linjc16/ctgov huggingface dataset:
Study of Efficacy and Safety of Investigational Treatment in Patients With Hidradenitis Suppurativa

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled, parallel-group phase 1b study to evaluate AT193 in approximately 44 participants with HS. The treatment period will be 8 weeks followed by a 2-week nontreatment follow-up. The primary objective of this study is to evaluate the safety and tolerability of AT193. The secondary objectives of this study are to evaluate the preliminary efficacy in the treatment of HS.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of AT193 in the Treatment of Patients With Hidradenitis Suppurativa

Conditions
-----------------
Hidradenitis Suppurativa

Intervention / Treatment
-----------------
* Drug: AT193


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of HS or signs and symptoms consistent with HS for at least 3 months before screening in the judgment of the investigator. Stable disease for at least 2 months before screening in the judgment of the investigator. A woman of childbearing potential must use appropriate contraceptive measures during the study period. A woman of childbearing potential must have a negative urine pregnancy test result at screening. Written informed consent must be obtained before any study procedure is performed. Exclusion Criteria: Pregnant or breastfeeding. Any active skin disease that may interfere with evaluation of study drug or outcome assessment. History or evidence of a clinically significant disorder, condition, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator. Change in smoking or marijuana history within 3 months before Day 1 or planned during study period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT193<br>Topical applied daily | Drug: AT193<br>* Topical<br>|
| Placebo Comparator: Placebo<br>Topical applied daily | Drug: AT193<br>* Topical<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events |  | 10 weeks |
Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The proposed study will be the first to examine whether changes in blood flow patterns within the brain account for the possible cognitive benefits of CR. A clearer understanding of this possibility may provide key insight into the way CVD affects the brain, help identify effective treatments, help a greater number of patients return to work, and improve quality of life.

Detailed Description
-----------------
Based on recent patient referrals, we expect that 30 participants will subsequently enroll in CR and 30 will not. CR patients will complete standardized neuropsychological tests (45-60 minutes) and Transcranial Doppler (30-40 minutes) during their first and last week in the CR program. Patients who do not enroll in CR will undergo testing at similar intervals to serve as a matched control group. Standard medical records will be collected for participants in both groups to obtain demographic and medical information. CR-specific medical records will also be collected to obtain information about possible mechanisms for cognitive benefits (e.g. improved stress test performance, reduced blood pressure, etc.). All participants will be compensated for their time.

Official Title
-----------------
Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Behavioral: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 50 to 85 years of age, able to communicate in English, history of heart disease Exclusion Criteria: - history of significant neurological disorders, such as stroke, Alzheimer's disease, or severe head injury significant psychological problems such as schizophrenia or bipolar disorder

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Observational|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Rehabilitation, Cognitive functioning, Cardiovascular disease
The Potential Biomark of Serious Psychosis:a Prospective,Case-controled Study

Study Overview
=================
Brief Summary
-----------------
Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and MRI.

Detailed Description
-----------------
Patients suffer from Schizophrenia and Mood Disorders may have variation in immunological factors(TNF-α,IL-2,IL-6,IL-10,etc),BDNF and Brain MRI.

Official Title
-----------------
The Potential Biomark of Serious Psychosis: Including the Variation of Brain MRI, BDNF and Oxidative Stress-related Immunological Factors in Different Phases.

Conditions
-----------------
Other Immunological States or Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis with Schizophrenia , Bipolar Disorder or Major Depression by DSM-5 Exclusion Criteria: Unstable physical conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative Stress-related Immunological Factors | Blood test will be conducted every 3 month to assess the concentration of oxidative stress-related immunological factors including TNFα,TGFβ， MCP-1，IL-1α，IL-2，IL-6，IL-10，IL-12. | 18 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDNF | Collecting participants' blood every 3 month to assess the concentration of brain derived neurotrophic factor. | 18 month |
Long Follow up on Patients With Obstructive Sleep Apnea That Undergo Diagnosis and Surgical Treatment

Study Overview
=================
Brief Summary
-----------------
Long follow up on patients with obstructive sleep apnea that undergo diagnosis and surgical treatment

