linjc16/ctgov huggingface dataset:
Graft-Augmented Rectocele Repair-A Randomized Surgical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.

Detailed Description
-----------------
Rectoceles may have a significant effect on the quality of life of women. Symptoms associated with rectoceles include a protruding vaginal mass, persistent pelvic pressure, and sexual dysfunction. Surgical repair is the most common treatment with success rates ranging from 65%-85% at 1-2 years. In an attempt to improve surgical outcomes, clinicians are using graft materials to augment weakened tissues in rectocele repairs: however, there is little data to support or refute these practices. The purpose of this study is to estimate the effect of graft augmentation on objective and subjective outcomes. Comparison: Rectocele repair without graft, compared to rectocele repair with the SurgiSIS (TM) graft.

Official Title
-----------------
Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial

Conditions
-----------------
Rectocele

Intervention / Treatment
-----------------
* Procedure: Graft augmented posterior repair
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with stage 2 or greater symptomatic rectocele Women electing to undergo surgical rectocele repair Women over age 21 years Women willing to comply with study procedures and follow-up Exclusion Criteria: Pregnant or nursing women History of porcine allergy History of connective tissue disease, pelvic malignancy, or pelvic radiation Women undergoing concurrent sacral colpopexy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Native tissue repair | Procedure: Control<br>* Native tissue repair<br>|
| Experimental: 2<br>Posterior repair with graft | Procedure: Graft augmented posterior repair<br>* Posterior repair with graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomic cure defined by standardized POPQ measures |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 12 months | 
| Sexual function |  | 12 months | 
| Patient centered goals |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectocele, pelvic prolapse, graft, surgical repair
Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects

Study Overview
=================
Brief Summary
-----------------
Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug.

Conditions
-----------------
Diabetes Mellitus, Type 2, Obesity

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: INCB013739


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have an established diagnosis of Type 2 Diabetes as determined by the investigator. Females will be postmenopausal for at least 1 year with documented FSH > 30 IU/L. Exclusion Criteria: Hypertriglyceridemia > 500 mg/dL at screening. BMI > 40 kg/m2. Receiving thiazolidinediones, insulin, or exenatide within the 3 months prior to screening. History or clinical manifestations of Addison's disease, Cushing's Syndrome, or other disorders involving glucocorticoids or mineralocorticoids. Current treatment or treatment within 30 days or five half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INCB013739<br> | Drug: INCB013739<br>* INCB013739 100 mg BID<br>|
| Placebo Comparator: Matching Placebo<br> | Drug: Placebo<br>* Matching placebo of 100 mg BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lipid profile laboratory values |  | Measured at baseline and weekly for four weeks | 
| Assessment of pharmacokinetics of INCB013739 through analysis of blood samples. |  | Measured at baseline and weekly for four weeks | 
| Assessment of pharmacodynamics of INCB013739 through analysis of blood samples |  | Measured at baseline and weekly for four weeks | 
| Assessment of ECGs, physical examinations and laboratory values for adverse events |  | Measured at baseline through study completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes;, Type II diabetes;, Non-insulin dependent diabetes;, Obesity
Treatment of Severe Male Infertility - Predictive Factors (Imaging)

Study Overview
=================
Brief Summary
-----------------
Testes of men with non-obstructive azoospermia (NOA) are imaged using MRI to find potential differences depending on the outcome, ie. sperm recovery in consequent microdissection testicular sperm extraction (MD-TESE).

Detailed Description
-----------------
Sperm recovery rate in non-obstructive azoospermia (NOA) men is 43% in Turku University Hospital, depending on the diagnosis leading to NOA. To date, there are no known parameters known to differentiate between successful and unsuccessful sperm recovery. MRI is performed on men prior to the operation, and the objective is to compare the functional parameters assessed by magnetic resonance imaging between the group of men with positive and the men with negative sperm recovery in testicular microdissection sperm extraction (MD-TESE).

