linjc16/ctgov huggingface dataset:
Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the effects of regular Viniyoga in patients suffering from primary insomnia.

Detailed Description
-----------------
Insomnia is very prevalent in Europe (14-27%). Cognitive behavioral therapy is the treatment of choice in patients suffering from primary insomnia, allowing to obtain a long term (2 years) sleep quality improvements in 62% of patients. Yoga is another behavioral therapy that have shown benefits in patients suffering from anxiety disorders. Few studies have been focused on yoga benefits in sleep disorders. The purpose of the study is to assess the effects of regular Viniyoga on sleep quality (subjective and objective) in patients suffering from primary insomnia.

Official Title
-----------------
Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia

Conditions
-----------------
Primary Insomnia

Intervention / Treatment
-----------------
* Behavioral: Yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -primary insomnia Exclusion Criteria: shift work, associated sleep disorder (sleep apnea, narcolepsy,..)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: 4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>Patients receiving Yoga lessons for 3 months | Behavioral: Yoga<br>* 4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total sleep time | total sleep time measured by polysomnography and actigraphy | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep latency | sleep latency measured by polysomnography and actigraphy | 3 months | 
| sleep efficiency | sleep efficiency measured by polysomnography and actigraphy | 3 months | 
| wake after sleep onset | wake after sleep onset measured by polysomnography and actigraphy | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
yoga, sleep quality, sleep quantity, sleep efficiency, insomnia
Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent

Study Overview
=================
Brief Summary
-----------------
Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.

Detailed Description
-----------------
Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate and safety at the 6 months after stenting.

Official Title
-----------------
A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.

Conditions
-----------------
Biliary Stricture, Malignant Neoplasms

Intervention / Treatment
-----------------
* Device: biliary stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who submitted a written informed consent for the this trial, and 18   90 years old Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly Patient who have life expectancy at least longer than 3 months (Karnofsky score >60%) Exclusion Criteria: Patient who previously had surgical biliary drainage Patient who carrying bleeding disorder Patient who have combined Hilar and/or intra-hepatic duct cancer Patient who is improper to endoscopic treatment

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel Eluting Covered Metal Stent<br> | Device: biliary stent<br>* palliative treatment for malignant patients<br>* Other names: Niti-S Biliary Stent_ComVi type;|
| Active Comparator: Covered Metal Stent<br> | Device: biliary stent<br>* palliative treatment for malignant patients<br>* Other names: Niti-S Biliary Stent_ComVi type;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulative Patency Rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulative Survival Rate |  | 6 months | 
| Stent migration rate |  | 6 months | 
| Possibility of Other Treatment after Obstruction |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paclitaxel, drug eluting stent
Clinical Study Investigating the Effect of Sodium Nitroprusside Infusion on Thyroidal Function

Study Overview
=================
Brief Summary
-----------------
Whether use of SNP during cardiac surgery has any effect on thyroid function has not yet been investigated in humans. The aim of this study was to investigate the effects of SNP administration during the rewarming period of cardiac operations on circulating levels of thyroid hormones.

Official Title
-----------------
Does Sodium Nitroprusside Infusion Affect Thyroidal Function in Patients Undergoing Coronary Artery Bypass Grafting, a Prospective Randomized Clinical Trial.

Conditions
-----------------
Nitroprusside, Thyroid Hormones

Intervention / Treatment
-----------------
* Drug: sodium nitroprusside
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients without history of: thyroidal disease hypertension pulmonary disease peripheral vascular disease stroke recent myocardial infarction within the week prior to operation unstable angina pectoris liver or kidney dysfunction morbid obesity cachexia sulfonylurea intake Exclusion Criteria: Patients who needed positive inotropic pharmacologic support during or after the operation Patients who developed atrial fibrillation in the post operative period requiring amiodarone therapy In addition, patients receiving any medication known to interfere with any step of thyroid hormone metabolism such as amiodarone propranolol furosemide non-steroidal anti-inflammatory agents steroids estrogens antacids diphenylhydantoin spironolactone

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>arm1: sodium nitroprusside group | Drug: sodium nitroprusside<br>* sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations<br>* Other names: nipruss;|
| Placebo Comparator: 2<br>arm2: control group,saline infused instead of sodium nitroprusside | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free T3 |  | on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total T3 |  | on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sodium nitroprusside, thyroid hormones, thoracic surgery
Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

Study Overview
=================
Brief Summary
-----------------
This study will be conducted to compare the efficacy and safety of Parecoxib versus Paracetamol for treatment of acute renal colic due to ureteric stones.

Detailed Description
-----------------
Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive IV 1 g of Paracetamol while group 2 patients will receive 40 mg of Parecoxib IV. The Visual Analogue Scale (VAS) will be calculated on presentation and at 30 minutes after analgesia administration. Patients who do not respond to an initial dose of the analgesia will receive rescue analgesia in the form of Morphine, 01.mg/kg, IV.

Official Title
-----------------
Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic Due to Ureteric Calculi: Randomized Controlled Trial

Conditions
-----------------
Acute Renal Colic, Ureteric Stone

Intervention / Treatment
-----------------
* Drug: Paracetamol
* Drug: Parecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical signs and symptoms consistent with acute renal colic Exclusion Criteria: Hypersensitivity to either Paracetamol or Parecoxib. History of peptic ulcer. Pregnant or breastfeeding females. Patients with hepatic impairment (Child-Pugh score >10). Patients with chronic kidney disease (CKD) Stage 4 or 5 (eGFR <30mls/min). History of coronary ischemia, peripheral vascular or cerebrovascular disease.

