linjc16/ctgov huggingface dataset:
CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma

Detailed Description
-----------------
This study will be a phase 4 open label interventional case series. Patients with retinoblastoma will be receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive chemotherapy on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 18 months .

Official Title
-----------------
CEV With/Without Periocular Carboplatin Chemotherapy for Nonmetastatic Extraocular Retinoblastoma Carboplatin--A Single Center, Retrospective Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Drug: carboplatin periocular injection
* Drug: CEV chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IRSS stage II or stage IIIa RB patients. for patients with IRSS stage II disease, if scleral surface invasion alone was observed, only systemic chemotherapy was administered, whereas other IRSS stage II and IIIa patients received systemic chemotherapy plus additional local chemotherapy. no tumor-related treatment was given prior to this chemotherapy regimen. Exclusion Criteria: metastasis, including lymph node metastasis. the diagnosis of IRSS stage I or above in the non-target eye.
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: CEV with/without carboplatin<br>CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection | Drug: carboplatin periocular injection<br>* chemotherapy together with/without 20mg/2ml carboplatin periocular injection<br>* Other names: carboplatin;Drug: CEV chemotherapy<br>* vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2<br>* Other names: carboplatin,vincristine, etoposide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free Survival Rate | measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinoblastoma, carboplatin
Effect of Fasting on Ghrelin and Growth Hormone in Healthy Young and Older Adults

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to determine the extent to which circulating ghrelin levels (total and bioactive ghrelin) are regulated by nutritional state and age.

Detailed Description
-----------------
Normal volunteers: young and older men and women studied under fed and fasting (total 62.5h) conditions, frequent blood sampling for ghrelin and other related hormones

Official Title
-----------------
Effect of Fasting on Ghrelin and Growth Hormone in Healthy Young and Older Adults

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Other: Fasting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy young (ages 18-30) and older (ages > 60) men and women with a body mass index (BMI) of <35 kg/m2. Young and older subjects will be matched for BMI. Exclusion Criteria: A history of coronary artery disease, congestive heart failure, peripheral vascular disease, diabetes mellitus, significant hypertension (BP >180 systolic or >100 diastolic at rest); renal, hepatic, pulmonary disease; untreated hypothyroidism, untreated hyperthyroidism; history of seizure disorder; history of malignancy (other than some skin cancers), history of active chronic infections (e.g., HIV, tuberculosis): abnormal screening laboratory tests. This information will be obtained through the use of screening labs, history and physical exam and the medical record. See the GCRC protocol for details of the labs. Hematocrit < 41% men, < 38% women History of daily tobacco use within past 3 months Chronic alcohol abuse Recent weight change of > 10 pounds in last 3 months Strenuous exercise for average of more than 60 min/day Investigational drug within past 6 weeks Any history of major psychosis, severe depression, anorexia nervosa Transmeridian travel within 2 weeks prior to or during study -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| normal men and women<br>normal volunteers: young and older men and women studied under fed and fasting (62.5h) conditions with frequent blood sampling for ghrelin and related hormones | Other: Fasting<br>* normal volunteers fast from food on one occasion for 62.5 h; on another occasion fed 3 meals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ghrelin concentration |  | 24-h mean | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ghrelin, growth hormone, aging, normal volunteers
Grazax Asthma Prevention

Study Overview
=================
Brief Summary
-----------------
Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with grass pollen allergy

Detailed Description
-----------------
Investigation of the effect of Grazax (ALK produced grass tablet) on asthma prevention in children with grass pollen allergy. Children in the age of 6-12 years will be randomised to either placebo or Grazax treatment. Grazax has been approved for treatment of grass pollen allergy in adults and children, diagnosed with a positive skin prick test and/or specific immunoglobulin (IgE) test to grass pollen and with clinically relevant symptoms. This study will explore prevention of asthma in children with grass pollen induced allergy.

Official Title
-----------------
Grazax Asthma Prevention

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Grazax
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A history of grass pollen allergy Positive Skin prick test to grass Positive specific IgE to grass Exclusion Criteria: Asthma

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Grazax<br>Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue. | Drug: Grazax<br>* Treatment with 75.000 SQ-T once daily<br>|
| Placebo Comparator: Tablet with no active grass<br>Tablet with no active grass component. One tablet per day administered under the tongue. | Drug: Placebo<br>* Tablet with no active grass component.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of allergy and asthma symptoms |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and adverse events |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rhinitis, allergic, Seasonal, grass, Asthma
Endotoxin Challenge Study For Healthy Men and Women

Study Overview
=================
Brief Summary
-----------------
The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support GSK256066 dose selection for future studies in COPD patients.

