linjc16/ctgov huggingface dataset:
Randomised Controlled Trial of the Effect of Music on Women Undergoing Assisted Reproductive Technology Treatments.

Study Overview
=================
Brief Summary
-----------------
To investigate whether listening to music at the time of embryo transfer reduces anxiety levels in women undergoing assisted conception treatment.

Detailed Description
-----------------
An assessor-blinded randomized case control study in an IVF center, England UK will randomise women into 'music' (listened to self-selected music during embryo transfer) or 'control' (no music) groups. Participants will complete the Spielberger State-Trait Anxiety Inventory prior to, and immediately following a post-treatment observation period. Total scores will be compared.

Official Title
-----------------
Randomised Controlled Trial of the Effect of Music on Women Undergoing Assisted Reproductive Technology Treatments.

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Other: Music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible participants were women aged between 25-40 years, undergoing IVF or ICSI with fresh or frozen embryos to completion from February 2013 to December 2013. Exclusion Criteria: Women unable to consent or with hearing impairment were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music<br>Played music during embryo transfer | Other: Music<br>* Self-selected music played via headphones<br>|
| No Intervention: Control<br>No music played during embryo transfer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level | Participants completed the Spielberger State-Trait Anxiety Inventory prior to, and immediately following a post-treatment observation period. Total scores were compared. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Background anxiety | Background anxiety is the state anxiety of the women | 20 minutes prior to ET | 
| Quality of life scores | Quality of life scores as measured by a specific fertility questionnaire | 20 minutes prior to ET | 
| Ongoing pregnancy rate | Ongoing pregnancy rate as measured by BHG and ultrasound | At 2 weeks and 6 weeks after ET | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Music, Anxiety, IVF
Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial

Study Overview
=================
Brief Summary
-----------------
To determine the effect of hawthorn extract 450 mg bid vs. placebo, in addition to standard medical therapy in ambulatory patients with NYHA class II to IV chronic heart failure on submaximal exercise as measured by the 6-minute walk test

Detailed Description
-----------------
See Brief Summary

Official Title
-----------------
Randomized Clinical Trial of a Crataegus Oxycantha Extract in Chronic Heart Failure

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Drug: Crataegus Special Extract WS 1442


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory individuals 18 years and older who had been diagnosed with CHF (NYHA functional classes II-IV) for > 3 months Left ventricular ejection fraction (LVEF) of ≤ 40 percent Receiving indicated standard therapy (if not contraindicated or intolerant for > 3 months) defined as a diuretic, an ACE-inhibitor or an angiotensin receptor blocker (ARB) and a beta-blocke Patients with NYHA class III or IV symptoms were also required to receive spironolactone. Doses of these drugs had to be stable for ≥ 3 months, except for diuretics, for which ≥ 1 month of stability was required. Exclusion Criteria: Hemodynamically severe uncorrected primary valvular disease Active myocarditis Hypertrophic cardiomyopathy Restrictive cardiomyopathy Myocardial infarction, stroke, unstable angina, coronary artery bypass graft surgery, valvular surgery, or angioplasty < 3 months before randomization Symptomatic or sustained ventricular tachycardia not controlled by antiarrhythmic drugs or an implantable cardioverter-defibrillator Any condition other than heart failure that would be expected to limit exercise (e.g., angina, peripheral vascular disease, pulmonary disease, arthritis, or an orthopedic problem severe enough to limit exercise) Nursing mothers, pregnant women and those planning a pregnancy during the study period

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: Crataegus Special Extract WS 1442|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance walked on a six minute walk test at six months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minnesota Living with Hearth Failure Questionnaire (Disease specific quality of life) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hawthorn, Crataegus, Herbs
Incidence, Predictors and Validation of Risk Scores to Predict Myocardial Infarction After Noncardiac Vascular Surgery

Study Overview
=================
Brief Summary
-----------------
Evaluate the incidence and predictors of post-operative mortality after noncardiac Vascular Surgery and compare the performance of existing risk scores.

Official Title
-----------------
Incidence, Predictors and Validation of Risk Scores to Predict Myocardial Infarction After Noncardiac Vascular Surgery, a Cohort Prospective Study

Conditions
-----------------
Complication of Surgical or Medical Care

Intervention / Treatment
-----------------
* Procedure: Noncardiac Vascular Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective arterial Vascular Surgery Patients > 18 years Exclusion Criteria: Urgent/Emergent Surgery Patients < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients submitted to VS<br> | Procedure: Noncardiac Vascular Surgery<br>* Noncardiac Vascular Surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Cardiac Events |  | 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30-day |
Clinical Evaluation of the RAVI-Guide

Study Overview
=================
Brief Summary
-----------------
Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid speculum during intravitreal injections Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with those of the conventional lid speculum and caliper approach

