linjc16/ctgov huggingface dataset:
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HbeAg-negative Chronic Hepatitis B (Perseas)

Study Overview
=================
Brief Summary
-----------------
This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.

Official Title
-----------------
Prognostic Factors of Long-term Response to Treatment With Pegylated Interferon Alfa-2a in Patients With HbeAg-negative Chronic Hepatitis B. (Perseas)

Conditions
-----------------
Hepatitis B, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/=18 years of age Diagnosis of HBeAg-negative chronic hepatitis B with compensated hepatic disease, virus multiplication, raised alanine amino transferase results and/or fibrosis Exclusion Criteria: Co-infection with hepatitis A, C or D Co-infection with human immunodeficiency virus (HIV) Severe hepatic dysfunction or decompensated liver disease

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> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with combined (virological and biochemical) response |  | 48 weeks after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of serum alanine aminotransferase |  | 12 months | 
| Safety (Incidence of adverse events) |  | 12 months |
Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of Olostar Tablet on blood pressure and lipid profiles, obtain safety-related information for subgroups that failed to participate in the clinical trials, and to evaluate variables that affect treatment effectiveness.

Official Title
-----------------
A Non-interventional, Multi Center, Prospective Observational Study to Evaluate the Effect of Improving Systolic Blood Pressure and Low-density Lipoprotein Cholesterol Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab. in Patients With Essential Hypertension and Dyslipidemia.

Conditions
-----------------
Hyperlipidemias, Hypertension

Intervention / Treatment
-----------------
* Drug: Rosuvastatin, Olmesartan Medoxomil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women over the age of 19 Patients who signed a written consent form to participate in the study Patients who are eligible for Olostar tablet prescription according to domestic permission Exclusion Criteria: A person who falls under 2. Do not administer to the following patients among the precautions for use in the user manual Patients in hospital (hospitals only; nursing care facilities can be recruited) A person who has been administered the study target drug or is being administered at the time of recruitment within 6 months based on the date of the study contract

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Experimental/ Olostar Tablet<br>Eligible Subjects who received Olostar Tablet treatment for 24 weeks. Dosage: 10/5mg, 10/10mg, 20/5mg, 20/10mg, 20/20mg, 40/10mg, 40/20mg | Drug: Rosuvastatin, Olmesartan Medoxomil<br>* Olostar Tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension reduction rate | To evaluate effectiveness of Olostar Tablet on hypertension | 24 weeks | 
| Lipid profile reduction rate | To evaluate effectiveness of Olostar Tablet on lipid profile. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment objectives | To evaluate whether treatment objectives (hypertension, LDL-C) have been achieved. | 24 weeks | 
| Construct prediction model | Construct a treatment effectiveness prediction model based on effectiveness of Olostar Tablet treatment (whether treatment goals are achieved or not). | 24 weeks | 
| Construct prediction model | Construct a compliance and persistence prediction model based on patients receiving Olostar Tablet treatment. | 24 weeks |
Magnesium Sulfate Versus Indomethacin for Preterm Labor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy of Indomethacin compared to Magnesium Sulfate (MgSO4) in reducing neonatal morbidity through a prospective double blind randomized clinical trial. The specific aim of the project is to test the hypothesis that Indomethacin, compared to MgSO4, will decrease the proportion of neonates diagnosed with major complications or death.

Conditions
-----------------
Labor, Premature

Intervention / Treatment
-----------------
* Drug: Indomethacin
* Drug: Magnesium sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Initial episode of preterm labor for enrollment The diagnosis of preterm labor Gestational age between 24 and 32 weeks Singleton or twin gestation The ability to understand the requirements of the study Exclusion Criteria: Cervical dilation >5 cms Suspected chorioamnionitis Fetal distress Vaginal bleeding Severe pre-eclampsia History of gastrointestinal bleeding Abnormal renal function Suspicion of fetal malformation by ultrasound Known allergy to, or intolerance of, Magnesium sulfate and/or Indomethacin Documented rupture of amniotic membranes Multiple gestations of triplets or more.
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

| Intervention/Treatment |
| --- |
|Drug: Indomethacin|nan|
|Drug: Magnesium sulfate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS Women

Study Overview
=================
Brief Summary
-----------------
An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify for 17b-HSD5 enzyme (71A>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has been suggested in previous studies. Given the role of 17b-HSD5 in androgenic metabolism producing testosterone from precursors, the investigators hypothesis is that women with PCOS and with the variant allele G have a poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive pill (OCP) treatment for 6 months.