Detailed Description
-----------------
Drug induced sleep endoscopy (DISE) is increasingly performed procedure, offering dynamic upper airway evaluation during artificial sleep before surgical treatment for patients with obstructed .)OSA(sleep apnea Aim: To evaluate the value of DISE for tailoring the proper treatment for patients with snoring and OSA DISE is a safe procedure, easily practicable, valid and reliable. We consider it a fundamental clinical procedure that is essential before choosing the surgical treatment. Our results so far suggest that a multilevel collapse is significantly associated with higher apnea hypopnea index values. We think that the weight did not play a significant role in RDI (Respiratory Disturbance Index) reduction. Our results till now show tailored surgery based on DISE may leverage sleep surgeries outcome significantly presenting 70% success rate based on our experience We therefore want to evaluate the patients in a long follow up period

Conditions
-----------------
OSA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fully diagnosed patients with OSA. Patients who are candidates for a surgery as a treatment to their condition. Exclusion Criteria: Pregnancy Patients who are not OSA surgery candidates. Patients with high surgical risk. Patients with hematological or oncological background.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| OSA diagnosed patients<br>patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA and are surgery candidates for their condition. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of daytime sleepiness- using Epworth sleepiness scale questionnaire |  | up to 3 years after surgery | 
| Sleep quality assessment questionnaire |  | up to 3 years after surgery |
Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Streptococcal Dermatitis

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to investigate, which of two antibiotic treatments - oral penicillin for 10 days or oral cefuroxim for 7 days - is more successful for patients (1-16 years of age) with perianal dermatitis caused by group A beta-hemolytic streptococci.

Detailed Description
-----------------
The goal of the study is to investigate, which of two antibiotic treatments - oral penicillin for 10 days or oral cefuroxim for 7 days - is more successful for patients (1-16 years of age) with perianal dermatitis caused by group A beta-hemolytic streptococci (GABHS). Diagnosis is based on positive perianal culture for GABHS. Informed consent will be obtained. The study will be performed in the region of Basel, Switzerland, in private practices of pediatricians, general practitioners, and selected pediatric dermatologists as well as in the out-patient departments of the University Children's Hospital Basel and the department for dermatology of the University of Basel. Patients (or their parents) will fill in a daily diary on signs and symptoms of disease; furthermore, clinical investigations (inspection of the site of infection) will be performed on enrollment (Day 1), Day 3, and at the end of treatment (Day 10).

Official Title
-----------------
Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Dermatitis - an Open, Randomized, Controlled Trial

Conditions
-----------------
Streptococcal Infections

Intervention / Treatment
-----------------
* Drug: Penicillin versus cefuroxim per os


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent age 1-16 years typical clinical symptoms for perianal dermatitis positive perianal culture for GABHS Exclusion Criteria: antibiotic treatment in previous 14 days immunodeficiency penicillin allergy cephalosporin allergy further bacterial infections

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 16 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Penicillin versus cefuroxim per os|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolving signs and symptoms of perianal dermatitis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiological cure (= negative culture for GABHS) at end of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perianal, dermatitis, streptococcus pyogenes
The Prospective Collection, Storage and Reporting of Data on Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing a Standard Preparative Regimen

Study Overview
=================
Brief Summary
-----------------
To provide the IRB approved mechanism for the prospective collection, analysis and reporting of data on patients who are undergoing either an autologous or allogeneic hematopoietic stem cell transplant for a disease in which a research question is not being addressed and for which peer reviewed, published data have demonstrated efficacy for this treatment approach.

Official Title
-----------------
The Prospective Collection, Storage and Reporting of Data on Patients

Conditions
-----------------
Hodgkin's Disease, Multiple Myeloma, Germ Cell Neoplasms, Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Immunodeficiency Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned standard of care dose intensive therapy and either an allogeneic or autologous bone marrow transplant Exclusion Criteria: Participation in any other treatment research protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data followup | Gather basic survival and complication data for operational and research databases for ongoing regulatory and future operational queries | 1 year |
Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin Hormone Secretion in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin hormone secretion in healthy volunteers

Detailed Description
-----------------
A mixed meal (524 kcal) is ingested rapidly (within 5 min) or slowly (10-15 min) and changes in insulin, glucagon, GIP and GLP-1 levels are followed for subsequent 300 min

Official Title
-----------------
Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin

Conditions
-----------------
Healthy Volunteers Recruited From the General Population

Intervention / Treatment
-----------------
* Other: Mixed meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Diabetes Liver disease Kidney disease Thyroid disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Healthy volunteers are ingesting a mixed meal either rapidly or slowly | Other: Mixed meal<br>* Ingestion of mixed meal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for insulin |  | 300 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for glucose-dependent insuinotropic polypeptide |  | 300 min | 
| Area under the curve for glucagon-like peptide-1 |  | 300 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mixed meal¨, insulin, glucagon, GIP, GLP-1
Correlation Between NAFLD, Epicardial Adipose Tissue and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)

