linjc16/ctgov huggingface dataset:
Serotonin, Impulsivity, and Cocaine Dependence Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects of citalopram versus placebo given in the context of contingency management for cocaine dependence.

Detailed Description
-----------------
Cocaine dependence continues to be a significant public health problem, for which there is no FDA approved pharmacotherapy. This study is a 12-week, double blind, placebo controlled trial of citalopram for cocaine dependence. The primary outcome measure is benzoylecgonine positive urines. Secondary measures of side effects and craving are also examined.

Official Title
-----------------
Serotonin, Impulsivity, and Cocaine Dependence Treatment

Conditions
-----------------
Cocaine Dependence

Intervention / Treatment
-----------------
* Drug: citalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence. female subjects: a negative pregnancy test Exclusion Criteria: current or past DSM-IV Axis I disorder other than substance abuse/dependence any serious non-psychiatric medical illness requiring ongoing medical treatment substance dependence other than cocaine within the last 3 months negative urine drug screen for cocaine at time of testing for female subjects: a positive pregnancy test

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: citalopram|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of cocaine metabolites in urine weekly. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate and cocaine cravings weekly. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine; citalopram; impulsivity; serotonin
Pharmacogenetics of Propofol and Depth of Anesthesia

Study Overview
=================
Brief Summary
-----------------
Propofol, (2,6-diisopropylphenol) is a short-acting anesthetic drug used for induction and maintenance of anesthesia. The aim of this study is to evaluate plasma concentrations of propofol in relation to depth of anesthesia, measured by continuous EEG and to correlate plasma concentrations with genetic analyses of liver enzymes responsible for drug elimination. Our hypothesis is that there is an individual requirement of Propofol plasma concentration depending on genetic differences in drug elimination. 200 patients, ASA classification 1, planned for elective surgery of a duration of at least 30 minutes will be included in this study.

Official Title
-----------------
The Effect of Pharamocogenetices on Anesthesia Induction With Propofol

Conditions
-----------------
Anesthesia, Propofol

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy caucasian patents, (ASAclassification 1) planned for elective surgery, with body mass index 20-30, free from analgetic drug > 12 hours prior to anesthesia Exclusion Criteria: Pregnancy, Smoking, allergy to propofol or peanuts, alcohol abuse, non-caucasian

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 200 patients,ASA 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG pattern in correlation to clinical anesthesia | EEG pattern in correlation to clinical anesthesia | 20120101 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propofol, depth of anesthesia, pharmacogenetics, Depth of anesthesia in correlation to plasma concentrations of propofol
Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome

Official Title
-----------------
Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome: A Randomized, Double-blinded,Placebo- Controlled Multicenter Study

Conditions
-----------------
Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Clostridium Butyricum
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the presence of Rome III criteria for IBS ; Aged between 18 and 65 years old Exclusion Criteria: Antibiotic, probiotic or laxative usage within 4 weeks. organic gastrointestinal diseases Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc. pregnancy or lactation. previous major or complicated abdominal surgery. severe endometriosis and dementia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clostridium Butyricum group<br>Irritable bowel syndrome patients treated with Clostridium Butyricum | Drug: Clostridium Butyricum<br>* Irritable bowel syndrome patients treated with Clostridium Butyricum<br>|
| Placebo Comparator: Placebo group<br>Irritable bowel syndrome patients treated with placebo | Drug: placebo<br>* Irritable bowel syndrome patients treated with placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS patients'quality of life | Quality of life was determined by using IBS-QOL scoring system for patients with IBS. | 7 months | 
| Composition of Microorganisms in stool | Primary coordination of fecal samples' 16s rDNA (ribosomal DNA) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA). | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritable Bowel Syndrome, Clostridium Butyricum
A Clinical Study of Epilepsy Localization and Prognosis Based on PET and Resting-state fMRI

Study Overview
=================
Brief Summary
-----------------
By following up the prognosis of surgical patients, the application value of Cortex ID quantitative analysis in the localization of epilepsy foci was studied. By studying the correlation between autonomic nerve function and epilepsy neural network in epilepsy patients, and analyzing the differences between different epilepsy patients, it can provide more information for judging the prognosis of epilepsy patients.

