cyrilzakka/clinical-trials huggingface dataset:
Faith-based Approaches in the Treatment of Hypertension (FAITH)

The purpose of this study is to test the effect of a church-based lifestyle intervention on blood pressure reduction in 400 hypertensive blacks (BP\> 140/90 mm hg).

This study will test the effectiveness of a church-based lifestyle intervention in improving blood pressure control among 400 hypertensive blacks in a group randomized controlled trial. The lifestyle intervention will be delivered by trained lay health advisers through group-based behavioral counseling and motivational interviewing (MINT-TLC) in 24 predominantly black churches in New York City.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diagnosis of hypertension
* Self-identified Black or African American
* SBP \> 140 mmHg or DBP \> 90 mmHg (based on the average of 3 blood pressure readings); or average SBP \> 130 mm Hg or DBP \> 80 mm hg (for those with diabetes or kidney disease) at the screening/baseline visits
* Able to speak English

Exclusion Criteria:

* Unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks).
* Pregnancy
Enhanced Support for Behavioral Barriers to Learning: An Evaluation of the SCHOOL STARS Program

This small pilot study will enroll children ages 5-12 years of age with disruptive behavior problems at school. These children and their families will be offered an enhanced model of primary care, which includes pre-visit record review, standardized content of primary care visits, post-visit care coordination by the primary care team, and coordination of services between the primary care team and the school. We hypothesize that children receiving this enhanced model of care will achieve better behavioral outcomes at both school and home.


Eligibility Criteria:
Inclusion Criteria:

* Student at a local public school
* Primary care patient at the Pediatric Primary Care Center (PPC) at CCHMC, or a CCHMC-affiliated school-based health center
* School disciplinary problems defined as: (1) any suspension from school within the last 2 school months and/or (2) frequent calls to the parent from school (1+ times per week x 1 month)
* Parent is in the contemplative, preparation, or action stage of readiness for starting medication or therapy if recommended by a healthcare provider for their child's behavior problems
* Student may or may not have an existing diagnosis of an externalizing behavioral health disorder, such as ADHD, Oppositional Defiant Disorder, or Disruptive Mood Dysregulation Disorder.

Exclusion Criteria:

* Non-English-speaking parent
* Enrolled in another ADHD study
* Severe developmental delay or autism
* Potential cardiac contraindications to starting stimulant medications without an EKG (personal or family history of heart disease in a child, family history of sudden death before age 50, family history of death due to heart disease before age 50, personal history of seizures, personal history of unexplained syncopal episodes)
* Patients who have an established relationship with a PPC Care Manager
* Patients who have seen the same primary care provider for the last two well child or behavior-related visits (unless approved/referred by that primary care provider)
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries

The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).

Due to the introduction of drug-eluting stents (DESs) and to improvements in therapy for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) patients, PCI is challenging CABG as the gold standard for treatment of three vessel (3VD) and left main (LM) coronary disease.

SYNTAX is a novel, randomized trial with nested registries comparing PCI with paclitaxel-eluting TAXUS stents to CABG for 3VD and LM patients to evaluate the best treatment for these patients with complex coronary disease.

Patients at participating centers will be evaluated by both a cardiothoracic surgeon and by an interventional cardiologist.

Those patients who are determined to be eligible for treatment by both PCI and CABG will be randomized to receive either PCI with a polymer-based paclitaxel-eluting TAXUS stent or CABG.

Patients who are determined to be unsuitable for treatment by PCI will be treated by CABG and will be entered into a CABG registry to help define the patient population in which stenting continues to be an unacceptable treatment option.

Similarly, patients who are determined to be unsuitable for treatment by CABG will be treated by PCI, using any interventional techniques or devices with or without the use of DES, and entered into a PCI registry to help define the patients for whom CABG is considered inappropriate.

