linjc16/ctgov huggingface dataset:
Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque

Official Title
-----------------
A 12-Week, Randomized, Semi Double-Blinded Study Evaluating the Effects of Daily Oral High-Dose Atorvastatin or BMS-582949 on Atherosclerotic Plaque Inflammation as Determined by FDG-PET in High Risk Atherosclerotic Patients

Conditions
-----------------
Vascular Diseases

Intervention / Treatment
-----------------
* Other: Placebo
* Drug: BMS-582949
* Drug: Atorvastatin
* Drug: Statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of documented atherosclerosis LDL between 70 and 130 mg/dL Patients receiving stable low- to moderate-dose statin BMI 18-37 kg/m² Must be able to swallow tablets Must be able to medically tolerate the procedures, contrast medium, and medications involved Exclusion Criteria: Statin intolerance Renal impairment (serum creatinine > 1.5 mg/dL) History of chronic viral hepatitis or other liver dysfunction Major infection requiring hospitalization or receipt of IV antibiotics due to an infection within 2 months prior to initiation of study treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: Placebo + background low to moderate dose statin<br>Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks | Other: Placebo<br> <br> Drug: Statin<br> <br> |
| Experimental: BMS-582949 + Background low to moderate dose statin<br>BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks | Drug: BMS-582949<br> <br> Drug: Statin<br> <br> |
| Active Comparator: Atorvastatin<br>Atorvastatin Tablets, oral, 80 mg once daily for 12 weeks | Drug: Atorvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FDG-PET signal of the carotid and/or ascending aorta |  | at 4 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory and thrombotic biomarkers |  | will be measured throughout the 12 weeks of treatment |
Efficacy and Safety of ATL-962 in Obese Diabetics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients

Detailed Description
-----------------
Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction. In this study patients with Type II diabetes who are clinically obese will receive ATL-962 at one of three dose levels, or placebo, or orlistat (another lipase inhibitor). The study will investigate the amount of weight lost after 12 weeks' treatment and will compare the safety and tolerability profile of ATL-962 and orlistat.

Official Title
-----------------
Multicentre Double Blind Placebo Controlled Parallel Group Dose Ranging Study of ATL-962 to Assess Weight Loss, Safety and Tolerability in Obese Patients With Type II Diabetes Being Treated With Metformin, in Comparison With Orlistat

Conditions
-----------------
Non-Insulin-Dependent Diabetes Mellitus, Obesity

Intervention / Treatment
-----------------
* Drug: ATL-962
* Drug: Orlistat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II diabetes Body mass index 28-45kg/m2 HbA1c 6%-10% Exclusion Criteria: Significant weight loss in the previous 3 months Weight gain during the run-in period Other serious systemic conditions, except controlled hypertension, mild asthma, and primary hypothyroidism History of GI disorders Previous surgery for weight loss

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

| Intervention/Treatment |
| --- |
|Drug: ATL-962|nan|
|Drug: Orlistat|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute weight loss compared to baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving 5% or 10% weight loss |  |  | 
| Changes in waist circumference |  |  | 
| Changes in lipid profiles |  |  | 
| Changes in markers of diabetes |  |  | 
| Incidence of gastrointestinal adverse effects |  |  | 
| Changes in other safety parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-insulin-dependent diabetes mellitus, NIDDM, Type II diabetes, Obesity, Lipase inhibitor
Assesment of Hearing in Patients With Vestibular Migra

Study Overview
=================
Brief Summary
-----------------
Evaluation of hearing in patients with vestibular migraine

Official Title
-----------------
Assesment of Hearing in Patients With Vestibular Migraine

Conditions
-----------------
Vestibular Migraine

Intervention / Treatment
-----------------
* Diagnostic Test: Pure tone audiometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: vertigo Exclusion Criteria: hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Patients with vestibular migraine and their relative<br> | Diagnostic Test: Pure tone audiometer<br>* Pure tone audiometer<br>* Other names: Otoacustic emission;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathology | For vestibular migraine | 2 years |
Bisphenol Role in the Pathogenesis of PCOS

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome (PCOS) is the most common and the most heterogeneous endocrine disorder in premenopausal women. Its prevalence is estimated from 5 to 10% depending on the diagnosis' criteria . Apart from signs of hyperandrogenism such as acne, hirsutism and hair loss; women with PCOS usually present with menstrual irregularities and fertility problems ..

Detailed Description
-----------------
Bisphenol A is formed from acetone and phenol, it is used in production of epoxy resin, polyster resins and polyvarbonate resins. Epoxy resins are used in plastics, adhesives, and structural composites . Humans are at the end of the food chain, thus they are exposed to the highest doses of these compounds. EDs have been detected in human adipose tissue and biological fluids such as: serum, urine, milk and amniotic fluid . Additionally, it has been proven that BPA can also directly stimulate androgen synthesis in the ovarian theca-interstitial cells. A correlation between increased serum testosterone levels observed in women with PCOS with serum BPA concentrations has also been found .

