linjc16/ctgov huggingface dataset:
Quality of Life After an Ambulatory Reconstruction of the Cruciate Ligament

Study Overview
=================
Brief Summary
-----------------
Study to compare the quality of life after reconstruction of the cruciate ligament in hospitalized versus day-clinic patient

Official Title
-----------------
Quality of Life After an Ambulatory Reconstruction of the Cruciate Ligament

Conditions
-----------------
Rupture of the Cruciate Ligament

Intervention / Treatment
-----------------
* Procedure: Reconstruction of the cruciate ligament


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rupture of the cruciate ligament Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Reconstruction of the cruciate ligament|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  |
Gonadal Function in Young to Middle Aged HIV-infected Men

Study Overview
=================
Brief Summary
-----------------
HIV infection is associated to premature decline of serum testosterone. However, prevalence and biochemical characterization of hypogonadism in HIV-infected men are still to be well defined. HIV-infection is strongly associated to erectile dysfunction in men, but preliminary data suggest that it is poorly associated with serum testosterone in this context.

Detailed Description
-----------------
The aim of this study is to evaluate the gonadal function of young to middle aged HIV-infected men in order to characterize hypogonadism by assessing circulating total testosterone with either Liquid Chromatography tandem Mass Spectrometry (LC-MS/MS) or chemiluminescent immunoassay. Furthermore, secondary aim is to assess the erectile function through the use of validated questionnaires (International Index of Erectile Function (IIEF) 15 and 5).

Official Title
-----------------
Gonadal Function in Young to Middle Aged HIV-infected Men Assessed by Isotopic Dilution-liquid Chromatography-mass Spectrometry (ID-LC-MS/MS) and Chemiluminescent Immunoassay

Conditions
-----------------
Human Immunodeficiency Virus, Hypogonadism, Male, Erectile Dysfunction

Intervention / Treatment
-----------------
* Other: No intervention is provided


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male gender Age 18-50 years HIV-infection Ongoing Highly Active Antiretroviral Therapy Exclusion Criteria: Previous treatment with androgens, anti-androgens Severe liver insufficiency Severe renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-infected male patients<br>Male patients (age 18-50 years) with HIV-infection and ongoing HAART therapy No intervention is provided | Other: No intervention is provided<br>* No intervention is provided<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum total testosterone | From blood sample - unit of measurement ng/dL | Assessed only once at the moment of enrollment with liquid chromatography tandem mass spectrometry | 
| Serum total testosterone | From blood sample - unit of measurement ng/dL | Assessed only once at the moment of enrollment with chemiluminiscent immunoassay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum free testosterone | Calculated formula (Vermeulen equation) | Calculated only once at the moment of enrollment | 
| Score at IIEF questionnaire | Total score at erectile function domain of IIEF-15 questionnaire | Assessed only once at the moment of enrollment |
Radiation Impact on Thromboembolic Events

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to determine the frequency and to identify main risk factors for venous thromboembolism of venous thromboembolic complications in a population of cancer patients treated with a curative intent by ionizing radiation.

Official Title
-----------------
Radiation Therapy and Venous Thromboembolic Events

Conditions
-----------------
Malignant Neoplasm

Intervention / Treatment
-----------------
* Biological: Biomarkers assays


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with a solid cancer (all locations) treated with radiation therapy and / or brachytherapy as curative intent to be 18 Exclusion Criteria: Patient with metastatic cancer, Patients whose follow-up at 6 months is not possible Patient receiving an anti-coagulative medication (curative doses) Pregnant or breastfeeding women, Person under protection of justice or unable to give consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer treated by radiotherapy<br>Patient with a solid cancer (all locations) treated with radiation therapy and/or brachytherapy as curative intent | Biological: Biomarkers assays<br>* D-Dimer assays, C-reactive protein, blood platelets assays<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Thromboembolism event | All venous thromboembolism, whether symptomatic or discovered incidentally, objectified (CT angiography, lung scintigraphy, venous Doppler) between J1 of radiation treatment, up to 6 months following discontinuation of radiation treatment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of D-dimer |  | 6 months | 
| C-reactive protein |  | 6 months | 
| Complete blood count |  | 6 months | 
| Time of occurrence of VTE | Time of occurrence of VTE | 6 months | 
| Symptomatic VTE | Symptomatic VTE. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiation therapy, Thrombosis
Correlation Study Between Socio-economical Deprivation and Oral Health in Children of 9 Years of Age

