cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

The purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all HP-positive participants.

The drug being tested in this study is called vonoprazan (TAK-438). Vonoprazan is being tested to treat people who have helicobacter pylori infection.

The study is planned to enroll 425 patients at the beginning and will enroll a maximum of approximately 510 patients based on the interim analysis results. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

Vonoprazan 20 mg

Esomeprazole 20 mg

All participants will be asked to take one tablet in combination with bismuth containing quadruple therapy (amoxicillin, clarithromycin and bismuth potassium citrate) twice at the same time each day throughout the study.

This multi-center trial will be conducted in China. The overall time to participate in this study is 10 weeks. Participants will make multiple visits to the clinic, and 28 days after last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Helicobacter pylori (HP)-positive participants as determined by \^13C-urea breath test (\^13C-UBT) at the start of the study (Visit 1 \[screening\]) and who require HP eradication in Physician judgment.

Exclusion Criteria:

1. Participant had any of the following conditions at the start of the study (Visit 1, screening): acute upper gastrointestinal bleeding, active gastric ulcer (GU) or duodenal ulcer (DU) characterized by defective mucos with white coating (with or without adherent blood clots) 3 mm or more in size, acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML). However, participants with gastritis, gastric or duodenal erosion are permitted to participate.
2. Participants with Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.
3. Participant has a history of malignancy or was treated for malignancy within 5 years before the start of the screening visit (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
4. Participant has a known acquired immunodeficiency syndrome or hepatitis infection, including hepatitis virus carriers (hepatitis B surface antigen \[HBsAg\] or hepatitis C virus \[HCV\]- antibody-positive).
The Use of Uncooked Sweet Manioc Starch to Treat Hepatic Glycogen Storage Diseases

Hepatic Glycogen Storage Diseases are a group of 10 serious genetic diseases that present in childhood and are characterized more frequently by the occurrence of repetitive hypoglycemia and dyslipidemia. Regarding treatment, the most commonly used strategy is the frequent administration of uncooked cornstarch, in average, every 4 hours. Although this treatment is successful, the use of large amounts of cornstarch can lead to overweight and, especially, to the decrease in the quality of life of patients and caregivers, due to the need to use the starch during the night. The search for a treatment that is widely available and that can lead to the prolongation of the fasting time, can collaborate to improve the care of these patients. The main scientific question to be answered by this research is: does sweet manioc starch, a Brazilian product, safely prolong the fasting time (with normoglycemia) of the patients as already suggested in experimental models? Main objective: To evaluate the efficacy and safety of the use of uncooked Sweet Manioc Starch in the treatment of patients with hepatic Glycogen Storage Diseases, using as model the Glycogen Storage Diseases type Ia.

A randomize and crossover study will be conducted on two consecutive days, comparing the use of classic cornstarch to the use of sweet manioc starch in patients with Glycogen Storage Disease type Ia. Ten patients diagnosed with Glycogen Storage Disease type Ia, confirmed by genetic analysis, will be included in the study. Sweet manioc starch and cornstarch, both of Brazilian origin, were analyzed in a previous study of the team in the artificial gastrointestinal model (TIM-1). They will be supplied uncooked, in the same way that cornstarch is currently used in the treatment of hepatic Glycogen Storage Diseases. Doses administered to patients will be 100 g of starch diluted in 200 ml of water at room temperature. To carry out the study, the patients will remain two consecutive nights in the hospital. They will remain in their normal diet until the administration of the starches at 22 hours. To perform the test, at 10 pm blood collection will be performed and after that the patient will ingest the starch (cornstarch or sweet manioc starch, determined by previous randomization). In sequence, blood collection will be performed every hour until the patient has a serum glucose value below 70mg/dL or after the patient stays 10h in a fast. Afterwards, the patient will return to his usual diet until the next test at 22 hours. The same procedures will be performed on the second night, the only change will be the starch used, and if the patient ingested uncooked cornstarch the first night, the same night will ingest the sweet manioc starch, or the opposite.If the patient has hypoglycaemia during the study, it will be discontinued.

Eligibility Criteria:
Inclusion Criteria:

* patients with a confirmed molecular diagnosis of glycogen storage disease type Ia who are already on uncooked cornstarch therapy

Exclusion Criteria:

-
Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection

The best antiseptic solution for cateheter care remains unknown.High concentration in aquous solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone iodine in aquous solutions. No study has compare alcoholic formulations of low concentration of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central venous catheters.

