linjc16/ctgov huggingface dataset:
Adolescent Postpartum Contraceptive Counseling Intervention

Study Overview
=================
Brief Summary
-----------------
Postpartum contraceptive counseling varies widely in its provision; no standardized practice has been well-established by the literature. We intend to evaluate how directed postpartum contraceptive counseling to adolescents aged 14-19 affects key outcomes over time. Subjects will be randomized to receive either the standardized contraceptive counseling intervention or routine postpartum care. We will then assess the difference in repeat pregnancy rates between the two groups

Official Title
-----------------
Evaluation of a Brief Standardized Postpartum Counseling Intervention's Effect on Repeat Pregnancy Rates Contraceptive Choice/Use/Continuation/Satisfaction in Adolescents

Conditions
-----------------
Adolescent Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Brief standardized contraceptive counseling intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14-19 years old primiparous immediately postpartum delivery of a full term live singleton infant (>37 weeks) at HUP Exclusion Criteria: not planning to reside in/near Philadelphia for the next year

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Care<br>Routine postpartum contraceptive counseling | |
| Experimental: Individual counseling<br>Brief standardized contraceptive counseling intervention | Behavioral: Brief standardized contraceptive counseling intervention<br>* The intervention employed an in-person counseling strategy that included empowerment messaging and an instrument to clarify the participants' preferences for contraception in the context of their goals for future childbearing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is repeat pregnancy rate | Repeat pregnancy rate of intervention and control groups will be assessed | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contraceptive choice, use and continuation rates postpartum as well as contraceptive satisfaction rates |  | 1 year |
Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine apoptotic signaling pathways such as Survivin, Bcl-2, Bax, c-Myc and caspase-9 expression levels in rats model with iatrogenic endometrial hyperplasia after metformin and medroxyprogesterone acetate administration.

Official Title
-----------------
The Effect of Metformin and Medroxyprogesterone Acetate on Apoptotic Signaling Pathways in Wistar-Albino Rats With Induced Endometrial Hyperplasia

Conditions
-----------------
Apoptotic Signal Pathways in Endometrial Hyperplasia

Intervention / Treatment
-----------------
* Drug: 17β estradiol hemihydrate
* Drug: Metformin
* Drug: medroxyprogesterone acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Forty-eight weeks old female Wistar-Albino rats, weighting between 180 and 260 g Exclusion criteria. We have no exclusion criteria because we examine drugs effects in the experimental rats

Ages Eligible for Study
-----------------
Minimum Age: 8 Weeks
Maximum Age: 10 Weeks

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Medicated with only 4mg/kg 17β estradiol hemihydrate for 20 days to develop endometrial hyperplasia | Drug: 17β estradiol hemihydrate<br>* 4mg/kg/day for 20 days<br>|
| Active Comparator: Metformin group<br>Having been obtained hyperplasia, the investigators continued medication with 50 mg/kg metformin in addition to 17β estradiol hemihydrate for 10 days | Drug: 17β estradiol hemihydrate<br>* 4mg/kg/day for 20 days<br>Drug: Metformin<br>* 50 mg/kg/day last 10 days<br>|
| Active Comparator: Medroxyprogesterone acetate group<br>Having been obtained hyperplasia, the investigators continued medication with 1mg/day medroxyprogesterone acetate in addition to 17β estradiol hemihydrate for 10 days | Drug: 17β estradiol hemihydrate<br>* 4mg/kg/day for 20 days<br>Drug: medroxyprogesterone acetate<br>* 1mg/kg/day last 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivin Gene Expression Levels in Rat Uterine Tissue |  | 4 months | 
| Bcl-2 Gene Expression Levels in Rat Uterine Tissue |  | 4 months | 
| Bax Gene Expression Levels in Rat Uterine Tissue |  | 4 months | 
| c-Myc Gene Expression Levels in Rat Uterine Tissue |  | 4 months | 
| Caspase-9 Expression Levels in Rat Uterine Tissue |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Apoptotic signal pathway, Survivin, Bcl-2, Bax, c-Myc, Caspase-9, endometrial hyperplasia, endometrium cancer
Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.

Detailed Description
-----------------
Patients with angiographically documented acute intracranial vertebrobasilar artery occlusion presenting within 24 hours of neurological symptom onset will be enrolled into this open-label trial. During study drug administration, angiograms will be repeated at regular intervals to determine degree of clot lysis.

