linjc16/ctgov huggingface dataset:
Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how Ibuprofen Cream (SST-0225) is absorbed and eliminated by the body under defined maximum dosing conditions and to evaluate the safety under these conditions.

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

Intervention / Treatment
-----------------
* Drug: Ibuprofen Cream (SST-0225)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed consent form Men, women, 18 to 55 years Females must not be pregnant or plan to become pregnant BMI 18 to 30 kg/m2 Past or non-smoker High probability of compliance with completion of study Healthy as determined by investigator based on medical history, physical exam, clinical laboratory tests, vital sign measurements, ECGs Exclusion Criteria: Presence or history of disorder that could interfere with completion of study Unstable medical condition Surgical or medical condition that may interfere with absorption, distribution, metabolism or excretion of test drug Positive Hep B, Hep C and/or HIV test Positive urine drug screen Any history of skin disorders, including psoriasis, eczema, tattoos, significant scarring, healing wounds, skin lesions on knees or elbows Significant disease Any clinically important deviation from normal limits in physical exam, vital sign measurements, 12 lead ECG, clinical laboratory test History of drug abuse with 1 year History of alcoholism with 1 year Use of prescription medications or ibuprofen within 30 days of Day 1, use of OTC drugs, herbal supplements and vitamins within 14 days of Day 1. Use of investigational drug within 30 day of Day 1 Acute disease state within 7 days of Day 1 Consumption of grapefruit or grapefruit containing products within 72 hours of Day 1 Tobacco use/caffeine use within 48 hours of Day 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: Ibuprofen Cream (SST-0225)<br> | Drug: Ibuprofen Cream (SST-0225)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, Tmax, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2 |  | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical laboratory change from baseline |  | 14 days | 
| Modified Berger Bowman Skin Assessment |  | 14 days | 
| Vital Signs |  | 14 days | 
| Adverse Events |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetic Study
a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4

Study Overview
=================
Brief Summary
-----------------
Phase II Study to evaluate the response on two blocks of topotecan and carboplatin

Detailed Description
-----------------
Phase II study for patients with chemosensible soft tissue sarcoma stage IV in children and adolescents ; response according to RECIST criteria following two blocks of combination therapy consisting of Topotecan and carboplatin

Official Title
-----------------
a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4

Conditions
-----------------
Sarcoma, Soft Tissue

Intervention / Treatment
-----------------
* Drug: Topotecan
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Soft tissue sarcoma chemosensible, stage IV age < 21 measurable tumor lesions Exclusion Criteria: Lack of cooperation by the patient no willingness of follow-up examinations participation on another clinical trial at the same time death due to the sickness within four weeks

Ages Eligible for Study
-----------------
Maximum Age: 21 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

| Intervention/Treatment |
| --- |
|Drug: Topotecan|nan|
|Drug: Carboplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response according to RECIST criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Overall-Survival |  |  | 
| Event-free-survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcoma, Soft Tissue
Traduction and Validation of the Central Sentitization Inventory Into French

Study Overview
=================
Brief Summary
-----------------
The study will include a translation of the Central Sensisization Inventory into French and a cultural validation of the French version of the questionnaire (Reliability, discrimination and comparison with other questionnaires).

Conditions
-----------------
Fibromyalgia, Heathy Volunteers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Diagnosis of Fibromyalgia (Group 1) Clinical Diagnosis of a Acute of Subacute Ankle Spain (Group 2) Healthy Volunteer (Group 3) Exclusion Criteria: Having any chronic pain (group 1 and group 2)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fibromyalgia Patients<br>The central Sensitization questionnaire will be filled in by each patients included. After One week, patients will filled it the questionnaire again to study the reliability. | |
| Ankle sprain Patients<br>The central Sensitization questionnaire will be filled in by each patients included. | |
| Healthy Volunteers<br>The central Sensitization questionnaire will be filled in by each volunteer included. After One week, volunteers will filled it the questionnaire again to study the reliability. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of the French version the Central Sensitization Inventory Score |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Questionnaire, Translation
Electronic Compliance Monitoring in Opioid Substitution Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve unsupervised dosing of opioid substitution medications. The aim of the study is to examine whether electronic compliance monitoring provides some advantages to patients'treatment and what kind of patients especially benefit from monitoring. We would also like to know if electronic compliance monitoring can prevent the abuse/diversion of medications and how implementing this method to wider treatment facilities succeeds.