Official Title
-----------------
17-hydroxysteroid Dehydrogenase Type 5 Gene Polymorphism (71A/G HSD17B5 SNP) and Effects of Oral Contraceptive Pill on Hirsutism, Androgens and Metabolic Profile in Non-obese PCOS Women: a Pilot Study

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: oral contraceptive pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hirsute women with polycystic ovary syndrome Exclusion Criteria: Use of any drugs known to interfere with hormone levels for at least 3 months before the study Women with type 2 diabetes, homa index > 3.8, liver or renal disease or thyroid dysfunction Other hyperandrogenic disorders than PCOS

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oral contraceptive pill|ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes at Ferriman- Gallwey score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes at testosterone levels |  | 6 months | 
| Changes in lipid profile |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, oral contraceptive pill, polymorphisms
Trim Tots Pre-school Obesity Prevention Programme

Study Overview
=================
Brief Summary
-----------------
Randomised controlled trial of a lifestyle intervention programme for mothers and children aged 1-5 years aimed at prevention of overweight and obesity.

Official Title
-----------------
TrimTots Pre-school Obesity Prevention Programme

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Lifestyle intervention
* Behavioral: waiting list control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who are currently overweight/obese or at increased risk of becoming so and their mother or usual carer.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 72 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Stratification by angiotensin converting enzyme (ACE) genotype | Behavioral: Lifestyle intervention<br>* Lifestyle intervention with Trim Tots pre-school programme.<br>|
| Placebo Comparator: 2<br>Waiting list controls | Behavioral: waiting list control<br>* waiting list control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass index |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular (CV) disease risk factors |  | 12 months | 
| Physical activity (accelerometry) |  | 12 months | 
| Motor co-ordination (ABC battery). |  | 12 months | 
| Motor co-ordination (ABC battery). Behaviour (general and dietary). |  | 12 months | 
| CV fitness (heart rate variability). |  | 12 months | 
| Waist circumference |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, overweight, BMI, ifestyle, diet, nutrition, physical activity, pre-school, toddlers, children, Prevention of overweight and obesity in pre-school children
Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-center, randomized, controlled, open-label, pilot study to evaluate the effectiveness of high dose statin loading in acute heart failure patients.

Official Title
-----------------
A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients

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

Intervention / Treatment
-----------------
* Drug: statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dyspnea at rest or minimal activity Tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray Exclusion Criteria: Acute coronary Syndrome Hospitalization plan for PTCA or CABG Cardiogenic shock (Systolic Blood Pressure < 80mmHg) Uncontrolled hypertension (Systolic Blood Pressure > 180mmHg) Allergy, adverse drug reaction, hypersensitivity to statin Troponin > 5 times upper limit of normal (ULN) Creatinine kinase-MB level > 3 times ULN AST, ALT > 3 times ULN or acute hepatitis Current or past history of muscle disease, rhabdomyolysis Life expectancy < 6 months (e.g. metastatic malignancy, liver cirrhosis) Pregnancy or women at age of childbearing potential

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

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: atorvastatin 80mg<br> | Drug: statin<br>* adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy acute heart failure therapy<br>|
| Active Comparator: conventional therapy (for heart failure)<br> | Drug: statin<br>* adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy acute heart failure therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hsCRP levels | to investigate the effect of high dose statin loading on the change of serum NT-proBNP, hsCRP levels in patients with acute heart failure | at hospital day #4 |
Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to establish the correlation between NT-proBNP measurements in fresh human whole blood samples and those in plasma samples from the same study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and measured by the StatusFirst™ CHF NT-proBNP device in conjunction with the DXpressTM Reader in a laboratory setting.

