linjc16/ctgov huggingface dataset:
Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

Study Overview
=================
Brief Summary
-----------------
Paroxysmal nocturnal hemoglobinuria (PNH) is a hematopoietic stem cell disorder in which unregulated activation of the complement system leads to significant ischemic morbidities with shortened lifespan. Life-threatening thromboembolism (TE) is the most feared complication of PNH, accounting for up to 45% of patient deaths. It is estimated that 40% of PNH patients experience a clinically evident TE and 60% of patients without clinically diagnosed TE demonstrate TE by high-sensitivity MRI, indicating the ongoing thrombotic risk in most patients with PNH. Much of these data come from PNH patients from European descent. To understand the impact of TE in patients with PNH from non-European regions, we performed this study to evaluate the clinical characteristics of Korean patients with PNH.

Detailed Description
-----------------
To evaluate the clinical characteristics in Korean PNH patients

Official Title
-----------------
Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Patients With PNH

Conditions
-----------------
Hemoglobinuria, Paroxysmal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data Exclusion Criteria: Patients have no Flow cytometry data

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
The Contribution of Melatonin Vs. Placebo in Benzodiazepine Withdrawal in Methadone Maintenance Treatment Patients

Study Overview
=================
Brief Summary
-----------------
We hypothesized that patient will success in benzodiazepine withdrawal if they get melatonin to solve sleep-problems which commonly occur during benzodiazepine withdrawal. Former heroin addicts, currently in Methadone maintenance treatment, who are also abusing benzodiazepine, started self benzodiazepine withdrawal, and got for 6 weeks melatonin (5mg/day, taken every night) or placebo and after 1 week, additional 6 weeks with placebo or melatonin (double blind for what got first).Success The benzodiazepine withdrawal success was evaluated by urine for benzodiazepines, and sleep quality was evaluated using PSQI questionnaire (baseline,and after weeks 6, 7, 13)

Detailed Description
-----------------
A total of 100 patients will participate. Follow-up of benzodiazepines in urine after study and 6 months later will be evaluated, as well as sleep quality (using PSQI)

Conditions
-----------------
Benzodiazepines

Intervention / Treatment
-----------------
* Drug: Melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Former opiates addicts, currently in methadone maintenance treatment, and abusing benzodiazepines who intend to withdrawal adults (>=18y) Exclusion Criteria: non abusing benzodiazepine Refuse making benzodiazepines withdrawal non methadone maintenance treatment patients

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: Melatonin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stop benzodiazepine abuse(Urine) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep quality (self report- PSQI) |  |  |
A Study to Evaluate RIST4721 in Familial Mediterranean Fever (FMF)

Study Overview
=================
Brief Summary
-----------------
A 12-week Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects with Familial Mediterranean Fever followed by an additional Open-label Extension Phase.

Official Title
-----------------
An Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects With Familial Mediterranean Fever

Conditions
-----------------
Familial Mediterranean Fever

Intervention / Treatment
-----------------
* Drug: RIST4721


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 1 FMF disease but no active flare at the time of screening according to Tel Hashomer criteria or EUROFEVER/Paediatric Rheumatology International Trials Organization (PRINTO) criteria for FMF Documented to be heterozygous or homozygous for at least one of the known clearly pathogenic MEFV gene exon 10 mutations Males and females must be willing to use birth control as indicated Exclusion Criteria: Breastfeeding or pregnant Known immunodeficiency or subject is immunocompromised Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 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: RIST4721 400 mg<br>RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks | Drug: RIST4721<br>* RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs |  | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of responders who achieve resolution of their index flare after initiating study treatment and do not experience a new flare from the time of resolution of the index flare until Week 12 |  | Baseline to Week 12 |
Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine ginger is effective in the prevention of abdominal distention in post Cesarean section patient.

