linjc16/ctgov huggingface dataset:
The Assessment of Physiotherapy Practice Validation as a Measure in Physiotherapy Student

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the reliability and validity of the assesment of physiotherapy practice (APP) in physiotherapy students. Concretely the study aims to verify if the APP created by the professors of specific methods of intervention in physiotherapy course is a reliable tool to evaluate student performance of history taking and physical examination in the same course.

Detailed Description
-----------------
Before evaluating this scale, the investigators want to verify the effectiveness of this online practice in the COVID period by processing the Mind Genomics questionnaire. After the fist online results of this practice evaluation the investigators have to interpret and evaluate the APP.

Official Title
-----------------
Validity and Reliability of the Assessment of Physiotherapy Practice Validation as a Measure in Physiotherapy Student

Conditions
-----------------
Assessment, Self, Clinical Performance

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: students of specific methods of intervention in physiotherapy course students of Catholic University of Murcia, Spain with a minimum of 19 years old in the second course of physiotherapy Exclusion Criteria: other courses participants professors segretary

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 39 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study|a reliability - validity study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Physiotherapy Practice (APP) | Validity and reliability of the Assessment of Physiotherapy Practice tool with a total of 10 point valoration | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physiotherapy, student, assesment tool
18-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).

Official Title
-----------------
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: xaliproden (SR57746A)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria Mild to moderate degree of severity of dementia as assessed by the Mini-Mental State Examination score of 16 to 26 (inclusive) Potential participant may be treated with conventional Alzheimer's disease therapy and must be on stable dose for at least 6 months prior to the randomization and during the entire study period Potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility Mother tongue is English, Spanish or French (oral and written fluency) Signed informed consent from potential participant or legal representative and identified caregiver Exclusion Criteria: Potential participant with any other cause of dementia. Potential participant with serious health problems other than Alzheimer's disease Use of an investigational drug within two months prior to randomization or during this study

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: xaliproden (SR57746A)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life. |  |  |
Diffusion Weighted MRI for Lymphnodes in the Axilla

Study Overview
=================
Brief Summary
-----------------
This study is going to compare diffusionweigthed MRI scanning to the result of surgey in patients with metastasis from brestcancer in the axilla

Official Title
-----------------
Diffusionsvægtet MR Skanning Med Henblik på axillære Lymfeknudemetastaser Hos Patienter Med primær Mammacancer - et Pilotstudie

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed breast cancer patients, where ultrasound and cytologi has proved one or more malignant lymphnodes in the axilla. Exclusion Criteria: Pacemaker metal in the body claustrphobia psychiatry patients pregnancy age below 18 years

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

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

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
-----------------
MRI diffusion mamma cancer
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.

Official Title
-----------------
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus

Conditions
-----------------
Hydrocephalus, Normal Pressure

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care. Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker capable of providing valid, signed informed consent. Exclusion Criteria: Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction; ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated; Presence of an interfering open wound or edema over any portion of the ventriculoperitoneal shunt.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| ShuntCheck<br>Participants will be administered the ShuntCheck diagnostic test. | Diagnostic Test: ShuntCheck<br>* The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of ShuntCheck test |  | 15 minutes | 
| Negative Predictive Value of ShuntCheck test |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of performing ShuntCheck test twice |  | 60 minutes | 
| Negative Predictive Value of performing ShuntCheck test twice |  | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asymptomatic Normal Pressure Hydrocephalus, Ventriculoperitoneal Shunt
Residual Sample Collection for Respiratory Viral Panel

Study Overview
=================
Brief Summary
-----------------
Collect de-identified, residual samples to support a clinical trial. Samples may be prospectively or retrospectively collected. Overall Study Objective Obtain clinical performance data to characterize clinical performance of the Respiratory Viral Panel on the GenMark Sample-to-Answer Platform.

Detailed Description
-----------------
The purpose of this investigational study is to collect clinical samples to establish the clinical performance characteristics of the in vitro diagnostic (IVD) Respiratory Viral Panel on the GenMark Sample-to-Answer Platform. Data obtained from the samples will be used to support premarket submissions/registrations for this GenMark product. Samples will be aliquotted, characterized by comparator methods and banked until the instrument and assay are available for testing. Sample collection may be prospective or retrospective. Prospective collection will preserve prevalence. Retrospective collection will be used to obtain sufficient numbers of certain sample types such as where the organism of interest is of low prevalence. The Sponsor will ensure that information identifying samples as prospectively or retrospectively collected is documented.

Official Title
-----------------
De-identified Residual Sample Collection for the Respiratory Viral Panel on the GenMark Sample to Answer Platform (ARM 1)

Conditions
-----------------
Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sample from patients exhibiting signs/symptoms of respiratory viral infection All medical standard-of-care testing requested by the submitting clinician is complete and has been reported to the clinician/requestor. Exclusion Criteria: Samples that are incorrectly de-identified
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 |
| --- | --- | --- |
| Sample collection study only | This is an IVD Diagnostic study. | prospective and retrospective sample collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory viruses
Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of secukinumab on the preservation of pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.