Official Title
-----------------
Electronic Compliance Monitoring in Opioid Substitution Treatment

Conditions
-----------------
Opiate Dependence

Intervention / Treatment
-----------------
* Device: Compliance monitoring with electronic device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: opiate dependence F11.22 according to ICD-10 Suboxone treatment the duration of substitution treatment before study at least one month stable medication dose Exclusion Criteria: unstable situation in life according to treatment staff's opinions

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic compliance monitoring<br>Suboxone treated patients in Kuopio city area get their unsupervised Suboxone doses in electronic compliance monitoring devices during the 4 month study. | Device: Compliance monitoring with electronic device<br>* Patients get all their unsupervised substitution medication doses in electronic monitoring devices during the study. Daily dose of the drug is possible to get from the device in given time points and in the meantime device is locked.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of treatment (Treatment Outcomes Profile TOP) | Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment. | Every two months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients´opinions about the treatment. | Questionnaire designed for this study to explore patients' opinions on the compliance monitoring and it's effect on their treatment and abuse and/or diversion of medications. | Once when the study phase ends (after four months). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opiate dependence, substitution treatment, unsupervised dosing, monitoring
Qualitative Research for Stage 4 Liver Cancer Patients and Their Caregivers

Study Overview
=================
Brief Summary
-----------------
This is opinion based, experiential research and is NOT a drug trial.

Official Title
-----------------
Phase 1 0 Qualitative Research for Stage 4 Liver Cancer Patients and Their Caregivers.

Conditions
-----------------
Stage 4 Liver Cancer

Intervention / Treatment
-----------------
* Behavioral: bulletin board or telephone depth interview (TDI)
* Behavioral: interview regarding experiences and opinions as to condition and treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage 4 liver cancer patients and caregivers Exclusion Criteria: loved ones passed away

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: bulletin board or telephone depth interview (TDI)|experiential based research. anonymous participation.|
|Behavioral: interview regarding experiences and opinions as to condition and treatment|not a drug trial. experential/opinion based research.|

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
-----------------
patients or caregivers, for caregivers, loved one must still be living
Amino Acid and Intestinal Protein Metabolism : Working Study

Study Overview
=================
Brief Summary
-----------------
Gut protein metabolism that could be influenced by protein supply is involved in the regulation of several physiological functions such as gut barrier function and represents a major contribution in the whole-body protein turnover. Intracellular pathways implicated in the transduction of amino acids effects remained unknown in the human gut. Thus, the aim of the present project is to evaluate and to understand the effects of amino acids (glutamine, leucine) on gut protein metabolism (synthesis and degradation) in young healthy humans.

Official Title
-----------------
Physiological Study on Glutamine and Leucine Effects on Intestinal Protein Metabolism

Conditions
-----------------
Transduction Pathway, Proteinic Synthesis, Proteolytic System

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteers with seronegativity for HIV1 and HIV2 and HCV and HVB good nutritional state with physical indication mass included between 18,5 and 25kg/m2 non-smoking volunteers volunteers without digestive, allergic or haemorrhagic history volunteers without progressive disease digestive endoscopy tolerance age >=18 and <= 50years consent obtained from volunteers Exclusion Criteria: smoking volunteers volunteers with digestive, or allergic history volunteers with haemorrhagic sign pregnancy progressive digestive disease significant progressive disease volunteers with therapeutic treatment (aspirin) digestive endoscopy intolerance volunteers with neurological disorder or with delicate psychological state

