linjc16/ctgov huggingface dataset:
Prolonged Hospital Stay and Readmission After Elective Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to analyse factors associated with prolonged length of hospital stay, readmission and death in a nationwide group of patients undergoing elective ventral hernia repair in search for areas of interest to improve outcome after ventral hernia surgery

Detailed Description
-----------------
Detailed analysis of reasons for prolonged hospital stay and readmission in patients undergoing a ventral hernia repair

Official Title
-----------------
Nationwide Analysis of Prolonged Hospital Stay and Readmission After Elective Ventral Hernia Repair

Conditions
-----------------
Ventral Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with elective ventral hernia repair in Denmark 2008 Exclusion Criteria: emergency repairs

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 |
| --- | --- |
| Study cohort<br>Patients with prolonged length of hospital stay (>5 days) or readmission after ventral hernia repair | |
| control group<br>Patients without prolonged length of hospital stay (>5 days) or readmission after ventral hernia repair | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | analyse factors associated with prolonged length of hospital stay (minimum 5 days). | participants will be followed for the duration of hospital stay, an expected average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission | reasons for readmission after a ventral hernia repair | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Length of hospital stay, readmission, ventral hernia
Sarcopenia and Osteoporosis in the Patients With Hemophilia

Study Overview
=================
Brief Summary
-----------------
Hemophilia is a bleeding disorder and repeated joint bleeding leads to hemophilic arthropathy. Among patients with hemophilia, vitamin D deficiency and hemophilic arthropathy have been associated with osteoporosis in several clinical studies.There is no data on the prevalence of osteoporosis in hemophilia patients in Taiwan or Asia. To the best of our knowledge, no previous studies have reported the prevalence of sarcopenia and correlation with osteoporosis in hemophilia adult patients. This study will investigate the prevalence and corelation of sarcopenia and low BMD in patients with hemophilia. patients in Taiwan. The study will estimate the prevalence of sarcopenia and body composition in the hemophilia population and compared baseline demographic and clinical characteristics between the non-sarcopenia and sarcopenia individuals, with particular emphasis on the overlap with osteoporosis and hemophilic arthropathy.

Official Title
-----------------
Sarcopenia and Osteoporosis in the Patients With Hemophilia

Conditions
-----------------
Sarcopenia, Hemophilia, Osteoporosis, Osteopenia, Hemophilic Arthropathy

Intervention / Treatment
-----------------
* Diagnostic Test: Dual-energy X-ray absorptiometry (DXA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemophilia patients Exclusion Criteria: History of total hip arthroplasty History of instrumentation in lumbar spine

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Hemophilia<br> | Diagnostic Test: Dual-energy X-ray absorptiometry (DXA)<br>* Body composition will be measured using whole-body DXA (GE Lunar iDXA, GE Healthcare Lunar, Madison, Wisconsin, U.S.A.). Extremity skeletal muscle mass will be calculated using the values measured via the DXA; ASM will be calculated as the sum of skeletal muscle mass in the arms and legs, assuming that the mass of lean soft tissue is a skeletal muscle. Appendicular skeletal mass index (ASM/Ht2 ) will be determined as the sum of the arm and leg lean mass (kg)/height2 (m2 ). BMD will be measured in lumbar spine and bilateral hip by the same DXA device (GE Lunar iDXA, GE Healthcare Lunar, Madison, Wisconsin, U.S.A.)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sacropenia | Extremity skeletal muscle mass will be calculated using the values measured via the DXA | up to 4 weeks |
Efficiency of Shock-wave Therapy in Symptomatic Hip Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.

Detailed Description
-----------------
The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Among them, shockwave therapy is not a new treatment method, and seems to be effective in rotator cuff pathology, tennis elbow, and also on knee osteoarthritis, but few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.

