linjc16/ctgov huggingface dataset:
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP

Study Overview
=================
Brief Summary
-----------------
This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.

Official Title
-----------------
An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA220JP or MRA221JP

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: MRA(Tocilizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria RA patients who participated in the previous studies Patients who completed the last observation in the previous studies Patients who were confirmed to have no problems with safety in the previous studies. Exclusion criteria Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product Patients who were not enrolled by 3 months after the last observation day of the previous study

Ages Eligible for Study
-----------------
Minimum Age: 20 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: 1<br> | Drug: MRA(Tocilizumab)<br>* 8mg/kg/4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study. |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. |  | Week 0, then every 4 Week |
A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using CTPA.

Study Overview
=================
Brief Summary
-----------------
This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission to predict adverse outcomes within 30 days after admission into hospital.

Detailed Description
-----------------
This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission. The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission into hospital. Eligible patients were randomized in some ratio into derivation and validation cohorts. The derivation cohort was used to develop and evaluate a multivariable logistic regression model for predicting the outcomes of interest. The discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. The consistency of the nomogram was evaluated using the validation cohort.

Official Title
-----------------
A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using Parameters Obtained by Computed Tomographic Pulmonary Angiography.

Conditions
-----------------
Pulmonary Embolism and Thrombosis, Deterioration, Clinical

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age of ≥ 18 years and a PE diagnosis based on CT pulmonary angiography Exclusion Criteria: pregnancy reception of reperfusion treatment before admission missing data regarding CT parameters, echocardiography, cardiac troponin I (c-Tn I), and N-terminal-pro brain natriuretic peptide (NT-pro BNP) levels.

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 |
| --- | --- |
| Acute pulmonary embolism<br>an age of ≥ 18 years and a PE diagnosis based on CT pulmonary angiography | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse outcomes | The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission. Adverse outcomes were defined as PE-related deaths, the need for mechanical ventilation, the need for cardiopulmonary resuscitation, and the need for life-saving vasopressor and reperfusion treatment. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Embolism and Thrombosis, Deterioration, Clinical
Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin as tocolytic for the treatment of preterm labour with short cervix (< 2.5cms).

Official Title
-----------------
Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.

Conditions
-----------------
Obstetric Labor, Premature

Intervention / Treatment
-----------------
* Drug: Nifedipine
* Drug: Indomethacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women between 24 and 34 weeks of gestation. Cervical length (determined by transvaginal ultrasound) of 2.5 cms or less Exclusion Criteria: All contraindications for tocolysis (fetal distress, abruptio placenta). Multiple pregnancy. All contraindications for the use of any of the two drugs (indomethacin or nifedipine).
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nifedipine<br>108 patients will receive nifedipine as tocolytic for 48 hours. | Drug: Nifedipine<br>* Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.<br>|
| Experimental: Indomethacin<br>108 patients will receive indomethacin as tocolytic for 48 hours. | Drug: Indomethacin<br>* Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of preterm labour (before 35 weeks). |  | 48 months | 
| Adverse effects | To determine the frequency of maternal adverse effects related to the use of both drugs (nifedipine and indomethacin). These include the development of any type of rash, nausea, weakness/hypotension, headache, dyspepsy or bleeding disorders of any kind. | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstetric labor, premature, Short cervix, Nifedipine, Indomethacin
The Effect of Bench-model Training in Cognitive Learning in the Operating Room

Study Overview
=================
Brief Summary
-----------------
Based on the motor learning theories, it is hypothesized that bench-model training will allow junior residents to be more interactive than trainees lacking similar active hands-on training.

Official Title
-----------------
The Effect of Bench-model Training in Cognitive Learning in the Operating Room

Conditions
-----------------
Sensitivity Training Groups

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students enrolled in first or second year of their residency from a variety of division Exclusion Criteria: Residents from higher year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Group 1<br>performers who will participate in the training sessions. | |
| Assistants<br>Assisants-paired with the performers and will be allowed to assists only, without the opportunity to practice the technical skills related to the task. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to show that bench model testing not only improves the technical skill of the student but that it also influences the student's ability to learn the didactic information and decision-making. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthopedics, bone fixation
Lumax DX / Linox DX Evaluation

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system. No hypothesis has been defined.

