linjc16/ctgov huggingface dataset:
Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.

Official Title
-----------------
Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity: a Double-Blind, Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Dietary Supplement: Mixture of various probiotics and fermentation products
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as based on medical history and physical examination BMI between 25 and 30 kg/m2 Willing not to serve as blood donor during the study Informed consent signed Exclusion Criteria: Food allergy Female subjects who are pregnant or nursing a child Participation in any clinical trial up to 90 days before Day 01 of this study Renal or hepatic dysfunction Heart disease Under medication Subjects who are taking functional food designed for weight loss or serum lipid reduction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: Mixture of various probiotics and fermentation products<br> <br> |
| Placebo Comparator: 2<br> | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat mass |  | Week -4, Week 0, Week 4, Week 12 | 
| Abdominal circumference |  | Week -4, Week 0, Week 4, Week 12 | 
| Visceral fat area by CT scan |  | Week 0, Week 12 | 
| Intestinal flora |  | Week 0, Week 12 | 
| Serum lipid profile |  | Week -4, Week 0, Week 4, Week 12 | 
| Serum adiponectin and leptin levels |  | Week 0, Week 12 | 
| Fasting serum glucose and HbA1c levels |  | Week -4, Week 0, Week 4, Week 12 |
Improved Management and in-Hospital Mortality

Study Overview
=================
Brief Summary
-----------------
The study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward.

Detailed Description
-----------------
Mortality at the national paediatric ward in Guinea-Bissau is very high. During a civil war in 1998/1999 the hospital case fatality (CF) decreased by more than 40%, increasing again after the the war. This was attributed to the available free drugs from the humanitarian aid and food incentives to the personnel. Free emergency kits for treatment of severe malaria was introduced, however the CF did not decline. Therefore, the ward was split into two groups of rooms: intervention and control. All the staff of the ward was trained in the use of a standardised guideline for treatment of severe malaria and randomly assigned to one of the groups. All children hospitalised for malaria received the drug emergency kits. The only difference in the intervention group were the small financial incentives and supervision for strict adherence to the guidelines procedures.

Official Title
-----------------
Reduced in-Hospital Mortality After Improved Management of Patients Hospitalised With Malaria. A Randomised Trial

Conditions
-----------------
Mortality, Malaria

Intervention / Treatment
-----------------
* Behavioral: Guideline adherence and financial incentive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalization due to malaria Non per os Exclusion Criteria: Consent from parent/caretaker declined

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Guideline adherence and financial incentive|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital case-fatality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative post-discharge mortality on day 28 and length of hospitalisation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malaria, mortality, hospital, incentive, personnel, paediatric
Comparison of CXR and MnDCT

Study Overview
=================
Brief Summary
-----------------
A comparison of chest x-ray (CXR) and Minimum dose CT (MnDCT) in the acutely ill patient. The hypothesis is that MnDCT is more sensitive than CXR in the detection of acute findings in the acutely ill patient.

Detailed Description
-----------------
A comparison of chest x-ray (CXR) and Minimum dose CT (MnDCT) in a cohort of 100 patients admitted for acute respiratory distress. Chest radiography (CXR) is compared to Minimum Dose CT (MnDCT) for the detection of consolidation;lung nodules, heart failure.

Official Title
-----------------
A Comparison of Chest Radiography and Minimum Dose Chest CT

Conditions
-----------------
Acute Dyspnoea

Intervention / Treatment
-----------------
* Procedure: Minimum Dose CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted for investigation of acute pulmonary embolus Exclusion Criteria: none

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Minimum Dose CT|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A comparison of CXr and MnDCT in the detection of acute findings within the thorax |  |  |
Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically demonstrated bladder cancer.

Detailed Description
-----------------
There will be no procedure(s) or treatment(s) carried out on patients. All data and samples will be taken from those already stored at the investigation sites. Clinical data collected will include patient demographics (age, gender), Tumor, Node, Metastasis (staging system) [TNM stage], and histopathologic description only. Strict anonymity of patient data will be maintained. This retrospective study is based upon the analysis of archived formalin-fixed paraffin-embedded tissue samples and patient-related data already available at the investigational site.

Official Title
-----------------
Analysis of the Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer

Conditions
-----------------
Neoplasms, Urinary Bladder

Intervention / Treatment
-----------------
* Other: Data acquisition and analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For inclusion of a tissue sample, all of the following criteria must be met: The patient had pathologically proven bladder cancer (any stage). All the data required are available from patient's records. There are no restrictions regarding operative technique (cystectomy or cystoscopy). - Many patients may no longer be alive, or no longer be in contact with the investigation sites. Thus, patients will not be required to give their informed consent before inclusion in the study. Exclusion Criteria: Not applicable.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer Group<br> | Other: Data acquisition and analysis<br>* Tumor tissue samples submitted for analysis together with a form containing clinical data previously collected and archived from patients with bladder cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the gene expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in pathologically demonstrated bladder cancer. |  | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients, Tumor antigens, Bladder cancer
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome

Study Overview
=================
Brief Summary
-----------------
Despite constant progress in in vitro fertilization (IVF) techniques and ovarian stimulation, pregnancy and embryo implantation rates remain modest . The phenomenon of embryo implantation depends both on the embryo itself and on endometrial receptivity

Detailed Description
-----------------
A favorable uterine medium is necessary for embryo implantation, but endometrial receptivity can be negatively affected by ovarian stimulation . Study of endometrial receptivity is especially limited in the context of IVF cycles . Biopsy of the endometrium cannot be considered during the treatment, and this has encouraged the development and use of ultrasonography and Doppler-like non-invasive methods to evaluate ovarian response to the stimulation and uterine receptivity .

