cyrilzakka/clinical-trials huggingface dataset:
Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis

This study is designed to determine whether 6 months of anti-HIV drugs given along with tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.

Tuberculosis (TB) is a common and serious complication of HIV infection in the developing world, especially in sub-Saharan Africa. Since the emergence of the HIV epidemic in Africa, the incidence rates of TB have risen dramatically, overwhelming national TB control programs across the continent. Over 50% of TB patients presenting to TB clinics in Africa are HIV infected. These patients often present in the early stages of HIV infection.

Recent World Health Organization guidelines on the management of HIV-associated pulmonary TB recommend antiretroviral (ARV) therapy in patients with CD4 cells less than 200 cells/mm3, but not for HIV infected TB patients who present with a high CD4 count. In Uganda, over half of HIV infected patients with active TB present to TB clinics with CD4 counts above 200 cells/mm3, and there is evidence that coinfected patients with a high CD4 count should be treated with ARV therapy. First, mortality in HIV-associated TB is high, even when patients respond to effective anti-tuberculosis therapy. Second, excess mortality associated with TB is most evident when CD4 counts are above 200 cell/mm3. Third, in coinfected patients, TB results in prolonged immune activation, which may enhance viral replication and accelerate the decline of CD4 cells.

This study will evaluate whether short-term ARV therapy of abacavir sulfate, lamivudine, and zidovudine given during treatment of active TB will slow progression of HIV disease in TB patients with CD4 counts of at least 350 cells/mm3. The study will also assess the possible risks (e.g., drug toxicities and resistance) and benefits (e.g., more rapid clearance of mycobacterium tuberculosis and reduced TB relapse) of punctuated ARV therapy.

Participants in this study will be HIV infected TB patients with CD4 counts of at least 350 cells/mm3. All participants will receive treatment for TB. Participants will be randomly assigned to receive 6 months of ARV therapy or to delay ARV therapy until CD4 counts drop below 250 cells/mm3. The participants will be followed for 2 years; CD4 counts will be compared between groups.

This study will also follow a group of HIV infected patients without active TB to quantify the extent to which CD4 cell decline is accelerated with active TB and to determine the extent to which a decline is neutralized in patients who receive punctuated ARV therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pulmonary TB (AFB smear-positive or culture-positive)
* HIV infected
* CD4 count greater than 350 cells/mm3
* Residence within 20 km of Kampala, Uganda
* Willing to use acceptable forms of contraception during the study and for 6 weeks after stopping study medication
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* Pregnancy
Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure

A randomized controlled trial to compare the efficacy of an electronic health record-based alert informing providers about evidence-based medications for HFrEF versus usual care (no alert) in outpatient clinics across a single health system.

Data from clinical trials suggest that pharmacological therapies prescribed at appropriate doses will lead to dramatic improvements in survival and hospitalization rates in patients with heart failure with reduced ejection fraction (HFrEF). Consequently, major cardiovascular societies assign the highest level of recommendation to use these therapies in all eligible patients. However, data from several registries over the last three decades has failed to see use of these evidence based therapies at levels noted in clinical trials, despite aggressive guideline recommendations and promotion by thought leaders in the field.

It remains unclear as to why many patients with HFrEF are not on evidence-based therapies, and why the percentages are consistent across national registries over time. One explanation might be that providers know the data regarding evidence-based therapies, but the therapies only benefit a narrow population. Another factor might be a lack of knowledge among providers about the appropriate management of HFrEF patients. A simple way to test this hypothesis is to examine whether electronic health record (EHR) based "best practice advisories" (BPAs) can increase use of evidence based therapies. If found to be effective, these low cost interventions can be rapidly applied across large healthcare systems.

This study will conduct a randomized controlled trial across outpatient clinics within a single health system comparing the effectiveness of an EHR-based alerting system that informs practitioners about what evidence-based medications they can prescribe for HFrEF patients versus usual care (no alert). One hundred eligible unique providers will be randomized to an intervention in which an alert will appear for all eligible patients with HFrEF, or to a control group in which no alert appears and usual care will continue, with a target patient enrollment of 1,310. The primary outcome for the trial will be the proportion of patients with HFrEF with an increase in evidence based medical therapies for HFrEF (beta-blockers, ACE-I/ARB/ARNI, MRA, SGLT2i). Secondary outcomes will include 30-day hospital admission rates, 30-day ED visits, one year all-cause mortality, and total 6 month healthcare costs.

