linjc16/ctgov huggingface dataset:
DPP4 Inhibitor and Coronary Atherosclerosis in Patients Receiving Insulin Therapy

Study Overview
=================
Brief Summary
-----------------
The study aim is to evaluate whether DPP4-inhibitor could reduce coronary atherosclerosis assessed by CT scan in patients receiving insulin for diabetes mellitus. In this retrospective study, changes in obstructive coronary artery disease prevalence and coronary calcium burden between two coronary CT scans will be compared in patients with and without receiving DPP4-inhibitor.

Detailed Description
-----------------
This is a retrospective study using medical records in two hospitals affiliated to the Catholic University of Korea. Patients with diabetes mellitus who received insulin are retrospectively enrolled. Among those, only patients who underwent coronary CT scan for more than two times will be included. Included patients will be classified into DPP4-inhibitor group and no DPP4-inhibitor group according to the prescribed medication. The changes in obstructive coronary artery disease prevalence and coronary calcium score per one year will be compared between the two groups.

Official Title
-----------------
Effect of DPP4 Inhibitors on Coronary Atherosclerosis in Patients With Diabetes Mellitus on Insulin Therapy

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: DPP4-inhibitor
* Drug: No DPP4-inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus Receiving chronic insulin therapy (prescription of insulin pen) Who underwent more than 2 times of coronary CT scan Exclusion Criteria: Age <18

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DPP4-inhibitor<br>Patients who were prescribed DPP4-inhibitor during the period between two coronary CT scan. | Drug: DPP4-inhibitor<br>* Prescription of DPP4-inhibitor during the period between the two coronary CT scan<br>|
| No DPP4-inhibitor<br>Patients who were not prescribed DPP4-inhibitor during the period between two coronary CT scan. | Drug: No DPP4-inhibitor<br>* No prescription of DPP4-inhibitor during the period between the two coronary CT scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of obstructive coronary disease | Change in the prevalence of obstructive coronary disease, defined as >50 percent stenosis in coronary CT scan | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in coronary calcium score | Change in coronary calcium score, measured by two coronary CT scan per one year. Agatston score has minumum value of 0 and no maximum vavlue. Higher agatston score indicated severe calcification and worse outcome | one year |
Chronic Migraine Epidemiology and Outcomes Study

Study Overview
=================
Brief Summary
-----------------
This is a population internet-based study to characterize migraine clinical course and impact on family.

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Other: No Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of migraine U.S. Member of Survey Panel Household member of study participant Ability to complete internet-based questionnaires Exclusion Criteria: No access to internet
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Migraines<br>Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study. | Other: No Treatment<br>* No Treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) | EM is defined as <15 headache days/month and CM is defined as ≥15 headache days/month. | Baseline | 
| Migraine Disability Assessment (MIDAS) | The Midas score is a patient completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. The Midas scores assessed at Months 3, 6, 9 and 12 were averaged. | 12 Months |
Efficacy of Prolonged GnRH Test in Male Adolescents With Postoperative HH

Study Overview
=================
Brief Summary
-----------------
The Hypogonadotropic Hypogonadism(HH) could be caused by sellar lesions, sellar surgery or sellar radiotherapy. The incidence of HH after sellar surgery was higher in men than in women, and the therapy of HH was insufficient. Gonadotropin-releasing hormone(GnRH) stimulation test is used to evaluate the function of pituitary-gonadal axis. GnRH can be used to diagnose and treat fertility disorders and other endocrine disorders caused by HH. After a single injection of GnRH, the patients with poor response of luteinizing hormone and follicle stimulating hormone need to take extended provocation test, which is conducive to the formulation of the following treatment. GnRH pump can pulse subcutaneous injection of gonadorelin, which can be used as the extended provocation test.

Official Title
-----------------
Efficacy of Prolonged Gonadorelin Stimulation Test in Male Adolescents With Postoperative Hypogonadotropic Hypogonadism

Conditions
-----------------
Hypogonadotropic Hypogonadism

Intervention / Treatment
-----------------
* Drug: Gonadorelin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with HH after surgery of the saddle area sufficient therapy of the hypothalamic-pituitary-adrenal(HPA) and hypothalamic-pituitary-thyroid(HPT) axis Exclusion Criteria: contradictions to gonadorelin androgen-dependent prostate cancer on the therapy of human chorionic gonadotropin(HCG) or testosterone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subcutaneous injection of gonadorelin is facilitated by GnRH pump<br>After non-dose GnRH stimulation test on day 1, GnRH pump pulse subcutaneous injection of gonadorelin on the next day until one month. | Drug: Gonadorelin<br>* GnRH pump pulse subcutaneous injection of gonadorelin in a month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of luteinizing hormone, follicle stimulating hormone and testosterone | after the GnRH pump of gonadorelin, the level of luteinizing hormone, follicle stimulating hormone and testosterone will be measured at 24h, 1, 2, 3 and 4 week | 1 month |
Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.

