linjc16/ctgov huggingface dataset:
Transversus Abdominis Plane Block Versus Erector Spina Plane Block

Study Overview
=================
Brief Summary
-----------------
Regional anesthesia and analgesia techniques are frequently used to provide pain control in pediatric surgical applications. The main advantages of these techniques include ease of application, good analgesic efficacy and low risk of complications (1). It reduces the need for parenteral opioids and increases the quality of postoperative pain control and the satisfaction of the patient and family (2). The aim of this study was to compare the contribution of TAP block and ESP block combined with sedation in pediatric surgery to anesthesia and analgesia during surgery without general anesthesia.

Official Title
-----------------
Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spina Plane Block in Pediatric Lower Abdominal Surgery

Conditions
-----------------
Intraoperative Pain Control

Intervention / Treatment
-----------------
* Device: Ultrasound guided erector spinae block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II, undergo elective lower abdominal surgery 2-6 years Exclusion Criteria: Psychiatric patients, weight> 40 kg, those with cardiac-pulmonary-neurological disease, those with bleeding disorders, infection or wound scarring at the injection site, known allergy to local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transversus abdominis plane block<br>Group 1 (n: 50): those who underwent TAP block after induction of propofol atropine and maintained with only 1 mg / kg / h propofol in anesthesia maintenance | Device: Ultrasound guided erector spinae block<br>* Group 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance<br>|
| Active Comparator: erector spinae block<br>Group 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance | Device: Ultrasound guided erector spinae block<br>* Group 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | effectiveness of erector spinae block on intraoperative anesthesia | 4 months |
A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.

Official Title
-----------------
A Multicenter, Open-Label Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy

Conditions
-----------------
Chemotherapy Induced Anemia

Intervention / Treatment
-----------------
* Drug: recombinant human erythropoietin
* Drug: recombinant human erythropoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer patients Exclusion Criteria: a history of myocardial, cerebral or pulmonary infarction severe hypertension beyond control by drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patient whose ΔHb is less than 1.0g/dL on the day of 7th administration | Drug: recombinant human erythropoietin<br>* 3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks<br>|
| Experimental: 2<br>patient whose ΔHb is 1.0g/dL or above on the day of 7th administration | Drug: recombinant human erythropoietin<br>* 36000IU(s.c.)/week for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The increase in Hb concentration |  | Day 28th or later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in QOL scores |  | 84 days |
Fetal Penile Length and Corpus Cavernosum Length - Normal Measurement Via Ultrasound

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Measurement of fetal penis length by ultrasound may be inaccurate when measured from the scrotum to the penile tip. we will provide normal values of penile length measured from the penile tip to the abdominal wall and measuring the corpus cavernosum length.

Official Title
-----------------
Prospective Cross-sectional Study of Fetal Penis and Corpus Cavernosum Length

Conditions
-----------------
Fetal Penis Length

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women at 14th through 34th week gestation, routine ultrasound not preformed for anomalies at the genitourinary system, estimated fetal weight corresponds to gestational age. Exclusion Criteria: women who's fetuses are suspected to be with fetal growth retardation, women who's fetuses are suspected to be with genitourinary anomaly.

Ages Eligible for Study
-----------------
Minimum Age: 14 Weeks
Maximum Age: 34 Weeks

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

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
-----------------
ultrasound, penis length, corpus cavernosum, length of fetal penis and fetal corpus cavernosum
Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices.

Official Title
-----------------
Mobius PT-INR Accuracy Clinical Study

Conditions
-----------------
Clotting Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are currently taking coumadin (warfarin) Are aged 18 years or older Able and willing to provide informed consent Can understand (read and write) English Required to provide a capillary sample as part of their routine medical check Exclusion Criteria: Previously participated in this 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 |
| --- | --- |
| Coumadin (warfarin)<br>Subjects currently receiving coumadin (warfarin) treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device | To determine the correlation of PT/INR values between an experimental and commercial device | Five days to collect data and up to two weeks to generate correlation graph |
Travelling in Patients With Sleep Related Breathing Disorders

Study Overview
=================
Brief Summary
-----------------
One questionnaire has been configured to ask therapy naive and treated patients about their travel activities. Travel activities include private and professional traveling. Another questionnaire collects medical information.