Official Title
-----------------
An Open-label, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Drug: Microplasmin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with angiographically documented vertebrobasilar artery occlusion Initiation of study drug treatment within 24 hours of the onset of neurological symptoms Age 18-75 (inclusive). Exclusion Criteria: Patients with coma > 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation Rapidly improving neurologic signs at any time before initiation of study drug administration. Known contrast agent-sensitivity Uncontrolled hypertension defined as a systolic blood pressure > 180 mm Hg or a diastolic blood pressure > 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy. History of stroke within the previous 6 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Drug: Microplasmin<br>* 2 mg/kg, IA over 75 mins<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recanalization rate |  | Day-7, Day-30 and Day-90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment |  | Day-7, Day-30 and Day-90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, vertebrobasilar, basilar, Acute vertebrobasilar artery occlusion
Comparison of Body Hydration State in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Estimation of hydration state in dialysis patients is a major challenge in clinical practice. Although many methods have been studied, none have been established yet for clinical routine practice. The investigators have developed a method, using segmental and calf bioimpedance spectroscopy (cBIS) techniques to measure body hydration. The device we used based on the FDA-approved Hydra 4200 (Xitron Technologies, San Diego, CA). The Hydra 4200 was initially developed to measure whole body and segmental body fluid volumes but Hydra is approved only for measuring healthy subjects. The cBIS monitors hydration state by continuously measuring change in resistance and resistivity in the calf during hemodialysis (HD) or it can be used for simple measurement before, during and after dialysis. Preliminary results in clinical studies have shown that optimal hydration state of HD patients may be determined by the calf method. This study aims to compare the Hydra 4200 to two other devices: the FDA approved ZOE (100 kHz) Fluid Status Monitor (Noninvasive Medical Technologies, Inc, Las Vegas) and a modified version ZOE 5 kHz. The modified ZOE monitor (ZOE (5 kHz)) delivers frequency of 5 kHz and 0.8 mA current instead of 100 kHz and 2 mA. The subjects of this study include a group of hemodialysis patients and a group of healthy controls. The healthy controls are used to identify a normal range within the healthy population for each method. Each hemodialysis patient will be studied twice in different hydration state. The study will not change the procedure of the patient's dialysis treatment. Since all devices are based on noninvasive bioimpedance technique, this study has minimal risk.

Official Title
-----------------
Comparison of Body Hydration State in Hemodialysis Patients With the Hydra 4200 and ZOE (100 and 5 kHZ) Bioimpedance Devices

Conditions
-----------------
Hemodialysis, Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically stable Exclusion Criteria: Implants including pacemakers, implantable pumps, artificial joints Limb amputations Pregnancy Simultaneous participation in another clinical study except observational trials.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Receiving hemodialysis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calf bioimpedance measurement |  | 2 dialysis treatments within 1 week |
Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Gut Dysbiosis had been involved in some way in the pathogenesis of some extra-intestinal disorders including metabolic syndrome, cardiovascular disease, and obesity.

Detailed Description
-----------------
Accumulating evidence had linked metabolic syndrome and diabetes to dysequilibrium in gut microbiota, which are a critical regulator of host metabolism and immune responses. gut microbiota interacts with host signaling pathways, leading to modulation of the endocrine system, immune responses. gut microbial metabolites, in particular, short-chain fatty acids, have been significantly associated with liability to diabetes. patients with positive fecal short-chain fatty acids will be given rifaximin

Official Title
-----------------
Rifaximin Improves Insulin Resistance in Metabolic Syndrome and Reduces Insulin Requirement in Type 2 Diabetes

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Drug: Rifaximin 200 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes with gut dysbiosis Exclusion Criteria: recent antibiotic use pregnancy diabetogenic drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study<br> | Drug: Rifaximin 200 MG<br>* patients with type 2 diabetes and gut dysbiosis will be given rifaximin<br>|
| No Intervention: CONTROL GROUP<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in glycemic control | Fasting blood sugar, post-prandial blood sugar (mg/dl) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptom questionnaire | symptomatic improvement in Dyspepsia, distension, abdominal pain | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gut dysbiosis, rifaximin, insulin resistance
Clinical Application of Novel Panels for Early Precision Diagnosis and Relapse Prediction in High-risk Leukemia

Study Overview
=================
Brief Summary
-----------------
Based on the investigator's previous data on risk classification for acute leukemia,the investigators will design a set of panels to detect the gene expression and genomic variants (SNPs, mutation, insertion, deletion and fusion genes, etc), and identify the high-risk subtypes of acute leukemia, such as Ph-like acute lymphoblastic leukemia. Furthermore, the target therapy (Tyrosine Kinase Inhibitors,et.al) will be used to treat the identified patients. In addition, more sensitive minimal residual disease (MRD) detection technology will be designed and used to detect the MRD in patients to early predict the disease relapse.

