series | NCT00441194 | Entailment |
1,657 | 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. Males and females (of childbearing and non-childbearing potential) , between 18 and 55
years of age, inclusive. Women of childbearing potential (WOCBP) must use highly
effective methods of birth control (see Inclusion #3).
2. Females of non-childbearing potential:
1. Natural (spontaneous) post-menopausal defined as being amenorrhoeic for at least
12 months without an alternative medical cause with a screening follicle
stimulating hormone level (FSH) >25 IU/L (or at the local laboratory levels for
post-menopause)
2. Premenopausal with irreversible surgical sterilization by hysterectomy and/or
bilateral oophorectomy or salpingectomy at least 6 months before screening (as
determined by participant medical history)
3. Women of childbearing potential that have or may have male sexual partners during the
course of the study must agree to the use of a double method of contraception of a
highly effective method of birth control combined with a barrier contraceptive
(condom) when appropriate from screening visit to until 60 days after the last dose of
IMP (covering a full menstrual cycle of 30 days starting after 5 half-lives of last
dose of IMP. This duration is based on the predicted half-life of IMP, and may be
amended once the actual half-life is calculated during this study). Note: Highly
effective birth control methods include: combined (oestrogen and progestogen
containing) oral/intravaginal/transdermal hormonal contraception associated with
inhibition of ovulation, progestogen-only oral/injectable/implantable hormonal
contraception associated with inhibition of ovulation, intrauterine device (IUD),
intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised
partner, or sexual abstinence or same sex relationship.
4. Male participants who have, or may have female sexual partners during the course of
the study must agree to use a double method of contraception including condom plus
diaphragm, or condom plus stable insertable (implant or IUD), injectable, transdermal
or combination oral contraceptive by the female partner, from the time of informed
consent through to 90 days after the last dose of the IMP (covering a full
spermatogenesis cycle of 60 days starting after 5 half-lives of last dose of IMP. This
duration is based on the predicted half-life of IMP, and may be amended once the
actual half-life is calculated during this study).
Abstinent male participants must agree to start a double method if they begin a sexual
relationship with a female during the trial, and through to 90 days after the last
dose of the IMP. Male participants with female partners that are surgically sterile or
post-menopausal (defined as being amenorrhoeic for at least 12 months without an
alternative medical cause), or male participants who have undergone sterilisation and
have had testing to confirm the success of the sterilisation, may also be included and
will not be required to use above described methods of contraception. Male
participants must also agree not to donate sperm up to 3 months after dosing with the
IMP.
5. Total body weight greater than or equal to 50 kg, and body mass index (BMI) between 18
and 32 kg/m2 inclusive.
6. Certified as healthy by a comprehensive clinical assessment (detailed medical history
and complete physical examination).
7. Normal vital signs after 5 minutes resting in supine position:
- Systolic blood pressure (SBP) - 90-140 mmHg,
- Diastolic blood pressure (DBP) - 40-90 mmHg,
- Heart rate (HR) 40-100 bpm.
8. Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine
position in the following ranges for both males and females: QT ≤ 500 msec, QTcF ≤450
msec, QTcB ≤450 msec, and PR interval ≤210 msec; and normal ECG tracing unless the
Principal Investigator or delegate considers an ECG tracing abnormality to be not
clinically significant.
9. Having given written informed consent prior to undertaking any study-related
procedure.
10. Available for the duration of the study and for 2 weeks following the End of Study
visit.
11. In the opinion of the Principal Investigator or delegate, the individual has a high
probability of adherence with and completion of the study, and willing and able to
withdraw and refrain from restricted medications.
12. Fluent in English and able to understand and comply with written and verbal
protocol-related requirements.
13. Willing to defer blood donations to a blood service for a minimum of 6 months after
the End of Study visit.
Exclusion Criteria
1. Haematology, biochemistry or urinalysis results that are abnormal/outside of
laboratory normal reference ranges AND are either:
- considered clinically significant by the Principal Investigator or delegate; OR
- considered not clinically significant by the Principal Investigator or delegate
BUT ARE ALSO outside of the Sponsor-approved clinically acceptable laboratory
ranges in Appendix 1 of the protocol.
NOTE: Participants are not excluded if abnormal/out of laboratory normal reference
range results are considered not clinically significant by the Principal Investigator
or delegate AND are within the ranges specified in Appendix 1 of the protocol of .
2. Positive serum pregnancy test at screening, positive urine pregnancy test upon
admission or at other timepoints as specified by schedule of assessments.
3. Male participants with a female partner(s) who is (are) pregnant or lactating from the
time of the administration of study medication.
4. Any history or presence of clinically relevant cardiovascular, broncho-pulmonary,
gastrointestinal, hepatic/ gallbladder*/ bile duct, renal, metabolic, haematological,
neurological, musculoskeletal/rheumatologic, systemic, ocular, gynaecologic (if
female), or infectious disease, or signs of acute illness. *including medical history
of asymptomatic gallbladder stones.
5. Any gastrointestinal surgery or any condition or disease that could affect drug
absorption, distribution or excretion (eg, gastrectomy, cholecystectomy, diarrhoea).
6. Severe recurring headaches (cluster or migrainous headaches) requiring prescription
medication/s. History of recurrent nausea and/or vomiting (for vomiting only: more
than twice a month).
7. Participation in any research study involving blood sampling (more than 450 mL/unit of
blood) or blood donation during the 8 weeks prior to IMP administration (Parts 1 and
2).
8. Any documented evidence of current or past cardiovascular disease including cardiac
arrhythmias or family history of congenital long QT syndrome, Brugada syndrome, or
unexplained sudden cardiac death. Symptomatic postural hypotension at screening
(confirmed on two consecutive readings), irrespective of the decrease in blood
pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood
pressure ≥20 mmHg within 2-3 min when changing from supine to standing position.
9. History or presence of diagnosed (by an allergist/immunologist) or treated (by a
physician) food or known drug allergies, or any history of anaphylaxis or other severe
allergic reactions including face, mouth, or throat swelling or any difficulty
breathing. Participants with seasonal allergies/hay fever or allergy to animals or
house dust mite that are untreated and asymptomatic at the time of dosing can be
enrolled in the trial.
10. History of convulsion (including drug or vaccine-induced episodes). A medical history
of a single febrile convulsion during childhood is not an exclusion criterion.
11. History of substance use disorder(s) within 5 years of screening, including alcohol
consumption of more than 40g/4 units/4 standard drinks per day or any prior
intravenous use of an illicit substance.
12. Smoked >1 pack of cigarettes per day for >10 years, or who currently (within 14 days
prior to IMP administration (Parts 1 and 2) smokes >5 cigarettes per day.
13. Any medication (including herbal such as St John´s Wort, vitamin supplements and over
the counter [OTC]) within 5 half-lives prior to IMP administration (Parts 1 and 2),
except occasional intakes (for acute pain) of ibuprofen at doses up to 1.8g/day,
paracetamol at doses up to 4g/day, acetylsalicylic acid (300 to 650 mg orally every 4
to 6 hours as needed Maximum dose: 4g in 24 hours), diclofenac (diclofenac potassium
liquid-filled capsules: 25mg orally 4 times a day; diclofenac free acid capsules: 18
or 35 mg orally 3 times a day; diclofenac potassium immediate-release tablets: 50mg
orally 3 times a day [initial dose of 100mg orally followed by 50mg oral doses
acceptable if required for better relief]) and contraceptives.
14. Any individual who, in the judgement of the Principal Investigator or delegate, is
likely to be noncompliant during the study, or unable to cooperate because of a
language problem or poor mental development.
15. Any individual in the exclusion period of a previous study according to applicable
regulations.
16. Any individual who cannot be contacted in case of emergency.
17. Any individual who is the Investigator, or delegates, research assistant, pharmacist,
study coordinator, project manager, or other staff thereof, directly involved in
conducting the study.
18. Any individual without a good peripheral venous access.
19. Participation in any investigational product study within the 12 weeks preceding IMP
administration (Parts 1 and 2) or 5 times the half-life of the Investigational
product, whichever is longer.
20. Positive serology test for hepatitis B (positive HB sAG or anti-HBc Ab), hepatitis C
(anti-HCV) or human immune deficiency virus (HIV) (positive for anti-HIV1 and
anti-HIV2 Ab).
21. Positive urine drug test at screening or prior to IMP dosing. Any drug from the list
of drugs tested unless there is an acceptable explanation to the Principal
Investigator or delegate (eg, participant has stated in advance that they consumed a
prescription of over the counter product which contained the detected drug) and/or the
participant has a negative urine drug screen on retest. Any participant tested
positive for paracetamol at screening may still be eligible for study participation,
at the Principal Investigator's or delegate's discretion.
22. Positive alcohol screen at screening or prior to IMP dosing.
23. Any consumption of citrus fruits (grapefruit, Seville oranges) or their juices within
5 days prior to IMP administration.
24. Use of antidepressant medication in the past 12 months prior to IMP administration in
Part 1 and 2.
25. Individuals with history of schizophrenia, bipolar disorder psychoses, disorders
requiring lithium, attempted or planned suicide, or any other severe (disabling)
chronic psychiatric diagnosis including generalised anxiety and obsessivecompulsive
disorders.
26. Individuals who have been hospitalised within five years prior to enrolment for either
a psychiatric illness or due to danger to self or others.
27. History of an episode of mild/moderate depression lasting more than 6 months that
required pharmacological therapy and/or psychotherapy within the last 5 years; or any
episode of major depression. The Beck Depression Inventory (BDIII) will be used as a
validated tool for the assessment of depression at screening. In addition to the
conditions listed above, individuals with a score of 20 or more on the BDI-II and/or a
response of 1, 2 or 3 for item 9 of this inventory (related to suicidal ideation) will
not be eligible for participation. These individuals will be referred to a general
practitioner or medical specialist as appropriate. Individuals with a BDI-II score of
17 to 19 may be enrolled at the discretion of an Investigator if they do not have a
history of the psychiatric conditions mentioned in this criterion and their mental
state is not considered to pose additional risk to the health of the individual or to
the execution of the trial and interpretation of the data gathered.
28. History of malignancy of any organ system (other than localized basal cell carcinoma
of the skin or in situ cervical cancer considered treated and cured), treated or
untreated, within 5 years of screening, regardless of whether there is no evidence of
local recurrence or metastases.
29. Any vaccination within 28 days of screening.
30. Any medical condition that in the opinion of the Principal Investigator or delegate
would jeopardize the individual's involvement in the study.
Specific to Part 2 only:
31. Any individual who, in the opinion of the Principal Investigator or delegate, would be
unwilling or unable to consume the pre-dose test meal during the fed arm.
32. Individuals with food intolerance or food allergy are excluded. Vegetarian individuals
must be excluded, unless they agree to eat a full diet during 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 55 Years | A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533. | NCT04323306 | Entailment |
6,569 | 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 patients at least 12 years of age
- At least 150 treatment exposure-days to previous FVIII products
- FVIII≤2% at screening or diagnosis (FVIII≤1% for PK study)
- CD4 Lympocyte cell count>400/㎕
- Patients willing to cooperate for the study
- Patient's or legal guardian's consent to participate in the study
Exclusion Criteria:
- FVIII inhibitor(neutralizing antibody to FVIII)≥0.6 Bethesda Units
- Coagulation disorders other than hemophilia A (e.g. Idiopathic Thrombocytopenic
Purpura, von Willebrand Disease)
- Platelet count≤100,000㎣
- Subjects with clinical evidence of symptomatic HIV disease regardless of
HIV-seroposive/seronegative
- Subjects with rFVIII antibody, mouse IgG antibody, or CHO antibody
- Creatinine levels more than 2 times of reference rage, GOT and GPT levels more than 3
times of reference range, diabetes mellitus or other metabolic disorder
- Subjects with diastolic blood pressure≥100mmHg not controlled with antihypertensive
medications
- Anemia(hemoglobin<12g/dL)
- Subjects with severe or life-threatening bleeding just before entry into the trial
- Subjects with a history of treatment failure due to formation of inhibitor to FVIII
- Subjects with a history of severe hypersensitive reactions to FVIII concentrate
- Subjects requiring pre-medication for FVIII infusion(e.g. antihistamines, etc)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A | NCT01568580 | Contradiction |
1,894 | 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. Signed informed-consent form.
2. Aged 18-80 years.
3. Had partial or total D2 gastrectomy and achieved R0 resection.
4. Histologically confirmed gastric or gastro-oesophageal junction
adenocarcinoma，mucinous adenocarcinoma ，signet-ring cell carcinoma
5. Pathologic Stage III (IIIA-C).
6. HER2-positive: (IHC 3+ or IHC 2+ and FISH positive).
7. Patients must have received no preoperative chemotherapy or radiation therapy.
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 .
9. Adequate liver/bone marrow function.Blood and biochemical parameters;
10. Compliant, and can be followed up regularly.
Exclusion Criteria:
1. Patients who do not meet the Inclusion Criteria.
2. Pregnant or breast-feeding female, or not willing to take contraception measures
during study.
3. Serious infection requiring antibiotics intervention during recruitment.
4. Allergic to study drug or with metabolism disorder.
5. Histologically confirmed small cell carcinoma of the stomach、gastric neuroendocrine
carcinoma or others.