Detailed Description
-----------------
Including a German sleep committee a new questionnaire has been created to ask patients about their travel Habits. Only travels over a onenightstay were of interest. All detailed Information about the Destination has been asked. A Special Point of interest were the Impacts of traveling. For each Patient a doctor completed the medical history including sleep related breathing disorder and relevant medical conditions e.g. orthopedic Impacts.

Official Title
-----------------
Travel Activities in Patients With Sleep Related Breathing Disorders

Conditions
-----------------
Travel, Sleep Related Disorder

Intervention / Treatment
-----------------
* Other: questionnaire for travel habits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with sleep related breathing disorder informed consent provided Exclusion Criteria: patients with no sleep related breathing disorder no informed consent provided

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| reference group<br>therapy naive patients with a sleep related breathing disorder | Other: questionnaire for travel habits<br>* questionnaire has been used to collect information about travelling<br>|
| therapy group<br>patients with devices treating their sleep related breathing disorder | Other: questionnaire for travel habits<br>* questionnaire has been used to collect information about travelling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| travel activities in sleep related breathing disorder, questionnaire | questionnaire has been used once in each patient | ten minutes |
Back Pain - Linking Phenotype to Pain Mechanism and Outcome.

Study Overview
=================
Brief Summary
-----------------
To investigate whether different clinical, psychophysical and neurophysiological phenotypes can be identified among low back pain patients

Detailed Description
-----------------
Low back pain patients will fill in a detailed questionnaire (incl. pain drawing) about their pain. Some of them will undergo a standardized quantitative sensory testing protocol and an fMRI procedure.

Official Title
-----------------
Back Pain - Linking Phenotype to Pain Mechanism and Outcome.

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: no intervention, observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -primary complaint: low back pain clinically not attributable to red flags Exclusion Criteria: any major medical or psychiatric condition that affects pain sensitivity contraindications to MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| low back pain patients<br>no intervention | Other: no intervention, observational<br>* no intervention, observational<br>|
| controls<br>no intervention | Other: no intervention, observational<br>* no intervention, observational<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spatial pain extent | spatial pain extent (body map) | baseline | 
| measures for central sensitization | temporal summation and conditioned pain modulation | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in spatial pain extent | changes in spatial pain extent (bodymap) | changes from baseline to 3 months | 
| changes in measures for central sensitization | changes in temporal summation and conditioned pain modulation | changes from baseline to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, phenotype
Effects of Human Leptin Replacement

Study Overview
=================
Brief Summary
-----------------
This study will test the hypothesis that leptin contributes to the regulation of the dynamics of human endocrine function.

Detailed Description
-----------------
The study aims to elucidate the role of leptin in the regulation of human endocrine function approached by a carefully designed, prospective clinical study of the rapidly-sampled dynamics of endocrine rhythms during the course of leptin-replacement treatment in the only three adult individuals identified in the world so far who are leptin-naive due to a functional leptin gene mutation. A study of leptin-naive subjects avoids all confounding factors and pitfalls, because the only bioactive leptin to which they will be exposed is the exogenously administered recombinant protein. Thus, this proposal will permit us to ascertain the endocrine effects of human leptin.

Official Title
-----------------
Effects of Human Leptin Replacement

Conditions
-----------------
Obesity, Metabolic Syndrome, Diabetes

Intervention / Treatment
-----------------
* Drug: Recombinant methionyl human leptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congenital leptin deficiency (these are only 3 adult individuals in the world that have been identified as leptin-naïve thus far). Exclusion Criteria: Pregnant, trying to become pregnant, breast-feeding an infant or sexually active women, not using contraception. Subjects with hemoglobin levels below 12 g/dl. Subjects whose body contains a ferromagnetic implanted device that might produce a safety hazard during fMRI.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Recombinant methionyl human leptin<br>Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss). | Drug: Recombinant methionyl human leptin<br>* Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.<br>* Other names: r-metHuLeptin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight |  | Baseline, 107 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glucose Levels |  | Baseline, 107 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Congenital leptin deficiency, Metabolic syndrome, Diabetes
Development of a Web-Based Course to Maintain Skills in Nurses Trained to Screen for Dysphagia