Detailed Description
-----------------
This study included diagnostic trials and case-control studies, which were observational studies with no intervention. First, the demographic and clinical information of epilepsy patients in the Neurology Department of Xijing Hospital were collected, including gender, age, age of onset, course of epilepsy, seizure performance before treatment, seizure frequency before treatment, type and dose of antiepileptic drugs, past history, Family history, etc., as well as imaging, EEG, quality of life, and neuropsychological assessment, etc. were collected; secondly, functional magnetic resonance imaging (fMRI) and 24-hour Holter monitoring were performed on patients who met the inclusion criteria. Positron Emission Computed Tomography (PET) images of patients who have undergone or plan to undergo surgery are analyzed; finally, appropriate statistical methods are used for analysis.

Official Title
-----------------
A Clinical Study of Epilepsy Localization and Prognosis Based on Positron Emission Tomography and Resting-state Functional Magnetic Resonance Imaging

Conditions
-----------------
Epileptic Seizure

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the diagnostic criteria for epilepsy, No contraindications for fMRI examination. The patient had no other heart and lung diseases except epilepsy. Patients and their families were aware of this study and signed informed consent. Exclusion Criteria: Patients with severe infection, cerebrovascular disease, malignant tumor and other systemic diseases that can affect the nervous system, and those with serious dysfunction of the heart, liver, kidney and other organs. Non-epileptic seizures such as syncope and hysteria. Pregnant or lactating women. Incomplete clinical data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| drug-resistant epilepsy<br>No intervention | Other: No intervention<br>* No intervention<br>|
| Medication is effective<br>No intervention | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure frequency |  | 2022-2024 | 
| Seizure duration |  | 2022-2024 |
US-Non Contrast Computed Tomography Real-time Fusion for Urinary Stones Follow up

Study Overview
=================
Brief Summary
-----------------
Urolithiasis is a universal problem, a large part of patients will be affected by multiple stones throughout their lifetime, with estimated recurrence rates of 75% within 20 years. The high recurrence rate requires an increasing amount of imaging follow-up. US-NCCT real-time fusion (Fusion) enables lesion assessment and follow up using both modalities as reference for each other. Our study proposes a novel approach for short term follow up of patients using Fusion instead of repeat NCCT exams. the goal of the study is to create an initial proof of concept that Fusion is effective for follow up of known urinary stones. the study is a prospective study on Patients with an obstructing ureteral stone found on a NCCT. Patients will undergo Fusion (using General Electric Logiq E9) after NCCT. The primary endpoint was the ability to locate the ureteral stone using US with guidance of the NCCT as a Road Map.

Official Title
-----------------
Ultrasound Non-contrast Computed Tomography Real-time Fusion for Urinary Stones Follow up

Conditions
-----------------
Urolithiasis, Ureterolithiasis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NCCT within 3 months prior to the US study with proved Urolithiasis Exclusion Criteria: Inability to perform a US study. Pacemaker

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 |
| --- |
|Other: Ultrasound study|Ultrasound study using real-time image fusion with a previous NCCT|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| US identification of ureteral stone seen on NCCT |  | up to 3 months after NCCT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney stones, ureteral stones
Induced Membrane Properties in Children and Adults

Study Overview
=================
Brief Summary
-----------------
Bone reconstruction in critical sized defect (CSD) remains a real challenge in orthopedic surgery in children and adults. The Masquelet technique is an innovative therapeutic technique, which offers a bone reconstruction in two steps, by the formation of an induced membrane (IM) around a polymethylmethacrylate (PMMA) spacer placed into the bone defect. After, PMMA removal, the cavity is filled with corticocancellous graft allowing bone healing. Up to date, all angiogenesis and osteogenic properties of IM remain unknown. The purpose of this study is to characterize angiogenesis and osteogenic properties of IM in children and adults.

