cyrilzakka/clinical-trials huggingface dataset:
Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance

Rates of cardiovascular disease and diabetes are more than 2-fold greater in HIV infected people than the general population. Protease inhibitor booster antiretroviral therapy (PI-ART) which is used by \~50% of HIV infected people in the USA is an established risk factor for diabetes. Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile salt, improves insulin sensitivity in HIV uninfected subjects, although the mechanisms for these benefits are unclear. This study will explore the hypothesis that TUDCA will improve insulin action in people with HIV who are receiving PI-ART. Further, this project will clarify the molecular mechanisms responsible for these improvements potentially benefiting society, irrespective of HIV status.

The purpose of this study is to determine if, and through which mechanisms, tauroursodeoxycholic acid improves insulin sensitivity in subjects with protease-inhibitor associated insulin resistance.

The investigators will perform body composition analysis by using a DEXA machine, liver fat measurement by using an MRI, and hyperinsulinemic euglycemic clamp procedures in 48 HIV infected, insulin-resistant/prediabetic subjects before and after 30 days of treatment with tauroursodeoxycholic acid or matching placebo. Biopsies of adipose tissue and skeletal muscle will be taken during fasting conditions and during insulin infusion, before and after treatment to measure markers of endoplasmic reticulum stress and thyroid hormone deiodinase.

Outcome measures:

The primary outcome measures will be change in glucose clearance during insulin infusion, change in markers of endoplasmic reticulum stress and change in content of D2 in muscle.

Eligibility Criteria:
Inclusion Criteria:

* HIV+
* receiving protease inhibitor containing antiretroviral therapy for \>6 months
* Undetectable viral load
* insulin resistant

  1. impaired fasting glucose (fasting blood glucose\>100mg/dl)
  2. impaired glucose tolerance (blood glucose \>140mg/dl at 2 hours during oral glucose tolerance testing).
* abstained from medications that affect glucose (e.g. prednisone, growth hormone)
* stable medications for \>3 months

Exclusion Criteria:

* weight loss of \>5% of body weight in prior 6 months
* active gastrointestinal disease (gallstones, pancreatitis, hepatitis, diarrhea)
* use of anti-diabetic medications
* cardiovascular disease (uncontrolled hypertension, heart attack, heart failure, prior endocarditis)
* history of or active substance abuse
* blood clotting disorder or taking medications that affect blood clotting (e.g. coumadin, warfarin)
* pregnant, planning to become pregnant or lactating
* unable to give informed consent
Use of Nanotechnology Structured Water for the Prevention of Recurrent Stone Formation

We assessed the effect of structured nano-water in the prevention of recurrent stone formation in patients with recurrent calcium oxalate stones and hypercalciuria.

The majority of stones (85%) contain primarily calcium oxalate. Most renal stones are idiopathic calcium stones, and the most common predisposing factor in these patients is hypercalciuria. Structured nano-water is a new type of water that has been prepared using different types of energy fields electromagnetic fields to produce this structured nano- water that has new and different characteristics from the ordinary water.

In this study, we compared the efficacy of the nano- water with hydrochlorothiazide and with ordinary bottled drinking water in the prevention of recurrent renal stones in patients with idiopathic hypercalciuria.

We conducted a three-year randomized trial comparing the effect of structured water with the effect of hydrochlorothiazide and ordinary bottled water in 325 patients with recurrent calcium oxalate stones and hypercalciuria.

The patients were randomly divided into three groups. Group A included 108 patients who used structured nano-water in a dose of 20 mL/kg as a daily dose.

Group B of 107 patients used 50 mg hydrochlorothiazide tablets as a daily dose, and group C consisted of another 110 patients used ordinary drinking bottled water in a daily dose of 20 mL/kg .

The assessments were done by urine analysis with renal ultrasonography and radiology ( Kidney Ureter Bladder KUB X-rays) were done at baseline, at yearly intervals, also at any time of recurrence, and at the end of the 3 years (36th month).