6. Uncontrolled brain metastasis or mental illness.
7. Organ transplant recipients (Autologous transplantation of bone marrow and peripheral
stem cell transplantation included).
8. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
9. With severe hepatic/kidney/respirator/disease,or chronic disease like uncontrolled
diabetes,hypertension,etc.
10. with other malignant tumors.
11. Can be followed up or obey protocol.
12. Ineligible by the discretion of the investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy | NCT02250209 | Entailment |
458 | 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:
- Major, under 45 years with intrauterine trophoblastic retention after incomplete
miscarriage in the first quarter (termination of pregnancy < 14 WA),
- With desire of pregnancy ;
- Intrauterine trophoblastic retention diagnosed by transvaginal pelvic ultrasound
finding a intrauterine heterogeneous image or intrauterine gestational sac more than
15 mm in thickness, complicated or not of endometritis ;
- Decision to surgical management of incomplete miscarriage by the health care team ;
- Patient beneficiary or affiliated to a health insurance
- Informed and signed consent
Exclusion Criteria:
Will not be included in the protocol patients :
- having a uterine malformation known ;
- having received surgical treatment for the current intrauterine retention ;
- with intrauterine retention diagnosed by transvaginal pelvic ultrasound of more than
50 mm in thickness ;
- requiring a haemostatic act in urgency for heavy vaginal bleeding (miscarriage
haemorrhage) ;
- bearer of intrauterine device ;
- having an evolutive pregnancy;
- having an ectopic pregnancy;
- having a trophoblastic retention following a voluntary abortion ;
- having a pregnancy achieved by medically assisted procreation
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 44 Years | Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions | NCT02201732 | Contradiction |
1,262 | 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:
- ≥18 years of age
- Supected intra-thoracic malignancies with pleural involvement and referred for a
diagnostic procedure by thoracoscopy, CT guided biopsy or endosonography
Exclusion Criteria:
- Inability and willingness to provide informed consent
- Patients with known allergy for fluorescein or risk factors for an allergic reaction
- pregnancy or lactating 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.
| Confocal Laser Endomicroscopy in Pleural Malignancies | NCT03290183 | Entailment |
2,814 | 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:
- Age greater than or equal to 18 years old.
- Diagnosis of either chronic pelvic pain, functional abdominal pain, axial low back
pain, or migraine with or without aura of at least 3 months duration.
- English speaking
- Ability and willingness to complete questionnaires and in-person assessments
- Current average daily pain score of greater than or equal to 4 on the Numeric Rating
Scale of Pain (0-10 scale)
- For patients with migraine diagnosis they must report at least 2 headaches in the
baseline headache diary in the 30 days preceding randomization.
Exclusion Criteria:
- Any conditions causing inability to complete assessments (education, cognitive
ability, mental status, medical status)
- Any significant psychiatric problems, including acute confusional state (delirium),
ongoing psychosis, or clinically significant depression
- Any suicidality as assessed by answer of greater than 0 on question 9 the PHQ-9
assessing suicidal thoughts.
- Any current illicit drug or alcohol abuse.
- Any history of recurrent or unprovoked seizures.
- Participation in another drug, device, or biologics trial concurrently or within the
preceding 30 days.
- Pregnancy, breast-feeding or lack of reliable contraception
- Changes in pain medications in the previous 4 weeks
- Implanted electrical stimulation device.
- Skin infection over stimulation sites.
- Any pain interventions in the preceding 6 weeks (epidural steroid injection,
sympathetic block, peripheral nerve block, lumbar medial branch blocks) Any botulinum
toxin injection in the previous 3 months
- For patients with migraine diagnosis additional exclusion criteria include receipt of
preventive anti-migraine treatment in the past 3 months, failure on greater than or
equal to 3 well-conducted preventive drug trials, concurrent medication overuse
headache diagnosis, and concurrent frequent/chronic tension type headache.
4. Frequent/chronic tension type headache
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.
| Vibratory Stimulation for the Treatment of Chronic Pain | NCT04069572 | Contradiction |
4,903 | 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:
- self defined Caucasian
- clinically healthy
- BMI of ≤ 30,
- a systolic arterial blood pressure ≤190 mmHg,
- no rash or dermatologic condition or tattoos which may interfere with the placement
site
- no neurovascular impairment.
- all female participants received a pregnancy test at the initial screening visit.
- Study population was restricted to Caucasians to enable an assessment of device caused
redness or skin lesions, not possible in a mixed study population.
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 | Neurologic Examination of Wide and Narrow Tourniquets | NCT02023476 | Contradiction |
4,480 | 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:
- aged 18-30
- healthy civilians volunteers
- with no background illnesses
- with history of combat unit service in the IDF.
- fit to perform 10 Km moderate march while carrying load.
Exclusion Criteria:
- The existence or suspicion of existing cardiac or respiratory disease.
- Hypertension.
- Diabetes.
- Any muscles or skeleton condition.
- Any hormonal disease or any other chronic illness that may inhibit participation in
the experiment.
- Infectious disease 3 days prior to the experiment.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years | Evaluation of Physical and Cognitive Performance After Simulated Road March Combines Physical and Cognitive Load Using a Virtual Reality Environment | NCT02644213 | Contradiction |
2,371 | 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:
Group A (ambulant patients)
- Documented diagnosis of DMD by mutation analysis in the dystrophin gene or by
substantially reduced levels of dystrophin protein (i.e. absent or <5% of normal) on
Western blot or immunostaining
- Stable treatment with glucocorticoids >6 months (no significant change in dosage
(>0.2mg/kg)) at screening; dosing adaptations according to weight change are allowed
- Male gender
- 6.5 to 12 years of age at time of screening
- weight >20kg
- ambulant patients
- able to walk at least 350 meters in 6 minute walking distance test without assistance
at screening
- MFM D1 subdomain of the MFM scale >40% at screening
- Ability to provide informed consent and to comply with study requirements
- Patients harbouring a nonsense mutation treatable with the approved drug ataluren
should be under stable ataluren treatment for at least 3 months or in case of
nontolerance being off ataluren treatment for at least 3 months before screening
Group B (non-ambulant patients)
- Documented diagnosis of DMD by mutation analysis in the dystrophin gene or by
substantially reduced levels of dystrophin protein (i.e. absent or <5% of normal) on
Western blot or immunostaining
- Not using glucocorticoids for >6 months
- Male gender
- Non-ambulant patients (walking distance less than 10 meters)
- 10 to 16 years of age at time of screening
- Ability to provide informed consent and to comply with study requirements
Open label extension
- Recent participation and completion of TAMDMD study
Exclusion Criteria:
- Known individual hypersensitivity or allergy to tamoxifen or other
ingredients/excipients of IMP
- Female gender
- Use of tamoxifen or testosterone within the last 3 months
- Known or suspected malignancy
- Other chronic disease or clinically relevant limitation of renal, liver or heart
function
- Known or suspected non-compliance
- Any injury which may impact functional testing, e.g. upper or lower limb fracture
- Planned or expected spinal fusion surgery during the study period (as judged by the
Investigator; i.e. due to rapid progressing scoliosis), previous spinal fusion surgery
is allowed if it took place more than 6 months prior to screening.
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders of the participant/parents (as judged by the investigator)
- Concomitant participation in any other interventional trial (and up to 3 months prior
to screening)
- Use of CYP2D6 inhibitors or of CYP3A4 inducers (apart from glucocorticoids), platelet
aggregation inhibitors and coumarin-type anti-coagulants
- Use of drugs metabolized by CYP2C9, such as phenprocoumon, phenytoin, warfarin,
celecoxib, fluvastatin, ginko biloba, St. John's wort and sulfamethoxazol
- Galactosemia (lack of galactose-1-phosphat-uridylyltransferase or
UDP-galactose-4-epimerase or galactokinase; Fanconi-Bickel-syndrome); congenital lack
of lactase; glucose-galactose malabsorption
- Presence of one or more of the following eye disorders: cataract, retinopathia, optic
neuropathy, alteration of the cornea
- Presence of one or more of the following laboratory abnormalities: anaemia,
thrombocytopenia, leukopenia, neutropenia or agranulocytosis
Group A:
- Glucocorticoid naïve patients
- Start of glucocorticoid treatment or change in dosage <6 month prior to screening
(dosing adaptations according to weight change are allowed)
Group B:
- Glucocorticoid treated patients or patients that stopped glucocorticoid treatment <6
month prior to screening
- Assisted ventilation of any kind necessary
Male
No healthy subjects accepted to join the trial.
Subject must be at least 78 Months old.
Subject must be at most 16 Years | Tamoxifen in Duchenne Muscular Dystrophy | NCT03354039 | Entailment |
5,806 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Clinical inclusion
- Adults ≥ 18 years old, both genres, who consent to participate of the study;
- Presence of symptomatic reticular lesion and/or white-gray papules. In
afro-descendent individuals, reticular lesions may be associated with
hyperpigmented lesions;
- Additional clinical features such as ulcerative, erythematous, plaque and bullous
lesions will be accepted in the presence of bilateral and symmetrical reticular
lesions.
- Histopathological inclusion criteria
- Presence of subepithelial infiltrate predominantly lymphocytic, in band and
confined to the subepithelial area.
- Liquefaction degeneration of the basal cells layer.
Exclusion Criteria:
- Clinical exclusion criteria
- Exclusion of contact lichenoid lesions: the pattern of reticular lesion and / or
papules should not be present only in areas of physical contact with restorative
materials;
- Exclusion of lichenoid reaction to the drug: difficult to differentiate from OLP,
however it is necessary to report all drugs in use by the patient; the comparison
between patients on medication, and those who do not use medication is important
to establish subgroups of OLP;
- Exclusion of chronic graft versus host disease (GVHD): differentiation between
OLP and GVHD is established in most cases by medical history;
- Exclusion of immunocompromised patients or patients with systemic diseases of
high complexity.
- Exclusion of patients who have previously used probiotic bacteria in the last 4
weeks prior to the study.
- Histopathological criteria for exclusion • Presence of epithelial dysplasia, absence
of the lymphocytic inflammatory infiltrate band and liquefaction degeneration.
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.
| Effect of Bifidobacterium Animalis Subsp. Lactis HN019 on Oral Lichen Planus | NCT03386643 | Entailment |
6,279 | 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 must satisfy all of the following criteria unless otherwise stated:
1. Willing and able to provide informed consent
2. Male or female patients > 18 years of age on the day of informed consent
3. Have received a confirmed diagnosis of COVID-19 (positive for SARS CoV 2), as
assessed by PCR or point-of-care within 72 hours of first dose on Day 1
4. Have mild to moderate signs or symptoms of COVID-19 with onset within 5 days of
first dose on Day 1, at least two of the following symptoms:
- stuffy or runny nose
- sore throat
- shortness of breath
- cough
- fatigue
- myalgia
- headache
- chills or shivering
- feeling hot or feverish
- nausea
- vomiting
- diarrhea
- anosmia
- ageusia
5. Outpatient with COVID-19 disease (not requiring oxygen therapy [WHO COVID-19
Clinical Improvement Ordinal Scale, score of 3])
6. Patient is aware of the investigational nature of this study and willing to
comply with protocol treatments, blood tests, and other evaluations listed in the
informed consent form (ICF).
Exclusion Criteria:
- Patients will be excluded from the study if they satisfy any of the following criteria
unless otherwise stated:
1. Females who are pregnant (negative pregnancy test required for all women of child
bearing potential at Screening) or breast-feeding
2. Male patients and women of childbearing potential (women who are not surgically
sterile or postmenopausal defined as amenorrhea for >12 months) who are not using
at least one protocol specified method of contraception
3. Severe COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement
Ordinal Scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6
(intubation and mechanical ventilation), or 7 (ventilation + additional organ
support pressors, renal replacement therapy [RRT], extracorporeal membrane
oxygenation [ECMO])
4. Expected survival less than 72 hours
5. Peripheral capillary oxygen saturation (SpO2) <90% while breathing room air
6. Treatment with other drugs thought to possibly have activity against SARS CoV 2
infection like remdesivir, favipiravir, within 7 days prior to enrollment or
concurrently
7. History of abuse of drugs or alcohol that could interfere with adherence to study
requirements as judged by the Investigator
8. Use of any other concurrent investigational drugs while participating in the
present study
9. Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of
prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs
(e.g., for organ transplantation or autoimmune conditions)
10. Known renal disease with an estimated glomerular filtration rate (eGFR) <50
mL/min based on local laboratory results
11. Patients with clinically apparent liver disease, e.g., jaundice, cholestasis,
hepatic synthetic impairment, or active hepatitis
12. Alanine transaminase (ALT) or aspartate transaminase (AST) >3 × upper limit of
normal (ULN) or alkaline phosphatase or bilirubin levels > 2 × ULN based on local
laboratory results
13. Co administration of clinical doses of orlistat with dalcetrapib
14. Inability to swallow oral medications or a gastrointestinal disorder with
diarrhea (e.g., Crohn's disease) or malabsorption at Screening
15. Any other clinically significant medical condition or laboratory abnormality
that, in the opinion of the Investigator, would jeopardize the safety of the
patient or potentially impact patient compliance or the safety/efficacy
observations in the study
16. History of an allergic reaction or hypersensitivity to the study drug or any
component of the study drug formulation.
