linjc16/ctgov huggingface dataset:
Study Evaluating the Safety and Tolerability of Single Ascending Dose (SAD) SLV-351 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Safety and tolerability of single oral doses in healthy subjects.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SLV-351 Administered Orally to Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: SLV-351


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men, aged 18-50 years. Women of nonchildbearing potential, aged 18-50 years.

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>0.5 mg SLV-351 (fasted) | Drug: SLV-351<br>* SLV-351 capsules taken once<br>|
| Experimental: 2<br>1 mg SLV-351 (fasted) | Drug: SLV-351<br>* SLV-351 capsules taken once<br>|
| Experimental: 3<br>2.5 mg SLV-351 (fasted) | Drug: SLV-351<br>* SLV-351 capsules taken once<br>|
| Experimental: 4<br>5 mg SLV-351 (fasted) | Drug: SLV-351<br>* SLV-351 capsules taken once<br>|
| Experimental: 5<br>10 mg SLV-351 (fasted) | Drug: SLV-351<br>* SLV-351 capsules taken once<br>|
| Experimental: 6<br>15 mg SLV-351 (fasted) | Drug: SLV-351<br>* SLV-351 capsules taken once<br>|
| Experimental: 7<br>20 mg SLV-351 (fasted) | Drug: SLV-351<br>* SLV-351 capsules taken once<br>|
| Experimental: 8<br>30 mg SLV-351 (fasted) | Drug: SLV-351<br>* SLV-351 capsules taken once<br>|
| Experimental: 9<br>xx mg SLV-351 (fasted and fed) | Drug: SLV-351<br>* SLV-351 capsules taken once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safet and tolerability |  | 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK and PD |  | 35 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SAD, Healthy
Observational Study in Patients Suffering From Benign Prostatic Hyperplasia Treated With Alpha-adrenergic Blockade

Study Overview
=================
Brief Summary
-----------------
The primary objective of this observational study was the assessment of prognosis factors for having recourse to prostatic surgery in patients with BPH who were administered class-1 alpha blockers. The secondary objectives were the assessment of the time from alpha-adrenergic blockade treatment initiation to surgery and the evolution of patients during the study.

Official Title
-----------------
Evolution of Patients Suffering From Benign Prostatic Hyperplasia (BPH) Treated With Alpha-adrenergic Blockade (JOSEPHINE)

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: alpha-adrenergic blocker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with BPH for whom alpha-blocker treatment is indicated Patients who are already on class-1 alpha-blockers can only participate in the study if all information required is known and/or available Exclusion Criteria: Patient's follow-up not possible Patients participating in another study History of BPH surgery Prostate cancer
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with BPH treated with alpha-andrenergic blockade<br> | Drug: alpha-adrenergic blocker<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of prognosis factors for having recourse to prostatic surgery |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time form alpha-adrenergic blockade treatment initiation to surgery |  | up to 2 years | 
| Occurrence of concomitant BPH diseases |  | up to 2 years | 
| Total International Prostate Symptom Score (IPSS) |  | up to 2 years | 
| Percentage of patients with ongoing BPH treatment |  | up to 2 years |
Turkish Translation of The Emphasis-10 Questionnaire

Study Overview
=================
Brief Summary
-----------------
Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined as an increase in mean pulmonary artery pressure ≥25 mmHg when measured at rest. PH often progresses to heart failure and premature deaths. PH is a progressive disease that has many causes, which can affect people of all ages, is characterized by shortness of breath, reduced exercise tolerance, psychological distress and tiredness and reduced quality of life. Surveys of SF-36, 'Nottingham Health Profiles' and 'Minnesota Life with Heart Failure' surveys are routinely performed in PH clinically. However, none of the questionnaires are specific to pulmonary hypertension, so they are incomplete in determining the condition of the disease and the patients. There is no Turkish questionnaire for patients with pulmonary hypertension and other surveys used are inadequate in determining the condition of the patient and the patient since they are not specific to the disease. The aim is to provide a Turkish questionnaire that is specific to pulmonary hypertension in the literature.

