cyrilzakka/clinical-trials huggingface dataset:
Randomized Placebo-controlled Pilot Trial of Prebiotics+Glutamine in HIV Infection

A rapid and almost complete loss of CD4+ T cells from the gut associated lymphoid tissue (GALT) occurs early in HIV infection, with a permanent damage in the intestinal barrier, changes in gut microbiota, increased bacterial translocation and persistent immune activation, changes that are not restored after the initiation of antiretroviral therapy. The investigators hypothesize than an intervention targetting the enterocyte barrier and the gut microbiota might modify the gastrointestinal tract towards a bifidogenic microbiota and improve markers of bacterial translocation, inflammation, immune activation and endothelial dysfunction.

This is a randomized placebo-controlled clinical trial to evaluate the safety and effectiveness to modify gut microbiota, bacterial translocation, immune activation and markers of endothelial dysfunction of a dietary supplement (prebiotics + glutamine) during a period of six weeks. The study will enroll four cohorts: 1) HIV-infected, treatment naive individuals; 2) HIV-infected subjects, currently on ART, with \>350 CD4+ T-cells/uL; 3) HIV-infected subjects, currently on ART, with \<350 CD4+ T-cells/uL; 4) HIV negative healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies.
* Aged over 18 years.
* Group 1: HIV+, Not receiving ART and no previous exposure to ART, at least 2 years since HIV diagnosis.
* Group 2: HIV+, currently receiving ART for more than 2 years, HIV-1 RNA levels less than 40 copies/ml and more than 350 CD4+ T-cells/uL.
* Group 3: HIV+, currently receiving ART for more than 2 years, HIV-1 RNA levels less than 40 copies/ml and less than 350 CD4+ T-cells/uL.
* Group 4: HIV-, healthy controls.

Exclusion Criteria:

* Major cardiovascular risk factors.
* Concomitant acute diseases.
* Gastrointestinal disorders.
* Pregnancy.
* Antibiotic exposure in the previous month.
* Regular use of foods or supplements containing prebiotics or probiotics within the 2 weeks prior to initiation of the study.
Interactions Between Immune Cells of Intestinal Mucosa or Peripheral Blood With the Extracellular Matrix in Inflammatory Bowel Disease (IBD)

The purpose of this study is to examine the effects of different environmental factors on immune cells in patients with IBD.

Background: Inflammatory bowel diseases, comprised of Crohn's Disease (CD) and ulcerative colitis (UC) are idiopathic disorders caused due to immunological, genetic, and environmental factors. These disorders are fairly common (in the US, there are 11 cases of CD and 7 cases of UC for every 100,000 people). The frequency of IBD, especially CD, are constantly rising (1). Clinical symptoms include diarrhea, rectal bleeding, abdominal pain, intestinal obstructions, and fistulas in CD. There are also systemic manifestations such as fever, weight loss, and anemia. The current hypothesis of IBD pathogenesis is an aberrant, ongoing, uncontrolled inflammatory response of the intestine, caused by commensal microbiota. The inflammatory response in IBD is mediated by T cells; in CD the pathologic lymphocytes are CD4 cells of Th1 type, while UC is considered an atypical Th2 response (2). CD4 T cells have a major role in initiation of inflammatory response in the gut, as well as a role in propagation and control of the inflammation.

Chemokines are low-molecular weight cytokines with chemoattractant capacity, and have a role in many inflammatory disorders. The chemokine CXCL12 is considered to be constitutively expressed (3). Our group found increased expression of CXCL12 in IBD (REF?). This finding suggests that CXCL12 might have a role in inflammatory processes of the gut.

Understanding phenotypical and functional differences of lymphocytes in mucosal homeostasis and IBD, elucidation of factors causing these differences, and recognition of causes for increased CXCL12 expression, will enable to increase knowledge of IBD; as well as lead to development of future therapeutic interventions in IBD.

Research Goals: To examine the effects of different environmental factors (cytokines, chemokines, extracellular matrix moieties) on immune cells from peripheral or intestinal source (in homeostasis or IBD) in terms of phenotypical and functional parameters.

Methods: 15 ml peripheral blood will be obtained from all participants. T lymphocytes will be isolated for the different experiments. Methods will include: Migration towards chemokines using the Transwell assay, proliferation will be assessed by either BrdU or thymidine incorporation, cytokine secretion will be determined using ELISA, phenotypical characterization will be done using flow cytometry and adhesion assays.

Ages: Adults and children aged 10-80. Research group: Approximately 40 patients (adults and children) suffering from IBD will be enrolled.

Control group: Approximately 100 controls will be enrolled in the research.