Study Overview
=================
Brief Summary
-----------------
Retrospective, observational cohort study. Objectives : To search for correlations between socio-economical deprivation and oral health in french children of 9 years of age. To study the annual use of oral and dental care of children from 6 to 9 years of age depending on their geographical and socio-economical environment, and the medical demography ; To identify and study the share of the cohort not using oral and dental care, and the socio-economical and geographical factors implicated in this non-use of care. The study will use data from the french nationwide healthcare systems database (SNDS) and data from the french national institute of statistics and economic studies (INSEE).

Official Title
-----------------
Correlation Study Between Socio-economical Deprivation and Oral Health in in French Children of 9 Years of Age in 2017. A Nationwide Database Retrospective Observational Cohort Study

Conditions
-----------------
Tooth Decay, Missing Tooth/Teeth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Being born in 2008 Being covered by the mandatory french national health insurance plan without discontinuity between 2014 and 2017 Living in France without discontinuity between 2014 and 2017 Exclusion criteria: - None

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 9 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 |
| --- | --- | --- |
| Correlations (odds-ratios) between several socio-economical indicators and oral care use | Correlations (odds-ratios) between several socio-economical indicators and oral care use | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean numbers of several types of oral cares depending on the patients geographical and socio-economical environment | Mean numbers of several types of oral cares depending on the patients geographical and socio-economical environment, and the medical demography | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deprivation, Oral health, Odontology, Epidemiology, Public health
A Prospective Chart Review to Validate the WFIRS (Weiss Functional Impairment Rating Scale)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the psychometric validation of the Weiss Functional Impairment Rating Scale and the Weiss Symptom Record. It is hypothesized that the Weiss Functional Impairment Rating Scale has strong psychometric properties and good convergent validity with other measures of functioning and discriminant validity from symptoms and quality of life.

Detailed Description
-----------------
The measures for this rating scale were developed at the request of the Canadian Attention Deficit Disorder Resource Alliance to provide clinician friendly tools free of charge as a way of improving screening for ADHD and comorbidity. Patients are consented during clinic visits and agree to allow use of clinic data for the purpose of this research. They complete additional measure(s) for the purpose of the study. The data is then entered. Internal consistency will be measured using Cronbach's alpha. Convergent, concurrent and discriminant validity will be measured using Pearson correlations. Domain reliability is determined with factor analysis. Up to 220 patients will be enrolled in the study.

Official Title
-----------------
Psychometric Validation of the Weiss Functional Impairment Rating Scale and the Weiss Symptom Record in Patients With Attention-Deficit Hyperactivity Disorder

Conditions
-----------------
Attention-Deficit/Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Compliance to complete the WFIRS is key to inclusion.

Ages Eligible for Study
-----------------
Minimum Age: 7 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
-----------------
ADHD, WFIRS, WSR
Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the enzymatic product Frucosin(R) is able to degrade fructose in vivo in the small intestine of patients with known fructose malabsorption by measuring hydrogen in the expiratory air.

Detailed Description
-----------------
Fructose malabsorption is a digestive disorder in which the uptake of fructose in the small intestine is deficient. This leads to an increase of the concentration of fructose in the large intestine after the intake of fructose-rich meals. The exzess fructose is then degraded by intestinal microbes into CO2, CH4, H2 and short chain fatty acids causing symptoms like bloating, diarrhea, flatulence or stomach pain. The clinical diagnosis requires a hydrogen breath test after challenge with fructose. After an oral challenge with fructose the emerging hydrogen is measured in the expiratory air. A fructose malabsorption is diagnosed if the hydrogen in the expiratory air reaches 20ppm or more. In the course of this study the participants will take 2 hydrogen breath tests. Before each of these tests the participants will take either the active treatment (Fructosin(R)) or a placebo. The active treatment should reduce the exhaled hydrogen indicating a reduced concentration of fructose in the large intestine after fructose metabolization by the verum.