To compare the incidence of central venous catheter colonization after skin disinfection with either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine, 0.025% Benzalkonium and 4% benzylic alcohol.

To compare the incidence of catheter related bacteremia in the to study groups. To compare the local and general tolerance of the two antiseptic formulations


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 yeras of age
* Requiring an internal jugular or sub-clavian central venous catheter for their care during at least 72 h
* Informed consent signed up

Exclusion Criteria:

* Bacteriemic infection not under control
* extensive cutaneous infection
* Women with childbearing potential
Analysis of Immune Responses to HIV Vaccines

This study will evaluate a test designed to measure immune system responses to HIV and HIV vaccines.

Assays for HIV-specific human CD4 and CD8 T cell immunity are needed in order to evaluate the immune response to HIV vaccines. Such assays should be robust, reproducible, and amenable to high throughput analysis of clinical specimens. Cytokine flow cytometry (CFC) assays can reliably and specifically detect human CD4 and CD8 T cell responses to AIDS-related opportunistic infections, including those caused by cytomegalovirus, Mycobacterium tuberculosis, the Mycobacterium avium complex, cryptococcus, and human papillomavirus. The purpose of this study is to devise and evaluate a similar CFC assay for the detection and quantitation of CD4 and CD8 T cell responses against HIV.

This study will evaluate a "Gag-IFNg CFC" assay by comparing the results of this assay with results from other assays of immune phenotype and function in long-term nonprogressors, untreated patients with progressive HIV disease, and recipients of candidate HIV vaccines. The study will also examine HIV-specific immune responses in HIV infected individuals who appear to exhibit significant immune protection from HIV disease.

Participants in this study will be drawn from other studies currently underway. As a part of those studies, participants will have regular blood tests. Blood samples from those studies will be used in this study. No participants will be directly enrolled in this study.

Eligibility Criteria:
Blood samples from 5 cohorts of HIV infected individuals and 2 cohorts of HIV uninfected individuals will be evaluated.

Varying stages of HIV disease are represented in these cohorts, including:

* Individuals who have been exposed but who have not seroconverted
* Individuals who have recently seroconverted
* HAART-treated patients who receive immune modulators such as IL-2 and therapeutic immunization
* HAART-treated patients who undergo structured treatment interruptions
* HAART-treated patients who have durable suppression of viremia
* HAART-treated patients who experience incomplete suppression of viremia
* HAART-treated patients followed with careful drug adherence monitoring
* Long-term nonprogressors
* Untreated progressors
Tinnitus and Arterial Hypertension

Many authors link tinnitus to arterial hypertension. The aim of this study is to establish a possible relationship between them, analyze the severity of tinnitus related to arterial hypertension and analyze a possible influence of ototoxic drugs used to treat arterial hypertension

Arterial hypertension has been cited as a possible tinnitus etiology. Vascular abnormalities associated with it may account for cochlear and central nervous system. However, a relationship between tinnitus and arterial hypertension has never been established. The aim of this study is to analyze this relationship, comparing groups with and without arterial hypertension and the incidence of tinnitus amongst them. Inclusion and exclusion criteria try to isolate arterial hypertension as the main etiological factor, as much as possible. Presbycusis, noise exposure, metabolical diseases and genetic factors will be ruled out. A comparison will be performed inside the arterial hypertension group between subgroups that use or not ototoxic medications, such as furosemide and beta-blockers

Eligibility Criteria:
Inclusion Criteria:

* age between 40 and 50
* arterial hypertension for group 1
* at least 5 years standing arterial hypertension

Exclusion Criteria:

* chronic noise exposure
* metabolic diseases
* family antecedents of hearing loss (except for presbycusis)
* pregnant women
* use of ototoxic drugs (except for anti-hypertensives)
Peptic Ulcer Perforation Study

The objective of this study is to implement an optimized perioperative course for patients surgically treated for peptic ulcer perforation in order to improve the outcome for these patients.

