linjc16/ctgov huggingface dataset:
CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
The CONCEPT study has been designed to evaluate the safety and the efficacy of Motor Cortex Stimulation (MCS) with a new cortical lead (circular lead, eight electrodes, Medtronic Inc, Minneapolis, USA) in the treatment of intractable neuropathic pain, in particular for central post-stroke pain (CPSP) and trigeminal neuropathic pain (TGN)/facial pain.

Official Title
-----------------
A Prospective, Randomized, Double Blind, Crossover, Multi-center Study to Evaluate the Safety and the Efficacy of Motor Cortex Stimulation With the Cortical Stimulation Lead Model 2976 in Patients With Neuropathic Pain

Conditions
-----------------
Pain, Intractable, Facial Pain

Intervention / Treatment
-----------------
* Device: Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CPSP or TGN/facial pain refractory to other medical treatments Pain > 1 year prior to baseline Pain intensity with an average daily VAS score > 5 demonstrated by 12 ratings across 4 days Stable pain medication for > 1 month prior to baseline Exclusion Criteria: CPSP with important paresis/severe motor deficit in the area of pain TGN/facial pain with complete deafferentation pain Atypical facial pain, i.e. when objective evidence for neuropathic facial pain syndromes is lacking and when specific psychological and behavioral factors can be identified Pain associated with malignant neoplastic disease anywhere in the body or head History of epilepsy Presence of a deterioration of cognitive functions

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events reports |  |  | 
| Pain assessed by Visual Analogue Scale (VAS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Disability |  |  | 
| Analgesic, sedative or psychoactive medication intake |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motor Cortex Stimulation, Pain treatment, Central post-stroke pain (CPSP), Trigeminal neuropathic pain (TGN), Facial pain, Neurostimuation, Cortical lead, Neuropathic pain
High Resolution Retina Imaging

Study Overview
=================
Brief Summary
-----------------
To increase the clinical experience of using the rtx1 camera in various retinal disorders and to follow the evolution of structural alterations during retinal diseases using adaptive optics imaging with the rtx1 camera

Official Title
-----------------
High Resolution Retina Imaging

Conditions
-----------------
Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy, Macular Edema, Retinal Degeneration, Diabetic Retinopathy, Occlusion Retinal Vein, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons over 12 years of age, of both sexes, presenting with retinal pathologies. Beneficiaries of the health insurance Exclusion Criteria: Any abnormality preventing good quality OA imaging on both eyes Major under guardianship or curatorship

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
| Evolution of retina diseases | Increase the clinical experience of using the rtx1 camera in various conditions with retinal impact | From date of inclusion until the date of last documented progression , assessed up to 5 years |
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer

Study Overview
=================
Brief Summary
-----------------
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.

Detailed Description
-----------------
The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.

Official Title
-----------------
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer

Conditions
-----------------
Lumbar Spinal Stenosis

Intervention / Treatment
-----------------
* Device: Superion™ IDS


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Scheduled to receive or previously received a commercially approved Boston Scientific Indirect Decompression Systems, per local Instructions for Use (IFU) Signed a valid, IRB approved informed consent form Key Exclusion Criteria: Meets any contraindication in BSC Indirect Decompression Systems local IFU

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Superion™ IDS<br>All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms. | Device: Superion™ IDS<br>* All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Back Pain Responder rate | Proportion of subjects with an improvement of 20 mm for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) | Up to 3 years post-procedure | 
| Leg Pain Responder rate | Proportion of subjects with an improvement of 20 mm for leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) | Up to 3 years post-procedure |
ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with carboplatin in patients with recurrent ovarian cancer, who previously have had a good response with cisplatin or carboplatin, is safe and helps to decrease or stop tumor growth.

Detailed Description
-----------------
This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is sponsoring this trial.

