cyrilzakka/clinical-trials huggingface dataset:
SER100 in Isolated Systolic Hypertension

Isolated Systolic Hypertension (ISH)is the dominating hypertensive disease in elderly people. Much attention has recently been drawn to the strong relationship between the systolic blood pressure and cardiovascular morbidity.

In previous clinical studies carried out in individuals with normal blood pressure at baseline SER100 decreased primarily the systolic blood pressure. It is hypothesized that the effect on systolic blood pressure in hypertensive patients will be larger or equal to the fall seen in normotensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Mean systolic blood pressure ≥ 150 mmHg and mean diastolic blood pressure \< 90 mmHg - as determined by daytime continuous ambulatory blood pressure measurement (ABPM)
* Male or female
* Age 50-80 years (both inclusive) at screening
* Patients must be on stable doses with one or more antihypertensives
* BMI \<32 kg/m2
* Written informed consent

Exclusion Criteria:

* Acute myocardial infarction in the last 6 months before screening
* Stroke in the last 6 months before screening
* Uncompensated heart failure (NYHA Class IV)
* Angina pectoris with an anticipated need for administration of short-acting nitrates
* Known, severe sleep apnoea
* Abnormal laboratory values (i.e. \> 2 x upper normal limit) at screening
* Subjects working night shifts (11 PM to 7 AM)
* Participation in any other clinical trial with an investigational medicinal product or device within 1 month prior to randomisation.
* Subjects with upper arm circumference ≤24 cm or ≥ 42 cm.
* Any general condition, serious disease or current evidence of any mental or physical disorder or collaboration attitude (e.g. dementia, substance abuse) which, in the judgment of the investigator makes the subject unsuitable for enrollment, and/or may interfere with the study evaluations or affect subject's safety and/or may cause risk for poor protocol compliance
* Pregnant or lactating women.
* Female subjects of childbearing potential, or male subjects whose female partner (unless post-menopausal for 1 year or surgically sterile) is unwilling to use adequate contraceptive measures throughout the duration of the study
Ambulatory Care Quality Improvement (ACQUIP)

Health care organizations, including the VA, are investing substantial effort to improve quality of care. As part of this process, greater emphasis is being placed on measurement of outcomes, and in particular, functional outcomes and satisfaction as reported by patients.

Background:

Health care organizations, including the VA, are investing substantial effort to improve quality of care. As part of this process, greater emphasis is being placed on measurement of outcomes, and in particular, functional outcomes and satisfaction as reported by patients.

Objectives:

ACQUIP was designed to determine whether quality and outcomes of health care improve when primary care providers have access to regular assessments of their patients' health and function along with routine clinical data and information about clinical guidelines.

Methods:

This study was a randomized trial conducted at the General Internal Medicine Clinics of seven VA facilities. Each participating GIMC is organized into discrete firms staffed by different groups of providers who care for different patients. One randomly selected firm received the intervention and one served as control. Patients who made at least one GIMC visit in the last year were eligible to participate. Patients were surveyed at baseline to determine active medical problems. Subsequent mailings included a general evaluation of health status (SF-36), a satisfaction questionnaire and, as appropriate, one of six condition-specific questionnaires: the Seattle Angina Questionnaire, the Seattle Obstructive Lung Disease Questionnaire, the Hopkins Symptom Checklist (depression), and questionnaires regarding diabetes, drinking, and hypertension. Clinical/utilization data were downloaded weekly from VISTA and supplemented with data from Austin. The intervention consisted of multi-faceted reports to patients' primary care providers (at the time of patient visits) showing trended physiologic and health status data and guideline-derived recommendations. Clinicians also received periodical reports displaying trends in the health status and satisfaction of their patients compared with their clinic as a whole. Reports were supplemented by training on QI and health status measures.

Status:

Data collection was completed on April 1, 2000. Analysis of trial results will be completed January, 2001.

Eligibility Criteria:
Inclusion Criteria:

Enrolled in VA GIM clinic with visit in past year

Exclusion Criteria:
Role of Parasitic Infection in Inflammatory Bowel Disease and Irritable Bowel Syndrome

Role of parasitic infection in Inflammatory bowel disease and Irritable bowel The burden of the parasitic disease is in-direct relation with the health and nutritional status of the host, inducing not only parasite-specific immunity but also can modify the host's immune responses . Many parasites can imitate inflammatory bowel disorders and some studies showed that infection with parasites can improve disorders like IBD or moderate the symptoms of inflammatory bowel disorders . Even though, many studies have shown that gastrointestinal infection is an important risk factor for the development of IBS

1. Detect the prevalence of parasite/s associated with Inflammatory bowel diseases (IBD) and Irritable bowel syndrome (IBS) in comparison with control subjects.
2. Evaluating the effect of the parasite on the course and prognosis of the diseases.
3. Evaluating the effect of the antiparasitic drugs on the course and prognosis of the diseases.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IBD will be confirmed using

  1. standard clinical,
  2. endoscopic,
  3. radiographic and4 pathological criteria according to the Montreal classification of the extent and severity of IBD
* Diagnosis of IBS will depend on Rome IV criteria

  1. Recurrent abdominal pain on average at least 1 day/week in the last 3 months,
  2. associated with two or more of the following criteria:
  3. Related to defecation;
  4. Associated with a change in the frequency of stool and/ or Associated with a change in the form (appearance) of stool.

