linjc16/ctgov huggingface dataset:
Uterocervical Angle in Induction of Labor

Study Overview
=================
Brief Summary
-----------------
To evaluate the performance of uterocervical angle (UCA) in the prediction of labor induction.

Detailed Description
-----------------
Induction of labor is a common procedure in obstetrics. In recent years, uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al concluded that the performance of UCA was even better than the cervical length in their cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor and narrow angle was less likely to have labor. The investigators are aimed to investigate predictive role of both cervical length and UCA in the labor induction in third trimester of pregnancy.The investigators focused on nulliparous women who are taking dinoproston for the cervical preparation and aim to measure their UCA.

Official Title
-----------------
Uterocervical Angle in Success of Induction of Labor

Conditions
-----------------
Labor Induction, Third Trimester

Intervention / Treatment
-----------------
* Other: uterocervical angle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparous singleton pregnancy no previous systemic illnesses Exclusion Criteria: abnormal Pap smear previous cesarean section history of dilatation and curettage (D&C) history of LEEP and cervical conization

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Induced labor in term pregnancies<br>100 singleton nulliparous patients are planning to complete the study period. Study group constitute of third trimester pregnancies between 37-40 weeks of gestation. All participants were nulliparous and had no systemic illnesses. The uterocervical angle will be measured in all participants before the induction of labor. | Other: uterocervical angle<br>* uterocervical angle is the angle between lower segment of uterus and cervix<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uterocervical angle | the angle between the lower segment of uterus and cervix | once at the beginning of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterocervical angle, labor induction
Exploring the Role of Magnesium in Rest Cramps

Study Overview
=================
Brief Summary
-----------------
This study sets out to show whether infusions of magnesium can lessen the frequency of rest cramps and to determine whether rest cramp sufferers have a deficiency in magnesium.

Detailed Description
-----------------
Subjects will be randomized to receive 5 days of 4 hour IV infusions of D5W either with or without 20 mmol magnesium sulfate added. Twenty four hour urinary excretion of magnesium will be determined on the first day of infusions to assess whether magnesium deficiency is present. Ten normal controls will also undergo a single infusion and collection of urine to serve as a comparison group for the urinary excretion data.

Official Title
-----------------
Magnesium Status & Effect of Magnesium Infusions on Rest Cramps

Conditions
-----------------
Rest Cramps

Intervention / Treatment
-----------------
* Drug: Intravenous Infusion of Magnesium Sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥2 leg or foot cramps per week in a 4 week run-in diary Exclusion Criteria: eGFR<50 Neurologic disease Pregnancy Heart block Bradyarhythmia without pacemaker Digoxin use Liver disease Addison's disease History of MI CHF Absence of detectable reflexes

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravenous Infusion of Magnesium Sulfate|See Detailed Description.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the frequency of leg cramps per week (active versus placebo) over the first 30 days post infusions compared to the 30 days prior to randomization (as recorded in patient diaries). |  | See above | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of magnesium status at trial entry as determined by 24 hour fractional excretion of magnesium on day 1 of infusions. |  |  | 
| Subjective assessment as to whether cramps were unchanged, more, or less frequent /painful/bothersome over the 3 months. following infusions. |  | See above | 
| Overall quality of life changes as measured by an SF36 questionnaire. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnesium infusion, magnesium sulfate, rest cramps, nocturnal leg cramps, muscle cramps, fractional urinary excretion, urinary excretion, 24 hour urine, serum magnesium, magnesium deficiency, family practice, general practice, richmond, cramp frequency, magnesium status, urinary magnesium, cramp diary, sf 36
Study to Evaluate the OrthoCor Active System for Pain Relief

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-center, randomized, pivotal study to evaluate the OrthoCor Active System in individuals prescribed its use in comparison with the standard of care intervention for pain relief.