Eligibility Criteria:
Patient Inclusion Criteria:

* Age 18 or over
* Seen in eligible internal medicine or cardiology clinic
* Left ventricular ejection fraction less than or equal to 40%
* Registered in the Yale Heart Failure Registry

Patient Exclusion Criteria:

* Opted out of EHR-based research
* Under hospice care
* Already receiving each targeted class of evidence-based HFrEF medical therapy

Selection of Providers:

* Practicing at an eligible internal medicine or cardiology clinic
* High frequency of visits by eligible patients based on retrospective chart review
The Effect of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Fibromyalgia

This study aimed to investigate the effectiveness of posterior tibial nerve stimulation (PTNS) in reducing pain, improving quality of life, and decreasing disease severity in patients with fibromyalgia.

This prospective, single-blind, randomized controlled trial included female patients newly diagnosed with fibromyalgia who had started duloxetine treatment (30 mg/day). Patients who met the inclusion criteria and agreed to participate in the study were randomized (1:1) into two groups. Group 1 (PTNS+duloxetine) underwent six sessions of posterior tibial nerve stimulation, twice weekly, 3-4 days apart, in addition to duloxetine (30 mg/day). Group 2 (duloxetine) received duloxetine only (30 mg/day). Randomization was performed manually, with assignments placed in opaque and sequentially numbered envelopes by off-site researchers who were not involved in patient care or follow-up. Outcome measures were assessed by two investigators who were blinded to each patient's group. The participants and nerve stimulators were not blinded to the group allocation. Patients were briefed to not disclose which group they were in during the assessment process.Patients in the study group received six sessions of posterior tibial nerve stimulation, twice weekly, 3-4 days apart, in addition to duloxetine; the controls received duloxetine only. The patients were evaluated three times (at baseline, 1st month, and 3rd month). Pain was evaluated using a numeric rating scale, the short-form McGill Pain Questionnaire, and quality of life with a 36-item Short-Form Health Survey (SF-36). Patient functional status and disease severity were evaluated using the fibromyalgia impact questionnaire (FIQ).

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 18 and 65 years, newly diagnosed according to the American Rheumatology Association 2016 revised FMS diagnostic criteria
* Patients who come regularly to sessions for posterior tibial nerve stimulation.

Exclusion Criteria:

* History of fracture/musculoskeletal surgery in the last 3 years
* Inflammatory joint disease, or neurological disease/neurological deficit with examination
* Receiving medical treatment for polyneuropathy
* Contraindications to PNS (pacemaker, epilepsy, diminished skin sensation in the area to be applied).
Correlation Analysis of the Effects of Management Pressure Goals and Control Volume Goals in Patients in Spinal Surgery

The investigators study 160 patients undergoing spinal surgery.Participants will be randomly divided into study group and control group.The study group will receive controlled hypotension by nitroglycerin and be divided into 3 groups according to CI.

This study will be done in Guangzhou Red Cross Hospital .The investigators study 160 patients aged from 45 to 70 years,weight from 48 to 68kg classified as American Society of Anesthesiologists (ASAs) physical status Ⅰ-Ⅱ who will be candidate for posterior decompression of vertebral canal,discectomy and internal fixation by pediclescrew(one centrum).The investigators excluded patients with cardiovascular and cerebrovascular diseases,hepatic or renal dysfunction,and patients receiving drugs that interfere with coagulation before surgery.