Official Title
-----------------
A Randomized, Double-blind, Multiple Dose, Placebo-controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Efficacy of Secukinumab in Adult and Pediatric Patients With New-onset Type 1 Diabetes Mellitus(T1D)

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Secukinumab
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged 18-35 years initially (subjects aged 8-17 may be included at a later stage, starting with age 12-17 years, followed by age 8-11 years). Body weight between 40-120 kg initially (subjects weighing 21-39 kg may be included at a later stage). Recent onset type 1 diabetes mellitus, diagnosed with 100 days of first dose. Peak stimulated C-peptide levels >/= 0.2 pmol/L following mixed meal tolerance test Exclusion Criteria: Any form of diabetes other than auto-immune type 1 (eg, type 2 diabetes, maturity onset diabetes of the young, latent autoimmune diabetes of the adult). Diabetic ketoacidosis within 2 weeks of screening. Pregnancy or lactation. Recent (within 2 weeks of screening), ongoing, chronic or recurrent infectious disease. Active infection with hepatitis B or C, Epstein-Barr virus, cytomegalovirus, or HIV. Tuberculosis infection. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secukinumab<br>Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year | Drug: Secukinumab<br> <br> |
| Placebo Comparator: Placebo<br>Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test | Study was terminated and no data were collected for the Outcome Measure. | Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes mellitus
Study With Oral Isovue in Abdominopelvic CT

Study Overview
=================
Brief Summary
-----------------
This is a retrospective clinical study with prospectively designed blinded evaluation of CT images in adult and pediatric patients who underwent CT examinations of the abdomen and pelvis and were orally administered a solution of Isovue-300 to opacify the GI tract to distinguish it from adjacent abdominal and pelvic structures. The study will collect already existing data, such as demographic data, adverse events and CT images, for all chronologically enrolled patients who meet the inclusion/exclusion criteria prospectively defined in this protocol

Official Title
-----------------
A Phase IIIB, Multicenter Study With Oral Administration of Isovue-300 for Opacification and Delineation of the Gastrointestinal (GI) Tract in Abdominopelvic Computed Tomography (CT)

Conditions
-----------------
Patients Requiring Abdominopelvic CT With Oral Administration of Contrast

Intervention / Treatment
-----------------
* Drug: Iopamidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients will be included in the study if: Demographic and safety data are available for analysis Complete set of CT images performed after oral administration of Isovue-300 are available for assessment Isovue-300 was orally administered during an interval time of 60-20 minutes before the CT scanning. Patients will be excluded from the study if: Oral contrast agent received within 1 week prior to the CT scan Undergone any abdominopelvic surgery procedure that resulted in alteration of the bowel transit time prior to the CT exam CT exam with oral administration of Isovue was performed because of a known or suspected condition of bowel obstruction Patient did not actively drink the contrast solution.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iopamidol|Previously administered Isovue-300 (300 mgI/mL) PO at a dilution of 2-3% (6-9 mgI/mL)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with adequate visualization of anatomic delineation of the GI tract |  | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral Isovue
Metabolism Associated With Abdominal Fat Mass Distribution

Study Overview
=================
Brief Summary
-----------------
Objectives: The primary objective of this clinical trial is to characterize metabolic signatures associated with abdominal fat distribution in 40 women with different BMI 29-40 and different abdominal distribution of fat (visceral vs. sub-cutaneous fat). No intervention with a product is planned. The subjects will be given one high fat meal with commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to test the post-prandial metabolic response.

Official Title
-----------------
Metabolism Associated With Abdominal Fat Mass Distribution

Conditions
-----------------
Obese

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 29-40 kg/m2 Aged 25-45 Exclusion Criteria: Diagnosed metabolic disorder such as Diabetes type 1 and 2, cardiovascular disease, metabolic syndrome Pregnancy Any pathology (infectious or other) having required an antibiotic therapy within 1 month prior to the beginning of the study. Any therapy (contraception apart) within the run-in period of one week before the test day. Subject who cannot be expected to comply with treatments and measures. Subject who is affected by any specific eating disorder Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study. Subjects having recently undergone a weight loss of more than 3 kilos during the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 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 |
| --- | --- |
| No product is tested<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic plasma, urine and faeces profiles as a function of fat mass distribution | Metabolic profiles of plasma, urine and feces samples are obtained by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry. Fat mass distribution is assessed using CT scan and DXA (Dual X-Ray Energy Absorptiometry). | Changes from baseline in metabolic profiles at one day following fat meal intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Insulin sensitivity is measured by oral glucose tolerance test | Measured on the day before the fat meal intake | 
| Basal Energy Expenditure | Basal Energy Expenditure is measured by indirect calorimetry | Basal Energy Expenditure is measured on the day preceding the fat meal intake | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obese women, fat mass distribution, Metabolomic profiles
Anti-adhesive Effect and Safety of Thermo-sensitive Adhesion Barrier (MEDICLORE)

Study Overview
=================
Brief Summary
-----------------
One of most important complication of thyroid surgery is adhesion. There are many anti-adhesive materials, but none of them showed significant outcomes. The investigators planned double blind prospective study of Thermo-sensitive Adhesion Barrier (MEDICLORE) to reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.

Official Title
-----------------
Anti-adhesive Effect and Safety of Thermo-sensitive Adhesion Barrier (MEDICLORE) by Using Double-blind Test in Thyroid Surgery

Conditions
-----------------
Adhesion, Thyroidectomy

Intervention / Treatment
-----------------
* Combination Product: MEDICLORE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned to perform thyroidectomy due to thyroid nodule no evidence of distant metastasis or invasion to adjacent organ in thyroid cancer normal preoperative vocal cord movement normal preoperative laboratory study Exclusion Criteria: uncontrolled hypertension, diabetes, chronic renal failure, coagulopathy history of keloid or hypertrophic scar Graves disease or hashimoto thyroiditis patients aspirin or anticoagulant medication within 7 days radiation exposure to the head and neck previous operation to the neck history of allergic reaction to drugs pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use MEDICLORE<br>use mediclore at the end of surgery | Combination Product: MEDICLORE<br>* use MEDICLORE at the end of surgery as antiadhesive product<br>|
| No Intervention: No antiadhesive product<br>use no antiadhesive product at the end of surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied. |  | Participants will be followed from the operation to postoperative 2weeks, 3months, 6months |