cyrilzakka/clinical-trials huggingface dataset:
A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy

A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy

This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients must provide written informed consent.
* Male and female outpatients and inpatients aged: ≥19
* Patients BMI shoule be ≤ 30

Exclusion Criteria:

* Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
* Patients with ongoing severe acute Inflammatory Bowel Disease.
* Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy.
* Pregnant women or pregnant women or pregnant women
* Severe heart disease (cardiac failure (NYHA class 3 and 4))
* Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases.
* People who have hypersensitivity or allergies to clinical trial drug components.
SuperB Trial: SUrgical Versus PERcutaneous Bypass

In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Recruitment will take the first two years and patients will be followed during five years. Patients with an indication for surgical bypass, classified category 3-6 with a \>50% stenosis or occlusion of the SFA over \>/=10 cm in length will be included. At least one crural artery should be patent without significant lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Informed consent
* Novo stenosis, restenosis \>50% or occlusion of the native SFA, all \> 10cm in length
* Patent popliteal artery at the upper margin of the patella to the trifurcation
* Diameter native SFA and popliteal artery are 5.0-7.5 mm
* Indication for surgical bypass
* Distal run-off at least one crural artery without significant stenosis
* Ankle-brachial index (ABI) at rest \< 0.8 in the study limb prior to procedure

Exclusion Criteria:

* Patient unsuitable for administration of contrast agent
* Pregnancy
* Dementia or altered mental status that would prohibit giving conscious informed consent
* Need for adjunctive major surgical or vascular procedures within one month
* Untreated flow-limiting aortoiliac occlusive disease
* Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
* Femoral or popliteal aneurysm of target vessel
* Non-arthrotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
* Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancies, dementia etc.) or other medical condition that would preclude compliance with study protocol
* Major distal amputation (above the transmetatarsal) in the study limb
* Any previously known coagulation disorder, including hypercoagulability
* Contraindication to anticoagulation or antiplatelet therapy
* Known allergies to stent/stent-graft components
* History of prior life-threatening reaction to contrast agent
* Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
* Planned surgical procedure or major amputation to occur after enrollment of the patient
Home Exercise to Enhance Mobility for Older Diabetics

The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. In this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (I) group versus a flexibility and toning, health education control (C) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year. This research can lead to an exercise/PA enhancement program that can coordinate with VA outreach programs, targeting older Veterans who are not in the immediate vicinity of a major VA site. Ultimately, this should create a model to which physicians and other providers could refer comorbid diabetes patients.

The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. To facilitate adherence to a long-term program, the investigators plan an individualized, home exercise/physical activity (PA) enhancement program with behavioral support. The rationale for this program is based on: 1) the feasibility of a previously funded VA RR\&D controlled trial (led by the present research team) in sedentary older adults with diabetes that improved mobility performance, specifically usual gait speed; 2) the need for longer term and functionally-relevant interventions (specifically mobility-oriented) for older adult diabetics; 3) the potential to use telephonic nurse support to assist in overcoming barriers to exercise and in dealing with intercurrent illness, factors that are key in this comorbid patient group; and 4) the potential to increase the focus on objectively measured physical activity. In this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (I) group versus a flexibility and toning, health education control (C) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary
* Type 2 Diabetes
* No medical contraindications to exercise

Exclusion Criteria:

* Enrolled in intensive exercise program
* Unable to cooperate with protocol (e.g. cognitive impairment)
The Effect of Emotional Freedom Technique on Perceived Stress and General Self-Efficacy in Nursing Students

The study was conducted to determine the effect of Emotional Freedom Technique (EFT) on perceived stress and general self-efficacy in obstetrics and gynecology nursing lesson in undergraduate nursing students with fear of birth.

The samples were applied to undergraduate nursing students satisfying the research criteria in a state university nursing faculty in Konya at November 2022.