Study Overview
=================
Brief Summary
-----------------
The purpose of this long-term study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatmentof dysmenorrhea associated with endometriosis.

Official Title
-----------------
Phase3,Open-label,Long-term,NSAID-Add-on,Clinical Trial of Mono-phase Low-dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Drug: Norethindrone,Ethinyl Estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dysmenorrhea associated with endometriosis Exclusion Criteria: severe hepatopathy pregnant woman

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Norethindrone,Ethinyl Estradiol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Eval EarlySense Bet Lowenstein Sleeplab

Study Overview
=================
Brief Summary
-----------------
The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Detailed Description
-----------------
EarlySense sensors will be placed under the mattress of subjects who have been included in the study. The sensors will not be in any contact with the patient. Two sensors will be utilized and placed under the subject's chest and pelvis area. Accuracy of the sensors will be compared to each other and to the reference device.

Official Title
-----------------
Evaluation of EarlySense - a Contact-less Heart and Respiration Rate Monitor in Hospitalized Patients

Conditions
-----------------
Obese, Sleep Apnea, Obstructive, Central Apnea, Sleep Disorders, Poor Quality Sleep

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or above Is willing to sign the consent form Exclusion Criteria: Age < 18 years Is not willing to sign the consent form

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 |
| --- | --- |
| sleeplab<br>Sleep Lab examined, usualy with some obesity or sleeping disorders. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab | the measurements from the EarlySense System will be compared with the Gold standard equipment that is being used in the sleep Lab | up to 12 hours |
Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and Neck

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.

Detailed Description
-----------------
Data collection will be obtained from the patient's medical records including initial evaluation, radiotherapy completion records and follow-up.

Official Title
-----------------
A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck

Conditions
-----------------
Central Nervous System Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Estimated >5 cc of the brain tissue to receive >5 CGE radiation Patient must be less than 21 years of age at time of consent. Patients that require localized and craniospinal irradiation. Patients and/or patient parent must complete baseline Quality of Life Questionnaire as applicable by patient age group. Exclusion Criteria: Prior radiation therapy. Evidence of metastases outside the central nervous system.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 20 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 |
| --- | --- |
| Observation and quality of life<br>Central Nervous System Tumors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure late effects of proton therapy on pediatric patients with CNS tumors |  | 5.4 years after treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival endpoints of local control, progression-free survival, and overall and cause-specific survival. |  | 12 years after treatment completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proton Radiation, Central Nervous System (CNS) Tumors, Brain, Spine, Cancer, Radiation Therapy (RT)
A Study of TQ-B3525 on Tolerance and Pharmacokinetics

Study Overview
=================
Brief Summary
-----------------
To study the pharmacokinetic characteristics of TQ-B3525 in the human body, recommend a reasonable regimen for subsequent research.

Official Title
-----------------
A Phase I Study of TQ-B3525 on Tolerance and Pharmacokinetics

Conditions
-----------------
Relapsed or Refractory Lymphoma or Advanced Cancer

Intervention / Treatment
-----------------
* Drug: TQ-B3525


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or refractory lymphoma or advanced solid tumor that diagnosed Pathologically or cytologically diagnosed ECOG PS≤1 Adequate blood cell counts, kidney function and liver function Patients should participate in the study voluntarily and sign informed consent Exclusion Criteria: Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history Hypertension (systolic BP ≥150 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQ-B3525<br> | Drug: TQ-B3525<br>* TQ-B3525 p.o. qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-Limiting Toxicities (DLT) | DLT: An adverse event occurring after initiation of TQ-B3525 that met any following criteria: >=Grade 3 of non-hematology toxicity Grade 4 hematology toxicity | Baseline up to 28 days | 
| Maximum Tolerated Dose (MTD) | MTD was defined as the highest dose level studied for which the incidence of first cycle DLT was < 33%. | Baseline up to 28 days |
Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

Study Overview
=================
Brief Summary
-----------------
Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

Official Title
-----------------
The Efficacy and Safety of Levocetirizine Dihydrochloride Oral Drops Given 0.125 mg/kg b.i.d. During 90 Days in the Treatment of Recurrent Cough Associated With Other Allergic Symptoms, e.g. Wheezing, in Children Aged 1-2 Years.

