cyrilzakka/clinical-trials huggingface dataset:
Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis

This is a multicenter, randomized, double-blind, incomplete block, three period fixed sequence crossover, multicenter, placebo-controlled study. The study will assess three oral doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in subjects with diabetic or idiopathic gastroparesis.

Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic gastroparesis by assessing changes in gastric emptying.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of gastroparesis (e.g., nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening
* Body Mass Index (BMI) between 18 and 35 kg/m2, inclusive
* Gastroparesis Cardinal Symptom Index (GCSI-2W) composite score ≥2 and ≤4 at Screening
* Delayed gastric emptying, defined as a gastric emptying half-time (GE t1/2) \> 160 minutes as determined by \[13C\]-octanoate breath test, at Screening
* Upper gastrointestinal (UGI) obstruction ruled out by endoscopy or other imaging reasonably proximal to the diagnosis of gastroparesis

Exclusion Criteria:

* Acute severe gastroenteritis within 2 weeks prior to Screening
* History of gastric outlet obstruction
* Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication
* Recurrent vomiting, defined as vomiting more than 2 days per week
* Hospitalization for treatment of gastroparesis or complications of diabetes within 4 weeks prior to Screening
* Presence of thyroid dysfunction not controlled by treatment. Subjects with abnormal thyroid stimulating hormone (TSH), hypothyroidism, or hyperthyroidism at Screening
* If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level \>10% or a glucose \> 250 mg/dL at Screening
CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.

While HIV prevalence among MSM in India is 10-15 times higher than in the general population (4.3% vs 0.3%), current interventions for Indian MSM have limited reach. In order to reduce the burden of HIV in MSM, innovative, far-reaching prevention and treatment strategies are needed. Guided by the increase access to internet-based social and mobile technologies (SMT) (e.g. SMS, WhatsApp, dating apps) globally and in India, this is a 3-arm parallel, pragmatic randomized controlled trial of community-developed, theory based behavioral intervention (CHALO! 2.0) delivered via WhatsApp (secure SMS application) compared to an Attention-Matched Control, or a Digital Coupon for free HIV testing only control conditions. The primary outcomes are HIV-testing at 6 months (3 months after the end of the intervention) and linkage-to-preventive care (counseling or pre-exposure prophylaxis) at 12 months. The secondary outcomes are the frequency of HIV-testing by 18 months.


Eligibility Criteria:
Inclusion Criteria:

* live or work in Mumbai or Thane
* fluent in Hindi or English
* have had anal sex with men in the past one year
* report that they have either never been tested for HIV, are unaware of HIV test results, or are HIV-negative with last HIV test at any time, and have engaged in anal sex since last HIV test
* able to provide and verify a WhatsApp mobile number and email address
* willing to answer online surveys for 18 months

Exclusion Criteria:

* participating in a concurrent HIV-related study
* intention to move out of the Mumbai metropolitan area in the next six months
A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring

This observational study aims to assess pregnancy and infant outcomes among pregnant women with psoriasis who have been exposed to deucravacitinib treatment in the USA.


Eligibility Criteria:
Inclusion Criteria:

* Maternal age 15 through 50 years at date of conception
* Start of pregnancy, defined as the estimated date of conception, during the accrual period (09-Sep-2022 through 31-Oct-2026)
* Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated date of conception
* Presence of psoriasis from 12 months prior to the date of conception through the end of pregnancy

Exclusion Criteria:

• Exposure to any known teratogens from 5 half-lives prior to the estimated date of conception through the end of the relevant exposure window
Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks

The study was conducted at 15 centers (2 of which did not enroll any patients). A total of 79 hemodialysis patients were assigned randomly to one of two treatment sequences.

Eligibility Criteria:
Inclusion Criteria:

* patient had received hemodialysis three times per week for 3 months or longer;
* patients were maintained on sevelamer hydrochloride as their primary phosphate binder with a total daily dose of ≤ 13.6 g with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL, the most recent iPTH ≤ 600 pg/mL and the most recent serum calcium within the normal range.

Exclusion Criteria:

* if patient had active bowel obstruction, dysphagia, swallowing disorders, or severe gastrointestinal motility disorders;
* active ethanol or drug abuse (excluding tobacco);
* need for antidysrhythmic or antiseizure medications used to control these conditions;
* poorly controlled diabetes mellitus or hypertension;
* active vasculitis;
* active malignancy other than basal-cell carcinoma;
* HIV infection; or
* any clinically significant unstable medical condition as judge by the Investigator.
Evaluation of the Safety and Efficacy of Albumin-bound Docetaxel

This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of albumin-bound formulation of docetaxel for intravenous infusion in patients with advanced solid tumors.