The study was designed to be randomly controlled. Block randomization method was used to determine the intervention and control groups. Randomization was done by a biostatistician outside the researcher. 50 nursing students were randomly assigned to the intervention and control groups. The study was carried out in three stages with three EFT applications, applied for approximately 20-30 minutes, at 7-day intervals. In the first stage, students who met the inclusion criteria were identified by interviewing students who thought they had a fear of childbirth. After informed consent was obtained from the students and pretest data were collected, they were randomly assigned to intervention and control groups. EFT application was applied to those in the intervention group. No intervention was made for the control group. Data was collected twice for the intervention group, before the first EFT application (pretest) and after the last EFT application (posttest). The control group was also tested at the first interview and again 3 weeks later. The applications were carried out face to face with the students as a group. For the collection of research data, "Descriptive Information Form", "General Self-Efficacy (GSE) Scale", "Perceived Stress Scale" and "The Subjective Units of Distress (SUD) Scale" were used.

Eligibility Criteria:
Inclusion Criteria:

* Female students who were taking the Obstetrics and Gynecology Nursing course at the Faculty of Nursing, who volunteered to participate in the study, and who thought they had a fear of childbirth were included in the study.

Exclusion Criteria:

* Female students who did not take the Obstetrics and Gynecology Nursing course at the Faculty of Nursing, did not volunteer to participate in the study, and did not think they had a fear of childbirth were not included in the study.
Phase 1 Pharmacokinetics of Intravenous Nexium in Children

The purpose of this research study is to evaluate how much of repeated once daily intravenous (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require acid suppression therapy.


Eligibility Criteria:
Inclusion Criteria:

* parent/guardian must sign consent form and the child will be asked to sign and Assent Form if he/she is old enough and is able to sign
* verbal assent will be acceptable if the child is old enough to understand, but unable to write
* female and/or male hospitalized patients aged 0-17 years old who should be considered for treatment with acid suppressive therapy.

Exclusion Criteria:

* female patients that are pregnant, or plan to become pregnant during the study period or is breast-feeding a child
* patients with a history of multiple drug allergies
* any illness, medical history, abnormal laboratory values, abnormal physical examination findings or abnormal vitals signs that could put the patient at risk when participating in the study
Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients

Difficult ventilatory weaning is associated with a 20% mortality rate. 40% of these patients will develop intensive care unit (ICU)-acquired neuromyopathy, associated with reduced cough strength and a 4-fold increase in the risk of reintubation. The objective measure of cough strength is peak expiratory flow (PEF). Instrument-assisted coughing is a respiratory physiotherapy technique capable of significantly increasing PEF in chronic neuromuscular patients and draining bronchial secretions.

The objective of the study is to determine whether an early, systematic, instrumental, intensive respiratory physiotherapy strategy in patients with difficult ventilatory weaning and ICU-acquired neuromyopathy significantly improves PEF immediately prior to extubation, compared with a conventional, protocolized management strategy.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years or more, affiliated to a social security system
* Patients on invasive mechanical ventilation for 48 hours or more
* Failure of at least one mechanical ventilation weaning test (spontaneous breathing trial, SBT)
* First successful SBT on the day of eligibility assessment
* Medical Research Council (MRC) score \< 48 and/or cough strength ≤ 2 on the 6-point Likert scale

Exclusion Criteria:

* Recent brain injury (\< 3 months, stroke, cardiopulmonary arrest)
* Delirium tremens (Cushman score \> 7)
* Chronic neuromuscular pathology
* Patient under continuous intravenous sedation
* Patient unresponsive to simple commands and Richmond Agitation and Sedation Scale (RASS) score \< -2 or \> +1
* FiO2: Inspired Oxygen Fraction\> 50%, percutaneous, O2: oxygen saturation \< 88%, positive end-expiratory pressure \> 5 centimeter of water (cmH2O) or respiratory rate ≥ 35 min-1
* Failure of 7 or more SBT at time of eligibility
* Vasopressor catecholamine at a dose \> 0.5 μg/kg/min
* Tracheostomized patient
* Undrained pneumothorax
* Pulmonary emphysema (identified as antecedent in medical record)
* Uncontrolled hemoptysis
* Surgery \< 3 months of esophagus and/or the ear, nose and throat (ENT) sphere
* Pregnancy or lactating
* Patient deprived of liberty by judicial or administrative decision
* Patient under guardianship or curatorship
* Patient already included in the same study or in another study sharing the same primary endpoint
Data Analysis of a Managed Care Weight Reduction Trial

This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in 2001 that evaluated the costs and effects of incremental components of a weight-loss program. Data analysis will involve cross-sectional and predictive analyses and may include: regression analyses to determine predictors of weight loss and cardiovascular risk, correlations between weight reduction strategies and biological indices, and interactions between biomarkers of inflammation and traditional cardiovascular risk factors. This data will also be available for economic modeling.

