linjc16/ctgov huggingface dataset:
Tx for Child Sexual Behavior Problems

Study Overview
=================
Brief Summary
-----------------
A significant minority of children (ages 5-12) display problematic sexual behavior and the persistence of this behavior is oftentimes as stable as other child behavior problems, such as aggression and defiance. Unfortunately, the only tested intervention protocols for these concerns utilize a group treatment modality that is not feasible in most community treatment settings. This project will define and pilot test an intervention for child sexual behavior problems that is applicable in most settings and can be easily disseminated as a first step toward validation in larger clinical trials.

Official Title
-----------------
Development and Pilot Testing of a Treatment for Children With Sexual Behavior Problems

Conditions
-----------------
Sexual Behavior

Intervention / Treatment
-----------------
* Behavioral: Phase-based treatment of sexual behavior problems of children


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A caregiver is willing to participate in treatment A clinically significant T-score on the Child Sexual Behavior Inventory Child is between the ages of 5 and 12, inclusive Exclusion Criteria: Child and/or caregiver IQ below 70 Active child and/or caregiver psychosis or suicidal/homicidal ideation Active substance use problems of the caregiver

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 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: Intervention<br> | Behavioral: Phase-based treatment of sexual behavior problems of children<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI) | Total raw score of the CSBI (potential range = 0-138). Higher scores indicate a greater number and frequency of reported problematic sexual behavior. | 4-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC) | The sexual concerns subscale on the TSCYC provides another metric of sexual behaviors of children. Scaore are reported in T-score, which have a mean of 50 and a standard deviation of 10. A score of 65-70 typically indicates a borderline or sub-syndromal level of concern, while a score of 70 or above indicates clinically significant concern. As such, a higher score indicates greater concern. While there is technically no limit for calculating minimum and maximum values, the reported range of scores is typically between 40 and 100. | 4-6 months |
Microsampling Approach for Monitoring of Kinase Inhibitor Targeted Therapies

Study Overview
=================
Brief Summary
-----------------
The MISTIK project aims at clinically validating the technique of oral anticancer drugs determination by volumetric absorptive micro-sampling and at comparing the results to measurements performed on venous samples.

Detailed Description
-----------------
The International recommendations for the validation of DBS-based methods will be applied (Capiau et al, TDM, 2019) by including 40 patients per molecule of interest. Nine drugs will be monitored : axitinib, olaparib, regorafénib, cabozantinib, niraparib, talazoparib, palbociclib, abemaciclib, tucatinib. Two samples will be collected from each patient, one by venous sampling and the second at the same time (approximately) using a capillary blood sample derived from a finger prick.

Official Title
-----------------
Development of a Microsampling Approach for Personalized Monitoring of Kinase Inhibitor Targeted Therapies

Conditions
-----------------
Blood Concentrations of Nine Anti-cancer Drugs : Axitinib, Olaparib, regorafénib, Cabozantinib, Niraparib, Talazoparib, Palbociclib, Abemaciclib, Tucatinib

Intervention / Treatment
-----------------
* Other: Measurement of drug concentrations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with one of the 9 drugs concerned by the study : axitinib, olaparib, regorafénib, cabozantinib, niraparib, talazoparib, palbociclib, abemaciclib, tucatinib person who does not object to their participation in the research Exclusion Criteria: Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty

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: Measurement of drug concentrations|Measurement of anti-cancer drug concentrations using volumetric absorptive micro-sampling (VAMS) and venous blood sample|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of venous blood vs VAMS concentrations | Comparison of drug concentrations measured from the venous blood samples with concentrations measured from VAMS | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ORAL CHEMOTHERAPIES, AT HOME THERAPEUTIC DRUG MONITORING, MICROSAMPLING STRATEGY, CONCENTRATION EFFECT RELATIONSHIP, PERSONALIZED MEDICINE
Impact in Life Quality of a Educational Program for Prevention of Occupational Musculoskeletal Disorders in Workers

Study Overview
=================
Brief Summary
-----------------
The study consists of evaluating the efficacy of an Educational Program for prevention of occupational musculoskeletal problems in workers. It is a randomized clinical trial with parallel groups and blinded evaluator, with a control group not submitted to the educational program, but that received a program for general orientation in health. The primary outcome was the change of the quality of life measured by means of Medical Outcomes Study 36-Term Short Health Survey (SF-36), that it is a generic instrument of evaluation of the quality of life, translated and validated in Portuguese of Brazil.