Official Title
-----------------
A Randomized Double-blind Placebo-controlled Trial on the Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient

Conditions
-----------------
Post Cesarean Section Patient

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post cesarean section women Exclusion Criteria: allergic to ginger time of cesarean section more than 1 hour perform another operation such as appendectomy, cystectomy former use carminative drugs already have abdominal distention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ginger<br>Ginger capsule (500 mg), oral form, 2 capsules 3 time after meal for 3 days | Drug: Ginger<br> <br> |
| Sham Comparator: Placebo<br>Placebo capsule, oral form, 2 capsules 3 time after meal for 3 days | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence abdominal distention as measured by diary chart (history taking and examination) |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal satisfaction as measured by questionaire |  | 72 hours | 
| Quality of life as measured by questionaire |  | 72 hours | 
| nausea vomiting as measured by questionaire |  | 72 hours | 
| first time to pass flatus/feces as measured by diary chart |  | 72 hours | 
| number of carminative drug use as measured by questionaire |  | 72 hours | 
| side effect as measured by questionaire |  | 72 hours |
Effect of Exercise on the Absorption of Inhaled Human Insulin in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with type 1 diabetes.

Official Title
-----------------
Effect of Exercise on the Pharmacokinetics and Pharmacodynamics of Inhaled Human Insulin in Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: inhaled human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes more than or equal to 12 months Baseline HbA1c less than or equal to 11% Body mass index (BMI) less than or equal to 29 kg/m2 Normal lung volumes Treatment with intensified insulin therapy for at least 3 months Exclusion Criteria: Any present or history of pulmonary disease Any findings from the cardiopulmonary exercise test compromising safety of moderate exercise Impaired hepatic or renal function Cardiac problems Uncontrolled hypertension Current proliferative retinopathy or maculopathy Treatment with drugs, which may interfere with insulin action, glucose metabolism or recovery from hypoglycaemia (judged by investigator) Current smoking or smoking within the last 6 months Blood donation (more than 500 mL) within the last nine weeks

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: inhaled human insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma insulin profile in the interval |  | From 30-150 min after trial product administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma insulin profile in the interval from 120-240 min after trial product administration |  |  | 
| Area under the plasma insulin profile in the interval from 240-360 min after trial product administration |  |  | 
| Area under the plasma insulin profile in the interval 0-600 min after trial product administration |  |  | 
| Maximum plasma insulin concentration |  |  |
A Prospective Registry to Assess the Effectiveness and Local Tolerability of Intravesical Valrubicin in Subjects With Non-muscle Invasive Bladder Cancer (NMIBC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe and describe the effectiveness and local tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a cohort of subjects treated under routine practice conditions.

Official Title
-----------------
A PROSPECTIVE REGISTRY TO ASSESS THE EFFECTIVENESS AND LOCAL TOLERABILITY OF INTRAVESICAL VALRUBICIN IN SUBJECTS WITH NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)

Conditions
-----------------
CIS, Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 18 years of age and older Diagnosed with NMIBC Prescribed intravesical valrubicin to treat NMIBC Understood and signed Informed Consent to participate Exclusion Criteria: None

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Muscle Invasive Bladder Cancer, CIS, BCG Refractory
Saline Sonohystrography and Office Hysteroscopy in Evaluation of Cases of Abnormal Uterine Bleeding

Study Overview
=================
Brief Summary
-----------------
comparing the efficacy of the 3D saline infusion sonohysterography to the diagnostic office hysteroscopy in the diagnosis of the cause of abnormal uterine bleeding in females during their reproductive age

Official Title
-----------------
Comparison Between 3D Saline Infusion Sonohystrography and Office Hysteroscopy in the Evaluation of Patients With Irregular Uterine Bleeding

Conditions
-----------------
Gynecologic Disease

Intervention / Treatment
-----------------
* Device: 3D saline infusion sonohysterography
* Device: Office Hysteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female aged between 20 and 45 years with no medical disorders approving to participate in the study Exclusion Criteria: vaginal or cervical lesions history or suspicion of PID IUD users bleeding disorders on anticoagulant therapy irregular use of oral contraceptive pills