This study was conducted in two stages. The first stage (Stage I) is a dose-escalation study. A classic 3+3 design will be used to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Patients with advanced solid tumors will be assigned to receive sequentially higher doses of albumin-bound formulation of docetaxel once every three weeks (a Cycle) by intravenous infusion, starting at a dose of 50mg/m2. Patients will receive the albumin-bound formulation of docetaxel

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18, ≤75 years, no gender limitation；
2. Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven to be ineffective, intolerable or unacceptable for the patient；
3. At least one measurable lesion as per RECIST version 1.1；
4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1；
5. Life expectancy ≥3 months；
6. Adequate bone marrow, cardiac, liver and renal function；

Exclusion Criteria:

1. Chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks of the first dose of the study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indications；
2. Currently enrolled in any other clinical study, or administration of other investigational agents w
Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial

The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF).

PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of catheter ablation for persistent AF is not established despite attempts of numerous left atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies for persistent AF, because PW originated from common tissue of PV and is considered to play a part in AF trigger and maintenance. However, this strategy is also not established in the recent international consensus statement. Following two reasons are considered. One is the procedural difficulty in creating durable PWI, and another is the existence of patients who can recover by only PVI. The latest technology, ablation index, can create durable PVI, and may create durable PWI. Several reports suggested that PVI only strategy was sufficient in the patients with persistent AF who could maintain sinus rhythm after pharmacological or electrical cardioversion. Therefore, we planed this randomized clinical trial that compared between PVI alone and additional PWI on PVI using ablation index in the patients with persistent AF without pharmacological sinus rhythm conversion.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for first catheter ablation of persistent atrial fibrillation
* Patients without conversion to sinus rhythm within 30 days after antiarrhythmic drug administration
* Patients with persisting duration of atrial fibrillation less than 3 years
* Patients with left atrial diameter less than 50mm
* Patients who can be followed up for 18 months
* Patients with written informed consent

Exclusion Criteria:

* Patients who can not be received adequate anticoagulation therapy
* Patients with history of myocardial infarction within 6 months
* Patients with history of open heart surgery
* Patients scheduled for open heart surgery
* Patients with severe valvular heart disease
* Patients during pregnancy
* Patients with expected life expectancy less than 1 year due to malignancy or non-cardiovascular disease
* Patients considered unsuitable for study by the attending physician
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis

The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.


Eligibility Criteria:
Inclusion Criteria:

1. At Visit 1 (start of the observation period), the participant must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 30% (120 participants) or more of the total participants.
2. Outpatient (including inpatient for examination)

Exclusion Criteria:

1. Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
2. Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis \[excluding Schatzki's ring\], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
3. Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit 1 (start of the observation period). However, participants with gastric or duodenal erosions are allowed to be included.
4. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309

This study is a Phase I, open label study to determine the Maximum Tolerated Dose(MTD) and the Recommended Phase II Dose (RP2D) in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced solid tumor for which no therapy of proven efficacy is available.
* Age ≥ 18
* Evidence of tumor progression with measurable or evaluable disease.
* Use of adequate contraceptive measures for male patients.
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
* Signed informed consent.

Exclusion Criteria:

* Concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors)
* Patients with a history of myocardial infarction or coronary artery bypass within the last 3 years.
* Patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure NYHA Class 3 or 4, hypertension BP\>150/100mmHg.
* Pre-diagnosed diabetes mellitus.
* Fasting glucose \> 7.0 mmol/L or HbA1c \> 6%.
A Study of LUCAR-20SP in Subjects with Relapsed/refractory B-cell Non-Hodgkin Lymphoma

This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.

This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LUCAR-20SP, an allogenic CAR-T cell therapy in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Patients who meet the eligibility criteria will receive LUCAR-20SP infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily participate in clinical research;
* Age ≥18 years old;
* Eastern Cooperative Oncology Group (ECOG) score 0-1;
* Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, histologically indolent lymphoma to diffuse large B-cell lymphoma; CD20 positive;
* At least one measurable tumor lesion according to the Lugano 2014.
* Expected survival ≥3 months;
* Clinical laboratory values in the screening period meet criteria.
* Effective contraception.

Exclusion Criteria:

* Prior antitumor therapy with insufficient washout period.
* Previous treatment with allogeneic cell and gene therapy (such as CAR-T); Except subjects with evidence that previous allogeneic cell and gene therapy products (such as CAR-positive T cells and CAR transgenes) in the subject have been below the lower limit of detection;
* Previously received allogeneic hematopoietic stem cell transplantation;
* Previously received gene therapy;
* Donor specific antibody (DSA) positive subjects will be excluded;
* Severe underlying diseases;
* Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive;
* Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
Candesartan Versus Propranolol for Migraine Prevention

The main aim of the present study is to compare candesartan with propranolol for migraine prophylaxis.

