linjc16/ctgov huggingface dataset:
Effect of Spiriva® on Health-related Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients Who Stopped Smoking During Treatment.

Study Overview
=================
Brief Summary
-----------------
Post marketing Surveillance to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) on health-related quality of life in COPD patients who stopped smoking during treatment and to obtain safety data regarding adverse events.

Official Title
-----------------
Effect of Spiriva® 18 Microgram on Health-related Quality of Life in COPD Patients Who Stopped Smoking During Treatment.

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Spiriva


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with COPD Smoker at start Exclusion Criteria: Patients presenting with any general and specific contraindications listed in the Patient Information Leaflet ('Gebrauchsinformation') and the Basic Product Information('Fachinformation')

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 |
| --- | --- |
| COPD patients who stopped smoking during treatment<br> | Drug: Spiriva<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in health related quality of life |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse events |  | 6 weeks |
Team Elements Associated With Mortality in Intensive Care

Study Overview
=================
Brief Summary
-----------------
The individual characteristics and interactions of health care workers in intensive care units may influence patient safety. This study aims to quantify the influence of team familiarity among the members of medical and nursing staffs on risk of patient death.

Official Title
-----------------
Influence of Medical and Nursing Teams Composition on Patient Mortality in Intensive Care

Conditions
-----------------
Intensive Care Unit Stay, Death

Intervention / Treatment
-----------------
* Other: Deaths in intensive care unit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who were admitted to 9 French intensive care units from January 1st 2011 to December 31st 2016 Exclusion Criteria: Patients admitted in pediatrics intensive care units and in specialized burns units

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 |
| --- | --- |
| Patient admitted to intensive care unit<br>All patients requiring intensive care unit stay | Other: Deaths in intensive care unit<br>* Assessment of the influence of team familiarity among the members of medical and nursing staffs on risk of patient death<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient mortality | Mortality with stratification on patients for whom a forego life-sustaining therapy decision was made | At the time of intensive care unit discharge up to a maximum of 6 years since admission |
Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

Study Overview
=================
Brief Summary
-----------------
Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Official Title
-----------------
Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)

Conditions
-----------------
Pelvic Inflammatory Disease

Intervention / Treatment
-----------------
* Drug: Ofloxacin
* Drug: Avelox (Moxifloxacin, BAY12-8039)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness; Adnexal tenderness on bimanual vaginal examination, Temperature > 38.0°C; - Elevated C-reactive protein value (CRP); Signed PIC/IC Exclusion Criteria: Pregnancy Abnormal lab values

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: Ofloxacin<br>* Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days<br>|
| Experimental: Arm 2<br> | Drug: Avelox (Moxifloxacin, BAY12-8039)<br>* Moxifloxacin 400 mg po od for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response 5 to 24 days after the last dose of study medication |  | 5 to 24 days after the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication |  | visit 28 to 42 days after last dose | 
| Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose |  | (Day 4-7) and at follow-up 28 to 42 days after last dose | 
| Reduction from baseline in pain report at the different assessment visits |  | Over the entire trial period (overall) | 
| Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up |  | Over the entire trial period (overall) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic treatment, Pelvic infection, Interventional study, Female
Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic anemia.

Official Title
-----------------
Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis, Anemia, Iron-Deficiency

Intervention / Treatment
-----------------
* Drug: Ferrous sulfate 325mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of Pseudomonas aeruginosa colonization of the lung Transferrin saturation (TSAT) less than or equal to 21% Hemoglobin concentration <15.5 gm/dl (men) Hemoglobin concentration <13.6 gm/dl (women) Exclusion Criteria: Use of iron-containing vitamin or supplement Pregnancy Lactation Cirrhosis History of chronic visible (gross) hemoptysis Hereditary hemochromatosis History of transfusion-related iron overload Use of iron chelator(s) Withdrawal of informed consent Contraindication to phlebotomy