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D saline infusion sonohysterography<br>participants presenting with abnormal uterine bleeding will undergo 3D saline infusion sonohysterography | Device: 3D saline infusion sonohysterography<br>* instillation of saline in the uterine cavity using pediatric foley's catheter, then performing 3D ultrasound scan of the uterus and adenexae<br>|
| Experimental: Office hysteroscopy<br>after undergoing 3D SIS, cases would undergo office hysteroscopy and the investigator would be blinded to the results of SIS | Device: Office Hysteroscopy<br>* an outpatient procedure done to assess the uterine cavity using the office hysteroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of SIS versus office hysteroscopy in the diagnosis of cause of AUB | The results of the two procedures would be compared with the operative findings and later histopathological assessment of the specimens | 6 months |
Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion (DEL) 5q [31]

Study Overview
=================
Brief Summary
-----------------
We are evaluating the incidence of significant hematological response, according to IWG criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System [IPSS]) MDS with a deletion (del) 5q[31]

Detailed Description
-----------------
Subjects meeting all inclusion and exclusion criteria will receive lenalidomide lenalidomide will be administered at 10 mg (two 5 mg capsules) once daily on Days 1-21, every 4 weeks. Bone marrow aspirate (baseline and during the course of the study at week 8, 16, 32, 52 and when clinically indicated/for assessment of disease progression) evaluations Subjects may participate in the study for up to 52 weeks ( in patients still responding after 52 weeks, the drug wil continue to be supplied).

Official Title
-----------------
Phase II Study of the Efficacy and Safety of Lenalidomide in Adult Subjects With Intermediate-2-or Higt Risk Myelodysplastic Syndrome(MDS) Associated With a Deletion (DEL) 5q [31]

Conditions
-----------------
Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Drug: LENALIDOMIDE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years at the time of signing the informed consent form MDS with IPSS scores Int-2 or high with deletion 5q(31) Prior thalidomide allowed Documented diagnosis of MDS (RA, RARS, RAEB, RAEB-T and CMML with WBC < 13,000/mm3 according to FAB classification) that meets IPSS criteria for intermediate-2 or high-risk disease and has an associated del 5q[31] (the deleted chromosomal region must include 5q[31]), with or without additional cytogenetic abnormalities Exclusion Criteria: Pregnant or lactating females Prior therapy with lenalidomide MDS with IPSS scores low or Int-1 Clinical neuropathy of greater than grade 2 Proliferative (WBC ≥ 13,000/mL) chronic myelomonocytic leukemia (CMML) Recombinant human erythropoietin (rHuEPO) therapy received within 28 days Use of androgens other than for treating hypogonadism

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LENALIDOMIDE|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDS INT-2MDS HIGH RISKDELETION 5q[31]Lenalidomide
Comparison of CTI Ablation Prior to or After LA Ablation for AF

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine if CTI prior to CPVA/PVI/Linear Lesions/Fractionation results in reduced left atrial ablation lesion sets prior to restoration of sinus rhythm in patients with long standing persistent atrial fibrillation in the absence of antiarrhythmic drug therapy compared to CTI after CPVA/PVI/Linear Lesions/Fractionation.

Official Title
-----------------
Randomized, Single-blind, Comparative Trial of Two AF Ablation Strategies (CTI Ablation Prior to LA Ablation Versus CTI After LA Ablation) to Eliminate Persistent AF

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: CTI ablation Timing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: continuous/persistent atrial fibrillation Exclusion Criteria: age<18 congenital heart disease pacemaker or ICD implant previous ablation

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTI First<br>CTI ablation prior to left atrial ablation | Procedure: CTI ablation Timing<br>* The timing of when the CTI ablation is performed. There are no other relevant interventions used in the procedure.<br>|
| Experimental: CTI second<br>CTI ablation after left atrial ablation | Procedure: CTI ablation Timing<br>* The timing of when the CTI ablation is performed. There are no other relevant interventions used in the procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Ablation Lines Required to Organize Atrial Fibrillation to an Atrial Tachycardia or Sinus Rhythm |  | Acute (intra procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early recurrence of atrial arrhythmias | Atrial Fibrillation or Atrial Tachycardia lasting longer than 30 seconds | 3 months |