linjc16/ctgov huggingface dataset:
Effect of Patient Participation in Mental Health Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of individual user involvement in an outpatient mental health center. The intervention consists of patients completing a self-report symptom and problem questionnaire and reviewing it with a clinician.

Official Title
-----------------
Randomised Controlled Trial on the Effect of Individual User Involvement in a Mental Health Center

Conditions
-----------------
Mental Health

Intervention / Treatment
-----------------
* Behavioral: Client feedback
* Behavioral: Treatment as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age. Exclusion Criteria: Not able to complete the questionnaires.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Client feedback<br> | Behavioral: Client feedback<br>* Client feedback during consultations using ORS (Outcome rating scale) and SRS (Session rating scale).<br>|
| Active Comparator: Treatment as usual<br> | Behavioral: Treatment as usual<br>* Treatment as usual, consultations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental health symptom score (Basis-32) |  | Baseline, 6 weeks, 6 months & 12 months | 
| Patient activation (Patient Activation Measure) |  | Baseline, 6 weeks, 6 months & 12 months | 
| Alliance (Inpatient treatment alliance scale) |  | Baseline, 6 weeks, 6 months & 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction (Client Satisfaction Questionnaire) |  | Baseline, 6 weeks, 6 months & 12 months | 
| Quality of life (Short form 12) |  | Baseline, 6 weeks, 6 months & 12 months | 
| Evaluation of problems (Outcome rating scale) |  | Baseline, 6 weeks, 6 months & 12 months | 
| Evaluation of consultations (Session Rating Scale) |  | Baseline, 6 weeks, 6 months & 12 months | 
| Evaluation of involvement |  | Baseline, 6 weeks, 6 months & 12 months |
A Prospective Study of Thin Prep Versus Papanicolau in Suspected Malignant Lesions During Endoscopic Ultrasound (EUS)

Study Overview
=================
Brief Summary
-----------------
Objective: The purpose of this study was to compare the performance of the monolayer preparation (Cyto Lyt or Thin prep) to the routine use of Papanicolau methods on the analysis of specimens obtained using EUS-FNA.

Detailed Description
-----------------
Introduction: The presence of a pathologist during an endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is often a luxury. In addition, preparation of multiple slides for a fine needle aspiration can be time-consuming for the gastroenterologist who waits for verbal feedback on the adequacy of the specimen. Often, a timely diagnosis is needed to direct patient management. Currently, there is no established standard of care for EUS-FNA preparation. A liquid based cytologic fixative preparation (Thin-prep or CytoLyt), is a well-established process used by pathologists for evaluating cervical smears. It has not yet been adopted or accepted for EUS-FNA. This method combines multiple aspirates on a single slide, thereby decreasing the number of slides that need to be processed and interpreted by the pathologist

Official Title
-----------------
A Prospective Study of Thin Prep Versus Papanicolau in Suspected Malignant Lesions During EUS

Conditions
-----------------
Suspected Malignant Lesions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with known or suspected malignancy (solid mass or lymph node) that are undergoing EUS will be eligible to participate in this study. Target lesions such as ascites and cystic lesions will not be considered for this study. However, if a patient has an abnormal solid lesion and abnormal lymph node in addition to the ascites or cystic lesion, they may still be considered for the study. That is, the solid lesions and abnormal lymph nodes are appropriate target lesions for this study. No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol. Subject must provide signed written informed consent. Exclusion Criteria: Subjects that have had a previous EUS-FNA are eligible for this study Target lesions such as ascites and cystic lesions will not be considered for this study.

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?
-----------------
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
-----------------
thin prep, EUS
Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

Study Overview
=================
Brief Summary
-----------------
Study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days.

Official Title
-----------------
A Blinded, Randomized, Multiple-Dose, Parallel Group Study to Characterize the Occurrence of Mild to Moderate Diarrhea After Administration of Neratinib Either 240-mg Once Daily or 120-mg Twice Daily for 14 Days to Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: neratinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female (non-child bearing potential) subjects Ages 18-50.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QD<br>Once daily | Drug: neratinib<br>* HKI-272<br>|
| Experimental: BID<br>Twice daily | Drug: neratinib<br>* HKI-272<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of diarrhea |  | 14 days |
Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.