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ferrous sulfate 325mg<br>Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks | Drug: Ferrous sulfate 325mg<br>* Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks<br>|
| Placebo Comparator: Placebo<br>Identical-appearing tablet taken by mouth daily for 6 weeks | Drug: Placebo<br>* Matching placebo capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin Concentration (gm/dl) |  | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Serum Iron (mcg/dl) |  | Baseline and 6 weeks | 
| Change From Baseline in Transferrin Saturation (%) |  | Baseline and 6 weeks | 
| Change From Baseline in Sputum Iron (ng/mg) |  | Baseline and 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron, Cystic fibrosis, Hepcidin, Anemia, Erythropoiesis
Wound Healing Abnormalities in Major Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
This clinical observational study investigates the incidence of wound healing abnormalities in patients undergoing major abdominal surgery. Second aim of the study is, if wound healing deficits may be accompanied by abnormalities in blood coagulation parameters.

Official Title
-----------------
Incidence of Wound-healing-abnormalities in Major Abdominal Surgery - Association With Factors of Coagulation

Conditions
-----------------
Impaired Wound Healing, Factor XIII Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Male or female Informed consent Major abdominal surgery Exclusion Criteria: Pre-existing coagulation abnormalities Pre-existing severe renal or liver failure Chemo- or radiochemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Study group<br>Patients undergoing major abdominal surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of wound healing abnormalities | Occurence of wound healing abnormalities within the first 28 days after surgery | from baseline to postoperative day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormalities in coagulation parameters | occurence of low platelets (<60.000) or factor XIII < 50% between the first and seventh postoperative day | postoperative day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
major abdominal surgery, coagulation, extracellular matrix proteins, wound healing after major abdominal surgery
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.

Official Title
-----------------
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 1)

Conditions
-----------------
Functional Dyspepsia

Intervention / Treatment
-----------------
* Drug: DWJ1252
* Drug: Gasmotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male of female of at least 19 years old Patient with functional dyspepsia met the ROME III criteria Exclusion Criteria: Patients with previous gastrointestinal surgery Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation Patients with history of gastrointestinal cancer

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWJ1252<br>DWJ1252 + Placebo of Gasmotin | Drug: DWJ1252<br>* DWJ1252 and Placebo of Gasmotin<br>|
| Active Comparator: Gasmotin<br>Gasmotin + Placebo of DWJ1252 | Drug: Gasmotin<br>* Gasmotin and Placebo of DWJ1252<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in GIS (Gastrointestinal Symptom Score) |  | At 4 Weeks |
Study Evaluating Venlafaxine Extended Release in Elderly Depressed Patients

Study Overview
=================
Brief Summary
-----------------
In this study we will assess as a primary objective the effect of venlafaxine retard treatment on primary care attended elderly patients with depressive syndrome. We will also study secondarily its effects on anxiety, somatic and painful symptoms of depression.

Official Title
-----------------
Vandral Retard (Venlafaxine Extended Release) in Depressive Syndrome With Anxiety and Painful Symptoms in Elderly Patients. Observational Study in Primary Care

Conditions
-----------------
Depressive Syndrome, Anxiety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 60 years Depressive syndrome with associated anxiety symptoms, according to a symptoms intensity HAM-D17³14 Exclusion Criteria: Participation in other studies in the last 3 months before the start of the study Known hypersensibility to venlafaxine Clinically significant abnormalities according to the venlafaxine labeling

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, depression, elderly
Sucralose in Subjects With Diabetes Mellitus Insulin Requesting

Study Overview
=================
Brief Summary
-----------------
To evaluate the acute effect of a preload of sucralose in presence of carbohydrate (HC) available on the glycemic response, postprandial C peptide and satiety in patients with type 2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).

