linjc16/ctgov huggingface dataset:
Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Adalimumab is a humanized recombinant monoclonal antibody fragment targeted against tumor necrosis factor. This study will assess the safety and efficacy of intravitreal adalimumab administered in patients with choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with intravitreal ranibizumab.

Official Title
-----------------
Open-label Clinical Trial to Evaluate Safety and Efficacy of Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Non-responders to the Conventional Treatment With Ranibizumab

Conditions
-----------------
Age-Related Macular Degeneration, Choroidal Neovascularization

Intervention / Treatment
-----------------
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with ranibizumab (active choroidal neovascularization after loading phase of one injection per month for three consecutive months, followed by a maintenance phase with 5 injections in the last 12 months or 3 injections in the last 6 months Exclusion Criteria: Only one functional eye Hypersensitivity to adalimumab or any component of the formulation Previous systemic treatment with adalimumab Cancer Life expectancy <1 year

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: Adalimumab<br> | Drug: Adalimumab<br>* Intravitreal adalimumab injection (0,1 ml= 50 mcg) in the eye of the included patients. Patients will be followed up every week for a total of 4 weeks, and after every month until 6 months. If it is necessary, repeat the injection every month, maximum three months<br>* Other names: Humira®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients proportion with electroretinogram alterations |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in retinal thickness measured by ocular coherence tomography |  | once a month to 6 months | 
| Changes in best corrected visual acuity |  | once a month to 6 months | 
| Incidence of adverse events |  | until 6 months |
Body Image Satisfaction In Relation To Body Mass Index And Self- Esteem Among Chinese Female Students

Study Overview
=================
Brief Summary
-----------------
Body image satisfaction and self- esteem level are important to be known among students in order to intervene in a correct time. Body dissatisfaction is one of the factors leading to negative self-perception, low mood, depression, and eating disorders. This may be detrimental to students in their academic performance. However, the correlations of body image satisfaction towards body mass index and self- esteem among university female students are still unclear in Malaysia. Thus, the purpose of this study is to determine its relationships among Chinese female students. university female participants will be included with convenience sampling method. Participants will completed Ronsenberg Self- Esteem Scale and 8 items version of Body Shape Questionnaire. These 2 scales used to measure level of self- esteem and body image satisfaction. Body mass index will be calculated from self- reported height and weight. The data will be analysed by using descriptive and correlation methods.

Official Title
-----------------
Body Image Satisfaction In Relation To Body Mass Index And Self- Esteem Among Chinese Female Students: A Cross Sectional Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and Chinese students Age more or equal than 20 years ( ≥20 ) UTAR students Exclusion Criteria: Male and non-Chinese students Age less than 20 ( <20 ) Non- UTAR students

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ronsenberg Self- Esteem Scale |  | Baseline | 
| body image satisfaction questionnaire |  | Baseline | 
| Body mass index |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Self esteem, Body mass index
Register of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía

Study Overview
=================
Brief Summary
-----------------
Register of treatment of unprotected left main coronary artery stenosis in Andalucia (RETRATO).

Official Title
-----------------
Multicenter, Prospective, Observational Study of of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía

Conditions
-----------------
Unprotected Left Main Coronary Artery Stenosis

Intervention / Treatment
-----------------
* Procedure: Coronary stent procedure (CSP)
* Procedure: Coronary-artery bypass grafting (CABG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New diagnosed of unprotected left main coronary artery stenosis (lesion ≥50%) Have signed informed consent Exclusion Criteria: Participating in other research protocol Inability to follow a monitoring
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Unprotected left main coronary artery stenosis patients<br> | Procedure: Coronary stent procedure (CSP)<br> <br> Procedure: Coronary-artery bypass grafting (CABG)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the MACE survival in the coronary-artery bypass grafting (CABG) group and in the coronary stent procedure (CSP) group, to identify the differences between both groups in the short and medium-term follow up | MACE= Major Adverse Cardiac Event (e.g., acute myocardial infarction, ischaemic stroke, coronary arterial occlusion, death) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary stent procedure (CSP, Coronary-artery bypass grafting (CABG)
Is a Reporting System for Gastritis or Duodenitis (Modified Lanza Scale) Reproducible?

