linjc16/ctgov huggingface dataset:
Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.

Official Title
-----------------
A Prospective, Randomized Double-blind Parallel Group Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects With Mild to Moderate Essential Hypertension

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Eprosartan
* Drug: Eprosartan Mesylate
* Drug: Placebo Eprosartan mesylate
* Drug: Placebo Eprosartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Males or females with essential hypertension, blood pressure values between 140 mmHg and 179 mmHg systolic and between 90 mmHg and 109 mmHg diastolic Given written informed consent prior to starting the study Exclusion Criteria Women with childbearing potential, breast feeding or pregnant; Inability to discontinue all prior antihypertensive medication; Secondary hypertension Severe hypertension Severe diabetes mellitus (HbA1c greater 8.5%)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eprosartan<br>Eprosartan + Placebo Eprosartan Mesylate | Drug: Eprosartan<br>* Eprosartan 450 mg<br>Drug: Placebo Eprosartan mesylate<br>* Placebo Eprosartan mesylate<br>* Other names: Placebo;|
| Active Comparator: Eprosartan Mesylate<br>Eprosartan Mesylate + Placebo Eprosartan | Drug: Eprosartan Mesylate<br>* Eprosartan mesylate 600 mg<br>* Other names: Teveten;Drug: Placebo Eprosartan<br>* Placebo Eprosartan<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline | Change from baseline of diastolic blood pressure (DBP), sitting | 8 weeks |
Experience of Lock Down Related to the Covid-19 Epidemic and Its Impact on the Project of Parenthood

Study Overview
=================
Brief Summary
-----------------
Observational, descriptive, cross-sectional, monocentric study, This Study is proposed to all couples followed in Assisted Reproduction and CECOS Nord for whom the protocols were stopped when they entered into confinement related to the Covid-19 epidemic on 13 March 2020.

Official Title
-----------------
Evaluation of the Experience of Lock Down Related to the Covid-19 Epidemic and Its Impact on the Project of Parenthood of the Couples Followed in Assisted Reproduction

Conditions
-----------------
Assisted Reproduction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: couples followed up in Assisted Reproduction and CECOS Nord the cessation of assistance reproduction protocols related to the Covid-19 outbreak on March 13, 2020. acceptance of teleconsultation Exclusion Criteria: Individuals refusing to participate in the study during the teleconsultation with the referring practitioner. I- ndividuals who do not respond to the questionnaire

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 |
| --- | --- | --- |
| Level of anxiety and/or depression of MPA patients (male and female couples) by Hospital Anxiety and Depression Scale (HAD) score. |  | Baseline |
Quality of Life After Transanal Endoscopic Microsurgery (TEM)

Study Overview
=================
Brief Summary
-----------------
This is a observational cohort study to determine the influence of Transanal endoscopic microsurgery (TEM) on patients Quality of Life

Detailed Description
-----------------
Patients who planning Transanal Endoscopic Microsurgery (TEM) for rectal neoplasms should undergoing fecal incontinence quality of life scale and Wexner score before and after surgery for measurement their quality of life. For objectification data sphinctrometry will be perform.

Official Title
-----------------
Quality of Life After Transanal Endoscopic Microsurgery (TEM) for Rectal Neoplasm

Conditions
-----------------
Transanal Endoscopic Microsurgery (TEM)

Intervention / Treatment
-----------------
* Diagnostic Test: sphincterometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a planned of Transanal endoscopic microsurgery (TEM) Have signed approved informed consent form for the study Exclusion Criteria: non epithelial malignancy recurrent neoplasm stoma formation

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: sphincterometry|Sphincterometry is a method of the spincter function examination, which allows to assess the state of the anal sphincter muscle and its function|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal incontinence quality of life scale | The FIQL is a standardized instrument that can be used to assess QOL issues related to fecal incontinence.The Fecal Incontinence Quality of Life Scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items), Coping/Behavior (9 items), Depression/Self-Perception (7 items), and Embarrassment (3 items).Each aspect is described as a score measured on a scale between 1 and 4, where 1 is very affected and 4 is not affected | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wexner score | Wexner score is composed of a total 5 items for each type of incontinence. Each aspect is described as a score measured on a scale between 1 and 4, where 0 is rarely, 4 - always/ 0 - perfect, 20 - complete incontinence. | 3 month | 
| Sphinctrometry | Anal pressure in mmHg | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transanal endoscopic microsurgery, TEM, QoL, quality of life, rectal cancer, rectal surgery, rectal neoplasm
Disability Among Adults With Asthma

Study Overview
=================
Brief Summary
-----------------
To identify risk factors for work disability among adults with asthma treated by pulmonary and allergy specialists.