The patients, care providers, and the investigators were blinded about the type of water used since the water bottles were unlabeled when given to the patients.

All patients were informed and signed a written informed consent form.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic hypercalciuria
* history of previous renal stones

Exclusion Criteria:

* already present renal stones
* previous surgery of the kidneys
* Congenital anomalies of the urinary system
* Renal failure
* Allergy to hydrochlorothiazide
Efficacy and Safety of LCZ696 Compared to Placebo in Patients With Essential Hypertension

This study is a phase 2 study in patients with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must give written informed consent before any assessment is performed.
2. Patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmHg and \< 110 mmHg, and mean sitting systolic blood pressure ≥ 140 mmHg and \< 180 mmHg).
3. Patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment.
4. Patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.

Exclusion Criteria:

1. Patients with severe hypertension.
2. Patients with history of angioedema, drug-related or otherwise
3. Pregnant or nursing women
4. Women of child-bearing potential , who do not use adequate birth control methods
5. History or evidence of a secondary form of hypertension.
6. History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, TIA, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease.
7. Diabetes mellitus.
8. Previous or current diagnosis of heart failure (NYHA Class II-IV).
9. Clinically significant valvular heart disease at the time of screening.

Other protocol-defined inclusion/exclusion criteria may apply
Health Professionals Follow-up Study

To test the hypothesis that increased risk of coronary heart disease, stroke, peripheral vascular disease, and cancer is related to diets high in saturated fat, animal protein, and hydrogenated vegetable oil, and low in polyunsaturated fat, fiber, vitamins A, C, and E, calcium, selenium, and chromium.

BACKGROUND:

The diet-heart hypothesis, that high dietary saturated fat and cholesterol intake increase the risk and high polyunsaturated fat reduces the risk of coronary heart disease in man is supported by ecologic studies, by experiments in rodents and non-human primates, by voluminous literature relating dietary factors to serum lipids, by several secondary prevention trials, and by the Lipid Research Clinics Trial demonstrating a reduction in coronary heart disease among participants assigned to cholestyramine.

Despite the substantial scientific interest and the obvious public health implications of the diet and heart disease issue, relatively few observational cohort or case-control investigations had been published prior to 1985. Although these observational studies were not entirely consistent, taken collectively, they tended to provide important general support for the diet-heart hypothesis. However, due to study design, limited numbers of endpoints, or methods of analysis, many central questions remained unanswered. The most important issue was the quantitative relationship between specific dietary factors and risk of coronary heart disease. Moreover, the interplay of dietary and genetic factors is poorly understood.

DESIGN NARRATIVE:

In this prospective cohort study, participants completed a mailed general medical and health questionnaire at baseline and an intensively validated semiquantitative food frequency questionnaire (SFFQ). At one year, tissue specimens were collected and catalogued for future nested case-control analyses of coronary heart disease risk in relation to levels of calcium, selenium, and chromium. Follow-up questionnaires to update exposure information and ascertain non-fatal endpoints were mailed at two-year intervals. All reported cases of non-fatal myocardial infarction, stroke, and cancer were documented with hospital records and/or pathology reports. Fatal events were ascertained with the National Death Index and documented. To standardize SFFQ nutrient scores against measurements of absolute intake, two one-week diet records were obtained from a random sample of 150 Boston-area participants.

The study was renewed in 1991, 1997, and in 2003 to continue the follow-up of 51,529 male health professionals. The cohort is followed by questionnaires mailed at two-year intervals to update exposure information and ascertain nonfatal events. Complete dietary assessments are included every four years.A subset of 18,225 participants provided blood samples between 1993 and 1995. Genotyping was performed among 435 cardiovascular disease cases and 878 controls using Affymetrix 6.0 platform.

