cyrilzakka/clinical-trials huggingface dataset:
Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena

MCE first algorithm is not inferior to standard of care algorithm in terms of further bleeding in hemodynamically stable patients with acute overt and non-hematochezia GI bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Presenting to the outpatient department or emergency department with melena (without hematemesis) within the previous 48 hours
* Hemodynamically stable (blood pressure \> 100/60 mmHg and heart rate \< 100 bpm) at presentation
* No endoscopy performed after the new onset of melena

Exclusion Criteria:

* Presenting with hematochezia and/or hematemesis within the previous 48 hours of presentation
* Hemodynamically stable after initial volume resuscitation
* Drop of hemoglobin level ≥ 2 g/dL/day, and/or need of transfusion ≥ 2 units of packed red blood cells per day
* Contraindications of CE (e.g. dysphagia, Zenker's diverticulum, esophageal stricture, known or suspected gastric or small bowel obstruction or perforation, gastroparesis, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or post-abdominal radiation, etc.)
* Presence of internal cardiac defibrillator (ICD), pacemaker and/or other implanted electronic devices (cochlea, drug infusion pump, nerve stimulator, etc.) or magnetic metal foreign bodies; possibility of requiring an MRI examination prior to capsule excretion
* Patients who cannot undergo surgery in the event of capsule retention
* Pregnant and/or lactating women
* Patients with altered mental status (such as hepatic encephalopathy)
* Patients moribund from terminal malignant diseases or other end-stage illnesses with a limited life expectancy
* Unable to consent
Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)

The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female outpatients between 7-17 years of age
* Primary diagnosis of Major Depressive Disorder (MDD)
* Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
* Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion Criteria:

* Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.
* History of suicidal behavior, or requires precaution against suicide
* Not generally healthy medical condition
* Seizure disorder
Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization

The purpose of this randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery.

Patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. After surgery patients will be randomized to either weight bearing as tolerated at two weeks with a cam boot or non-weight bearing with a cam boot. Randomization will be performed by number allocation with odd numbers in the early weight bearing group and even numbers in the non-weight bearing group. The surgeon will be blinded to this until after the surgery. The patients will all be placed in a short leg cast post operative and made non-weight bearing for 2 weeks until sutures are removed which is current standard treatment. Both groups will be asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is non weight bearing in a cam boot, the latter being standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Operative unstable ankle fractures

Exclusion Criteria:

* Requirement of syndesmotic fixation
* Pilon fractures
* Open fractures
* Patients with diabetic neuropathy
* BMI\>40
* Polytrauma patients
* Patients who are unable to comply with non-weight bearing
* Patients who are unable to follow up
Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)

This is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. The patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or Kirschner wires.

The aim of this pilot study is to allow a sample size calculation for a main randomized controlled trial (RCT). The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a pilot study it is intended to generate a study hypothesis for the main RCT.


Eligibility Criteria:
Inclusion Criteria:

* Isolated, extraarticular, unstable Colles' fracture of the metaphysis of the distal radius (AO type A3)
* Age 65 years or older
* Patient agreed with and signed the "informed consent" form

Exclusion Criteria:

* Fractures older than 7 days (more than 1 week between injury and treatment)
* Other injuries of the hand
* Other relevant injuries of the upper extremities
* Open fracture
* Patients with one hand missing
* Clinical or radiological signs of any rheumatoid disease, osteoarthritis, or polyarthritis
* Previous skeletal injury or severe soft tissue injury of the arm
* History of drug or alcohol abuse
* Patients unlikely to cooperate or attend all scheduled visits
* Patients who have participated in any other device or drug clinical trial within the previous month
* Patients with legal incompetence
Hydrogen Sulfide and Pulmonary Vascular Remodeling on HRCT in Patients With COPD

HRCT was used to evaluate pulmonary vascular remodeling in COPD. The role of H2S in pulmonary vascular remodeling in COPD was analyzed, in order to provide a basis for seeking new therapeutic targets.

This study aimed to investigate the relationship between endogenous H2S and pulmonary vascular remodeling on HRCT in patients with COPD through the determination of H2S and its synthase mRNA levels in blood and pulmonary vessels by HRCT, to evaluate the role of H2S in pulmonary vascular remodeling in COPD and to provide a basis for seeking new therapeutic targets. This study had predictive value for clinical prognosis of patients. It had important clinical guiding significance and social and economic benefit to comprehensively understand the pathogenesis of COPD.