Official Title
-----------------
A Double Blind, Placebo Controlled, Repeat Dose Study to Compare the Effectiveness of Two Doses of GSK256066 With Placebo in Reducing Lung Inflammation Following Segmental LPS Challenge in Healthy Volunteers

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: GSK256066
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females (contraception restrictions), 18-50yrs, BMI 19-31kg/m2, Non-smokers, FEV1 >/= 80% predicted Exclusion Criteria: Abnormal troponin and/or CK MB, Participated in any GSK study involving the administration of COA for >/= 21 days.

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects receiving GSK256066<br>Eligible subjects will be randomized to receive GSK256066 with inhaled doses of 25 micrograms or 87.5 micrograms once daily for 7 days, administered via an ACCUHALER. | Drug: GSK256066<br>* GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.<br>|
| Placebo Comparator: Subjects receiving placebo<br>Eligible subjects will be randomized to receive placebo for 7 days, administered via an ACCUHALER. | Drug: Placebo<br>* Subjects will receive placebo inhaler.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute BAL neutrophils at 24 h post LPS exposure The total and differential cell count (absolute and percentage cell counts) in BAL at 24 h post LPS exposure |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs, ECG, FEV1, Serum concentration of protein inflammatory biomarkers, BAL concentrations of protein inflammatory biomarkers BAL concentrations of GSK256066, Day 1,Day 7&DAY 8 |  | Day 1,Day 7&DAY 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LPS challenge,, Healthy volunteers
Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis

Study Overview
=================
Brief Summary
-----------------
Purpose To compare the performance of the two currently employed urinary acidifications tests in stone formers, the furosemide/fludrocortisone and ammonium chloride loading test. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on urinary acidification in stone formers.

Official Title
-----------------
Comparison of Furosemide/Fludrocortisone With Ammonium Chloride Loading Test in the Diagnosis of Incomplete dRTA in Kidney Stone Formers

Conditions
-----------------
Acidosis, Renal Tubular, Nephrolithiasis, Vacuolar Proton-Translocating ATPases

Intervention / Treatment
-----------------
* Drug: Furosemide-Fludrocortisone-Test (test for urinary acidification)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One or more episodes of nephrolithiasis Exclusion Criteria: Absence of informed consent All conditions affecting renal acidification Pregnancy Nursing

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All study participants<br>Furosemide-Fludrocortisone-Test and Ammonium chloride-Loading Test will be performed in renal stone patients. | Drug: Furosemide-Fludrocortisone-Test (test for urinary acidification)<br>* The presence of a lack of urinary acidification will be assessed by an appropriate test in all patients.<br>* Other names: Application of Furosemide (Lasix® ) and Fludrocortisone (Florinef®);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capability of urinary acidification |  | Five to six hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polymorphisms in the ATP6V1 gene |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal tubular acidosis, V-ATPase, kidney stones
A Study on the Effect of Mepolizumab Therapy on Daily Physical Activity of Patients With Severe Eosinophilic Asthma

Study Overview
=================
Brief Summary
-----------------
Daily physical activity in adult patients with asthma remains overlooked. Limited evidence demonstrates reduced levels of daily physical activity in asthma populations but studies examining the potential effect of available therapies are missing. This study aims to investigate the overall levels of daily physical activity in patients with severe eosinophilic asthma and whether anti-interleukin-5 therapy with mepolizumab, on top of existing, maximal, and optimised asthma treatment, may improve patient's daily physical activity.

Detailed Description
-----------------
A multi-centre, prospective, observational study of continuous patients who fulfil the definition of severe asthma and the criteria for mepolizumab (nucala; GSK) therapy. Patients have their daily physical activity recorded using triaxial accelerometry (DynaPort MoveMonitor; McRoberts) prior to treatment, and at 6 and 12 months of mepolizumab therapy (100 mg subcutaneously once every 4 weeks).

Official Title
-----------------
A Prospective Observational Study on the Effect of Mepolizumab add-on Therapy on Daily Physical Activity in Patients With Severe Eosinophilic Asthma

Conditions
-----------------
Severe Eosinophilic Asthma

Intervention / Treatment
-----------------
* Drug: Mepolizumab 100 MG Injection [Nucala]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe asthma Criteria for mepolizumab therapy: blood eosinophils ≥150 cells/μL at screening or ≥300 cells/μL in the past 12 months. Exclusion Criteria: Comorbidities limiting physical activity

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mepolizumab 100 MG Injection [Nucala]|100 milligrams subcutaneously once every 4 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily moving time | Moving time in minutes | 7 days | 
| Change in daily movement intensity | Movement intensity in m/s^2 | 7 days | 
| Change in daily time in moderate-to-vigorous-intensity activity | Time in moderate-to-vigorous-intensity activity in minutes | 7 days | 
| Change in daily steps | Step count | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
severe asthma, biologic therapy, physical activity monitoring
Genome Sequencing in Refractory Breast Cancer to Molecular Targeted Therapy and Young Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate and analyse genomic profiles in patient with breast cancer who failed standard treatment, refractory and young breast cancer.