Official Title
-----------------
Impact in Life Quality of a Educational Program for Prevention of Occupational Musculoskeletal Disorders in Workers.

Conditions
-----------------
Occupational Musculoskeletal Disorders, Healthy

Intervention / Treatment
-----------------
* Behavioral: educational program
* Behavioral: General education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All workers from a specific company, including administrative and production sections. Exclusion Criteria: Workers absent from the workplace during all the study period.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Action group<br> | Behavioral: educational program<br>* 6-week educational program for prevention of occupational musculoskeletal diseases.<br>|
| Other: Control group<br>Non-specific educational program for general health. | Behavioral: General education<br>* Non-specific educational program for general health.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Outcomes Study 36-Item Short Form Health Survey - (SF-36) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work Limitation Questionnaire |  | 6 months | 
| Work absenteeism |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
repetitive strain injury, quality of life, functional capacity, workers
Melatonin Treatment After Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep disturbances and general wellbeing.

Detailed Description
-----------------
Postoperative fatigue and sleep disturbances occur after minimally invasive surgery. The pathophysiological background is unknown, but several studies have shown disturbed melatonin secretion after surgery. It is unknown whether melatonin substitution will improve general wellbeing, fatigue or sleep disturbances after laparoscopic cholecystectomy. We set out to study in a randomized clinical trial to investigate the effect of 5 mg melatonin versus placebo, on postoperative sleep disturbances, fatigue and general wellbeing.

Official Title
-----------------
The Effect of Melatonin Treatment on Postoperative Fatigue and Sleep Disturbances: A Placebo Controlled Randomized Clinical Trial

Conditions
-----------------
Fatigue, Postoperative Complications, Dyssomnias

Intervention / Treatment
-----------------
* Drug: melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operation for gall bladder disease Age over 18 years Exclusion Criteria: Known preoperative sleep disturbance Anticoagulant therapy Psychiatric disease Lack of written informed consent Treatment with hypnotics within one week prior to surgery

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: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality |  |  | 
| general wellbeing |  |  | 
| pain |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melatonin,, fatigue,, sleep quality,, circadian,, postoperative, Postoperative fatigue, postoperative sleep disturbance, general wellbeing
Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers

Study Overview
=================
Brief Summary
-----------------
pilot clinical study, multicenter, prospective, open, nonrandomized

Detailed Description
-----------------
The hypothesis is that ablation targeting PVI alone for the treatment of persistent AF is less efficient that ablation targeting electrophysiologic areas with spatio-temporal-dispersion with or without PVI

Official Title
-----------------
Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers

Conditions
-----------------
Fibrillation, Atrial, To Evaluate the Intraoperative Efficiency of the AIFIB Software in the Detection of Atrial Fibrillation Driver During an Ablation Procedure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major patient with an indication of AF or AT ablation - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| AF termination | conversion to sinus rhythm or stable atrial tachycardia | during the ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AT termination | conversion to sinus rhythm | during the ablation procedure |
Medial Border of Laparoscopic D3 Lymphadenectomy for Right Colon Cancer

Study Overview
=================
Brief Summary
-----------------
This study investigats the gastrointestinal functional outcomes of laparoscopic D3 lymphadenectomy for right colon cancer with the medial border along the left side of superior mesenteric artery (SMA) versus the left side of superior mesenteric vein (SMV). This is a single center, prospective cohort study with a sample size of 264 patients. The primary endpoint is the incidence of diarrhea (evaluated using the Diarrhea Assessment Scale) one month after surgery.

Official Title
-----------------
the Medial Border Along the Left Side of SMA Versus the Left Side of SMV in Laparoscopic D3 Lymphadenectomy for Right Colon Cancer, a Prospective Cohort Study

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Procedure: medial border along the left side of SMA
* Procedure: medial border along the left side of SMV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 75 years American Society of Anesthesiologists (ASA) score I to III A biopsy proven histological diagnosis of colorectal carcinoma tumor located at right half of colon Undergoing laparoscopic right hemi-colectomy preoperative staging cT2-4aN0M0 or cTanyN+M0 willing to participate and informed consent signed Exclusion Criteria: Pregnant or lactating women Synchronous colorectal carcinoma History of colorectal cancer or other malignant tumors Clinical evidence of metastasis Preoperative staging cT1N0 or cT4bNany Emergency procedure

