linjc16/ctgov huggingface dataset:
Betaferon® Regulatory Post-Marketing Surveillance

Study Overview
=================
Brief Summary
-----------------
To identify problems/questions about following items in the clinical practice using Betaferon Unknown adverse event (especially serious adverse event) Identification of adverse event occurred in the real practice Factors that may affect the safety of drug Factors that may affect the effectiveness of the drug

Official Title
-----------------
Betaferon® Regulatory Post-Marketing Surveillance

Conditions
-----------------
Multiple Sclerosis, Clinically Isolated System

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b (Betaseron, BAY86-5046)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of MS or CIS and decision taken by the physician to prescribe Betaferon Patients who have not participated in Betaferon regulatory Post Marketing Surveillance before. Exclusion Criteria: Exclusion criteria must be read in conjunction with local product information

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Group 1<br> | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* EOD, dosage frequency and duration will be decide by physicians.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables will be summarized using descriptive statistics based on adverse events. |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse. |  | During 6 month | 
| Progression or aggravation to Multiple sclerosis (MS) will be identified based on the change of Expanded Disability Status Scale (EDSS) and the Magnetic Resonance Imaging (MRI) outcome. |  | 0, 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Clinical Isolated Syndrome (CIS)
Zero Calorie Drink Products

Study Overview
=================
Brief Summary
-----------------
This will be a clinical test to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus. This research trial will evaluate the effect of three different solutions on blood glucose level. One solution is plain water, the second a standard high glucose (sugar) solution used typically in diabetes testing, and the third a low calorie drink (Zero Coke). Based on a prior study evaluating a diet for effective weight loss, we observed that patients who drank large volumes of diet soda did not lose weight as readily as those who did not drink diet soda. Therefore, we propose to examine the actual effect of one diet soda (Zero Coke) on the body's glucose level and compare it to water and a high glucose solution. All participants in this study must have 3 Glucose tolerance evaluations - one with each solution: water, high glucose, and Zero Coke.

Official Title
-----------------
Determination of Clinically Significant Carbohydrates Added to Zero Calorie Drink Products

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

Intervention / Treatment
-----------------
* Other: Glucose tolerance test
* Other: glucose tolerance test solution
* Other: Diet Coke
* Other: Coke Zero


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, asymptomatic individuals for diabetes and pre-diabetes, especially for people at high risk of developing diabetes, such as those with a family history of diabetes, those who are overweight, and those who are more than 40 to 45 years old Exclusion Criteria: Patients with chronic illnesses, especially diabetes

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>glucose tolerance test solution | Other: Glucose tolerance test<br>* 10 ounces glucose tolerance test solution<br>Other: glucose tolerance test solution<br>* 75 grams glucose load<br>|
| Other: 2<br>Diet Coke | Other: Diet Coke<br>* 10 ounces of Diet Coke<br>|
| Other: 3.<br>Coke Zero | Other: Coke Zero<br>* 10 ounces of Coke Zero<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus. |  | 3 days |
Validity of Scales to Assess Severity in Acute Heart Failure

Study Overview
=================
Brief Summary
-----------------
The scales measuring the severity of acute decompensate heart failure (ADHF) in emergency departments have not achieved an adequate discriminative ability for decision making. Objectives: 1) Identify baseline variables, and evolutionary variables that may provide a good predictive ability of the model.2) Create and validate clinical predictive rules of mortality during admission/a week after ED visit in those discharged from ED, 30 and 60 days after ED visit as well as identify predicitive factors of short-term readmission (90 days)Design: Prospective cohort study. The sociodemographics and clinical variables will be collected from emergency medical records to identify predictors. Outcome variables and evolution of variables will be collected from hospital medical records / ambulatory during admission and up to 90 days after the episode of ADHF. Baseline predictors and evolutionary variables will be identified through logistic regression models using 60% of the final sample. The models that best fit will be applied in 40% of the sample to assess the predictive validity of this scale.