Official Title
-----------------
Prospective, Multi-Center, Randomized Study to Evaluate the OrthoCor Active System for Pain Relief

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Device: OrthoCor Active System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals presenting with pain in superficial soft tissue, such as ankle, back, knee, wrist, elbow, shoulder, foot, or neck pain, or minor muscular and joint aches and pains associated with over exertion, strains, sprains, or arthritis Prescribed use of the OrthoCor Active System or Standard of Care (SOC) intervention Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR) Exclusion Criteria: Have a cardiac pacemaker, cardioverter defibrillator, neurostimulator, infusion pump or any active medical implant Have an implanted metallic lead or any type of wire coil implant, or any implanted system that may contain lead Who are or may be pregnant Have an open wound at the area of application Are not capable or fully aware to the sensation of heat Have poor circulation or heart disease Have diabetes Under the age of 18 or individuals with open bone growth plates Unable to provide consent or obtain consent from a LAR Unwilling or unable to use the OrthoCor Active System or Standard of Care (SOC) intervention Unwilling or unable to complete the daily pain assessment Enrolled in a study to evaluate an investigational drug Prisoner or under incarceration

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OrthoCor Active System<br> | Device: OrthoCor Active System<br>* The OrthoCor Active System is a portable (battery operated) non-invasive device that delivers Pulsed Electromagnetic Field (PEMF) therapy for General Use of temporary pain relief, utilizing wraps that position the therapy, such as on the ankle, back, knee, wrist, elbow, shoulder, foot, or neck.<br>|
| No Intervention: Standard of care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety EndPoint | Incidence of adverse events | after 2 weeks of use | 
| Primary Efficacy EndPoint | comparison of Mankoski pain scale between OrthoCor and standard of care | after 2 weeks of use |
Study Evaluating DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
To compare the antidepressant efficacy and safety of DVS-233 SR with those of placebo in adult outpatients with MDD.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study Of DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: DVS-233 SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 to 75 years of age, inclusive. Sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article Subjects must have a primary diagnosis of major depressive disorder Exclusion Criteria: Treatment with DVS-233 SR at any time in the past Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1 Known hypersensitivity to venlafaxine (IR or ER)

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DVS-233 SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of the Clinical Scoring System and Cytokines for Prediction of Inflammatory Response in Major Surgery

Study Overview
=================
Brief Summary
-----------------
Cardiac surgery with cardiopulmonary bypass (CPB) and hepatic surgery are major operations, associated with a systemic inflammatory response syndrome. The aim of this study is to assess the effectiveness of clinical scoring systems and inflammatory cytokine levels for predicting systemic inflammation. This correlation might identify peri-operative clinical outcomes, then forecast further systemic inflammation in cardiac and hepatic surgical patients.

Detailed Description
-----------------
Systemic inflammatory response syndrome (SIRS) is commonly found in most major surgery. Early detection of SIRS will lead to early treatment. Serum cytokines levels are reliable markers for SIRS detection but with high cost and inconvenience. Clinical Scoring Systems are commonly used for assessment of patients with SIRS. If they have good correlation with cytokine levels, they might be used to predict peri-operative clinical outcomes.

Official Title
-----------------
Prediction for Systemic Inflammation With Clinical Scoring Systems and Inflammatory Cytokine Levels in Adult Cardiac and Major Abdominal Surgical Patients

Conditions
-----------------
Heart; Dysfunction Postoperative, Cardiac Surgery, Cytokine Release Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients who had undergone elective cardiac surgery with CPB Exclusion Criteria: under 18 years of age needing emergency surgery needing intra-aortic balloon pump

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 |
| --- | --- |
| patients with elective cardiac surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of clinical scoring systems and inflammatory cytokine levels | Blood samples were collected sequentially at 0, 0.5, 4, 12, and 24 h after CPB for cytokines [Interleukin (IL)-6, IL-8, and IL-10] investigation and leukocyte counts. Clinical scoring systems [Acute Physiology and Chronic Health Evaluation (APACHE) II, Sequential Organ Failure Assessment (SOFA) and Multi-Organ Dysfunction (MOD)] were calculated and recorded at each time point. Correlations were assessed. | 24 h after CPB | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytokine, cardiac surgery, clinical scoring system
Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto Following an Acute Deep Vein Thrombosis (DVT)

Study Overview
=================
Brief Summary
-----------------
The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with acute deep vein thrombosis treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.