Detailed Description
-----------------
The hypothesis is that genomic profiling measured by CancerSCAN, cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be helpful to find out tolerance for chemotherapy and innovate new therapeutic strategies.

Official Title
-----------------
Genome Sequencing in Refractory Breast Cancer to Molecular Targeted Therapy and Young Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed breast cancer that is either metastatic or young breast cancer(≤ 40 years of age). HER2 positive patient who failed HER2 target therapy including trastuzumab with feasible biopsy site. Triple Negative Breast Cancer patient who failed standard therapy with feasible biopsy site. Hormone Receptor positive patient who failed standard therapy with feasible biopsy site. Age ≥ 21 years Written informed consent Exclusion Criteria: No feasible biopsy site No written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Metastatic Breast Cancer, Young Breast Cancer<br>Patients with feasible biopsy site. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Mutated Genes and/or Abnormal Gene expression and/or Different Immune signature That Affect to Treatment Outcome. |  | 1 year |
Anterior Tibial Subluxation in the Setting of ACL-injury and After ACL Reconstruction

Study Overview
=================
Brief Summary
-----------------
To identify the related factors for anterior tibial subluxation (ATS) on anterior cruciate ligament-injured MRI images.

Detailed Description
-----------------
Demographic data and MRI images of anterior cruciate ligament-injured patients were retrospectively analyzed. Anterior tibial subluxation was measured and factors were examined via univariate and multivariate analysis.

Official Title
-----------------
A Retrospective Study of Anterior Tibial Subluxation in the Setting of Anterior Cruciate Ligament Injury and After Anterior Cruciate Ligament Reconstruction

Conditions
-----------------
Anterior Cruciate Ligament Injuries

Intervention / Treatment
-----------------
* Other: Demographic data and MRI images were extracted and analyzed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed anterior cruciate ligament injuries Available preoperative MRI images at our hospital Exclusion Criteria: Patients were excluded in the case of under 18 years of age Bilateral anterior cruciate ligament injuries Concomitant posterior cruciate ligament injuries Concomitant collateral ligament injuries No access to the preoperative MRI scan at our hospital

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 |
| --- | --- |
| Group 1<br>Anterior cruciate ligament-injured patients | Other: Demographic data and MRI images were extracted and analyzed<br>* Demographic data and MRI images were extracted and analyzed. Related factors for anterior tibial subluxation were examined in anterior cruciate ligament-injured patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior tibial subluxation | Anterior tibial subluxation was measured preoperatively. | Preoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anterior tibial subluxation
Effects of Remimazolam on Quality of Recovery After Ambulatory Surgery

Study Overview
=================
Brief Summary
-----------------
Remimazolam is a novel ultra-short acting benzodiazepine with rapid onset of effects, short maintenance and faster recovery time. Due to its recent development, few studies have investigated the effect of remimazolam on postoperative recovery mainly focusing on physiologic endpoints, recovery time and possible adverse events. Although these parameters are crucial and need evaluation, the investigators ignore quality of recovery from participant's perspective. For this purpose, various measurment tools have been developed for psychometric evaluation of QoR score.

Detailed Description
-----------------
To date, there has not been a study investigating the impact of remimazolam on quality of recovery (QoR). This study evaluates the effect of remimazolam on QoR of participants undergoing general anesthesia using remimazolam-remifentanil total intravenous anesthesia (TIVA) for hysteroscopy as day surgery basis. Herein, the investigators used the translated Korean version of the 15-item Quality of Recovery-15 (QoR-15K) questionnaire, which was previously validated in Korean surgical participants.

Official Title
-----------------
Effects of Remimazolam Combined With Remifentanil on Quality of Recovery After Ambulatory Hysteroscopic Surgery: a Prospective, Observational Study

Conditions
-----------------
Day Surgery, Patient Outcome Assessment, Quality of Recovery, Remimazolam

Intervention / Treatment
-----------------
* Drug: Remimazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult woman scheduled for ambulatory gynecological surgery under general anesthesia American Society of Anesthesiology grade 1 or 2 Exclusion Criteria: Underlying diseases: liver, kidney, brain nervous system, glaucoma Patients with BMI greater than 30 and less than 18.5 Patients diagnosed with sleep apnea Alcohol or drug dependent patients Patients with severe or acute respiratory failure Lactose intolerance Dextran 40 hypersensitivity Patients in shock or coma

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Remimazolam|Effects of remimazolam on quality of recovery scores after ambulatory hysteroscopic surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery | the translated Korean version of 15-item Quality of Recovery scale (QoR-15K) | 24 hours after ambulatory hysteroscopic surgery |