Detailed Description
-----------------
BACKGROUND: Disability among those with asthma is common and costly. Little is known about the causes of disability in asthma; experience with other chronic diseases suggests that illness severity alone does not adequately predict disability. There is a theoretical and experimental basis upon which to postulate that other variables, including factors such as job flexibility, asthma self-efficacy, social supports, and cigarette smoking may be predictors of disability in asthma. The study helped to explain the inter-relationships among illness severity, other co-factors and disability in asthma, addressing a major research gap. DESIGN NARRATIVE: The study was a cross-sectional survey, including retrospective work history data. A random sample was conducted of 40 board certified pulmonologists in Northern California enrolling persons with asthma. Pulmonologists maintained a log of all persons meeting a clinical definition of asthma presenting to their offices for treatment over a one month period. A total of 601 subjects with any history of laborforce participation were interviewed by a trained survey worker in order to assess severity of disease using a severity scale based on symptoms, medications, and past-asthma history. The computer-assisted, telephone-administered interviews used established survey instruments to assess psychosocial variables, smoking exposure and work history. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Phase II Study of TKI258 in Advanced Urothelial Carcinoma

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer

Official Title
-----------------
A Phase II Multi-center, Non-randomized, Open Label Study of TKI258 in FGFR3 Mutated and FGFR3 Wild Type Advanced Urothelial Carcinoma

Conditions
-----------------
Urothelial Cancer

Intervention / Treatment
-----------------
* Drug: TKI258


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with transitional cell cancer of the bladder, urethra, ureter, or renal pelvis Patients who have archival tumor tissue available for FGFR3 mutational status screening Patients with progressive disease Patients with measurable disease by RECIST Patients previously treated with at least 1 but not more than 3 systemic cytotoxic regimens with at least one of these regimens including at least one of the following: cisplatin, carboplatin, gemcitabine or taxane administered in the perioperative or advanced setting Age ≥ 18 years WHO Performance Status ≤ 2 Patients willing and able to take oral medication, follow scheduled visits, treatment plan and laboratory tests Patients with signed and witnessed informed consent form Patients with adequate organ function Exclusion Criteria: Patients with brain cancer Patients with other cancers except for certain skin, cervical & prostate cancers Patients who have not recovered from previous cancer treatment Patients who have severe and/or uncontrolled medical conditions which could affect participation in the study Other protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FGFR3 wild type<br> | Drug: TKI258<br> <br> |
| Experimental: FGFR3 mutant<br> | Drug: TKI258<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate |  | 4 Months | 
| Progression free survival |  | 4 Months | 
| overall survival |  | 4 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced urothelial cancer
Perception and Multisensory Integration in Neurological Patients Using fMRI

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to explore and map brain areas involved in sensory perception and multisensory integration in patients with central or peripheral neurological damage. The investigators hypothesize for example, that a change (compare to healthy subjects) in the perceptual maps and body representation could be detected and characterize in patients suffering from impairments of peripheral nerve conduction.

Official Title
-----------------
Perception and Multisensory Integration in Neurological Patients Using fMRI

Conditions
-----------------
Acute Inflammatory Demyelinating Polyradiculoneuropathy, Myasthenia Gravis, Stroke, Anosognosia, Asomatognosia

Intervention / Treatment
-----------------
* Device: Siemens magnetom avanto1.5 Tesla, Siemens magnetom trio A Tim system 3 Tesla


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of the investigated neuronal disease Exclusion Criteria: contraindication for MRI scan pregnancy refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: study group<br>fMRI | Device: Siemens magnetom avanto1.5 Tesla, Siemens magnetom trio A Tim system 3 Tesla<br>* functional magnetic resonance imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing hemodynamic responses by measurement of the Blood-oxygen-level dependence(BOLD)signal | Distinct maps of sensory and multisensory representations related to certain disorders will be assed by measurement of the Blood-oxygen-level dependence(BOLD)signal. | 1 year |
Methylphenidate Raclopride Positron Emission Tomography (PET) Test - 11

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate PET methodology to study in vivo synaptic dopamine release.