Eligibility Criteria:
Inclusion Criteria:

* IBD
Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer

This study will help determine if a short course of radiation therapy is effective to treat rectal cancer in older patients. A shorter course of radiation treatment may be better tolerated than a longer course or surgery for the treatment of rectal cancer in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* 70 years or older at time of diagnosis
* No restrictions on gender or ethnicity
* Ability and willingness to make follow up appointments
* Pathologic diagnosis of rectal cancer
* Presentation could be symptomatic or asymptomatic
* T1-T3 primary rectal adenocarcinoma as determined on TRUS, CT, or MRI pelvis
* Peri-rectal node positive allowed
* Inability to tolerate radical surgery, as judged by geriatric oncology or surgeon and tumor board OR patient refusal of surgery
* Inability to receive chemoradiation therapy, defined as concurrent chemotherapy and radiation doses of 45-50.4 Gy, as judged by radiation, medical, or geriatric oncology
* Patients with dementia eligible if Health Care Proxy (HCP) is available and supportive of follow up schedule

Exclusion Criteria:

* Age under 70 years of age
* Ability and desire to receive definitive surgical intervention
* Ability and desire to receive concurrent chemoradiation therapy
Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions

It is an open-label, balanced, randomized, five-treatment, five-period, five-sequence, multiple oral dose, crossover comparative bioavailability study of different strengths of carbidopa/levodopa extended-release tablets with carbidopa and levodopa tablets in normal, healthy adult human subjects under fasting and fed conditions. The primary objective of the study is to compare the pharmacokinetic profiles between WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg following three times a day after oral administration in fasting and fed conditions in healthy subjects and to compare relative bioavailability between treatments.

Study WD-1603-1005 is to compare the fluctuation index between WD-1603 extended-release formulations and Carbidopa and Levodopa Tablets following three times a day oral administration and the food effect on the initial absorption of levodopa in the morning in healthy subjects. At least 15 subjects will be enrolled at the beginning of the study and the order of receiving the Treatment A, B, C, D \& E for each subject during all the periods of the the study will be determined according to a randomization schedule.

Eligibility Criteria:
Inclusion Criteria:

1. Normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive).
2. Having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg/ height in m2, a minimum body weight of 50.0 kg.
3. Not having any significant disease or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG, and X-ray chest (P/A view) recordings.
4. In the case of female subjects:

a. Surgically sterilized at least 6 months prior to study participation or If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra-uterine device during the study and for at least 28 days after the last study drug administration.

And b. Serum Pregnancy test must be negative.

Exclusion Criteria:

1. Known hypersensitivity or idiosyncratic reaction to Carbidopa or Levodopa or any of the excipients or any related drug.
2. History or presence of any disease or condition which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
3. Ingestion of a medicine (prescribed \& over the counter (OTC) medication including herbal remedies and MAO inhibitors) at any time within 30 days before first dosing in Period I. In any such case, subject selection will be at the discretion of the Principal Investigator.
A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed Subjects With Type 1 Diabetes Mellitus

The rationale for the study is to determine if Campath-1H can be used in patients recently diagnosed with type I DM, to induce a state of immunological unresponsiveness such that subjects can safely preserve beta cell mass and eliminate or lower insulin requirements, preserving excellent metabolic control.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ages 18-35, with new onset type 1 diabetes mellitus (within 2-12 weeks of diagnosis), one or more islet autoantibody to GAD, IA2, IAA or islet cell cytoplasmic antibody (ICA) within 2 weeks of diabetes diagnosis.

Exclusion Criteria:

* Subjects under 18 years of age or over 35 years of age.
* Subjects who have previously received an organ transplant.
* Subjects who are currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation of corticosteroids is contraindicated.
* Subjects with a history of other medical condition(s) known to affect blood glucose values (i.e., Cushing's disease, acromegaly).
* Subjects with a history of other chronic systemic inflammatory or autoimmune disease or other severe medical condition. (A history of treated hypothyroidism with documentation of normal serum thyroid hormone levels will not be exclusionary.)
* Patients with a history of hepatitis B, hepatitis C, or HIV.
* PPD positive at the time of evaluation.
* Thrombocytopenia or neutropenia. Individuals will be considered to have thrombocytopenia if they have a platelet count \<100,000 platelets/mm2 or \<3,000 WBC/ml.
* Subjects with a history of renal, pulmonary, or cardiac failure
* Subjects with severe systemic infections. Only those subjects who have completed treatment and have shown a complete clinical resolution will be considered eligible for the study.
Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy

Objectives and Specific Aims Time efficiency of robot assisted radical cystectomy (RARC) with totally intracorporeal stapled orthotopic neobladder remains a main drawback of this procedure. According to a recent consensus panel, the benchmark for intracorporeal orthotopic neobladder should be 5 hours in high volume centers .

