cyrilzakka/clinical-trials huggingface dataset:
Controlled Hyperventilation as Prophylaxis for Acute Mountain Sickness

This study evaluates the safety and efficacy of the voluntary ventilatory response as prophylaxis for acute mountain sickness, measured by the Lake Louise Self-Report Score, comparing to a group using acetazolamide.

Rationale: Acute mountain sickness (AMS) is a common condition among people who go to altitude and stay at altitude. Acclimatization is the most important mechanism in order to reduce the risk of AMS, however, this is not possible or adequate in a large part of the cases. Recently, there are indications that adjustment of respiration by means of a voluntary increase in the respiratory minute volume can have a similar prophylactic effect. The purpose of this study is to measure the effect of the voluntary increase of the minute volume by means of controlled hyperventilation as prophylaxis for acute mountain sickness without prior acclimatization, with AMS being expressed in the Lake Louise Self-Report Score (LLSRS).

Objective: To investigate the safety and efficacy of the voluntary increase in minute ventilation by means of controlled hyperventilation as prophylaxis for AMS, measured by the LLSRS in a randomized controlled trial ascending to 4954m altitude.

Study design: Prospective randomized controlled trial, safety and efficacy.

Study population: 30 healthy subjects

Intervention: The investigational prophylaxis is controlled hyperventilation. Participants in the interventional group will be trained to hyperventilate in a controlled fashion doing a series of exercises during the 4 days prior to the ascent. They will also be taught in a practical way to recognize early clinical signs and symptoms of hypocapnia.

Main study parameters/endpoints: Safety and efficacy measured by comparing the LLSRS between the two groups. Target end-tidal CO2 ( PETCO2) will be measured to objectify adequate hyperventilation. Symptoms of hypocapnia due to the (pre-)intervention as well as any adverse events will be reported and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Living at lower altitude than 900 meters

Exclusion Criteria:

* Cardiac or pulmonary comorbidity
* Smoking
* Infectious disease during the last 30 days
* BMI\> 30
* Pharmaceutical use as diuretics, corticosteroids, acetazolamide, or anti -inflammatory drugs during the 2 weeks prior to the study
* A history of high altitude cerebral edema or high altitude pulmonary edema
* Cardiovascular risk factors such as a personal history of cardiovascular disease, familial history of major adverse cardiovascular events (MACE) at age younger than 45 yrs, hypercholesterolemia and stroke.
Cost-effectiveness Study of the New Nutrition Screening Tool CIPA at Hospital Admission

Objectives: To evaluate the cost-effectiveness of implementing a malnutrition screening tool "CIPA" at the Hospital Universitario Nuestra Señora de la Candelaria (HUNSC), comparing the impact on health and the healthcare costs of hospitalised patients who are screened for malnutrition and of patients following standard clinical practice. Methodology: The study will consist of a controlled trial on patients admitted to the Internal Medicine and General and Digestive Surgery wards at the HUNSC. In both wards patients will be assigned to a control or to an intervention group. The control group will follow usual hospital clinical care, while the intervention group will be administered the screening tool "CIPA" for early detection of malnutrition cases and they will be treated according to the screening results. The following variables will be evaluated: length of stay in hospital, mortality, readmissions and in-hospital complications. Cost-effectiveness analysis will be undertaken measuring effectiveness by Quality-Adjusted Life Years (QALYs). Cost per patient will be measured by identifying health care resource utilisation, and the cost-effectiveness measure will be the Incremental Cost-Effectiveness Ratio (ICER). Investigators will calculate the incremental cost per QALY gained related to the intervention. This analysis will allow to quantify the costs (incurred and saved) related to the introduction of the malnutrition screening tool CIPA in the hospital context and to measure the health impact of screened patients.


Eligibility Criteria:
Inclusion Criteria:

* Formal consent to participate in the study.
* Patients admitted to the Internal Medicine or General Surgery wards.

Exclusion Criteria:

* Patients treated with nutritional support before CIPA screening is performed.
* Patients transferred from other wards.
* Patients with an expected length of stay less than 72 hours.
* CIPA screening unfeasible for any reason.
* Patients with poor short-term prognosis.
* Bed destination at hospital admission nonrandomized.
* Patients participating in other investigation study.
* Pregnancy
Early Revascularization in Stable Ischemic Heart Disease Using P.E.T. Imaging

To compare the impact of revascularization and Optimal Medical Treatment (OMT) on the extent of severely reduced coronary flow capacity in stable ischemic heart disease.