Official Title
-----------------
Efficiency of Shock-wave Therapy in Symptomatic Hip Osteoarthritis

Conditions
-----------------
Hip Osteoarthritis

Intervention / Treatment
-----------------
* Device: Shock Wave Therapy
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral or bilateral hip osteoarthritis Exclusion Criteria: other disorders that are contraindications for shockwave or ultrasound application
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Shock Wave therapy on the affected hip, for 10 days, 1 application every 2 days | Device: Shock Wave Therapy<br>* Shock Wave therapy - hip osteoarthritis program<br>|
| Active Comparator: Control group<br>Ultrasound therapy on the affected hip, for 10 days, 1 application daily | Device: Ultrasound<br>* Ultrasound 0.7W/cm2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline Visual Analogue Scale (VAS) score at 10 days and 30 days | 10mm to 100mm, higher scores mean a worse outcome | at baseline, after 10 days, after 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 10 days and 30 days | 24-item questionnaire for osteoarthritis, higher scores mean a worse outcome | at baseline, after 10 days, after 30 days |
Neuromusculaire Monitoring Survey - Usability

Study Overview
=================
Brief Summary
-----------------
This survey aims to better define Anesthesiologist's perceived usability of existing anesthesia Neuromuscular Monitoring devices.

Detailed Description
-----------------
This study consists of a simple online survey that takes approximately 2 minutes to complete. The study aims to assess Anesthesiologist's perceived usability of the different types of anesthesia neuromuscular monitoring devices (quantitative and qualitative). The survey is targeted to individual anesthesiologists, independetly of their degree of experience.

Official Title
-----------------
Neuromusculaire Monitoring Survey - Usability

Conditions
-----------------
Survey, Usability

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active Anesthesiology department heads of European Anesthesiology departments. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Participants are asked to fill in a questionnaire and provide extensive information.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overall trial<br>People who complete the questionnaire. | Other: Survey<br>* Questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | Is there a use for Neuromuscular monitoring applications in their department? - questionnaire | 4 months |
TNF Polymorphism and Implantation Rate

Study Overview
=================
Brief Summary
-----------------
Do TNF-308 and -238 polymorphisms impact the embryo implantation rate after in vitro fertilization (IVF) in women without female infertility factor ?

Detailed Description
-----------------
This study was performed in order to verify whether TNF-308 allele was associated with a higher implantation rate and multiple pregnancy rates in women without known infertility factors after ovarian hyperstimulation with exogenous FSH for IVF

Official Title
-----------------
Tumor Necrosis Factor-308 Polymorphism a Embryo Implantation Rate in Women Undergoing in Vitro Fertilization

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: biological and ultrasound test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women normal karyotype, age under 38 years serum follicle-stimulating hormone (Day-3 FSH) levels below 10 UI/l Exclusion Criteria: age under 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: biological and ultrasound test|biological and ultrasound test 20 days after implantation in order to see the implantation rate|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate by biological test |  | 20 days after implantation | 
| Implantation rate by ultrasound test |  | 20 days after implantation |
Bioequivalence Study to Compare Two Formulations of Deanxit®

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered single dose in fasted and fed condition

Official Title
-----------------
Interventional, Randomized, Single Dose, Open-label, Crossover, Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®) - in Fasted and Fed Conditions

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: test treatment: flupentixol/melitracen
* Drug: reference treatment: flupentixol/melitracen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women ≥18 and ≤55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 28 kg/m2. Women must be non-pregnant and non-lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A1 Fasted condition<br>Subjects in cohort A1 will be administered the Investigational Medicinal Product in a fasted state, 30 subjects per cohort | Drug: test treatment: flupentixol/melitracen<br>* 0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose<br>Drug: reference treatment: flupentixol/melitracen<br>* 0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose<br>* Other names: Deanxit®;|
| Experimental: Cohort A2 Fed condition<br>Subjects in cohort A2 will be administered the Investigational Medicinal Product in a fed state, 30 subjects per cohort | Drug: test treatment: flupentixol/melitracen<br>* 0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose<br>Drug: reference treatment: flupentixol/melitracen<br>* 0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose<br>* Other names: Deanxit®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-72h: flupentixol | the area under the flupentixol plasma concentration-time curve | from zero to 72 hours post-dose | 
| Cmax: flupentixol | maximum observed plasma concentration of flupentixol | from zero to 72 hours post-dose | 
| AUC0-72h: melitracen | the area under the melitracen plasma concentration-time curve | from zero to 72 hours post-dose | 
| Cmax: melitracen | maximum observed concentration of melitracen | from zero to 72 hours post-dose |
Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty

Study Overview
=================
Brief Summary
-----------------
Prospective intervention study to assess the accuracy of the predicted QFR-derived virtual angioplasty compared to hyperaemic and non-hyperaemic pressure-wire derived indexes after PCI, as well as with QFR post-PCI.

Official Title
-----------------
Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty

Conditions
-----------------
Coronary Occlusion

Intervention / Treatment
-----------------
* Diagnostic Test: Quantitative Flow Ratio (QFR) measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis with PCI indication. Exclusion Criteria: Severe stenosis of the left main coronary artery. Patients admitted with ST-elevation myocardial infarction. Culprit lesions in Non-ST-Elevation Acute Coronary Syndromes (NSTEACS) patients. Unability to identify the culprit lesion in NSTE-ACS patients.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QFR Intervention<br>Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis between 50 and 90% and PCI indication with paired assessment of QFR, dFR, RFR and FFR, before and after PCI once informed consent is provided. | Diagnostic Test: Quantitative Flow Ratio (QFR) measurement<br>* Quantitative flow ratio (QFR) is a novel approach enabling rapid computation of FFR pullbacks from three-dimensional quantitative coronary angiography (3D-QCA) without using a pressure wire.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical agreement between predicted post PCI QFR (residual QFR) and post PCI dPR RFR-FFR, as well as direct QFR post-PCI mesurement. |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity |  | 1 hour | 
| Specificity |  | 1 hour | 
| Summary of the receiver-operator characteristics curve (sROC) |  | 1 hour | 
| Negative predictive value |  | 1 hour | 
| Positive predictive value |  | 1 hour | 
| Positive likelihood ratio |  | 1 hour | 
| Negative likelihood ratio |  | 1 hour | 
| Identification of independent predictors for increased predicted postPCI QFR (residual QFR) and post PCI dPR-RFR-FFR. |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QFR, Quantitative Flow Ratio, Percutaneous Coronary Intervention
Bariatric Surgery and Pharmacokinetics of Enalapril

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on enalapril are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Enalapril: BAR-MEDS Enalapril

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

Intervention / Treatment
-----------------
* Drug: Enalapril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enalapril|Patients are tested for their normal prescription enalapril medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enalapril concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Enalapril
Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms. Patients receive oral metformin (arm I) or oral placebo (arm II) three times daily for 8 weeks. All patients who do not ovulate by day 28 receive oral clomiphene citrate daily on days 36-40.

Conditions
-----------------
Hyperinsulinism, Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: clomiphene citrate
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Obese women with chronic anovulation due to polycystic ovary syndrome (PCOS) Must have oligoamenorrhea and hyperandrogenemia --Prior/Concurrent Therapy-- At least 2 months since prior standard therapy (including over the counter drugs) At least 2 months since prior investigational agents --Patient Characteristics-- Hematopoietic: Hematocrit greater than 38% Hepatic: Liver function normal No clinically significant hepatic disease Renal: No clinically significant renal disease Creatinine less than 1.4 mg/dL No proteinuria Cardiovascular: No clinically significant cardiac disease Pulmonary: No clinically significant pulmonary disease Hormonal: Thyroid function normal Prolactin normal Fasting 17 alpha-hydroxy progesterone less than 200 mg/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No diabetes mellitus No clinically significant neurologic, psychiatric, infectious, neoplastic, or metabolic disease No clinically significant malignant disease except nonmelanomatous skin cancer At least 1 year since any prior drug abuse or alcoholism

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: clomiphene citrate|nan|
|Drug: metformin|nan|

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
-----------------
endocrine disorders, hyperinsulinism, polycystic ovarian syndrome, rare disease