This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in 2001. Using a 3-arm, 12-month randomized clinical trial, Wylie-Rosett et al. evaluated the costs and effects of incremental components of a weight-loss program. The study included 588 individuals (BMI\> 25 kg/m2) in a freestanding health maintenance organization and achieved an 81% completion rate. The intervention used a cognitive behavioral approach for tailoring lifestyle modification goals. The incremental levels of interventions included a) a workbook alone, b) the addition of computerized tailoring using onsite computer kiosks with touch screen monitors, and c) the addition of both computers and staff consultations. For the increasing levels of intervention intensity, the mean 12-month weight losses were 2.2, 4.7, and 7.4 pounds, with the respective cost per participant being $12.33, $41.99, and $133.74. The decreases in mean BMIs for these respective intervention levels were 0.4, 0.9, and 1.2. All groups reported a decrease in energy and fat intake and an increase in blocks walked (p\<.01). Intervention variables that correlated with weight loss included more computer logons, achieving computer-selected goals, more self-monitoring, increased walking, and decreased energy and fat intake, as well as higher attendance in staff consultation group sessions for that treatment condition. Weight loss correlated with decreases in fasting glucose and blood pressure. Wylie-Rosett et al. (2001) concluded that, in a weight-loss program, computers can facilitate selecting behavioral change goals. More frequent usage resulted in greater weight loss, and staff counseling to augment the computer intervention achieved the most weight loss. The purpose of this study will be secondary analysis of the data collected in the original MODELS study.

Eligibility Criteria:
Inclusion Criteria:

* BMI of more than 25 (or a BMI of 24 or more plus 1 cardiovascular risk factor), and the willingness to follow the study protocol, which included a refundable $100 deposit

Exclusion Criteria:

* Intention to move beyond commuting distance in the next 12 months,
* Medical conditions that would interfere with study participation,
* Unwillingness to follow the study protocol.
Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar

Tuberculosis (TB) whole genome sequencing (WGS) allows outbreak identification and disease transmission tracking.

It is hypothesized that prospective WGS-guided epidemiological investigations improve case detection compared to current best practices by adapting contact tracing strategies to local transmission patterns.

A cluster randomized controlled trial (cRCT) will be performed in high TB incidence villages of Haute Matsiatra region in Madagascar. Communities will be randomized in three separate TB control strategies comparing (1) standard of care, (2) the World Health Organization (WHO) recommended best practices and (3) a novel intervention involving TB WGS cluster-guided epidemiological investigations. The incremental value of TB WGS on case notifications and reduction of TB burden will be measured.

Secondary studies will be nested within this cRCT will include:

* A qualitative study which will increase the understanding of the factors facilitating and hindering implementation of WGS-based diagnostics within health systems.
* A cost effectiveness analysis study which will measure the cost effectiveness of newly implemented laboratory methods.

Field and genomic epidemiology data from this project will inform future work on the design of community-level TB elimination strategies in collaboration with Madagascar National TB program


Eligibility Criteria:
Inclusion Criteria:

* Subjects suspected TB
* subject living in the study area

Exclusion Criteria:

* unable to take a sputum sample
Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection

To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint or spacer infections


Eligibility Criteria:
Inclusion Criteria:

* Prosthetic knee or hip joint infection
* Infected joint spacer
* Able to swallow tablets
* Able to voluntarily sign the informed consent form
* Females of childbearing potential must use an acceptable method of birth control
* The joint infection must be attributed to bacterial pathogens sensitive to fusidic acid and rifampin

Exclusion Criteria:

* History of hypersensitivity or intolerability to sodium fusidate (Fucidin®), or to rifampin
* Females who are pregnant or lactating
* Requirement for significant immunosuppression
* Bacteremia
* Known cirrhosis or decompensated liver disease
* Current treatment for HIV or Hepatitis C
* Seizure disorder, requiring anti-convulsants
Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Effect of Systematic Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

This study is proposed to explore the effect of systemic Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery.