The initial Positron Emission Tomography (PET) scan will be performed as part of clinical practice. If the patient is a potential candidate for the study, the patient will be screened for inclusion and exclusion criteria. After being informed about the study potential risks, all patients giving written informed consent will be randomized into one of two groups: Urgent revascularization combined with Optimal Medical Treatment (OMT) or OMT with delayed revascularization. Following the initial PET scan, randomization and treatment, each group will undergo a second PET scan at the 3-4 month mark and a third PET scan at the one year mark. Some crossover may occur with the two groups. The OMT without urgent revascularization patients will remain in that group, if clinically stable, up to three months. At their first follow-up visit (Day 105±20), patients will be offered the option of continued medical treatment or elective revascularization consistent with informed patient preference and clinical judgement. Patients, in consultation with their physicians, may elect to undergo revascularization at any time thereafter.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Stable ischemic heart disease as determined by an investigator.
3. Areas of severely reduced CFC or relative stress images on the Rentrop diagnostic PET MPI consistent with clinical judgement as follows:

   • PETs with a defect on rest relative images of ≤60% of max for ≤5% of LV (no large scar) plus: i. ≥2% of LV with CFCblue\* or ii. ≥10% of LV with CFCgreen\* plus at least one pixel with CFCblue\*

   \*CFCblue is defined as a dipyridamole induced stress flow ≤ 0.83 ml/min/g of myocardium and a CFR ≤ 1.27. CFCgreen is defined as a dipyridamole induced stress flow ≤1.09 and \>0.83 ml/min/g of myocardium and a CFR ≤1.60 and \>1.27.
4. Willing to comply with the follow-up schedule of the trial.
5. Subject must sign the informed consent in English or Spanish.

Exclusion Criteria:

1. Any conditions that may compromise or prevent the necessary imaging requirements.
2. Less than one-year life expectancy.
3. Currently pregnant or planning to become pregnant during the course of the study.
4. Any other issues that the Investigator believes may interfere with treatment or follow-up.
5. Subjects who lack capacity to consent for themselves.
AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes

This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.


Eligibility Criteria:
Inclusion criteria:

* Body mass index \> or = to 25 kg/m2.
* HbA1c \> or =7% and \< or =10% at screening.
* FPG \> or = 7.0mmol/L (126mg/dL) at visit 2.
* Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
* Female subjects must be postmenopausal or using effective contraceptive measures.

Exclusion criteria:

* Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
* Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
* Subjects with a history of severe hypoglycaemia.
* Renal disease or renal dysfunction.
* Presence of clinically significant hepatic disease.
* Presence of unstable or severe angina or known NYHA grade I-IV congestive heart failure.
* Subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.

Male subject diagnosed with a stricture in the anterior urethra that can be treated with the Optilume Urethral DCB. Thirty-Four (34) subjects will be enrolled at up to ten (10) sites in the United States. Clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months post-treatment evaluating Lower Urinary Tract Symptoms (LUTS), sexual function, and voiding function. Semen quality parameters will be assessed at Baseline, 3 months, and 6 months post-treatment. Subjects with an abnormal semen quality result at 6 months will have an additional assessment at 12 months post-treatment and periodically thereafter until results return to normal.

Eligibility Criteria:
Inclusion Criteria:

1. Male subjects between 22 and 65 years of age
2. Subject diagnosed with a stricture in the anterior urethra that is able to be treated with the Optilume Urethral DCB in accordance with the approved Instructions for Use
3. Subject is willing to provide written informed consent and comply with study required follow-up assessments
4. Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):

   1. total sperm ≥39 million
   2. sperm concentration ≥15 million/mL
   3. total motility ≥40%
   4. progressive motility ≥32%
   5. morphology ≥4%

Exclusion Criteria:

1. Subjects with a known hypersensitivity to paclitaxel or structurally related compounds
2. Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
3. Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
4. Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
5. Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
6. History of cancer in any body system that is not considered in complete remission
Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments

Study comparing different groups of people and how they respond to application of the non-pneumatic anti-shock garments. Investigators will divide all recruited participants into three groups based on health status (group 1: hemodialysis patients; group 2: patients with severe chronic kidney disease but not on dialysis; group 3: healthy participants with no clinically known kidney disease). Each group, which will comprise of 10 people, will receive the same treatment using the non-pneumatic anti-shock garments.

