linjc16/ctgov huggingface dataset:
Clavicular Shortening Post-fracture - Does it Change? - a Prospective Study of 70 Patients

Study Overview
=================
Brief Summary
-----------------
In an attempt to answer if clavicular length changes after a fracture e.g. that any shortening becomes worse or better, 70 patients will be followed 3 times over 21 days using a novel ultrasound method.

Conditions
-----------------
Stability of Clavicular Fractures Within the First 3 Weeks

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who sustain a displaced medial, mid and lateral clavicle fracture from March 2014 to August 2015 referred from Slagelse and Holbæk emergency departments are eligible. The last patients are seen end of mid-July 2015 given the 21 days of follow up. Exclusion Criteria: Patients that have bilateral clavicle fractures and/or prior operations involving the clavicle are excluded. Malignant diagnoses are excluded.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 90 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 |
| --- | --- |
| Clavicle fractures<br> | Device: Ultrasound<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clavicular length | The dynamic testing of clavicular length and when or which fracures that are stabile. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford shoulder score |  | 21 days |
Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum

Study Overview
=================
Brief Summary
-----------------
Women report inappropriate health professional behaviour towards them during pregnancy or childbirth on social networks. However, to date, no data are available to estimate the number of women concerned. These data are necessary to characterize these behaviours to get out of this polemic and build a reflection on the improvement of the patient relationship and the emotional security of women.

Official Title
-----------------
Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum

Conditions
-----------------
Childbirth Problems, Pregnancy Related, Behavior Problem

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major women who understand french language Exclusion Criteria: Women refusing to participate having given birth at home whose fetus or newborn has died

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaires|Reporting of medical gestures or acts, speech, embarrassing or hurtful attitudes during pregnancy follow-up or during hospitalization outside childbirth, or during childbirth or immediate after birth among women giving birth in one of the 26 maternity hospitals in the period of observation period.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women reporting inappropriate behavior | An inappropriate behavior, also called obstetric violence is defined by medical gestures or acts, speech, embarrassing or hurtful attitudes during pregnancy follow-up or during hospitalization outside childbirth, or during childbirth or immediate after birth. Womens will compleat a questionnaire to report this inappropriate behavior at the exit of the maternity. | about 1 week | 
| Proportion of women reporting inappropriate behavior | An inappropriate behavior, also called obstetric violence is defined by medical gestures or acts, speech, embarrassing or hurtful attitudes reported by womens with a questionnaire 2 months after exit of the maternity. | at 2 months |
Dilapan Versus Laminaria

Study Overview
=================
Brief Summary
-----------------
This is a randomized, blinded clinical trial comparing overnight laminaria versus same-day Dilapan for cervical preparation for surgical abortions occurring between fourteen and eighteen weeks gestation. Comparisons will be made between procedure time, need for additional dilation, occurrence of complications, and patient and provider satisfaction. Hypothesis: Cervical preparation for surgical abortion, between fourteen and eighteen weeks gestation, with same-day Dilapan is non-inferior to cervical preparation with overnight laminaria within a five-minute difference. Primary objective: Determine differences in procedure times Secondary objectives: Examine complications, and need for additional dilation between early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria

Official Title
-----------------
Same-day Dilapan Versus Overnight Laminaria for Cervical Preparation for Early Second-trimester Surgical Abortion

Conditions
-----------------
Cervical Preparation

Intervention / Treatment
-----------------
* Device: laminaria
* Device: Dilapan-S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy between fourteen and eighteen weeks gestation Request for elective abortion and certainty of decision to proceed Exclusion Criteria: Incarceration Minor status (women younger than eighteen years) Allergy to Dilapan or laminaria Inability to speak and understand Spanish or English

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

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laminaria<br>laminaria placed for cervical dilation; usual standard of care in study clinic | Device: laminaria<br>* place device in cervix for dilation<br>|
| Experimental: Dilapan-S<br>experimental treatment | Device: Dilapan-S<br>* Place in cervix for dilation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Time | Procedure time to complete early second-trimester dilation and evacuation (D&E) | Day of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Who Experienced Complications or Need for Additional Dilation | Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria | Day of procedure |
Serial Measurements of Biomarker in Patients With Acute Decompensated Heart Failure

Study Overview
=================
Brief Summary
-----------------
Evaluation of serial measurement of novel biomarker for diagnosis, prognosis or therapy monitoring in patients presenting with acute decompensated heart failure.