Official Title
-----------------
Efficacy of Fructose Metabolizing Enzymatic Product Fructosin(R) in Patients With Fructose Malabsorption

Conditions
-----------------
Fructose Malabsorption

Intervention / Treatment
-----------------
* Dietary Supplement: Fructosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed fructose malabsorption Exclusion Criteria: Gravidity diabetes mellitus recent gastrointestinal surgery recent endoscopy recent antibiotics therapy

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1<br>single arm of study in cross-over design | Dietary Supplement: Fructosin<br>* Three capsules of Fructosin before one of the hydrogen breath tests.<br>* Other names: Frutosin(R);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area under the curve (AUC) of the exhaled breath hydrogen in ppm*min |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation) |  | 24 hours |
18519 - Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment - Darkening Dose

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987517<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number: SR15-43-Y65-158)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which Arm (capecitabine + irinotecan versus capecitabine + cisplatin) shows higher response rates in the treatment of advanced gastric-oesophagal cancer Furthermore, comparison of progression-free survival, 1-year survival, Quality of Life and safety

Detailed Description
-----------------
capecitabine + irinotecan versus capecitabine + cisplatin, as published by Kang et al. (ASCO 2006)

Official Title
-----------------
A Prospective, Open, Comparative Multicentre Phase II Study for the Evaluation of Irinotecan and Capecitabine Versus Cisplatin and Capecitabine in Advanced Gastric Adenocarcinoma or Gastric-Oesophagal Junction

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Cisplatin, Irinotecan, Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gastric or gastric-oesophagal junction adenocarcinoma unidimensional measurable disease Karnofsky index >/=60% Exclusion Criteria: prior chemo- or radiotherapy colorectal diseases brain metastases

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cisplatin, Irinotecan, Capecitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  |  | 
| progression free survival |  |  | 
| 1 year survival |  |  | 
| Quality of Life |  |  | 
| Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cisplatin, capecitabine, gastric, irinotecan, metastatic, chemotherapy
A Study of the Ability of Functional Magnetic Resonance Imaging (fMRI) to Detect and Characterize the Effects of Two Marketed Centrally Active Drugs, Placebo, and RO4917523 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to characterize the response to three centrally active drugs and placebo.

Official Title
-----------------
Randomized, Observer-blind, Placebo-controlled, Four-way Cross-over Study to Study the Ability of Functional Magnetic Resonance Imaging (fMRI) of the Brain to Detect and Characterize the Effects of Single Doses of a Selective Serotonin Reuptake Inhibitor (Escitalopram [Lexapro&#61650;]), a Dopamine

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: RO4917523
* Drug: escitalopram
* Drug: methylphenidate
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, 18 to 45 years of age In good general health Weight of &#x2265;120 lbs (55 kg) and a body mass index (BMI) between 18 to 30kg/m² Males and females with reproductive potential: willing to use a reliable method of contraception Exclusion Criteria: Evidence of clinically significant disease Medical or surgical condition that could alter the absorption, metabolism, or elimination of drugs Family history of sudden death or ventricular arrhythmia History of any psychiatric disorder and/or marked anxiety History of glaucoma History (including family) of motor tic or diagnosis of Tourette's syndrome Active suicide ideation Contraindication to MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RO4917523<br>* Oral single dose<br>Drug: escitalopram<br>* Oral single dose<br>* Other names: Lexapro;Drug: methylphenidate<br>* Oral single dose<br>* Other names: Ritalin;Drug: placebo<br>* Oral single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the ability of fMRI to detect and characterize the effect of the three drugs on brain activity at rest and during emotional stimuli |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the ability of other behavioural paradigms/scales to detect drug effects |  | 8 weeks | 
| To correlate the fMRI measures with the clinical/behavioral measures |  | 8 weeks | 
| To investigate the safety of single doses of RO4917523 in healthy volunteers |  | 8 weeks |