Exclusion Criteria:

* any patient who received antipiotic or antiparasitic drug within the past 4 weeks
Adjunctive Local Application of Lidocaine During Scleral Buckling Under General Anesthesia

The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling surgery.


Eligibility Criteria:
Inclusion Criteria:

* Retinal detachment
* Retinal tear less than 3 hour clock

Exclusion Criteria:

* Vitreous hemorrhage
* Proliferative vitreoretinopathy
Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes

This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate the effect of dairy products with full or low fat on glycemic control and cardio-metabolic risk factors in comparison to a regular diet.

This is a randomized, controlled clinical study in which 108 subjects with type 2 diabetes will be randomized into 3 different groups:

Full fat dairy group (Group A): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet

Low fat dairy group (Group B): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet

Control group (Group C): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products

Subjects in Groups A and B will be educated about different dairy products' serving sizes and fat content. Subjects in all 3 groups will be asked to record their daily intake of dairy products in a dedicated log book. Subjects randomized to groups A and B will be asked to only use only dairy products with either the full fat or and low (≤1%) fat dairy (≤1% fat content) content respectively. Purchase of the dairy products will be the responsibility of study subjects for which a subsidy of $500 (about $20/week for 24 weeks) will be provided for each subject. All study participants will also be asked to record their food intake for 3 days before each study visit in a 3-day food log.

Eligibility Criteria:
Inclusion Criteria:

* Having type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication
* A1C ≥7 %
* Consuming \<3 servings of dairy products per day
* On stable dose of diabetes, blood pressure or cholesterol medications for 3 months
* Body weight is within 10% of current weight over the last 6 months before starting the study

Exclusion Criteria:

* Pregnancy or lactation
* Lactose intolerance
* Allergy to milk or any of its components
* Use of orlistat
* History of pancreatitis
* History of gastric bypass surgery or sleeve gastrectomy
* Active malignancy
* History of recent cardiovascular event
* Having a heart pacemaker
* Enrollment in other studies that may affect study outcomes
Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository

POEM (Per-Oral endoscopic myotomy (creating a muscle \[esophagus\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia.

Achalasia is a disease of the muscle of the esophagus (food tube) \& means "a failure to relax." The esophagus consists of 3 parts: the first part (uppermost part) is the upper esophageal sphincter (UES). The UES is a specialized ring of muscle which separates the esophagus from the throat, \& prevents food in the second part (body) of the esophagus from regurgitating into the throat. The third part of the esophagus (lower esophageal sphincter \[LES\]) also consists of a specialized ring of muscle which separates the body of the esophagus from the stomach, \& prevents food \& acid from regurgitating into the body of the esophagus. When achalasia is present, patients experience dysphasia (difficulty swallowing food, \& \[sometimes\] liquids), chest pain \& can experience recurrent pneumonia \& loss of weight.

Current treatments for achalasia include oral medications (calcium channel blockers) to relax the LES (difficult to swallow pill/capsule), dilation (stretching) of the LES, (temporary relief) \& Esophagomyotomy (general surgery to cut the LES).

POEM (Per-Oral endoscopic myotomy (creating a muscle \[esophagus\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia.

Eligibility Criteria:
Inclusion Criteria:

18 years of age Referral for the treatment of Achalasia

Exclusion Criteria:

Less than 18 years of age; Absence of Achalasia
Using Walk With Ease Walking Program With Men 65 and Older Being Treated for Prostate Cancer

This study is testing a walking program called Walk with Ease by the Arthritis Foundation with men undergoing treatment for prostate cancer. The researchers are interested in how easy or difficult it is for these men to participate in this program and whether or not is is helpful to them during their care.

Purpose: This pilot study evaluates the feasibility of implementing a moderate-intensity physical activity (PA) program in a sample of men age 65 or older with a prostate cancer diagnosis undergoing various forms of treatment or active surveillance.

Participants: Men, 65 and older, with a prostate cancer diagnosis.

Procedures (methods): This study will enroll subjects in a 6 week walking program called Walk with Ease (WWE) and see if walking can be sustained for up to three months. In addition, the study will perform a Geriatric Assessment and gather preliminary data on self-reported quality of life outcomes and self-reported physical activity as captured in a daily walking log.

