linjc16/ctgov huggingface dataset:
Integrated Diagnostic for Heart Failure

Study Overview
=================
Brief Summary
-----------------
A prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink.

Detailed Description
-----------------
Patients with systolic heart failure (HF) implanted with Medtronic wireless implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy device with defibrillation capabilities (CRT-D) devices will be enrolled in the study. The purpose of the study is to evaluate the usability of CareLink HFRS to manage a patient's heart failure.

Official Title
-----------------
Integrated Diagnostic for Heart Failure

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 18 years of age or older Patient ( or patient's legally authorized representative) is willing and able to provide written informed consent Patient is willing and able to comply with the required study follow up visits Patient is implanted with a Medtronic wireless ICD or CRT-D device capable of OptiVol fluid monitoring feature Patient is on Medtronic CareLink network or is willing to be enrolled on the CareLink network Patient is being managed, or has been managed, by a HF clinician Patient has signed an informed consent for CareLink Network Services Patient is implanted with device for at least three months Patient is willing and able to transmit data using the CareLink home monitor (2490C). Exclusion Criteria: Patient is participating in another study that may interfere with TRIAGE-HF protocol required procedures Patient with an implantable cardiac device that is indicated to reach ERI in less than 12 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no treatment<br>non-randomized, all subjects who have been implanted with an ICD or CRT-D for at least 3 months | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Risk Status Performance Characterization | The clinical signs and symptoms of worsening HF that are associated with an Heart Failure Risk Status triggered by an OptiVol alert | from baseline until a subject completes 8 months of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Risk Status and medical management | The correlation between HFRS burden and clinician's assessment of a subject risk and the subject's medical management | from baseline for each subject until they complete 8 months of follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, HFRS, OptiVol, ICD, CRT-D
A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.

Official Title
-----------------
A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure

Conditions
-----------------
SARS CoV-2 Infection

Intervention / Treatment
-----------------
* Biological: Human Amniotic Fluid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Age ≥18 2. Hospitalized and symptomatic (cough, fevers, SOB, or sputum production) 3. SARS CoV-2 laboratory positive obtained within 14 days of enrollment Exclusion Criteria: 1. None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment groups: 1. Acute care and ICU - 10mL intravenous amniotic fluid every 24 hours for 5 days (6mL) | Biological: Human Amniotic Fluid<br>* Administration of amniotic fluid in SARS-CoV-2 positive patients<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator Free Days | Days alive and off mechanical ventilation at day 60. Measured only among patients who receive invasive mechanical ventilation. | Measured from hospital admission day 60 after admission. | 
| Duration of supplemental oxygen use | Duration from hospital admission until cessation of supplemental oxygen use. Measured only among patients who do not receive invasive mechanical ventilation. | Measured from hospital admission to day 60. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Survival at day 60 or hospital discharge | Measured at day 60 or at hospital discharge, whichever comes first. | 
| Systemic inflammation | Systemic inflammation at 5 days measured by serum IL-6. | Measured at day 5 post enrollment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amniotic fluid, Respiratory failure, Critical illness
A Study to Assess the Effectiveness of an Investigational Drug in Elderly Subjects With Low Vitamin D Levels (0822A-009)

Study Overview
=================
Brief Summary
-----------------
This study will assess the effectiveness of an investigational drug in elderly subjects with low vitamin D levels.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Study to Assess the Effect of Vitamin D3 8400IU Once Weekly on Body Sway and Neuromuscular Function in Men and Women Aged 70 Years or Older

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: MK0822A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or a woman 70 years old or older in general good health Exclusion Criteria: Having any form of neurological impairments that may impair motor function.

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0822A|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mediolateral body sway at 16 weeks. |  | at 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status assessed using the Short Physical Performance Battery Test determined at 16 weeks. General safety and tolerability at 16 weeks. |  | at 16 weeks |
Effects of Sleep Deprivation on Food Intake and Motor Activity in Man

Study Overview
=================
Brief Summary
-----------------
Evidence that shortened period of sleep could be a risk factor for weight gain and obesity has grown over the past decade. Concurrent with the obesity epidemic, numerous studies have reported a parallel epidemic of chronic sleep deprivation. Sleep is important in maintaining energy balance (i.e. acute sleep deprivation impact the normal secretion of ghrelin and decreases leptin plasma levels). Surprisingly, in humans, there is no direct evidence that a shortened night has direct effect on energy metabolism during the following day. This study is set up to determine whether a partial sleep deprivation night has an impact on appetite and food energy intake and, concomitantly, on physical activity, during the following day.