This prospective single-stage phase 2 trial is designed to assess the time efficiency of using robotic stapler versus the conventional motorized staplers (Linear stapler articulated Endo GIA™, Covidien) in achieving the target outcome (total operative time \<5 hr).

Perioperative complications (intraoperative and 30-d postoperative complications according to the Clavien classification system), 30-d/90-d/ 180-d complication and readmission rates, early functional outcomes (time to recovery of urinary continence), 180-d and 360-d neobladder stone formation rates will be analyzed to assess the safety and the cost effectiveness of the procedure.

The primary end point by which the sample size was determined was a total operative time \<5hr. In the last 50 cases of our series (data unpublished) this benchmark was obtained in 60% of patients (p0), while we expect to improve the time efficiency of the procedure with the use of robotic staplers maintaining the total operative time of the procedure \<5hrs in at least 80% (p1) of cases. According to A'Hern, in order to verify the significance of this hypothesis, the estimated sample size is 33 patients with a power of 80% at a significance level of 5%. The trial will be successful if the total operative time will be \<5hrs in at least 25 out of 33 patients.

The population of this study will include 35 patients with muscle invasive bladder cancer without contraindications to orthotopic neobladder. The first two cases will be excluded in order to provide the entire surgical team the minimal skill necessary for a proper and time efficient use of the new surgical device (robotic stapler). The following 33 consecutive cases will be enrolled and the outcomes analyzed. The estimated time to complete the enrollment is 9 months.

Eligibility Criteria:
Inclusion Criteria:

- Pathologically confirmed muscle invasive bladder cancer or recurrent high grade urothelial carcinoma (BCG failures)

Exclusion Criteria:

* All absoulte contraindications to orthotopic neobladder;
* Anesthesiologic contraindications to penumoeperitoneum and steep Trendelenburg position.
* cT4 disease;
* clinical evidence of metastases (cM1) outside the pelvis.
Northern Board Beet Breathlessness Trial

Hypothesis: Beetroot juice increases the exercise tolerance of patients with chronic lung disease.

Using the already established pulmonary rehabilitation model, we aim to split the group of 8 into 2 groups, each group taking 500ml of beetroot juice 24 hours before there class on alternate (differing) weeks to see if it improves their overall exercise tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Already planned to attend the pulmonary rehabilitation class

Exclusion Criteria:

* Angina Prescribed regular nitrates, a resting heart rate \>100bpm, a resting blood pressure \<110 systolic, postural hypotension, prescribed PDE5 inhibitors.
Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics

This study focuses on the use of Metanx® as the sole treatment for improving and reversing nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two equal study groups enrolled in this randomized double blinded study. The minimum sample size of enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. The maximum number of participants will be set at 100 (50 per group). Patients who are pre-diabetic or patients who have been diagnosed with diabetes type II for less than five years are included in this study. The control group will receive placebo pill twice daily versus the treatment group which will receive one Metanx® tablet twice daily. Each group will have intraepidermal nerve fiber densities obtained by skin biopsies taken at the beginning of the study before any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of twelve months to re-biopsy. In addition each group will answer three sets of questionnaires relating to their peripheral neuropathy at initial, three months, twelve month visitations. If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density and an improvement in the subjective score versus the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetics
* Pre-diabetics
* Symptoms of peripheral neuropathy

Exclusion Criteria:

* Pregnancy
* Under age 18
* HIV (+)
Healthfulness of Food From Grocery Stores Versus Eating Out Among People Receiving Food Benefits (SNAP)

The objective of this cross-sectional study was to characterize the dietary intake of SNAP participants and nonparticipants by food source, including grocery stores, sit-down restaurants, and fast food.

The study used 4,237 low-income adults from the National Health and Nutrition Examination Survey (NHANES) (2003-2006 and 2011-2014). De-identified data was collected from demographic questionnaires and 24 hour dietary recalls. We assessed intake of calories, solid fats, added sugars, and servings of non-starchy vegetables, whole fruits, and whole grains, by food source in SNAP participants and income-eligible nonparticipants. Associations between SNAP participation and dietary intake were analyzed using multivariate linear regression controlling for relevant sociodemographic characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 20 - 64
* At or below 200% of the federal poverty level
* Completed at least one 24-hour dietary recall

Exclusion Criteria:

* Younger than 20 years old or 65 years and older
* Income above 200% the federal poverty level
* No participation in dietary recall
The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion

The aims of the study are to determine the effectiveness of Mindfulness-Based Interventionas a workplace health promotion program on psychological distress, prolonged fatigue, job strain (job control and job demand), and perceived stress and to explore the influences of personal characteristics (including gender, age, education, and occupation) on the outcomes of the intervention with time.