Official Title
-----------------
Treatment of Severe Male Infertility - Predictive Factors (Imaging)

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Diagnostic Test: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non obstructive azospermia Exclusion Criteria: malignancy contraindication for fertility treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRI Positive<br>Men with sperm found in MD-TESE | Diagnostic Test: MRI<br>* Pelvis MRI<br>|
| MRI Negative<br>Men with no sperm found in MD-TESE | Diagnostic Test: MRI<br>* Pelvis MRI<br>|
| Control group<br>No intervention, fertile | Diagnostic Test: MRI<br>* Pelvis MRI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional difference in testicular MRI depending on MD-TESE outcome (=sperm recovery) | ADC differences by diagnosis and outcome | Baseline/ pre-invention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Azospermia, Micro Dissection Testicular Sperm Extraction, Male infertility, Testis
Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the evolution of the impact on daily life activities over the first 12 months following the introduction of interferon beta-1b treatment in patients presenting RRMS or patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating event

Official Title
-----------------
Prospective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMS

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b, (Betaseron BAY86-5046)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria The choice of treatment must be clearly dissociated from the decision to include the patient in the study.

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 |
| --- | --- |
| Group 1<br> | Drug: Interferon beta-1b, (Betaseron BAY86-5046)<br>* The cohort included is described in section 8.5 (inclusion criteria)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the Daily Life score: Analysis of variance for repeated measurements. |  | After 1, 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements |  | Over 12 months | 
| Correlation coefficient with quality of life scales |  | Over 12 months | 
| Kinetics of treatment discontinuation: Kaplan Meier |  | Over 12 months | 
| Rate of treatment continuation |  | After 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Quality of life
Assessment of the Sympathetic Nervous System Blockade of the Upper Limb After a Brachial Plexus Block in Patients With End Stage Renal Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate what effect a local anesthetic nerve block of the arm in patients with end stage renal failure has upon blood flow in the skin of the arm.

Detailed Description
-----------------
Aim To quantify the degree of sympathetic blockade in the upper limb in patients with end stage renal failure produced during a regional anaesthetic technique, using laser Doppler flowmetry. Hypothesis Regional anaesthesia of the upper limb results in blockade of motor and sensory nerves, providing surgical and post-operative analgesia. Sympathetic nerves are also blocked resulting in local vasodilatation. This may be of benefit in surgery where enhanced blood flow is beneficial such as arterio-venous fistula creation. The degree and duration of sympathetic blockade produced by regional blocks however, has never been quantified. This study aims to quantify sympathetic blockade by measuring the changes in skin blood flow and skin temperature after placement of a brachial plexus block.

Official Title
-----------------
Assessment of the Sympathetic Nervous System Blockade of the Upper Limb After a Brachial Plexus Block in Patients With End Stage Renal Failure

Conditions
-----------------
Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with end stage renal failure Over 18 years of age Written consent obtained Due to undergo surgery for forearm fistula creation under a regional block Exclusion Criteria: Smokers Damaged skin on the arm Circulatory disorders such as Raynaud's disease, systemic sclerosis, sickle cell trait or disease Current use of beta blockers undergoing haemodialysis for more than 12 months

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 |
| --- | --- |
| Arterio-venous fistulae creation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pilot Study of Non-exposure Simple Suturing EFTR With Sentinel Lymph Node Navigation for EGC (Senorita3-pilot)

Study Overview
=================
Brief Summary
-----------------
Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. Current stomach preserving surgery after sentinel lymph node dissection produce transmural communication and expose the tumor to the peritoneum during operation. An endoscopic full-thickness resection method with a simple suturing technique that does not expose the gastric mucosa to the peritoneum (non-exposure simple suturing, NESS) was recently developed. This is the pilot study to prove the feasibility of NESS-EFTR with sentinel node navigation in early gastric cancer patients.

Official Title
-----------------
Pilot Study of Non-exposure Simple Suturing EFTR (NESS-EFTR) With Sentinel Lymph Node Navigation for Early Gastric Cancer (Senorita3-pilot)

Conditions
-----------------
Early Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: NESS-EFTR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single lesion of adenocarcinoma in preoperative endoscopic biopsy clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography tumor size: less than 3cm in differentiated type, less than 2cm in undifferentiated type location: 2cm far from the pylorus or cardia aged 20 to 80 ECOG 0 or 1 patient who signed the agreement patient who is suspected to underwent laparoscopy assisted gastrectomy Exclusion Criteria: indication of endoscopic submucosal resection inoperable due to poor cardiac, pulmonary function pregnant having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: NESS-EFTR<br>This arm will be received non-exposure simple suturing endoscopic full-thickness resection after sentinel lymph node navigation | Procedure: NESS-EFTR<br>* NESS-EFTR includes steps of laparoscopic seromuscular suturing, EFTR of the inverted stomach wall, and endoscopic mucosal suturing with endoloops and clips.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete resection | single piece resection with clear resection margin | 3 months |
Referral to Pharmacists - Ambulance Clinician Experience Survey

