linjc16/ctgov huggingface dataset:
Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy

Conditions
-----------------
Diabetic Neuropathies, Pain

Intervention / Treatment
-----------------
* Drug: DVS SR
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes type 1 or 2 Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months Exclusion Criteria: Major Depression Uncontrolled diabetes

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: desvenlafaxine succinate sustained-release (DVS SR) 50mg<br> | Drug: DVS SR<br> <br> |
| Experimental: desvenlafaxine succinate sustained-release (DVS SR) 100mg<br> | Drug: DVS SR<br> <br> |
| Experimental: desvenlafaxine succinate sustained-release (DVS SR) 200mg<br> | Drug: DVS SR<br> <br> |
| Experimental: desvenlafaxine succinate sustained-release (DVS SR) 400mg<br> | Drug: DVS SR<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Pain Severity Score From Baseline to 13 Weeks | Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline. | Baseline and 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With ≥50% Reduction in Mean Pain Severity Score. | Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline. | Baseline and 13 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuropathic pain, diabetic peripheral neuropathy
Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels.

Study Overview
=================
Brief Summary
-----------------
Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.

Detailed Description
-----------------
Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored. Treatment is prior to and independent of the patient's participation in the study and is governed by clinical judgment criteria and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice. Patients are older than 14 years who suffer from inflammatory bowel disease and who receive remsima as routine treatment. The source of information will be the patient's medical history.

Official Title
-----------------
Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels in Patients With Inflammatory Bowel Disease.

Conditions
-----------------
Inflammatory Bowel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with inflammatory bowel disease. Over 14 years old. Receive Remsin as a treatment for his disease. And always this treatment that the patient is going to receive is governed by the criteria of clinical judgment and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice. Exclusion Criteria: Patients with inflammatory bowel disease under 14 years of age. Or older than this age with inflammatory bowel disease who do not attend the established check-ups

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| Cases<br>Patients treated with infliximab sc. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perform an efficacy assessment and monitoring of subcutaneous infliximab levels in patients with inflammatory bowel disease. | Number of hospitalizations of patients treated with subcutaneous infliximab suffering from inflammatory bowel disease. | Up to 16 weeks. |
Pretreatment of Patients Expecting Bariatric Surgery With the GLP-1 Analogon Liraglutid

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue.

Detailed Description
-----------------
The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue. As GLP-1 is presumed to improve insulin sensitivity and associated parameters the investigators hypothesize that this might be due to changes in lipid metabolism which might be involved in the regulation of insulin sensitivity. Therefore the investigators intend to investigate changes of metabolic pathways before and after treatment with the GLP-1 analog liraglutide that could play a crucial role in pathogenesis as well as regulation of insulin sensitivity and atherogenic dyslipidemia such as: de novo lipogenesis and reverse cholesterol transport

Official Title
-----------------
Pretreatment of Patients Expecting Bariatric Surgery With the GLP-1 Analogon

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: GLP-1 (Liraglutide)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 35-55 Kg/m2 Fasting Blood glucose >140mg/dl Planned bariatric surgery Diabetic Medication (Metformin, Sulfonylurea, Insuline) Exclusion Criteria: Known hypersensitivity against Liraglutid Pretreatment DPP-4 Inhibitors or GLP-1 Analogue the last 3 months HbA1c >10%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 77 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 |
| --- | --- |
| Active Comparator: GLP-1 (Liraglutide)<br>Daily subcutaneous injection of Lirglutide over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg | Drug: GLP-1 (Liraglutide)<br>* GLP-1 Analogon<br>* Other names: Victoza;|
| Placebo Comparator: Placebo Comparator<br>Daily subcutaneous injection of PL1/PR1 Placebo over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg | Drug: Placebo<br>* Placebo<br>* Other names: PL1 PR1;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight reduction | to compare body weight with type 2 Diabetes scheduled for weight loss surgery after 8 weeks of preoperative treatment with either placebo or liragludite | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLP-1 Levels | Measurement of GLP-1 levels during the defined period | 4 years |
Feasibility of the Portable YouGrabber System

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine the feasibility of the portable version of the YouGrabber® system in children with central motor disorders.

Detailed Description
-----------------
In a feasibility trial with the portable version of the YouGrabber® system it will be determined if the technique and equipment are ready to be used in a home setting where children with central motor disorders train with assistance of caregivers but without a therapist. Furthermore, it will be examined if children and adolescents with central motor disorders accept this home-based system and if they are motivated for using it.

Official Title
-----------------
Feasibility of a Home-based Interactive System for Upper Limb Therapy (YouGrabber)

Conditions
-----------------
Cerebral Palsy, Stroke, Traumatic Brain Injury, Meningomyelocele, Central Nervous System Diseases

Intervention / Treatment
-----------------
* Device: YouGrabber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Central motor disorders Ability to sit in an upright position for 45 minutes Exclusion Criteria: Manual Ability Classification Scale (MACS) V Severe visual or auditory impairments Severe photosensitive epilepsy

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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: YouGrabber training<br>Home-based YouGrabber training | Device: YouGrabber<br>* 2 weeks of home-based therapy with a virtual-reality enhanced upper limb training system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User satisfaction (Questionnaire about usability, motivation, general opinion) | Questionnaire about usability, motivation, general opinion | week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device usage (Total time of exercise per week; time of training session) | Total time of exercise per week; time of training session | week 2 | 
| Error rate (Error prone games; application problems as a home-based system) | Error prone games; application problems as a home-based system | week 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Rehabilitation, Telerehabilitation, Upper limb therapy
New Strategies of Genetic Study of Patients With Oculocutaneous Albinism

Study Overview
=================
Brief Summary
-----------------
The oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. In 20% of patients no mutation is identified. The optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients.