Eligibility Criteria:
Inclusion Criteria:

* Patients meet the GOLD 2016 guidelines for diagnostic criteria of COPD: dyspnea, chronic cough and/or sputum symptoms, exposure to risk factors, and pulmonary function after inhalation of bronchodilator with forced expiratory volume (FEV1)/forced vital capacity (FVC) \< 70%.

Exclusion Criteria:

- 1. Other lung diseases such as pneumonia, lung cancer, tuberculosis, pulmonary embolism, heart diseases such as heart failure, ventricular septal defect, patent ductus arteriosus, thoracic deformity and pleural diseases.

2. Patients who are unable to understand and/or complete questionnaire.
Computerized Screening and Brief Physician Advice to Reduce Teen Drinking

The goal of this project is to adapt a computerized Screening and Brief Advice (SBA) protocol that has demonstrated efficacy in reducing underage drinking among adolescent primary care patients and then to test it in a multi-site randomized controlled trial (RCT).

The specific aims of the proposed multisite RCT are:

1. To establish the efficacy of the computerized SBA protocol on alcohol use, on DWI/RWID, and other alcohol-related health risk behaviors;
2. To test the effect of Technological Extenders (TE) on prolonging the beneficial effects of the SBA protocol;
3. To identify moderators, mediators, and optimal responders to the SBA/TE interventions;
4. To examine the association between cessation of underage drinking and other health-risk behaviors in an adolescent primary care sample.

Eligibility Criteria:
Inclusion Criteria:

* 12-21 years old
* patients arriving for routine medical care
* provide informed assent (for those \<18) or informed consent (for those 18-21)

Exclusion Criteria:

* medically or psychologically unstable at time of visit
* receiving behavioral health services
* cannot read or understand English at a 6th grade reading level
* unavailable for follow-up assessments
Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy

The study hypothesis is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve 3-year overall survival in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma.

It is planned to include 36 patients with locally advanced intrahepatic cholangiocarcinoma, not eligible for initial surgery and without metastases. Participants will be recruited from care facilities in France.

The hypothesis of the study is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve the overall 3-year survival of patients with locally advanced intrahepatic cholangiocarcinoma (unresectable but not metastatic).

All patients over 18 and under 65 years of age with histologically evidence, pauci-nodular (N≤5), locally advanced Intrahepatic cholangiocarcinoma (IHC) without extrahepatic involvement, considered technically unresectable by a panel of experts, eligible for treatment with SIRT, gemcitabine + cisplatin chemotherapy and Liver Transplant (LT).

Following treatment with SIRT + chemotherapy, tumor response or absence of tumor progression will be verified by a morphological workup combining CT-imaging, hepatic MRI and PET-CT.

After exploratory surgery to rule out any contraindications for LT, the patient will be list , with a minimum waiting of 3-month Follow-up will include assesment of Liver graft function, efficiency and tolerance of immunosuppressive therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 65
* With histologically documented intrahepatic cholangiocarcinoma (primary diagnosis):

  * Uni or pauci nodular (≤ 5 lesions (all lesions are counted, even those less than 1 cm))
  * Without extrahepatic or lymph node involvement
  * Technically unresectable R0 according to an expert panel
* Tumor target \> 2 cm
* WHO 0-1
* free and informed consent signed
* highly effective contraception for men and women of childbearing age during study participation up to 2 years post TH

Exclusion Criteria:

* Extrahepatic, vesicular or perihilar cholangiocarcinoma
* Tumor infiltration of more than 50% of the liver
* Mixed cholangiocarcinoma, hepatocellular carcinoma, fibrolamellar carcinoma
* Previous treatment for CCI
* Cirrhosis ≥ Child B7
* Chronic alcoholism
* Uncontrolled chronic active infections (patients with HBV, HCV or HDV infections may be included if infections are controlled)
* Stage III A, IIIB, IV and V chronic renal failure (glomerular filtration rate 59 ml/min)
* Contraindications to liver transplant