Eligibility Criteria:
Inclusion Criteria:

* ≥65 years of age
* Histologically confirmed Stage I, II or III prostate cancer (endocrine (± radiation) patients may be Stage IV)
* Undergoing prostate cancer treatment (post-surgery only, radiation only, endocrine therapy (± radiation), or active surveillance)
* English speaking
* IRB approved, signed written informed consent
* Approval from their treating physician to engage in moderate-intensity physical activity
* Patient-assessed ability to walk and engage in moderate physical activity
* Willing and able to meet all study requirements

Exclusion Criteria:

* One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
* Major surgery scheduled within the study period
* Unable to walk or engage in moderate-intensity physical activity
* Already actively walking (150 minutes per week)
Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia

The present study determined the effect of Xylose consumption on postprandial hyperglycemia in normal (n=25) and hyperglycemic subjects (n=50).

In this double-blind crossover designed study, Participants were randomly assigned to consume a sucrose drink (Control, sucrose 50g + deionized water 100g) or a sucrose drink additionally containing 5 g (Test 1, sucrose : xylose = 10:1), 3.33 g (Test 2, sucrose : xylose = 15:1) or 2.5 g (Test 3, sucrose : xylose = 20:1) of D-xylose with a week interval.

Eligibility Criteria:
Inclusion Criteria:

1) healthy subject or Impaired fasting glucose (fasting serum glucose between 100 and 125 mg/dL)

Exclusion Criteria:

1. history of taking an insulin-injection or oral hypoglycemic agents
2. evidence of alcohol abuse or alcoholism
3. pregnancy or breast feeding
4. chronic gastrointestinal disorder
5. seriously abnormal liver or renal function
6. an occupation at risk of death when hypoglycemia occurs
Efficacy of Dolutegravir Plus Lamivudine in HIV-1-infected Treatment-naïve Adults Without a Baseline Genotyping Test

The purpose of this study is to evaluate the efficacy of DTG + 3TC versus DTG + TDF/FTC over 48 weeks in HIV-1 naive patients in a real life setting with no baseline HIV genotypic resistance testing available.

This is a 48-week, Phase IV, randomized, open-label, to assess the non-inferior antiviral activity (VL \< 50 c/ml) of 2DR DTG+3TC versus 3DR TDF/FTC + DTG over 48 weeks in HIV1 naïve adult patients without baseline GT available at Day 1 visit. Subjects will be stratified by screening HIV-1 RNA (≤100,000 c/mL or \>100,000 c/mL) and Screening CD4+ cell count (≤ or \>200 cells/mm3).

The study will comprise:

* a 28-day Screening Phase (which may be extended to 35 days to allow receipt of all Screening assessment results).
* an Open-label Randomized Phase (Day 1 to Week 48).

Approximately 200 HIV-1 naïve adult patients will be randomized 1:1 to receive 2DR DTG+3TC versus 3DR TDF/FTC + DTG for 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Subject should be antiretroviral naïve (defined as \<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection).
2. Age ≥ 18 years
3. Screening plasma HIV-1 RNA ≥1000 c/mL
4. CD4 cell count nadir: any value
5. Effective contraception for women of childbearing potential.
6. Informed consent form signed by patient and investigator

Exclusion Criteria:

1. History of suicide ideation, intention or action.
2. Evidence of HBV infection based on the results of testing at Screening\* for HBV surface antigen (HBsAg), HBV core antibody (anti-HBc), HBV surface antibody (antiHBs or HBsAb), and HBV DNA as follows: Subjects positive for HBsAg are excluded; Subjects negative for anti-HBs and HBsAg but positive for anti-HBc and positive for HBV DNA are excluded.
3. Anticipated need for any HCV therapy during the first 48 weeks of the study.
4. Acute symptomatic HIV Infection.
5. Any active Opportunistic Infection (category C, CDC 2014).
6. Current pregnancy or breastfeeding.
7. No effective contraception for the women of childbearing.
8. Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening period to verify a result.
9. ALT (Alanine Aminotransferase) ≥ 5 x upper limit of normal value (ULN) or AST (Aspartate Aminotransferase) ≥ 3 x ULN and bilirubinemia ≥ 1.5 x ULN (with 35% direct bilirubinemia).
10. Unstable liver disease (ascitis, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice).
11. Creatinine clearance of \<50 mL/min/1.73 m2 (Cockroft-Gault method).
12. History or presence of allergy to the trial drugs or their components.
13. Severe hepatic insufficiency (Child Pugh Class C).
14. Any available historical resistance test result.
Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease

The goal of the study is to determine whether grape consumption can reduce the risk of cardiovascular disease by reducing the presence of inflammatory molecules and positively altering cholesterol levels, lipid profiles, and immune cell responses.

