linjc16/ctgov huggingface dataset:
Can Genetic Markers Predict Weight Loss After Gastric By-pass Surgery

Study Overview
=================
Brief Summary
-----------------
There is a variability in weight loss after gastric bypass surgery for obesity despite a standardised surgical procedure. This study aims to investigate if genetic markers can predict outcome after gastric by-pass surgery in treatment of obesity. The investigators will also study if adenovirus infection can influence the outcome after surgery. In a subgroup of patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid and protein patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as well as liver biopsies and whole blood are stored in a biobank. The same tissues will be collected from non-obese controls undergoing gallbladder surgery.

Official Title
-----------------
Can Genetic Changes Predict Weight Loss and Outcome After Bariatric Surgery and Can it Related to Virus Infection and Function of Liver and Adipose Tissue as Well as Lipid and Protein Profiles.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: Gastric bypass or cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparoscopic gastric by-pass with BMI greater than 35 Exclusion Criteria: unable to understand swedish

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obesity<br>Gastric bypass surgery and non-obese controls undergoing cholecystectomy | Procedure: Gastric bypass or cholecystectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic markers | Blood samples and tissue biopsies taken at the time of surgery and at follow-up. | day of surgery and 1 and 2 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid and protein patterns in plasma and tissues | Blood samples taken and tissue biopsies taken at the time of surgery and at follow-up | day of surgery and at 1 and 2 years postoperatively | 
| Previous viral infection | Blood samples taken before surgery | At time of surgery | 
| Genexpression and comorbid disease | Gene expression studies in tissue biopsies and whole blood at time of surgery and follow-up | At time of bariatric surgery and 1-2 years postoperatively |
Effect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients

Study Overview
=================
Brief Summary
-----------------
Evaluation of the antipsychotic efficacy and safety of ziprasidone versus olanzapine, risperidone or quetiapine in patients with schizophrenia, schizoaffective and schizophreniform disorders under naturalistic conditions of clinical practice

Official Title
-----------------
Tolerability, Safety, And Efficacy Of Ziprasidone (80 - 160 Mg/D) Versus Olanzapine (10 - 20 Mg/D), Risperidone (4 - 8 Mg/D) Or Quetiapine (300 - 750 Mg/D) In Pretreated Patients With Schizophrenia, Schizoaffective Disorder Or Schizophreniform Disorders - A 12-Week Open-Label, Multicenter Clinical Trial.

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder, Psychotic Disorders

Intervention / Treatment
-----------------
* Drug: ziprasidone versus olanzapine , risperidone or quetiapine
* Behavioral: Panss , CGI-C, UKU-SERS-Pa
* Procedure: Blood tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients or outpatients with schizophrenia, schizoaffective and schizophreniform disorders (DSM-IV). Patients without adequate current treatment (i.e. intolerance to their current treatment or lack of efficacy of current treatment) based on clinical judgement of the investigator Exclusion Criteria: A history of intolerance to ziprasidone, olanzapine, risperidone or quetiapine or any of its ingredients

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

| Intervention/Treatment |
| --- |
|Drug: ziprasidone versus olanzapine , risperidone or quetiapine|nan|
|Behavioral: Panss , CGI-C, UKU-SERS-Pa|nan|
|Procedure: Blood tests|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS (The Positive And Negative Syndrome Scale) in a 12 week period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-C score (Clinical Global Impression of Change), UKU-SERS-Pa (Patient self rating version). Safety and tolerability: ECG, serum cholesterol, triglycerides, prolactin, glucose and body weight |  |  |
Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is the first multiple-dose experience in humans with MOA-728 in an oral formulation. This study will provide an assessment of the safety, tolerability, and pharmacokinetics (PK) of MOA-728 following administration of ascending multiple oral doses to healthy subjects.

Official Title
-----------------
Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of MOA-728 Administered Orally to Healthy Subjects

Conditions
-----------------
Postoperative Complications, Constipation

Intervention / Treatment
-----------------
* Drug: MOA-728


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women

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

Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MOA-728|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Health, Pharmacokinetics, ileus
A Comparison of XELOX Regimen and EOX Regimen as Neoadjuvant Chemotherapy Regimen for Locally Advanced Gastric Cancer.