Detailed Description
-----------------
The objective of this study is to evaluate PET methodology to study in vivo synaptic dopamine release.

Official Title
-----------------
Methylphenidate Raclopride PET Test

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy normals Exclusion Criteria: History of head trauma or loss of consciousness. Significant medical history. History of seizures.

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: Diagnostic
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dopamine receptor availability |  |  |
Development of Novel Designed Force Plate for Measuring the Balance Ability for the Elders

Study Overview
=================
Brief Summary
-----------------
To develop a force plate with a proper computing algorithm that can be used in the average household as well as within community care centers. An affordable price range will also be necessary.

Detailed Description
-----------------
Many studies using force plates to examine the elders' balance ability for fall prevention. However, few studies compare the reliability differences among age in postural sway measurements even though many studies find significantly greater postural sway in the elder population than compared to the younger cohort. Investigation of this age difference is important for choosing variables to represent their postural sway improvement in order to determine the intervention outcome.

Official Title
-----------------
Kaohsiung Medical University Chung-Ho Memorial Hospital Institutional Review Board

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

Intervention / Treatment
-----------------
* Other: Closed eyes double-leg stance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young adults between 20 and 25 yrs Seniors between 67 to 75 yrs. Exclusion Criteria: Lower limb neuromuscular diseases Musculoskeletal injuries Any negative response

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Closed eyes double-leg stance<br>Body relaxed with both arms naturally placed beside thighs, eyes closed for 40 seconds. | Other: Closed eyes double-leg stance<br>* Closed eyes double-leg stance: Body relaxed with both arms naturally placed beside thighs, eyes closed for 40 seconds.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center of Pressure (COP) | Balance means the coordination module of transferring the center of pressure (COP). | 40 seconds. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Force plate, Balance ability
Prostate Impendance Test Project

Study Overview
=================
Brief Summary
-----------------
Impedance-based analysis could provide an adequate response to the need to identify a safe and reliable tool alternative to bioptic diagnosis. Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods will be subjected to impedance measurement. Aim of this study is to be able to structure a bivariate analysis of the distribution of impedances detected in patients with neoplasia in order to detect test median reference values.

Official Title
-----------------
Prostate Impendance Test Project (PROS.IT) in Prostate Cancer Diagnosis: a Cross-sectional Observational Study

Conditions
-----------------
Prostatic Neoplasms, PSA, Prostatic Biopsy, Impedance Test

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 45 years up of total PSA values beyond the normal range (> 4 ng / ml) presence or absence of suspicious prostate nodule Exclusion Criteria: previous history of cancer BMI>30 patients with previous diagnosis of PIN HG at prostate core biopsy or in active surveillance

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients undergoing prostatic biopsy<br>Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impedance-based analysis based on phase-sensitive sensors |  | during rectal examination |
PT vs no PT Following THA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if outpatient physiotherapy results in improved and/or more rapid achievement of functional outcomes and quality of life in comparison to those patients who do not undergo outpatient physiotherapy after total hip arthroplasty

Official Title
-----------------
Study to Evaluate Outpatient Physiotherapy in Total Hip Arthroplasty: A Prospective Randomized Controlled Trial

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Outpatient physiotherapy
* Procedure: Self-guided physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient undergoing unilateral primary total hip arthroplasty with age > 60 Exclusion Criteria: Post-traumatic osteoarthritis Rheumatoid arthritis or other peripheral inflammatory disease Avascular necrosis Revision or conversion THA Post-septic osteoarthritis Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Outpatient physiotherapy<br>two weeks of in-home physiotherapy following total hip replacement followed by two months of outpatient physiotherapy with 2-3 weekly sessions | Procedure: Outpatient physiotherapy<br> <br> |
| Active Comparator: No outpatient physiotherapy<br>two weeks of in-home physiotherapy following total hip replacement followed by two months of self-guided physiotherapy exercises | Procedure: Self-guided physiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | This is a validated instrument | 4 weeks |