Eligibility Criteria:
Inclusion Criteria:

* Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD (left anterior descending \[LAD\], left circumflex \[LCX\], right coronary artery \[RCA\] territory)
* De novo lesions with at least 50% stenosis
* Myocardial ischemia (stable, unstable, silent)

Exclusion Criteria:

* Prior PCI or CABG
* Acute myocardial infarction (with creatinine kinase \>2x upper limit of normal)
* Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement)
* Participation or planned participation in another cardiovascular clinical study before 1 year follow-up is completed
* Inability to give informed consent due to mental condition, mental retardation, or language barrier
Pharmacokinetics of Thiamine in Breastfeeding Mothers and Infants

Thiamine deficiency causes beriberi and is common in parts of rural Cambodia, where it appears to be a leading cause of infant death. The change in maternal and infant thiamine level after administration of thiamine to either Cambodian mothers or their infants is unknown. Normal human breast milk thiamine levels in thiamine-replete mothers are poorly characterized. The aim of this study is to determine if thiamine administered to nursing Cambodian mothers normalizes maternal and infant thiamine levels. Levels will also be obtained in nursing Caucasian mothers residing in the United States.

In this pharmacokinetic study, thiamine hydrochloride 100 mg will be administered to nursing Cambodian mothers and thiamine levels will be measured in their blood and breast milk before and after supplementation. Their infant's blood thiamine levels will also be measured. A control arm of American breast feeding mothers taking prenatal vitamins will also be enrolled, to allow comparison of maternal blood and breast milk levels between Cambodian and American mothers. Ethics committee approval was obtained in Cambodia (National Ethics Committee for Health Research #208, 2011) and in the United States (Mayo Clinic Rochester IRB #12-004047)for the Cambodian and American portions of the protocol, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Mother is at least 18 years of age
* Infant is between 1 and 12 months of age
* Cambodian infant is exclusively breast fed
* Cambodian mother has not taken vitamin supplements within the past month
* American mother has been taking prenatal vitamins throughout pregnancy and postpartum while breastfeeding
* Mother and infant do not have an acute illness at the time of enrollment
* Mother and infant are able to comply with study visits

Exclusion Criteria:

* Mother is not able to provide informed consent
* Cambodian infant has received thiamine injections within the past 2 months
Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

The objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.

30 patients are divided into 2 groups, one treatment group and one control group.Treatment group will be implanted with peripheral blood stem cell and receive convention stroke therapy ,and control group only receive convention stroke therapy. We expect that transplantation of the peripheral blood CD34+ cells has the potential of significant benefit to neurological recovery. In a previous phase I clinical trial, we have shown that transplantation of CD34+ cells obtained from the peripheral blood of the chronic stroke patients was safe and beneficial for neurological recovery. We expect this trial can further prove the efficacy of this treatment method.

Eligibility Criteria:
Inclusion Criteria:

* aged 35-70 chronic stroke adult patient,
* with stroke history of more than 6 months, less than 60 months，
* with stable hemiplegia condition, and
* NIHSS (NIH Stroke Scale) score is between 9-20.

Exclusion Criteria:

* patients aged less than 35 or more than 70,
* hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory，NIHSS is not in the range of 9-20,
* pregnant women,
* impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.
A Multicenter, Retrospective, Chart Review Study Evaluating the Impact and Utility of the Blood-Based Proteomic Integrated Classifier and Auto-Antibody Tests in the Real-World

This study is a multicenter retrospective chart review. Sites with at least 100 patients tested with the IC and AAT tests, who have index dates (date of IC and AAT testing) at least one year prior to data collection date will be eligible for participation.

This study is a multicenter retrospective chart review. Sites with at least 100 patients tested with the IC and AAT tests, who have index dates (date of IC and AAT testing) at least one year prior to data collection date will be eligible for participation.

The protocol will require institutional IRB approval and a waiver of patient consent will be obtained. The data to be collected will be de-identified when entered into the study database. The collection of this de-identified data does not pose any risk to the subjects and does not require any further testing of the patient. The chart review will utilize a third-party Clinical Research Associate (CRA) with certified ICH-GCP training for data collection and documentation. Biodesix, Inc. in conjunction with the CRA will develop and maintain the Electronic Data Capture (EDC) system.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated at sites with ≥100 patients who have been evaluated with the IC and AAT tests.
* Patients who are at least 40 years of age on the index date.
* Patients who have index dates (date of IC and AAT testing) at least one year prior to data collection date.