  * Severe untreatable conditions
  * Recent history (less than 5 years) of cancer
  * severe comorbidities
  * Psychiatric or psychological disorders
* Pregnant or breast-feeding women
* Patient under guardianship
* Not affiliated to a Health care system
* Participating in another interventional study or within the exclusion period of a previous study involving the human body
A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers

This study was a single-center, non-randomized, open-label, one-sequence, two-period, within-subject study to investigate the effects of multiple doses of rifampicin on the PK and safety of multiple doses of balovaptan in healthy subjects. The study was conducted at 1 site in the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, urinalysis, and serology.
* Body Mass Index of 18 to 30 kg/m2, inclusive.
* For women of childbearing potential: agreement to use at least 2 acceptable contraceptive methods during the treatment period and for 90 days after the last dose of study drug.
* For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm until 90 days after the last dose of study drug.

Exclusion Criteria:

* Female subjects who are pregnant or lactating.
* Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.

Rifampicin-related Exclusion Criteria:

* Subjects diagnosed, or suspected of having porphyria, and subjects with first-degree relatives diagnosed, or suspected of having porphyria.
* Known hypersensitivity to rifampicin
The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation

Numerous epidemiological studies have investigated the association between Helicobacter pylori (H. pylori) infection and inflammatory bowel disease (IBD) with various conflicting results. The main objective of this study is to further explore the possible association between H. pylori infection and IBD and its impact on disease course. The investigators sought to conduct a prospective observational study and enroll a total of 182 IBD patients who were screened for H. pylori infection. All the participants will be clinically evaluated at the initial visit and bimonthly for 3 months. Several factors will be explored such are diet, physical activity, life style and considering specific environmental exposures that impact the development of disease or its relapse.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with inflammatory bowel disease condition

Exclusion Criteria:

* Having irritable bowel disease
* Being younger than 18 years
Improving Performance in Drivers With Mild Cognitive Impairment

The objective of this study is to assess the effectiveness of an intervention to address both executive function and processing speed changes that contribute to poor driving performance in adults with Mild Cognitive Impairment (MCI).

Our hypotheses are that the study intervention will improve performance on a driving simulator and will improve (i) executive function, specifically attention and planning, (ii) useful field of view, (iii) mood, (iv) quality of life, and (v) reported motor vehicle crashes and driving infractions.

Executive function and processing speed are recognized critical correlates of driving performance and have been shown to decline in older adults and in persons with mild cognitive impairment. Members of our research team have shown that group executive function training such as Goal Management Training results in benefits for healthy older adults, including improved simulated daily activities. The ultimate purpose of our research is to develop interventions to help maintain older adults' mobility in order to assist their 'aging at home'. The planned study will assess the effectiveness of an intervention that includes Goal Management Training + processing speed training (using DriveSharp software), which is designed to address both executive function and processing speed changes that contribute to poor driving performance in people with diagnosed mild cognitive impairment. The investigators will measure the effectiveness of the intervention on driving performance, sustained attention, divided attention, executive function, depressive symptoms and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* mild cognitive impairment
* currently driving or voluntarily stopped driving within the past year
* fluent in English

Exclusion Criteria:

* visual problems that cannot be corrected with standard lenses
* alcohol/substance abuse
* stroke with residual motor /sensory deficit
* traumatic brain injury
* seizure in the past two years
* Parkinson's disease
* Multiple sclerosis
* untreated sleep apnea
* history of motion sickness
* history of dizziness, vertigo
* active primary psychiatric disorder requiring treatment
* on a dose of cognitive enhancing medication for less than 3 months
A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients

* To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of the study includes : overall survival, relapse free survival, distant metastasis and local-regional control rates.
* To evaluate the toxicities of the two treatment methods.

The head and neck contracts study tested induction and maintenance chemotherapy in patients with advanced head and neck cancers.There were no significant differences in survival between the two groups, but disease free survival was prolonged in the maintenance arm and not in the induction arm. Time to and frequency of distant metastases as the first site of relapse were significantly better for those on the maintenance arm. Many trials, designed several years ago, delivered single agent chemotherapy and were not particularly intensive. Most clinical trials were dealing with a heterogenous group of head and neck cancer patients. We felt that a better choice of adjuvant chemotherapy on cancers should include: (1) localized cancers with high metastatic potential following effective local treatment; (2) effective chemotherapy available; (3) chemotherapy should be intensive and effective enough to avoid the development of drug resistance. Of course, NPC had long been regarded as one of the most suitable head and neck cancers that may benefit from adjuvant chemotherapy due to its unique high response rate to chemotherapy and high metastatic potential after radiotherapy for localized, advanced staged disease.

