cyrilzakka/clinical-trials huggingface dataset:
Technology Assisted Treatment for Binge Eating Behavior

Binge-eating behavior is a central feature of eating disorders (e.g., binge-eating disorder, bulimia nervosa, anorexia nervosa-binge-eating/purging subtype) and is associated with higher rates of psychopathology, psychosocial impairment, medical comorbidity, and more severe obesity, all of which pose significant public health problems. Passive detection of binge eating episodes combined with a context-based reminder intervention could assist a patient in resuming healthy eating patterns. This study will test a smartwatch app that identifies binge eating behavior and provides CBT strategies to the patient after the episode.


Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥18 years of age
2. EDE diagnosis of bulimia nervosa or binge eating disorder, with binge-eating episodes occurring at least 2x/week

Exclusion Criteria:

1. Pregnancy or lactation
2. Acute medical or psychiatric risk
3. Psychosis or bipolar disorder (lifetime history)
4. Current substance use disorder within the past six months
5. BMI less than 18.5 kg/m2
6. Acute suicidality requiring hospitalization
7. Food allergies
8. Receiving current psychotherapy
9. On psychotropic medications that have not been on a stable dose for at least six weeks
Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited. Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles) were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S): Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.

MAIN OUTCOME MEASURE(S): Occurrence of ovulation, endometrial thickness and pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* Females with anovulatory infertility 20-38 years of age.
* Diagnosis of anovulatory infertility as established by standard criteria.
* Normal Pelvic USG and bilateral tubal patency
* Willingness and giving written Informed Consent.

Exclusion Criteria:

* Uterine and adnexal pathology e.g. leiomyomata
* Ovarian cyst
* Hyperprolactinaemia
* Hyperthyroidism or Hypothyroidism\*
* FSH \>9mIU/ml (during early follicular phase).\* (As per Chemoluminescence method)
* Previous surgery related to genital tract as per history
* Appendicitis, peritonitis, genital tuberculosis as per history and/or having an abnormal pelvic anatomy
* Impaired hepatic /renal function
* Diabetes mellitus/Random blood sugar- \> 140mg/dl
* Drugs likely to interfere with ovulation
* Alcohol intake as per history
* History of hypersensitivity to the study drug or to its excipients
* Planned travel outside the study area for a substantial portion (\>5 days) of the study period by potential participants
* Lack of willingness to give informed written consent
* Participation in any clinical study within the preceding 1 month
Defocus-Enhanced vs. Single Vision Spectacles in Myopia Control Visual Function Training

The purpose of this study is to compare the effectiveness of vision function training using defocus-enhanced spectacles (DIMS) versus single vision spectacles combined with vision function training in controlling myopia progression in children aged 6-18 years.


Eligibility Criteria:
Inclusion Criteria:

* Aged 6-18 years.
* Diagnosed myopia with SER between -0.50D and -4.00D.
* Astigmatism ≤ 2.50DC.
* Anisometropia \< 1.25D.

Exclusion Criteria:

* Suspected genetic syndromes (e.g., Stickler, Marfan).
* Other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus).
* Myopia progression \<0.50D SER in the last year.
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study

In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).

The China extension study will include participants previously enrolled in China in the global study for MK-3475-966 (NCT04003636) plus those enrolled during the China extension enrollment period. A total of approximately 158 Chinese participants will be enrolled.

Eligibility Criteria:
Inclusion Criteria

* Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
* Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
* Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
* Has a life expectancy of greater than 3 months
* Has adequate organ function

Exclusion Criteria

* Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)
* Has ampullary cancer
* Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms
* Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
* Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator
* Has had an allogenic tissue/solid organ transplant
Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19

Ivermectin which is an FDA-approved broad spectrum anti-parasitic agent, has also anti-viral activity. In vitro study have shown its activity against SARS-CoV-2, however its clinical effect on patients with COVID-19 never been tested.

In this RCT we would like to evaluate the effect of Ivermectin on reduction of viral shedding among mild to moderate COVID-19 patients, and in shortening the symptom resolution time.


