linjc16/ctgov huggingface dataset:
Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?

Study Overview
=================
Brief Summary
-----------------
The traditional model of localizing a nerve for blockade is using a peripheral nerve stimulator, PNS. Recent advances in UltraSound technology has allowed UltraSound to guide nerve blockade. However despite excellent visualization nerve block success has not significantly improved. I aim to show that this is because the PNS stimulation of a nerve is more than a proximity response as thought but a correct fascial plane response and hence the high success rate of this blind approach.

Official Title
-----------------
Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?

Conditions
-----------------
Musculoskeletal Pain

Intervention / Treatment
-----------------
* Device: Stimuplex HNS 12


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 to 3 patients for any shoulder surgery or unilateral ACL knee surgery Exclusion Criteria: Refusal to consent Allergy to Chirocaine local anaesthetic Pace maker in situ Sepsis at site of regional block

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Interscalene block<br> | Device: Stimuplex HNS 12<br> <br> * Other names: Peripheral nerve stimulator for nerve location;|
| Other: Femoral block<br> | Device: Stimuplex HNS 12<br> <br> * Other names: Peripheral nerve stimulator for nerve location;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve stimulation resulting in muscle contraction or not | Whether the nerve is successfully stimulated, resulting in muscle contraction, or not when the needle is on the wrong side of the fascial layer. | Five minutes |
Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of the trial is to induce normal pubertal development in girls with Turner Syndrome in accordance with that of their peers and their individual state psychosocial maturation.

Official Title
-----------------
Induction of Puberty With 17-Beta Estradiol in Girls With Turner Syndrome. An Open Randomized Trial

Conditions
-----------------
Genetic Disorder, Turner Syndrome

Intervention / Treatment
-----------------
* Drug: 17-beta estradiol
* Drug: 17-beta estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Turner Syndrome Treatment with growth hormone Bone age minimum 12 years and maximum 14 years Clear signs of ovarian insufficiency Well documented growth rate during the last 12 months Exclusion Criteria: Signs of spontaneous puberty Known or suspected hypersensitivity to trial product Acute or chronic liver disease Previous treatment with estrogen Undiagnosed abnormal genital bleeding Known thyroid diseases not adeadequately treated Porphyria
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 |
| --- | --- |
| Experimental: Individual dose<br> | Drug: 17-beta estradiol<br>* 5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally<br>|
| Experimental: Fixed dose<br> | Drug: 17-beta estradiol<br>* 0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pubertal stage assesed by Tanner score |  |  | 
| FSH (Follicle Stimulating Hormone) levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height velocity |  |  | 
| Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair |  |  | 
| Adverse events |  |  |
A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery

Official Title
-----------------
A Phase 2b, Double-Blind, Double-Dummy, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Twice Daily Dosing and Once Daily Dosing of YM150 in Subjects Undergoing Primary Elective Knee Arthroplasty

Conditions
-----------------
Arthroplasty, Replacement, Knee

Intervention / Treatment
-----------------
* Drug: YM150
* Drug: Warfarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is scheduled for elective primary knee arthroplasty Written Informed consent obtained Exclusion Criteria: Subject has documented history of previous VTE Subject is considered to be at increased risk of VTE Subject has active bleeding or any condition associated with increased risk of bleeding Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. YM150 Dose X, twice daily<br> | Drug: YM150<br>* Oral<br>|
| Experimental: 2. YM150 Dose Y, once daily<br> | Drug: YM150<br>* Oral<br>|
| Experimental: 3. YM150 Dose Y, twice daily<br> | Drug: YM150<br>* Oral<br>|
| Experimental: 4. YM150 Dose Z, once daily<br> | Drug: YM150<br>* Oral<br>|
| Active Comparator: 5. Warfarin<br>various doses | Drug: Warfarin<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of total venous thromboembolisms (VTE). |  | 6 Weeks | 
| The incidence of bleeding events classified as major by the Adjudication Committee |  | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause |  | 6 Weeks | 
| Incidence of the bleeding types: major, clinically relevant nonmajor, minor |  | 6 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee Arthroplasty, Factor Xa, VTE, Thrombosis, Anticoagulants
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519) until hGH products have been approved for GHDA in Japan.

