linjc16/ctgov huggingface dataset:
Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

Study Overview
=================
Brief Summary
-----------------
Comparison of open and laparoscopic pyloromyotomy

Official Title
-----------------
Recovery After Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis: a Double-blind Multicentre Randomised Controlled Trial

Conditions
-----------------
Pyloric Stenosis

Intervention / Treatment
-----------------
* Procedure: laparoscopy pyloromyotomy
* Procedure: open pyloromytomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of infantile hypertrophic pyloric stenosis Exclusion Criteria: Presence of co-existing congenital or chromosomal abnormality The need to perform any additional procedure at the time of pylotomyotomy Failure to receive informed consent

Ages Eligible for Study
-----------------
Minimum Age: 0 Months
Maximum Age: 3 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laparoscopic pyloromyotomy<br> | Procedure: laparoscopy pyloromyotomy<br>* laparoscopic pyloromyotomy<br>|
| Active Comparator: open pyloromyotomy<br> | Procedure: open pyloromytomy<br>* open pyloromyotomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to full feeds |  | 6 weeks | 
| Post operative length of stay |  | 6 weeks | 
| Episodes of post-operative vomiting |  | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-operative complications |  | 24h | 
| Post-operative complications |  | 6 weeks | 
| Anaesthetic time |  | 24h | 
| Operating time |  | 24h | 
| Post-operative pain and analgesia requirements |  | 6 weeks | 
| Cosmetic outcome |  | 6 weeks | 
| Total in-hospital costs |  | 6 months |
Group-Based Contingency Management for Substance Abuse Treatment - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of prize-based contingency management (CM) when administered exclusively in groups. Substance dependent patients (N=360) at community-based treatment programs are randomly assigned to one of two conditions: (a) standard, non-CM treatment or (b) standard treatment plus prize CM delivered in groups. In the CM condition, patients earn the opportunity to win prizes for attending groups and submitting drug-free biological specimens. Substance use and psychosocial problems are measured at intake, month 1, month 3 (post treatment), and at 6-, 9-, and 12-month follow-up evaluations. We also assess patient characteristics that may be associated with improved outcomes within and across conditions.

Official Title
-----------------
Group-Based Contingency Management for Substance Abuse Treatment

Conditions
-----------------
Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: Contingency management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age > 18 years current DSM-IV diagnosis of cocaine, opioid or alcohol abuse or dependence willing to provide breath and urine samples for 12 weeks English speaking willing to sign informed consent Exclusion criteria: serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975) in recovery from pathological gambling

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Contingency management|Receive rewards (prizes) abstinence and attendance|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  | baseline and at each follow-up | 
| Retention |  | each follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contingency management, Substance abuse treatment
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

Study Overview
=================
Brief Summary
-----------------
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

Detailed Description
-----------------
All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.

Official Title
-----------------
Medtronic CRDM Product Performance Report

Conditions
-----------------
Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. Inclusion Criteria: • Subject or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information as required by an institution's IRB/MEC/REB AND one of the following must also apply: Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data Exclusion Criteria: Subjects who are, or will be inaccessible for follow-up Subjects with exclusion criteria required by local law (EMEA only) Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead related complications for each lead model. | All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable. | Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Pacing, Implantable Cardioverter Defibrillator, pacemaker, Sinus Bradycardia
Local Recurrence Due to Rectal Cancer in Sweden

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective national registry study is to validate the reporting of local recurrence in the registry. Another aim is to identify preoperative risk factors for local recurrence. This can in turn indicate the need for a more intense follow-up. The treatment of local recurrence, including the impact of the multidisciplinary team conference (MDT) and the surgical procedure and the referral pathways of local recurrences will also be determined. We aim to evaluate treatment outcome after local recurrence for patients operated or treated between 2007-2018.