Official Title
-----------------
Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Breeze Pocket BR (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Dermacyd Breeze Pocket BR (Lactic Acid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Integral skin test in the region; To use products of the same category; Exclusion criteria: Lactation or gestation; Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs; Cutaneous disease (local or spread) in the evaluation area; Pathology which may cause immunity depression, such as HIV, diabetes; Endocrine pathology Solar exposure 15 days before evaluation; Treatment until four months before the selection. Allergic or atopic history to cosmetics products The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dermacyd Breeze Pocket BR (Lactic Acid) | Drug: Dermacyd Breeze Pocket BR (Lactic Acid)<br>* Dermacyd Breeze Pocket BR (Lactic Acid) during 21 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of irritation |  | Throughout the study | 
| Good acceptability |  | Throughout the study |
A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.

Official Title
-----------------
A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: BMS-663513


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSCLC who are eligible to receive a 6 week course of RT Part 1 - not candidates for definitive RT Part 2 - candidates for definitive RT Exclusion Criteria: Severe COPD, pulmonary infection or interstitial pneumonitis Recent cellulitis Autoimmune disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Active | Drug: BMS-663513<br>* mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks<br>* Other names: Anti-CD137;|
| Experimental: 2<br>Active | Drug: BMS-663513<br>* mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks<br>* Other names: Anti-CD137;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the MTD and assess safety and tolerability of single ascending doses of BMS-663513 when given in combination with radiotherapy alone or radiotherapy plus paclitaxel and carboplatin to subjects with Non Small Cell Lung Carcinoma |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers |  | end of study | 
| Describe anti-tumor activity |  | throughout the study | 
| Obtain blood and plasma for exploratory research |  | several timepoints throughout the study | 
| Obtain archival tissue for predictive marker research |  | at screening |
Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment

Study Overview
=================
Brief Summary
-----------------
The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in relapsing MS patients

Official Title
-----------------
Nasal Administration of Dexamethasone for MS Treatment

Conditions
-----------------
MS Patient With Relpasing Remitting Attacks

Intervention / Treatment
-----------------
* Drug: Dexamethasone soduim phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MS patients with esatblished relapsing remitting attacks increase in EDSS of at least 1 point for a least one day Exclusion Criteria: children under 18 pregnant patients patients with diabetes known allergy to steroids patients who received steroids within 3 months prior to the study

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>only one experimental treated group | Drug: Dexamethasone soduim phosphate<br>* nasale administation of Dexamethasone in 20mg dose/day (in two divided doses) fpr sevem days of treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in the EDSS functional system score |  | four months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, relapsing remitting, Dexamethasone
The Analgesic Effect of Auditory Inputs and Its Relation to Psychological and Neurobiological Mechanisms

Study Overview
=================
Brief Summary
-----------------
The study investigates the analgesic effect of different auditory inputs. Employing a within-subject design, the study includes healthy participants that are exposed to thermal stimuli while listening to three different auditory inputs. By repeating this on separate test days, the involvement of bodily processes is investigated.

Official Title
-----------------
The Analgesic Effect of Auditory Inputs and Its Relation to Psychological and Neurobiological Mechanisms

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Behavioral: Auditory inputs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants with normal hearing Exclusion Criteria: Chronic pain conditions Other medical, psychiatric or neurological disorders Use of pain-relieving medication 24 hours prior to testing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Healthy participants<br> | Behavioral: Auditory inputs<br>* Three different auditory inputs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scales | Acute pain assessed on visual analogue scales (0-100) examining pain intensity and pain unpleasantness | An average of 3 weeks (Participants are tested at three different test days across an average of 3 weeks; the primary outcome measure will be assessed after each thermal stimulus at the three test days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Auditory inputs
Melatonin for Cerebral Palsy Children's Sleep and Health