Detailed Description
-----------------
Background: Heart failure (HF) is a chronic and progressive illness resulting from a variety of cardiac causes, including ischemic and valvular heart disease, dilatative cardiomyopathy or hypertension. HF may also develop suddenly, particularly as a complication of acute myocardial infarction or as an acute exacerbation in patients with previously compensated chronic HF. Diagnosis and in-hospital management of HF is often demanding and outcome especially regarding rehospitalizations is impaired. Novel biomarker may be very helpful in assessment of diagnosis, prognosis, and severity of HF as well as for treatment monitoring. Design: Prospective, multicenter observational study Setting: University Hospital Basel, Kantonsspital Aarau, Kantonsspital Luzern, Kantonsspital Wolhusen Patients: Patients with acute HF not requiring ICU admission Measurement of serial biomarker (BNP, NT-proBNP, MR-proADM, ST2, hs-cTnI and Copeptin) will be performed at presentation, at 6 hours (h), 12h, 18h, 24h, at 48h, at day 6 and at hospital discharge. Follow- up will be performed at 6 Month, 1 year and 2 years.

Official Title
-----------------
Prognostic Value of Serial Biomarker Measurements in Patients With ADHF

Conditions
-----------------
Acute Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute HF Informed consent Exclusion Criteria: Cardiogenic shock, ST-elevation myocardial infarction, or other clinical conditions that require immediate ICU admission or urgent PTCA

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 |
| --- | --- | --- |
| Course of BNP, NT-proBNP, MR-proADM, Copeptin, ST2, hsTnT |  | Entry, 6h, 12h, 18h, 24h, 48h, 6 days, discharge |
Cephea Transseptal Mitral Valve System FIH

Study Overview
=================
Brief Summary
-----------------
To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.

Official Title
-----------------
Cephea Mitral Valve and Transseptal Delivery System FIH

Conditions
-----------------
Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: Transcatheter Mitral Valve Replacement via Transseptal Access


Participation Criteria
=================
Eligibility Criteria
-----------------
MVARC

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter Mitral Valve Replacement<br>Replacement valve delivered through a transfemoral access and transseptal approach | Device: Transcatheter Mitral Valve Replacement via Transseptal Access<br>* The Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by freedom from major adverse events | Freedom from major adverse events, including: All-cause mortality Disabling stroke Myocardial infarction Renal failure requiring dialysis Life-threatening bleeding Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention. | 30 days | 
| Performance | Reduction in mitral regurgitation to ≤1+ | 30 days |
Efficacy of Herbal Galactogogues in Breastfeeding Mothers

Study Overview
=================
Brief Summary
-----------------
Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.

Detailed Description
-----------------
Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. Mothers of premature babies often have problems in breastfeeding and this study was designed to investigate if such herbal teas has any effect on the increasing of breast milk in mothers of premature babies. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.

Official Title
-----------------
Efficacy of Herbal Galactogogues on Weight Gain of the Newborns Within the First Month of Life in Breastfeeding Mothers

Conditions
-----------------
Weight Gain

Intervention / Treatment
-----------------
* Dietary Supplement: Still-Tee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Babies with gestational age of 35-42 weeks Breasfed babies Lactating mothers Babies admitted to outpatient clinics of neonatology within the the first week of life Exclusion Criteria: Babies with gestational age of <35 weeks Not breast feeding mothers Babies admitted to outpatient clinics of neonatology within the the first week of life

Ages Eligible for Study
-----------------
Minimum Age: 3 Days
Maximum Age: 30 Days