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.
| Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19 | NCT04676867 | Entailment |
314 | 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:
- Aged of 18 to 45
- Having menstrual cycle duration of 24 to 38 days
- Undergoing no more than 3 previous IVF/ICSI - FET cycles
- Having indications for frozen-thawed embryo transfer
- Agreeing to have no more than 2 embryos transferred
Exclusion Criteria:
- Menopausal/ Anovulatory women
- Having contraindication for exogenous hormones administration: breast cancer, risks of
venous thromboembolism
- Having embryos from in vitro Maturation or oocyte donation or PGT (pre-implantation
genetics testings) cycles
- Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/
bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Natural Cycle vs. Modified Natural Cycle vs. Artificial Cycle Protocol for Endometrial Preparation. | NCT04804020 | Contradiction |
3,245 | 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:
- Patients with watery eyes who are listed for punctoplasty surgery
- Patients with dry eyes secondary to Sjögren's (i.e. presence of anti-Ro/SSA or La/SSB
autoantibodies, reduced Schirmer's test less than 5mm over 5 minutes without local
anaesthesia or typical clinical presentation).
- Members of staff at our eye clinic with no history of previous ocular surgery or
watering/dryness.
Exclusion Criteria:
- Previous eyelid or lacrimal surgery
- Patients without capacity to consent
- Patients unwilling to participate
- Age under 18
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Optical Coherence Tomography of Ocular Structures in Epiphora and Dry Eye Syndrome. | NCT02849093 | Entailment |
2,175 | 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:
- Clinical diagnosis of gout
- Must be able to understand questionnaires
Exclusion Criteria:
- Diagnosis not validated by rheumatologist
- Not able to sign informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Italian Observational Study Assessing the Impact of Gout on Patients Disability and Quality of Life | NCT01549210 | Contradiction |
3,341 | 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:
- bilateral sensorineural hearing loss
- normal middle ear status
Exclusion Criteria:
- pregnant or lactating
- serious mental health illness or medical/psychiatric hospitalization
- treatment with cancer chemotherapeutic agents or aminoglycoside antibiotics
- taking Aspirin, Ibuprofen, Naprosyn, Aleve
- taking any Quinine-related drugs
- taking any loop diuretics
- have a developmental disability or cognitive impairment
- history of drug abuse
- involved in litigation or claim related to hearing loss
- regularly exposed to significant occupational or recreational noise
- have a photosensitivity disorder
- have a retinal disease
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | The Effect of Low-Level Laser Stimulation on Hearing Thresholds | NCT01820416 | Contradiction |
5,444 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Age: between 18-45 years old
- Hemoglobin concentration: less than or equal to 11.5 g/dL, greater than or equal to
8.0 g/dL
- BMI: less than or equal to 35
- Menstrual cycle: previous menstrual cycle interval between 26 to 34 days with less
than or equal to 10 days of bleeding
- Contraception: at least two months from implant removal, or six months from their last
depo-provera or depo-Lupron injection, or recently(at least 2 months) discontinued
oral, patch or intravaginal ring contraceptives
- On cycle day 1-3 of the current menstrual bleeding episode
Exclusion Criteria:
- NSAID, or aspirin containing medications during the 48 hours preceding the current ER
visit
- Estrogen or progestin treatment during the 30 days preceding the current ER visit
- Using Paraguard
- Pregnant and or lactating
- History of endometrial ablation
- Women with thromboembolic disease, or coagulopathy
- Women with history of myocardial infarction, or cerebrovascular occlusion
- Uncontrolled high blood pressure (blood pressure greater than 150/90)
- Sensitivity to estrogen, or tranexamic acid
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding | NCT01659008 | Entailment |
5,195 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal women of age group 50-70 having T score less than -2.5 SD or lower at
lumbar spine or proximal femur.
Exclusion Criteria:
- Patients with renal dysfunction (serum creatinine >1.5)
- Primary and secondary hyperparathyroidism
- Secondary osteoporosis
- Unexplained elevated ALP (alkaline phosphatase)
- History of therapeutic radiation
- Active malignancy and patients having implant
- Patients who have received i.v. or oral bisphosphonates in their disease course
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 70 Years | Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis | NCT01760798 | Entailment |
5,842 | 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:
- Patients with clinical symptoms of acid regurgitation, heart burn, or feeling of
acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven
by endoscopy were recruited
Exclusion Criteria:
- taking antisecretory agents, such as PPIs and histamine-2 receptor antagonists within
2 week prior to the endoscopy
- coexistence of peptic ulcer or gastrointestinal malignancies
- pregnancy
- coexistence of serious concomitant illness (for example, decompensated liver cirrhosis
and uremia),
- previous gastric surgery
- allergy to dexlansoprazole or esomeprazole
- symptom score of a validated questionnaire (Chinese GERDQ) less than 12
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.
Subject must be at most 80 Years | Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole and Esomeprazole for GERD Grade A and B | NCT03128736 | Contradiction |
1,510 | 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:
- Patients aged 55+
- Patients showing impaired safety of the deglutition during the V-VST (volume -
viscosity swallow test): Cough oxygen desaturation ≥3% or voice change.
- Neurodegenerative or ischemic/hemorrhagic cerebral cause (stroke) or elderly subjects
Exclusion Criteria:
- Patients radiated for treatment of head and neck cancer Idiosyncrasis
- Allergy to food or medication, especially contrast products (iodine)
- Major respiratory disease needing oxygen as standard treatment.
- Any major and relevant abdominal, head and neck, or chest surgery within the three
months preceding the study.
- Have a high alcohol consumption (more than 2 drinks/day)
- Subject who cannot be expected to comply with the study procedures, including
consuming the test products.
- Currently participating or having participated in another clinical trial during the
month preceding the study
- Patients with relevant mucosal damage or with in-mouth irritation
- Patients with pacemaker or electrode implants
- Epileptic patients
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
| Efficacy of Natural Ingredient to Improve the Swallowing Response of Patients With Oropharyngeal Dysphagia | NCT02422576 | Entailment |
5,528 | 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 classified according to the following criteria:
- Age at onset of disease ≥ 50 years.
- History of ESR ≥ 30 mm/hr or CRP ≥ 10 mg/L.
- Unequivocal cranial symptoms of GCA (new-onset localized headache, scalp or temporal
artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw
pain upon mastication) AND/OR symptoms of polymyalgia rheumatica (PMR) defined as
shoulder and/or hip girdle pain associated with inflammatory morning stiffness
- Temporal artery biopsy revealing features of GCA AND/OR
- evidence of large-vessel vasculitis by angiography or cross-sectional imaging study
such as magnetic resonance angiography (MRA), computed tomography angiography (CTA),
positron emission tomography-computed tomography (PET CT), or ultrasound
Patients with new onset GCA or relapsing GCA (Definition new onset: diagnosis of GCA within
6 weeks of Baseline Visit; Definition relapsing GCA: diagnosis of GCA (in accordance with
inclusion criterion no. 4) > 6 weeks before Baseline Visit and in the meantime achieved
remission (absence of signs and symptoms attributable to GCA and normalization of ESR (< 30
mm/hr) and CRP (<10.0mg/L) included) including previous treatment with ≥ 25 mg/day
prednisolone equivalent for ≥ 2 weeks.)
Active disease as defined by the presence of signs and symptoms of GCA (cranial or PMR) and
elevated ESR ≥ 30 mm/hr, or CRP ≥ 10 mg/L, attributed to active GCA within 6 weeks of
Baseline.
Prednisolone dose of 25-60 mg/day at Baseline.
Exclusion Criteria:
Previous exposure to secukinumab or other biologic drug directly targeting
Interleukin(IL)-17 or IL-17 receptor.
Patients treated with any cell-depleting therapies including but not limited to anti-CD20
or investigational agents (e.g. anti-CD3, anti-CD4, anti-CD5 or anti-CD19).
Patients who have previously been treated with any biologic agent including but not limited
to tocilizumab, sirukumab, abatacept, or tumor necrosis factor alpha (TNFα) inhibitors
(infliximab, adalimumab, etanercept, certolizumab, golimumab).
Patients who have previously been treated with tofacitinib or baricitinib.
Patients treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to
Baseline.
Patients treated with cyclophosphamide, tacrolimus or everolimus within 6 months prior to
Baseline.
Patients treated with hydroxychloroquine, cyclosporine A, azathioprine, sulfasalazine or
mycophenolate mofetil within 4 weeks of Baseline.
Patients treated with leflunomide within 8 weeks of Baseline unless a cholestyramine
washout has been performed in which case the patient must be treated within 4 weeks of
Baseline.
Patients treated with an alkylating agent except for cyclophosphamide as mentioned above.
Patients requiring systemic chronic glucocorticoid therapy for any other reason than GCA.
Chronic systemic glucocorticoid therapy over the last 4 years or longer; or inability, in
the opinion of the investigator, to withdraw glucocorticoid therapy through
protocol-defined taper regimen due to suspected or established adrenal insufficiency.
Patients requiring chronic (i.e. not occasional "prn") high potency opioid analgesics for
pain management.
Active ongoing inflammatory diseases or underlying metabolic, hematologic, renal, hepatic,
pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which
in the opinion of the investigator immunosuppressed the patient and/or places the patient
at unacceptable risk for participation in an immunomodulatory therapy.
History of renal trauma, glomerulonephritis, or patients with one kidney only, or a serum
creatinine level exceeding 1.8 mg/dL (159.12 μmol/L).
Screening total white blood cell (WBC) count < 3000/μL, or platelets < 100 000/μL or
neutrophils < 1500/μL or hemoglobin < 8.3 g/dL (83 g/L).
Major ischemic event, unrelated to GCA, within 12 weeks of screening.
Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C at
screening or randomization.
Life vaccinations within 6 weeks prior to Baseline or planned vaccination during study
participation until 12 weeks after last study treatment 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 50 Years old.
| A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis | NCT03765788 | Entailment |
4,567 | 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 18-29 years old
- Unprotected vaginal or anal sex with at least one man that they perceive as engaging
in risky behavior OR
- Unprotected vaginal or anal sex with more than 1 man regardless of perceived partner
risk
- Can understand written and spoken English
Exclusion Criteria:
- Women younger than 18 years old
- Women older than 29 years old
- Cannot understand written or spoken English
- Previously participated in the study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 29 Years | Reducing HIV Risk in Urban Women: Soap Opera Videos on Video-Capable Cell Phones | NCT03330522 | Contradiction |
1,975 | 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:
- confirmed diagnosis of stomach cancer
- advanced stomach cancer of stage IV
- adequate blood chemistry, blood counts and kidney function
- willing to participate to study requirements and sign an informed consent document
Exclusion Criteria:
- prior chemotherapy for the stomach cancer in its advanced stage
- excessive toxicities related to prior therapies
- pregnant or breastfeeding patients
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 Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer | NCT00555620 | Entailment |
1,632 | 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:
- Request for an initial appointment with a primary care physician at Beth Israel
Deaconess Medical Center who has agreed to participate in the study
- English as first language
- Internet access at home
Exclusion Criteria
- Under 18 years of age
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Patient Computer Dialog in Primary Care | NCT00386776 | Entailment |
2,951 | 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:
Inclusion Criteria for subjects with early ALS:
- Probable or definite ALS according to World Federation of Neurology diagnostic
criteria4.
- Early stage ALS defined as presence of:
1. Normal lower extremities muscle strength (≥ 4/5 in manual muscle strength or ≥
80% in the computerized dynamometer quantitative muscle strength);
2. ALSFRS score of ≥ than 30;
3. FVC of ≥75% predicted;
4. Ambulatory without the use of any assistive device.
- 18 - 75 years of age.
- Able to provide informed consent.
Inclusion Criteria for control subjects:
- Healthy 18 - 75 years of age without significant medical condition as defined by the
investigator.
- Able to provide informed consent.
- Not having any of the exclusion criteria listed below.
Exclusion Criteria:
- Age < 18 or > 75 years.
- History of falls (2 or more in the last year), history of fainting, history of
cerebrovascular accident (CVA) or myocardial infarction (MI), history of lower limb
joint replacement.
- History of neuromuscular dysfunction "except diagnosis of ALS for individuals with
ALS".
- Post-traumatic, septic, inflammatory, or neuropathic arthritis.
- Lower extremity injury/surgery that may effect balance.
- Vestibular pathology (i.e., inner ear problems, vertigo, meniere's).
- Peripheral neuropathy.
- Parkinson's Disease.
- Currently taking anti-convulsive medications (e.g., clonazepam, diazepam,
lorazepam,phenytoin, zonegran, carbamazepine, depakote, gabapentin, lamotrigine,
lamotrigine, oxcarbazepine, tiagabine, topiramate)
- Diabetes Mellitus.
- No history of neurological or medical condition that may interfere with balance as
defined by investigators.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS) | NCT00956501 | Entailment |
5,849 | 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 must have had a pH probe test at Thomas Jefferson University between July
2004 and January 2006 with findings consistent with GERD.