Official Title
-----------------
Clinical Evaluation of the Rapid Access Vitreal Injection Guide (RAVI-Guide)

Conditions
-----------------
Retinal Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 18 years or older who undergo intravitreal injection for clinical indications. Exclusion Criteria: Patients under the age of 18 years Patients unable to give informed consent Disorders that preclude the ability to judge pain or discomfort associated with intravitreal injection Disorders that preclude the ability to assess for complications of intravitreal injection Inability to assess the landmarks by which localization of intravitreal injection sites is determined, such as obscured corneal limbus Inability to communicate directly to the physician and immediately after the procedure the level of pain or discomfort

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 |
| --- | --- | --- |
| Pain severity associated with instrument type used for holding eyelids open during intravitreal injection | A pain severity scale of 0 to 10, with 0 being no pain, and 10 being worst imaginable pain, will be used to grade pain severity. | Within 15 minutes of injection procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural complications associated with instrument use during intravitreal injection procedure | A questionnaire that queries about procedural complications will be completed by the treating physician. | Within 15 minutes of injection procedure |
Efficiency and Efficacy of the Distress Thermometer in the Burn and Wound Population (Research Mentoring High Student Project)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test the efficiency and efficacy of the Distress Thermometer of patients admitted to the tertiary Burn and Wound Center. The American Cancer Society and the National Comprehensive Cancer Network published treatment guidelines in 2005 adopting the use of the Distress Thermometer as the preferred adjunct assessment tool of a patient's emotional well-being. A literature search provided extension of the tool to a Cardiac Follow-up Clinic. The Distress Thermometer is currently used with oncology patients at Saint Elizabeth. The emotional well being of patients and their significant others is a hallmark of wholistic care. The simple Likert scale of 0-10 has a trigger for further assessment and/ or intervention at four. The validity testing of the tool was done against the Hospital Anxiety and Depression Scale (HADS) and the Brief Symptom Inventory (BSI-18). The purpose of this study is to measure the efficiency and efficacy of the documentation of the Distress Thermometer to patients admitted to a tertiary Burn and Wound Care Center. The frequency of the documentation will be counted and type of documentation will be categorized.

Official Title
-----------------
Prospective Observational

Conditions
-----------------
Burns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nursing staff will be nurses working the evening/night shift beginning at 1900. Exclusion Criteria: all patients on the ventilator.

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?
-----------------
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
-----------------
Burn Department Nursing Staff
The Number of Blastocysts Formed in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate

Study Overview
=================
Brief Summary
-----------------
A prospective study of the blastulation rate in the outcome of the Freeze all strategy

Detailed Description
-----------------
A prospective study of the blastulation rate in women under the age of 40 years following Freeze all strategy, according to AMH levels and sperm parameters. Study group 1: number of vitrified blastocysts 0-4 Study group 2: number of vitrified blastocysts 5-7 Study group 3: number of vitrified blastocysts >7

Official Title
-----------------
The Impact of Blastulation Rate in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate

Conditions
-----------------
Pregnancy, Ovarian

Intervention / Treatment
-----------------
* Diagnostic Test: Pregnancy Rate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary infertility age 20-39 years; body mass index (BMI) 18-29kg/m2; regular menstrual cycle of 26-35days, presumed to be ovulatory; >1mil/ml spermatozoa; short antagonist protocol Exclusion Criteria: poor responders; age ≥40; TESE sperm; PGS cycles; donor oocytes; donor sperm

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 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 |
| --- | --- |
| 0-4 blastocysts<br>group A: cumulative pregnancy rate of 0-4 blastocysts vitrified | Diagnostic Test: Pregnancy Rate<br>* The pregnancy and live birth rate according to number of blastocysts formed in our three groups<br>|
| 5-7 blastocysts<br>group B: cumulative pregnancy rate of 5-7 blastocysts vitrified | Diagnostic Test: Pregnancy Rate<br>* The pregnancy and live birth rate according to number of blastocysts formed in our three groups<br>|
| >7 blastocysts<br>group C: cumulative pregnancy rate of >7 blastocysts vitrified | Diagnostic Test: Pregnancy Rate<br>* The pregnancy and live birth rate according to number of blastocysts formed in our three groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Live Birth rate according to blastulation rate | Cumulative Live Birth rate according to blastulation rate | 5 days of embryo culture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Pregnancy rate according to blastulation rate | Cumulative Pregnancy rate according to blastulation rate | 5 days of embryo culture | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blastocyst, Freeze-all, IVF, Cumulative results, cumulative delivery rate
Electromyography of the Pectoral Muscle in Mastalgia Patients

Study Overview
=================
Brief Summary
-----------------
Mastalgia is a common problem for women. The aim of this study is to investigate the role of neuromuscular pathologies of the thorax wall at mastalgia ethiopathogenesis.