Official Title
-----------------
Local Recurrence Due to Rectal Cancer in Sweden - the Actual Incidence, Treatment and Outcome After Treatment

Conditions
-----------------
Rectal Neoplasms

Intervention / Treatment
-----------------
* Procedure: Treatment for local recurrence with surgery or other treatments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectal cancer with a curative intent Exclusion Criteria: Rectal cancer without curative intent

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with local recurrence<br> | Procedure: Treatment for local recurrence with surgery or other treatments<br>* All types of treatment for local recurrence will be evaluated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of local recurrences |  | Between 2007-2018 | 
| 3 year survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage R0 resection after local recurrence |  | 1-2 months after initiated treatment | 
| MDT effect on treatment of local recurrence |  | 1-3 months after diagnosis of recurrence |
Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Elderly Cancer Patients Within a Comprehensive Geriatric Assessment

Study Overview
=================
Brief Summary
-----------------
Over the last few years, there has been a considerable interest in the development of screening tools to assess the capability of elderly cancer patients to tolerate anti-cancer treatment. Therefore, the NCCN Guidelines in Senior Adult Oncology recommend an assessment of co-morbid conditions that are likely to interfere with cancer treatment and tolerability. As presbyacusis is common in an older population, elderly cancer patients are at high risk for social isolation and a reduced quality of life. Therefore, in this project the investigators aim to validatie uHear™ as a quick and reliable screening tool to screen for presbyacusisf in routine clinical oncology practice.

Official Title
-----------------
Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Elderly Cancer Patients Within a Comprehensive Geriatric Assessment

Conditions
-----------------
Hearing Loss, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should have reached the age of 70 or more at enrolment Histologically confirmed diagnosis of solid cancer or hematologic malignancy. All stages of cancer are eligible Patients should be fluent in Dutch or French Patients must receive their primary oncology care in the participating hospital Patients should be cognitively capable of performing the audiology assessment Patients should have signed informed consent Exclusion Criteria: Patients who do not match the above inclusion criteria Patients who are visiting the oncology clinic for a second opinion and do not wish to be treated in this clinic Patients presenting with clinically diagnosed Ménière's disease, retrocochlear hearing loss, autoimmune inner ear disease, fluctuating hearing loss or a history of sudden sensory neural hearing loss Patients who already have a hearing aid or a previously diagnosed hearing loss

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- | --- |
| Validation of uHear™ as a screening tool to detect hearing loss in elderly cancer patients |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the prevalence of presbyacusis in an elderly cancer population |  | Baseline | 
| To compare objective and subjective hearing screening measures |  | Baseline | 
| To measure hearing impairment in G8 positive patients compared with G8 negative patients |  | Baseline | 
| To compare uHear™ with the Whispered Voice Test |  | Baseline | 
| To evaluate the use of uHear™ as a measure to determine eligibility for cisplatin treatment in elderly cancer patients |  | Baseline |
Heating Precondition of Epidural Catheter Decrease the Incidence of Injury to Blood Vessel During Epidural Catheter Placement

Study Overview
=================
Brief Summary
-----------------
To explore the effect of heating precondition of epidural catheter on the incidence of injury to blood vessel during epidural catheter placement.

Conditions
-----------------
Epidural Anesthesia

Intervention / Treatment
-----------------
* Other: heating precondition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective cesarean delivery Epidural anesthesia. Exclusion Criteria: blood coagulation disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: incidence of bleeding<br>the effect of the epidural catheter filled with heated or normal saline before inserting into epidural on the incidence of bleeding. | Other: heating precondition<br> <br> |
| Placebo Comparator: inserting time of catheter<br>record the time from beginning of catheter inserting to completing the placement of the catheter. | Other: heating precondition<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of injury to blood vessel during epidural catheter placement |  | 5 minutes |
The Therapeutics Effects of Yoga in Individuals With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
To determine if yoga is beneficial in improving physical function quality of life and medical status in people with Parkinson's disease

Detailed Description
-----------------
This pilot study is a randomized controlled study of 20-30 individuals with Parkinson's disease will have a control group with no training and a research group with yoga training. The control group will have the opportunity to attend yoga training of the same intensity after the study is completed. The effects of yoga will not be on the control group. Data on physical function will be derived from assessments including strength, balance, flexibility, ROM. gait, posture and functional analysis performed in the Georgia Holland Cardiopulmonary and Neuromuscular Research Lab. Questionnaires related to quality of life, depression and falls will determine psychological impact or yoga training. Vital signs, pulmonary function tests and blood draws will be done in the General Clinical research Center (GCRC) and protein analysis will be done in the diabetes research lab.