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Still-Tee<br>Generic name: galactogoe herbal tee, still-tee Dosage: Three cups (each 200 ml) of tea of Still-Tee galactogogue tea will be used Frequency: Three times in a day Duration: for 4 weeks after birth | Dietary Supplement: Still-Tee<br>* The mothers of the babies will receive Still-Tee galactogogue tea<br>|
| Placebo Comparator: Placebo<br>The mothers of the babies will receive placebo tea which does not contain galactogogue herbs | Dietary Supplement: Still-Tee<br>* The mothers of the babies will receive Still-Tee galactogogue tea<br>|
| No Intervention: Water<br>The mothers of the babies will receive water | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk volume |  | 4 weeks |
Emergency/Compassionate Use - Muscular VSD Occluder

Study Overview
=================
Brief Summary
-----------------
Expanded access to the AMPLATZER Muscular VSD Occluder

Conditions
-----------------
VSD, Muscular, Ventricular, Septal, Defects

Intervention / Treatment
-----------------
* Device: AMPLATZER Muscular VSD Occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER Muscular VSD clinical trial
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AMPLATZER Muscular VSD Occluder|AMPLATZER Muscular VSD Occluder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or ocular hypertension.

Official Title
-----------------
A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travoprost
* Drug: Latanoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult patients of any race and either sex with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Travoprost|nan|
|Drug: Latanoprost|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
-----------------
Glaucoma, POAG, OAG, OHT
Role of Tissue C4d in Differentiation Between Acut e Rejection and HCV Recurrence After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for differentiating between acute rejection and Hepatitis C (HCV) recurrence in recipients post living donor liver transplantation (LDLT) .As each condition require different treatment

Detailed Description
-----------------
Role of tissue c4d assessment by immunohistchemistry in liver biopsy in differentiation between recurrent hepatitis c and rejection after liver transplantation.pathological examination may be sometimes confusing between the rejection and recurrent hepatitis C

Conditions
-----------------
Liver Disease

Intervention / Treatment
-----------------
* Other: liver biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients transplanted for HCV related disease that are presented with elevated liver enzyme and/or hyperbilirubinemia and normal Abdominal Doppler ultrasound and Magnetic resonance cholangiography (MRCP). Exclusion Criteria: Evidence of other causes of elevated liver enzyme and/or hyperbilirubinemia as abnormal Abdominal Doppler ultrasound and/or Magnetic resonance cholangiography MRCP findings.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients with elevated liver enzymes<br>Patients with elevated liver enzymes and/or hyperbilirubinemia post transplantation for hepatitis C virus related disease will have liver biopsy | Other: liver biopsy<br>* C4d assessment by immunohistchemistry in liver biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who developed Acute cellular rejection after transplantation | Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for differentiating between acute rejection and hepatitis C recurrence in recipients post living donor liver transplantation (LDLT) .Each condition require different therapeutic management and the differentiation between them by ordinary methods is confusing due to overlapping pathological features between the rejection and recurrent hepatitis C desease | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis C recurrence, Rejection, Liver Transplantation, Liver biopsy
Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns

Study Overview
=================
Brief Summary
-----------------
This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.

Detailed Description
-----------------
Patient enrollment and electroencephalographic (EEG) and clinical data collection stopped May 2009. Data analysis is ongoing, and results have been described (O'Reilly D, Navakatikyan MA, Filip M, Greene D, Van Marter LJ. Peak to Peak Amplitude in Neonatal Brain Monitoring of Premature Infants. Clin Neurophysiol 2012 May 16), via publication in a peer-reviewed journal. Another manuscript has been completed and is undergoing revision for resubmission. We anticipate several additional articles will be completed from the data collected during this study. There is no relationship between industry and no current funding for this study. We maintain institutional review board approval due to ongoing data analysis.

Official Title
-----------------
Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury

Conditions
-----------------
Brain Injury, Seizures, Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants inborn below 28 weeks gestation Exclusion Criteria: At birth, deemed not likely to survive 7 days or more Major intracranial congenital anomaly

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 36 Months

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
-----------------
brain, electroencephalography, premature infant, neurodevelopment