Study Overview
=================
Brief Summary
-----------------
The modified Lanza scale (Lanza FL, 1984) has been widely utilized to grade the degree of gastritis and duodenitis. However, the inter-rater or intra-rater reproducibility of this scale has never been validated. As a quality improvement program, it is important to study the reproducibility of the scale between different operators and the operators himself. Method: During upper endoscopic examinations, one investigator performed the procedure and the second investigator look at the endoscopic image. The degree of gastritis and duodenitis is graded. The results of the grading are blinded to the other investigator. The endoscopic video is stored for reassessment to determine the intra-rater reliability. The patient identifier is stored in serial number. The investigator will not retrieve the report of the first assessment during the second assessment.

Official Title
-----------------
Reproducibility of Modified Lanza Scale for the Reporting of Gastritis and Duodenitis

Conditions
-----------------
Gastritis, Duodenitis

Participation Criteria
=================
Eligibility Criteria
-----------------
All patients undergo upper endoscopy are included after written informed consent is obtained

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 |
| --- | --- | --- |
| Kappa coefficient for the intra and inter-rater agreement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastritis, duodenitis, inter-rater reliability, intra-rater reliablity, gastroscopy, duodenoscopy
A Study to Evaluate the Safety and Effectiveness of a New Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), (+)-Calanolide A, in HIV-Positive Patients Who Have Never Received Anti-HIV Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the safety and effectiveness of a new non-nucleoside reverse transcriptase inhibitor (NNRTI), (+)-calanolide A, in HIV-positive patients who have never received anti-HIV treatment.

Detailed Description
-----------------
Patients are randomized into 2 cohorts, with Cohort 2 receiving a higher dosage than Cohort 1. Patients in each cohort receive either (+)-calanolide A or a placebo for 14 days, followed by a 14-day follow-up period. Following study treatment, patients may elect to receive an open-label, 6-month course of anti-HIV drugs to be selected by and administered under the care of the patient's physician.

Official Title
-----------------
A Phase 1B Dose-Range Study to Evaluate the Safety, Pharmacokinetics, and Effects of (+)-Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Calanolide A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a CD4 count of at least 250 cells/mm3. Have an HIV count (viral load) of at least 5,000 copies/ml. Are at least 18 years old. Exclusion Criteria You will not be eligible for this study if you: Have received prescription or nonprescription medications within 14 days of study entry, or if you will need to take any of these medications during the study. Have ever received anti-HIV medications. Test positive for hepatitis B. Have received a blood (or red blood cell) transfusion within 3 months prior to study entry. Have severe diarrhea. Have severe heart, liver, kidney, or neurological (brain and spinal cord) disease. Have hemophilia or another blood disorder. Have received certain medications or vaccines within 30 days prior to study entry. Have received chemotherapy or radiation within 16 days prior to study entry, or if you will need either of these during 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?
-----------------

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Calanolide A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-HIV Agents
Dehydroepiandrosterone Supplementation for Poor Responder Patients During in Vitro Fertilization Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the effect of dehydroepiandrosterone supplementation on in vitro fertilization performance and outcome among poor-responder patient.

Conditions
-----------------
Ovarian Stimulation

Intervention / Treatment
-----------------
* Drug: dehydroepiandrosterone crystalline fine powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous poor response to ovarian stimulation in IVF. Exclusion Criteria: patients over the age of 42 patients who received DHEA at any time.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHEA supplementation<br>DHEA was added to induction of ovulation by recombinant FSH and recombinant LH, in IVF long protocol | Drug: dehydroepiandrosterone crystalline fine powder<br> <br> |
| No Intervention: only induction of ovulation by same long protocol without DHEA<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak estradiol level. |  |  | 
| number of retrieved oocytes. |  |  | 
| Embryos that were graded as a top quality (according to the number of cells and percent of fragmentation) |  |  | 
| number of embryos reserved for transfer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate. |  |  | 
| live birth rate. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dehydroepiandrosterone, DHEA, IVF outcome, long protocol IVF, poor-responder, recombinant LH, embryo quality, pregnancy rate, live birth rate, poor response to ovarian stimulation
3D Echocardiography and Cardiovascular Prognosis in Mitral Regurgitation