Primary Aim: To determine how blood flow restriction to the lower extremities using non-pneumatic anti-shock garments affects hemodynamic and cardiovascular parameters such as blood pressure in Hemodialysis (HD) patients while they are not on dialysis.

Investigators propose a pilot study to assess the effects of blood flow restriction using non-pneumatic anti-shock garments in HD patients while they are not on dialysis.

Outcomes: The primary objective will be a measurement of blood pressure upon application of the non-pneumatic anti-shock garments.

Secondary outcomes will include the following: baroreflex sensitivity; trends in beat-to-beat blood pressure upon application of the anti-shock garments; patient tolerability of the non-pneumatic anti-shock garments, ejection fraction via echocardiogram analyses.

Eligibility Criteria:
Inclusion Criteria:

Healthy participants

1. Male and female, age≥18 years old
2. No clinical diagnosis of CKD

CKD patients not on dialysis

1. Male and female, age≥18 years old
2. Stage 4 or Stage 5 CKD patients

CKD patients on dialysis

1. Male and female, age≥18 years old
2. Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility

Exclusion Criteria:

1. Not meeting inclusion criteria
2. Severe heart failure (New York Heart Association grade IV)
3. Pulmonary hypertension
4. Mitral stenosis
5. Cardiac transplant recipients
6. Mental incapacity to consent
7. Declined to participate
8. Absence of lower limbs or lower limb injury
9. Pregnancy
Prepared Meals to Prime and Perpetuate Reduced Dietary Sodium Intake in Hemodialysis

This is a randomized clinical trial in which maintenance hemodialysis patients will be provided with salt restricted 'dialysis friendly' meals and compared to a control arm receiving usual care.

Patients randomized to the intervention arm will receive 2 months of meals plus dietary counseling. Counseling will continue for an additional 3 months while the control arm will have 5 months of usual care followed by 2 months of meal provision. Effects on interdialytic weight gain, achievement of target dry weight, intradialytic hypotension episodes, blood pressure, and a volume assessment using lung U/S to assess lung water will be measured. Salt sensitivity will be tested throughout the study. Self reported questionnaires about the burden of adhering to the low salt diet and the level of adherence with it will be completed at baseline and throughout the study. The investigator hypothesizes that the prepared meals with prime patients behavior and may alter salt taste perception and that these effects will be sustained after the prepared meals have stopped.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18
2. Treated with outpatient hemodialysis for \>60 days
3. Mean IDWG over the past 30 days \>2 kg
4. Speaks and understands English or Chinese
5. Patient has a freezer at home with space to store at least 7 prepared meals
6. Cognitively intact (able to provide informed consent and answer questionnaires)

Exclusion Criteria:

-
A Serious Game to Rehabilitate Gaze Stability in Children with Vestibular Deficit

Since the early 2000s, vestibular rehabilitation has been proposed as a therapeutic tool to improve the balancing function and the various motor skills in children, in particular in children with hearing loss suffering from concomitant vestibular deficit. It has been demonstrated in adults with vestibular deficit that the fact of adding to the classic exercises on the control of balance per se and habituation, specific exercises of adaptation and substitution of the vestibulo-ocular reflex brought therapeutic benefit. These exercises, which are started in the presence of the physiotherapist and then continued by the patient himself at his home, aim to improve the stabilization of the gaze during head movements. In pediatrics, however, performing them is more difficult than conventional exercises, since their immediate interest is not well understood by the child, who may be reluctant to perform them. The present project aims to enrich the therapeutic offer by a pediatric rehabilitation method of eye stabilization sufficiently playful to win adherence to treatment, including in the absence of the physiotherapist when the child is at home.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a vestibular disorder by the batteries of tests used in clinical routine.
* Supported by the multidisciplinary team of the Audiology and Otoneurological Exploration Department at the HFME
* Patient or parents able to understand the ins and outs of the study
* No opposition from children and parents

Exclusion Criteria:

* Associated visual sensorineural deficit
* Orthopedic or muscular disorder in the cervical spine
Medical Self-Management for Improving Health Behavior Among Individuals in Community Mental Health Settings

This study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behavior of people who are receiving care at a community mental health center.

People with serious mental disorders tend to have shorter life expectancies and elevated rates of unhealthy behaviors and chronic illnesses. Peer-led medical illness self-management programs have been shown to be effective in improving the health and health behaviors of people with chronic medical conditions. This type of intervention, however, has yet to be systematically tested in individuals with mental disorders. Community mental health centers provide care to many people of low socioeconomic status who lack medical insurance. This study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behaviors of people who are receiving care at a community mental health center.