Study Overview
=================
Brief Summary
-----------------
The present study was prospective uncontrolled, single-armed and un-blinded study. Held in the Pediatric neurology clinic, Children's hospital l, Faculty of Medicine, Ain Shams University from June 2016 to June 2018 of 24 months timeframe. All cerebral palsy (CP) patients following up in Pediatric neurology clinic aged between 2 and 12 years. Melatonin given for 3 months. Anthropmetric measures, gastroeintestinal symptoms, Children's sleep habits questionnaire (CSHQ) Arabic version, polysomnography, Chalfont epilepsy severity score, and EEG were done at enrollment and after the 3-months.

Detailed Description
-----------------
A prospective, cohort study conducted in Pediatric Neurology Clinic, Children's Hospital, Faculty of Medicine, Ain Shams University. Forty children with sCP with sleep and seizure problems, aged 2-12 years were enrolled. The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months. Children's sleep habits questionnaire (CSHQ) Arabic version, polysomnography, Chalfont epilepsy severity score, and EEG were done at enrollment and after the 3-months. The ethical approval number is (FMASU MD 202/2016).

Official Title
-----------------
Effect of Melatonin Supplementation on Sleep and Health of Children With Cerebral Palsy

Conditions
-----------------
Growth, Cerebral Palsy, Melatonin, Children, Only

Intervention / Treatment
-----------------
* Drug: Melatonin 3 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cerebral palsy children with sleep problem and seizure disorder, aged 2 - 12 years Exclusion Criteria: any auditory and peripheral visual impairments

Ages Eligible for Study
-----------------
Minimum Age: 2 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
Interventional Model Description: A prospective, cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cerebral palsy<br>Not included | Drug: Melatonin 3 mg<br>* The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months.<br>* Other names: Melatonin CP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in total Children's sleep habits questionnaire score | response to melatonin as decrease in total sleep score | after 3-months | 
| Improvement in growth | response to melatonin in improvement of growth | 3-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Children's sleep habits questionnaire (CSHQ) Arabic version, Anthropometry, Constipation, Polysomnography
Prevalence of Clinical Strains of Enterobacteria With Reduced Susceptibility to Carbapenems in the North-West Region of France

Study Overview
=================
Brief Summary
-----------------
Enterobacteria constitute a family of Gram negative bacilli of the gastrointestinal flora. These micro-organisms are frequently responsible for nosocomial or community-acquired infections, for which treatment is essentially based on the use of beta-lactam antibiotics. This class of antibiotics comprises penicillins, cephalosporins, monobactams and carbapenems. Carbapenems have the advantage of possessing a broad antibacterial spectrum and the capacity to resist the hydrolytic action of a large number of beta-lactamases, widespread inactivating enzymes. However, new enzymes, called carbapenemases, able to confer resistance to carbapenems either alone or in combination with additional resistance mechanisms such as loss of membrane permeability or overexpression of efflux systems, are currently emerging all over the world. Carbapenemases represent a major public health problem because of the risk of therapeutic impasse and their high epidemic potential.

Official Title
-----------------
Prevalence of Clinical Strains of Enterobacteria With Reduced Susceptibility to Carbapenems in the North-West Region of France

Conditions
-----------------
Enterobacteriaceae

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in whom the results of bacteriological examinations reveal the presence of an Enterobacteria strain with reduced susceptibility to carbapenems Control : patients ( infected or colonized ) a strain of Enterobacter sensitive to carbapenems immediately isolated after a strain of Enterobacter having decreased susceptibility to carbapenems from the same service and same hospital ( 2 strains susceptible strain with reduced sensitivity). Exclusion Criteria: Duplicate : same strain to a first strain of reduced sensitivity in isolated the same patient during the study period ( same bacterial species , even after characterization resistance mechanism).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Enterobacteria<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of clinical strains of Enterobacteria |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characterization of the mechanisms responsible for carbapenems resistance |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carbapenems