cyrilzakka/clinical-trials huggingface dataset:
Improving Function, Participation and Function After Acute Hospitalization in Older Adults

Hospitalization increases the risk for new disability in older adults. In the current health care system, home health physical therapy is understudied and often does not return older adults to prior levels of function. The proposed evidence-based multicomponent intervention that combines high intensity strength training and motor control based systems of gait and balance training will advance clinical practice by providing an intervention strategy for practitioners. If successful, improving patient function and decreasing re-hospitalization rates and falls will have large cost saving implications.

Background: Hospitalized older adults are 59.8 times more likely to develop disability than those who are not hospitalized. No studies have examined the effectiveness of Home Health (HH) physical therapy on improving function in older adults with multiple co-morbidities after hospitalization. Our goal is to enable older adults with multiple chronic conditions to recover function by providing adequate content and dose of intervention after hospitalization. This intervention is designed to work within the existing Medicare system and has potential for immediate clinical impact.

Purpose: The primary aim of our study is to determine if a progressive multi-component (PMC) intervention, initiated upon discharge from an acute care hospital, improves gait speed at the end of one 60-day episode of care, more than documented usual care (UC) physical therapy. We hypothesize that there will be a greater improvement in gait speed measured for the PMC group compared to the UC group following one episode of care. Benefits of PMC will be apparent at the end of usual care and will increase further at the end of the 60 day episode of care (primary endpoint).

Design: We propose to conduct a single blind randomized two arm clinical trial (RCT) in older adults discharged from acute care and referred to HH physical therapy. Both interventions (PMC \& UC) will be Medicare-reimbursed. All assessments and interventions will occur in the patients' homes.

Methods: Twenty individuals who are 65 years of age or older with multiple co-morbid conditions will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* referred to home care physical therapy
* have at least 3 comorbid conditions
* ambulatory without human assistance prior to hospitalization

Exclusion Criteria:

* acute lower extremity fractures with weight-bearing restriction
* elective joint replacement surgery
* active cancer diagnosis
* acute cardiac surgery
* lower extremity amputation
* referred to hospice home health physical therapy
* dialysis
* hospice care
IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery

This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.

Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria

1. Female subject is between the ages of 18 and 75, inclusive.
2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® surgical system with Firefly® fluorescent imaging.
3. Subject is willing and able to provide informed consent.

Exclusion Criteria:

1. Subject is pregnant or nursing.
2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
3. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
4. Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile.
5. Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
6. Subject has any of the following screening laboratory values:

   1. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2
   2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × upper limit normal (ULN)
   3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × upper limit normal (ULN).
Safety and Effectiveness of Two Different Formulations of an HIV Vaccine in Infants Born to HIV-Infected Women

The purpose of this study is to test the safety and effectiveness of two different formulations of an HIV vaccine in infants born to HIV-infected women.


Eligibility Criteria:
Inclusion Criteria

Infants may be eligible for this study if they:

* Are 1 to 3 days old.
High Flow Nasal Therapy in Covid 19 Patient

This study aims to To identify factors that predict success of high flow nasal therapy in covid19 patients .

Coronavirus disease 2019 (COVID-19) is a potentially fatal infection caused by the novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)\[1\]. The highly contagious nature and exponential spread of SARS-CoV-2, coupled with its potential for a rapid progressto acute respiratory distress syndrome (ARDS), has overwhelmed health care systems globally, contributing to the high mortality rates in early reports \[1,2\].

The initial approach for respiratory support for severe COVID-19 pneumonia centredaround invasive mechanical ventilation and the standard lung protective strategy recommended for ARDS\[3\]. This may have been detrimental to a proportion of patients due to ventilator induced lung injury (VILI) and associated systemic inflammation\[4\]. Furthermore, other strategies to improve oxygenation may be more appropriate in patients with hypoxemic respiratory failure who do not require ventilatorysupport\[4\].

High-flow nasal oxygen (HFNO) is delivered by an air/oxygen blender, an active humidifier, a single heated circuit, and a nasal interface.

It delivers adequately heated and humidified medical gas at flow-rates of up to 60L/min, and is considered to have a number of physiological benefits, including the reduction of anatomical dead space and work of breathing, the provision of a constant fraction of inspired oxygen with adequate humidification and a degree of positive end-expiratory pressure (PEEP) \[5,6\].

Eligibility Criteria:
Inclusion Criteria:

* All Patients above 18 y old that will be diagnosed as COVID 19 based on PCR testing, who fulfil criteria that indicate need for high flow nasal therapy.

Exclusion Criteria:

* o Children less than 18 y old

  * Oropharyngeal and Nasopharyngeal swap negative patients
  * Patients who will refuse inclusion in the study
Employment and Quality of Life in Patients With Malignant Melanoma

Within the first year after diagnosis, data on employment and quality of life will be collected and evaluated in patients with malignant melanoma


Eligibility Criteria:
Inclusion Criteria:

* first diagnosis of malignant melanoma stage 0 to stage IIIC within the last 6 weeks
* written informed consent

Exclusion Criteria:

* diagnosis of malignant melanoma stage IV
* inability to follow the protocol
Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).