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SMA group<br>the medial border along the left side of superior mesenteric artery (SMA) | Procedure: medial border along the left side of SMA<br>* to place the medial border along the left side of SMA in laparoscopic D3 lymphadenectomy for right colon cancer<br>|
| SMV group<br>the medial border along the left side of superior mesenteric vein (SMV) | Procedure: medial border along the left side of SMV<br>* to place the medial border along the left side of SMV in laparoscopic D3 lymphadenectomy for right colon cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of diarrhea | Diarrhea Assessment Scale: stool score ≥ 5 | one month after surgery |
Clinical Utility of Neuromodulation on Tinnitus

Study Overview
=================
Brief Summary
-----------------
The aim of the present narrative review is to one of the first to critically evaluate the clinical effectiveness of neuromodulation as a therapeutic option for patients with tinnitus. Our method involves conducting a systemic review and the findings reported following PRISMA statement. Pubmed, Cochrane database and Google Scholar databases literature search was conducted for articles reporting the use of neuromodulatory interventions on tinnitus patients. Each article was evaluated using the Cochrane risk of bias tool.

Official Title
-----------------
Clinical Utility of Neuromodulation on Tinnitus: A Systematic Review

Conditions
-----------------
Tinnitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tinnitus patients At least one of the neurofeedback methods Single and multi-center Randomized control trials and observational studies Exclusion Criteria: Non-peer-reviewed papers, letters, editorials Not English language

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus severity scores |  | 9 months |
Research and Characterization of New Genes Involved in Intellectual Disability

Study Overview
=================
Brief Summary
-----------------
Intellectual disability (ID) occurs in 2 to 3 % of the general population but the cause is identified only in 30 to 60% of cases. The purpose of this study is to indentify genes involved in ID with new genetics tools (SNP-arrays, next generation sequencing...) and establish genotype-phenotype correlations.

Official Title
-----------------
Recherche et caractérisation de Nouveaux gènes impliqués Dans la déficience Intellectuelle.

Conditions
-----------------
Intellectual Disability

Intervention / Treatment
-----------------
* Genetic: gene analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: for the patients: Clinical diagnosis of intellectual disbility for the unaffected sibs: to be aged at least 3 years informed consent Exclusion Criteria: absence of informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intellectual disability<br>patients with intellectual disability or psycho-motor retardation and their parents and sibs (affected or not) | Genetic: gene analysis<br>* gene analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with genetic cause identified | Number of participants for which the causative gene of intellectual disability will be identified and number of genes involved in intellectual disability identified with new technologies including microarray and next generation sequencing | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genotype-phenotype correlations | Explore genotype-phenotype correlations when a new gene involved in intellectual disability will be identified | genotype-phenotype correlations (according to the genes identified in a period of 5 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intellectual disability, Autism spectrum disorders, gene, Next generation sequencing
Evaluation of a Novel Method for Hematocrit Level Determination

Study Overview
=================
Brief Summary
-----------------
The hematocrit level is defined as the ratio of plasma volume and red blood cell mass. Determination of this level is important for the diagnosis and follow-up of various hematological and renal disorders. In clinical practice, automated hematology analyzers are commonly used. Recently, a new method for hematocrit level determination has been introduced which employs layered resonant piezoelectric sensors. In the present study this technique will be applied in blood samples of healthy subjects and compared to a standard laboratory method.

Official Title
-----------------
Evaluation of a Novel Method for Hematocrit Level Determination

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

Intervention / Treatment
-----------------
* Other: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged between 18 and 80 years Men and women will be included in equal parts Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant Exclusion Criteria: Symptoms of a clinically relevant illness in the 3 weeks before the study day Systemic treatment with anticoagulants Intake of any medication that could lead to spurious hematocrit values Presence of any medical condition that could lead to spurious hematocrit values Blood or plasma donation during the previous 3 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy subjects<br>Hematocrit level of each subject will be assessed by two different techniques | Other: Blood draw<br>* A venous blood sample will be taken (15 ml). Blood will be collected in 5 tubes. To avoid hematocrit variations due to the blood draw procedure, the first tube will be discarded. After that, the tourniquet which is used for venipuncture will be removed and 4 EDTA tubes (each 3 ml) will be filled with blood for hematocrit determination, one tube will be sent to the Department of Laboratory Medicine, and the other ones will be processed at the Department of Clinical Pharmacology.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of hematocrit level determined by two different techniques |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hematocrit, layered resonant piezoelectric sensors