Study Overview
=================
Brief Summary
-----------------
The 3D-PRIME study will analyse whether use of 3D echocardiography can improve risk stratification and cardiovascular outcome in patients with mitral regurgitation of different etiologies.

Official Title
-----------------
3D Echocardiography and Cardiovascular PRognosis In Mitral REgurgitation (3D-PRIME)

Conditions
-----------------
Mitral Regurgitation

Intervention / Treatment
-----------------
* Diagnostic Test: Use of 3D echocardiography in patient follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with primary or secondary mitral regurgitation (MR) MR of moderate or severe degree 3D echocardiographic examinations of >= good spatial and temporal resolution Exclusion Criteria: Co-existence of another valve disease of severe degree Inability to give 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary mitral regurgitation<br>Patients with mitral regurgitation due to mitral valve disease | Diagnostic Test: Use of 3D echocardiography in patient follow-up<br>* Patients will undergo clinical and echocardiographic examination including detailed 3D echocardiography at study inclusion and at least one follow-up visit.<br>|
| Secondary mitral regurgitation<br>Patients with mitral regurgitation due to ventricular or atrial disease | Diagnostic Test: Use of 3D echocardiography in patient follow-up<br>* Patients will undergo clinical and echocardiographic examination including detailed 3D echocardiography at study inclusion and at least one follow-up visit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiovascular event | Death, mitral valve intervention, heart failure hospitalization | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 24 months | 
| Cardiovascular death |  | 24 months | 
| Mitral valve intervention |  | 24 months |
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy Japanese young male and elderly subjects.To provide the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy Japanese young male and elderly subjects.

Official Title
-----------------
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Young Male and Elderly Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: SAM-531


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Men aged 20 to 45 years, inclusive, at screening. Elderly men or women aged 65 years and above as of screening. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg. Exclusion critereia Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of normal at screening. Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before study day 1 until the end of the inpatient confinement period.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>SAM 531 + placebo | Drug: SAM-531<br>* Multiple ascending doses of SAM 531: 1,5; 3 and 5 mg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics and pharmacodynamics |  | 9 months |
Warm Contrast Media for Pain Reduction During Hystersalpingography

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare between body-temperature to room-temperature contrast media used during hysterosalpingography. We hypothesize that warmed medium will reduce pain associated with the procedure.

Detailed Description
-----------------
Infertility occurs in about 15% of all couples. One of the common methods for evaluation of mechanical infertility is hysterosalpingography (HSG). Several reports have shown that this common procedure is associated with moderate pain, i.e. around 5 on a visual analog scale (VAS)of 1-10. It is therefore important to find modes for pain reduction for HSG. According to a report on sonohydrosonograpy, a similar technique using sonography, insertion of media warmed to body temperature into the uterus significantly reduced the pain during the procedure compared with media at room-temprature. The use of room-temperature media is the routine in our institution, as well as in many others. A comparison between the media at different temperatures has not been reported so far. We plan to perform a prospective trial in which patients referred for HSG will be randomized to the procedure using either warmed or room-temperature media. we will asses pain levels using VAS during the procedure.

Official Title
-----------------
Prospective Randomised Controlled Trian of Warmed vs. Room Temperature Contrast Media for Hystersalpingography

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

Intervention / Treatment
-----------------
* Procedure: Temperature of contrast medium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis: infertility sex: female age: 18-45 Exclusion Criteria: active pelvic inflammotory disease known sensitivity to contrast medium

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Temperature of contrast medium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hysterosalpingogram, mechanical infertility, hysterosalpingography