Official Title
-----------------
Validition of Scales for the Assessment of Sverity in Acute Decompensated Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: preidictive model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They were diagnosed as heart failure) HF is defined, clinically, as a syndrome in which patients have typical symptoms (e.g.breathlessness, ankle swelling, and fatigue) and signs (e.g. elevated jugular venous pressure, pulmonary crackles, and displaced apex beat) resulting from an abnormality of cardiac structure or function.(8) We included the following presentation of acute heart failure (AHF) at ED: acute decompensated heart failure, hypertensive acute heart failure, pulmonary oedema, cardiogenic shock, and high output failure. (9;10) Exclusion Criteria: Patients whose main diagnosis in the ER is different than acute heart failure and those not wishing to participate in the study or signing the informed consent.

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

| Intervention/Treatment |
| --- |
|Other: preidictive model|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poor evolution |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| readmission |  | 3 months |
Vitamin D Deficiency Among Women With Unexplained Infertility

Study Overview
=================
Brief Summary
-----------------
Does vitamin D is more deficient in women with unexplained infertility than in fertile pregnant women or not?

Detailed Description
-----------------
The study will be done on women with unexplained infertility as a case group and fertile pregnant women as control group to detect if there's a difference in serum level of vitamin D between two groups which will help in the future for curing unexplained infertility women.

Official Title
-----------------
Vitamin D Deficiency Among Women With Unexplained Infertility

Conditions
-----------------
Case Control Study

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with unexplained infertility. pregnant fertile women as control group. Exclusion Criteria: • Endocrinopathies such as (diabetes mellitus, thyroid disorders, parathyroid disorders and hyperprolactinemia), cardiovascular related diseases, severe infection, malignancies and concomitant diseases contribute to Vit D deficiency. Women with ovulatory factor like PCOS,anovulation and poor ovarian reserve are excluded. Women with endometriosis are excluded. Women with autoimmune diseases like antiphospholipid antibodies or lupus erythematosus are excluded. Documented uterine anomalies, tubal factor, cervical factor and other local causes of infertility. Male factor of infertility is excluded. Bone and metabolic disease, liver diseases and kidney related diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Case group contain cases of unexplained infertility women | |
| Group B<br>Control group contain fertile pregnant women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D level | Serum vitamin D level in women with unexplained infertility and fertile pregnant women. | 6 months |
Apical Support During Hysterectomy for Pelvic Organ Prolapse-NSQIP Analysis.

Study Overview
=================
Brief Summary
-----------------
This is a retrospective descriptive study using the American College of Surgeon's National Surgical Quality Improvement Program® (ACS NSQIP®) data to determine whether gynecologic surgeons are already meeting the recently recommended best practice of supporting the vaginal apex at time of hysterectomy for pelvic organ prolapse (POP).

Detailed Description
-----------------
The prevalence of pelvic organ prolapse (POP) in the United States is estimated to be between 40-50% with an anticipated increase over the next several decades. Approximately 300,000 women undergo surgeries to repair POP in the United States every year. Following pelvic reconstructive surgery, recurrence rates of symptomatic prolapse range between 6-30%. Our understanding of pelvic anatomy and its support has been significantly improved over recent decades, with many researchers reporting on details and mechanics previously not understood. In November 2017, the American College of Obstetricians and Gynecologists released a new practice bulletin outlining the current standard of care for the treatment of women with pelvic organ prolapse. In this bulletin, they state that a hysterectomy alone is not adequate treatment for POP, and further that any woman having a hysterectomy for POP should undergo a concurrent apical suspension procedure as a standard of care. The purpose of this study is to determine the proportion of patients undergoing hysterectomy for the indication of POP having concurrent apical suspension among the population whose cases are reported within the NSQIP database, and who underwent hysterectomy between 2015 and 2017.

Official Title
-----------------
Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse: A NSQIP Analysis.