Official Title
-----------------
Evaluation of the Lumax DX ICD and the Linox DX Lead (ICD=Implantable Cardioverter Defibrillator, DX=Extended Diagnostics)

Conditions
-----------------
Cardiac Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient meets the indication for ICD therapy LVEF ≥ 30% Patient's compliance with protocol Signed patient informed consent form Exclusion Criteria: Patient meets one contraindication for ICD therapy Permanent atrial tachyarrhythmia Age < 18 years Cardiac surgery planned within the next 6 months Life expectancy of less than 6 months Limited contractual capability Participating in another clinical study of an investigational cardiac drug or device

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 |
| --- | --- |
| ICD therapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of appropriate atrial sensing |  | 3 months | 
| Rate of successfully terminated tachyarrhythmia episodes |  | 3 months | 
| Serious adverse device effect rate |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac disease (ICD indication)
Psychiatric Inpatient Discharge Data - Rwanda

Study Overview
=================
Brief Summary
-----------------
The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda

Detailed Description
-----------------
For a one-year period, descriptive data on all inpatients with age > 18 years, discharged from Ndera Hospital the only inpatient psychiatric hospital in Rwanda, will be collected from files. The descriptive data includes diagnosis, duration of hospitalization, medication, addiction, insurance, Somatic- and psychiatric comorbidity, referral pathways, employment status, number of previous hospitalizations. To the investigators' knowledge, there is no descriptive data on psychiatric inpatients in the country of Rwanda. Therefore, this. Information will be crucial for understanding the service provision at the referral hospitals and the accessibility to intensive mental health care in Rwanda. The data will be anonymized and recorded - this ensures the data cannot be linked to anyone subject which supplied it.

Official Title
-----------------
Psychiatric Inpatient Discharge Data - Rwanda

Conditions
-----------------
Mental Disorder

Intervention / Treatment
-----------------
* Other: Admission to inpatient psychiatric unit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients discharged from the inpatient psychiatric unit at Ndera Hospital, Rwanda 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Admission to inpatient psychiatric unit|All persons in the study are hospitalized at the only inpatient mental health hospital in Rwanda - Ndera. Data will be collected when the person is being discharged.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis | Data will be collected from files | 1 year | 
| Psychiatric comorbidity | Data will be collected from files | 1 year | 
| Somatic comorbidity | Data will be collected from files | 1 year | 
| Alcohol or drug addiction | Data will be collected from files | 1 year | 
| Medical drug provided during this hospitalisation | Data will be collected from files | 1 year | 
| Who made the referral | Data will be collected from files | 1 year | 
| Number of previous hospitalisations | Data will be collected from files | 1 year | 
| Insurance | Data will be collected from files | 1 year |
VAS-2 Vasectomy With the Vax-X

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to study an experimental vasectomy device called the Vas-X. This is an experimental study of this new approach to vasectomy.

Detailed Description
-----------------
The Vas-X works by stripping the lining of the vas deferens, the tube that sperm pass through during ejaculation. It is used in a way very similar to routine vasectomy, however, in a routine vasectomy, the vas is burned with an electrical device. With the Vas-X, there is no burning. The investigators are testing the Vas-X to determine whether it will offer a better way of performing a vasectomy. The investigators will conduct this study at the University of Washington Medical Center, Seattle.