Detailed Description
-----------------
patient eligibility criteria: newly diagnosed acute leukemia patients with clinical high-risk markers, reflactory and relapsed patients.

Official Title
-----------------
Early Precision Diagnosis and Relapse Prediction Technology Development in High-risk Acute Leukemia and Clinical Application

Conditions
-----------------
Leukemia, Acute

Intervention / Treatment
-----------------
* Diagnostic Test: High-risk subtype detection panels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment Exclusion Criteria: chronic leukemia

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 75 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 |
| --- | --- |
| high-risk group<br>Selected by High-risk subtype detection panels | Diagnostic Test: High-risk subtype detection panels<br>* The designed detection technology were used to identify the high-risk patients cohort.<br>|
| non high-risk group<br>Selected by High-risk subtype detection panels | Diagnostic Test: High-risk subtype detection panels<br>* The designed detection technology were used to identify the high-risk patients cohort.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission | Patients achieve complete remission after initial treatment | From date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | 
| relapse | Patients' disease progress after complete remission | From date of randomization or complete remission until the date of first documented relapse from any cause, whichever came first, assessed up to 100 weeks |
Freezing of Gait and Cognition

Study Overview
=================
Brief Summary
-----------------
The study was aimed to investigate the role of cognition n in FoG.

Detailed Description
-----------------
Alteration of cortical circuits in PD leads to cognitive dysfunctions associated with the development of FoG. The study was aimed to investigate the role of cognition in FoG.

Official Title
-----------------
Freezing of Gait and Cognition: What Can we Learn From Cognition?

Conditions
-----------------
Gait Disorder, Sensorimotor, Cognition Disorders, Parkinson Disease

Intervention / Treatment
-----------------
* Other: freezers
* Other: non freezers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of idiopathic Parkinson's disease according to Gelb et al. Exclusion Criteria: Any other neurological conditions other than PD

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FoG+<br>Parkinsonian patients with Freezing of Gait | Other: freezers<br>* neuropsychological evaluation<br>Other: non freezers<br>* neuropsychological evaluation<br>|
| FoG-<br>Parkinsonian patients withou Freezing of Gait | Other: freezers<br>* neuropsychological evaluation<br>Other: non freezers<br>* neuropsychological evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS | Unified Parkinson's DIsease Rating Scale | 5 years | 
| MMSE | Mini-Mental State Examination | 5 years | 
| FAB | Frontal Behavioural Assessment | 5 years | 
| WCST | Wisconsin Card Sorting Test | 5 years | 
| TMT A-B | Trial Making Test A and B | 5 years | 
| Rey Auditory-Verbal Learning Test | RAVLT | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6MWT | Six-Minute Walk Test | 5 years | 
| TUG | Timed Up and Go Test | 5 years |
CO2-laser Treatment for Caesarean Section Scars

Study Overview
=================
Brief Summary
-----------------
Fractional Co2-laser for treatment of mature caesarean section scars.

Detailed Description
-----------------
Randomized split scar study to document improvement of caesarean section scars as compared to untreated control scar.

Official Title
-----------------
Fractional CO2-laser Treatment of Caesarean Section Scars - A Randomized Controlled Split-scar Trial With Long Term Follow-up Assessment

Conditions
-----------------
Cicatrix

Intervention / Treatment
-----------------
* Device: Fractional Co2-laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mature caesarean section scar Exclusion Criteria: systemic uncontrolled disease recent or current cancer smoking keloid formation wounds or local disease int treatment area pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractional CO2-laser<br>3 treatments with fractional co2-laser | Device: Fractional Co2-laser<br>* laser treatment<br>* Other names: Ablative fractional laser;|
| No Intervention: Untreated control<br>untreated control side of caesarean section scar | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient observer scar scale | validated scar scale evaluations | up until 6 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erythema measured by reflectance | measured by reflectance | 1 months post treatment | 
| pigmentation measured by reflectance | measured by reflectance | 1 months post treatment | 
| erythema measured by reflectance | measured by reflectance | 3 months post treatment | 
| pigmentation measured by reflectance | measured by reflectance | 3 months post treatment | 
| erythema measured by reflectance | measured by reflectance | 6 months post treatment | 
| pigmentation measured by reflectance | measured by reflectance | 6 months post treatment | 
| histology of scar tissue |  | 3 months post treatment |