Official Title
-----------------
Influence de la Privation Aigue de Sommeil Sur la Prise Alimentaire et l'activité Physique Chez l'Homme

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male age between 18 and 30 healthy non smoker less than 5 hour of sport per week BMI between 20 and 25 kg/m/m Exclusion Criteria: eating disorders, dieting or fasting restrained (score >9), disinhibited (score >11) or hungry subjects (score >9), according to the Three-Factor Eating Questionnaire general healthiness, food-snacking (more than twice a day),

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily food intake |  | 24h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep deprivation, Food intake, Motor activity, Normal, healthy subjects
A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this study is to evaluate the safety and effectiveness of liraglutide in subjects with type 2 diabetes mellitus.

Official Title
-----------------
A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes, including newly-diagnosed patients / those already receiving other anti-diabetic medications including GLP-1 analogues, who require treatment with liraglutide according to the clinical judgment of their treating physician Subjects who are capable of giving study-specific signed informed consent before any collection of information Exclusion Criteria: Subjects with type 1 diabetes Subjects who are or have previously been on liraglutide Subjects who have previously been enrolled in the study Subjects who are participating in another clinical trial Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections) Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: liraglutide<br>* Self-administered subcutaneously (under the skin) once daily at any time, independent of meals, in the abdomen, thigh or upper arm.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of serious adverse drug reactions (SADRs) during the study period |  | during 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse drug reactions (ADR) during the study period |  | during 26 weeks of treatment | 
| The number of serious adverse events (SAE) during the study period |  | during 26 weeks of treatment | 
| Frequency of hypoglycaemic episodes |  | during 26 weeks of treatment |
Prospective Radiologic Evaluation of Changes Following Fat Grafting

Study Overview
=================
Brief Summary
-----------------
Breast implants are currently used for cosmetic breast augmentation and in breast reconstruction following mastectomy for breast cancer. Fat grafting is a technique where fat is injected around the periphery of a breast implant to camouflage the transition between implant and the body. The investigators propose to show mammography images of women who have had breast implants with fat grafting to informed and blinded radiologists and evaluate their readings of the images. Hypothesis: with mammographic screening, radiologists will be able to distinguish between findings associated with fat grafting and those which are suspicious for breast cancer.

Official Title
-----------------
Prospective Radiologic Evaluation of Changes That Might Affect Breast Cancer Diagnosis Following Fat Grafting and Silicone Breast Implants

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with silicone implants and fat grafting Exclusion Criteria: Procedures performed outside the University of Minnesota or Clinique Spontini Paris, France

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with implants<br>Patients with silicone implants and fat grafting. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiologist dictations of mammograms | We will compare the Bi-Rad level score readings, and recommended follow-up of the blinded and non-blinded radiologist's read of study participants mammograms. | We will obtain mammograms and MRIs of participants at intervals of 6 months for up to 24 months post fat grafting. |
A Study of IMC-1 In Patients With Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled, 16-week study designed to evaluate the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia symptoms or recurrence. IMC-1 is a combination treatment that is designed to suppress this suspected virus and thus alleviate fibromyalgia symptoms.

Official Title
-----------------
A Double-Blinded, Randomized, Placebo-Controlled, Proof of Concept Phase 2a Study Exploring the Safety and Efficacy of IMC-1 for the Treatment of Patients With Fibromyalgia

Conditions
-----------------
Fibromyalgia, Chronic Pain, Myofascial Pain

Intervention / Treatment
-----------------
* Drug: IMC-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of fibromyalgia English speaker Exclusion Criteria: Rheumatologic diseases Bipolar disease, OCD, severe anxiety, schizophrenia Systemic infection, severe cardiac disease, chronic steroid usage chronic opioid usage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMC-1<br>Experimental intervention | Drug: IMC-1<br> <br> |
| Placebo Comparator: Matching placebo<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain from baseline | Comparison of the change from baseline in patient self reported pain scores between IMC-1 and placebo treatment, over 16 weeks of treatment | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change | Patients will rate their global improvement over the duration of the trial | 16 weeks | 
| Fibromyalgia Impact Questionnaire |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myofascial, fibromyalgia
Screening Scottish Swimmers for Asthma and Rhinitis

Study Overview
=================
Brief Summary
-----------------
The Scottish National and District swimming teams will be screened for asthma and rhinitis using both mannitol challenge and sport-based exercise challenge.