Official Title
-----------------
Evaluation of the Validity and Reliability of the Turkish Translation of The Emphasis-10 Questionnaire in Patients With Pulmonary Hypertension

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Other: Quality of Life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been diagnosed with Pulmonary Hypertension Following at least 6 months of Pulmonary Hypertension policlinic Native Turkish People age 18 years or older Exclusion Criteria: Those with cognitive impairment Those who have difficulty understanding or speaking Turkish

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Quality of Life|Patients self administor quality of life questionnaires such as Minnesota Living with Heart Failure Questionnaire and EmPHasis-10 questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity | Validity of EmPHasis-10 Questionnaire | 8 months | 
| Reliability | Reliability of EmPHasis-10 Questionnaire | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life
Evaluation of Labour Progress by PC Angle

Study Overview
=================
Brief Summary
-----------------
- Ultrasound during first stage of labour has a very important role in prediction of mode of delivery

Detailed Description
-----------------
-Operative delivery and cs delivery are increasing nowadays so US during labour is vital to predict these interventions

Official Title
-----------------
Evaluation of Role of TP US in Progress of Labour by PC Angle & OS Angle

Conditions
-----------------
Labour

Intervention / Treatment
-----------------
* Diagnostic Test: TP us in labour


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primigravida pregnant full term no medical disorders Exclusion Criteria: multigravida any medical disorders preterm labour

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: TP us in labour|TP US will be made to pregnant lady in first stage of labour with OS and PC angel measurements|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of participants who will deliver by NVD without instrumental intervention | the number of pregnant ladies in first stage of labour who will deliver by NVD and who will have normal progress or prolonged progress of labour | within 36 hours |
Changes in Everydaylife Activity of Children With CP During HABIT-ILE

Study Overview
=================
Brief Summary
-----------------
Studying in a RCT the changes in everyday llife activities of children with CP during HABIT-ILE or control period, changes being scored by parents and by experts.

Detailed Description
-----------------
Studying in a RCT the changes in everyday llife activities of children with CP (unilateral and bilateral) during HABIT-ILE or control period, changes being scored by parents and by experts on ABILHAND-Kids, the PEDI, the ACTIVLM-CP and the COPM. Investigate neuroplastic changes and correlation with everyday life changes.

Official Title
-----------------
Effet de la réadaptation Sur Les déficiences, Limitations d'activité et Restriction de la Participation Des Enfants présentant Des lésions Neurologiques Non-évolutives. Part IIb

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Other: HABIT-ILE
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cerebral palsy ability to make a few steps with a walking device ability to pick a light object from a table with the more affected hand ability to understand simple games Exclusion Criteria: no active seizure no botulinum toxin in the 6 months previous to the intervention or during intervention time major visual deficit

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HABIT-ILE<br>HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks. | Other: HABIT-ILE<br>* Hand and arm bimanual intensive therapy including lower extremities<br>|
| Active Comparator: Control<br>A two weeks period of usual customary care. | Other: Control<br>* Usual customary care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activity measure (questionnaires) | change in a measure of daily activities through ABILHAND-Kids, ACTIVLIM-CP and the COPM | 2 weeks of intervention and 4 months (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS) | measure of neuroplastic changes through TMS and MRI | baseline and 2 weeks of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
motor skill learning, functional changes, neuroplastic changes
Laparoscopic Cholecystectomy - Fundus First and Harmonic Ace Compared With Conventional Technique

Study Overview
=================
Brief Summary
-----------------
Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as a fundus first dissection. Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way of dissection has to be established. Patients are at 4 hospitals randomised to the different techniques and the different methods of dissection.

Detailed Description
-----------------
Patients at the participating hospitals are randomized to: dissection starting at the triangle of Calots with electrocautery. dissection by fundus first technique with electrocautery. dissection by fundus first technique with ultrasonic dissection.

Official Title
-----------------
Randomized Multicentre Trial: Comparison of Harmonic Ace and Eletrocautery; Comparison of Fundus First and Conventional Dissection

Conditions
-----------------
Cholecystectomy

Intervention / Treatment
-----------------
* Procedure: Laparoscopic cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparoscopic cholecystectomy Exclusion Criteria: age >Z65 ASA >3 obesity previous extensive gastrointestinal surgery