- Male or female over the age of 18
Exclusion Criteria:
- Hypersensitivity to zolpidem or any of its components
- Pregnancy
- History of depression or hypnotic/substance abuse
- Prior esophagus or stomach surgery
- GI tract motility disorder
- Any sleep disorder or contraindications to the use of hypnotic medications.
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 Influence of Hypnotic Medications on Sleep Arousal and Its Effect on Gastroesophageal Reflux | NCT00462137 | Contradiction |
1,946 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Age 18 years-old or above
- Suffering from solid neoplasms of the stomach, liver, kidney or adrenals (<5cm in
largest diameter) that is indicated for treatment.
- Unsuitable for surgery, due to one (or more) of the following items:
- ASA score > II*
- An alternative advanced malignancy
- Unsuitable for surgery upon expert's opinion for any other reason
- Healthy individuals who are not keen for surgical resection
- Eligible for endoscopic intervention
- Written informed consent
Exclusion Criteria:
- Coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater
than twice that of control), platelet count <50,000x103/uL
- Pregnancy
- Patients with a poor mental condition or mental retardation, unable to understand the
nature and possible consequences of the study
- Patients unwilling to undergo follow-up assessments
- Patients with liver cirrhosis, portal hypertension and/or gastric varices.
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.
| EUS-guided RFA for Solid Abdominal Neoplasms | NCT03221335 | Entailment |
6,388 | 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:
- Adult patients (>18 years)
- Confirmed COVID-19 infection by real-time PCR from a respiratory or other body sample
within 48 hours of testing.
- Mild to moderate infection or asymptomatic patients with comorbidities: Symptomatic
patients with fever >37.9ºC or cough or dyspnea or chest pain, not fulfilling severity
exclusion criteria. We will include patients regardless of time since symptom onset.
In addition, we will include asymptomatic patients with comorbidities including
cardiac, pulmonary, diabetes, chronic renal failure or liver disease hospitalized for
observation.
- Informed consent from patient or legal representative.
Exclusion Criteria:
- Severe infection, defined as need for invasive or non-invasive ventilator support,
ECMO or shock requiring vasopressor support.
- Unable to take oral medication
- Known allergy to HCQ or chloroquine
- Prolonged QT, defined as QTc ≥450 milliseconds for men and as QTc ≥470 for women
- Severely reduced LV function (Ejection fraction<30%)
- Retinopathy
- Pregnancy or breast feeding
- Concomitant treatment with azithromycin, flecainide, amiodarone, digoxin,
procainamide, propafenone, thioridazine, pimozide.
- Chronic chloroquine/ HCQ treatment (within 1 month)
- Need for hemodialysis
- Participating in another RCT for treatment of COVID-19
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.
| Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death | NCT04323631 | Entailment |
1,877 | 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:
- Patients must have histologically or cytologically confirmed adenocarcinoma of the GE
junction or stomach, which is beyond the scope of surgical resection
- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >=
20 mm with conventional techniques or as >= 10 mm with spiral CT scan
- Patients may have received adjuvant therapy for resected disease
- Patients who have received no prior systemic therapy for advanced disease are
eligible to receive PS341 + irinotecan
- Patients are eligible for PS-341 as a single agent if they have received any
number of prior regimens for gastric cancer
- Life expectancy of greater than 6 weeks
- ECOG performance status =< 2 (Karnofsky >= 60%)
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >=100,000/uL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits
- When possible, patients will undergo an esophagogastroduodenoscopy (EGD) with biopsy
prior to therapy then at 24 hours after starting PS-341
- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation; should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents, concurrent radiation
therapy, or other chemotherapy; patients who have had photodynamic therapy either
within 4 weeks of study entry or concurrently are ineligible, unless it was used to
relieve esophageal obstruction that could not be treated with laser, stent or
dilatation
- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to PS 341 or other agents used in the study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with PS341
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study
- Patients with a concurrent malignancy are excluded (except for early stage squamous
cell carcinoma of the skin or cervix which can be treated locally); patients with an
advanced malignancy within the past five years are not eligible; patients with a prior
malignancy who have been disease free for five years are eligible
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.
| Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach | NCT00061932 | Entailment |
5,553 | 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:
- Birth length below -2 SD
- Height at start below - 2 Sd
Exclusion Criteria:
- Any endocrine or chronic disease
- Any known syndrome with short stature
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 7 Years | Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age | NCT00174408 | Contradiction |
3,129 | 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:
- Patients diagnosed as Secondary Sjogren syndrome according to the 2002 American
European consensus group (AECG) criteria, which require the presence of well defined
major connective tissue disease (such as rheumatoid arthritis and systemic lupus
erythematosus.
- All patients show chronic symptoms of burning, foreign body sensation, itching in both
eyes, abnormal Schirmer test <5 mm wetting of the paper after 5 minutes, and abnormal
tear breakup time (TBUT) < 10 seconds.
- Wash out period of 30 days before start of the immunomodulatory eye drops included in
the investigator's study
Exclusion Criteria:
1. Any inflammation or active structural changes in the iris or anterior chamber.
2. Patients receiving or who had received systemic cyclosporine or tacrolimus.
3. Patients receiving any systemic drug that can cause dry eye as some antidepressants ,
antihistaminic drugs , hormonal therapy…etc
4. Glaucoma.
5. Previous ocular surgery.
6. Use of any topical medication other than artificial tears.
7. Contact lens wearers.
8. Presence of any corneal infection.
9. Any corneal diseases (ulcer, opacity, scar, bullous keratopathy, symblepharon or
tumors).
10. Deforming structural lid or conjunctival abnormality.
11. Pregnancy.
12. Prior diagnosis of any of the following conditions would exclude participation in AECG
study :
Past head and neck radiation treatment Hepatitis C infection Acquired immunodeficiency
disease (AIDS) Pre-existing lymphoma Sarcoidosis Graft versus host disease
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.
Subject must be at most 70 Years | Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome | NCT03865888 | Contradiction |
4,990 | 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:
- Essential Tremor
- Subjects must be 50 years of age or older.
- Subjects must have been diagnosed with Essential Tremor
- Subjects must live within 3 hours of UTSW
- Parkinson's Disease
- Subjects must be 50 years of age or older.
- Subjects must have been diagnosed with Parkinson's Disease
- Subjects must live within 3 hours of UTSW
- Healthy Individuals
- Healthy individuals living within 3 hours of UTSW
- Subjects must be 50 years of age or older
- You are healthy and have not being diagnosed with any neurological disease
- Essential Tremor and Parkinson's Disease
- Subjects must be 50 years of age or older.
- Subjects must have been diagnosed with Essential Tremor
- Subjects must have been diagnosed with Parkinson's Disease preceded by at least 3
years of enrollment in study
- Subjects must live within 3 hours of UTSW
Exclusion Criteria:
- Healthy Individuals
- Subjects with medical history of neurological conditions
- Subjects with family history of neurological condition
- Subjects with spouse diagnosed with Essential Tremor or Parkinson's Disease
- Essential Tremor
- Subjects with medical history of another movement disorder such as Parkinson's
Disease or dystonia
- Subjects with head tremor that preceded hand tremor
- Parkinson's Disease
--Subjects with medical history of Essential Tremor
- Essential Tremor and Parkinson's Disease
- Criteria that does not meet inclusion
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| Environmental Epidemiology of Essential Tremor | NCT04576676 | Entailment |
1,721 | 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 Criterion:
- Age ≥ 18 and ≤ 60 years.
- Control subjects without any history of wrist injury or disease.
Exclusion Criteria (applied to both wrists for control subjects):
- Previously-diagnosed rheumatological conditions or connective tissue diseases;
- Inability to be appropriately positioned in the scanner for the imaging;
- Congenital malformations of the wrist or forearm;
- Diagnosed wrist osteoarthritis
- Age under 18 or over 60.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | A Study to Evaluate 4DCT Controls | NCT04736537 | Entailment |
5,542 | 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:
- Age > 50 years
- GCA fulfilling ≥3/5 ACR criteria
- Newly diagnosed GCA or relapsing GCA if treatments
(Glucocorticoids±immunosuppressants) have been stopped for at least 6 months
- Glucocorticoids started for less than 21 days
- Proof of large vessel vasculitis:
- Positive temporal artery biopsy (TAB)
- Aortitis, as defined by regular circumferential wall thickening ≥3mm in the
absence of calcification and/or significant atheroma on angio-CT images; or a
homogeneous vascular signal more intense than the liver on 18FDG-PET images.
- For men and women of a child-bearing age, an effective method of contraception must be
used by the patient or his or her partner throughout the treatment with tocilizumab
(or placebo) and for 3 months after the end of the treatment. Breast-feeding is not
authorised until 3 months after the end of treatment with tocilizumab. Women not
considered at risk of pregnancy are those defined by menopause of at least one year or
surgically steriles (ligature of the fallopian tubes, bilateral ovariectomy or
hysterectomy)
- Persons who have provided written informed consent
- Persons covered by the National Health Insurance Agency
Exclusion Criteria:
- Pregnancy
- hospitalization in the previous year for drug or alcohol intoxication
- current treatment for another autoimmune or inflammatory disease
- known hypersensitivity to TCZ or one of its excipients or another human or murine
monoclonal antibody
- treatment with anti-TNF-α, methotrexate, cyclophosphamide, dapsone, methylprednisolone
pulses or any other immunosuppressive or immunomodulatory drug or biotherapy within 6
months before inclusion
- long-course systemic GC therapy
- prednisone therapy >1 mg/kg/day, whatever the duration
- serious or chronic proven infections requiring hospitalization or intravenous
antibiotics within 30 days before inclusion
- other proven infections that required antibiotics within 14 days before inclusion
- opportunistic infections
- evidence of active tuberculosis or latent tuberculosis (as defined by a positive
interferon gamma release assay)
- active chronic hepatitis B or C or HIV
- cancer or lymphoproliferative disorders within the 5 years before inclusion (with the
exception of in situ cervical cancer and squamous or basal cell carcinoma with R0
resection)
- past history of sigmoid diverticulitis
- any active hepatic disease
- hepatic failure; thrombocytopenia <50 G/L
- neutropenia <0.5 G/L
- history of moderate to severe congestive heart failure or demyelinating disease
- recent stroke
- current signs or symptoms of severe, progressive, or uncontrolled disease, not due to
GCA, which contraindicates TCZ
- severe and uncontrolled hypercholesterolemia
- high cardiovascular risk (former cerebral or coronary vascular event, or vascular risk
>20% at 10 years according to the Framingham risk score [24]); dementia; non-compliant
patients
- patients under ward of court, tutelage or legal guardianship.
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.
| Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. | NCT01910038 | Entailment |
4,431 | 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:
- HMRS of the elbow, distal humerus or total humerus
Exclusion Criteria:
- Unwillingness to participate
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Management of Bone Defects Around the Elbow | NCT00873145 | Contradiction |
991 | 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:
- Included in this study were male and female subjects
- Age between 18 and 90 years
- With complaint of skeletal muscle pain
- Do not present cognitive deficit that makes the study impossible
Exclusion Criteria:
- Individuals who did not agree to participate in the study
- Volunteers with decreased range of motion
- Volunteers without complaint of skeletal muscle pain
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 90 Years | Application and Comparison of Fuzzy Scale for the Evaluation of Pain Skeletal Muscle With the Numerical Pain Scale | NCT03710954 | Entailment |
4,600 | 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. Women within ages of 18 to 45 years old with good health and regular menstrual cycles
with last menstrual cycle occurred within 5 weeks of enrolment; subjects can be
rescreened after completion of menstrual cycle
2. Women who use sanitary pads as their only menstrual hygiene product.
3. Women who agree to use only the study menstrual hygiene device and not sanitary pads
or other menstrual hygiene products for menstruation during the night time of study
duration.
4. Women who are able to understand instructions for correct use of study menstrual
hygiene product (i.e. the investigational device).
5. Literate women who can complete the study questionnaire on their own in a language of
their choice which are English, Malay and Chinese; and attending all study visits.
Exclusion Criteria:
1. Known history of vaginal or uterine infection(s), and/or urinary tract infections;
these subjects can be rescreened after 14 days after successful treatment.
2. Ongoing or past history of sexually transmitted disease, pelvic inflammatory disease,
and/or injuries to the pelvis requiring surgical intervention and/or pelvic floor
physiotherapy.
3. Female subject who is pregnant (established by urinary pregnancy test).
4. Sensitivity or allergy to polyurethane and acrylic adhesive hypoallergenic.
5. Staff who work directly under the investigators and/or employed directly by the device
manufacturers, sponsor and study team.
6. Moving outside Sibu area during study period and have difficulty to return for Visit
2.
7. Female subjects who have menopause (absence of menstruation for more than 6 months in
female) or any other circumstances that cause secondary amenorrhea (absence of
menstruation for more than 6 months in a normal female of reproductive age that is not
due to pregnancy) such as side effect from hormonal contraceptive.
8. Use any medications or preparation applied topically to the perineum or intravaginally
to the genitalia but subjects can be rescreened 14 days after the recovery if the
application is for acute illness.
9. Use of any medications which known to influence menstruation or study results for any
reasons within 14 days, 30 days before Visit 1 and during the intended study duration.