Patients randomly divided into study group(group H,n=120)and control group (group C,n=40).The study group according to CI(Cardiac Index) levels of intraoperative hypotension period(mean of CI at T2,T3,T4) were divided into three groups: 1st group: CI: 1.5-2.0 L /(min•m2), 2nd group: CI: 2.0-3.0 L /(min•m2), 3rd group: CI: 3.0-4.0 L /(min•m2),and which CI \< 1.5 or CI \> 4.0 was eliminated the experimental group, which, in control group, CI\< 2.5 or CI \>4.0 was eliminated the experimental group.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 35 and 70 years
2. Patients, undergoing canal decompression, intervertebral disc extraction and pedicle screw fixation (1 vertebral body)

Exclusion Criteria:

1. History of cardiovascular function

   1. congestive heart failure \[CHF\]
   2. coronary artery disease \[CAD\]
   3. cerebrovascular insuffiency)
2. poorly controlled arterial hypertension
3. pre-existing coagulation defects
4. Patients taking anticoagulatory medication including aspirin
5. Patients taking corticosteroid therapy
Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)

The aim of the study is to demonstrate a beneficial effect in reducing symptoms that negatively affect the quality of life of IBS patients, and to demonstrate a positive effect on inflammatory and intestinal function markers.

The double-blind, randomized, placebo-controlled study will be conducted on 48 patients (18-55 years old) with Irritable Bowel Syndrome (IBS). The study will consist of 2 months of supplementation with three parallel arms: 1) probiotic strains and prebiotic (Partially Hydrolyzed Guar Gum); 2) probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry fruit extract; 3) placebo.The study will assess symptoms associated with IBS, using the IBS-QOL questionnaire and the Bristol Stool Formation Scale. Markers of inflammation and intestinal barrier permeability , will be determined in blood and stool samples collected from patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Irritable Bowel Syndrome.
* Women and men, 18-55 years old.
* Signed informed consent.

Exclusion Criteria:

* Intake of supplements containing plant extracts, polyphenols or anthocyanins, and supplements containing fiber, probiotics and prebiotics.
* Participation in another clinical trial.
* Inability to swallow an oral study drug/placebo.
* Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study.
* Women who are pregnant, planning to become pregnant during the study, or breastfeeding,
Citrulline in Severe Sepsis

This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis is that intravenous L-citrulline will decreased the development or progression of acute lung injury in patients with severe sepsis compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Severe Sepsis

Exclusion Criteria:

* No Consent
* Malignant or other irreversible condition
* Moribund and not expected to survive 48 hours
* End Stage Liver Disease
* Enrolled in another IND study
* Pregnant or breast feeding female
* Age\<13 years old
* Allergy to citrulline or arginine
Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo.

The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.


Eligibility Criteria:
Key Inclusion Criteria:

* Individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, 18 to 75 years of age based on the date of the screening visit.
* Ulcerative colitis (UC) of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening.
* Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal Bleeding, and Endoscopic Finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader).
* Previous treatment history of approved UC therapy with at least one advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action.
* A surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for individuals with UC.

Key Exclusion Criteria:

* Current diagnosis of Crohn's Disease (CD) or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis.
* Individuals with disease limited to the rectum (ulcerative proctitis) during screening endoscopy.
* Requirement for ongoing therapy with or prior use of any prohibited medications.
* Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks.

of randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization.

* History of opportunistic infection.
* Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Modulation of the Gut Microbiota and Metabolism in Elderly by Algae Products.

The goal of this clinical trial is to determine whether a fermented black soybean and adlay supplement can improve frailty. The main questions it seeks to answer are:

* Does the fermented black soybean and adlay supplement improve physical performance?
* What is the effect of the fermented black soybean and adlay supplement on gut microbiota? Researchers will compare the fermented black soybean and adlay supplement to a placebo (a non-fermented black soybean and adlay supplement) to assess its impact on physical performance.

Participants will:

* Take either the fermented black soybean and adlay supplement or a placebo daily for 12 weeks.
* Visit the clinic for checkups and tests before and after consuming the product.