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess what is the better neoadjuvant chemotherapy regimen for patients with initially unresectable locally advanced gastric cancer.

Official Title
-----------------
A Comparison of XELOX Regimen and EOX Regimen as Neoadjuvant Chemotherapy Regimen for Locally Advanced Gastric Cancer

Conditions
-----------------
Locally Advanced Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 2 regional bulky lymph nodes macroscopic tumor type is either the Borrmann type 4 or large type 3 tumor invades adjacent structures (T4b) Exclusion Criteria: peritoneal metastasis confirmed by CT scan lung metastasis, liver metastasis, pleural effusion, and/or other distant metastasis

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chemotherapy regimen<br>those with XELOX regimen and those with EOX regimen | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 6 months after diagnosis |
FOCUS Fatigue Outcome in Copaxone USers

Study Overview
=================
Brief Summary
-----------------
The study primarily investigates the effect of copaxone on fatigue during treatment, compared to baseline in patients with relapsing-remitting multiple sclerosis. Secondary outcome measures are:disability, relapse rate, quality of life and depression.

Official Title
-----------------
Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Glatiramer acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: relapsing-remitting Multiple Sclerosis (MS), at least 2 relapses in previous 2 years prior to copaxone or interferon beta treatment, ambulant patients i.e disability score EDSS MAX 5,5, clinically stable MS relapse free and steroid free at least 30 days prior to start copaxone treatment Exclusion Criteria: hypersensitivity to glatiramer acetate or mannitol, pregnancy, fertile female not willing to use effective contraception, previous treatment with copaxone 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

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 |
| --- | --- |
| Experimental: single group<br> | Drug: Glatiramer acetate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue impact scale |  | at baseline, month 6 and month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate |  | at baseline, month 6 and month 12 | 
| quality of life |  | at baseline, month 6 and month 12 | 
| depression |  | at baseline, month 6 and month 12 | 
| disability |  | at baseline, month 6 and month 12 | 
| Adverse events |  | at baseline, month 6 and month 12 |
Buteyko Method for Asthmatic Children With Mouth Breathing

Study Overview
=================
Brief Summary
-----------------
To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of asthmatic children with mouth breathing.

Official Title
-----------------
THE EFFECTS OF THE BUTEYKO METHOD IN MOUTH BREATHING ASTHMATIC CHILDREN: A CONTROLLED RANDOMIZED STUDY

Conditions
-----------------
Asthma, Mouth Breathing

Intervention / Treatment
-----------------
* Other: Buteyko Method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children from 7 up to 12 years old with asthma diagnose Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks. Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, and tuberculosis), retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations. Exclusion Criteria: Children that are not able to perform some of the necessary procedures, give up participating in the research and present acute symptoms of respiratory tract during the assessments.

Ages Eligible for Study
-----------------
Minimum Age: 7 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buteyko Method<br>Children will perform 6 sessions (twice a week) of treatment with the Buteyko Method. | Other: Buteyko Method<br>* Intervention will be held twice a week during 3 weeks.<br>|
| No Intervention: Control<br>Asthma education. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep disturbance (questionnaire) | Sleep disturbance will be assessed by the sleep disturbance scale for children (SDSC). | Baseline, three weeks later and six months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spirometry (FVC, FEV1, FEV1/FVC, FEF25-75%, PEF) |  | Baseline, three weeks later and six months after treatment | 
| Change in ventilometry (minute volume and vital capacity) | Minute volume and vital capacity (liters) | Baseline, three weeks later and six months after treatment | 
| Number of hospitalizations |  | Through study completion, an average of three weeks and six months after treatment | 
| Number of days off-school |  | During the three weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child, Breathing exercises
Oral Rehydration Therapy in Children With Mild to Moderate Dehydration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine parental attitudes towards oral rehydration therapy for children with mild to moderate dehydration.