Official Title
-----------------
Investigation of the Efficacy and Safety of hGH in Long Term (More Than 48 Weeks) in GHDA.

Conditions
-----------------
Growth Hormone Disorder, Adult Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who completed GHLiquid-1519. If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded. Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies. Exclusion Criteria: Subject with a history of acromegaly. Subject with diabetes mellitus. Subject suffering from malignancy. Several medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 67 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid-related laboratory tests parameters (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) |  | at the end of treatment | 
| GH-related laboratory parameters (IGF-I, IGF-I SDS, IGFBP-3, IGFBP-3 SDS and IGF-I / IGFBP-3 molar ratio) |  | at the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| FPG, insulin, and HbA1C |  |  | 
| Clinical laboratory tests |  |  |
Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles.

Official Title
-----------------
Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: Irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with diagnosis of primary adenocarcinoma of the breast Presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent At least one measurable lesion >20mm (or >10 mm with spiral CT scan) Must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting Women at least 18 years old, with performance status 0-2 Exclusion Criteria: Prior treatment with another topoisomerase I inhibitor Current enrollment in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Irinotecan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and efficacy of Irinotecan in refractory breast cancer. |  |  |
Hemodynamic Measurements at Different Inclinations of the Head

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether hemodynamic measures vary in angles bedside before and after volume challenge.

Detailed Description
-----------------
Check if values of central venous pressure (CVP), pulse pressure variation (Δpp), heart rate (HR), mean arterial pressure ((PAM) vary in different angles headboards Compare values of CVP, Δpp, HR and MAP as predictors of blood volume after supply of 500 ml of 0.9% saline solution.

Official Title
-----------------
Comparison of CVP Values , ΔPP and Echocardiographic at Different Angles Headwaters Before and After Volume Challenge

Conditions
-----------------
Hypovolemic Shock

Intervention / Treatment
-----------------
* Other: 0.9% saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being in circulatory shock and have at least one of the following criteria to identify loss of tissue perfusion: systolic blood pressure <90 mmHg or need for vasoactive drugs, urine output below 0.5 ml / kg / h. Being under sedation, assessed by the scale of Richmond agitation and sedation (RASS) -5, mechanically ventilated in volume control mode with tidal volume between 8 to 12 ml/kg, PEEP to 8 cm H2O. Tue signing the informed consent by legal guardian. Exclusion Criteria: Presence cardiac arrhythmias. Presence of abdominal or thoracic trauma. Contraindication for passive elevation of the members. Hypoxia significant PaO2/FiO2 < or equal 100.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 0.9% saline solution<br>comparing values obtained before and after administration of 500 ml of 0.9% saline | Other: 0.9% saline solution<br>* comparing values obtained before and after administration of 500 ml of 0.9% salin<br>* Other names: Solution of 0.9% NaCl in distilled water;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Different Backrest position's effect on CVP, CO and ∆PP measures |  | Data collection was performed at admission or within 10 days of hospitalization between September 2013 and February 2014. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac output, Fluid administration, Right atrial pressure, Resuscitation
N-methyl Glycine (Sarcosine) for the Treatment of Obsessive Compulsive Disorder (OCD)

Study Overview
=================
Brief Summary
-----------------
Several lines of evidence implicate glutamatergic dysfunction in the pathophysiology of obsessive compulsive disorder (OCD). Sarcosine, also known as N-methylglycine, is an endogenous antagonist of glycine transporter-I (GlyT-I), which potentiates glycine's action at the glycine site of N-methyl-D-aspartate (NMDA) receptors. In this 10-week open-label trial, we examined the efficacy and safety of sarcosine treatment in OCD patients.