Obese individuals are at high risk for the development of hypertension and cardiovascular disease. Adipose tissue is a major source of pro-inflammatory molecules which can promote the development of atherosclerosis. Development of atherosclerotic plaques are mediated by oxidized or otherwise modified LDL cholesterol and infiltration of activated immune cells into the atherosclerotic lesions. Grapes contain high levels of polyphenols, a class of compounds known to possess antioxidant and anti-inflammatory properties. The overall goal of this proposal is to determine whether grape consumption can reduce the risk of cardiovascular disease by reducing the presence of inflammatory molecules and positively altering cholesterol levels, lipid profiles, and immune cell responses. Using a randomized cross-over design, twenty obese subjects will consume beverages containing either four servings of grape powder per day or the caloric equivalent without grape powder (placebo control) for a total of three weeks. After a two week washout period, the beverages will be switched for a further three weeks. Blood will be taken from each person at six intervals to determine lipid profiles, measure inflammatory markers in plasma, and analyze immune cell responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* BMI 30 - 45 kg/m2
* Commitment to the dietary intervention and scheduled testing

Exclusion Criteria:

* Subjects will be excluded from this study if their blood cell counts or blood chemistry profiles are outside of the normal range
* smoking or use of tobacco products
* drink more than one alcoholic beverage per day (1 oz. distilled liquor, 3 oz. wine, or 12 oz. beer)
* taking cholesterol-lowering medications
* taking steroids for asthma or other inflammatory states
* taking thyroid-regulating drugs
* taking over-the counter weight loss products
Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers

This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma.

The purpose of this research study is to test a new method for determining the stage and prognosis of patients with malignant pleural mesothelioma. Currently, it is not possible to accurately determine cancer stage prior to surgery or another treatment. This new method may allow doctors to better classify cancer stage and give a better estimate for prognosis prior to surgery or another treatment.

In this research study, the investigators would like to use biopsied tissue to study certain characteristics that will help test the new method for determining cancer stage and estimating prognosis.

In this research study, the investigators are...

* Obtaining pleural specimens at the time of routine diagnostic biopsy during the participant's standard treatment.
* Storing your biopsied tissue
* Studying the tissue to determine if the new method of staging and prognosis is accurate and valid

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with a diagnosis of malignant pleural mesothelioma undergoing

  * diagnostic pleural biopsy
  * pleuroscopy
  * and/or VATS resections
* Participants must be 18 years of age or older.

Exclusion Criteria:

-Any patient who is found to be unsuitable for

* surgery,
* treatment
* diagnosis,
Trial to Optimally Show the Pharmacological Action of Z-100

The objective of this clinical trial is to evaluate the change of the immunological parameter levels in FIGO stage IIIB cervical cancer subjects by administration of Z-100


Eligibility Criteria:
Inclusion Criteria:

1. FIGO stage (2008): IIIB, cervical cancer
2. Pathologically confirmed squamous cell carcinoma of the cervix
3. Subjects with treatment-naive cervical cancer
4. Subjects without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node
5. Subjects ≥21, ≤79 years of age at informed consent
6. Subjects for whom it is considered possible to carry out intracavitary radiation in radiotherapy
7. Subjects for whom it is considered possible to carry out concurrent cisplatin treatment with radiotherapy
8. Eastern Cooperative Oncology Group Performance Status: 0-2
9. Subjects with the following organ functions; (1) WBC ≥3,000/mm3 (2) Platelet count ≥100,000/mm3 (3) Hemoglobin ≥9.5 g/dL (correction by medication, e.g. blood transfusion, iron compounds, is allowed) (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (6) Creatinine clearance: ≥50 mL/min
10. Subjects who are willing to give informed consent

Exclusion Criteria:

1. Subjects who have a double cancer or are being treated for that
2. Subjects who have suffered from cancers other than cervical cancer within 5 years prior to obtaining consent
3. Subjects with cancer of the cervical stump which is judged by the investigator
4. Subjects who have a history of being diagnosed of autoimmune disease
5. Subjects who have a history of radiotherapy in the pelvis
6. Subjects who have a history of hypersensitivity to cisplatin or other medical agents which contain platinum
7. Subjects complicated with a serious drug allergy
8. Subjects with a serious complication (poorly controlled hypertension, haemorrhagic tendency, connective tissue disease being treated with steroid)
9. Pregnant women, nursing mothers or subjects who desire pregnancy during the trial period
10. Subjects who have ongoing infection of human immunodeficiency virus (HIV), active hepatitis B virus (HBV), hepatitis C virus (HCV)
11. Subjects with symptomatic tuberculosis at the date of obtaining consent
12. Subjects who have received any other investigational medicinal products or medical devices within 28 days prior to obtaining consent
13. Other subjects considered inappropriate to participate in the trial by the investigator