Conditions
-----------------
Parent, Attitudes

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of dehydrated children aged 0-18 Exclusion Criteria: Child with severe dehydration Child with chronic disease causing dehydration

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 |
| --- | --- |
| Parents<br>Parents reporting to the emergency room with dehydrated children | Other: Questionnaire<br> <br> |

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
-----------------
Dehydration
Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the side effects of radiation treatment and surgery versus radiation alone, where no surgery is done to move the salivary gland and place it under the chin region where it can be shielded from radiation.

Official Title
-----------------
To Evaluate the Effects of Transfer of Submandibular Salivary Gland to the Submental Region (Outside the Radiation Field) on Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Procedure: radiation treatment and surgery
* Procedure: radiation alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a histological diagnosis of squamous cell carcinoma Patients with unilateral or no neck involvement of the nasopharynx The submandibular transfer will be done on the uninvolved side of the neck. Karnofsky score greater than or equal to 70 Expected survival greater than one year A signed informed consent Exclusion Criteria: Bilateral neck nodes involvement. Involvement of level 1 lymph nodes on the side of the proposed procedure.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: radiation treatment and surgery|nan|
|Procedure: radiation alone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment interruptions |  |  | 
| Incidence of percutaneous endoscopic gastronomy (PEG) |  |  | 
| Incidence of oral candidiasis |  |  | 
| Overall survival |  |  | 
| Disease free survival |  |  | 
| Pattern of recurrence |  |  | 
| Complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasopharynx, xerostomia, prevention
Use of the PSA 4000 Monitor in the Post-Operative Period in Patients Undergoing Major Surgery

Study Overview
=================
Brief Summary
-----------------
Evaluate correlation between the values from the PSA monitor and clinical assessment of sedation with the RASS on postoperative patients.

Detailed Description
-----------------
Assessing level of sedation in critically ill patients is an integral part of intensive care practice. Sedation scales, such as the Richmond Agitation-Sedation Score (RASS) 1, have been developed, but are imperfect in a general population and of limited use when muscle relaxants are administered. Instruments have been developed to examine cerebral electrical activity using processed EEG in an attempt to determine state of awareness.2 The Bispectral Index (BIS) is a statistically derived measure of cerebral electrical activity to assess cortical-subcortical interaction. The BIS was determined by repeated studies on patients anesthetized in the operating room (OR) with the assumption that sedation is associated with a lack of awareness and recall.2 The Patient State Analyzer (PSA 4000) is a 4-channel processed EEG reading using an advanced algorithm that interprets changes in regional brain activity providing a numerical assessment (ranging from 0-100; 0 = no central nervous system [CNS] activity, 100 = awake) to assess the degree of sedation. The PSA 4000 (PSA) is an advancement over the BIS monitor as the BIS is a single channel whereas the PSA is a 4-channel monitor. Additionally, the PSA monitor has new proprietary software for analysis of the EEG data. The PSA is relatively new and thus there is little published data to evaluate its use in the operating room (OR) or the intensive care unit (ICU).

Official Title
-----------------
Use of the PSA 4000 Monitor in the Post-Operative Period in Patients Undergoing Major Surgery

Conditions
-----------------
Postoperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Detailed Population Description: The study population will include those patients that have undergone surgery under general anesthesia at St. Marys Hospital, Mayo Clinic Rochester, admitted to the 7MB D/E Intensive Care Unit and require intubation and mechanical ventilation for a period of at least 4 hours after admission

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 |
| --- | --- | --- |
Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will assess the regional cerebral oxygen saturation and cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine administration for the prevention/management of cerebral vasospasm.

Official Title
-----------------
Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases

Conditions
-----------------
Subarachnoid Hemorrhage, Aneurysmal

Intervention / Treatment
-----------------
* Drug: Nimodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aneurysmal subarachnoid hemorrhage potential or actual cerebral vasospasm Exclusion Criteria: non-aneurysmal subarachnoid hemorrhage outside the 4-21 day window after ictus peripheral deoxygenation contraindication for nimodipine administration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine |  | Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the cardiac output measured using near NICOM technology after administration of nimodipine | unit of measurement will be L/min | Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine | 
| Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine |  | Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral vasospasm, nimodipine