Official Title
-----------------
Induced Membrane Properties in Children and Adults

Conditions
-----------------
Bone Loss, Surgery

Intervention / Treatment
-----------------
* Procedure: harvesting induced membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated at CHU Amiens-Picardie for bone critical sized defect treated using the induced membrane reconstruction technique. patients from 9 months to 60 years old Exclusion Criteria: Patients managed by another reconstruction technique for critical sized defect Patients under guardianship, curators or deprived of liberty. Pregnant and nursing women. Patients who refused to participate in the study and to sign informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Procedure: harvesting induced membrane|The induced membrane will be harvested during the second step of the bone reconstruction.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the BMP2 concentration of the induced membrane by immunodetection | Measure of the osteogenic property of the induced membrane will be made after harvesting the induced membrane | one year (one year from day of surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMP2 concentration of the induced membrane implanted in adults measured by immunodetection | measurement of osteogenic property of the induced membrane in adults | one year (one year from day of surgery) | 
| BMP2 concentration of the induced membrane implanted in children measured by immunodetection | measurement of osteogenic property of the induced membrane in children | one year (one year from day of surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
induced membrane, critical size defect
A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients.

Official Title
-----------------
A Phase 3 Safety and Efficacy Study of Vitreosolve® for Ophthalmic Intravitreal Injection in Retinopathy Subjects

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Vitreosolve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a history of systemic diabetes (type I or II) Subject with a documented history of Non Proliferative Diabetic Retinopathy (NPDR) Subjects with no PVD at baseline exam in the study eye. Exclusion Criteria: Subjects with Retinal pathology in the study eye other than (NPDR) Subjects with high myopia in the study eye Subjects who have monocular vision or contra lateral vision of 20/200 or worse BCVA in the non-study eye. Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment Subjects that have had either vitrectomy surgery, intravitreal injections, or laser treatments in the study eye.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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: 1<br> | Drug: Vitreosolve<br>* Intravitreal injection<br>|
| Experimental: 2<br> | Drug: Vitreosolve<br>* Intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound |  | 7 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound, OCT, Safety |  | 7 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic retinopathy
Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

Detailed Description
-----------------
Bixalomer is administered at initial oral dosage of 500 mg three times a day just before a meal. The dosage can be adjusted based on symptoms and serum phosphorus level.

Official Title
-----------------
Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphataemia Receiving Hemodialysis

Conditions
-----------------
Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis

Intervention / Treatment
-----------------
* Drug: Kiklin capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Chronic renal failure patients with hyperphosphataemia receiving hemodialysis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kiklin group<br> | Drug: Kiklin capsules<br>* oral<br>* Other names: bixalomer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the incidence of adverse events, physical exam and lab-tests |  | for one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum phosphate level |  | Baseline and 1, 2, 3, 6, 12 months after administration | 
| Serum calcium level |  | Baseline and 1, 2, 3, 6, 12 months after administration | 
| Intact PTH (parathyroid hormone) level |  | Baseline and 1, 2, 3, 6, 12 months after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1585, Hemodialysis, CKD (chronic kidney disease), Hyperphosphatemia
Implementing & Testing Assessment and Referral Technologies in Juvenile Justice

Study Overview
=================
Brief Summary
-----------------
Assess the impacts of implementing a juvenile assessment, referral, placement, and treatment planning (J-ARPP) protocol, and of different strategies for transferring J-ARPP technology, on service utilization of youth entering the juvenile justice system. Assess the impacts of implementing J-ARPP, and of different strategies for transferring J-ARPP technology, on measures of organizational readiness and motivation, and staff attitudes about assessment and service. Assess the impacts of implementing J-ARPP, and of different strategies for transferring J-ARPP technology, on measures of systems integration. Assess fidelity to the J-ARPP protocol and the relationship between fidelity to the J-ARPP protocol and service utilization of youth entering the juvenile justice system.

Conditions
-----------------
Skill Development of Staff, Use of Standardized Assessment Tools

Intervention / Treatment
-----------------
* Behavioral: Booster Sessions
* Behavioral: Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all offices

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced<br>A external consultant works with the team to develop skills and trains an in-house coach | Behavioral: Booster Sessions<br>* Provides onsite booster sessions for one year to the group after participating in standard care<br>|
| Experimental: Trainer<br>External consultant provides booster session | Behavioral: Booster Sessions<br>* Provides onsite booster sessions for one year to the group after participating in standard care<br>|
| Experimental: Standard<br>Receive agency training | Behavioral: Training<br>* memorandums, staff meetings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Service utilization |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
technology transfer, skill development, organizational change