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Underwent hysterectomy for pelvic organ prolapse, between 2015 and 2017 Exclusion Criteria: Age < 18 years old Pelvic Organ Prolapse was not recorded in their postoperative diagnoses

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

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

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 |
| --- | --- | --- |
| proportion of patients having concurrent apical suspension performed | proportion of patients who had concurrent apical support procedures performed | procedure (at time of hysterectomy for pelvic organ prolapse) |
Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.

Official Title
-----------------
Single-Dose Fasting In Vivo Bioequivalence Study of Valacyclovir Hydrochloride Tablets (1000 mg; Mylan) to Valtrex® Tablets (1000 mg; GlaxoSmithKline) in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Valacyclovir Hydrochloride Tablets 1000 mg
* Drug: Valtrex® Tablets 1000 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Valacyclovir Hydrochloride Tablets 1000 mg | Drug: Valacyclovir Hydrochloride Tablets 1000 mg<br>* 1000mg, single dose fasting<br>|
| Active Comparator: 2<br>Valtrex® Tablets 1000 mg | Drug: Valtrex® Tablets 1000 mg<br>* 1000mg, single dose fasting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collections through 24 hours |
Investigating the Role of Impella 2.5 System in Acutely Decompensated Chronic Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess safety and feasibility of IMPELLA 2.5 in Acute Decompensated Heart Failure patients.

Official Title
-----------------
RELIEF I: Investigating the Role of IMPELLA 2.5 System In Acutely Decompensated Chronic Heart Failure Patients. A Prospective, Single Center Feasibility Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Impella 2.5


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: Chronic heart failure patients, hospitalized due to decompensated heart failure (ADHF) with NYHA Class III-IV symptoms (ADHF is defined by the presence of at least one of the following symptoms/signs: dyspnea w/orthopnea, jugular venous distension, peripheral edema +2, abdominal ascites, signs of CHF on chest X-Ray) LVEF ≤ 40 % within the past 3 months Major Exclusion Criteria: Acute Q-wave myocardial infarction or Acute coronary syndrome within past 30 days Cardiac surgery within the past 30 days Implantation of cardiac resynchronization device within past 30 days or a possibility of implanting a biventricular pacer within 90 days of randomization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Impella 2.5|Impella 2.5 implant in patients with acute decompensated heart failure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events |  | 30 day or discharge(whichever is longer) |
Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients

Study Overview
=================
Brief Summary
-----------------
To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.

Official Title
-----------------
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Drug: ALV003
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 to 80 years Physician diagnosed celiac disease Adherence to a gluten-free diet Experiencing symptoms of celiac disease over a 1-month period Willing to take study medication for 12 weeks Willing to comply with all study procedures Sign informed consent Exclusion Criteria: Active inflammatory bowel disease Active dermatitis herpetiformis Use of certain specific medications prior to entry History of alcohol or illicit drug abuse in previous 6 months Pregnant or lactating Received any experimental drug within 30 days of enrollment Uncontrolled chronic disease or condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALV003<br> | Drug: ALV003<br>* ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Intestinal mucosal morphometry | Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Intestinal intraepithelial lymphocyte density | Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells) | 12 weeks | 
| Safety: safety and tolerability of ALV003 | Incidence of adverse events between baseline and week 12 | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celiac disease, Gluten-free diet, Coeliac disease, Celiac sprue
Imaging Perilymphatic Fistulas After Barotrauma

Study Overview
=================
Brief Summary
-----------------
Our objective is to validate the CT / MRI combination of non-injected rock for the rapid positive diagnosis of perilymphatic fistulas.

Official Title
-----------------
Fast and Accurate Diagnosis of an Oval or Round Window Perilymphatic Fistula on CT and MRI, Without Injection, on 101 Patients With Surgical Confirmation

Conditions
-----------------
Perilymphatic Fistulas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 Clinical suspicion of perilymphatic fistula Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal) Exclusion Criteria: - Refusal of the patient to participate in the study

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 |
| --- | --- | --- |
| Diagnosis of perilymphatic fistula |  | 1 hour after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vertigo, perilymphatic fistulas, magnetic resonance imaging (MRI), surgery, round window, tinnitus, cophosis