Candesartan was shown to be effective for migraine prophylaxis in a randomized double blind cross-over study published in 2003. The drug is now widely used for this purpose in many countries, although no confirmatory study has been published. The aims of the present study are: 1) to see if the results in the first candesartan study can be replicated in a new patient population, including patients with chronic migraine, and, 2) to perform a head-to-head comparison of candesartan 16 mg/day with standard treatment with propranolol 160 mg slow release. We also intend to study whether responsiveness to these drugs may be related to heart rate variability and baroreceptor sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65 years
* retrospectively have ≥ 2 migraine attacks per month during the last 3 months
* during the baseline period have ≥ 2 migraine attacks
* debut of migraine at least one year prior to inclusion
* start of migraine before age 50 years.

Exclusion Criteria:

* interval headache not distinguishable from migraine
* chronic tension-type headache or other headache occurring on ≥ 15 days/month
* pregnancy, nursing or inability to use contraceptives
* heart conduction block on ECG or significant ECG abnormality on inclusion
* heart rate \< 54 after 3 minutes rest
* previous or present asthma, diabetes; decreased hepatic or renal function
* hypersensitivity to active substance
* history of angioneurotic edema
* significant psychiatric illness
* use of daily migraine prophylactics less than 4 weeks prior to start of study
* having tried ≥ 3 prophylactic drugs against migraine during the last 10 years
* previous use of propranolol or candesartan in adequate doses
* previous discontinuation of either Atacand or Inderal Retard (or another beta blocker) due to side effects
* current use of antihypertensive medication
* require use of rizatriptan (Maxalt) 10 mg tabl.
* subjects requiring detoxification from acute medication (ergotamines, opioids)
* patients who consistently fail to respond to any acute migraine medication
* patients with alcohol or illicit drug dependence
Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation

A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to \< 18 years diagnosed with functional constipation.

To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.

Eligibility Criteria:
Inclusion Criteria:

* Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
* At least 6 years of age but less than 18 years of age at the time of randomisation
* Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if participant is taking antidepressants

Exclusion Criteria:

* Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation
* Untreated faecal impaction at the time of screening
* Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication
Antibody Response to COVID-19 Vaccines in Liver Disease Patients

Currently the Pfizer-Biontech (mRNA), Sinovac (inactivated virus) and Astrazeneca-Oxford (adenovirus-vector) COVID-19 vaccines are available for vaccination in HK. The American Association of Liver Disease has recently published consensus statements for COVID-19 vaccination in subjects with chronic liver disease (CLD). Patients with CLD have dysregulated innate and adaptive immune response that may be associated with vaccine hypo-responsiveness and there are no data as to whether these patients may respond differently to the various vaccines. The Humanity and Health Medical Center (HHMC) is an active participant of the HK government COVID-19 vaccination programs and patients with CLD follow-up at HHMC will have access to the three different vaccines. The aim of this prospective study is to compare the antibody response of CLD subjects to the Pfizer-Biontech (mRNA), Sinovac (inactivated virus) and Astrazeneca-Oxford (adenovirus-vector) COVID-19 vaccines.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with chronic liver disease (CLD) at the Humanity and Health Medical Group and eligible for the HK government vaccination programme;
2. Able to understand and sign informed consent.;
3. Underlying CLD- defined as patients with chronic hepatitis B or C infections, liver cirrhosis, metabolic associated liver disease, hepatocellular carcinoma, alcoholic liver disease, autoimmune hepatitis, hemochrombtosis.

Exclusion Criteria:

1. Patients contraindicated for the COVID -19 Vaccination Program due to uncontrolled co-morbitities;
2. Past allergies to other vaccines;
3. Pregnant subjects.
Evaluation of Retention for Hydrophilic and Hydrophobic Sealants in Uncooperative Children

To evaluate and compare the retention and cariostatic effect of hydrophilic and hydrophobic resin-based sealants for sealing pits and fissures of permanent molars in uncooperative children.


Eligibility Criteria:
Inclusion Criteria:

1. Children with good health and without any systematic diseases history which may interfere with their oral hygiene.
2. Children ranging in age from 6 to 9 years.
3. Children with bilateral fully erupted mandibular first permanent molars with deep fissures having a score of 0 following the International Caries Detection and Assessment System II (ICDAS II).
4. Uncooperative children with "definitely negative" or "negative" behavioral ratings according to the Frankl behavior classification scale.
5. Informed consent to the child's participation in the study signed by one of his/her parents/guardian.
6. No children will be excluded on the basis of gender, race, social or economic status

Exclusion Criteria:

1. Children with systemic diseases.
2. Children with oral habits affecting occlusion.
3. Children with any physical or mental disorders.
4. Children with cavitated, defected, missed or restored contralateral tooth.
5. Children with history of allergy to resin or latex.
6. Teeth with restorations, cavitated lesion, hypoplasia and any developmental defects.
7. Not approving to sign the consent.
Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based supporting tool for improving the diagnosis and management of ST-elevation myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Patients in emergency department or inpatient department.
* Patients recieved at least 1 ECG examination.

Exclusion Criteria:

* The patients recieved ECG at the period of inactive AI-ECG system.