Official Title
-----------------
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in Prediction of Pregnancy Rate in ICSI

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Diagnostic Test: Transvaginal US with Doppler study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Maternal age from 20 to 40 years. Women with BMI range from 20 - 35 Women diagnosed with primary infertility Exclusion Criteria: Maternal chronic medical disorder (diabetes mellitus or hypertension). Women diagnosed with autoimmune diseases or antiphospholipid syndrome

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Transvaginal US with Doppler study|Transvaginal Ultrasound with doppler study on endometrium will be made|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients who will have positive pregnancy rate | patients who will get pregnant in ICSI cycle with measuring their doppler indices before ovum pick up | within 2 months |
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)

Study Overview
=================
Brief Summary
-----------------
This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.

Official Title
-----------------
Non-Interventional Study to Document the Efficacy in Routine Clinical Practice of Mircera in Pakistan (NORM)

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Mircera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, age 18 years or above Chronic kidney disease (CKD) with anemia Patients on dialysis receiving short-acting epoetin (EPO) Serum ferritin level >/=100 ng/ml or transferrin saturation (TSAT) >/=20% Exclusion Criteria: Patients unwilling to give informed consent Uncontrolled hypertension Transfusion of red blood cells within 8 weeks of the start of Mircera treatment Relevant acute or chronic bleeding history Hemolysis Hemoglobinopathies Pure red cell aplasia

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 |
| --- | --- |
| Cohort<br>Mircera | Drug: Mircera<br>* Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha will be observed for a period of 6 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study |  | Month 4 up to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Achieve Hb Level to 11-12 g/dL |  | Up to 6 months | 
| Number of Dose Adjustments Required to Maintain Hb Levels |  | Up to 6 months | 
| Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC) |  | Up to 6 months |
Rollover Study Of Lapatinib In Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending FDA approval.

Official Title
-----------------
An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.

Conditions
-----------------
Neoplasms, Breast

Intervention / Treatment
-----------------
* Drug: GW572016 oral tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently receiving clinical benefit as defined by CR, PR or SD from treatment with lapatinib through participation in a Phase I study of lapatinib either as monotherapy or as part of a combination regimen. Ability to understand and provide written informed consent to participate in this trial. Is male or female. Female and male subjects agree to the protocol specific birth control measures Exclusion Criteria: Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure. Is a pregnant or lactating female. Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations. Currently receiving treatment with any medications listed on the prohibited medication list (see Section 7.2). Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. Has a left ventricular ejection fraction (LVEF) < 40% based on MUGA or ECHO.

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: Arm 1<br>Lapatinib either 750, 1000, 1250 or 1500 mgs | Drug: GW572016 oral tablets<br>* Lapatinib either at 750, 1000, 1250 or 1500 mgs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen |  | Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival |  | Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, tolerating lapatinib, Lapatinib
Clinical Feasibility Study of Allium's Biliary Stent

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent in malignant obstructions of the common bile duct.

Detailed Description
-----------------
Biliary duct stenoses are caused by intrinsic malignant disease of the common bile duct or by compression or infiltration of malignancies of the abdominal organs, i.e. pancreas, liver, stomach, duodenum, etc, or by iatrogenic reasons such as endoscopic biliary stone manipulations, biliary anastomoses or biliary duct reimplantation. In these diseases, a stent can be placed in the biliary duct canal to open it and relieve the obstruction. The Allium Biliary Stent is to be inserted into the biliary duct to allow free flow of biliary fluid from the liver to the duodenum by supporting the obstructed area of the biliary duct lumen, keep it open, and prevent its re-obstruction.

Official Title
-----------------
A Clinical Feasibility Study to Evaluate the New Allium Biliary Stent, in Patients Suffering From Malignant Biliary Duct Obstruction (Endoscopic Insertion)

Conditions
-----------------
Malignant Obstruction of the Common Bile Duct

Intervention / Treatment
-----------------
* Device: Allium Biliary Stent
* Device: allium biliary stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 18 years or older Patient has malignant obstructive jaundice Patient is unfit for surgery Patient is capable of giving informed consent Patient is willing to comply with study requirements Exclusion Criteria: Patient has a benign biliary duct obstruction Patient cannot tolerate any form of antibiotic treatment Patient is currently receiving anticoagulation therapy Patient has history of illness, medication, or surgery that may affect the efficacy of the stent (e.g.: a previous surgical change in the anatomy of the common bile duct)

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

| Intervention/Treatment |
| --- |
|Device: Allium Biliary Stent|device|
|Device: allium biliary stent|allium biliary stent|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature measurement, patient comfort analysis, sonographic measurements of the duct channels, abdominal X-ray imaging of the stent, and blood tests will be performed at 24 hours, 30 days, 3, 6, and 12 months following stent insertion. |  | up to 12 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
common, bile, duct, biliary, malignant, obstruction, stent
Repair of Subscapularis Tear :Clinical Results and MRI Analysis

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the magnetic resonance imaging (MRI) and clinical results of arthroscopic repair of subscapularis tears

Detailed Description
-----------------
ROM UCLA Constant ASES VAS MRI Goutallier

Official Title
-----------------
Arthroscopic Repair of Subscapularis Tear :Clinical Results and MRI Analysis

Conditions
-----------------
Rupture Subscapularis Tendon

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients suffering from rotator cuff injury scheduled for an arthroscopic procedure. A partial- or full-thickness subscapu-laris tendon tear Exclusion Criteria: - revision repairs or open repairs.
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 |
| --- | --- | --- |
| Clinical results and MRI analysis | ROM UCLA Constant ASES VAS MRI | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
apularis, MRI clinical, results