Official Title
-----------------
A Pilot Study to Identify the Prevalence of Exercise- Induced Asthma and Rhinitis in Scottish Swimmers, Using Mannitol Challenge as a Screening Tool.

Conditions
-----------------
Asthma, Rhinitis

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: member of the Scottish national and district swimming team informed consent obtained Exclusion Criteria: pregnant, lactating or planning to become pregnant concomitant use of medicines (prescribed, over-the-counter or herbal) that may interfere with the trial. any clinically significant medical condition, as deemed by the clinical investigators, which may endanger the health of the participant or jeopardise the protocol. inability to comply with the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 23 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Scottish swimming team<br> | Other: no intervention<br>* this is a screening study, not an interventional study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tidal Nitric Oxide |  | This test will be performed prior to entering the pool, and on exiting the pool | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mannitol Challenge |  | This test will be performed once on a district and once on a national squad training day | 
| Sport-based Challenge |  | This test will be performed once on a district and once on a national squad training day | 
| Nasal Nitric Oxide |  | This test will be performed prior to entering the pool, and on exiting the pool | 
| Skin Prick Test |  | This test will be performed once on a district and once on a national squad training day | 
| Mini Nasal Lavage |  | This test will be performed prior to entering the pool, and on exiting the pool | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, rhinitis, swimmers, mannitol
Expression of STEAP-1 and p40 in Prostatic Carcinoma and Its Mimickers

Study Overview
=================
Brief Summary
-----------------
Prostatic carcinoma is the second most common cancer in men with high incidence of morbidity and mortality. It is a common health problem. Most cases occur at the age of 50 years, reaching its peak at 60-70 years of age. Diagnosis of prostatic carcinoma is still a problematic issue as accurate diagnosis can be very challenging due to the presence of either a small focus of cancer or the presence of many benign mimickers of malignancy. Six transmembrane epithelial antigen of the prostate 1 (STEAP-1) is primarily localized at the cell membrane, mostly at cell-cell junctions, but it may also be found dispersed in the cytoplasm. In prostate, the expression of STEAP-1 is higher in neoplastic tissues compared to its restricted expression in normal prostatic samples. The antibody designated as p40 recognizes exclusively ΔNp63 and not TAp63. In prostate tissues, it has been shown that p40, the ΔNp63 isoform of p63, stains prostatic basal cells as reliable as p63 in most cases. Furthermore, aberrant staining of tumor cells was seen more rarely with p40 than with p63. In this study, the investigators hope to solve some problematic issues in diagnosis of prostatic carcinoma and reach the better way to distinguish prostatic carcinoma from mimicking lesions by using both STEAP-1 and p 40. Also, the way to detect cancer at early stage of development and its progression which is extremely important as it allows establishing the most effective treatment and predicting patient's outcome.

Official Title
-----------------
Expression of STEAP-1 and p40 in Prostatic Carcinoma and Its Mimickers: An Immunohistochemical Study

Conditions
-----------------
Prostatic Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trans-rectal ultrasound guided biopsy (TRUS) procedure, transurethral resection prostatectomy (TURP) and radical prostatectomy. Prostatic adenocarcinoma and prostatic lesions that mimic prostatic adenocarcinoma Exclusion Criteria: Patients with recurrence of the primary tumor. Patients with a history of preoperative chemotherapy and/or radiotherapy. Insufficient or tiny tissue biopsies
Sexes Eligible for Study
-----------------
Male

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of Prostatic Carcinoma | Immunohistochemical Expression of STEAP-1 and p40 in Prostatic carcinoma and mimickers | One or two days after staining sections with the markers |