Official Title
-----------------
Vasectomy With the Vas-X, a Simple, Minimally Invasive Device for Male Sterilization: A Pilot Study

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

Intervention / Treatment
-----------------
* Device: Vas-X


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male with normal physical findings normal testicular volume (15-30mL) detectable sperm in ejaculates Exclusion Criteria: Men with past history of hypertension significant cardiovascular thromboembolic disorders renal (including undiagnosed urinary tract bleeding) hepatic, prostatic and testicular disease prior vasectomy or scrotal surgery infertility Men with a past history of drug abuse will also be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Device study only.<br> | Device: Vas-X<br>* mechanical vasectomy device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absence of sperm in ejaculated semen 6 months after vasectomy |  | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any side effects as well as degree of occlusion of the resected segment of vas deferens |  | 6-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vasectomy, Contraception
Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions

Study Overview
=================
Brief Summary
-----------------
Using a retrospective analysis of a large commercial claims database and a Medicare database, the investigators evaluated DDEs that have the potential to cause DDIs among chronic low back pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450 enzyme system, concomitant with other CYP450-metabolized drug(s).

Official Title
-----------------
Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions

Conditions
-----------------
Chronic Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic low back pain Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
-----------------
retrospective chronic low back pain
Adaptive Arm Training for Children With Hemiplegia

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to provide limb training in children with hemiplegia using a bimanual-to-unimanual training approach. Twenty pediatric patients aged 5-17 years with acquired brain injury will receive training on the bimanual-to-unimanual device for a period of 9 weeks. During the training, children use both arms to operate robotic arms to play a video game. We will assess changes in hand impairment after the training.

Official Title
-----------------
Adaptive Arm Training for Children With Hemiplegia

Conditions
-----------------
Cerebral Palsy, Hemiplegia, Hemiparesis, Acquired Brain Injury

Intervention / Treatment
-----------------
* Device: Bimanual Arm Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemiplegia due to brain injury at least 3 months before study enrollment. Exclusion Criteria: Any social or medical problem that precludes compliance with the protocol. Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment. Implanted neuromodulatory or electronic device or other complicating illness.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 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: Bimanual Arm Training<br>Children in the study will all receive the same treatment, which includes 9 weeks of training on the bimanual arm trainer robotic device. | Device: Bimanual Arm Training<br>* Device-based bimanual-to-unimanual training will be provided with the Bimanual Arm Trainer (BAT, Mirrored Motion Works, NC). The device provides bimanual-to-unimanual training of simultaneous shoulder external rotation and elbow extension, and independent training of pronation-supination and grasp and release of each hand. Range of motion and speed are recorded during training and feedback and motivation are provided through age-appropriate gaming modules.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Assisting Hand Assessment | The Assisting Hand Assessment evaluated how effectively children use their hands to complete bimanual tasks. | Before intervention compared to after intervention | 
| Change in Box and Box Test | The Box and Blocks test measures how many blocks a child can move with one hand from one box to another in one minute with the impaired hand. | Before intervention compared to after intervention | 
| Change in range of motion | The robotic device measures range of motion of the shoulder. | Before intervention compared to after intervention |
Pre-operative Radiological Measurement to Assess Femur Rotational Alignment

Study Overview
=================
Brief Summary
-----------------
Purpose: This study outlines the benefits of the proximal tibia angle (PTA) in evaluation of the pre-operative individual condylar twist angle (CTA) in total knee arthroplasty. Methods: Condylar twist angle and proximal tibia angle were obtained from 33 female healthy participants using computed tomography (CT). The CTA, angle between clinical transepicondylar axis and posterior condylar line were measured. The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line. The correlation between the CTA and the PTA was analyzed statistically with the linear regression.

Official Title
-----------------
Pre-operative Radiological Measurement of Proximal Tibia Angle to Assess Femur Rotational Alignment in Total Knee Arthroplasty

Conditions
-----------------
Total Knee Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis Varus knee deformity Exclusion Criteria: Rheumatoid arthritis valgus knee OA previous knee surgeries posttraumatic arthritis

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CT<br>Measured with computed tomography | |
| plain Radiography<br>Measured with plain Radiography | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proximal tibia angle (PTA) | The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line. | Four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condylar twist angle (CTA) | The CTA is the angle between clinical transepicondylar axis and posterior condylar line | Four months |