Exclusion Criteria:

* Patients with no prior AAT and/or IC testing at the study site.
* Patients less than 40 years of age on the index date.
Investigating the Inverted-U Relationship Between Cognitive Performance and Plasma Epinephrine

Abstract Although acute resistance exercise has been suggested to enhance inhibitory control, a critical component of executive function, the mechanism by which acute exercise influences inhibitory control is unclear and there are methodological limitations in previous empirical studies. According to the locus coeruleus-norepinephrine (LC-NE) theory, the activity of the LC, the major releaser of NE in the brain, regulates inhibitory control. Because there is reciprocal communication between circulating epinephrine and the LC. Plasma epinephrine is chosen as the index of LC-NE activity. However, only one study in acute exercise-inhibitory control measured the plasma epinephrine. Therefore, this registered report aims to extend its findings by a four-arm crossover randomized controlled design with three different intensities, using free-weight, multiple-joint, and structural resistance exercises. Moreover, most studies showed some methodological limitations such as failing to report the process of randomization, implementing a familiarization of resistance exercise before the maximal strength test, and publishing the protocol. Without a transparent report on how the participants were allocated, the results were at risk of bias. Without a familiarization of resistance exercise, the maximal muscle strength was likely to be underestimated. Without publishing the protocol before data collection, these findings were threatened by undetected researchers' degrees of freedom such as HARKing (hypothesizing after the results are known), cherry picking, and p-hacking. This registered report will address the limitations of previous studies by incorporating cognitive and resistance exercise familiarization, transparently reporting the randomization process, and submitting it as a registered report.


Eligibility Criteria:
Inclusion Criteria:

1. healthy young male aged 18-40 years;
2. recreational resistance-trained (≥ 1 time/week for the previous 6 months);
3. free from cardiovascular, cerebrovascular, and neurological disorders and other chronic diseases;
4. free from any medical condition listed on the 2014 update of the Physical Activity Readiness Questionnaire (PAR-Q+);
5. non-smoker; and
6. normal or corrected-to-normal vision.

Exclusion Criteria:

1. athlete trained in a competitive sports team or engaging in exercise for more than 20 hours/week;
2. unable to perform any of the intervention exercises (barbell squat, press, and deadlift); or
3. color blind
Primary Versus Secondary Metal Stent Implantation in PTBD

The aim is to compare percutaneous transhepatic biliary drainage (PTBD) with primary metal stent implantation (one stage-procedure) with PTBD with secondary metal stent implantation in terms of adverse events.

Percutaneous transhepatic biliary interventions (PBI) are used in biliary tract diseases when endoscopic access was not successful or not possible due to anatomical changes after abdominal surgery. Self-expandible metal stents (SEMS) can be applied percutaneously in patients with malignant extrahepatic bile duct obstruction. In this setting, PTBD is usually performed as a two step-procedure with primary drainage of the accumulated bile fluid by an external or an external/internal plastic stent and a secondary metal stent implantation at an interval of a few days. PTBD with primary metal stent implantation might shorten the hospital stay and is therefore equal to the increasingly used method of endoscopic ultrasound-guided biliary drainage (EUS-BD). EUS-BD offers a one step-procedure with primary metal stent implantation which is probably associated with lesser adverse events (AE) than PTBD with secondary metal stent implantation. However, it is not clear whether PTBD with primary metal stent implantation shows fewer adverse events than PTBD with secondary stent implantation. The aim of this study is to retrospectively analyze the prospectively collected data of PTBDs with primary or secondary metal stent implantation in patients with proximal and distal malignant bile duct obstruction. The focus of this single center study will be to compare the two approaches in terms of adverse events. Adverse events in PTBD might range from very mild to fatal. Therefore, the severity of the adverse events has been considered in the calculation.

Eligibility Criteria:
Inclusion Criteria:

* PTBD with metal stent implantation into the extrahepatic bile duct
* malignant and non-resectable extrahepatic bile duct obstruction

Exclusion Criteria:

* benign extrahepatic bile duct obstruction
Impact of Oral Diets on Postoperative Fluid Collection

Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.

Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections, which requires either prolonged drainage or multiple punctuations. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.

Eligibility Criteria:
Inclusion Criteria:

* confirmed breast cancer or melanoma
* scheduled surgery with axillary lymph nodes resection
* informed consent
* eligible for surgery

Exclusion Criteria:

* benign disease
* no consent
Steroid Injection for Adhesive Capsulitis

This study was conducted to compare the efficacy of hydrodilatation with low dose steroid with high dose steroid for treating adhesive capsulitis.

Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with low dose steroid ) and group 2 (hydrodilatation with high dose steroid). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, Shoulder Pain And Disability Index

Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosis of adhesive capsulitis
2. a duration of complaints more than 3 months
3. a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.

Exclusion Criteria:

1. prior manipulation of the affected shoulder under anesthesia;
2. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
3. neurologic deficits affecting shoulder function in normal daily activities;
4. shoulder pain caused by cervical radiculopathy
5. a history of drug allergy to hyaluronic acid;
6. pregnancy or lactation;
7. received injection into the affected shoulder during the preceding 3 months
Written Exposure Therapy for Post-traumatic Stress Syndrome

To investigate if written exposure therapy is feasible for patients with post-traumatic stress disorder

A non-inferiority trial in JAMA Psychiatry showed that written exposure therapy (WET) was non-inferior to a gold standard CBT treatment. In comparison to other trauma-focused CBT protocols, WET generally demands less therapist-time, and specifically, less than half compared to CBT that consists of 12 weekly sessions á 60 minutes. The aim of this study is to translate and replicate these results in a Swedish context. This first step is a small feasibility trial which will guide a subsequent large-scale trial.

Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for PTSD.
* If taking psychotropic medication, then the dose must be stable for at least 4 weeks prior to study entry.
* ≥ 18 years
* Situated in Sweden
* Be able to express themselves in Swedish, both in verbally and written form.
* Informed consent

Exclusion Criteria:

* Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI)
* Ongoing CBT for trauma
* Ongoing trauma-related threat (e.g. living with a violent spouse)
Obesity Treatment Enhanced With Working Memory Training

This study will examine the effects of providing subjects who have attention deficits, with or without a formal diagnosis of attention deficit hyperactivity disorder (ADHD), with Working Memory computerized training and explore whether this training is a feasible way to help them better engage in a weight loss treatment program, thereby enhancing weight loss results. Half of the participants will receive five weeks of online adaptive WM training concurrently while attending an in-person 24-week behavioral weight management program and half will receive five weeks of a non-adaptive form of cognitive training concurrently while attending a 24-week behavioral weight management program in person.

Populations with ADHD or attention issues tend to have more weight loss attempts, struggle more with losing weight, and drop out of treatment more frequently than those without attention difficulties. Adaptive working memory training has been used to strengthen working memory and to mediate the symptoms associated with ADHD. The adaptive training becomes progressively more challenging as participants master each level of the training, while non-adaptive training remains at the same level throughout. Both groups will attend 24 weekly, in-person weight management classes on the University of Vermont Campus. Both groups will do cognitive training on their own home computers five days a week for 30-40 minutes for five weeks concurrently while engaged in the weight loss program.

Eligibility Criteria:
Inclusion Criteria:

* Must score 4 or higher on the ASRS v. 1.1
* Must live within 45 minutes driving distance from UVM campus
* Must be able to exercise
* Must have a computer with internet access and ability to utilize flash
* Must be 18 or older

Exclusion Criteria:

* Health issues that preclude exercise
* use of medications that interfere with the ability to lose weight
* vacation longer than two weeks
* current participation in another weight loss program
* reside more than 45 minutes from UVM campus in Burlington
* no internet access, no home computer, or computer cannot use flash
Effect of Hypotensive Anesthesia on the Perfusion Index

Controlled hypotension has been used as a mean of reducing intraoperative blood loss and better visualization of the surgical field in nasal surgeries. Perfusion index has been considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and serum lactate for central perfusion. Many medications were used to induce hypotension. In this study we will compare the effects of tridil and labetalol on the perfusion.

The purpose of this study to detect the degree of hypotension that helps the surgeon and dosen't impair patient's perfusion and to compare the hypotensive effects of both tridil and labetalol infusions on the perfusion.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II males and females aged 18-45 years who were scheduled for Functional Endoscopic sinus surgery (FESS)

Exclusion Criteria:

* uncontrolled hypertension, cerebrovascular disorders, bleeding and coagulation disorders, coronary artery diseases, renal or hepatic diseases or known hypersensitivity to the drugs used and pregnant.