Conditions
-----------------
Cough

Intervention / Treatment
-----------------
* Drug: levocetirizine dihydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants from 2 to 24 months both inclusive suffering from recurrent cough associated with other allergic symptoms hospitalized for respiratory or allergy related problems laboratory results within normal ranges height and weight between percentile 5 and 95 Exclusion Criteria: having taken any of the disallowed medication suffering form any disorder history of sleep apnea having concomitant chronic disease known relevant renal, hepatic, cardiac or metabolism dysfunction known alcohol or drug addiction, severe psychiatric disease for the parent/guardian

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 24 Months

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levocetirizine dihydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy based on daily record cards recordings |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and pharmacokinetics at 90 days; skin reactivity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
levocetirizine dihydrochloride Xyzal tablets
SPATAX: Clinical and Genetic Analysis of Cerebellar Ataxias and Spastic Paraplegias

Study Overview
=================
Brief Summary
-----------------
Cerebellar ataxias (CA) and spastic paraplegias (SP) are genetically and clinically very heterogeneous. More than 40 loci are already known but the number of phenotypes is even greater suggesting further genetic heterogeneity. These progressive disorders are often severe and fatal, due to the absence of specific therapy. The SPATAX network combines the experience of European clinicians and scientists working on these groups of diseases. Over the past year, they have assembled the largest collection of families and achieved a number of tasks (initiation of a clinical and genetic database, distribution of DNA to participating laboratories, mapping of three new loci, and refinement of several loci). In addition to clinicians from Europe and Mediterranean countries, who play a major role in collecting families according to evaluation tools developed and validated by the SPATAX members, the group includes major European laboratories devoted to the elucidation of the molecular basis of these disorders. Each laboratory will centralize all families with a subtype of autosomal recessive (AR) CA (n=116) or SP (n=207) in order to efficiently map and identify the responsible gene(s). Genome-wide scans are already underway in 61 families. Given the expertise of the participants, the researchers expect to map and identify several genes during the course of this project. The spectrum of mutations and phenotype/genotype correlations will be analysed thanks to this unique series of patients with various phenotypes. The knowledge gained will be immediately applicable to patients in terms of improved positive diagnosis, follow-up and appropriate genetic counselling. In the long term, models for genetic entity will be developed in order to understand the pathophysiology and to identify new targets for treatment. The series of patients assembled and the precise knowledge of natural history will facilitate the implantation of therapeutic trials based on rational approaches.

Official Title
-----------------
Clinical and Genetic Analysis of Autosomal Recessive Forms of Cerebellar Ataxias and Spastic Paraplegias

Conditions
-----------------
Cerebellar Ataxias, Spastic Paraplegias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Progressive ataxia or paraplegia Exclusion Criteria: Lack of signed informed consent

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 70 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebellar ataxias, Spastic paraplegias, Mutations spectrum, Linkage studies, Genetic counselling
Effects of Pretreatment With Ibuprofen in Post-Electroconvulsive Therapy (ECT) Headache

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether ibuprofen reduces post-ECT headache or reduces its severity.

Detailed Description
-----------------
The aim of the study is to compare the severity of headache between patients who are receiving ibuprofen prior to ECT treatment with patients receiving placebo prior to ECT treatment. Patients will be randomly assigned to receive either 600 mg ibuprofen 90 min prior to treatment or placebo orally, blinded to patient, physician and treatment team. Patients will be asked about their headache with a visual analogue scale (VAS) 2 hours prior to and within 2 hours after treatment, 2-month, 6- month and 1 year follow-up [5].

Official Title
-----------------
Effects of Pretreatment With Ibuprofen in Post- ECT Headache

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Drug: Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving ECT Exclusion Criteria: Pregnancy, contraindications to ibuprofen

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ibuprofen|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
-----------------
Psychiatric disorders, ECT, Headache, Ibuprofen