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 |
| --- | --- |
| Active Comparator: 1<br>Dissection staring at the triangle of calots. Dissection with electrocautery. | Procedure: Laparoscopic cholecystectomy<br>* Randomized to three arm.<br>* Other names: Randomised study.;|
| Active Comparator: 2<br>Dissection as fundus first with electrocautery. | Procedure: Laparoscopic cholecystectomy<br>* Randomized to three arm.<br>* Other names: Randomised study.;|
| Active Comparator: 3<br>Dissection as fundus first with ultrasonic dissection. | Procedure: Laparoscopic cholecystectomy<br>* Randomized to three arm.<br>* Other names: Randomised study.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time, bleeding, pain, nausea, quality of life, analgetics, sick leave, surgical complications, conversion rate |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical complications |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholecystectomy
The Effect of Probiotic and Zinc Supplementation on the Common Cold

Study Overview
=================
Brief Summary
-----------------
The purpose with this study is to investigate the preventative effect of a supplement containing a combination of probiotic bacteria and fungi as well as zinc on the common cold. The hypothesis is that it will shorten the duration, alleviate the severity of symptoms or even decrease the number of infectons during the intervention period. This study is a randomzed placebo controlled human study were healthy adults will consume the supplement for three months.

Official Title
-----------------
The Effect of Probiotic and Zinc Supplementation on the Common Cold in Healthy Adults

Conditions
-----------------
Common Cold

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults Exclusion Criteria: Diagnosed gastrointestinal disorders Autoimmune diseases or immuno compromized Antibiotic treatment in the last month

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Rice flour | Dietary Supplement: Placebo<br>* The participants will consume 2 capsules daily for three months<br>|
| Active Comparator: Probiotic<br>Probiotic bacteria, yeast, zinc and rice brand | Dietary Supplement: Probiotic<br>* The participants will consume 2 capsules daily for three months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms severity | Decrease in the severity of symptoms will be determined using a common cold questionnaire. | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composition of gut and oral microbiome | Change in gut and oral microbiome will be measured using 16SrRNA and 18SrRNA sequencing | Three months | 
| IgA | Changes in levels of IgA in saliva and/or feces will be measured using ELISA | Three months | 
| Duration of symptoms | Decrease in duration of cold will be determined using a common cold questionnaire | Three months | 
| Number of colds | Decrease in number of colds will be determined using a common cold questionnaire | Three months |
Subjective Well Being of Schizophrenic Patients in Greece

Study Overview
=================
Brief Summary
-----------------
Non-interventional study aiming to provide data on the subjective effects of antipsychotic medication assessing subjective well-being and global functioning of patients with Schizophrenia under antipsychotic medication. Moreover it aims to assess their adherence to the treatment and will investigate whether there is any correlation of these factors with the clinical condition of these patients.

Official Title
-----------------
Subjective Well Being of Schizophrenic Patients in Greece

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Diagnosis of schizophrenia according to DSM-IV The patient must have been prescribed an atypical antipsychotic for at least 4 weeks before the first study visit Exclusion Criteria: -

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 |
| --- | --- | --- |
| Assessment of Subjective well being |  | Relative score reported in SWBN scale at the visit. No baseline comparison | 
| Assessment of functioning |  | Relative score reported in GAF scale at the visit. No baseline comparison | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Compliance to therapy |  | Relative score reported in BARS scale at the visit. No baseline comparison | 
| Assessment of General Psychopathology |  | Relative score reported in PANNS scale at the visit. No baseline comparison | 
| Assessment of Clinical Condition |  | Relative score reported in CGIS scale at the visit. No baseline comparison | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, antipsychotics, social functioning, subjective well being, Patients suffering from Schizophrenia
Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas

Study Overview
=================
Brief Summary
-----------------
This study should compare the propofol concentration in breathing gas and in plasma (before and) after lung passage. Propofol concentrations in breathing gas are continuously measured by a sensor. For comparison a discontinuous method is used. Neurophysiologic parameters for determination of depth of anesthesia are compared to the continuous measured propofol concentration in breathing gas. Study hypothesis: continuous measured propofol concentration in breathing gas correlates to propofol concentration in plasma and depth of anaesthesia.

Official Title
-----------------
Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas - Compared With Propofol Concentration in Plasma (Before and) After Lung Passage and Neurophysiological Parameters

Conditions
-----------------
General Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient destined for general anesthesia Exclusion Criteria: Heart insufficiency NYHA IV Allergy to propofol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Monitoring, Breathing Gas, Propofol