Official Title
-----------------
Sarcosine as Primary or Adjunctive Therapy in Obsessive Compulsive Disorder: A Prospective, Open-label Study

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: N-methyl glycine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a primary OCD according to DSM-IV at least 1 year's duration of OC symptoms and a minimum severity score of ≥16 on Yale-Brown Obsessive Compulsive Scale drug naïve at study entry or being free from psychotropic medication for at least 8 weeks at study entry,or inadequately responded to ongoing psychotropic medications at study entry (defined by a Y-BOCS score of ≧16 despite treatment with maximum tolerated dose of a SRI medication for at least 8 weeks) Exclusion Criteria: patients with moderate to severe depression defined by a 21-item Hamilton Depression Rating Scale score of >17, a history of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychosis as defined by DSM-IV, or if they were at significant risk of suicide, and with clinically significant organic disease including cardiovascular, hepatic, pulmonary, neurologic, metabolic, or renal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: N-methyl glycine|staring from 500mg/day, increased by 500mg biweekly, up to maximin of 2000mg/day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale |  | week0, 2, 4, 6, 8, and 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Rating scale |  | week0, 2, 4, 6, 8, and 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obsessive compulsive disorder, sarcosine, glycine transporter I, NMDA receptor
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.

Official Title
-----------------
Prevention of NEC in Preterm Infants With B. Lactis

Conditions
-----------------
Necrotizing Enterocolitis

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic supplementation
* Dietary Supplement: Milk containing placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight between 800 - 1500g Tolerating enteral feeding within 48 hours Having obtained his/her parents or legal representative informed consent Exclusion Criteria: Chromosomal abnormality Hydrops featalis Congenital malformation of the gastrointestinal tract Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance Currently participating in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 12 Hours
Maximum Age: 48 Hours

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milk containing B. Lactis<br>Milk = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula. | Dietary Supplement: Probiotic supplementation<br>* one capsule containing probiotics per day added to milk<br>|
| Placebo Comparator: Milk containing placebo<br>Milk = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula. | Dietary Supplement: Milk containing placebo<br>* one capsule containing placebo per day added to milk<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEC onset |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic administration and stool microbiology |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
B. lactis, Preterm, Necrotizing Enterocolitis (NEC)
Clinical Staging Tools for the Impacts of Obesity on Individuals

Study Overview
=================
Brief Summary
-----------------
This study will assess various published staging tools to assess the health impacts of obesity on individuals. The aim is to identify benefits and drawbacks, and thus help Obesity Centres and GPs better assess obese individuals as well as better identify who benefits most from having weight loss treatment.

Detailed Description
-----------------
This study will assess various published staging tools to assess the health impacts of obesity on individuals. The aim is to identify benefits and drawbacks, and thus help Obesity Centres and GPs better assess obese individuals as well as better identify who benefits most from having weight loss treatment

Official Title
-----------------
Assessing Clinical Staging Tools for Tracking the Impacts of Obesity on Individuals

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: Bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbid obesity At least 1 year follow-up after bariatric surgery Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Obese patients<br>Obese patients for Bariatric surgery | Procedure: Bariatric surgery<br>* Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Obesity Scores After Weight Loss Treatment | Changes were measured in the following clinical domains -Airway, Body Mass Index, Cardiovascular risk, Diabetes, Economic, Functional. Gonadal, Body Image. An improvement was considered when any 1 of these domains changes for the positive. Thus, if a patient had an improvement in cardiovascular risk the intervention was considered beneficial even if no other domains changed. Out measure is calculated as the count of participants achieving at least 1 improvement (Count) | Minimum of 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Obesity Scores in Various Subgroups | Changes in obesity scores in patients with carious co-morbid conditions (eg, type 2 diabetes, sleep apnoea) before bariatric surgery | Minimum of 1 year follow-up |