Eligibility Criteria:
Inclusion Criteria:

Participants eligible for inclusion will include non-pregnant adult (\>18 years old) with molecular confirmation of COVID-19. \[Participants will be eligible in a period of no longer than 72 hours after exposure\].

Exclusion Criteria:

* Severe infection ( defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support).
* Weight below 40Kg or above 100Kg
* Unable to take oral medication
* Known allergy to the drugs
* Pregnancy or breast feeding
* Participating in another RCT for treatment of COVID-19.
Effect of Semiconductor Embedded Therapeutic Gloves for Hand Osteoarthritis

The goal of this study is to evaluate change in symptoms using semiconductor embedded gloves for hand osteoarthritis.

The semiconductor embedded fabric emits mid-level and far infrared waves and negative ions to the tissue which can increase circulation of both blood and lymph, plus facilitates the anti-inflammatory nitric oxide cascade by accelerating the binding of Calcium to Calmodulin. Nitric oxide down-regulates interleukin1 beta and inducible nitric oxide synthase in certain cell types, which leads to reduced cyclooxygenase-2 and prostaglandins-molecules responsible for causing inflammation and pain. Unlike other systemic COX-2 inhibitors such as nonsteroidal anti-inflammatory drugs (NSAIDs), targeted infrared and negative ion therapy stimulate localized reaction pathways, thereby reducing pain and inflammation. This study seeks to identify patient reported subjective and clinically measured objective outcomes for hand osteoarthritis pain management and hand function with application of semiconductor embedded fabric in the affected area.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with erosive hand OA, non-erosive hand OA, or first carpometacarpal joint OA with a Kellgren- Lawrence grade \>1 as determined by radiographic assessments and the American College of Rheumatology (ACR) classification
2. Patients age 40-75
3. Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
4. Patients who are willing and able to sign corresponding research subject consent form.

Exclusion Criteria:

1. Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
2. Patient has had prior surgical treatment of the hands in the last 5 years or injection treatment in the last 6 months
3. Patient has secondary OA including causes such as gout, rheumatoid arthritis, psoriatic arthritis
4. Patient has used topical creams or gels for arthritic pain including nonsteroidal anti-inflammatory drugs, capsaicin, lidocaine, or counterirritants in the last 1 week
5. Patient has a history of carpal tunnel syndrome, cubital tunnel syndrome, or radial tunnel syndrome
6. Patient has a history of peripheral neuropathy
7. Patient has chronic pain conditions unrelated to hand condition
8. Patient has auto-immune or auto-inflammatory diseases
9. Patient has used tobacco within the last 90 days
10. Patient is not within the ages of 40-75
11. Patient has an active infection (local or systemic)
12. Patient is unwilling or unable to sign the corresponding research subject consent form
13. Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.

    -

    Exclusion Criteria:

    -
Registry Of Acute meDical Emergencies in Brazil

Critical patients in emergency room are seriously situations that need quickly diagnosis and treatment. Different predictors of prognosis can be related with mortality and morbidity in-hospital and in long-term. In Brazil, this kind of registry is not available. The aim of the study is analysis and report data about critical patients in Emergency Departments over all country, showing demographic, clinical and prognosis data about that in Brazil.

This will be a prospective and multicentric data-bank registry. Initially, all patients with acute coronary syndromes (ACS), acute decompensated heart failure (ADHF), warfarin intoxication, acute pulmonary edema, acute aortic dissection, chest pain, pulmonary embolism and syncope will be included. There will be not exclusion criteria. The inclusion criteria will be followed by definition of each illness described in recent guidelines. Investigators estimated annually over than 500 cases with ACS/chest pain, 300 cases of ADHF, 200 cases of aortic dissection, 200 of pulmonary embolism, 200 cases of warfarin intoxication, 100 cases of syncope and 150 of acute pulmonary edema. Clinical data, electrocardiographic and echocardiographic findings, laboratory results and prognosis will be related. Routine of treatment will be defined by each center. The analysis includes minimum, medium and maximum values. Variables will be adjusted according with each diagnosis and all data will be included using the REDCap digital data entry. Probabilities will be determined by logistic regression and will be considered significate when p \< 0.005. Prospectively, investigators will use the Cox model to calculate associations.