Eligibility Criteria:
Recruited through their professional organizations or occupation from mailing house lists.
Anti-obesity Pharmacotherapy and Inflammation

This study evaluates the relationship between weight loss, circulating inflammatory markers and lipids from 24 patients before and after 6 months of pharmacotherapy as a standard of care for anti-obesity treatment

This study aims to determine if weight loss by pharmacotherapy with liraglutide, semaglutide, or phentermine-topiramate promotes the reduction of pro-tumoral inflammatory cells Myeloid-derived suppressor cells (MDSC), simultaneously to the improvement of lipid profile (LDL-Cholesterol, HDL-Cholesterol, triglycerides, and free fatty acids) and concentration in the blood.

Liraglutide, semaglutide, and phentermine-topiramate are FDA-approved medications to treat obesity and obesity-associated comorbidities.

Twenty-four patients undergoing standard of care for anti-obesity treatment at VA Medical Center, and Tulane Center for Clinical Research (TCCR) will be recruited before initiation of pharmacotherapy as part of their standard of care and followed up to 6 months to compare the primary study variables.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI): over 30 kg/m2
* Age: 35 to 60 years old

Exclusion Criteria:

* Taking medications with anti-inflammatory properties like glucocorticoids, prednisone, or non-steroidal anti-inflammatory medications, such as aspirin or Motrin Subjects on medications for long-term weight management such as phentermine-topiramate (Qsymia), orlistat (Xenical), naltrexone-bupropion (Contrave), and the glucagon-like peptide-1 receptor agonists such as liraglutide (Saxenda), and semaglutide (Wegovy).
* Prior history of cancer
* Having any clinical symptoms of systemic inflammation, acute infections such as Coronavirus disease 2019, or chronic diseases such as cancer, tuberculosis, autoimmune disease, and AIDS
* An adult unable to consent
* Prisoner
* Pregnancy or breastfeeding women
Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab

Single Patient Expanded Access

Background:

Please refer to National Cancer Institute Surgery Branch (NCI-SB) protocol 18-C-0049, Amendment F.

Objective:

Under Individual Patient Expanded Access, to treat a patient with metastatic prostate cancer with autologous peripheral blood lymphocytes (PBL) that have been transduced with genes encoding T-cell receptors that recognize the mutated TP53 shared oncogene in the autologous cancer.

Eligibility:

* Must have measurable, metastatic disease as assessed per RECIST v1.1 criteria.
* Must sign the informed consent document.
* Willing to sign Durable Power of Attorney Form.
* Must have all regulatory approvals prior to start of treatment.

Design:

* Please refer to NCI-SB protocol 18-C-0049, Amendment F.
* The patient will be treated with a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine, followed by the infusion of autologous transduced PBL and then high-dose aldesleukin. The patient will also receive pembrolizumab on Day -2 prior to cell administration and additional doses every 3 weeks following cell infusion until the time of disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Measurable (per RECIST v1.1 criteria), metastatic prostate cancer.
* Refractory to approved standard systemic therapy.
* Ability of subject to understand and the willingness to sign a written informed consent document.
* Willing to sign a Durable Power of Attorney Form.
* Willing to practice birth control from the time of enrollment on this study and for four months after treatment.
* Subject must be co-enrolled on protocol 03-C-0277.

Exclusion Criteria:

Not applicable.
Parent-delivered Massage for Children With Autism

Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute at Western Oregon University (WOU) will be conducting research on the effect of a parent-delivered massage program on measures of autism and general development in young children with autism. Families will participate in an initial training, and receive 24 sessions of ongoing support and training from a trained therapist over the first nine months.

Children will be randomly divided into treatment groups and wait-list control groups. The control groups begin treatment five months after the treatment groups begin.

All children will be tested on three occasions in the first year: prior to beginning treatment, and five and twelve months later. Follow-up testing will be conducted at the end of the second year. Results will be shared with parents at the end of each year. Testers will remain blinded as to which group is currently receiving treatment.

There is no cost to parents for participation in this research study. Families meeting the eligibility criteria will be accepted into the study on a first-come, first-served basis.

