linjc16/ctgov huggingface dataset:
Study Evaluating Effexor XR in Elderly Patients With Major Depression.

Study Overview
=================
Brief Summary
-----------------
Phase III study evaluating Effexor XR in elderly patients with major depression.

Official Title
-----------------
Phase III Study of Effexor XR for the Treatment of Elderly Patients With Depression

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

Intervention / Treatment
-----------------
* Drug: Effexor XR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with major depression based on DSM-IV-TR Patients having minimal total score of 18 on the HAM-D17 and minimal score of 2 on the item of depressed mood of HAM-D at baseline Exclusion Criteria: Patients with schizophrenia or any other psychotic disorder Patients with history or presence of bipolar disorder

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- |
|Drug: Effexor XR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of total score of HAM-D17 between baseline and final-on-therapy |  |  | 
| Remission rate of HAM-D17 at the final-on-therapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression
Investigation of an Adaptive Treatment Algorithm for Post-op Thoracic Patients to Reduce the Length of Drainage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to reduce the length of drainage using a treatment protocol to control the manipulation of the applied vacuum to the pleural cavity.

Detailed Description
-----------------
In this prospective study, a treatment algorithm is tested in a subgroup of patients with postoperative pulmo-pleural fistula. The primary aim is to reduce the duration of pulmo-pleural fistulation. Secondary aim is to reduce the duration of chest tube therapy.

Official Title
-----------------
Implementation of an Adaptive Algorithm to Improve Chest Tube Therapy in Patients With Pulmonary Leaks Following Thoracic Surgery

Conditions
-----------------
Pulmonary Fistula

Intervention / Treatment
-----------------
* Procedure: Thoracic Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a post operative air leak after 16 to 24 hours bigger than 50ml/min. Exclusion Criteria: Patients with an empyema Patients with a spontaneous pneumothorax

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 |
| --- | --- |
| Digital chest tube<br>All patients will be treated with the digital chest tube device | Procedure: Thoracic Surgery<br>* Wedge Resection Segmental Resection Lobectomy<br>* Other names: Thopaz Drainage Device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of pulmo-pleural fistulation | The duration of a postoperative pulmo-pleural fistula is monitored. | July 2011 - March 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Chest tube therapy | Duration of postoperative chest tube therapy is monitored. | July 2011 - March 2012 | 
| Applicability of a diagnostic Leakage Scale | Applicability of a generated scale that categorizes the pulmonary air leak is tested. | July 2011 - March 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Algorithm, Treatment Protocol, Thoracic Drainage Device
Should Any One Airway Clearance Technique be Recommended for People With Cystic Fibrosis?

Study Overview
=================
Brief Summary
-----------------
The study was to evaluate the long term effects, over one year, of five airway clearance techniques used by people with cystic fibrosis (active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure (R-C Cornet and Flutter)). The primary outcome measure was forced expiratory volume in one second (FEV1)and the null hypothesis was that there are no differences among the regimens.

Official Title
-----------------
A Comparison of Five Airway Clearance Techniques in the Treatment of Adults With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Procedure: Airway clearance technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cystic fibrosis (genotype or sweat sodium concentration greater than 70 mmol/litre) Forced expiratory volume in one second greater than or equal to 25% predicted, on assessment for entry to the study. Exclusion Criteria: Evidence of a current respiratory exacerbation (Thornton et al 2004) Current severe haemoptysis Past history of pneumothorax Awaiting lung / heart-lung transplantation Pregnancy Recent (within 3 months) acquisition of Burkholderia cepacia

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Active cycle of breathing techniques | Procedure: Airway clearance technique<br> <br> |
| Other: 2<br>Autogenic drainage | Procedure: Airway clearance technique<br> <br> |
| Other: 3<br>R-C Cornet | Procedure: Airway clearance technique<br> <br> |
| Other: 4<br>Flutter | Procedure: Airway clearance technique<br> <br> |
| Other: 5<br>PEP | Procedure: Airway clearance technique<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in one second (FEV1) |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (Short Form-36 and Chronic Respiratory Questionnaire) |  | 48 weeks | 
| Exercise capacity (Modified shuttle test) |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic fibrosis, Airway clearance
Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the psychosocial burden in women who have experienced an abnormal pap results after screening interventions.