10. Subject participating in another clinical study involving menstrual hygiene device.
11. Acute disease at the time of enrolment. Acute disease is defined as the presence of a
moderate or severe illness with or without fever. Fever is defined as axillary /
tympanic / rectal temperature ≥ 38°C. Subjects can be rescreened 14 days after the
recovery;
12. Blood dyscrasias, bleeding disorder, leukaemia, lymphomas of any type, or other
malignant neoplasms affecting the bone marrow or lymphatic systems;
13. Presence of a clinically significant disorder involving the cardiovascular,
respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine,
or nervous system(s) or psychiatric disease or other conditions that may interfere
with the health conditions (such as in case the women subject become pregnant), or
would place the subjects at increased risk, as determined by the investigator(s).
Significant is defined as any disease/condition that, in the opinion of the researcher,
would put the subject's safety at risk through study participation, or which would confound
the interpretation of the study results if the disease/condition exacerbated during the
study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Proof Of Concept Menstrual Hygiene Product-Wondaleaf® | NCT02857972 | Entailment |
232 | 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:
- 18 to 40 years of age
- BMI of 18 to 30 kg/m2
- regular menstrual cycles from 25 to 32 days
- established diagnosis of infertility.
Exclusion Criteria:
- Less then 18 or more then 40 years old
- BMI less then 18 or more then 30 kg/m2
- irregular menstrual cycles
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Oocyte Retrieval Progesterone Levels and IVF | NCT04447677 | Contradiction |
315 | 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:
- Single intrauterine pregnancy
- Gestational age less than 10 weeks
Exclusion Criteria:
- Any condition distorting uterine cavity as myoma, uterine anomalies.
- Absent fetal pulsations
- Any condition needing termination of early pregnancy as molar pregnancy or severe
deteriorating maternal disease
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Relation of Implantation Site to Placental Site | NCT02765984 | Contradiction |
4,959 | 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:
- Male or female
- 18 years of age or older
- Any ethnic background
- History of a primary diagnosis of essential tremor or Parkinson's disease
- Present for the MRgFUS tremor treatment
- Ability to understand and agree to informed consent as determined by referring
physician
Exclusion Criteria:
- Inability to give informed consent
- Contraindications for MRI, including
1. Intracranial clips
2. Metal implants
3. External metallic devices/objects/clips within 10 mm of the head
4. Suspected or confirmed metal in eyes (history of welding or similar activity)
5. Cardiac pacemaker
6. Pregnant or potentially pregnant - pregnancy tests will be offered to women of
childbearing age at no cost to the patient. (A SOC pregnancy test (Urine test)
will be done for women of child bearing age if requested/required at the time of
check-in at Tisch.This will be billed to the research study). The result of the
test (if performed) will be added to the patient's chart in EPIC.
7. No vulnerable populations will be enrolled.
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.
| Mapping the Target for the MRgFUS Treatment of Tremor | NCT04661241 | Entailment |
5,857 | 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. Aged greater than or equal to 18 years and less than or equal to 70 years.
2. BMI >27.5 (based on kg/m2)
4. Not taking acid suppressant PPI and H2 receptor blockers 5. Not taking antacids or
alginate preparations, except those administered as part of study procedure.
Exclusion Criteria:
1. Those with gastrointestinal symptoms indicative of GERD, gastric carcinoma, previous
or current peptic ulcer disease.
2. Those with a history of upper GI surgery prior to this.
3. Those with haematological disorders, bleeding tendency, recurrent nose bleeds or
treatment with anti-coagulants).
4. Those who had any previous history of allergy or known intolerance to any of the study
drugs or the following formulation constituents: Gaviscon® liquid: sodium alginate,
sodium bicarbonate and calcium carbonate
5. Those with physical, neurological or psychiatric conditions preventing repeated visits
to hospital or compliance with study procedures.
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 | Efficacy of Gaviscon-Advance® in Suppressing Post-supper Acid-pocket and Night-time Acid-reflux in Obese Participants | NCT03516188 | Contradiction |
2,865 | 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:
- Familial or sporadic ALS diagnosed as probable, laboratory-supported probable or
definite according to the World Federation of Neurology El Escorial criteria,
- Age 18 or older,
- Capable of providing informed consent and complying with trial procedures,
- Appel ALS score less than 100,
- Able to stand on a scale with assistance,
- Willing to chart food intake during the 12 week study,
- Patients either not taking Riluzole (Rilutek) or on a stable dose for 30 days or more,
- Not taking Coenzyme Q10 or on a stable dose and brand for 30 days,
- Absence of exclusion criteria.
Exclusion Criteria:
- Forced vital capacity <40% of predicted,
- Dependence on mechanical ventilation for more than 12 hours per day,
- Exposure to any experimental agent within 30 days of entry or at any time during the
trial,
- Women who are breastfeeding, who are pregnant or are planning to become pregnant,
- Women of childbearing potential not practicing a medically accepted form of
contraception,
- Enrollment in another research study within 30 days of or during this trial,
- Mini-Mental State Exam (MMSE) score <20,
- Patients with symptomatic cardiac disease or hypercholesterolemia,
- Patients with myocardial infarction within 6 months of this trial,
- Renal dysfunction defined as BUN and creatinine >2xULN,
- Known mitochondrial disease,
- BMI<18.5,
- Prior use of a 4:1 ketogenic diet or Atkins diet within 1 month of this trial,
- Impaired liver function, defined as AST or ALT of 3xULN,
- Patients who have a pacemaker or other internal electronic medical device,
- Known allergy or hypersensitivity to milk or soy products.
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 | Safety of Caprylic Triglycerides in ALS: A Pilot Study | NCT02716662 | Entailment |
4,564 | 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:
- BMI 28-35
Exclusion Criteria:
- Severe disease
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 65 Years | Dietary Advice on Prescription in Kungsbacka | NCT01385930 | Contradiction |
2,989 | 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:
1. Diagnosis of Fragile X syndrome by genetic testing of molecular biology, full mutation
result methylation.
2. Having an older age of 1 year and less than 9 years
3. Having signed the informed consent document before starting their participation in the
trial.
Exclusion Criteria:
1. Any advanced, severe or unstable disease.
2. Individuals with other psychiatric diagnosis as the first diagnosis.
3. It have been suffered serious medical problems in the last 12 months.
4. Be taking more than 100 mg of vitamin E or C a day in the last month.
5. Having physical, mental or sensory impairments that prevent the assessment of
effectiveness.
6. Hypersensitivity to any component of the preparation.
7. Liver failure or severe renal or previous history of kidney stones.
8. Any treatment regimen, including treatment with psychotropic drugs and / or
anticonvulsant therapy that has not been stable for a period ≥ 4 weeks before
randomization.
9. Current treatment with more than two psychoactive medications, excluding medication
used specifically for the control of seizures.
10. Hypoprothrombinemia secondary to vitamin K deficiency
11. Sensitivity to any of the compounds of formula treatment.
12. Patients diagnosed with congenital or idiopathic methemoglobinemia for diagnosis of
glucose-6-phosphate dehydrogenase deficiency.
13. Use of oral anticoagulants, iron or vitamin A.
14. Forecast initiate or change pharmacological or no pharmacological interventions during
the course of the study.
15. Patients weighing less than 4.2 kg
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 8 Years | Clinical Trial for Asses the Safety and Efficacy of Vitamin C and Vitamin E in Combination Versus Placebo for Treating Cognitive and Behavior Disorder in Children With Fragile X Syndrome | NCT02942498 | Contradiction |
5,409 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
1. Male or female 7 years of age or older
2. The subject has been diagnosed of inherited VWD of Type 3 as determined by subject's
medical records.
3. The subject needs a surgical procedure (at least 10 surgical procedures have to be
considered as "Major" according to the criteria of the protocol).
4. The subject is expected to respond to exogenously administered FVIII/VWF according to
Investigator's judgment.
5. The subject freely gives written informed consent. Patients who are not legally
permitted to provide written consent must sign a form of assent for study
participation, and written consent must be provided by a parent or legal guardian.
Exclusion Criteria:
1. The subject has been diagnosed of acquired VWD.
2. The subject is known to have history of intolerance to any Alphanate® containing
substance.
3. The subject is known to have history of anaphylactic reaction(s) to blood or blood
components.
4. Liver function tests (AST, ALT, bilirubin) > 2.5 x upper limit of normal (ULN).
5. Renal function test (creatinine, BUN) > 1.5 x ULN.
6. The subject is known or suspected to have present or past inhibitor activity
(antibodies) directed against FVIII or VWF.
7. The subject is known to abuse alcohol or illicit drug use within the past 12 months.
8. The subject is participating in another clinical study involving an investigational
treatment, or participated within the past 4 weeks (except if the patient is
participating in another Alphanate® study). Studies consisting of data and blood
sampling collections on a regular or long-term basis are exempt from this exclusion.
9. The subject is unlikely to adhere to the protocol requirements 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 7 Years old.
| Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients | NCT00555555 | Entailment |
2,205 | 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:
- Meets the diagnosis of gout according to the American Rheumatism Association (ARA)
Criteria for the Classification of Acute Arthritis of Primary Gout.
- Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.
- If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.
- Must have had at least 2 gout flares in the past year.
Exclusion Criteria:
- Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of
wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
- History or suspicion of drug abuse.
- History of autoimmune disease requiring systemic treatment.
- Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or
hepatitis B antibody (HBsAg) infection.
- History of malignancy within the previous 5 years (with the exception of nonmelanoma
skin cancer that has been treated with no evidence of recurrence, treated cervical
dysplasia or treated in situ Grade 1 cervical cancer).
- Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or
IV heart failure, or stroke within the last 12 months.
- Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure
above 95 mm Hg).
- Estimated creatinine clearance < 30 mL/min by Cockcroft-Gault formula.
- Kidney or other organ transplant.
- Active peptic ulcer disease requiring treatment.
- History of xanthinuria, active liver disease, or hepatic dysfunction.
- If unable to take gout flare prophylaxis of either colchicine or nonsteroidal
anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal
function, use of contraindicated medications).
- Known hypersensitivity or allergy to allopurinol.
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 85 Years | Allopurinol Outcome Study | NCT01391325 | Contradiction |
6,338 | 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:
- Age 18 years or older.
- Test result indicating presence of SARS-CoV-2 virus. Sites must have results from
assays that are approved as FDA-emergency use authorized or as standard-of-care by
other applicable regional governing bodies. For timing of testing, please see group
specific criteria below.
- Ability and willingness to provide informed consent.
- Willingness to have clinical research staff come to place of residence or hospital if
needed.
- Willingness to be followed for the planned duration of the study.
- Assessment of understanding: volunteer demonstrates understanding of this study.
- Agreement to allow access to medical records.
- Asymptomatic participants:
- No current symptoms.
- No symptoms consistent with COVID-19 within 2 weeks prior to positive test
according to the clinical judgement of the investigating clinician. Symptoms
include, but are not limited to, fever, headache, sore throat, cough, dyspnea,
rhinorrhea, diarrhea, myalgias, chills, and anosmia. Please refer to
https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html for the
current list of symptoms consistent with COVID-19.
- Positive SARS-CoV-2 RNA test or antigen test within six days prior to enrollment
(target time) up to 10 days prior to enrollment (upper allowable window).
- Symptomatic (non-hospitalized) participants:
- Onset of mild symptoms consistent with COVID-19 within 6 days prior to enrollment
(target time) up to 14 days prior to enrollment (upper allowable window).
Symptoms of COVID-19 to be determined by the clinical judgement of the
investigating clinician including-- but not limited to-- fever, headache, sore
throat, cough, dyspnea, rhinorrhea, diarrhea myalgias, chills, and anosmia.
Please refer to
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html for the
current list of symptoms consistent with COVID-19.
- Positive SARS-CoV-2 RNA test or antigen test within six days prior to enrollment
(target time) up to 10 days prior to enrollment (upper allowable window).
- Symptomatic (hospitalized) participants
- Participant hospitalized for COVID-19 within 3 days prior to enrollment (note:
there is no timeframe for either symptom onset or timing of SARS-CoV-2 PCR or
antigen testing for hospitalized participants)
Exclusion Criteria:
- Any medical, psychiatric, occupational, or other condition that, in the judgment of
the investigator, would interfere with, or serve as a contraindication to, protocol
adherence or a volunteer's ability to give informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study of Immune Responses to the Virus That Causes COVID-19 | NCT04431414 | Entailment |
4,804 | 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:
- Five years of age or older at the time of implantation
- Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000,
and 4000 Hz) of 90 dB or greater in the ear to be implanted
- Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap
less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and
4000 Hz and a diagnosed pathology of the outer or middle ear
- Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined
by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less
- Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
- Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS)
hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction,
or traditional hearing aid, as deemed appropriate by investigator
- Fluent in English
Exclusion Criteria:
- Duration of profound hearing loss of 10 years or more
- Absence of cochlear development or non-functionality of cochlear nerve
- Other retrocochlear hearing loss
- Evidence of severe cochlear malformation (i.e., common cavity or ossification)
- External or middle ear infection
- Suspected developmental or cognitive concern
- Other medical contraindication for surgery or anesthesia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
| Single-Sided Deafness and Asymmetric Hearing Loss | NCT04506853 | Entailment |
5,515 | 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:
1. Patients with newly onset Giant Cell Arteritis (GCA) with diagnosis of GCA within 4
weeks before screening visit, satisfying ACR criteria and a CRP > 25 mg/L AND biopsy
proven GCA (according to ACR criteria) OR a large vessel vasculitis assessed by MR
Angiography (MRA) or PET/CT (PET).