Eligibility Criteria:
Inclusion Criteria:

* all patients with:
* acute coronary syndromes (ACS) or,
* acute decompensated heart failure (ADHF) or,
* warfarin intoxication or,
* acute pulmonary edema or,
* acute aortic dissection or,
* chest pain or,
* pulmonary embolism or
* syncope.

Exclusion Criteria:

-There will be not exclusion criteria.
A Study to Assess the Potential for Pre-systemic Inhibition of CYP3A by Idebenone Using Midazolam as a Substrate

This phase I open label study is conducted to assess the potential pharmacokinetic interaction of Raxone® with midazolam in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male aged 18 to 55 years.
2. A Body Mass Index (BMI) of 18-30. BMI = Body weight (kg) / Height (m)2.
3. Male subject willing to use an acceptable effective contraceptive measure for the entire duration of study participation.
4. No clinically significant abnormal serum biochemistry, haematology and urine examination values.
5. A negative urinary test for drugs of abuse and alcohol breath screen. A positive alcohol test may be repeated at the discretion of the Investigator.
6. Negative HIV and Hepatitis B and C results.
7. No clinically significant abnormalities in 12 lead electrocardiogram (ECG).
8. No clinically significant abnormalities in blood pressure, pulse or oral temperature.
9. No allergy or sensitivity to midazolam, idebenone or any of their excipients.
10. No current or past medical condition that might significantly affect the pharmacokinetic or pharmacodynamic response to midazolam.
11. Subject must be available to complete the study (including follow-up visit).
12. Subject must satisfy a medical examiner about their fitness to participate in the study.
13. Subject must provide written informed consent to participate in the study.
14. Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.

Exclusion Criteria:

1. A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
2. Use of any medication (prescription or OTC, including health supplements and herbal remedies, except paracetamol, within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of trial medication.
3. Use of any medication known to induce or inhibit any of the enzymes within the CYP3A system within 28 days of Day 1, or grapefruit within 7 days of Day 1
4. Evidence of renal, hepatic dysfunction, cardiovascular or metabolic dysfunction.
5. History of obstructive sleep apnoea syndrome.
6. History of any significant drug allergy including benzodiazepine.
7. A clinically significant history of drug or alcohol abuse.
8. Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
9. Participation in a clinical trial of a New Chemical Entity within the previous 3 months or of a Marketed Product within the previous 30 days (or 5 times the half-life, whichever is longer).
10. Donation of 450 mL or more blood within the previous 3 months.
11. Smoking or use of tobacco products or substitutes within the previous 6 months, as determined at the Screening visit.
12. Need for administrative or legal supervision.
13. Subject who would receive more than 4500 euros as indemnities for participation in biomedical research within 12 months, including the indemnities for the present study.
Effectiveness of a Low Carbohydrate Diet Versus a High Carbohydrate Diet in Promoting Weight Loss and Improved Health

This study will examine the effects of a low carbohydrate diet versus a high carbohydrate diet on weight loss.

The number of overweight and obese Americans has increased significantly in recent years. There are now many different diet plans being promoted by doctors and the media. The Atkins diet, a low carbohydrate nutritional plan, is especially popular; its advocates claim that following the diet will result in long-term weight loss with no negative effects. Another diet, called the Dietary Approaches to Stop Hypertension (DASH) diet, is a high carbohydrate diet designed to help treat and prevent high blood pressure. However, more thorough investigation of these claims is needed. This study will compare the short- and long-term effects of the Atkins diet to the (DASH) diet. This trial will enroll overweight and obese participants.