Official Title
-----------------
Role of Bisphenol A (BPA) in the Pathogenesis of the Polycystic Ovary Syndrome

Conditions
-----------------
PCOS

Intervention / Treatment
-----------------
* Diagnostic Test: Measurement of Bisphenol in urine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age group: 18-40 Females Diagnosed a case of polycystic ovary syndrome Exclusion Criteria: • Female patients with other acute or chronic illness Cardiovascular disease Neoplasms Current smoking, diabetes mellitus, Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm Hg).

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCOS group<br>patients who have PCOS | Diagnostic Test: Measurement of Bisphenol in urine<br>* to see level of this material in blood of women<br>|
| control group<br>patients who donnot have PCOS | Diagnostic Test: Measurement of Bisphenol in urine<br>* to see level of this material in blood of women<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of participants who will have high level of bisphenol in btheir blood |  | within 6 weeks |
Genetic Causes of Discrepant Clinic in Monogenic Twins

Study Overview
=================
Brief Summary
-----------------
In the DISCO-TWIN study (prospective, open-label molecular-genetic study), twin pairs with one healthy and one affected twin with molecularly undiagnosed diseases will be analysed by means of omics technologies and/ or re-analysed using existing datasets. Phenotype and omics data will be shared within the University Hospital Tübingen and with external collaborators to improve the diagnostic rate of the subjects included in the study.

Official Title
-----------------
Genetic Causes of Discrepant Clinic in Monogenic Twins

Conditions
-----------------
Rare Diseases, Genetic Predisposition to Disease

Intervention / Treatment
-----------------
* Genetic: NGS Diagnostic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Twin pair monozygotic clinically (phenotypic) discordant twins Unclear diagnosis Suspected (mono-)genetic cause of the disease in one twin Exclusion Criteria: Missing informed consent of both twin/ legal representative No distinct phenotype
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy twin<br> | Genetic: NGS Diagnostic<br>* Blood take for genetic diagnostic.<br>* Other names: Omics Technology;|
| Effected Twin<br>Twin with unclear rare diseases, clinically characterized in the context of outpatient/ inpatient standard care at the University Hospital Tübingen (UKT) or cooperating location. | Genetic: NGS Diagnostic<br>* Blood take for genetic diagnostic.<br>* Other names: Omics Technology;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new Candidate Genes | Number of new Candidate Genes for complex or serious diseases through a comparative genetic analysis of monozygotic clinically discordant twins | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of putative disease causes | Number characterizations of the identified putative disease causes. | Day 1 | 
| Number of diagnosis | Number of patients receiving appropriate therapy after successful diagnosis | Day 1 | 
| Number of molecular causes of diagnostically unclear rare diseases | Number of molecular causes of diagnostically unclear rare diseases | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rare Diseases, Genetic Predisposition, Omics Technology, Next Generation Sequencing (NGS)
Antioxidants for Prevention of Cataracts Follow-up Study

Study Overview
=================
Brief Summary
-----------------
Aravind Eye Hospital and the University of California, San Francisco (UCSF) Proctor Foundation collaborated on the Antioxidants for the Prevention of Cataract Study from 1997-2002. (1) In the study, 798 participants aged 35-50 years were enrolled from 5 rural villages, and randomized to thrice weekly antioxidants (vitamin C, 500 mg; beta carotene, 15 mg; and alpha-tocopherol, 400 IU) or placebo. After 5 years of supplementation, there was no significant difference in cataract formation between the antioxidant group and placebo. In this follow-up study, we will return to study villages to determine whether rates of cataract surgery are different in the 2 groups. 1. Gritz DC, Srinivasan M, Smith SD, et al. The Antioxidants in Prevention of Cataracts Study: effects of antioxidant supplements on cataract progression in South India. The British journal of ophthalmology 2006;90:847-51.

Official Title
-----------------
Antioxidants for Prevention of Cataracts Follow-up Study

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Dietary Supplement: Antioxidant
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participation in previous cataract study Exclusion Criteria: refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

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

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

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 |
| --- | --- |
| Active Comparator: Antioxidant supplementation<br>Randomized to receive antioxidant supplementation (vitamin C, 500 mg; beta carotene, 15 mg; and alpha-tocopherol, 400 IU) three times per week for five years. | Dietary Supplement: Antioxidant<br> <br> |
| Placebo Comparator: Placebo<br>Randomized to receive placebo three times per week for five years | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cataract surgery | Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model | 15 years post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for cataract surgery | Association of risk factors assessed via questionnaire 15 years ago with cataract surgery in a multiple logistic regression model | 15 years post-intervention | 
| All-cause mortality |  | 15 years post-intervention |
Impact of Prokinetic Use After Emergency Intestinal Anastomosis on Postoperative Clinical Outcomes

Study Overview
=================
Brief Summary
-----------------
Prokinetic drugs used to accelerate healing of intestinal anastomosis of urgent cases which not prepared preoperative by increase intestinal motility and gastric emptying and decrease postoperative adhesions They are many types of prokinetics as cholinergic agonists, dopamine antagonist, serotonergic agonists and macrolides Agents of prokinetics administered immediately post operation and at the time of hospitalization

Detailed Description
-----------------
By evaluation the effect of prokinetic use versus non use after emergency intestinal intestinal anastomosis on short and long term clinical outcome It will be prospective cohort study which conducted in sohag university hospital Study will include patients presented with urgent anastomosis Inclusion criteria: all adults underwent emergency intestinal anastomosis Exclusion criteria: pediatrics, patients with comorbidities and patients with electively resection and anastomosis. Primary goals are to detect effect of prokinetics on incidence of leakage rate Secondary outcomes include early bowel opening, enteral feeding, post operative pain, wound infection and adhesion formation rate.