2. Previous treatment with GC for a maximum of 10 days since diagnosis of GCA at a
maximal dose of 60 mg/day of prednisone or equivalent.
3. Patient's written informed consent.
Exclusion Criteria:
1. Rheumatic diseases (except for CPPD/chondrocalcinosis) other than GCA or polymyalgia
rheumatica (i.e., RA, autoimmune connectivitides, other systemic vasculitides, a.o.)
2. Chronic use of systemic CS with inability, in the opinion of the investigator, to
withdraw CS treatment at day 4 according to protocol
3. Evidence of significant and/or uncontrolled concomitant disease such as, but not
limited to, cardiovascular disease, nervous system, pulmonary, renal, hepatic,
endocrine (in particular diabetes mellitus) or gastrointestinal disorders (including
previous complicated diverticulitis) which, in the investigator's opinion, would
preclude patient participation or impact the benefit-risk ratio
4. Any condition or general state of health which, in the Investigator's opinion, would
preclude participation in the study
5. Actual or recent myocardial infarction (within the last 3 months before screening
visit)
6. Significant cardiac disease (NYHA Class III and IV), known severe chronic obstructive
pulmonary disease (COPD) (FEV1 < 50% predicted or Functional dyspnea > Grade 3 on the
MRC Dyspnea Scale) or other significant pulmonary disease
7. Uncontrolled disease (such as asthma, psoriasis or inflammatory bowel disease) where
flares are commonly treated with oral or injectable corticosteroids
8. Known active infection of any kind, or any major episode of infection requiring
hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or
completion of oral anti-infectives within 2 weeks before screening visit
9. History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within
52 weeks before screening visit
10. Any surgical procedure, including bone/joint surgery within 8 weeks prior before
screening visit or planned within the duration of the study
11. History of serious recurrent or chronic infection (for screening for a chest infection
a chest radiograph will be performed at screening if not performed within 12 weeks
before screening visit
12. Lack of peripheral venous access
13. Body weight > 150 kg or BMI > 35
14. Previous treatment with tocilizumab or any other biological agent within last 6 months
before screening visit; Rituximab within 12 months before screening visit
15. Treatment with any investigational agent within 28 days of screening visit or 5
half-lives of the investigational drug (whichever is the longer)
16. History of severe allergic or anaphylactic reaction to any biologic agent or known
hypersensitivity to any component of tocilizumab
17. Receipt of any vaccine within 28 days prior to screening visit (a patient's
vaccination record and need for immunization prior to receiving tocilizumab/placebo
must be carefully investigated)
18. Positive tests for hepatitis B surface antigen (HBsAg) or hepatitis C serology
19. Positive Quantiferon-TB test for latent Tb without subsequent INH prophylaxis
20. Patients with active Tb which had to be treated for Tb within 2 years before the
screening visit
21. Absolute neutrophil count (ANC) < 2.0 x 103/L, white blood cells < 2.5 x 103/L,
platelet count < 100,000/L
22. Hemoglobin < 8.0 g/dL
23. Concentrations of serum IgG and/or IgM below 5.0 mg/mL and 0.40 mg/mL, respectively
24. Serum creatinine > 2.0 mg/dL
25. Alanine aminotransferase (ALT) or aspartate amino-transferase (AST) > 1.5 times the
upper limit of normal (ULN)
26. Total bilirubin > 1.5 times the upper limit of normal (ULN)
27. Triglycerides > 400 mmol/dL (non-fasted) or > 250 mmol/dL (fasted) at screening
28. Premenopausal status and nursing (definition of postmenopausal status: Female
participants who are surgically sterilised / hysterectomised or post-menopausal for
longer than 2 years are not considered as being of child-bearing potential)
29. Technical implants such as cardiac pacemakers (for MR-angiogram)
30. Claustrophobia (for MR-angiogram)
31. Known allergy against the contrast media (Multihance® or Dotarem® as alternative)
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.
| Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab | NCT03745586 | Entailment |
6,681 | 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
- Hemophilia A or B
- Pregnancy between 2014 and 2016
Exclusion Criteria:
- Opposition
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Health Practice of Hemophilia Patiente Care During Pregnancy, Delivery and Newborn Children | NCT03360149 | Contradiction |
3,475 | 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:
- Type 2 diabetes mellitus with stable antidiabetic treatment since at least three
months
- Total cholesterol concentrations >135mg/dl and/or concomitant lipid lowering therapy
with HMGCoA inhibitors
- Serum creatinine ≤1.5mg/dl
- Urinary albumin excretion rate < 200μg/min
- Written informed consent
Exclusion Criteria:
- History of myocardial infarction, stroke or hospital admission for angina within the
previous 6 months
- History of percutaneous transluminal coronary angioplasty or coronary artery bypass
grafting
- Clinically manifest heart failure (grade III or above according to New York Heart
Association criteria)
- Poor glycemic control (HbA1C >11%)
- Primary hyperlipidemia
- Uncontrolled thyroid diseases
- Infectious disease within 4 weeks of starting
- Acute liver disease or hepatic dysfunction
- Inflammatory muscle disease or evidence of muscle problems
- Concurrent treatment with systemic steroids, androgens, cyclosporin and other
immunosuppressive drugs, fibrates, high-dose niacin or cholestyramine
- Pregnancy or lactating
- Women of childbearing potential without following a scientifically accepted form of
contraception
- Life-threatening conditions or terminal concomitant diseases other than diabetes
- Specific contraindications or history of hypersensitivity to the study drugs or other
statins
- Legal incapacity and/or other circumstances rendering the patient unable to understand
the nature, scope and possible consequence of the trial
- Evidence of an uncooperative attitude
- Any evidence that patient will not be able to complete the trial follow-up
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 | Ezetimibe and Simvastatin in Dyslipidemia of Diabetes | NCT00157482 | Entailment |
3,179 | 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:
To be eligible for inclusion, each Participant must meet each of the following:
1. Male or female aged ≥ 18 years and ≤ 79 years at date of consent
2. Primary Sjögren's Syndrome diagnosed by a rheumatologist
3. Patient has symptoms of dry eye, and has failed to achieve symptom relief on adequate
trial of standard topical therapy
4. Willing and able to attend Glasgow Caledonian University Vision Sciences Eye Clinic
for therapy assessment; and to comply with all procedures and follow-up visits
5. Participant must have personally given written informed consent to allow anonymised
data to be used in publications and presentations.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria are met:
1. Females who are pregnant, planning pregnancy or breastfeeding
2. Active ocular infection or current corneal ulceration
3. Ocular surgery within 6 months of study start date
4. Current contact lens wear
5. Any prior and/or current topical ophthalmic treatments that in the opinion of the CI
or PI may interfere with the study outcomes
6. Started or changed the dose of chronic systemic medication known to affect tear
production including, but not limited to antihistamines, anticholinergics,
antidepressants, diuretics, corticosteroids or immunomodulators within 30 days prior
to enrolment
7. Participants with known allergies to ingredients in any of the study treatments, or
fluorescein
8. Participants who are judged inappropriate for inclusion in the study by the CI or PI.
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 | LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients | NCT03140111 | Entailment |
4,331 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Vital Signs, EKG and Clinical Laboratory Values within the normal range
- Body mass index (BMI) [20-29kg/m2]
- Caucasian male
- Age between [18-55]
- Healthy by physical exam
- Non or ex-smoker
Exclusion Criteria:
- Presence or history of intolerance or hypersensibility to proton pump inhibitors or
HMG-CoA reductase inhibitors.
- Significant illness. History of cardiovascular, kidney, liver or gastrointestinal
disease. Presence of cardiovascular, pulmonary, hematologic, neurologic, psychiatric,
endocrine, immunologic or dermatologic disease.
- consumption of an investigational product or donation of blood in the previous 28 days
preceding the study.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Drug-drug Interaction Study in Healthy Male Volunteers Following the Administration of Pantoprazole and Rosuvastatin | NCT01146483 | Contradiction |
895 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Diagnosis of KOA;
2. Age 40-75 years;
3. KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 3 months;
4. NRS score of pain at least more than 4 points;
5. Single/bilateral knee pain, duration of more than 6 month; If the patient has KOA on
both legs, the heavier leg is selected for study.
Exclusion Criteria:
1. Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
2. Knee pain caused by other diseases (such as joint bodies, severe effusion of joint
cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
3. Oral administration of hormones within 3 month, intra-articular injection within 6
months, knee injuries or open injuries within 6 months, or knee arthroscopy within 1
year.
4. Severe acute/chronic organic or mental diseases;
5. Pregnant women, pregnant and lactating women;
6. Coagulation disorders (such as hemophilia, etc.), or the skin diseases at the site of
operation;
7. Device support treatment after knee osteoarthritis disability;
8. Participation in another clinical study in the past 3 months;
9. History of receiving acupuncture, massage, manipulation, or any medical plaster
treatment within 3 months
10. Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may
be construed as non-compliance and may be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Chinese Tuina Therapy for Treatment of Knee Osteoarthritis | NCT03966248 | Entailment |
3,708 | 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:
- Male and female individuals aged between 40 and 70 meeting the American College of
Rheumatology (ACR) criteria for primary knee OA with radiographic and symptomatic
evidence of TF OA for ≥6 months.
- Radiographic osteoarthritis Kellgren-Lawrence Grade II-III (radiographs taken at
entry) in affected knee.
- Average pain numeric rating (defined as moderate level) of 4 - 8 on a scale of zero to
10 over the past week.
- No previous viscosupplement therapy in any joint in past 12 months at the time of
randomization.
- No intra-articular steroids in the past 6 months.
- Currently sedentary per American College of Sports Medicine (ACSM) criteria (MET level
<9) and at least one of the following cardiovascular risk factors:
- Obesity (BMI between 30 and 40)
- Diabetes mellitus
- HTN (JNC guidelines for HTN stage 1: Systolic >/=140 and diastolic >/= 90)
- Dyslipidemia (ATP3 Guidelines for dyslipidemia: LDL>160, total cholesterol >/=240 and
HDL<40)
- Established CAD per clinical or imaging diagnosis
- Allowed medications include stable prescription dose of NSAIDS and/or tramadol. Ad lib
use of OTC analgesics will be allowed in both groups.
Exclusion Criteria:
- Grade I and IV OA.
- History of viscosupplementation in any joint in the past 12 months at the time of
baseline visit.
- Isolated patello-femoral OA or isolated anterior knee pain (patello-femoral OA
co-existing with tibia femoral KOA may be included).
- Symptomatic bilateral knee OA (unless the contra-lateral knee involvement is limited
to radiographic OA and not symptomatic).
- Ipsi-lateral symptomatic OA of hip or ankle; contra-lateral symptomatic OA of hip,
knee, or ankle, or clinical evidence of hip disease.
- Clinically apparent tense effusion or other acute inflammation of the target knee at
baseline.
- History of:
- Septic OA of any joint
- Inflammatory arthropathy such as rheumatoid arthritis, gout, pseudogout, lupus,
crystalline arthropathy, chondrocalcinosis and other rheumatology diagnosis in
judgment of the investigator.
- Active infection of lower extremity (e.g., cellulitis).
- Prosthetic implant in hip and/or lower extremities.
- Any clinical indication for arthroscopic surgery at the time of enrollment.
- Planned surgeries during the trial period (e.g., scheduled/awaiting for arthroscopy or
a knee replacement procedure for OA of the knee).
- Plans to initiate other OA treatments including, but not limited to non-pharmacologic,
pharmacologic, surgical, chiropractic, acupuncture, yoga, Tai chi, physical therapy
during the study period
- Any other intra-articular knee joint injection during the study.
- History of systemic and/or intra-articular steroid injection in target knee within six
months of baseline visit.
- History of arthroscopic surgery in affected knee in past 12 months at baseline visit.
- Cruciate/collateral knee ligament instability, ligament laxity, or meniscal
instability of target knee.
- Significant alignment deformity such as varus/valgus of target knee in the judgment of
the investigator.
- Venous or lymphatic stasis in either leg.
- Peripheral vascular disease.
- Concurrent multi-system or multi-limb trauma.
- Pregnancy or mothers who are breastfeeding. Urine pregnancy test will be administered
at baseline for women of childbearing potential.
- On chronic opioid analgesic therapy that cannot be altered. Chronic is defined as ≥6
months.
- Known contraindication to acetaminophen.
- Currently enrolled in another clinical trial or history of trial enrollment within
three months at baseline.
- Plans to move/relocate significantly out of area during study period.
- Workman's Compensation beneficiary at base line visit.
- The presence of secondary diagnosis such as neuropathy (any type), radiculopathy, or
other nervous system conditions in the judgment of the investigator, contributing to
other lower extremity pain that limits activity.
- Physical Therapy for OA of the lower extremity within 6 months prior to enrollment
into the study.