This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with symptomatic typical atrial flutter will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.

Eligibility Criteria:
Inclusion Criteria:

* Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFL occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including atrial fibrillation.
* At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
* 18 years of age or older
* Informed consent

Exclusion Criteria:

* Intracardiac thrombus
* Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure
* Women who are pregnant
* Cardiac surgery (ventriculotomy or atriotomy) within the past two months
* Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement
* Unstable angina or acute myocardial infarction within 3 months
* Awaiting cardiac transplantation
* Heart disease in which corrective surgery is anticipated within 6 months
* Presence of condition that precludes appropriate vascular access
* Enrolled in any investigational device exemption (IDE) investigating study for a device or drug
* High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician)
* Radio frequency (RF) ablation for typical atrial flutter within the past 2 months
Stress Reduction Study for Partners of Early Stage Dementia

This is a study designed to pilot a WOOP (Wish Outcome Obstacle Plan) intervention for spouses of persons with early stage dementia for the purposes of future research. The investigators will be using two cohorts. One who will get the intervention and the other who will be wait listed and receive the intervention at a later date. Spouses of persons with dementia will use WOOP, a brief goal attainment sequence, every day for 16 days. Participants will complete surveys before the intervention, at Day 16, and at a 3-month follow-up. The outcome measures are goal attainment, emotion regulation skills, psychological health, and support quality. As of 9/2020 this entire study is being conducted remotely.


Eligibility Criteria:
Inclusion/Exclusion Criteria:

* The couple is married or in a cohabiting, committed relationship.
* One partner has early Adult Dementia (AD) or a related dementia using criteria: symptoms consistent with early-stage dementia or memory impairment (e.g., AD, vascular dementia) and scores on the Neuropsychiatric Inventory (NPI) ≥3; Mini-Mental State Examination (MMSE) ≥18 and ≤27; and Barthel Index (BI) ≥5 and ≤1923. Or\>20 on Telephone Interview for Cognitive Status. (TICS)
* The spouse will have to score 27 or higher on the MMSE. Or\>25 on TICS.
* Both participants must agree to participate and complete baseline interviews.
* Both partners are at least 60 years old.
Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis Feasibility Study

Objective: The primary aim of this 60 patient feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol.

Background: Intravenous albumin (25%) boluses are frequently given to critically ill patients during slow low-efficiency dialysis (SLED) treatments for acute kidney injury (AKI). The intention of giving albumin during SLED is to stabilize the blood pressure to permit more aggressive overall fluid removal with ultrafiltration; however, there is little evidence to support this expensive practice.

Objective: The primary aim of this feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol.

The results of this feasibility trial will help us to plan and carry out a multicentre pilot trial comparing the efficacy of the interventions in achieving fluid removal in critically ill patients with AKI on SLED.

Design: A randomized controlled trial with two parallel arms. Setting: The mixed medical-surgical intensive care units of a Canadian tertiary care hospital.

Study Population: 60 patients with AKI requiring treatment with SLED (by definition, Kidney Disease Improving Global Outcomes (KDIGO) stage 3 AKI). Intervention: Participants will be randomized to receive either albumin (25%) boluses or normal saline placebo boluses during their SLED treatments.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 yrs;
2. AKI treated with SLED (stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines48).

Exclusion Criteria:

1. SLED initiated for non AKI-related indication (i.e. concurrent intoxication; treatment of hypothermia);
2. receiving chronic dialysis treatments;
3. history of allergic reaction to albumin;
4. pregnancy.
Endoscopic Remission, Histologic Remission and Barrier Healing for Predicting Disease Behaviour in IBD

Within this study, the investigators aim to directly compare the value of endoscopic remission, histologic remission and barrier healing for predicting long-term disease behavior in a large cohort of clinically remittent IBD patients.

Mucosal healing is a key therapeutic goal in the management of patients with inflammatory bowel diseases (IBD) that is associated with favorable long-term disease outcome. In addition, histologic remission is an emerging endpoint and first data suggest that functional assessment of the integrity of the intestinal barrier, i.e. barrier healing, by confocal laser endomicroscopy (CLE) correlates to clinical disease behavior and outcome.

Within this study, the investigators will prospectively include IBD patients in clinical remission and assess endoscopic remission, histologic remission and barrier healing during baseline ileocolonoscopy. Participants will then be closely followed up in the IBD outpatient department of the University Hospital Erlangen every 4 to 8 weeks for participants under biological therapy and every 8 weeks for participants under conventional therapy. At each visit, clinical disease activity using the Mayo Clinical Score (MCS) and the Crohn's disease activity Index (CDAI), respectively, routine laboratory parameters and current and past medications will be recorded. Further, at each visit, major clinical events (MCE), defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded. The primary endpoint of this study is to comparatively assess the predictive values of barrier healing, endoscopic remission and histologic remission for predicting occurrence of MCE in IBD patients in clinical remission

Eligibility Criteria:
Inclusion Criteria:

* patients with an established IBD diagnosis for at least 12 months duration
* IBD patients in clinical remission

Exclusion Criteria:

* patients with poor bowel preparation
* patients with total colectomy,
* patients with concomitant beta blocker therapy,
* patients with known allergy to fluorescein
* patients with a planned change in IBD-related pharmacotherapy
Utilizing Tailored Step-Count Feedback to Enhance Physical Activity in the Elderly

Individually tailored, mediated pedometer feedback will provide an effective method to promote physical activity adoption in the elderly


Eligibility Criteria:
Inclusion Criteria:

1. Male or female individuals living in the community.
2. Aged between 50 and 85 years, at screening.
3. Sufficient physical function not to have limitations to participate in physical activity demonstrated by:

   * Habitual gait speed ≥ 1.5 mph, AND
   * No use of a cane or walker, AND
   * Able to walk ≥ 50 feet unaided
4. Sufficient cognitive function, as demonstrated by responses to the mini-mental state examination(\>23 score).
5. Be able to read and write in English
6. Sedentary behavior, demonstrated by no regular activity / exercise for previous 6 months and/or a Stage of Change 2 and 3

Exclusion Criteria:

1. Presence of a rapidly progressive or terminal illness condition that is expected to result in significant functional decline during the course of the proposed studies.
2. Significant uncontrolled cardiovascular disease and conditions, e.g. unstable or new onset angina, unrepaired aortic aneurysms, critical aortic stenosis or CAD without bypass, persistent moderate to severe uncontrolled hypertension.
3. Significant uncontrolled metabolic disease, e.g. hemoglobin A1c levels greater than 8.0 and/or glucose levels greater than 300 mg/dL.
4. Fracture of lower extremity within three months.
5. Amputation other than toes.
6. Current history of severe arthritis or orthopedic condition precluding physical activity.
7. Participation in any regular structured exercise (resistance training, Tai Chi, high intensity walking, jogging, cycling, stair climbing, stepping, within the previous 6 months.
8. Individuals that start a new medication that can impact health variables examined during study period (e.g., beta blockers, glucose or cholesterol altering medications), or individuals who alter medication dose that can impact health variables examined within study period.
Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations

A remote study to find out if a mobile phone application (HealthMode Stool) can serve as a useful tool to track and characterize daily bowel movements. The application provides participants with a single place to record their bowel movements either as a part of their general health self-monitoring, or because they may be dealing with a bowel movement condition. The minimal study duration is 1 month, and participants can continue using the application up to 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Females and males over 18 years old
* Willing to use their own/personal mobile phone (iPhone 6 or higher, running iOS 11 or higher) for participation
* Willing to share demographic data with the sponsor of the study
* Willing to follow app use instructions during the course of the study
* Willing to log the bowel movement events on a daily basis with manual input of additional characteristics
* Willing to complete survey instruments as described in study procedures
* Willing to provide electronic informed consent
* Able to read and understand the english language well enough to complete electronic informed consent

Exclusion Criteria:

* New to HealthMode Stool application:
* No additional exclusion criteria.

OR

* Current HealthMode Stool User:
* Is an active participant in any other study using HealthMode Stool app in its protocol.
Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.

Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.

Pharmacodynamic study of pathophysiological nature to assess the effects of prolonged administration of human albumin in the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years and less than 80 years.
* Diagnosis of liver cirrhosis by biopsy or by clinical, laboratory, or ultrasound.
* Daily requirement of diuretics at least 200mg of spironolactone or 100mg of spironolactone and 40 mg of furosemide
* Renal dysfunction defined by a plasma concentration of serum creatinine ≥ 1.2 mg / dl, blood urea nitrogen ≥ 25 mg / dl or a serum sodium concentration ≤ 130 mEq / L.

Exclusion Criteria:

* Refractory Ascites (paracentesis requirements over 1 month.
* Neoplastic disease including liver cancer if it exceeds the Milan criteria (one nodule\> 5 cm or three nodules\> 3 cm).
* History of transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt
* Gastrointestinal bleeding or bacterial infection documented in the past 15 days.
* Heart failure or structural heart disease.
* Organic renal insufficiency(proteinuria, hematuria and / or ultrasound data nephropathy).
* Moderate or severe lung chronic disease.
* Transplant.
* Infection with human immunodeficiency virus.
* Active addiction to drugs.
* Mental state that prevents the patient understand the nature, extent and consequences of the study, except for hepatic encephalopathy.
* Pregnancy.
A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder

Primary Objective:

* To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Objectives:

* To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder
* To evaluate plasma concentrations of SSR125543

This duration of this trial is 11 weeks.

Eligibility Criteria:
Inclusion criteria:

* Patients with a diagnosis of major depressive disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).

Exclusion criteria:

* Inpatient hospitalization at screening
* Symptoms of depression present for \<30 days or \>2 years
* Significant suicide risk
* Mild depression as measured by standard clinical research scales
* History of failure to respond to antidepressant treatment
* Other psychiatric conditions that could obscure the results of the study
* For women of child-bearing potential, the unwillingness to use highly effective means of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.