Detailed Description
-----------------
Mastalgia is a common health problem for women especially these days. Studies demonstrated that 48% of the women with mastalgia have serious difficulties in their sexual life, 36% have physical activity difficulties, 13% have social activity difficulties and 6% have work or school activity difficulties. The etiology of the mastalgia is not clear. Because of the women with mastalgia tested out lots of examinations for the etiology. Also this problem has financial load because of the unknown etiology.

Official Title
-----------------
The Comparison Both of the Electromyography Results of the Pectoral Muscle in Unilateral Mastalgia Patients

Conditions
-----------------
Mastalgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has unilateral mastalgia Exclusion Criteria: Subject has pregnancy Subject has breast cancer Subject has a history of breast operation Subject has diabetes mellitus Subject has 1 cm or above cystic or solid lesions in the breasts.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| The breast with mastalgia<br>Electromyography will be performed to the pectoral muscle that is placed behind the breast with mastalgia. | |
| The breast without mastalgia<br>Electromyography will be performed to the pectoral muscle that is placed behind the breast without mastalgia. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyography results of the pectoral muscle. | The electromyography results of the pectoral muscle which are placed behind the healthy breast (group 1) and the breast with mastalgia (group 2) will be evaluated. The results of the both groups will be compared. | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mastalgia, electromyography, Pectoral
A Safety PK/PD Study of SLV337 in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV337 in Patients With Type 2 Diabetes on Metformin Monotherapy

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: SLV337
* Drug: SLV337
* Drug: SLV337


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Type 2 diabetes ,stable dose of Metformin,HbA1c >= 7%, but < 9% Exclusion Criteria Type 1 diabetes mellitus, Body Mass Index (BMI) >40.0 kg/m2, evidence of unstable cardiovascular diseases, NYHA class I to IV, ALT > 1.5 times UNL, creatinine clearance <60 mL/min

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Placebo<br>|
| Experimental: 2<br> | Drug: SLV337<br>* SLV337 400 mg/day<br>|
| Experimental: 3<br> | Drug: SLV337<br>* SLV337 800 mg/day<br>|
| Experimental: 4<br> | Drug: SLV337<br>* SLV337 1400 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in alanine amino transferase level to Day 35 |  | 35 days | 
| Change from baseline in Creatinine level to Day 35 |  | 35 days | 
| Change from baseline in the count of Red blood cells to Day 35 |  | 35 days | 
| Change from baseline in White blood cells count to Day 35 |  | 35 days | 
| Change from baseline in Creatinine kinase level to Day 35 |  | 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Fasting plasma glucose level to Day 28 |  | 28 days | 
| Change from baseline in Adiponectin level to Day 28 |  | 28 days | 
| Change from baseline in Triglycerides level to Day 28 |  | 28 days | 
| Change from baseline in High density lipoprotein cholesterol level to Day 28 |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PD, PK, type 2 diabetes, interventional, placebo, controlled, safety
Limb Remote Ischemic Preconditioning for Heart and Intestinal Protection During Laparoscopic Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The investigators hypothesized that limb remote ischemic preconditioning (RIPC) would reduce heart and gastrointestinal function injury in middle-aged and elderly patients undergoing elective laparoscopic colorectal surgery.

Conditions
-----------------
Laparoscopic Colorectal Surgery

Intervention / Treatment
-----------------
* Procedure: Limb remote ischemic preconditioning (LRIP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >40 years old ASA I-II receive elective laparoscopic colorectal surgery written informed consent can be obtained Exclusion Criteria: coagulation disorders patients with cardiac pacemaker patients with severe cardiac,or pulmonary,hepatic,renal disease ,or can not tolerate laparoscopic surgery patients with peripheral vascular disease affecting the upper limbs patients with mental,or hearing, vision disorder, who is not able to communicate with physicians difficult airways that can not receive rapid induction

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: precondition<br> | Procedure: Limb remote ischemic preconditioning (LRIP)<br>* Limb remote ischemic preconditioning (LRIP) consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb remote ischemic preconditioning may have effective protection of heart and intestinal in middle-aged and elderly patients undergoing elective laparoscopic colorectal surgery. | We hypothesized that limb remote ischemic preconditioning (RIPC) would reduce heart and intestinal injury in patients undergoing elective laparoscopic colorectal surgery.The primary outcomes included the biomarkers reflecting intestinal injury (serum intestinal fatty acid binding protein, endotoxin levels and),time (hours) from end of operation to first passage of stool or flatus,the biomarker reflecting heart injury (CTnI,serum heart fatty acid binding protein ).Perioperative electrocardiographic was also recorded. In addition, the severity of intestinal injury was assessed with pathological scoring methods. Markers of systemic inflammation (CRP) were measured as well. | within the first 7 days after surgery |