- Any musculoskeletal condition besides OA of the knee that limits exercise or normal
daily function.
- Acute coronary conditions that are deemed inappropriate for participating in an
exercise program.
- Pulmonary conditions limiting functional capacity.
- Known allergy to hylan G-F 20 or any, of its components, or to avian proteins, eggs,
feathers, down or poultry.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Pilot Study of Therapy With Hylan G-F 20 Exercise Capacity | NCT01810848 | Contradiction |
334 | 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. Women aged between 20 to 35 years old and with a history of infertility (fail to get
pregnant after over one year's regular, unprotected sex), who receive IVF/ICSI for one
of the following reasons:
① Tubal factor: e.g. peritubal adhesions, tubal obstruction, etc.. Patients with
hydrosalpinx can be enrolled after salpingectomy or tubal ligation;
② Male factor: e.g. oligospermia, asthenozoospermia, teratozoospermia, etc.;
③ Unexplained infertility: patients with a history of infertility more than 1 year but
with no specific cause for infertility (ovulation, tubal, endometrial and male
factor), or still not get pregnant after the above-mentioned causes being removed.
2. Women with a normal ovarian reserve according to: ①basal steroid hormone on day 2-4 of
menstrual cycle: basal FSH≤10mIU/ml, estradiol (E2) <50pg/ml;②1.5<anti-Müllerian
hormone (AMH)<4.0；③8≤antral follicle count (AFC) ≤15;
3. First IVF/ICSI cycle;
4. BMI≥18 and ≤25kg/m2;
5. Informed consent
Exclusion Criteria:
1. Women with a negative reproductive history, including a history of:
① recurrent miscarriage: women with twice and more than twice spontaneous miscarriage,
missed abortion, biochemical pregnancies, etc.;
② fetal malformation or chromosomal abnormalities;
③ intrauterine death.
2. Women with a history of one side adnexectomy;
3. Women with a poor ovarian response or diminished ovarian reserve (based on Bologna'
criteria);
4. Women with ovulation dysfunction;
5. Women with PCOS (based on Rotterdam's criteria);
6. Women with endometriosis;
7. Women with the following uterine abnormalities: uterine malformation (unicornuate
uterus, uterus bicornis, uterus duplex, mediastinum uterus), adenomyosis, submucosa
myoma, intrauterine adhesion;
8. Chromosomal abnormality for either or both of the couple;
9. Women with contraindications for ART or pregnancy: uncontrolled diabetes mellitus,
cardiac disease, undiagnosed liver and/or renal function, vaginal bleeding, suspected
or a past history of cervical cancer, endometrial cancer, breast cancer, and a history
of deep venous thrombosis, pulmonary embolism, stroke, etc.;
10. Women who are enrolled in other clinical trials.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 35 Years | The Effectiveness and Safety of the Prolonged Down-regulation Protocol for Controlled Ovarian Hyperstimulation | NCT03809221 | Contradiction |
3,545 | 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. | PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Primary adrenal insufficiency (Addison's disease) Serum
dehydroepiandrosterone less than 0.5 nmol/L --Prior/Concurrent Therapy-- No concurrent
investigational drug Stable glucocorticoid/mineralocorticoid dose over past year required
--Patient Characteristics-- Hepatic: No hepatic disease Cardiovascular: No vascular disease
No thrombotic disorder No angina No elevated blood pressure on 2 readings taken 15 minutes
apart in 1 visit, i.e.: Systolic greater than 165 mm Hg OR Diastolic greater than 95 mm Hg
Other: No clinically significant medical abnormality No gallbladder disease No malignancy
No estrogen- or androgen-dependent neoplasia Benign prostatic hyperplasia eligible No other
endocrine disease Controlled thyroid disease with normal thyroid-stimulating hormone
eligible Mammogram required within 1 year prior to entry for women aged 40 and over No
clinically significant abnormality No undiagnosed vaginal or uterine bleeding within 6
months prior to entry Pap smear required within 1 year prior to entry No dysplasia
(squamous intraepithelial lesion low-grade or higher)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency | NCT00004313 | Entailment |
5,435 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
Patients who meet all of the following criteria are eligible for the study:
- Aged ≥6 years at the time of screening
- VWD type 1 (baseline von Willebrand factor activity [VWF:Ristocetin Co-factor (RCo)]
<30 IU/dL, 2A, 2B, 2M, or 3 according to medical history requiring substitution
therapy with a VWF-containing product to control bleeding
- Currently receiving on-demand treatment with a VWF-containing product with at least 1,
and an average of ≥2, documented spontaneous BEs per month in the last 6 months, with
at least 2 of these BEs requiring treatment with a VWF-containing product
- Availability of records to reliably evaluate type, frequency, and treatment of BEs for
at least 6 months of on-demand treatment before screening
- Female patients of child-bearing potential must have a negative urine pregnancy test
at screening and agree to use adequate birth control measures; in case hormonal
contra-ception is used, the medication class should remain unchanged for the duration
of the study
- All patients to provide voluntarily given, fully informed written and signed consent
obtained before any study-related procedures are conducted
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for the study:
- Having received on-demand or prophylactic treatment with a VWF-containing product but
having no records available to reliably evaluate the type, frequency, and treatment of
BEs over a period of at least 6 months of on-demand treatment
- History, or current suspicion, of VWF or FVIII inhibitors
- Medical history of a thromboembolic event within 1 year before enrolment
- Severe liver or kidney diseases (alanine aminotransferase [ALAT] and aspartate
trans-aminase [ASAT] levels >5 times of upper limit of normal, creatinine >120 µmol/L)
- Platelet count <100,000/µL at screening (except for VWD type 2B)
- Body weight <20 kg at screening
- Patients receiving, or scheduled to receive, immunosuppressant drugs (other than
an-tiretroviral chemotherapy), such as prednisone (equivalent to >10 mg/day), or
similar drugs
- Pregnant or breast-feeding at the time of enrolment
- Cervical or uterine conditions causing abnormal uterine bleeding (including infection,
dysplasia)
- Treatment with any IMP in another interventional clinical study currently or within 4
weeks before enrolment
- Other coagulation disorders or bleeding disorders due to anatomical reasons
- Known hypersensitivity to any of the components of the 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 6 Years old.
| Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD | NCT04052698 | Entailment |
3,784 | 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:
- Male or female outpatient aged at least 18 years
- Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without
effusion. The diagnosis must be based on American College of Rheumatology (ACR)
criteria. Radiological grade will be assess according to Kellgren-Lawrence scale
- Assessment of pain on active movement (i.e. walking) (by the patient) must be at least
40 mm on a 100 mm VAS
- Patient who received at least two courses of at least ten days within the last three
months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated
continuously for the last two month with slow-acting anti-osteoarthritis drugs
- Patient's informed written consent obtained in accordance with French legislation
Exclusion Criteria:
- Patient suffering from acute congestive osteoarthritis flare of the target knee (at
the time of inclusion) which means that concomitantly to knee effusion at least 2 of
the following criteria are present:
- nocturnal disturbances due to knee pain
- morning stiffness over 45 minutes
- increase of knee pain more than 50% within the last week
- articular reddening
- articular heat
- Intra-articular administration of hyaluronic acid in the target knee within the
previous year
- Intra-articular administration of hyaluronic acid in the target knee within the three
previous months
- Any other intra-articular injection in the target knee within the last 6 months
- Any contraindication to intra-articular injections
- Present or past history of infected target knee joint
- Previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of
the target knee
- Arthroscopy, articular lavage, debridement, menisectomy of the target knee within the
previous year
- Planned knee surgery within the nine following month
- Any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis
or the evaluation of its severity
- Known hypersensitivity to avian products
- Presence of lymphatic or venous stasis
- Pregnancy or breastfeeding
- Clinical evidence of or known severe cardiac, hepatic, renal, metabolic,
haematological disease, mental disturbance
- Participation in another clinical trial during this study or during the previous month
- Previous participation in this trial
- Patient who requires help concerning shopping or house keeping
- Patient unable to comply with the protocol (e.g. patient unable to attend each trial
visit or to fill the diary booklet or the quality of life questionnaire)
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.
| Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis | NCT02197026 | Entailment |
5,636 | 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:
- Girls aged ≥9 years old
- Prepubertal - Tanner stage 1. (gonadarche) Breast at Tanner stage 1)
- Height and weight ≤ 10th percentile for age and gender.
- Height-SDS ≥ -2.5 SDS
- BMI-SDS>-2 SDS
- Low proportion between weight and height
- Signing inform consent forms
Exclusion Criteria:
- Diagnosis of Growth Hormone (GH) Deficiency or treatment with GH
- Any known chronic disease or dysmorphic syndrome including: bone diseases, organic
brain diseases, neurological disease, past or current malignancy, chronic cardiac,
renal or pulmonary problems
- Any known gastrointestinal disease including malabsorption
- Any known organic reason for growth retardation
- Any chronic treatment with medication that might affect appetite, weight or growth
(for example SSRI's).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 9 Years old.
Subject must be at most 14 Years | Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls | NCT02397200 | Contradiction |
2,066 | 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:
- Inclusion Criteria for Probable Idiopathic Pulmonary Fibrosis (IPF)
- Adult male or female patients aged 40 to 85 years
- Women of childbearing age should not be pregnant, planning to get pregnant or
breast-feeding.
- Command of the English language to be able to give informed consent.
- Probable IPF requiring bronchoscopy to confirm the diagnosis, agreed within the local
multi-disciplinary team (MDT).,according to the American Thoracic Society/European
Respiratory Society/Japanese Respiratory Society/ American Latin Thoracic Association
(ATS/ERS/JRS/ALAT) guidelines (2018) (3)
- IPF disease diagnosis within the past 5 years
- Usual Interstitial Pneumonia (UIP) on HRCT scan.
- Recent lung function criteria:
- Forced vital capacity (FVC) >40% of predicted value.
- Carbon monoxide diffusing lung capacity (DLco) corrected for haemoglobin >30% of
predicted value
Inclusion criteria for Sarcoidosis
- Adult male or female patients aged 18 years and over
- Women of childbearing age should not be pregnant, planning to get pregnant or
breast-feeding.
- Clinical symptoms, CT scan and biopsy diagnosis of sarcoidosis
- Patients with lung parenchymal disease and pulmonary stage II or more
- Recent lung function criteria
- FVC>50% predicted
- DLCO >40% predicted
Inclusion criteria for Healthy Volunteers
- Age between 40 to 85 years, age and sex to match the group with IPF
- Healthy subjects without any diseases that may cause inflammation
- Women of childbearing age should not be pregnant, planning to get pregnant or
breast-feeding.
- Currently non-smokers: see exclusion criteria
Exclusion Criteria:Exclusion Criteria for probable IPF and Sarcoidosis Patients
Respiratory Conditions other than IPF or sarcoidosis:
- Confirmed diagnosis of occupational lung disease
- Drug-induced lung disease or hypersensitivity pneumonitis
- Lung and systemic autoimmune disease including connective tissue disease. Patients
with an auto-immune profile considered diagnostic for a specific connective tissue
disease will be excluded, even in the absence of systemic symptoms. Non-specific rises
in auto antibodies e.g. rheumatoid factor; anti-nuclear antibody etc. will not be used
to exclude individuals from the study.
- Asbestosis or other asbestos related disease (pleural plaques, mesothelioma, asbestos
pleural effusions)
- Granulomatous lung disease.
- Pulmonary artery hypertension (PAH) requiring a specific treatment.
- Predominant chronic obstructive pulmonary disease (COPD) with forced expiratory volume
in 1 second /forced vital capacity (FEV1/FVC) <0.70.
- Patients with active tuberculosis or incompletely treated latent tuberculosis
infection
- Lung cancer
- Upper respiratory tract infections in the past 6 weeks.
Systemic Conditions
- History of vasculitis, autoimmune or connective tissue disease
- Known human immunodeficiency virus (HIV) or chronic viral hepatitis
- Clinically significant diseases (other than IPF or sarcoidosis) that may alter
respiratory biomarkers: including other respiratory, gastrointestinal, endocrine,
haematological, cardiovascular, genitourinary, skin or neurological diseases.
- Recent or ongoing malignant diseases.
- Significant nasal anatomical defects preventing nasal sampling: including hypertrophy
of turbinates, major septum deviation, nasal polyposis or recurrent sinusitis and
nasal mucosal defects
Bronchoscopy Contraindications
Any contra-indication to bronchoscopy as set out in British Thoracic Society guidelines
(34)
Smoking
A detailed smoking history will be taken from all participants: to include total pack
years, smoking in the past year, and smoking in the past 2 weeks.
The history will include cigarettes, pipe smoking, cigars, vaping, and shisha. Any form of
smoking is not permitted within 2 weeks of bronchoscopy.
5.4.2 Exclusion Criteria for Healthy Volunteers
- Current inflammatory/ immunological conditions. Any clinically significant diseases
that may alter respiratory biomarkers: including respiratory, gastrointestinal,
endocrine, haematological, cardiovascular, genitourinary, skin or neurological
diseases.
- Recent or ongoing malignant diseases.
