linjc16/ctgov huggingface dataset:
Mushroom Effects on Satiety and Gut Health Markers

Study Overview
=================
Brief Summary
-----------------
The Investigator will compare the effect of mushrooms to ground beef in an intervention study and measure satiety markers and gut health markers

Detailed Description
-----------------
Subjects will consume their habitual diet and the investigators will compare the acute effect of mushroom consumption on satiety and food intake. Additionally, subjects will consume mushrooms for 10 days and the investigators will measure gut health markers, including short chain fatty acids, microbiota, and fecal weight.

Official Title
-----------------
Mushroom Effects on Satiety and Gut Health Markers

Conditions
-----------------
Diet Modification

Intervention / Treatment
-----------------
* Dietary Supplement: mushroom
* Other: ground beef


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Willing to consume mushrooms or ground beef for 10 days Exclusion Criteria: Disease (chronic) Smoking,

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ground beef<br>ground beef instead of mushrooms | Other: ground beef<br> <br> |
| Active Comparator: Mushroom<br>2 servings of mushrooms | Dietary Supplement: mushroom<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satiety | Measure satiety subjectively after consumption of breakfast with mushrooms | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut health | Measure stool weight and gut microbiota after consumption of mushrooms | 10 days |
Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, safety, and tolerability of pantoprazole.

Official Title
-----------------
CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: Pantoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Written informed consent Endoscopically confirmed GERD (Los Angeles classification A-D) Patients whose compliance is expected to be high with respect to the completion of the questionnaires Main Exclusion Criteria: Other gastrointestinal diseases Severe concomitant diseases Proton pump inhibitors (PPIs) during last 14 days before start H2 receptor antagonists, prokinetics during last 7 days before study start Helicobacter pylori (H. pylori) eradication during last 28 days before study start

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| further efficacy criteria |  |  | 
| safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Pantoprazole, Complete Remission
Identification of PAthways of Kinase Inhibitors TOxicity

Study Overview
=================
Brief Summary
-----------------
The investigators are identifying clinical diagnoses and toxicities associated with kinase inhibitors prescription. This identification will be applied will be applied in an electronic-health-record (EHR) cohort including North American and European.

Official Title
-----------------
Identification of PAthways of Kinase Inhibitors TOxicity Through Patient Databases

Conditions
-----------------
Kinase Inhibitors Toxicity

Intervention / Treatment
-----------------
* Drug: Kinase inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient treated with a kinase inhibitor Patient identified in the VUMC EHR cohort or having a toxicity reported in the VigiBase Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VUMC EHR cohort<br>De-identified version of the electronic health record (EHR) at Vanderbilt University Medical Center (VUMC). | Drug: Kinase inhibitor<br>* Patients treated with kinase inhibitors for cancer or other conditions<br>|
| Toxicity induced by kinase inhibitors in Vigibase database<br>Case reported in the World Health Organization (WHO) of toxicity or complication of patient treated by KIs, with a chronology compatible with the drug toxicity | Drug: Kinase inhibitor<br>* Patients treated with kinase inhibitors for cancer or other conditions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the incidence of kinase inhibitor (KIs) induced toxicities in health records and their associations with co-medications to identify new mechanisms of drug induced toxicity | Identification of a mechanism of a toxicity associated with a KI using comedications and comparing it to reported outcomes | population included in VUMC database and/or WHO's database resource up to march 2019 |
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.

Official Title
-----------------
Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Knee Replacement Surgery -

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: YM150
* Drug: Placebo
* Drug: Enoxaparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects is scheduled for elective primary total knee replacement surgery Written informed consent obtained before screening Exclusion Criteria: Subject has history of deep vein thrombosis and/or pulmonary embolism Subject has a hemorrhagic disorder and/or coagulation disorder Subject has had clinically important bleeding occurred within 90 days prior to the screening visit Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia Subject is receiving anticoagulants/antiplatelets

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YM150 group-1<br>YM150 low dose group | Drug: YM150<br>* oral<br>|
| Experimental: YM150 group-2<br>YM150 high dose group | Drug: YM150<br>* oral<br>|
| Placebo Comparator: Placebo group<br> | Drug: Placebo<br>* oral<br>|
| Active Comparator: Enoxaparin group<br> | Drug: Enoxaparin<br>* injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall incidence of venous thromboembolism |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of individual venous thromboembolism |  | 2 weeks | 
| Incidence of bleeding events |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YM150, Thrombosis, VTE, Knee Replacement, Anticoagulant, FXa inhibitor
Clinical and Pathophysiological Description of Ocular Ischemic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the disease Ocular Ischemic Syndrome.

Detailed Description
-----------------
The disease Ocular Ischemic Syndrome (OIS) is not a well described entity. It occurs after a long-standing period of extremely low blood supply to the retina caused by atherosclerosis of the carotid arteries. In this study we will analyze why OIS is developed in some patients and not developed in others. The patients with OIS will be thorough examined and will be compared with 1) a control group of healthy people and 2) with control group of patients with diabetic retinopathy. Furthermore the impact of vascular surgery on OIS will be analyzed.

Official Title
-----------------
Pathophysiological Analysis of Ocular Ischemic Syndrome and the Response to Vascular Surgery

Conditions
-----------------
Retinal Degeneration, Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ocular ischemic syndrome Exclusion Criteria: Any other active ocular disease

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular Ischemic Syndrome
Cytokine Hemadsorption in Covid 19 Patients With Bacterial Sepsis

Study Overview
=================
Brief Summary
-----------------
In this retrospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis.