If radiotherapy plus adjuvant chemotherapy can improve the treatment results of standard radiotherapy by increasing the survival rate, decreasing the metastatic rate and local recurrence rate, then many NPC patients may benefit.

Therefore, we propose this phase III study of radiotherapy with or without adjuvant PFL chemotherapy in advanced stage NPC patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically proven nasopharyngeal carcinoma who have just completed curative radiotherapy treatment.
* Original stage must be stage IV disease (M0)
* Patients must have a complete response, partial response or stable disease assessed 4 weeks after radiotherapy.
* Performance status scale ECOG grade 0，1.
* Creatinine ≦ 1.5mg/dl and bilirubin ≦ 2.0mg/dl, WBC ≧ 3,000/mm3 and PLT ≧ 100,000/mm3,or Creatinine Clearance \> 45ml/min if Creatinine \> 1.5mg/dl.
* Patients must be younger than 70 year-old.
* Patients must give signed informed consent.

Exclusion Criteria:

* Patients had progressive disease after radiotherapy
* Patients had evidence of distant metastasis.
* Patients had completed radiotherapy for more than 7 weeks.
* The presence of life-threatening illness
* History of prior malignancy excluding basal cell carcinoma or squamous carcinoma of the skin or in-situ cervical cancer within 3 years of the diagnosis of NPC cancer.
* Previous chemotherapy.
* Pregnancy.
Veteran Peer Coaches Optimizing and Advancing Cardiac Health

The purpose of this study is to test if having a Veteran peer health coach will improve blood pressure control among Veterans with high blood pressure and at least one other Cardiovascular disease (CVD) risk factor. The intervention will deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk, including healthy diet, regular to moderate-intensity physical activity, and smoking cessation. Facilitators, barriers, and costs of the intervention will be determined.

The Vet-COACH study is a peer health coaching program to help reduce Cardiovascular disease (CVD) risk among Veterans. The goal of the study is to test the effectiveness of a home-visit peer health coach intervention to promote health outcomes and behavior change among Veterans with multiple CVD risk factors with a hybrid type 1 implementation study. The study will focus on Veterans with poorly controlled hypertension and at least one other CVD risk factor to target a high risk population.

The study will conduct a randomized controlled trial to enroll n=400 Veterans to compare a peer health coach intervention consisting of home visits, telephone support, and linkages to appropriate community-based and clinic resources compared to usual VHA primary care. The primary outcome is reduction in systolic blood pressure from baseline to follow-up at 1-year. Secondary outcomes include a reduction in Framingham Cardiovascular risk score, individual cardiovascular risks (tobacco use, lipids), health related quality of life, and health care use. The investigators will also assess the effects of the peer health coach intervention on intermediate outcomes including social support, patient activation, patient/provider communication and health behaviors (e.g. medication adherence, physical activity, nutrition, alcohol use, and stress management). The cost of the intervention will be assessed to inform feasibility for future studies, determine Veteran and staff satisfaction with the intervention, and identify barriers and facilitators to adoption.

Note, the intermediate outcomes were not prespecified in the protocol for evaluation and were not specified in the grant, protocol paper, or in our SAP as outcomes and were removed from results analysis.

Eligibility Criteria:
Inclusion Criteria:

* Must be a Veteran
* Have \> 1 visit to VA Puget Sound Health Care Center(Seattle or American Lake VA) primary care or women's clinic in the past year
* Poorly controlled hypertension (\> 150/90 mmHg)
* At least one other CVD risk (including overweight or obesity, body mass index \> 25 kg/m2, tobacco use, hyperlipidemia LDL-c \> 130 mg/dL)

Exclusion Criteria:

* Hospitalization in the past 3 months for cardiovascular-related conditions (IHD, Cerebral Vascular Accident \[CVA\], PVD)
* Severe illness that precludes lifestyle program, end-stage renal disease (ESRD) on dialysis
* Nursing home resident, homeless
* Severe cognitive impairment
* Receiving home-based primary care (including VA Home Tele-Health and patients who received palliative care or are enrolled in hospice care)