The optimized perioperative course consists of a number of interventions carried out before, during and after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients surgically treated for benign peptic ulcer perforation

Exclusion Criteria:

* Age \< 18 years
* Pregnant and breastfeeding women
* Malign ulcer perforation
Restless Legs Syndrome Exercise Intervention

A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome (RLS). We, the researchers at Northeastern Ohio Universities College of Medicine, hypothesize that, relative to a control group, RLS sufferers who participate in an aerobic exercise intervention will demonstrate:

1. reduced RLS symptoms;
2. improved sleep quality;
3. reduced daytime sleepiness.

We will implement an exercise intervention among persons who suffer from RLS.

Study members will be Veterans, over the age of 40, who have been identified as RLS cases as part of our larger study of "The Prevalence and Outcomes of Restless Legs Syndrome among Veterans." We will use a cross-over design in which Veterans will be randomly assigned to the exercise intervention or control. Each arm of the study will be 3 months duration.

The protocol for the intervention will consist of twice weekly supervised exercise sessions. The goal for exercise participants will be to engage in continuous aerobic exercise for 45 minutes at an intensity of approximately 60% of VO2max. The control will be weekly support group meetings.

Outcomes will be measured using standardized sleep scales, actigraphy, and daily sleep and exercise logs.

Eligibility Criteria:
Inclusion Criteria:

* Meets case definition for RLS with symptoms at least one day a week
* Age 40 and older
* Moderate or severe insomnia
* Able to engage in moderate exercise
* Permission of primary care physician to participate in exercise.

Exclusion Criteria:

* Serum ferritin below 50 ng/ml
* Body mass index (BMI) greater than 40
* History of recent myocardial infarction or stroke
* Alcohol use, more than 3 drinks a day
* Current use of medications for sleep
GENErating Behavior Change, An Integrative Health Coaching and Genetic Risk Testing Pilot

The purpose of this 4 group (2x2) pilot randomized controlled trial is to test the feasibility and logistics of incorporating genetic risk information (9p21)into standard Coronary Heart Disease (CHD) risk counseling or health coaching intervention (or both) in primary care at 2 Duke Clinics.


Eligibility Criteria:
Inclusion Criteria:

* age 18+,
* presence of at least one of the following:

  * FPG \> 100,
  * HbA1c \> 5.7%,
  * diabetic,
  * LDL \> 129,
  * triglycerides \> 150,
  * total cholesterol \> 200,
  * SBP \> 130,
  * BMI \> 25,
* able to speak and understand English,
* able and willing to give informed consent

Exclusion Criteria:

* diagnosed CHD (MI or documented coronary artery disease),
* inability to ambulate or participate in physical activity,
* serious chronic disease related complications,
* current participation in a risk communication study for chronic disease,
Vitamin D, Hashimato's Thyroiditis and Thyroid Functions

The goal of this retrospective observational study is to determine whether vitamin D levels differ in patients with Hashimoto's thyroiditis (HT) compared to those without Hashimoto's thyroiditis. The main research questions are:

Are vitamin D levels lower in HT patients compared to non-HT patients? Do vitamin D levels vary between HT and non-HT patients based on thyroid function status?

The study was conducted by retrospectively reviewing the medical records of patients who visited the hospital outpatient clinic.


Eligibility Criteria:
Inclusion Criteria:

Patients with the following biochemical parameters:

* Vitamin D (25(OH)D) levels
* Thyroid-stimulating hormone (TSH) levels
* Free triiodothyronine (fT3) levels
* Free thyroxine (fT4) levels
* Anti-thyroid peroxidase (anti-TPO) levels
* Anti-thyroglobulin (anti-Tg) levels

Exclusion Criteria:

-
A Study of LY353381 (Arzoxifene) for Patients Who Benefitted From This Drug in Other Oncology Trials and Wished to Continue Treatment

Patients who were previously enrolled on the LY353381 arm of any LY353381 oncology trial could enroll in this "roll-over" study if they had exhibited clinical benefit from treatment and wished to continue on treatment. Patients were monitored for safety.


Eligibility Criteria:
Inclusion Criteria:

* Participation in a clinical trial of LY353381 that has met its main safety and efficacy objectives, and could otherwise close.
* Evidence of continuing benefit with LY353381 (eg. complete response, partial response or stable disease with no symptomatic or clinical evidence of disease progression).
* Adequate bone marrow reserve, liver and renal function, consistent with the previous LY353381 protocol, with no recent significant deterioration or metabolic condition that could affect patient safety or compliance with the protocol (eg, hypercalcemia).
* Written informed consent from patient.
* Childbearing potential either terminated by surgery, radiation, menopause, or attenuated by use of an intra-uterine contraceptive device or barrier method during and for 3 months after the trial.

