linjc16/ctgov huggingface dataset:
Psychophysiological Correlates of Mindfulness Based Cognitive Therapy (MBCT) in Recurrent Depression

Study Overview
=================
Brief Summary
-----------------
The study investigates cognitive attention, rumination and psychophysiological (EEG) processes in healthy subjects and remitted patients with at least three previous depressive episodes. The investigators expect that Mindfulness Based Cognitive Therapy prevents future depressive episodes and has influence on cognitive and psychophysiological measures.

Official Title
-----------------
Psychophysiological Correlates of Mindfulness and Attention in Recurrent Depression and Healthy Volunteers

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Based Cognitive Therapy
* Other: Waiting List Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent depression with at least 3 previous MD-episodes, currently remitted (no symptoms) Exclusion Criteria: current depression lifetime schizophrenia bipolar or schizoaffective disorder any neurological disorders other psychopathology during last 3 years

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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wait List Control<br>Patients do ot receive psychotherapy. The wait list control group will be assessed according to study protocol and offered MBCT after 6 month | Other: Waiting List Control<br>* Patients receive MBCT with a delay of 6 months.<br>|
| Experimental: Mindfulness Based Cognitive Therapy<br>The published protocol of MBCT will be used. This is an eight week group program. Participants learn mindfulness techniques but also cognitive techniques to prevent new depressive episodes | Behavioral: Mindfulness Based Cognitive Therapy<br>* Group treatment over 8 weeks with training in meditation, stress regulation, shift attention, stay present, in addition with cognitive and behavioral strategies (following Williams et al. Manual 2002)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse (MDE) |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalography (EEG) |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent depression,, mindfulness training, attention, Evoked EEG potentials, Relapse prevention in recurrent depression
Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5 mg in comparison with placebo, when administered over a long-term period, on an as needed basis, in patients with chronic primary insomnia. Secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to placebo administered over a long-term period, on an as needed basis.

Official Title
-----------------
Evaluation of the Long-Term Efficacy and Safety of Zolpidem-MR 12.5 mg Compared to Placebo, When Both Are Administered Over a Long-Term Period as Needed, in Patients With Chronic Primary Insomnia

Conditions
-----------------
Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Drug: zolpidem-MR (SL800750)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with chronic primary insomnia The investigator will evaluate whether there are other reasons why a patient may not participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: zolpidem-MR (SL800750)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is item 1 (which assessed sleep aid) of the Patient Global Impression (PGI) scale at week 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main secondary variables are the Clinical Global Impression (CGI) improvement item and to items 2, 3, and 4 of the PGI scale at week 12. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary insomnia, chronic insomnia
Blood Pressure Lowering Effect of Supplementation With Korea Red Ginseng Associated With Reductions in Circulating Lp-PLA2 Activity and Lysophospatidylcholines and an Increase in Dihydrobiopterin in Prehypertensive Subjects

Study Overview
=================
Brief Summary
-----------------
This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting plasma metabolomes.

Detailed Description
-----------------
A randomized, double-blind, placebo-controlled study was conducted on nonobese, nondiabetic and prehypertensive subjects. Over a 12 week test period, the red ginseng group (n=31) consumed 10 capsules (total 5g) daily containing red ginseng, while the placebo group (n=31) consumed the same product without red ginseng. Fasting plasma metabolomes were profiled using UPLC-LTQ-Orbitrap mass spectrometry.