This study was one component of the Taiwan Workplace Mental Health Promotion Scheme. The study adopted a study design of a randomized controlled trial. Two large-scale manufacturing factories were chosen for this study. All of the factories' 3270 full-time employees were requested to fill in a questionnaire comprising questions regarding mental health and job strain. Of these employees, 2849 individuals were willing to complete the questionnaire. A total of 431 employees (15.13%) were found to be in psychological distress with job strain. The screening procedure was carried out between June and July in 2011. A letter of invitation with an introduction to MBI was sent to these employees. Of these 431 employees, only 144 responded that they would be willing to take part voluntarily in the study. These 144 workers were allocated randomly into the intervention group (Group I, n=72) or the waiting-list control group (Group C, n=72).

All the participants were measured five times with an interval of four weeks between measurements. These measurements were taken at pre-intervention (T1), at mid-intervention (T2), at the completion of intervention (T3), four weeks after intervention (T4), and eight weeks after intervention (T5). The data related with the effectiveness of the intervention were obtained between August and December in 2011.

Eligibility Criteria:
Inclusion Criteria:

* Healthy employees with psychological distress and job strain
* Full-time paid workers

Exclusion Criteria:

* Age \< 18y or \> 65y
* Part-time workers
* The workers are not willing to take part in the study
Examining the Effectiveness of Wysa for Worry Program

The goal of this randomized controlled trial is to test for the effectiveness of Wysa's Worry computerized cognitive behaviour therapy (cCBT) program (a digital mental health intervention) in comparison to a digital app that offers psychoeducation to patients who have mild to moderate symptoms of anxiety.

People dealing with worry can receive augmented support from digital mental health interventions. The intervention being tested in this study is Wysa's Worry cCBT program. Its outcomes will be compared to a randomized, controlled arm that offers psychoeducation.

For the purpose of this study participants will be recruited through different online channels and will be randomly assigned to either the intervention or control group. Regardless of their assignment they will be completing weekly standardized assessments examining their symptoms of anxiety and depression, and examining any improvement.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the study is as follows:

  * Patients who are at least 18 years of age.
  * Patients who have mild to moderate symptoms of anxiety (scores: 5-15, according to GAD-7).
  * Patients who are not already engaged in psychological therapy and not intending to start psychological therapy in the next eight weeks.
  * Patients who haven't used any DMHI (Digital Mental Health Interventions) in the last 6 months.
  * Patients without risk of suicidal ideation and behaviour.
  * Patients who are capable of reading and understanding English and have provided written or verbal informed consent to participate.
  * Patients who own and use a smartphone with functional audio.

Exclusion Criteria:

* Patients who are at an increased risk of suicide.
* Patients with diagnosis of or receiving treatment for alcohol/substance use disorder.
* Patients who've had their psychiatric medication or dose changed in the last 1 month.
* Patients who suffer from severe anxiety
* Patients with diagnosis of or receiving treatment for an active state of psychosis.
Database Registry of the Intermountain Heart Collaborative Study

The purpose of the registry is to collect and analyze clinical and laboratory data and tissue samples from patients who are diagnosed with any type of heart disease and to collect the same information and samples from healthy controls in participating Intermountain Healthcare facilities.

This is a registry (database) project; there are no investigational treatments, drug or procedures associated with participation in registry activities. This project is an organized data gathering and storing (database) endeavor with specific focus on the precursors, modifiers, biological, and genetic parameters of heart disease and related medical conditions. Data collection will not immediately influence the course of treatment for any patient.Sample testing and data utilization for basic science, clinical, and epidemiologic and publication projects can be initiated using the databank.

The registry will enable researchers to determine best medical practices for predicting, preventing, and treating heart disease. The registry will: 1) develop standard methods to collect data and specimens which will be used for research to characterize patients diagnosed with heart disease as well as healthy controls and to assess differences in demographics and patient outcomes in both populations; 2) collect, process, and store patients' clinical data and tissue/blood samples; 3) analyze data collected; 4) use these resources to identify genes, genetic polymorphisms, genetic mutations, clinical methods and procedures, and/or biomarkers that predict, prevent, or treat heart disease and/or are associated correlate with lifestyle or disease outcomes; 5) publish and disseminate results.

Eligibility Criteria:
Inclusion Criteria:

1. The patient (male or non-pregnant female) must be \> 18 years of age.
2. The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.

Exclusion Criteria:

1. Neither patient nor patient representative understands spoken English.
2. Neither patient nor the patient's personal representative is willing to give written consent for participation.
3. Healthy control patients must sign their own consent document.