Exclusion Criteria:

* No concurrent systemic therapy (immunotherapy, hormone therapy or chemotherapy) for cancer. Palliative radiotherapy is allowed (eg, for pain) as long as there is no evidence of disease progression. Investigational agents, other than LY353381, within the 4 weeks prior to this study enrollment and other SERMs are also not permitted.
* No concurrent use of oral contraceptives, GnRH agonists, or coumarin (warfarin).
* No serious concomitant systemic disorders incompatible with the study (at the discretion of investigator), including predisposition to thromboembolic disorder.
* Must not be pregnant or breast-feeding.
* Must not have a gap in treatment of more than 4 weeks between previous LY353381 study and enrollment in current study.
Clinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants

To evaluate, in a prospective multicenter study, ultrashort-term heat inactivation for the prevention of Cytomegalovirus (CMV) transmission in preterm infants (\<32 weeks gestational age or \<1500 g birth weight) under clinical conditions. Inactivation will be done only during the period of infectivity of breast milk, characterized by viral excretion strongly associated with subsequent infection, monitored by periodic virologic examinations of BM and urine of the infant. Thus the investigators hypothesis is that no CMV transmission through breast milk will occur using a gentle ultrashort heat inactivation procedure applied to infective breast milk.

The protocol has been approved by the ethics committee of Tuebingen University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* \<32 Weeks or GA or \<1500g BW
* mother CMV IgG positive
* breast milk feeding

Exclusion Criteria:

* parents disagree
Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection

This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) greater than or equal to 18 kg/m\^2.
* HCV RNA greater than or equal to 1000 IU/mL at screening.
* Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
* Screening laboratory values within predefined thresholds.
* Use of two effective contraception methods if female of childbearing potential or sexually active male.
* Healthy according to medical history and physical examination with the exception of HCV diagnosis.

Exclusion Criteria:

* Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
* Prior exposure to an HCV NS5a inhibitor.
* Pregnant or nursing female.
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
* History of solid organ transplantation.
* Current or prior history of clinical hepatic decompensation.
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
* Known hypersensitivity to LDV, SOF, or formulation excipients.
Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment

This nationwide, multicenter, single arm, prospective, non-interventional study will evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use in a representative cohort of participant with moderate to severe active RA who have either responded inadequately to, or who were intolerant to previous therapy with one or more synthetic disease modifying anti-rheumatic drug (sDMARD), and for whom the physician has made the individual decision to initiate tocilizumab (subcutaneous \[SC\] or intravenous \[IV\]) as first biological disease modifying anti-rheumatic drug (DMARD) therapy according to the summary of product characteristics (SPC).


Eligibility Criteria:
Inclusion Criteria:

* Participants with moderate to severe active RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more sDMARDs and for whom the physician has made the individual decision to be treated with tocilizumab (SC or IV)
* Current users of NSAIDs due to RA as assessed by the physician

Exclusion Criteria:

* Contraindications to treatment with tocilizumab as per SPC
* Prior therapy with tocilizumab
The Effect of Whole Body Vibration Training on Trunk Muscle Strength, Body Composition and Performance Parameters

Whole body vibration (WBV) trainings are widely used in the field of sports medicine and rehabilitation. It is accepted that these trainings are a modality that can safely increase muscular activation and performance. However, although many exercise models have been tried on vibration platforms, a standard WBV program for trunk muscles has not been established. A total of 45 healthy individuals will be included in the study. Participants will be divided into 3 groups. Group 1 will perform exercises at 40hz frequency, group 2 will perform exercises at 25hz frequency on WBV. The control group will perform the same exercises at 0 Hz. The training will last 6 weeks and each session consists of 5 exercises.The training consists of basic core exercises that the individual does with his or her own body weight. Each training session is approximately 30 minutes. All participants will be evaluated using an isokinetic strength test with a Cybex dynamometer at the beginning and at the end of the additional treatment protocol. In addition, balance, body composition and anaerobic performance of individuals will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* The age range should be between 20-35

Exclusion Criteria:

* Having an orthopedic problem
* Having orthopedic surgery in the last 6 months
* Doing daily exercise and sport