linjc16/ctgov huggingface dataset:
Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia

Study Overview
=================
Brief Summary
-----------------
To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.

Official Title
-----------------
A 4-Weeks Treatment, Randomised, Double-Blind, Parallel-Group Study Evaluating The Efficacy and Safety of JTT-705 300 to 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia

Conditions
-----------------
Type II Hyperlipidaemia

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: JTT-705 300mg
* Drug: JTT-705 600mg
* Drug: JTT-705 900mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with of Type II hyperlipidaemia Patients having lipid values as indicated below: HDL-C < 1.6 mmol/l TG < 4.5 mmol/l Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception) Exclusion Criteria: Body Mass Index (BMI) > 35 kg/m² Pregnant, breast feeding, or woman with child bearing potential without an effective method of contraception Concomitant use of medications identified in the protocol

Ages Eligible for Study
-----------------
Minimum Age: 22 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br>* Placebo tablet, 3 tablets, oral, once daily after breakfast<br>|
| Experimental: 2<br>JTT-705 300mg | Drug: JTT-705 300mg<br>* JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast.<br>|
| Experimental: 3<br>JTT-705 600mg | Drug: JTT-705 600mg<br>* JTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast<br>|
| Experimental: 4<br>JTT-705 900mg | Drug: JTT-705 900mg<br>* JTT-705 tablet, 3 tablets, oral, once daily, after breakfast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %change from baseline in HDL-C, Inhibition of CETP activity |  | 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %change from baseline in LDL-C and TC/HDL ratio |  | 4-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CETP Inhibitor, HDL-C, LDL-C, Apolipoprotein
Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that both lack and excess of growth hormone (GH) is associated with cardiac abnormalities. Cardiac function and morphology will be evaluated by MRI before and after treatment.

Detailed Description
-----------------
It is an open prospective noninterventional clinical study. Treatment and follow-up will be according to usual guidelines, and will be unaffected by inclusion in the study. GHD patients will be treated with daily subcutaneous GH injections. Patients with acromegaly will be treated with either transsphenoidal surgery or by medical treatment with long acting somatostatin analogues, dopamine agonist, GH antagonist or combinations of these treatment modalities. Patients will be examined by Cardiac MRI before treatment and after one year of treatment.

Official Title
-----------------
Impact of Growth Hormone on Serum N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) and on Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly

Conditions
-----------------
Growth Hormone Deficiency, Cardiac Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peak GH below 6.0 ng/mL during Pyridostigmine-GHRH test. Nadir GH above 0.4 ng/mL and elevated levels of IGF-I during oral glucose tolerance test Exclusion Criteria: Contraindications for magnetic resonance scan

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GH<br>Patients with GHD | |
| Pegvisomant and Somatostatin analogues<br>Acromegaly | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiac function i relation to changes in the activity of the GH-axis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The GH-system and cardiac function
Automated Breast Ultrasound Screening

Study Overview
=================
Brief Summary
-----------------
Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. The study evaluates prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when BIRADS category 3 lesions are given a 1 year follow-up recommendation.

Detailed Description
-----------------
Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. If the women agrees to participate and sign informed consent she undergoes an automated whole breast scan. The scan is interpreted independent of the mammogram. Scans are assigned a BIRADS category score of 1, 2, 3,or 0. BIRADS category 3 lesions are reported as no evidence of malignancy and a 1 year follow-up is recommended. BIRADS category 0 lesions are requested to have a hand held ultrasound including elastography. Follow up is then determined by BIRADS score and elastography results of hand held ultrasound. The study evaluates prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when BIRADS category 3 lesions are given a 1 year follow-up recommendation.

Official Title
-----------------
Automated Breast Ultrasound Screening in Women With Dense Breasts (BIRADS 3 or 4) and BIRADS Category 1 or 2 Mammogram Assigning BIRADS 3 Lesions to Yearly Follow-up

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

Intervention / Treatment
-----------------
* Procedure: Breast ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women age >18 scheduled for routine screening mammogram. Women with Density 3 or 4 and BIRADS category 1 or mammogram are asked to participate in study Exclusion Criteria: Inability to give informed consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Breast ultrasound|automated whole breast ultrasound|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased recall rate for screening breast ultrasound while maintaining cancer detection rate |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased positive biopsy rate |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Automated whole breast ultrasound, BI-RADS category 3 lesions
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.

Official Title
-----------------
A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants

Conditions
-----------------
Pneumococcal Infection

Intervention / Treatment
-----------------
* Biological: 13-valent Pneumococcal Conjugate Vaccine
* Biological: 13-valent Pneumococcal Conjugate Vaccine
* Biological: 13-valent Pneumococcal Conjugate Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at the time of enrollment is: 18 through 55 years (before the fifty sixth birthday) for Group 1. 3 through 5 years (before the sixth birthday) for Group 2. 42 to 98 days for Group 3. Healthy subject as determined by medical history, physical examination, and judgment of the investigator. Exclusion Criteria: Previous vaccination with licensed or investigational pneumococcal vaccine. Previous anaphylactic reaction to any vaccine or vaccine-related component. Contraindication to vaccination with pneumococcal vaccine.