- Significant nasal anatomical defects preventing nasal sampling: including hypertrophy
of turbinates, major septum deviation, nasal polyposis or recurrent sinusitis and
nasal mucosal defects
- Upper respiratory tract infections in the past 6 weeks.
- Cigarette smoking:
no cigarettes in the last 2 weeks not more than 10 cigarettes in the past year <10 year
lifetime pack history of smoking
-
No condition on gender to be admitted to the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | Development of Airway Absorption Sampling Methods | NCT04494334 | Entailment |
2,980 | 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:
1. Intelligence tests results of less than 40 (patients <3 years old using the Gesell
Developmental Scale for screening; patients of 3-6 years old using Little Wechsler
Intelligence Scale for screening; patients >6 years old using Old Wechsler
Intelligence Scale for screening).
2. Neurodevelopmental defects can be expressed as mental retardation, motor development
retardation, language delay, epilepsy, etc. May have or not have Multiple congenital
abnormalities, families with more than one affected patient will be enrolled priority
3. Families went through at least one of the high throughput technology(WES or CMA) and
receive the negative result
Exclusion Criteria:
1. Intellectual disability caused by pregnancy, perinatal infection, ischemia, and
hypoxia and other non-hereditary causes,
2. Obvious genetic metabolic diseases (such as different types of genetic metabolic
diseases, bone disease, fragile X syndrome, etc.);
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 | Whole Genome Sequencing in the Detection of Rare Undiagnosed Genetic Diseases in Children in China | NCT03424772 | Contradiction |
6,163 | 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:
- Age ≥ 18
- COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed).
- Tympanic Temperature of ≥37.5 AND at least one of the following: Cough, Sputum
production, nasal discharge, myalgia, headache or fatigue) on admission.
- Time of onset of the symptoms should be acute ( Days ≤ 10).
- SpO2 ≤ 93%
- Respiratory Rate ≥ 22
Exclusion Criteria:
- Refusal to participate expressed by patient or legally authorized representative if
they are present.
- Patients with prolonged QT or PR intervals, Second or Third Degree heart block and
Arrhythmias.
- Patients using drugs with potential interaction with Azithromycin or
Hydroxychloroquine.
- Pregnant or lactating women.
- History of alcohol or drug addiction in the past 5 years.
- Blood ALT/AST levels > 5 times the upper limit of normal on laboratory results.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Azithromycin in Hospitalized COVID-19 Patients | NCT04359316 | Contradiction |
1,110 | 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:
- Adult patients ≥18 years of age who underwent thoracotomy for septal myectomy.
Exclusion Criteria:
- Patients with severe liver and renal disease, severe central nervous system disease,
malignancy, defibrillators and age under 18 years old
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Risk Factors of Postoperative Complications in HCM Patients | NCT04275544 | Entailment |
3,649 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- the patients were registered in the ED from Jan, 2015 to Dec, 2015.
Exclusion Criteria:
- the patients were excluded because of left without seeing a physician.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Reducing Length of Stay in the Emergency Department | NCT03185533 | Entailment |
846 | 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:
- Osteoarthritis of the knee according to American College of Rheumatology criteria:
Knee pain with 3 of the following:
- age >50 years
- stiffness less than 30 min
- crepitus,
- bony tenderness,
- bony enlargement,
- no palpable warmth
- Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0
on an 11-point numerical rating scale for pain intensity (NRS-PI).
- All concurrent medications taken for any reason stable for 14 days
- Ability to follow protocol with reference to cognitive and situational factors (e.g.
stable housing, ability to attend visits)
- Ability to read and write English
- Willing and able to give informed consent
Exclusion Criteria:
- Currently using other topical agents for treatment of pain or inflammation
- Use of glucosamine, methysulfonylmethane or other regular anti-inflammatories within 2
weeks prior to completing baseline pain measure and during the trial
- Presence of significant medical disorder that would compromise the participant's
safety to take part in the trial (e.g. cancer, immunosuppressed)
- Pregnant and breastfeeding women.
- Type I or Type II diabetes and other endocrine disorders
- Use of exercise or transcutaneous electrical nerve stimulation prior to and during the
trial
- A history or present disease (i.e. inflammatory, infectious joint disease) which may
affect the outcome of the trial
- Currently taking NHPs for joint health
- Currently enrolled in other clinical trial involving a pharmaceutical 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.
Subject must be at most 80 Years | Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee | NCT03152578 | Entailment |
4,991 | 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:
- Aged 18 years or older
- Clinical diagnosis of idiopathic Parkinson's disease or essential tremor
- Able to provide informed consent
Exclusion Criteria:
- Significant medical or psychiatric illness
- Not capable of following the required clinical instructions
- Serious medical conditions that compromise safety
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Movement Disorder Quantification Algorithm Development | NCT01534650 | Entailment |
629 | 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:
- Symptomatic NYHA Class II-III heart failure >3 months
- Guideline-recommended heart failure treatment for > 3 months
- Hemoglobin >13 g/dl for men and >12 g/dl for women
- Functional iron deficiency (defined as serum ferritin level <100 ng/ml or between 100
and 299 ng/ml with transferrin saturation <20%)
- Left ventricular ejection fraction <40%, or left ventricular ejection fraction ≥40%
with left atrial enlargement (left atrial volume index >28 ml/m2) and/or left
ventricular hypertrophy (left ventricular mass index >95 g/m2 (women) or >115 g/m2
(men) determined by echocardiogram within last 24 months.
- Able and willing to provide written informed consent
Exclusion Criteria:
- Presence of implantable defibrillator, permanent pacemaker, other metal implant not
compatible with 3TMRS/MRI, or other contraindication to 3T MRS/MRI procedures
- Heart failure due to infiltrative cardiomyopathy, restrictive cardiomyopathy, or
hypertrophic cardiomyopathy
- Weight <50 kg or >120 kg
- Coronary or cerebral atherothrombotic events in the past 6 months
- Hospitalization of emergency room visit for heart failure within past 3 months
- ICD shock in last 3 months
- Known peripheral artery disease or ankle-brachial index <0.9 at screening visit
- Exercise primarily limited by angina, lung disease or neuromuscular disease
- Systolic blood pressure <100 or >160 mmHg
- Heart rate <50 or >110 min-1
- Estimated glomerular filtration rate <30 ml/min
- Liver function tests >3 times upper limit of normal
- Serum phosphate below normal limit
- Pregnant or breast-feeding women
- Women of child-bearing potential unwilling to use recommended contraception methods
during the study
- Treatment with oral iron supplements (except multivitamins) in past year
- Treatment with intravenous iron in past year
- Treatment with erythropoiesis stimulating agents in the past year
- Known intolerance of intravenous iron
- History of anaphylaxis
- Participation in another clinical trial within last 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.
Subject must be at most 75 Years | Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency | NCT03218384 | Contradiction |
647 | 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:
- Willing and able to give informed consent for participation in the study
- Men and women aged 18 years or older and generally in good health
- Detectable tricuspid regurgitation on echocardiography during both normoxia and
hypoxia enabling measurement of pulmonary arterial pressure
- For iron-deficient volunteers: ferritin ≤15microg/L and transferrin saturation <16%
- For iron-replete volunteers: ferritin ≥20microg/L and transferrin saturation ≥20%
Exclusion Criteria:
- Haemoglobin <8.0g/dl
- Haemoglobinopathy
- Iron overload defined as ferritin >300microg/L
- Hypoxia at rest or on walking (SaO2 <94%) or significant comorbidity that may affect
haematinics, pulmonary vascular or ventilatory responses, e.g. current infection, a
chronic inflammatory condition, known cardiovalvular lesion or pulmonary hypertension,
uncontrolled asthma or chronic obstructive pulmonary disease
- Exposure to high altitude (>2,500m) within the previous six weeks or air travel >4
hours within the previous week
- Iron supplementation or blood transfusion within the previous 6 weeks
- Pregnancy or breast feeding
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Iron Status and Hypoxic Pulmonary Vascular Responses | NCT01847352 | Contradiction |
2,805 | 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:
- At least 18 years of age
- Sporadic ALS diagnosed as definite, probable, or laboratory-supported probable as
defined by the revised El Escorial criteria
- Slow vital capacity (SVC) ≥60% of the predicted value at screening
- Onset of ALS symptoms within 72 weeks (18 months) prior to screening
- Total ALSFRS-R score of ≥30 at screening
- Have vaccination within 5 years against Streptococcus pneumoniae, Neisseria
meningitidis (types A, C, W, Y, and B), and Haemophilus influenzae (type B) or agree
to receive vaccination
Exclusion Criteria:
- Confirmed or suspected other causes of neuromuscular weakness
- Diagnosed with another neurodegenerative disease (examples include Parkinson's disease
and Huntington's disease)
- Significant pulmonary disorder not attributed to ALS (eg, chronic obstructive
pulmonary disease, pulmonary fibrosis, cystic fibrosis, pulmonary arterial
hypertension)
- If taking riluzole, participant must be on a stable dose for 30 days prior to the
start of the screening period. Use of riluzole is not required for participation.
- If taking edaravone, participant must be on a stable dose for 60 days prior to the
start of the screening period. Use of edaravone is not required for participation.
- Participation in any other investigational drug trial or exposure to other
investigational agent, device, or procedure within 30 days or within 5-half lives of
the treatment (whichever is longer) prior to the start of the screening period or
during study participation
- Use of any other complement inhibitor within 30 days or within 5-half lives of the
treatment (whichever is longer) prior to the start of the screening period or during
study participation
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.
| MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS) | NCT04579666 | Contradiction |
4,210 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Age 18-50 of both genders
2. Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
3. History of episodic wheezing, chest tightness, or shortness of breath consistent with
asthma, or physician diagnosed asthma.
4. Positive methacholine test. A positive test is defined as a provocative concentration
of methacholine of 10 mg/ml or less producing a 20% fall in Forced Expiratory Volume
in 1 second (FEV1) (PC20 methacholine) by the method used in a separate screening
protocol.
5. FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of
bronchodilating medications for 12 hours or long acting beta agonists for 24 hours),
consistent with lung function of persons with no more than mild episodic or mild
persistent asthma.
6. Allergic sensitization to at least one of the following allergen preparations: (House
Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1,
Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive
immediate skin test response.
7. Symptom Score (this will be submitted as an attachment) no greater than 16 (out of a
possible 24) for total symptom score with a value no greater than 3 for any one score.
No more than one score may be greater or equal than 3.
8. subjects must be willing to avoid caffeine for 12 hours prior to all visits.
Exclusion Criteria:
1. Any chronic medical condition considered by the PI as a contraindication to the
exposure study including significant cardiovascular disease, diabetes, chronic renal
disease, chronic thyroid disease, history of chronic infections/immunodeficiency,
history of tuberculosis
2. Physician directed emergency treatment for an asthma exacerbation within the preceding
12 months
3. Moderate or Severe asthma
4. Exacerbation of asthma more than 2x/week which would be characteristic of a person of
moderate or severe persistent asthma as outlined in the current NHLBI guidelines for
diagnosis and management of asthma.
5. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest
tightness) which would be characteristic of a person of moderate or severe persistent
asthma as outlined in the current National Heart, Lung and Blood Institute (NHLBI)
guidelines for diagnosis and management of asthma. (Not to include prophylactic use of
albuterol prior to exercise).
6. Viral upper respiratory tract infection within 2 weeks of challenge.
7. Any acute infection requiring antibiotics within 2 weeks of exposure or fever of
unknown origin within 2 weeks of challenge.
8. Severe asthma
9. Mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the participant's ability to comply with study
requirements.
10. Medications which may impact the results of the Clinical Center Reference Endotoxin
(CCRE) exposure, interfere with any other medications potentially used in the study
(to include steroids, beta antagonists, non-steroidal anti-inflammatory agents)
11. Any history of smoking in the year prior to study enrollment; lifetime smoking history
> 10 pack years
12. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a
clearly recognized viral induced asthma exacerbation) which would be characteristic of
a person of moderate or severe persistent asthma as outlined in the current NHLBI
guidelines for diagnosis and management of asthma
13. Allergy/sensitivity to study drugs, including E coli, or their formulations.
14. Known hypersensitivity to methacholine or to other parasympathomimetic agents
15. History of intubation for asthma
16. Unwillingness to use reliable contraception if sexually active (Intrauterine device,
birth control pills/patch, condoms).
17. Abnormal Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) values at
screening or during the treatment period. Normal values will be those published by the
clinical lab (Labcorp, INC).
18. Any bleeding disorder
19. Radiation exposure history will be collected. Subjects whose exposure history within
the past twelve months would cause them to exceed their annual limits will be
excluded.
20. Pregnancy
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 50 Years | Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled LPS | NCT02104505 | Contradiction |
3,033 | 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:
- Have completed all scheduled visits in protocol 22001 and have shown they can
adequately follow the protocol, with sufficient medical justification to continue on
open-label treatment with STX209, as assessed by the principal investigator
Exclusion Criteria:
- Subjects with a medical condition that might interfere with the conduct of the study,
confound interpretation of the study results, or endanger their own well-being.
- The occurrence or continuation of any adverse event or condition during study 22001
that, in the opinion of the Investigator, should exclude the subject from
participating in this open-label extension.
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.
Subject must be at most 40 Years | An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome | NCT01013480 | Entailment |
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