Participants in this study will be randomly assigned to either partake in peer-led medical illness self-management group sessions or receive care as usual. Participants assigned to care as usual will continue to receive any services they would have otherwise been offered, but will not receive any additional services through the study. Participants assigned to the medical illness self-management program will attend group sessions once a week for 6 weeks. Sessions will focus on medical self-management, healthy behaviors, and effective use of the general medical system.

Eligibility Criteria:
Inclusion Criteria:

* Currently receiving treatment at Dekalb Community Service Board
* Chronic disease

Exclusion Criteria:

* History of more than two psychiatric or medical hospitalizations within the year prior to study entry
The Effectiveness of a Recovery Program for People With Mental Illness: A Multicenter Study

Recovery-oriented approach has been the main trend in mental health field. However, few recovery-oriented programs are available in Taiwan, and many Taiwanese people with mental illness don't understand the concepts of recovery. A program which provides recovery knowledge and assists in setting recovery goals is beneficial for Taiwanese people with mental illness. Hence, this study aimed to investigate the effectiveness of a recovery program for people with mental illness.

This is a randomized control trial. Participants will be recruited from the psychiatric rehabilitation organizations in Taiwan. They will be randomly assigned to the intervention group or control group. The recovery program has 2 phases and consists of 20 classes, 1.5 hour per class and one class per week. We will introduce concepts of recovery and personal strengths in phase 1. Then, we will help participants to set goals and implement their plans in phase 2. Participants will fill out five questionnaires during the recruitment meeting, including Stages of Recovery Scale, Medical Outcomes Study Social Support Survey, The Hope Scale, Rosenberg Self-Esteem Scale and Brief Symptom Rating Scale-50. They will fill out the same questionnaires plus the course satisfaction survey in the end of phase 1 and 2. Six months later, participants will receive a follow-up interview and fill out the questionnaires again. The control group will receive a spiritual book and complete the questionnaires at the same time as the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mental illness
* lived in community

Exclusion Criteria:

-
ViewFlex X ICE First-in-Human Study

This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System).


Eligibility Criteria:
Inclusion Criteria:

A patient will be eligible for clinical trial participation if they meet the following criteria:

1. Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
2. Plans to undergo any EP procedure utilizing ICE
3. At least 18 years of age

Exclusion Criteria:

A patient will be excluded from enrollment in the study if they meet any of the following criteria:

1. Subject is currently participating in another clinical investigation.
2. Implanted left atrial appendage occluder
3. Implanted mechanical mitral or tricuspid valve replacement
4. Implanted intracardiac device within 30 days
5. Pregnant or nursing
6. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
The IDEAL-PCI Extended Registry

The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).

IDEAL-PCI Extended is the continuation of the IDEAL-PCI registry with additional focus on bleeding events and net clinical benefit

Determination of platelet reactivity in patients with percutaneous coronary Intervention as described in the IDEAL-PCI registry.

In the IDEAL-PCI Extended Registry an additional deescalation arm with reduction of the standard dual antiplatelet therapy (DAPT) dosis in case of low platelet reactivity to P2Y12 Inhibition or Aspirin with or without bleeding is implemented.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive PCI patients

Exclusion Criteria:

* pregnancy
Pulmonary Vein Isolation Versus Botulinum Toxin Injection Plus Pulmonary Vein Isolation in Patients With Atrial Fibrillation

The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different treatment strategies, PVI only versus PVI plus BT injection, in patients with persistent and paroxysmal AF. Results were assessed after follow-up of at least 1 years with the use of an implanted monitoring device (IMD).


Eligibility Criteria:
Inclusion Criteria:

* Persistent and paroxysmal AF

Exclusion Criteria:

* congestive heart failure
* LV ejection fraction \< 35%
* left atrial diameter \> 60 mm
Biomechanics/Motion Analysis Laboratory Data Bank

The purpose of the data bank is to collect data on joint motion.

Biomechanical aspects, including ground reaction forces, range of motion of involved extremities, EMG data and videotape records of human motion will be collected and stored as part of the normal clinical care of patients seen in the UF Biomechanics/Motion Analysis Laboratory. All persons seen in motion analysis laboratory will be told of study and asked to participate. Those agreeing to participation will give informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Any person having joint analysis done for medical or personal need

Exclusion Criteria:

* None, any person having joint analysis done for medical or personal need and interested in participation will be asked to sign informed consent.