Study Overview
=================
Brief Summary
-----------------
Falls in people aged 65 years and over are a common reason for calling the emergency ambulance service. Falls can be serious, with about 1 in 20 people having to be taken to hospital because they have been injured. Thankfully, in more than 4 out of 10 cases, people are not seriously injured and can be left at home. However, it is important that the reason for the fall is found and future falls are prevented where possible. Yorkshire Ambulance Service can already make a referral to another local service to get specialist practical help for falls prevention when people are left at home after a fall. Research has shown that the safe use of medicines can prevent future falls, but that did not form. Now a new service has been set up for Yorkshire Ambulance Service to refer patients to the Leeds General Practice (GP) Confederation. A pharmacist working in the patients GP surgery will undertake a review of the patient's use of their medicines. However, it is unknown how ambulance staff identify patients who may be at risk of future falls due to medicines being taken or issues with medicines management at home. This data is not currently collected in any ambulance patient records. It is also not known what their current practice is when a patient who is not managing their medicines well is identified. A literature search has revealed no papers on this topic. This research survey seeks to understand how ambulance clinicians identify and assist patients who are having difficulty in managing their medicines. Therefore, the results of this study are likely to provide new knowledge which will be generalisable to United Kingdom (UK) ambulance service practice.

Official Title
-----------------
Referral to Pharmacists - Ambulance Clinician Experience Survey

Conditions
-----------------
Pharmacist-Patient Relations, Fall Patients

Intervention / Treatment
-----------------
* Other: Online survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical staff working operationally, providing frontline ambulance care in Yorkshire Ambulance Service National Health Service (NHS) Trust during the PREFACES project (24th May, 2019 to 31st May 2020) Exclusion Criteria: Clinical staff NOT working operationally, providing frontline ambulance care in Yorkshire Ambulance Service NHS Trust Non-clinical staff

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: Online survey|Anonymous survey using the online survey tool, JotForm|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weighted average of factors that identify patients having difficulty managing their medicines, ranked in order of importance by ambulance clinicians |  | Baseline |
Nurse-To-Family Telehealth

Study Overview
=================
Brief Summary
-----------------
This study will be a pilot test of using telehealth to allow nurses to connect with parents/guardians of pediatric patients who are being transferred between hospitals.

Official Title
-----------------
Nurse-to-Family Telehealth for Pediatric Transfers: A Randomized Controlled Pilot Trial

Conditions
-----------------
Pediatric Disorder

Intervention / Treatment
-----------------
* Behavioral: Nurse-to-Family Video Chat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who: are aged 8 days to <=18 years present to a participating community hospital ED are accepted for inter-facility transfer to UC Davis are assigned to UC Davis unit D10, D7, or T6 have an English-speaking adult parent/guardian at the bedside Exclusion Criteria: does not have an English-speaking adult parent/guardian at the bedside For parent surveys -- Inclusion Criteria: are parents/guardians of the eligible patients (described above) are age 18 years and older are English-speaking Exclusion Criteria: are age less than 18 years have a preferred language that is other than English

Ages Eligible for Study
-----------------
Minimum Age: 8 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Parents have the option to use telehealth to virtually connect with the nurse before transfer | Behavioral: Nurse-to-Family Video Chat<br>* A Nurse-To-Family Video Chat will be offered to parents/guardians to virtually connect with their post-transfer nurse; this intervention is changing the behavior of how providers deliver healthcare and how parents/guardians engage in their child's care.<br>|
| No Intervention: Control<br>Standard of care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assignment adherence | Proportion of eligible patients for whom the protocol assignment (telehealth vs standard of care) was followed | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fidelity: Launch prior to patient arrival | Whether or not telehealth connection was initiated prior to patient's arrival to UC Davis | Day 0 | 
| Survey response rates | Proportion of completed surveys among eligible respondents | Day 0/Day 30 |