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Enterally fed with leucine | |
| 2<br>Enterally fed with glutamine | |
| 3<br>Enterally fed with protein powder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of intestinal protein synthesis stimulation by Leucine or glutamine in duodenal biopsy |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of involved signaling pathways |  | 18 months | 
| Assessment of intestinal proteolysis |  | 18 months | 
| Assessment of protein synthesis rate in intestinal mitochondria |  | 18 months |
Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The investigators have developed a simple, accurate, and a point-of-care, computer-based clinical decision support system (CDSS) not only to detect the presence of sleep apnea but also to predict its severity. The CDSS is based on deploying an artificial neural network (ANN) derived from anthropomorphic and clinical characteristics. The investigators hypothesize that patients with severe OSA defined as AHI≥30 can be diagnosed with the use of ANN without undergoing a sleep study, and that empiric management with auto-CPAP has similar outcomes to those who undergo a formal sleep study.

Official Title
-----------------
Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Other: computer model
* Other: Polysomnogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be an adult (≥18 years old) Must have symptoms suggestive of OSA, and be considered for sleep study by the sleep specialist provider. Exclusion Criteria: Pregnancy or breast feeding Patients with severe congestive heart failure (eg, NYHA Class IV, ejection fraction < 35%). Patients with end-stage renal disease on hemodialysis Patients with CVA, Parkinson, neuromuscular degenerative disease. Patient on narcotics. Patients with severe lung disease requiring oxygen at night and/or during the day. Patient with predominant insomnia or sleep hygiene problems, and who are not considered for PSG by the sleep specialist.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: artificial neural network<br> | Other: computer model<br>* Diagnosis of Sleep apnea and treatment guidance will rely on a computer model prediction.<br>|
| Active Comparator: Polysomnogram<br> | Other: Polysomnogram<br>* Diagnosis of sleep apnea will rely on polysomnogram<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that using an ANN directed management of OSA is not inferior to PSG directed management of OSA in terms of sleepiness related functional outcome |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
artificial neural network
Soy Protein in Early Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
Diabetic nephropathy is a frequent cause of end-stage renal disease. Reduction of dietary protein has been used to slow down renal disease progression, but patients are often unwilling to make these dietary changes. Other research suggests that changing the quality of dietary protein may be as effective as reducing the total amount of ingested protein. This study hopes to show that soy protein, a plant protein relatively high in essential amino acids and with high nutritional value, maye be beneficial to Type I diabetic patients with incipient renal disease.

Official Title
-----------------
Soy Protein in Early Diabetic Nephropathy

Conditions
-----------------
Diabetic Nephropathy, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: soy protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age 18-40; Diabetic nephropathy; Type I diabetes mellitus.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: soy protein|nan|

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
-----------------
diabetic nephropathy, nephropathy, diabetes, diabetes mellitus, type I diabetes, soy protein
Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C

Study Overview
=================
Brief Summary
-----------------
A clinical trial to establish the long term response of using intraoperative 5-fluorouracil (5-FU) versus mitomycin C (MMC) in trabeculectomy glaucoma surgery. Antiproliferative agents such as 5-fluorouracil and Mitomycin C have been used extensively in trabeculectomy surgery to improve the success of the surgery and prevent further visual loss and blindness in glaucoma patients.

Detailed Description
-----------------
Glaucoma is a life-long progressive disease, and patients are living longer. Therefore, a long term full evaluation of the efficacy of intraoperative 5-FU and MMC needs to be performed to assess the true efficacy of MMC compared to 5-FU. We, therefore propose, a long-term prospective study of patients previously enrolled in the prospective study involving the evaluation of single intraoperative application of mitomycin C versus 5-fluorouracil in low to moderate risk glaucoma patients.

Official Title
-----------------
Intermediate Term Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin c in Trabeculectomy Surgery.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: 5-fluorouracil
* Drug: Mitomycin C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy. Exclusion Criteria: Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy.
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: 5-fluorouracil|nan|
|Drug: Mitomycin C|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Control |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitomycin Complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trabeculectomy, 5-fluorouracil, Mitomycin C