Eligibility Criteria:
Inclusion Criteria:

* Have a medical and/or educational diagnosis of autism
* Be under age 6
* Parents willing to attend the parent training session and transport the child to treatment sessions with trained staff 20 times in the first five months
* Parents willing to give the fifteen-minute massage daily
* Parents willing not to start any new interventions unless medically necessary

Exclusion Criteria:

* Taking psychoactive medication or pharmaceutical chelation therapy
* Additional chronic disability (for example, cerebral palsy or uncontrolled seizures)
* Receiving more than five hours per week of intensive behavioral treatment for autism (e.g. ABA therapy)
Turmeric for Patients With Basal Joint Arthritis

The aim of this study is to assess whether the use of a commercially available nutraceutical, turmeric, is an effective option to manage pain and stiffness in patients with basal joint arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric on basal joint arthritis.


Eligibility Criteria:
Inclusion Criteria:

* 40 years of age or older
* English fluency and literacy
* Seeking care for basal joint pain
* Tender over basal joint
* Positive distraction rotation test (rotation of the thumb metacarpal base while applying axial traction)
* Radiographic evidence of Eaton stage 1 and 2 only

Exclusion Criteria:

* Secondary gains (litigations or worker compensation) procedures that may interfere with patients' motivation for treatment
* Inability or unwillingness to participate in a trial study
* Rheumatoid Arthritis or other inflammatory disorder diagnoses
* Post-traumatic osteoarthritis
* Patients on Coumadin/Steroids/NSAIDs/Tylenol
* Diabetes Mellitus
* Pregnant or lactating women
* Basal joint arthritis of Eaton stage 3
* Patients seeking other treatment for their basal joint arthritis (splint, corticosteroid injection, surgery)
Determine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders.

Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.


Eligibility Criteria:
Inclusion Criteria:

* Must have completed the double-blind portion of the preceding trial
* Completed any protocol specified withdrawal phase and follow-up visits.

Exclusion Criteria:

* Patient cannot participate if they experienced a serious adverse event or a nonserious, but medically significant adverse event during the preceding efficacy study that was judged to be related to the study medication.
Ipilimumab-induced Lung Toxicity: Observational Study

Serial spirometries and measurements of CO-diffusion capacity (DLCO) in patients with MM before and during treatment with ipilimumab are performed. A reduction from baseline of forced vital capacity (FVC) of ≥10%, or ≥15% of DLCO was defined clinically meaningful, thus indicative for pulmonary toxicity.

The aim of this prospective observational study is to determine the prevalence of ipilimumab lung toxicity defined by a significant decline of the diffusing capacity of the lung for carbon monoxide (DLCO) and/or forced vital capacity (FVC) in patients with MM.

Patients aged over 18 years with an established diagnosis of MM who are treated and followed up at the Department of Dermatology are asked to participate in the study after the indication for treatment with ipilimumab is given by the interdisciplinary skin tumorboard conference. After written informed consent is obtained, patients undergo a baseline evaluation (V1) including a medical history, physical examination, laboratory analyses (hemoglobin, leucocytes count, C-reactive protein, and pulmonary function tests (PFTs) with spirometry and measurement of DLCO. Thereafter, the first dose of ipilimumab (3mg/kg) is given intravenously over a period of 90 minutes without premedication. The subsequent three doses of ipilimumab are administered three weekly with analogue dose. Subsequent study visits (V2, V3, V4) including PFTs are scheduled on the same day as ipilimumab is administered. Thus, study visits are thoroughly adapted to the clinical visits, which is given by the administration of ipilimumab (total of four injections each separated by three weeks). In case of new respiratory symptoms during the study period, additional PFTs and a high-resolution computed tomography (HR-CT) of the chest are performed. In case of early study termination during follow-up pulmonary function test values which are already obtained are used for the final analysis.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of metastatic melanoma

Exclusion Criteria:

* Acute pulmonary infection at enrolment
Effects of Left Atrial Appendage Resection and Marshall Ligament Amputation on Clinical Outcome in Patients Undergoing Off-pump Coronary Artery Bypass