Detailed Description
-----------------
This study will be a Thailand, clinic-based, cross-sectional, questionnaire study. Approximately 151 female participants will be enrolled. Study staff will interview the subject to collect basis demographic data and self reported medical history. And the subjects will be given the questionnaire packet for self-administration. After subjects complete the packet, study staff will review the questionnaires for completeness prior to the study subject leaving the clinic.

Official Title
-----------------
Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions

Conditions
-----------------
Papanicolaou Smear

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female, between 18 and 45 years of age and must have recently experienced an abnormal pap results within the past 3 months. Exclusion Criteria: has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives has other concurrent/active STD's has a history of known prior vaccination with an HPV vaccine has a history of recent (within 1 year from date of enrollment) or ongoing alcohol abuse or other drug abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| negative pap-smear<br> | |
| positive pap-smear<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychological burden of women with abnormal pap-smear |  | 3 months |
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of erythropoietin (r-HUEPO) administered to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

Conditions
-----------------
HIV Infections, Cytopenias

Intervention / Treatment
-----------------
* Drug: Epoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: History of any primary hematologic disease. Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS. AIDS-related dementia. Uncontrolled hypertension (diastolic Blood Pressure > 100 mmHg). Presence of concomitant iron deficiency. Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy. Acute opportunistic infection. History of seizures. Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded. Prior Medication: Excluded within 30 days of study entry: Experimental drug or experimental device. Cytotoxic chemotherapy. Excluded within 2 months of study entry: Androgen therapy. Clinical diagnosis of AIDS and related anemia. Clinical diagnosis of AIDS. Clinically stable for 1 month preceding study entry. Substance abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epoetin alfa|nan|

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
-----------------
Recombinant Proteins, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, Zidovudine
Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)

Study Overview
=================
Brief Summary
-----------------
This study will examine resting dopamine function as well as dopamine response in the brain as it interacts with medicines normally prescribed to subacute Traumatic Brain Injury (TBI) patients.

Official Title
-----------------
Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-penetrating TBI Age between 18-50 years old Admitted to a North Texas TBI Model Systems-affiliated rehabilitation facility within 16 weeks of injury Rated at Rancho VI Los Amigos Levels of Cognitive Functioning Scale of less than or equal to Stage V at the time of enrollment Disability Rating Scale total score >/= 7 Exclusion Criteria: Central Nervous System disorder resulting in functional disability predating TBI Documented diagnosis of disease processes impacted by the dopamine system (e.g., Parkinson's Disease, clinician diagnosed Attention Deficit Hyperactivity Disorder, substance abuse/dependence (excluding marijuana, alcohol, tobacco), or schizophrenia) Pre-injury use of dopaminergic pharmaceuticals (i.e., methylphenidate, amantadine, or dopamine receptor blockers such as olanzapine or quetiapine) Documented contraindication to use of methylphenidate including allergy Uncontrolled epilepsy Pregnant Medical condition not compatible with use of Methylphenidate Recent diagnosis or therapeutic study using radiopharmaceuticals Contraindications to the use of Ioflupane Allergic to Iodine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Dopamine Imaging<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Disability Rating Scale | The primary outcome measure will be the change in Disability Rating Scale over 4 weeks. The Disability Rating Scale is a commonly used and reliable instrument for monitoring minor changes occurring throughout the course of a patient's recovery (Rappaport et al., 1982). | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| John F Kennedy Coma Recovery Scale Revised |  | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks | 
| Functional Independence Measure (FIM) |  | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks | 
| Functional Assessment Measure (FAM) |  | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks | 
| Orientation Log (O-Log) |  | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TBI
A Study of Acequias Contamination & Association of Infectious Diseases in Peru

Study Overview
=================
Brief Summary
-----------------
A major water supply utilized in the Lambayeque region are acequias. Acequias are irrigation canals that are utilized by the agriculture industry for the cultivation of consumables. Utilization of contaminated water to irrigate consumables can lead to foodborne illnesses. Contamination studies on the acequias in the Lambayeque region have not been performed to date. The purpose of this study is to test contamination of acequias in 9 districts in Lambayeque and determine if a difference in infection rates exists in districts with contaminated acequias vs. districts without contaminated acequias for the following diseases: H. pylori, Adenovirus, Rotavirus.