Conditions
-----------------
Prehypertension

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nondiabetic, nonobese and prehypertensive subjects with blood pressures ranging 120 - 139 mmHg (systolic) or 80-89 mmHg (diastolic) were enrolled in this study. Exclusion Criteria: exclusion criteria included previous diagnosed clinical hypertension self-reported use of antihypertensive medication abnormal liver or renal function history of cardiovascular disease kidney disease cancer thyroid or pituitary disease or any other serious life-threatening illness that required regular medical treatment we also excluded women who were pregnant, breast feeding or intending to become pregnant during the time of study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KRG<br>5g Korea red ginseng (KRG) | Dietary Supplement: KRG<br>* 5g Korea red ginseng (KRG)<br>|
| Placebo Comparator: Placebo<br>5 g placebo (corn starch) | Dietary Supplement: Placebo<br>* 5g placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes from baselilne in blood pressure |  | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes from baseline in plasma metabolites |  | 12 week |
PiCCO Guided Therapy in Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Prospective comparison of standard therapy in liver cirrhosis versus standard therapy plus intensified hemodynamic monitoring using the PiCCO system.

Detailed Description
-----------------
Patients presenting with advanced liver cirrhosis will receive either standard treatment or standard treatment plus hemodynamic monitoring with the PiCCO device. Fluids and vasoacitve drugs will be administered according to the measurements over a period of 5 days.

Official Title
-----------------
Optimized Therapy of Decompensated Liver Cirrhosis by Hemodynamic Monitoring Using the PiCCO System

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Procedure: Hemodynamic monitoring system PiCCO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cirrhosis Child-Pugh-Score > 7 Ascites > 500 ml Exclusion Criteria: Coronary heart disease Apoplexia < 6 months ago Vasculitis Thrombosis Arterial occlusive disease > stadium II

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hemodynamic monitoring system PiCCO|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal complications |  |  | 
| Length of intensive care |  |  | 
| Change in APACHE II |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver cirrhosis, Hemodynamics, Fluid balance
Monitoring of the IOP After SLT Using iCare Home

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate how much selective trabeculoplasty (SLT) influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).

Detailed Description
-----------------
Sixty glaucoma patients (POAG and PEX) planned for SLT will be recruited. At baseline, patients will be trained to use the iCare Home tonometer, a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. Thereafter, a new measurement will be obtained by the study staff (an optometrist or a nurse) using the same device. No IOP values will be visible for the examiner at that point. Thereafter, a single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will then borrow the iCare Home tonometer to meaure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve. Patients will come for a second visit where new measurements will be made in the same way as at baseline. Two months after SLT, a new IOP curve will be obtained following the same procedure as pre-operatively. Patients' daily activities (diet, motion or sleeping habits) will not be controlled.

Official Title
-----------------
Monitoring of the Intraocular Pressure After Selective Laser Trabeculoplasty Using iCare Home

Conditions
-----------------
Glaucoma Open-Angle Primary, Pseudo Exfoliation Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: POAG PXG Exclusion Criteria: previous SLT reduced hand and arm mobility (e.g. due to rheumatism)

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 |
| --- | --- | --- |
| Lowering of IOP fluctuations after SLT | The amplitude of the IOP fluctuations pre- and post SLT will be compared | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowering of IOP level after SLT | Mean IOP pre- and post SLT | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IOP fluctuations, iCare Home, SLT, self-tonometry
Retrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to retrospectively study the influence of age at start of growth hormone (GH) treatment on height gain in children born small for gestational age (SGA).

Official Title
-----------------
Retrospective Study Of The Influence Of Age At Start Of Growth Hormone (Gh) Treatment On Height Gain In Children Born Small for Gestational Age (SGA)

Conditions
-----------------
Small For Gestational Age (SGA)

Intervention / Treatment
-----------------
* Drug: growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SGA children. Treated with GH at least 36 months. Exclusion Criteria: Patients treated with GH for other indications (not SGA).

Ages Eligible for Study
-----------------
Minimum Age: 4 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 |
| --- | --- |
| Small For Gestational Age (SGA) Children<br>SGA children under growth hormone treatment for more than 36 months. | Drug: growth hormone<br>* 36 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| height SDS | height SDS of SGA children after 36 months of treatment | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| height increase |  | 36 months | 
| Change from Baseline in Lipid Parameters at Month X | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SGA, Growth hormone
Age, Traumatic Brain Injury and Injury Severity as Independent Risk Factors for In-Hospital Mortality in Polytrauma Patients.