This study will last 30 months and will comprise two phases. Participants will be randomly assigned to either the Atkins or DASH diet for 30 months. During Phase 1, all participants will undergo 6 months of weekly group therapy to encourage weight loss. Phase 2 is a weight loss maintenance phase. During Phase 2, participants will have monthly meetings with a therapist for weight loss support. Study visits will occur at study entry and at Months 3 and 30. At each study visit, weight measurements, blood and urine collection, and x-rays will occur to determine participants' weight loss, cardiovascular health, kidney function, and bone density.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 27 to 50
* Fasting glucose less than 126 mg/dl
* Total fasting cholesterol less than 260 mg/dl
* Total fasting triglycerides less than 400 mg/dl
* Permission of primary care provider to participate in the study
* Normal liver and kidney function
* Willing to modify diet and other health behaviors
* Willing to use an acceptable method of contraception for the duration of the study

Exclusion Criteria:

* Any medical condition that may make weight loss medically inadvisable
* Weigh more than 400 lbs
* History of kidney failure
* Current use of more than 3 blood pressure medications
* Change in blood pressure medications within 3 months prior to study entry
* Diagnosis of cardiovascular disease within 6 months prior to study entry
* Cancer diagnosis within 2 years of study entry. Participants with basal cell skin cancer are not excluded.
* History of psychiatric hospitalization within 2 years prior to study entry
* Consumption of more than three alcoholic drinks a day
* Type I or II diabetes
* Current use of hypolipidemics, antipsychotics, hypoglycemics, glucocorticoids, or thyroid medication
* Plan to move during study
* Current participation in another clinical trial
* Pregnancy or breastfeeding
Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis

The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.


Eligibility Criteria:
Inclusion Criteria:

* Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal.
* Aged 18 to 80 years inclusive at screening (Visit 1)
* Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram
* Be sputum producers with a history of chronic expectoration on most days of most weeks of the year. Patients should have a history of spontaneously producing sputum on a daily basis and should be able to provide at least 2 of the 3 required baseline sputum samples with an average of 3 mL or more.
* Be on a stable treatment regimen, as judged by the investigator.

Exclusion Criteria:

* Any clinically significant disease or disorder
* Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2
* An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2
* An FEV1 of \<30% of predicted normal at Visit 1
* Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2)
* Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis
* Bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate
Total Shoulder Arthroplasty Multi-Center Registry

The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.

The study is a non-randomized multi-center prospective registry and subjects will be treated according to standard of care at each center. Subjects will be approached for participation in this study after they have made the decision to undergo a primary or revision shoulder arthroplasty procedure. The treating surgeon will obtain verbal consent from the patient for a research coordinator to screen for eligibility. Patients who meet all criteria will be offered enrollment into the study. The total enrollment goal is a minimum of 500 anatomic shoulder arthroplasty and 500 reverse shoulder arthroplasty subjects enrolled in the multi-center registry.

Eligibility Criteria:
Inclusion Criteria:

1. Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
2. Patient is between the ages of 18 and 100 years.
3. The patient has a planned primary or revision implantation of an anatomic (hemi-arthroplasty or total arthroplasty) or a reverse shoulder prosthesis system manufactured by Arthrex.
4. Patient has a standard of care preoperative CT taken within 6 months that has been submitted for Arthrex VIP (Virtual Implant Positioning) planning.

Exclusion Criteria

1. Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.
Magnitude of Osteoarthritis disadVantage on pEoples liveS

Estimate the prevalence of self-reported osteoarthritis and its characterization in adults over 45 years of age:

* Characterization of self-reported patients with OA (socio-demographic, comorbidities, VAS for intensity of pain)
* Characterization of OA diagnosis in patients with self-reported OA
* Impact of self-reported OA in the working abilities, quality of life and functionality (SF-12 v2.0)
* Characterization of treatment approaches (therapeutic and non-therapeutic) for self-reported patients with OA
* Patient perception of impact of OA in its life and importance given to disease

Magnitude of Osteoarthritis disadvantage on peoples lives.

Eligibility Criteria:
Inclusion Criteria:

- Adults over 45 years old with self-reported osteoarthritis

Exclusion Criteria:

- NA