Study Overview
=================
Brief Summary
-----------------
This research aims to facilitate the successful implementation of the new Heart and Stroke Foundation of Ontario dysphagia screening model for acute stroke patients. The objectives will be 1) to determine the natural history of dysphagia screening skill decay, and 2) to assess the benefit of independent web-based practice and periodic feedback on screening skill maintenance. We will enrol a convenience sample of nurses who currently work with stroke patients but who have had no prior formal training with dysphagia screening. The study will consist of 2 phases: A) an initial pilot phase followed by B) a prospective randomized controlled study. During Phase A, three new web-based, self-instructed skill refresher courses will be developed to help nurses maintain the skills they will learn in an 8-hour workshop on dysphagia screening. During Phase B, nurses will receive the 8-hour workshop and one-on-one evaluation by a speech-language pathologist (SLP). Following training, competent screeners will be randomized into one of two groups: Group A - Control group with no refresher course or periodic feedback from SLP; Group B - Web-based skill refresher courses only. Nurses will be evaluated at several timepoints throughout Phase B to assess theoretical dysphagia screening knowledge and skills.

Official Title
-----------------
Development of a Web-Based Course to Maintain Skills in Nurses Trained to Screen for Dysphagia

Conditions
-----------------
Stroke, Deglutition Disorders, Dysphagia

Intervention / Treatment
-----------------
* Other: TOR-BSST© Refresher Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nurses who care for acute stroke patients
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A Nurses<br>Participants receive neither web-based refresher courses nor periodic feedback by SLP | |
| Experimental: Group B Nurses<br>Participants receive web-based skill refresher courses but no periodic feedback by SLP | Other: TOR-BSST© Refresher Training<br>* Web-based refresher training in dysphagia screening<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skill decay over time among nurses trained to use the TOR-BSST© to screen for dysphagia in stroke patients |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skill Maintenance, Skill Decay, Screening
A Retrospective Database Assessment of Clinical Effectiveness in Type 2 Diabetes Patients Treated With Liraglutide From Primary Care Centers in Sweden

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this study is to investigate a retrospective database assessment of clinical effectiveness in type 2 diabetes patients treated with liraglutide from primary care centers in Sweden.

Official Title
-----------------
A Retrospective Database Assessment of Clinical Effectiveness in Type 2 Diabetes Patients Treated With Liraglutide From Primary Care Centers in Sweden

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

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients from EMR (electronic medical record) system in the primary care in Sweden Patients equal to or more than 18 years of age Starting treatment with liraglutide or sitagliptin from January 2010 to December 2013 Minimum of 180 days of prior follow-up/history within the database before their index date Exclusion Criteria: Patients with cancer, end stage liver disease, end stage renal failure (non-diabetes related) Female patients with gestational diabetes during pregnancy Patients with previous GLP-1 (glucagon-like peptide-1) or DPP-IV (dipeptidyl peptidase-4 ) inhibitor use, i.e. patients should be incretin naïve

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 |
| --- | --- |
| Liraglutide / Sitagliptin<br> | Drug: liraglutide<br>* No treatment given.<br>Drug: sitagliptin<br>* No treatment given.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent (%) of patients achieving at least 1 %-point HbA1c (glycosylated haemoglobin) reduction |  | Day 0, Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent (%) of patients with HbA1c (glycosylated haemoglobin) reduction at least 1 %-point and weight reduction at least 3% (NICE clinical guidelines, liraglutide only) |  | Day 0, Day 180 | 
| HbA1c (NGSP standard, in %) change |  | Day 0, Day 180 | 
| Change in weight (in kilograms) |  | Day 0, Day 180 | 
| Change in blood pressure (systolic, in mmHg) |  | From baseline to 180 days of therapy | 
| Change in lipids (HDL, LDL and triglycerides, in mmol/L) |  | Day 0, Day 180 | 
| Change in creatinine |  | Day 0, Day 180 |