Detailed Description
-----------------
The oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. In 20% of patients no mutation is identified. The optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients. .

Official Title
-----------------
New Strategies of Genetic Study of Patients With Oculocutaneous Albinism

Conditions
-----------------
Oculocutaneous Albinism, Mutation

Intervention / Treatment
-----------------
* Other: Genetic analyzes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Oculocutaneous albinism (diagnosis validated by a clinician at the initial genetic consultation and did not show mutations of the TYR, OCA2, TYRP1, SLC45A2 genes) Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Genetic analyzes|Analysis by CGH array, homozygotic cartography and candidate gene sequencing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of a genetic anomaly | Analysis by CGH (Comparative Genomic Hybridization) array : The Log2 values of the patient / reference fluorescence intensity ratios (Log2R) are -1 in the case of a heterozygous deletion, 0.5 in the case of heterozygous duplication and 0 in the absence of rearrangement. | At the screening | 
| Identification of a genetic mutation | By sequencing candidate genes : homozygotic cartography and candidate gene sequencing | At the screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CGH array chip, Homozygosity mapping
First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Official Title
-----------------
Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Subcutaneous and Oral Doses of GLPG0187 in Healthy Subjects.

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

Intervention / Treatment
-----------------
* Drug: GLPG0187
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male, age 18-50 years BMI between 18-30 kg/m², inclusive Exclusion Criteria: significantly abnormal platelet function or coagulopathy smoking drug or alcohol abuse

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG0187<br>Single dose | Drug: GLPG0187<br>* Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching subcutaneous or oral placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single subcutaneous and oral dosing |  | up to day 10 postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of single subcutaneous and oral doses |  | up to 10 days postdose | 
| Exploratory evaluation of S-CTX |  | up to 24 hrs postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Pharmacokinetics
Fertility Awareness in University Students

Study Overview
=================
Brief Summary
-----------------
Recent evidence showed that undergraduate students have inappropriate knowledge about reproductive health and infertility. The investigators' aim was to assess the effectiveness of a brief intervention (video) in increasing the knowledge regarding fertility issues, fertility risk factors and infertility definition.

Official Title
-----------------
Fertility Awareness in University Students

Conditions
-----------------
Educational Video

Intervention / Treatment
-----------------
* Other: Video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergraduate student Exclusion Criteria: Having knowledge of a fertility problem

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>2 minutes video with information and images on age-related fertility, infertility definitions, infertility risk factors, probabilities of fecundity according to age and cycle. | Other: Video<br>* Video-Audio Media<br>|
| No Intervention: Control<br>No intervention | |
| Active Comparator: Control 1<br>2 minutes video with same images but information on work-family balance. | Other: Video<br>* Video-Audio Media<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in fertility knowledge | This measure assesses fertility knowledge by asking 10 questions on the probability of conception and fertility treatment success rates. | T1 - immediatly after intervention; T2 - one week later; T3 - one month later; T4 - 12 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in age of desired parenthood | Subjects are asked to write how many children would they like to have in the future and what is the desired age for having the first and the last child. | T1 - immediatly after intervention; T2 - one week later; T3 - one month later; T4 - 12 months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, fertility awareness, health interventions, young adults
Specifying Interventions From the Sickle Cell Disease Implementation Consortium (SCDIC)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to specify the interventions, implementation strategies and control conditions from the Sickle Cell Disease Implementation Consortium (SCDIC) using a mixed-methods approach to study site materials and conduct semi-structured qualitative interviews with site representatives (N=3 per site).

Detailed Description
-----------------
The long-term goal of this line of research is to identify the most effective components of SCD interventions while also identifying effective implementation strategies informed by a systematic and rigorous work done by the members of the SCDIC consortium to improve the quality of life of people with SCD, a life-threatening hematological disorder. This study aims to collect detailed information about the planned interventions, the implementation strategies and the control conditions from each site.

Official Title
-----------------
The Implementation of Cognitive Screening and Educational Support to Improve Outcomes of Adolescents and Young Adults With Sickle Cell Disease: From Clinic to the Community and Back

Conditions
-----------------
Anemia, Sickle Cell

Intervention / Treatment
-----------------
* Behavioral: SCDIC interventions
* Behavioral: SCDIC control groups


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: three representatives of each of the SDIC sites: the Principal Investigator, and two people nominated by the PI. Exclusion Criteria: none

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SCDIC interventions<br>Careful detail the intervention components and the implementation strategies (i.e., the mechanisms by which the interventions are being delivered in usual care) being developed by the consortium. | Behavioral: SCDIC interventions<br>* The research team will characterize the intervention components and their implementation strategies.<br>|
| SCDIC control groups<br>Careful detail the control conditions of each of the SCDIC sites for each of the interventions being developed. | Behavioral: SCDIC control groups<br>* The research team will characterize the control settings, including patients, providers and organization.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCDIC Framework of Interventions | Detailed descriptions of the interventions being developed by the SCDIC including a) entity, or entities, targeted by the intervention; (b) functional domains targeted by the interventions; and (c) delivery system characteristics | 2 years |