Official Title
-----------------
Comparison of Cytokine Hemadsorption as an Immunomodulator Therapy in Covid 19 Patients With and Without Bacterial Sepsis

Conditions
-----------------
INTERLEUKIN 6

Intervention / Treatment
-----------------
* Device: cytokine hemadsorption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 patients were the available data of laboratory diagnosis of COVID-19 (a positive throat swab nucleic acid test or positive serum COVID-19 specific antibody test), patients with COVID-19 induced sepsis was detection of bacterial agent in blood or tracheal culture Exclusion Criteria: below 18 aged those who did not undergo hemoperfusion

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid with sepsis<br>Covid patient with sepsis | Device: cytokine hemadsorption<br>* to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis.<br>|
| covid without sepsis<br>Covid patient without sepsis | Device: cytokine hemadsorption<br>* to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interleukin 6 | level of interleukin 6 | 1 month |
Role of Hematological Parameters in the Stratification of COVID-19 Disease Severity

Study Overview
=================
Brief Summary
-----------------
The hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity.

Detailed Description
-----------------
Objective: COVID-19 virus involves respiratory as well as other body systems including cardiovascular, gastrointestinal, neurological, immunological and hematopoietic system. Patient of covid-19 pneumonia presents with wide range of hemostatic abnormalities. These hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity. Material and Method: This was a retrospective study, conducted in Department of Pathology and Department of medicine, FMH college of Medicine and Dentistry from May 2020 to July 2020. Total of 101, confirmed cases of covid-19 disease, both genders between 17 to 75-year age were included. Hematological parameters were compared in mild, moderate, severe and critical disease group. Continuous variables were analyzed by using non parametric, Kruskal Wallis test while categorical variables were analyzed by chi-square test.

Official Title
-----------------
Role of Hematological Parameters in the Stratification of COVID-19 Disease Severity

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: not required


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed cases of covid-19 disease Both genders 17 to 75 year age Exclusion Criteria: known case of chronic liver disease known hematological diseases were excluded

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 75 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 |
| --- | --- |
| Covid-19 disease severity<br>Mild, moderate, severe and critical disease | Diagnostic Test: not required<br>* Diagnostic tests( hematological parameters) were assessed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete blood count- Hemoglobin. White blood count, platelet count, Neutrophil to lymphocyte ratio | disease severity was assessed on basis of hematological parameters. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PT, APTT and D-dimer | improvement in PT, APTT and D-dimer levels were assessed | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19 disease, Neutrophil to Lymphocyte ratio, hematological manifestations
STILDEP: Zolpidem in Depressive and Dysthimic Patients

Study Overview
=================
Brief Summary
-----------------
Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease.

Official Title
-----------------
Additive Beneficial Effect of Zolpidem Onto the Antidepressant Therapy in Depressive and Dysthimic Patients in the Acute Phase of the Disease

Conditions
-----------------
Sleep Initiation and Maintenance Disorders, Depression

Intervention / Treatment
-----------------
* Drug: Zolpidem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Depressive and dysthimic patients in acute phase of mild to moderate severity Depressive and dysthimic patients suffering from secondary insomnia (DSM IV) recent antidepressant therapy (less than 1 week) Exclusion Criteria: Regularly use of sleeping pills in the last 2-3 month Use of any sleeping pils in the last week Insufficient hepatic Myasthenia gravis Proven hypersensivity to Zolpidem Evidence of clinically relevant nervous system disorders (other neurologic/psychiatric diseases associated with depression) History of evidence of alcohol or drug abuse Evidence of clinically relevant cardiovascular, haematologic, hepatic, gastrointestinal, renal, pulmonary or endocrinologic diseases Abnormal snore Work an alternating shift Suffering from periodic leg movement disorder and sleep apnea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To show that the combination of Stilnox+ antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease |  |  |
Physical Activity and Preterm Birth With Cervical Dynamics

Study Overview
=================
Brief Summary
-----------------
this RCT is designed to investigate the influence of physical activity on the risk f preterm birth for women with cervical dynamics.

Official Title
-----------------
Influence of Physical Activity on Preterm Birth for Women With Cervical Dynamics

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Behavioral: activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women between 24-34 weeks of gestation singleton cervical length<25 mm willing to download an application which traces physical activity on medical indication for reducing activity Exclusion Criteria: refusal to participate medical advise to minimize activity (symphysiolysis) maternal morbidity fetal compromise vaginal bleeding rapture of membranes severe preeclampsia twins pregnancy -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: activity<br> | Behavioral: activity<br>* physical activity<br>|
| No Intervention: bed rest<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preterm birth | birth prior to 37 weeks of gestation | assessed from recruitment to delivery |
Study Evaluating The Coadministration of Begacestat And Donepezil

Study Overview
=================
Brief Summary
-----------------
This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.

Official Title
-----------------
Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Donepezil plus placebo
* Drug: Donepezil
* Drug: Begacestat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Men and women of non-childbearing potential Non smoker or smoker of <10 cigarettes per day and able to refrain from smoking during study 18-50 years old Exclusion Criteria: Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Cardiac rhythm abnormalities Family history of cardiac risk factors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Donepezil plus placebo<br> | Drug: Donepezil plus placebo<br>* 5- and 10-mg tablets, single dose<br>* Other names: Aricept;|
| Experimental: Donepezil plus begacestat<br> | Drug: Donepezil<br>* 5- and 10-mg tablets, single dose<br>* Other names: Aricept;Drug: Begacestat<br>* 6 x 50-mg capsules, single dose<br>* Other names: GSI-953, WAY-210953, PF-05212362;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG). |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters including Cmax, AUC, and t 1/2 |  | 5 months | 
| Safety and tolerability as assessed by results of 12-lead ECGs, cardiac telemetry, laboratory tests, vital signs, physical examinations and reported adverse events. |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer Disease