Official Title
-----------------
A Study of Acequias Contamination & Association of Infectious Diseases in Peru

Conditions
-----------------
Water-Related Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Adenovirus
* Diagnostic Test: Rotavirus
* Diagnostic Test: H. pylori


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently reside in one of the following districts: Eten, Pomalca, Pimentel, Patapo, Pucala, Santa Rosa, Reque, Monsefu and Sana 18 years of age or older Consent to participate Exclusion Criteria: Currently taking antiviral or antimicrobial medication

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Contaminated acequias<br> | Diagnostic Test: Adenovirus<br>* Diagnostic test for the presence of the adenovirus in the population groups<br>Diagnostic Test: Rotavirus<br>* Diagnostic test for the presence of the Rotavirus in the population groups<br>Diagnostic Test: H. pylori<br>* Diagnostic test for the presence of H. pylori infection in the population groups<br>|
| Non-contaminated acequias<br> | Diagnostic Test: Adenovirus<br>* Diagnostic test for the presence of the adenovirus in the population groups<br>Diagnostic Test: Rotavirus<br>* Diagnostic test for the presence of the Rotavirus in the population groups<br>Diagnostic Test: H. pylori<br>* Diagnostic test for the presence of H. pylori infection in the population groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contamination of acequias | Presence of Fecal Coliforms in the acequias | March 20th - April 1st | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of population with infections | Proportion of populations with adenovirus, rotavirus and H. pylori infections | March 20th - May 1st |
Blood Loss Quantification During Major Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
Blood loss quantification during surgery remains unreliable and inaccurate. The purpose of the study is compare several methods of blood loss quantification in real surgical settings and to analyze the effect of blood loss on postoperative complications.

Official Title
-----------------
Blood Loss Quantification During Major Abdominal Surgery: Study Protocol for a Prospective Cohort Trial.

Conditions
-----------------
Blood Loss, Surgical, Blood Loss, Postoperative, Postoperative Complications

Intervention / Treatment
-----------------
* Other: Measurement of external blood loss
* Diagnostic Test: Serum Hemoglobin concentration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient scheduled for liver or pancreatic surgery age of patient ≥ 18 years signed informed consent provided Exclusion Criteria: patient coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants). use of cell saver suctioning during operation damage/clotting of blood samples

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 |
| --- | --- |
| HPB group<br>Adult patients undergoing for elective liver or pancreas surgery at Department of Surgery, University Hospital Hradec Kralove, Czech Republic. | Other: Measurement of external blood loss<br>* Measurement of external blood loss<br>Diagnostic Test: Serum Hemoglobin concentration<br>* Serum Hemoglobin concentration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loos quantification | Estimated blood loss by surgeon (sEBL) Estimated blood loss by anesthesiologist (aEBL) Gravimetric blood loss weighted (vGBL) Calculated blood loos based on anthropometric and hematological parameters (vCBL) Spectrophotometric measured hemoglobin mass loss (hbMBL) Measured blood loss using using hbMBL and patient's average pre- and postoperative serum hemoglobin (vMBL) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | The effect of blood loss measured by spectrophotometric method on postoperative complications. | 1 year |
Fat Distribution in Healthy Early Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
A Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled, Two-arm, Phase IV Study to Investigate the Influence of a Continuous Combined Estrogen-progestin Regimen Containing 2 mg Estradiol Valerate and 2 mg Dienogest (Climodien® / Lafamme®) on the Fat Distribution in Otherwise Healthy Early Postmenopausal Women

Conditions
-----------------
Healthy, Postmenopause

Intervention / Treatment
-----------------
* Drug: Climodien / Lafamme (BAY86-5027)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy early postmenopausal women BMI between 25 and 30 Exclusion Criteria: Contra-indication(s) for hormone treatment Metabolic diseases Concomitant medication with influence on lipid metabolism

Ages Eligible for Study
-----------------
Minimum Age: 48 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Climodien / Lafamme (BAY86-5027)<br>* 1 tablet daily (2 mg EV + 2 mg DNG)<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* 1 tablet daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual relative change of abdominal visceral fat measured by magnetic resonance imaging |  | Baseline and after 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters of body composition and lipid metabolism |  | Baseline and after 24 weeks of treatment | 
| Adverse events collection |  | During whole study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early postmenopausal state, Climacteric symptoms, Hormone replacement therapy