Official Title
-----------------
Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto® Following an Acute Deep Vein Thrombosis (DVT)

Conditions
-----------------
Venous Thrombosis

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with a diagnosis of deep vein thrombosis (DVT) within the past 9 months, enabling at least 3 months of therapy Exclusion Criteria: Patients who do not fulfil the Belgian reimbursement criteria of deep vein thrombosis (DVT)

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 |
| --- | --- |
| Rivaroxaban<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with major bleedings |  | up to 1 year or 30 days after end of rivaroxaban | 
| Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE) |  | up to 1 year or 30 days after end of rivaroxaban | 
| All-cause mortality |  | up to 1 year or 30 days after end of rivaroxaban | 
| Adverse events |  | up to 1 year or 30 days after end of rivaroxaban | 
| Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS) |  | up to 1 year or 30 days after end of rivaroxaban | 
| Quantities of resource use consumption |  | up to 1 year or 30 days after end of rivaroxaban | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of acute deep vein thrombosis, Prevention of recurrence, Oral anticoagulation, Real-life setting
The Use of an Inhaled Salt Solution to Treat Viral Lung Infections in Infants.

Study Overview
=================
Brief Summary
-----------------
Bronchiolitis is a common viral lung infection in infants. Standard treatment often includes the use of inhaled medications which are usually first mixed with a standard salt solution. Inhalation of a more concentrated salt solution (hypertonic saline) has been successfully used to treat other types of lung disease in children and adults. The purpose of this study is to see if using inhaled hypertonic saline helps infants with bronchiolitis get better more quickly.

Detailed Description
-----------------
Bronchiolitis is a common illness in infants and is associated with a significant morbidity. Standard therapy is controversial and largely ineffective; care is mostly supportive although nebulized medications continue to be commonly used. These medications are typically mixed with normal saline to produce a sufficient volume for efficient nebulization. Inhaled hypertonic saline has been used to aid airway clearance in children with cystic fibrosis. It has also been used, in low dose, in two small studies in children with bronchiolitis. The current study is a randomized, double-blind, placebo-controlled, multi-center trial comparing frequent dosing with 3% hypertonic saline compared to normal saline in the treatment of infants hospitalized with bronchiolitis.

Official Title
-----------------
Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: 3 % hypertonic saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corrected age maximum 18 months, plus History of preceding viral upper respiratory tract infection, plus Presence of wheezing and/or crackles on auscultation, plus Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater, or oxygen saturation of 93% or less in room air, plus Admitted to hospital Exclusion Criteria: Prior history of wheezing, or History of chronic cardiopulmonary disease or immunodeficiency, or Critical illness at presentation requiring admission to ICU, or Use of nebulized hypertonic saline within previous 12 hours, or Prematurity (gestational age 34 weeks or less).

Ages Eligible for Study
-----------------
Maximum Age: 18 Months

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 3 % hypertonic saline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchiolitis, hypertonic saline
ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this 12-month, observational, follow-up study is to collect additional data (by telephone contact) with which to assess the efficacy, safety, and effects of intramyocardial injections of adult autologous CD34+ cells on quality of life (QoL) in subjects with chronic refractory myocardial ischemia. No treatments will be administered during this study. However, the investigators and other study site personnel and the subjects will remain blinded to the treatment assignments from the core therapeutic study (# 24779) so as to provide a total of 24 months of blinded data.

Official Title
-----------------
A 12-Month Follow-Up Study to Protocol 24779 (A Double-blind, Prospective, Randomized, Placebo-controlled Study to Determine the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial Injections of G-CSF Mobilized Auto CD34+ Cells for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia [ACT34-CMI])

Conditions
-----------------
Myocardial Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have received treatment with Auto-CD34+ cells or with placebo and who have completed the final study visit (Month 12) of the core therapeutic study 24779 Subjects who are willing to comply with the specified follow-up evaluations in this study and to provide written informed consent to participate in this study

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 81 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 |
| --- | --- |
| Test 1 (n=50)<br>1 x 10^5 (+/-10%) CD34+ cells/kg of body weight | |
| Test 2 (n=50)<br>5 x 10^5 (+/-10%) CD34+ cells/kg of body weight | |
| Placebo (n=50)<br>Saline plus 5% autologous plasma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety of intramyocardial injections of Auto-CD34+ cells relative to placebo for reducing the number of angina episodes in subjects with refractory chronic myocardial ischemia over a 12-month follow-up period. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term efficacy of Auto-CD34+ cells relative to placebo for reducing the number of angina episodes in subjects with refractory chronic myocardial ischemia and the effects of this treatment on quality of life (QoL) over a 12-month follow-up period |  | 12 months |