Official Title
-----------------
The Therapeutic Effects of Yoga in Individuals With Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Behavioral: Yoga Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's Disease Stage 1-3 Hoehn & Yahr Exclusion Criteria: Decline in immune function 6 month joint surgery spinal fusions decline in mental status measured by Folstein Mini Mental Status Exam

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Yoga Training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test, serum protein levels BP, HR, RR, strength testing using microFET, flexibility and range of motion testing using goniometer, balance/posture gait optitrk system, Berg balance scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale |  |  | 
| Hoehn & Yahr Classification Scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease
Safety and Efficacy Study of Gamaline+Hipericin in PMS

Study Overview
=================
Brief Summary
-----------------
GAMALINE is already register for PMS and HIPERICIN as antidepressive drug. Both plant extracts. The investigators will try the mixture and see if the vasomotor symptoms will disappear. The investigators expect that together all symptoms will be covered better than Gamaline alone. The investigators will run for 180 days measuring at T0, T1 and T6 (starting point, 30 days and 180 days).

Detailed Description
-----------------
This protocol wants to show the advantages for the mixture GAMALINE 900mg+HIPERICIN 300mg - 2 herbal extracts for PMS treatment against the individual use of GAMALINE

Official Title
-----------------
Phase IV Study of Combined GAMALINE and HIPERICIN for Treating Pre-Menstrual Syndrome and Vasomotor Symptoms

Conditions
-----------------
Edema, Depression, Hot Flashes, Anxiety, Irritability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: climacteric pre-menopausal women between 45 e 55 anos women between 25 e 44 anos Exclusion Criteria: Age inferior 25 anos or superior 55 anos and/or decline invitation. Patients pos-menopause Under hormone therapy Thyroid disease Under psychiatric therapy or medication History for allergies and hypersensitivity to one or both extracts Breast feeding or pregnancy No knowledge for writing and/or reading

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 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 |
| --- | --- |
| 1 - Gamaline+Hipericin - fertile women<br> | |
| 2- Gamaline+Hipericin - climateric women<br> | |
| 3- Gamaline- control - fertile women<br> | |
| 4 - Gamaline control - climateric women<br> | |

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
-----------------
PMS, climacteric, depression
Red Blood Cell Distribution Width and Charlson Comorbidity Indeces in the Frail Polytraumatized Patient.

Study Overview
=================
Brief Summary
-----------------
In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS>16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. RDW values on admission as well as preexisting comorbidities were evaluated.

Official Title
-----------------
RDW and CCI in the Frail Polytraumatized Patients. A Retrospective Cohort Study in a Level 1 Trauma Center.

Conditions
-----------------
Polytrauma, Red Blood Cell Distribution Width, Comorbidities and Coexisting Conditions

Intervention / Treatment
-----------------
* Other: retrospective


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ISS >16 points AIS >3 in one body region at least 2 body regions affected Exclusion Criteria: patients younger than 18 years of age isolated traumatic brain injury minor injuries (AIS <3 or ISS <16 points)

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 |
| --- | --- |
| polytraumatized patients<br>Patients with an ISS >16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. | Other: retrospective<br>* The investigators retrospectively analyzed the short- and long-term outcome in polytraumatized patients and the possible influence of RDW values on admission as well as preexisting comorbidities on these outcomes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality in polytraumatized patients |  | January 2012 to December 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Possible influence of RDW values (%) on admission on the long-term outcome | The influence of RDW Values (%) in polytraumatized patients on admission on the long-term outcome (late-phase death (days)) will be examined. | January 2012 to December 2015 |