linjc16/ctgov huggingface dataset:
Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

Study Overview
=================
Brief Summary
-----------------
Purpose The aim of this study was to analyze the microbiota of patients undergoing LSG or LRYGB on three levels of gastrointestinal tract, using oral swab and stool sample. We compared samples from patients achieving favorable outcomes in terms of weight-loss with patients, who did not respond optimally to the bariatric operation. Materials and methods Design This prospective cohort study was conducted in one academic, teaching hospital. The recommendations of the Metabolic and Bariatric Surgery Section of the Polish Surgical Society were used as indication for surgery, that is: Body Mass Index (BMI) ≥35 kg/m2 with obesity-related comorbidities or BMI ≥40 kg/m2 . Analysis and endpoints Primary endpoint was to determine the difference in microbiota present in oral cavity and large intestine between patients ing Group 1 and Group 2. Secondary endpoint was to compare the results of microbiota analysis between LSG and LRYGB.

Official Title
-----------------
Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent to participate in the study, meeting the eligibility criteria for bariatric treatment, either for LSG or LRYGB. Exclusion Criteria: type 1 or type 2 diabetes, treatment with antibiotics within 30 days prior to gathering microbiological material, treatment with probiotics within 30 days prior to gathering microbiological material, gastrointestinal infections, inflammatory bowel disease, thyroid diseases, cancer (especially the digestive tract), immunodeficiency.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Favorable outcome of bariatric surgery<br>Excess weight loss above 50% | Procedure: bariatric surgery<br>* (Laparoscopic Sleeve Gastrectomy, laparoscopic Roux-en-Y gastric bypass)<br>|
| Unfavorable outcome of bariatric surgery<br>Excess weight loss below 50% | Procedure: bariatric surgery<br>* (Laparoscopic Sleeve Gastrectomy, laparoscopic Roux-en-Y gastric bypass)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of microbiota in oral cavity |  | 6 months | 
| Change of microbiota in large intestine |  | 6 months |
Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to evaluate if the analysis of NT-proBNP might be used as an initial step for the diagnosis of chronic heart failure in patients with COPD in primary health care, and to select patients for a further examination by echocardiography.

Detailed Description
-----------------
Patients with a confirmed diagnosis of COPD were examined regarding chronic heart failure. An interview regarding symptoms: breathlessness, orthopnoea, night cough, nocturia, walking distance. Physical examination: weight and height, heart and lung auscultation, blood pressure measurement after 5 minutes' rest in the sitting position and the presence of peripheral oedema. Electrocardiography. Natriuretic peptide- NT-proBNP (Immulite 2500, Siemens Healthcare Diagnostics AB Sweden). Patients with the NT-proBNP level of > 1200 pg/ml were referred for echocardiography to assess left ventricular function.

Official Title
-----------------
Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Chronic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 65 years and older with the following diagnosis codes according to International Statistical Classification of Diseases and Related Health Problems - Tenth Revision:J44 (COPD) and J41, J42 (chronic bronchitis) registered during the period 1 January 2008-16 April 2008 according to the electronic patient record. Exclusion Criteria: Impaired cognitive function and/or anticipated difficulties in carrying out spirometry due to immobility, psychiatric disorders or terminal illness.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| NT-proBNP,ejection fraction ,COPD stage.<br>The group comprised 25 women (47%) and 28 men (53%). The mean age was 75.4 years (SD 7.9), 76.3 (SD 7.6) for men and 74.4 (SD 8.2) for women. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with elevated NT-proBNP. | NT-proBNP has taken only once in each patient without follow up follow up. Three months was a period when we collected data from all participants. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with abnormal left ventricular function assessed by echocardiography. Association between elevated NT-proBNP and symptoms, signs and electrocardiography. | Echocardiography was performed once in each referred patient. Three months was a period of data collection. | 3 months |
MRS and DTI of White Matter in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The white matter change of the Alzheimer's disease could be studied by diffusion tensor image and MR spectroscopy to see the microstructral and biochemical change.

Official Title
-----------------
MR Spectroscopy and Diffusion Tensor Imaging of White Matter in Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease, Vascular Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: probable Alzheimer's disease or subcortica type vascular dementia Exclusion Criteria: large vessel infarct, major trauma

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 95 Years

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

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

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
-----------------
Diffusion tensor imaging, MR spectroscopy, dementia, white matter
The Use of Narrow Band Imaging in Screening Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Narrow band imaging (NBI) is an imaging technique that allows a better definition of capillary pattern and improves the contrast between adenomas and the surrounding mucosa. Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the impact of NBI is being tested in several screening scenarios. The investigators evaluated whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of screening colonoscopy improved adenoma detection.

Official Title
-----------------
The Impact of Narrow Band Imaging in Screening Colonoscopy: a Randomized Controlled Trial.

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Procedure: Narrow Band Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50-69 year-old asymptomatic subjects at average-risk of CRC positive FOBT participating in a national mass-screening program and referred for colonoscopy Exclusion Criteria: ongoing anticoagulation therapy inadequate bowel cleansing incomplete colonoscopy refusing to participate

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 69 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>standard white light | |
| Experimental: 2<br>Narrow Band Imaging | Procedure: Narrow Band Imaging<br>* Narrow Band Imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection | Detection of adenoma, defined as the number of patients with > 1 adenoma, under White Light or NBI visualization | duration of colonoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Flat and/or Depressed Adenomas | number of patients with at least 1 flat and/or depressed adenoma | duration of colonoscopy procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening colonoscopy, narrow band imaging
Study of TLK286 (Telcyta) vs. Gefitinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if TLK286(Telcyta) is more effective than gefitinib (Iressa) in the treatment of non-small cell lung cancer.