Official Title
-----------------
Phase 1/2 Study of ZK-Epothilone (ZK-Epo; ZK-219477) in Combination With Carboplatin in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Drug: Sagopilone (ZK 219477) + carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Must have evidence of ovarian cancer measurable by computed tomography (CT) scan or by CA125 blood levels- No radiation therapy in last 4 weeks- No chemotherapy in last 24 weeks - No immunotherapy in last 4 weeks- Good response after previous treatment with carboplatin or cisplatin and then the ovarian cancer got worse again after at least 6 months- Additional criteria determined at screening visit Exclusion Criteria:- Having had more than one treatment regimen with carboplatin or cisplatin- Prior treatment with other epothilones (e.g. ixabepilone)- Use of any investigational drug in the last 4 weeks- Previous radiation to the whole pelvis- Symptomatic brain tumors requiring radiation to the brain - Active infection- Pregnant or breast feeding- Additional criteria determined at screening visit

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Sagopilone (ZK 219477) + carboplatin<br>* Chemotherapy for recurrent ovarian cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment with ZK-Epo after 6 cycles |  | After 6 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ZK-Epo given with carboplatin |  | Sept. 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian cancer, Ovarian neoplasms, epithelium
Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis

Study Overview
=================
Brief Summary
-----------------
Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis

Detailed Description
-----------------
Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results of treatment at different time intervals was done.

Official Title
-----------------
Continuous Versus Interrupted Use.of Vaginal Probiotic Plus Vaginal Clindamycin Cream for Bacterial Vaginosis a Randomized Controlled Study

Conditions
-----------------
Bacterial Vaginosis Treatment

Intervention / Treatment
-----------------
* Drug: Vaginal Clindamycin Cream
* Drug: Vaginal Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 18 years has recurrent Bacterial Vaginosis Exclusion Criteria: pregnancy use of other antmicrobial not provide informed consent

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

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

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

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: Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic<br>Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days | Drug: Vaginal Clindamycin Cream<br>* Vaginal Clindamycin Cream<br>* Other names: dalacin c cream;Drug: Vaginal Probiotic<br>* Vaginal Probiotic<br>* Other names: dicoflor vaginal capsules;|
| Active Comparator: Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic<br>Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use | Drug: Vaginal Clindamycin Cream<br>* Vaginal Clindamycin Cream<br>* Other names: dalacin c cream;Drug: Vaginal Probiotic<br>* Vaginal Probiotic<br>* Other names: dicoflor vaginal capsules;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initial cure rate | number of women completely cured | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate | number of women had recurrence | 4,6,8and12 months |
Observational Study of the Performance of Cephen Reagents in the Context of Research Into Lupus Anticoagulants

Study Overview
=================
Brief Summary
-----------------
Lupus anticoagulants (are antiphospholipid antibodies (PSA), the screening of which is done by demonstrating prolongation of coagulation times corrected by the intake of phospholipids (PL). Learned societies (ISTH, CLSI) thus recommend, for the research of LA, to carry out initially two screening tests with a low concentration in PL: a time of diluted Russell viper venom (DRVVT) as well as a time activated partial thromboplastin (TCA). If one of these screening tests is positive, it is recommended to perform a second confirmation test using the same principle (DRVVT or TCA) and containing a higher concentration of PL. The current LA screening method at the Hematology Laboratory of Strasbourg University Hospital includes: a pair of DRVVT screening / confirmation (STA-Staclot DRVV Screen and Confirm, Diagnostica Stago, France) and a screening TCA (PTT-A , Diagnostica Stago, France). This study aims to compare with the current method of the investigators a pair of TCA screening / confirmation (Cephen LS / Cephen, Hyphen Biomed, France).

Official Title
-----------------
Observational Study of the Performance of Cephen Reagents in the Context of Research Into Lupus Anticoagulants

Conditions
-----------------
Lupus Anticoagulant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject blood sample already analyzed in the laboratory as part of the treatment by the reference method Patient who did not express his opposition to the reuse of his data and his blood sample for the technical study. Exclusion criteria: Minor patient Patient under curatorship, guardianship or legal protection Patient who expressed his opposition to the use of his data Insufficient sample

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observational study of the performance of Cephen reagents in the context of research into lupus anticoagulants |  | Files analysed retrospectively from January 01, 2019 to December 31, 2021 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus Anticoagulant, Coagulation, Phospholipid
Use of Temperature Controlling Mattress Pad for Sleep Improvement

Study Overview
=================
Brief Summary
-----------------
A dual arm interventional study in which chliipad and ooler sleep system users voluntarily opt out of using their device for 2 out of 4 weeks. Assessments of sleep via self report and Oura Ring sleep quality and duration.