Ages Eligible for Study
-----------------
Minimum Age: 21 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
Interventional Model Description: Eligible patients will be randomized to one of the two treatment groups.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracetamol<br>Patients will receive IV 1 g of Paracetamol | Drug: Paracetamol<br>* Paracetamol 1g IV<br>* Other names: Perfalgan;|
| Active Comparator: Parecoxib<br>Patients will receive 40 mg of Parecoxib IV | Drug: Parecoxib<br>* Parecoxib 40 mg IV<br>* Other names: Dynastat;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The need for rescue analgesia (Morphine) | Patient who had persistent pain | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse effects due to medication used | Assessment of adverse effects of the drug used | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute renal colic, Ureteric stone, Selective COX2 inhibitor, Parecoxib, Paracetamol
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in patients taking lipid lowering agents for at least 3 months ( with no drug change or dose amendment for a minimum of 6 weeks).

Detailed Description
-----------------
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

Official Title
-----------------
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and above on current lipid lowering drug for at least 3 months with no dose change for a minimum of 6 weeks Subject must provide informed consent and comply with the survey procedures Exclusion Criteria: Less than 18 years less than 3 months on antidyslipidemic agent Subjects who are unwilling or unable to provide informed consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HYPERCHOLESTEROLEMIC PATIENTS<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , overall and by country |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes |  | 24 weeks | 
| The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Third Joint European Task Force guideline, in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes |  | 24 weeks | 
| Determinants (e.g. patient and physician characteristics , country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia |  | 24 weeks | 
| Physician characteristics associated with the allocation of treatment regimen. |  | 24 weeks | 
| The proportion of patients on lipid-lowering treatment reaching the non HDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the sub-population patients with fasting triglycerides<200 mg/d |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multi-Center Survey, patients currently on lipid-lowering pharmacological treatment, level of Control of Hypercholesterolemia in Egypt
Cognitive Impairement In Frontotemporal Dementia

Study Overview
=================
Brief Summary
-----------------
This is an observational study that aims to better understand the genetic causes of frontotemporal degeneration (FTD), Multiple Systems Atrophy (MSA), and Progressive Supranuclear Palsy (PSP). It is hoped the information gathered in this study will help lead to better diagnostics and future treatments.

Detailed Description
-----------------
Comparative and longitudinal studies reveal clinical differences between subgroups of patients with frontotemporal dementia (FTD), including Progressive Non-fluent Aphasia (PNFA), Semantic Dementia (SD), patients with a disorder of social comportment and personality (SOC), and non-aphasic patients with executive dysfunction (EXEC). MRI studies of cortical atrophy and fMRI studies show correlated neural defects in FTD subgroups. The investigators will obtain converging evidence from multiple sources to test hypotheses about the neural basis for cognitive functions such as semantic memory, grammatical processing, and social functioning in these FTD subgroups, while improving clinical care for these patients. Recent studies have linked progressive supra nuclear palsy (PSP) and multiple systems atrophy (MSA) to FTD. The investigators will obtain comparable neuropsychological and biomarker data in order to compare these patient groups.

Official Title
-----------------
Cognitive Impairement In Frontotemporal Dementia

Conditions
-----------------
Frontotemporal Degeneration, Progressive Supranuclear Palsy, Multiple System Atrophy

Intervention / Treatment
-----------------
* Other: None-Observation Only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who have been diagnosed with FTD, PSP, and MSA Exclusion Criteria: Individuals under 18 years of age People with pacemakers or certain metallic implants pregnant women

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 |
| --- | --- |
| FTD Cohort<br>No intervention-observation only | Other: None-Observation Only<br>* No intervention-this is an observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression | Changes over time in MRI and cognitive testing data. | This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impaired semantic memory in Semantic Dementia (SD). | The impact of cortical atrophy on language processing. | This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed |
Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device

Study Overview
=================
Brief Summary
-----------------
The objectives of the Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device are: 1.To evaluate the performance of S-There Device in comparison to the golden standard used in the lab.

Official Title
-----------------
(In Spanish, Spain) Validación Clínica Mediante Estudio analítico Con Muestras de Orina Para Comparar la Eficacia y Seguridad de un Smart Device

Conditions
-----------------
Renal Insufficiency, Chronic, Heart Failure, Diabete Mellitus, Diabetes; Nephropathy (Manifestation), Hematuria, Urinary Tract Infections

Intervention / Treatment
-----------------
* Device: Lab Gold Standard
* Device: S-There


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who came to the emergency room, primary care and nephrology unit. Exclusion Criteria: Subject cannot collect urine in receptacle. Urinary Catheter

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All participants (single arm)<br>All study participants once enrolled into the study were asked to collect their midstream urine in the designated urine cups. The urine sample was then sent the Lab and tested sequentially; first by the golden standard techniques used by the Lab (first intervention) and by the S-There device (comparative device - second intervention). | Device: Lab Gold Standard<br>* First intervention (assigned to the All participants arm).<br>Device: S-There<br>* Second intervention (assigned to the All participants arm).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy to compared device | The primary objective of the study is to evaluate the accuracy of the S-There device compared to the Lab gold standards, for each analyte. | Through study completion, an average of 1 month |
A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases

Study Overview
=================
Brief Summary
-----------------
The consortium will develop a new in vitro diagnostic (IVD) test to screen donated blood for bloodborne infectious pathogens, saving blood banks time and costs required for analysis of mandatory pathogens. The IVD test is a multiplex immunoassay that simultaneously screens for six bloodborne infectious diseases per blood sample. In this project, a mix of diagnostic protein markers will be developed and validated to lowdown an IVD test ready for commercial scale-up and CE-IVD certification.

Official Title
-----------------
A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases (SAFE-Blood)

Conditions
-----------------
HIV, Viral Hepatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Samples having been tested positive or negative for the serological markers explored in the study Exclusion criteria: - to refuse to participate 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Analytical performances | Analytical performances | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Field evaluation | Field evaluation | day 1 | 

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