Official Title
-----------------
Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples

Conditions
-----------------
Congestive Heart Failure (CHF)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR Be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease. Exclusion Criteria: Be 45 years of age or younger

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| 1<br>Subjects with diagnosed congestive heart failure | |
| 2<br>Subjects not diagnosed with congestive heart failure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| StatusFirst CHF NT-proBNP test result |  | At presentation to study site (no follow-up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive Heart Failure (CHF), NT-proBNP
Immunity and Infections in the Psychiatric Population

Study Overview
=================
Brief Summary
-----------------
The main objective of this multicenter cohort study is to determine the degree of COVID19 infection immunization of a population of psychiatric patients. The secondary objective of this cohort follow-up is to: Clinically characterize COVID patients who are positive for serological testing Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis Immunologically characterize COVID patients who are positive for serological testing Exploring the links between susceptibility to COVID19 and erythrocytic blood groups

Detailed Description
-----------------
All patients accepting to participate will be included in participating psychiatry services and will have a COVID Serological Test for Inclusion with confirmation at J15 including immune-genetics data. A Comparison of COVID patients versus no COVID patients will be based on a clinical examination (psychiatric, somatic) and blood samples collected at J0 and J15.

Official Title
-----------------
Immunity and COVID Infections in the Psychiatric Population

Conditions
-----------------
COVID, Psychiatric Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: COVID19 immunization testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient Hospitalized in one of the participating psychiatric wards during the inclusion period Signed informed consent Exclusion Criteria: Inability to obtain the consent of the patient or legal representative, if applicable Patient under safeguard of justice

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: psychiatric patient<br>patients who are hospitalized in psychiatric department | Diagnostic Test: COVID19 immunization testing<br>* serological COVID19 test with confirmation at J15 during hospitalization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of COVID-positive patients | Number of COVID-positive patients, defined by a positive serological test result by immuno-chromatography at inclusion or at 15 days. | day 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID infection, psychiatric population
Prevalence of Impaired Glucose Tolerance (IGT) in Patients With Frozen Shoulder

Study Overview
=================
Brief Summary
-----------------
Idiopathic Adhesive Capsulitis, Frozen Shoulder is a condition in which there is a limitation and significant pain at the shoulder and it is increases with shoulder movements. The causes are not clear. The prevalence of this condition is four times higher in diabetic patient compare to the general population. The relation between frozen shoulder and impaired glucose tolerance remain unclear. Our hypothesis is that patients with no diabetes and that suffer from frozen shoulder have a higher prevalence of impaired glucose tolerance than the general population age matched.

Conditions
-----------------
Frozen Shoulder, Impairment Glucose Tolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 30-60. previous Xray that eliminates other disease of the shoulder. previous US that eliminates tendon shoulder rupture shoulder movement in all directions, with limitation in the external rotation (at least 50%) Exclusion Criteria: Diagnosed Diabetes (pregnancy diabetes includes) Taking Hyperglycemic medications (like Steroids) Fracture or operation in the shoulder before the diagnosis of frozen shoulder.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- |
| 1<br> | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy

Official Title
-----------------
A Phase 2b Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Chronic Painful Diabetic Peripheral Neuropathy (DPN).

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: [S,S]-Reboxetine
* Drug: Any


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy Patients at screening must have a score >/=40 mm on the pain visual analogue scale Exclusion Criteria: Patients with significant hepatic impairment Patients with other severe pain, that may impair the self-assessment of the pain due to DPN

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Treatment<br>[S,S]-reboxetine | Drug: [S,S]-Reboxetine<br>* [S,S]-reboxetine<br>|
| Other: Standard Care<br>Standard Care | Drug: Any<br>* Any standard of care treatment for DPN<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs |  | duration of study | 
| Physical examination |  | duration of study | 
| 12-lead ECG |  | duration of study | 
| Hematology/Biochemistry |  | duration of study | 
| Adverse events |  | duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual Analogue Scale |  | duration of study | 
| Neuropathic Pain Symptom Inventory |  | duration of study | 
| Modified Brief Pain Inventory-Short Form |  | duration of study | 
| Patient Global Impression of Change |  | duration of study | 
| SF-12 Health Survey |  | duration of study | 
| EQ-5D |  | duration of study | 
| Analgesic Treatment Satisfaction Scale |  | duration of study | 
| Pain-related Medication Utilization |  | duration of study |