Study Overview
=================
Brief Summary
-----------------
Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques. Non-alcoholic fatty liver disease (NAFLD) is closely associated with many cardiometabolic risk factors. NAFLD can be detected by measuring liver fat accumulation using computed tomography (CT). Also epicardial adipose tissue (EAT) volume as determined by computed tomography (CT) is an independent marker of cardiovascular events in the general population. Therefore, the purpose of this investigators study is to compare the NAFLD severity and EAT volume with FDG uptake measured by PET/CT.

Conditions
-----------------
Atherosclerosis, Non-alcoholic Fatty Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy patients for visiting routine medical check in our clinic Exclusion Criteria: History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization) Diabetes Stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg) Malignancy Severe renal or hepatic disease Subjects taking medications that might affect inflammation such as nonsteroidal antiinflammatory drug and statin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 18FDG-PET/CT<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between vascular inflammatory status measured by 18FDG PET and NAFLD measured by un-enhanced CT |  | 12 weeks | 
| Correlation between vascular inflammatory status measured by 18FDG PET and epicardial adipose tissue measured by CT |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship of NAFLD with carotid intima media thickness |  | 12 weeks | 
| The relationship of epicardial adipose tissue volume with carotid intima media thickness |  | 12 weeks |
Reducing Nephrotoxicity of Vancomycin: A Prospective Study of Continuous Versus Intermittent Infusion of Vancomycin

Study Overview
=================
Brief Summary
-----------------
This study is being carried out to find out whether there is reduction in vancomycin-induced kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous infusion. This study will recruit 220 subjects from 2 hospitals over a period of 3 years. Participants are invited if they have an infection that requires prolonged vancomycin therapy (> more than 10 days).

Official Title
-----------------
Reducing Nephrotoxicity of Vancomycin: A Prospective, Randomized Study of Continuous Versus Intermittent Infusion of Vancomycin

Conditions
-----------------
Infections Requiring Prolonged Duration (>10 Days) of Vancomycin

Intervention / Treatment
-----------------
* Drug: continuous vancomycin infusion
* Drug: intermittent vancomycin infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 21-80 years Documented infection requiring prolonged (> 10 days) of vancomycin therapy Creatinine clearance > 50 ml/min (using Cockroft-Gault equation) Exclusion Criteria: Patient already received 7 days or more of vancomycin therapy Pregnancy Severe burns > 40% body surface area Spinal cord injuries Participation in another interventional trial in previous 30 days Inability to obtain informed consent

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: continuous vancomycin infusion<br> | Drug: continuous vancomycin infusion<br>* 24-hour continuous infusion of vancomycin<br>|
| Active Comparator: intermittent vancomycin infusion<br>vancomycin in this arm will be administered as intermittent infusion | Drug: intermittent vancomycin infusion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nephrotoxicity | nephrotoxicity as defined by the acute kidney injury network (AKIN) criteria using only serum creatinine criteria | occurring any time while on vancomycin treatment up to 14 days post treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biomarkers for detection of early nephrotoxicity | serum and urine NGAL and cystatin C | measured weekly from the date of randomization until 14 days post completion of vancomycin |
Comparison of Data Obtained by Echocardiography and Magnetic Resonance Imaging in Hypertrophic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
Compare data (structural and functional) obtained by transthoracic rest echocardiography and magnetic resonance imaging (with gadolinium) in 30 patients with hypertrophic cardiomyopathy

Detailed Description
-----------------
All data from consecutive patients with HCM explored by 2D-echo or MRI in our institution will be analyzed blindly by a senior echocardiographist and a senior radiologist to highlights the respective interest of each of these examinations for the detection of structural or functional abnormalities in HCM.

Official Title
-----------------
Comparison of Data Obtained by Echocardiography and Magnetic Resonance Imaging in Hypertrophic Cardiomyopathy

Conditions
-----------------
Hypertrophic Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertrophic cardiomyopathy Age > 18 years Exclusion Criteria: Pregnancy Pacemaker IACD Allergy to gadolinium Secondary hypertrophy

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertrophic cardiomyopathy, echocardiography, magnetic resonance imaging