Official Title
-----------------
Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions
-----------------
Non Small Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Drug: TLK286 (Telcyta) HCl for Injection
* Drug: gefitinib (Iressa)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of non-small cell lung cancer Non-small cell lung cancer that is not curable with surgery, radiation, or combined modality chemoradiation Failed two prior chemotherapy regimens which must have included platinum Measurable disease Exclusion Criteria: Treatment with more than two prior chemotherapy regimens History of bone marrow transplantation or stem cell support Pregnant or lactating women Known history of prior gefitinib therapy Known history of prior TLK286 therapy

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: TLK286 (Telcyta) HCl for Injection|nan|
|Drug: gefitinib (Iressa)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction

Study Overview
=================
Brief Summary
-----------------
The correction of the pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patient's quality of life. There are a few studies that have explored the effect of pelvic reconstructive surgery on female sexual function (1,2) but no studies have evaluated the male partner's sexual experience. The investigators intend to use a newly psychometrically validated questionnaire to capture this aspect. The sexual experience questionnaire (SEX-Q) is the first questionnaire to solely and exclusively combine functional and quality of life concepts (erection, individual satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more focused and less burdensome evaluation of the sexual experience in men (3). Another issue is the density of the mesh material and if it can be felt vaginally even if it is not eroded and to what degree this might bother the male partner during intercourse.

Conditions
-----------------
Sacral Colpopexy, Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sexually active couple at the time of pre-operative visit Female partner scheduled to undergo a mesh augmented repair Exclusion Criteria: Not sexually active Use of other graft material than polypropylene mesh Contraindications to surgery based on existing medical conditions Pregnancy Desire for pregnancy in the future

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

Sexes Eligible for Study
-----------------
Male

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

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
-----------------
uterine prolapse, vaginal prolapse
Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).

Official Title
-----------------
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Sbi-087 Administered To Subjects With Systemic Lupus Erythematosus.

Conditions
-----------------
Lupus Erythematosus, Systemic

Intervention / Treatment
-----------------
* Drug: SBI-087


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology [ACR] Revised Criteria) greater than 6 months before study day 1. History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent. Exclusion Criteria: Treatment with more than 20 mg of prednisone per day. Evidence of unstable clinically significant disease (e.g., cardiovascular, cerebrovascular, respiratory, or renal disease, or any other unstable serious disorder) other than SLE. History of cancer (other than resected cutaneous basal and squamous cell carcinoma or in situ cervical cancer) with less than 5 years' documentation of a disease-free state.

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
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBI-087<br> | Drug: SBI-087<br>* Single IV or SC dose of SBI-087<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (physical examinations, laboratory tests, adverse events) and tolerability (dose-limiting toxicities) of ascending single doses of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, pharmacokinetics
A Comparison of Epidural Techniques for Labour Analgesia

Study Overview
=================
Brief Summary
-----------------
A trial comparing outcomes for different epidural techniques in labour analgesia

Detailed Description
-----------------
Epidurals are the most common form of pain relief in labour. There are two techniques in use at the moment to place the epidural: epidural or combined spinal epidural (CSE). CSE has been shown to work faster and provide better pain relief than epidural alone. The investigators aim to show that CSE also requires less medication over the course of labour as this may mean it has fewer side effects. The amount of medication needed during labour between the two different techniques given in a standardized way will be compared.

Official Title
-----------------
A Comparison of Epidural Techniques for Labour Analgesia

Conditions
-----------------
Labour Analgesia

Intervention / Treatment
-----------------
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, singleton presentation at term Exclusion Criteria: Significant comorbidities likely to alter outcome of labour

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Active Comparator: Standard Epidural Technique<br>Epidural will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered. | Drug: Bupivacaine<br>* 16 mL of 0.125% bupivacaine<br>|
| Experimental: Combined Spinal Epidural Technique<br>CSE will be performed Initial dose of 16 mL of 0.125% bupivacaine will be given Upon patient request, rescue bolus based on protocol will be administered. | Drug: Bupivacaine<br>* 16 mL of 0.125% bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bupivacaine requirement for analgesia | milligram of bupivacaine used per hour | From randomization until delivery |
Testosterone Implants and the Incidence of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This current chart review study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.

Detailed Description
-----------------
A prior ten-year prospective, observational, study was initially approved in March of 2008 by the IRB board through the Atrium Medical Center, Premier Health Partners in Middletown, Ohio 45005 and registered through the Office for Human Research Protections (OHRP). Expedited approval continued annually through 2013 at which time the IRB board was closed. All participants signed a study consent and HIPPA consent. Recruitment closed in 2013. The original protocol was designed to investigate the incidence of breast cancer in women presenting with symptoms of hormone deficiency treated with subcutaneous testosterone implants or, testosterone combined with the aromatase inhibitor anastrozole implants. A computer program was specifically designed to track and follow patients prospectively and all patients continued to be followed through 2018.

Official Title
-----------------
Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Testosterone Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients treated between March 2008 - March 2013 Women who received at least two testosterone pellet insertion procedures Women previously accrued to the prospective cohort study Exclusion Criteria: Pre-existing breast cancer Women who received a single testosterone pellet insertion

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 92 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Testosterone Implant|Testosterone implants or combination testosterone + anstrozole implants used to treat symptoms of hormone/androgen deficiency|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of invasive breast cancer | The incidence of invasive breast cancer in women treated with testosterone therapy | 10-year results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ductal carcinoma in situ | The incidence of DCIS in women treated with testosterone therapy | 10-year results |