Official Title
-----------------
Effect of a Sucralose Preload on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy - Controlled Clinical Trial

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: Sucralose
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum period of six month intensive insulin therapy Prescription rapid insulin in the breakfast Aged 35 to 70 years BMI 25 to 39.9 kg / m2 HbA1c lower than or equal to 10% (86 mmol / mol) Menopausal women under hormone replacement therapy Exclusion Criteria: History of intolerance artificial sweetener sucralose Pregnant women Puerperal women Subjects with neurological disease, endocrine disorder no treatment, kidney disease stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, HIV Subjects with history of stroke , acute myocardial infarction and gastrointestinal resection

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sucralose<br>14 mg sucralose (Zero K sucralose powder, IANSA®) an 200 mL of water | Other: Sucralose<br>* Subjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast.<br>|
| Placebo Comparator: Water<br>200 mL of water | Other: Placebo<br>* Subjects drank 200 mL of water alone (placebo), followed by a standard breakfast.<br>* Other names: Water;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemia | Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake. | up to 120 minutes | 
| C peptide | C-peptide at -15 and 60 minutes with respect to breakfast intake | up to 60 minutes | 
| Satiety | Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast). | up to 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GLYCEMIA, SATIETY, C PEPTIDE, PRELOAD, INSULIN
Extended Depth of Focus Contact Lenses for Presbyopia

Study Overview
=================
Brief Summary
-----------------
VTI has an FDA cleared soft contact lens product. Its optical design creates an enhanced depth of focus (EDOF), which provides clear distance, intermediate, and near vision. This study is to quantify the enhanced depth of focus and visual impact.

Official Title
-----------------
Extended Depth of Focus Contact Lenses for Presbyopia

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Device: NaturalVue Multifocal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suitable and able to wear contact lenses Normal best corrected vision (20/25 or better) Need reading add +2.00 or stronger Exclusion Criteria: Pre-existing ocular condition that would contraindicating lens wear

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects will serve as their own control using objective baseline data.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Presbyopia<br>Subject's baseline vision will be compared with vision wearing treatment product | Device: NaturalVue Multifocal<br>* EDOF<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LogMAR Visual Acuity | Vision at different viewing conditions | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
soft contact lens
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV immune response.

Detailed Description
-----------------
To assess the impact of HSCT on the immune response to HIV by measuring HIV specific antigens in peripheral blood (via immune assays such as ELISA and Western blot) longitudinally. To measure the decay of persisting HIV by sequencing and quantitating HIV RNA in plasma, and HIV DNA and RNA in peripheral blood cells including CD4+ T cells and CD4+ T cell subsets, as well as in tissue cells derived from fine needle lymph node aspirates, and/or bone marrow aspirates, and/or rectal tissue. To determine the presence of the CCR5 delta 32 allele in the patient prior to and following HSCT which will provide information regarding the presence of this gene in the donor cells. To correlate these findings to the clinical outcome of the individuals enrolled in this study based on their clinical standard of care assessments following HSCT.

Official Title
-----------------
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients

Conditions
-----------------
HIV-1 Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 infection, requiring allogeneic, haematopoietic SCT as determined by their treating Physician (Haematologist). Over 18 years of age Provision of written, informed consent Exclusion Criteria: In the opinion of the investigator that the patient is not able to provide informed consent Hb < 9 (g/dL) CD4+ T cell count <100 (cells/µl) Serious coagulation abnormalities, platelet count < 50. Patients currently taking medications that significantly affect the bleeding time (e.g. warfarine, clexane, FXa antagonists) History of allergy to local anaesthetics Pregnancy

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 |
| --- | --- | --- |
| Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR | HIV-1 DNA in CD4+ T cells will be measured by real-time PCR and reported as HIV-1 DNA copies in 10e6 CD4+ T cells | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in HIV-1 Antigens and Antibodies measured by ELISA and Western Blot | HIV-1 antigens and antibodies (Ag/Ab) in peripheral blood will be measured by 4th generation chemiluminescence microparticle immunoassay (CMIA) and by Western blot (WB). | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Persistence, Reservoirs, Stem Cell Transplant, Functional Cure