After hand and wrist surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.

In this study, investigators compare different doses of systemic Dexamethasone. Before the anesthesia, the patients receive Dexamethasone intravenously. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.2mg/kg.

The investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously covers the need for good pain relief and fast recovery postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* children scheduled for hand/wrist surgery
* body weight \> 5kg

Exclusion Criteria:

* infection at the site of the regional blockade
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use
Treatment of Periodontal Intrabony Defects With A-PRF+ or EMD

The aim of this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) to enamel matrix derivatives (EMD) in periodontitis patients.

Thirty (30) intrabony defects of 18 patients (9 males, 9 females) were randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects were filled with A-PRF+ (n=15) in the test group, respectively with EMD in the control group, and fixed with sutures to ensure wound closure and stability.

Eligibility Criteria:
Inclusion Criteria:

* no systemic diseases that could influence the outcome of the therapy, a good level of oral hygiene, he presence of a 2-, 3-, or combined 2-3-wall intrabony defect with a defect angle of 20-40 (+/- 5) degrees, with a minimum PPD of 6 mm and intrabony component of a minimum 4 mm as detected on radiographs, no smoking

Exclusion Criteria:

* systemic diseases that could influence the outcome of the therapy, poor oral hygiene, smoking, horizontal bone loss
Effects of Spironolactone on Matrix Metalloproteinases (MMPs) in Heart Failure

The purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels and insulin resistance in patients with chronic heart failure.

Myocardial fibrosis is observed in failing hearts. MMPs are considered markers of fibrosis. Recently, circulating MMPs can be measured and are elevated in patients with chronic heart failure (CHF). It has been reported that spironolactone improves myocardial fibrosis in CHF animal models. Therefore, the purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels in patients with chronic heart failure.

Eligibility Criteria:
Inclusion Criteria:

* chronic stable heart failure
A Study to Evaluate the Conformis iTotal Identity Knee Replacement System

This is a prospective multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation.


Eligibility Criteria:
Inclusion Criteria:

* Clinical condition included in the approved Indications For Use for the iTotal Identity CR KRS
* Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
* Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
* \> 18 years of age with complete development of musculoskeletal structures

Exclusion Criteria:

* Simultaneous bilateral procedure required
* BMI \> 40
* Active malignancy (defined as a history of any invasive malignancy - except nonmelanoma skin cancer), unless subject has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
* Poorly controlled diabetes (defined as HbA1c \>7 or Investigator discretion)
* Neuromuscular conditions which prevent subject from participating in study activities
* Active local or systemic infection which precludes TKR procedure
* Immunocompromised in the opinion of the Investigator
* Medically diagnosed fibromyalgia or similar conditions that might impact the subject's ability to differentiate source of pain
* Rheumatoid arthritis or other forms of inflammatory joint disease
* Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified
* Diagnosed with or receiving treatment for osteoporosis that is likely to confound results in the opinion of the Investigator
* Other physical disability affecting the hips, spine, or contralateral knee that is likely to confound results in the opinion of the Investigator
* Severe instability due to advanced loss of osteochondral structure
* Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
* Compromised PCL or collateral ligament
* Severe fixed valgus or varus deformity of \>15º
* Extensor lag \> 15º
* Fixed flexion contracture ≥ 15º
* Unwilling or unable to comply with study requirements
* Participation in another clinical study which would confound results
* Allergy to any of the implant materials
* Pregnant or planning to become pregnant prior to study TKR procedure (in case of pregnancy after study TKR procedure, eligibility to continue with the protocol will be reviewed)