Study Overview
=================
Brief Summary
-----------------
In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS>16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. Possible prognostic factors were evaluated.

Official Title
-----------------
Age, Traumatic Brain Injury and Injury Severity as Independent Risk Factors for In-Hospital Mortality in Polytrauma Patients. Experiences From a Level I Trauma Center.

Conditions
-----------------
Polytrauma, Traumatic Brain Injury

Intervention / Treatment
-----------------
* Other: retrospective analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ISS >16 points AIS >3 in one body region at least 2 body regions affected Exclusion Criteria: patients younger than 18 years of age isolated traumatic brain injury minor injuries (AIS <3 or ISS <16 points)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Polytrauma Patients<br>Patients with an ISS >16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. | Other: retrospective analysis<br>* The investigators retrospectively analyzed the outcome and possible prognostic factors in polytrauma patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality in polytrauma patients. |  | January 1, 2012 to December 31, 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Possible prognostic factors influencing the outcome of polytrauma patients. | Evaluation of concomitant traumatic brain injury, resuscitation, injury severity and trauma mechanisms in polytrauma patients. | Januar 1, 2012 to December 31, 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prognostic factors, New Berlin Definition, Polytrauma
Gut Microbiota And Radiotherapy

Study Overview
=================
Brief Summary
-----------------
A pilot, single arm, single center study to determine the feasibility of obtaining stool samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the gut microbiota and to obtain preliminary data about possible correlation of baseline composition and changes in gut microbiota with tumor response, local control, and development of pneumonitis/other side effects.

Official Title
-----------------
Gut Microbiota And Radiotherapy

Conditions
-----------------
Lung Tumor

Intervention / Treatment
-----------------
* Other: Stool Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is planned to receive Stereotactic Body Radiotherapy (SBRT) to a lung lesion (either presumed or biopsy-proven NSCLC Age 18 years old or older Patient capable of giving informed consent Exclusion Criteria Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration Active infection with oral temperature >100°F Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4). Confirmed or suspected HIV, HBV or HCV Chronic constipation (bowel movements less frequent than every other day) Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (recurrent) or Helicobacter Pylori infection (untreated) Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time Patients on anti-diarrheal medications Patients on probiotics

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: Stool Collection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subject providing stool samples |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stereotactic Body Radiotherapy, SBRT
Vitamin D Supplementation in Childhood Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to investigate the therapeutic role of vitamin D supplementation in a subset of patients with atopic dermatitis (AD): children with disease onset or worsening in the winter. The investigators hypothesis is that (1) vitamin D supplementation in patients with either wintertime onset or exacerbation of AD will improve Eczema Area and Severity Index (EASI) scores, and (2) vitamin D supplementation will improve the Investigator's Global Assessment.

Official Title
-----------------
Randomized Trial of Vitamin D Supplementation in Winter-related, Childhood Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Dietary Supplement: cholecalciferol (vitamin D)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 2-17 years AD rated 10-72 by EASI scale Wintertime onset or exacerbation of AD Exclusion Criteria: Active skin infection History of summertime onset or exacerbation of AD History of underlying illness causing immunosuppression within the past 2 years (eg. hematologic malignancies) Medications causing iatrogenic immunosuppression (eg. cyclosporine; azathioprine, oral steroids) taken within the past month Parathyroid disease Acute or chronic renal disease Hypercalcemia or hypocalcemia Thyroid disease History of osteomalacia or Paget's disease of bone History of malabsorption (eg cystic fibrosis) Planned trip to sunny climate during the one-month study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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: 1<br> | Dietary Supplement: cholecalciferol (vitamin D)<br>* 1000 IU once daily x 1 month Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.<br>* Other names: Placebo group will receive placebo drops.;|
| Placebo Comparator: 2<br> | Dietary Supplement: Placebo<br>* 1000 IU once daily x 1 month Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EASI score |  | 1 month | 
| Investigator Global Assessment (IGA) |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, atopic dermatitis, eczema, winter