This study aims to evaluate the effects of fermented black soybean and adlay supplements on frailty and gut microbiota in older adults. Older participants are recruited from National Taiwan University Hospital. Parcitipants will be stratified randomization into placebo and experimental groups based on their robustness status. Older participants will take either the fermented black soybean and adlay supplement or a placebo daily for 12 weeks. Baseline characteristics of the participants, including demographic data, chronic disease history, and anthropometric data, will be collected. Cognitive function will be evaluated using the Mini-Mental Status Examination. A 15-item version of the Geriatric Depression Scale will be used to identify depressive symptoms. Nutritional status will be assessed with the Mini Nutritional Assessment. Blood and fecal samples, as well as data on physical performance and frailty status, will be collected before and after consuming the product.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* Independent in activities of daily living

Exclusion Criteria:

* Being bedridden or residing in a nursing home
* Having a life expectancy of less than 6 months
* Having severe hearing or communication disorders
* Having hyperuricemia, gouty arthritis, or swallowing dysfunction
Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Amla has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Amla has an excellent potential for the prevention and treatment of metabolic syndrome.

A randomized, double-blind, placebo-controlled clinical trial will be conducted in 28 patients, 30-59 years old, with diagnosis of Metabolic Syndrome according with modified International Diabetes Federation criteria. Patients will be randomly assigned to receive Amla (500mg) or homologated placebo orally twice daily, for 90 days. Before and after the intervention, the components of Metabolic Syndrome will be evaluated, waist circumference, blood pressure, levels of fasting glucose, triglycerides, cholesterol high density lipoprotein (C-HDL), total insulin secretion (Insulinogenic index), first phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

Eligibility Criteria:
Inclusion criteria:

* Diagnosed Metabolic Syndrome according to the IDF criteria:
* - - Waist circumference: ≥80 cm (women) ≥90 cm (men), plus two or more of the following:
* - - Fasting glucose ≥ 100 mg/dL to \<126 mg/dL.
* - - Triglycerides ≥150 mg/dL to \<499 mg/dL
* - - HDL-C: Men ≤40 mg/dL, women ≤50 mg/dL
* - - Systolic blood pressure ≥130 to \<140 mmHg
* - - Diastolic blood pressure ≥85 to \<89 mmHg
* Body Mass Index between 25 and 34.9 kg/m²
* No pharmacological treatment for Metabolic Syndrome

Exclusion Criteria:

* Pregnancy or breast-feeding
* Known allergy to Amla or placebo
* History of hepatic, kidney or thyroid disease
* Drugs or supplements consumption with proven properties that modify the behavior of the Metabolic Syndrome
Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry

The purpose of this study is to evaluate the accuracy of continuous SpHb measurement ( Rainbow DCI, Masimo, Irvine Ca, USA) compared to the current method of monitoring (blood sampling), both during phases of hemoconcentration and hemodilution.


Eligibility Criteria:
Inclusion Criteria:

* All patients: Age \> 18 years
* ASA class I and II patient requiring hepatic resection

Exclusion Criteria:

* Patient refusal
* Patients with a perioperative blood loss exceeding 5ml/kg
Engaging Patients in Mutual Goal-Setting in Hospitalized Patients

Mutual goal setting and action planning in patients with long-term conditions in outpatient settings is associated with favorable effects on measures of physical health, psychological health, subjective health status, self-management self-efficacy levels, activation levels, and perceived empowerment. The purpose of this study is to examine the impact of an educational intervention delivered to the staff nurses of two surgical units on how to engage patients in mutual goal-setting in the acute care setting. Staff nurses from two 32-bed surgical units will be scheduled to attend an hour-long educational intervention. A total of 630 chart audits will be conducted one month prior and one and three months following the intervention per unit, to examine the number of patients with a daily goal recorded in the prior 24 hours and the quality of the recorded goal using the SMART-GEM. The self-efficacy of engaging in mutual goal-setting with patients will be examined by asking nurses to complete the Appraisal Inventory Tool (AIT) prior to and immediately following the intervention. The patient experience of engaging in mutual goal-setting will be examined by having a total of 165 patients complete the Patient Experience of Mutual Goal-Setting Tool (PEMGST) one month prior to the intervention and one and three months following the intervention on each of the two units.


Eligibility Criteria:
Inclusion Criteria

* At least 18 years of age or older
* Must be alert and oriented to person, place, and time
* Inpatient on one of two included units

Exclusion Criteria

* Less than 24 hour length of stay
* Non English-speaking