Surgical occlusion of the left atrial appendage (LAAO) is sometimes performed during the cardiac surgery to reduce long-term risk of stroke.A previous study found that LAAO may be associated with increased risk of postoperative atrial fibrillation.New-onset atrial fibrillation (NOAF) after coronary artery bypass graft is related to an increased short-term and long term risk of stroke and mortality.Marshall ligament amputation may reduce the occurence of atrial fibrillation. However, little is known whether this approach is justified during the coronary artery bypass graft.Therefore, this study aimed to investigate whether LAAO and Marshall ligament amputation during off-pump coronary artery bypass was associated with reduced risks of postoperative new-onset atrial fibrillation and stroke.


Eligibility Criteria:
Inclusion Criteria:

* isolated first off-pump coronary artery bypass

Exclusion Criteria:

* Preoperative atrial fibrillation or a history of atrial fibrillation;
* Concurrent cardiac or non-cardiac surgery
* Intraoperative convert to bypass bypass surgery
* Emergency surgery
* History of previous cardiac surgery
* Severe organ dysfunction
Phase 1, Multiple Dose Study of MPC-6827 in Subjects With Refractory Solid Tumors

Phase 1, Multiple Dose Study of MPC-6827 in Subjects with Refractory Solid Tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Advanced or Metastatic Cancer
2. Measurable / Evaluable Disease
3. Karnofsky score greater than or equal to 70%
4. Adequate Hematology / Organ function
5. No Baseline peripheral or central neuropathy above grade 1

Exclusion Criteria:

1. Hypersensitivity to Cremophor EL
2. Pregnant or Lactating
3. Spinal Cord Compression
4. Pre-existing Dementia / Cognitive Disfunction
5. Require Neupogen or Neulasta to Maintain Neutrophil Count
6. Have Primary Brain Cancer
7. Have history of Ischemic Heart Disease
8. Have Diabetes
Mesh Alone VS Combined Mesh and Darn in the Management of Primary Inguinal Hernia in Adult Males

A prospective randomized study involved 228 individuals with primary inguinal hernia, operated in our departments, between January 2015 to February 2018. The duration of hospital stay, operative time, duration of returning to routine activities, postsurgical sequels and recurrence rates estimated. We randomly allocated it into two groups: mesh repair was applied to 166 patients (Group 1) and combined both mesh, and darn repair applied to 162 patients (Group 2).

Background In spite of the era of laparoscopy still, open repair in primary inguinal hernia is currently the most commonly performed general surgical operation. To evaluate whether the combined darn repair plus Lichtenstein compare Lichtenstein repair alone in the treatment of inguinal hernias regarding postoperative complication and recurrence.

Materials and methods:

A prospective randomized study involved with 218 patients with primary inguinal hernia, operated in our departments, between 2015 and 2018. The duration of the operation time, hospitalization, and time to return to daily activities and postoperative complication and recurrence rates were evaluated. We randomly allocated into two groups: Lichtenstein repair was applied to 169 patients (Group 1), and combined both modified darn repair plus Lichtenstein repair was applied to 160 patients (Group 2).

Results:

The average follow-up period was 48 months. For the alone Lichtenstein procedure, the average duration of operation was 62 min; the average time to return to routine activities was 21 days. The number of patients with postoperative complications was 12 (11.3 %), and the number of patients with recurrence was 1 (0. 9%). For darn repair plus Lichtenstein procedure, the average duration of operation was 72 min; the time to return to daily activities was 21days. The number of patients with postoperative complication was 13 (11.6%), and no recurrences were noted. The hospitalization time of the groups was similar.

Conclusion:

Two-year follow-up, combined mesh and darn better than mesh alone in recurrence rate, both had the same postoperative complication, hospitalization time and return to routine activity.

Eligibility Criteria:
Inclusion Criteria:

* primary hernia
* male

Exclusion Criteria:

* Female
* bilateral
* recurrent hernia