Official Title
-----------------
The Chili + OURA Sleep Study

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Device: Chili Sleep System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: has a chili sleep system has an Oura Ring Exclusion Criteria: medically treatable issue recent injury expected significant travel over study period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: In the four week study, participants were randomized into multiple arms, and asked to not use their device for 1 week, and then use it the next. Arms alternated back and forth.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Initial Off<br>Individuals were asked to not use their device on weeks 1 and 3 of the study. They were asked to use their device on weeks 2 and 4. | Device: Chili Sleep System<br>* A mattress pad that cools or warms bed to maintain a constant temperature.<br>|
| Other: Initial On<br>Individuals were asked to not use their device on weeks 2 and 4 of the study. They were asked to use their device on weeks 1 and 3. | Device: Chili Sleep System<br>* A mattress pad that cools or warms bed to maintain a constant temperature.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Deep Sleep as Measured by Oura Ring | Oura Ring is a connected health device worn on the finger that measures sleep. Deep sleep summaries per day will be compared between week 1 and week 2. | From week 1 to week 2 | 
| Change in self-reported sleep quality via Jenkins Sleep Scale | A 8 item self-assessment questionnaire of sleep quality. | From week 1 to week 2 |
Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the tolerance of two forms of vitamin C in adults with sensitivity to acidic foods.

Official Title
-----------------
A Randomized, Double-blind, Crossover Study Comparing the Tolerance of Two Forms of Vitamin C in Acid Sensitive Adults

Conditions
-----------------
Tolerance

Intervention / Treatment
-----------------
* Dietary Supplement: Calcium ascorbate
* Dietary Supplement: Ascorbic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by laboratory results and medical history Females not of child bearing potential Self-reported sensitivity to acidic foods Agrees to consume a low vitamin C diet Exclusion Criteria: Pregnant, breastfeeding, or planning to become pregnant during the trial Use of medications known to interact with vitamin C or cause epigastric effects Use of supplements containing containing vitamin C Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months Use of antacids and/or acid suppressors within 4 weeks of randomization History of irritable bowel syndrome and related disorders Alcohol use > 2 standard alcoholic drinks per day; alcohol or drug abuse within the past year History of cardiac disease within the past 6 months History of or current diagnosis of cancer Uncontrolled hypertension Unstable renal and/or liver disease History of kidney stones Unstable psychiatric disorder History of or current immunocompromise History of hemoglobinopathies Participation in another clinical research trial <30 days Abnormal liver function Serum creatinine > 1.5 x upper limit of normal (ULN) Anemia of any etiology Uncontrolled and/or untreated thyroid disorder BMI ≥ 35 kg/m2 Unstable medications <30 days Allergy or sensitivity to test article ingredients Cognitively impaired and/or unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium ascorbate -> ascorbic acid<br> | Dietary Supplement: Calcium ascorbate<br> <br> Dietary Supplement: Ascorbic acid<br> <br> |
| Experimental: Ascorbic acid -> calcium ascorbate<br> | Dietary Supplement: Calcium ascorbate<br> <br> Dietary Supplement: Ascorbic acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days |  | 0, 5 and 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin C, calcium ascorbate, ascorbic acid
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-201 Clinical Trial

Study Overview
=================
Brief Summary
-----------------
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.

Detailed Description
-----------------
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a burn.

Official Title
-----------------
A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 2 Clinical Trial of ALLO-ASC-BI-201

Conditions
-----------------
Burn

Intervention / Treatment
-----------------
* Biological: ALLO-ASC-DFU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-BI-201. A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided. Exclusion Criteria: 1. Subjects who are considered not suitable for the study by the principal investigator.

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

| Intervention/Treatment |
| --- |
|Biological: ALLO-ASC-DFU|ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a burn. This tudy is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Evaluation of AE | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancouver Burn Scar Scale | Evaluation of Vancouver Burn Scar Scale | Every time of visit for follow up to 24 weeks |