Ages Eligible for Study
-----------------
Minimum Age: 42 Days
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Adults aged 18 through 55 years (before the fifty sixth birthday) | Biological: 13-valent Pneumococcal Conjugate Vaccine<br>* suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose<br>|
| Experimental: Group 2<br>Children aged 3 through 5 years (before the sixth birthday) | Biological: 13-valent Pneumococcal Conjugate Vaccine<br>* suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose<br>|
| Experimental: Group 3<br>Infants aged approximately 2 months (42 to 98 days) | Biological: 13-valent Pneumococcal Conjugate Vaccine<br>* suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting Adverse Events |  | Baseline to Month 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
13vPnC, Healthy subjects, China
Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

Study Overview
=================
Brief Summary
-----------------
Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no molecular markers for this physiopathological connection have been identified. This project aims to determine non-invasive biomarkers that may allow better comprehension of the metabolic consequences of OSAS, as well as assess the effect of Continuous positive airway pressure (CPAP) on these metabolic parameters. This project will integrate the clinical, metabolic, genetic/proteomic and biologic systems to further explore the mechanisms behind OSAS, as well as the effect of the treatment with CPAP.

Official Title
-----------------
Obstructive Sleep Apnoea and Associated Metabolic/Cardiovascular Disorders: Understanding Mechanisms Towards Early Diagnosis and Prognosis

Conditions
-----------------
Obstructive Sleep Apnoea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 25-60 years Mild/Moderate/Severe OSAS Exclusion Criteria: Female Other sleep disorders Previous CPAP therapy Type 1 diabetes mellitus Familiar Dyslipidemia Severe organ pathology Acute disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CPAP<br>Patients with moderate/severe OSAS will be treated with CPAP | |
| Control<br>Patients with snoring will not be subject to treatment with CPAP | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with clinical improvement | Treatment efficacy of CPAP will be assessed at the end of treatment through a clinical observation. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of occurence of biomarkers | Using Mass Spectrometric Immunoassay, we will identify which biomarkers have a positive association with long-term treatment effect. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NOVA MEDICAL SCHOOL, CPAP, OSAS, CEDOC (Centro de Estudos de Doenças Crónicas), FCM (Faculdade de Ciências Médicas), UNL (Universidade Nova de Lisboa, FCT (Fundação para a Ciência e Tecnologia)
Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable.

Detailed Description
-----------------
Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population. Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL.

Official Title
-----------------
Weekly Bendamustine and Bortezomib Combination Therapy in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or B-CLL: A Single-Center Phase 2 Study

Conditions
-----------------
Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Drug: Bendamustine
* Drug: Bortezomib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic recurrent or refractory indolent NHL or B-CLL Adequate organ and bone marrow function Karnofsky greater than 50% Exclusion Criteria: Candidates for autologous stem cell transplantation Secondary high grade lymphoma Concurrent severe medical condition

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bendamustine and Bortezomib<br>Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section | Drug: Bendamustine<br>* starting with 60 mg/m^ 2, IV, dose escalation, weekly d1,8,15 q5w<br>* Other names: Ribomustin, SDX-105;Drug: Bortezomib<br>* weekly 1.5mg/m^2, IV, d1,8,15,22 q5w<br>* Other names: Velcade;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal Bendamustine Dosage for Further Studies |  | Three weeks after treatment termination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Non-Hodgkin, Low-Grade
Dexmedetomidine Versus Hyalase Treatment of Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline versus dexmedetomidine upon the median nerve could offer symptoms and clinical improvement

Detailed Description
-----------------
Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.

Official Title
-----------------
Dexmedetomidine Versus Hyalase Local Injection for Pain Alleviation in Patients With Carpal Tunnel Syndrome; A Randomized Clinical Trial

Conditions
-----------------
Carpal Tunnel Syndrome, Pain, Chronic

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Hyalase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients complaining of carpal tunnel syndrome of 3 month duration or more diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study Exclusion Criteria: • patient refusal infection at the site of intervention local anesthetic allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Dexmeditomidine group<br>injection of 1 microgram/kg dexmedetomidine + 10 cc saline injection nearby median nerve as hydrodissection | Drug: Dexmedetomidine<br>* injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydrodissection<br>|
| Active Comparator: Hyalase<br>injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection | Drug: Hyalase<br>* injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain alleviation | pain alleviation improvement of pain measured by visual analog scale , no pain the scale equal zero , and worst pain the scale equal 10 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median nerve cross sectional area | Changes in ultrasound imaging change of cross sectional area in cubic mellimeter | 6 months |
Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities

Study Overview
=================
Brief Summary
-----------------
Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25 dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone metabolism and also bone morrow, muscle, heart and immune system. For a long time, maternal low vitamin D level is a well known problem for our country and the level was reported as <10 ng/ml for 46-80% of mothers.The most prominent risk factor was determined as low socioeconomic status. Therefore, the level of 25-hydroxy-vitamin D is supposed to be in relation with several neonatal morbidities and maternal complications of pregnancy.

Conditions
-----------------
Neonatal Hypocalcemia, Neonatal Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term or preterm newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital Exclusion Criteria: Preterm babies born before the 24. gestational week Babies with complex cardiac anomalies and/or dysmorphic features

Ages Eligible for Study
-----------------
Maximum Age: 30 Minutes

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 |
| --- | --- | --- |
| sepsis |  | 3 months but patients will be followed until discharge | 
| feeding intolerance |  | 3 months but patients will be followed until discharge | 
| hypocalcemia |  | 3 months but patients will be followed until discharge | 
| bronchopulmonary dysplasia |  | 3 months but patients will be followed until discharge | 
| patent ductus arteriosis |  | 3 months but patients will be followed until discharge | 
| retinopathy of prematurity |  | 3 months but patients will be followed until discharge | 
| maternal complications of pregnancy |  | from the beginning of gestation until birth process | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rachitism |  | 4 months but patients will be followed until discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, cord blood, neonatal sepsis, neonatal morbidity