Official Title
-----------------
Impact of Prokinetic Use After Emergency Intestinal Anastomosis on Short and long_term Clinical Outcome

Conditions
-----------------
Prokinetic Use After Emergency Intestinal Anastomosis

Intervention / Treatment
-----------------
* Drug: Prokinetic Motility Agents as primpiram and gastreg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adult patients Exclusion Criteria: pediatrics patients associated with comorbidities patients with electively resection and anastomosis

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prokinetic use in accelerate healing of urgent intestinal anastomosis<br>Prikinetic agents administered immediately post operative and time of stay at hospital twice daily | Drug: Prokinetic Motility Agents as primpiram and gastreg<br>* Prospective cohort study to evaluate the effect of pro kinetic use in emergency intestinal anastomosis<br>* Other names: Primpiram and gastreg and erythromycin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage rate | Fecal fistula | 5 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early bowel opening | Duration taken to patient to pass feces and flatus | 3 days postoperative |
Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting

Study Overview
=================
Brief Summary
-----------------
patients undergoing carotid stenting take dual anti platelet therapy to prevent thrombotic complications usually used drugs are aspirin plus clopidogrel but there are patients not respond so ticagrelor may be an effective and safe alternative

Official Title
-----------------
Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting

Conditions
-----------------
Carotid Stenosis

Intervention / Treatment
-----------------
* Drug: Ticagrelor
* Drug: Clopidogrel
* Procedure: Carotid stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemis stroke of both sex. More than 18 years. Accepting all study requirements. Exclusion Criteria: Refuse to comply with all study requirements. bleeding tendency or liver diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aspirin + ticagrelor before carotid stenting<br>patients undergoing carotid stenting take aspirin 150 mg + ticagrelor 90mg for 15 days before carotid stenting | Drug: Ticagrelor<br>* Half of patients undergoing carotid stenting take ticagrelor+aspirin<br>Procedure: Carotid stenting<br>* Patients with carotid stenosis will undergo carotid stenting<br>|
| Active Comparator: aspirin + clopidogrel before carotid stenting<br>patients undergoing carotid stenting take aspirin 150 mg + clopidogrel 75 mg for 15 days before carotid stenting | Drug: Clopidogrel<br>* Other half ofpatients undergoing carotid stenting take clopidogrel+aspirin<br>Procedure: Carotid stenting<br>* Patients with carotid stenosis will undergo carotid stenting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare efficacy of ticagrelor and clopidogrel in patients undergoing carotid stenting | patients undergoing carotid stenting are divided into 2 groups comparing efficacy of ticagrelor and clopidogrel | 15 days before carotid stenting | 
| Compare safety of ticagrelor and clopidogrel in patients undergoing carotid stenting | Patients undergoing carotid stenting are divided into two groups comparing safety of ticagrelor and clopidogrel | 15 days before carotid stenting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of carotid stenosis | Incidence of carotid stenosis in patients come to Assiut university hospitals | 1 year |
lncRNA-based Nomogram to Assist Childhood Asthma Diagnosis

Study Overview
=================
Brief Summary
-----------------
Asthma is the most common chronic disease in children, however, underdiagnosis of childhood asthma is an important issue in asthma management. The lack of reliable and objective diagnostic indicators requires the development of rapid and accurate strategies for the early diagnosis of childhood asthma. Recent studies have found a correlation between long-chain non-coding RNA (lncRNA) expression and childhood asthma, suggesting that lncRNA may be a potential biomarker for asthma diagnosis.

Detailed Description
-----------------
The investigators envision exploring the early diagnosis of asthma by combining lncRNA with electronic medical records. In this project, the investigators will combine high-throughput sequencing, asthma case database, electronic medical record and informatics to investigate the feasibility of combining lncRNA with electronic medical record for asthma diagnostic model. The expected results will establish the foundation for the diagnosis and treatment of childhood asthma and open up new ideas.

Official Title
-----------------
LncRNA and Predictive Model to Improve the Early Diagnosis of Childhood Asthma

Conditions
-----------------
Childhood Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with recurrent wheezing Exclusion Criteria: diagnosis of other chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary dysplasia, etc) immunodeficiency- acquired or congenital neuromuscular disease congenital heart disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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 |
| --- | --- |
| It's just an observational study, no interventions<br>children with recurrent wheezing | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of early diagnosis of childhood asthma | a diagnosis of transient wheeze or asthma was made by a pediatric pulmonologist. This classification was based on symptoms, use of asthma medication, and lung function features. | 24 months |