linjc16/ctgov huggingface dataset:
Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment

Study Overview
=================
Brief Summary
-----------------
The study is designed to answer the following questions: What is the levels of visceral adiposity index and Triglycerides/HDL cholesterol ratio in hypogonadism? What is the effect of testosterone replacement on the visceral adiposity index and Triglycerides/HDL cholesterol ratio?

Detailed Description
-----------------
This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2007-2010.

Official Title
-----------------
Phase 4 Study of Effect of Testosteron Treatment on the Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men Congenital hypogonadism Treatment Naive Exclusion Criteria: Previous history of androgen replacement Hypertension Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 26 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: testosterone<br>testosterone gel per day for 6 months testosterone 250 mg injection per 3-4 weeks for 6 months | Drug: Testosterone<br>* Testosterone 250 mg injection per 3-4 weeks for 6 months<br>* Other names: sustanon 250 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to change of visceral adiposity index with testosteron replacement |  | baseline and 6 months | 
| time to change of TG/HDL cholesterol ratio with testosteron replacement |  | baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
visceral adiposity index, triglycerides / hdl cholesterol ratio, testosterone
Magnesium Associated With Morphine for Cancer Pain Relief

Study Overview
=================
Brief Summary
-----------------
This study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain.

Detailed Description
-----------------
The study is prospective, randomized, double-blind. The patients will be allocated into two groups. After approval by the Ethics Committee and signed informed consent, 40 patients, aged > 18 years of both genders with cancer pain, will be studied. The patients in group 1 (n = 20) will receive a dose of magnesium sulfate (65 mg) po twice daily. Patients in Group 2 (n = 20) will receive placebo twice a day. The Mg and placebo capsules are identical. Everyone will receive morphine as needed. Will be recorded: tumor location, factors which worsen the pain, quality of pain. Pain intensity will be assessed by numerical scale from zero to 10 at T0 (first visit) and after 1, 2, 3. and 4wk. The patient will note the intensity of pain and side effects at home. Functional performance assessment will bes done by the Karnofsky Performance Status Scale. Quality of life will be assessed by the QLQ-c30.

Official Title
-----------------
Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief

Conditions
-----------------
Cancer-related Problem/Condition

Intervention / Treatment
-----------------
* Drug: Magnesiun


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After approval by the Ethics Committee and signed informed consent, 40 patients, > 18 years, with cancer pain, and taking morphine (third step of the analgesic ladder recommended by WHO) were studied Exclusion Criteria: Were excluded from the study patients with hypersensitivity to drugs and pregnant

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
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Magnesiun, pain relief, sugar pills<br>Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h | Drug: Magnesiun<br>* 75mg pills; each 12h; 12wk<br>* Other names: NMDA receptor antagonist;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief |  | 12 wk | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine dose |  | 12 wk | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer pain, Magnesiun
Elevated LDH Serum Levels and FDG-PET in Metastatic Melanoma Patients

Study Overview
=================
Brief Summary
-----------------
A retrospective study investigating the relationship between FDG-PET uptake and LDH levels.

Detailed Description
-----------------
Patient characteristics, tumour characteristics including the BRAF mutation status and baseline serum S100B and LDH levels of each patient will be retrospectively determined from the electronical patient file. In each patient, tumour burden and 18F-FDG uptake of the tumour lesions will be measured using multiple standard quantification parameters of the baseline 18F-FDG-PET scan. Tumour burden will also be measured on the baseline contrast enhanced CT scan. The correlation of each FDG-PET parameter with baseline LDH and S100B levels, respectively, will be analyzed using univariate and multivariate regression analysis.

Official Title
-----------------
Elevated LDH Serum Levels and FDG-PET in Metastatic Melanoma Patients

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients >18 years with histologically proven metastatic melanoma (American Joint Committee on Cancer [AJCC] stage IV melanoma) treated in the UMCG between May 2014 and December 2015. Exclusion Criteria: participation in interventional studies missing baseline 18F-FDG PET scan and/or baseline contrast enhanced CT scan missing baseline serum LDH level missing BRAF mutation status, concurrent malignancies or a history of previous malignancies.

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 |
| --- | --- |
| Metastatic melanoma patients<br>All patients >18 years with histologically proven metastatic melanoma (American Joint Committee on Cancer [AJCC] stage IV melanoma) treated in the UMCG between May 2014 and December 2015. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Independent correlation between baseline serum LDH level and 18F-FDG uptake of tumour lesions |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between baseline serum LDH level and tumour 18F-FDG uptake in subgroups separated by metastasis site |  | 3 months | 
| Correlation between baseline serum S100B level and tumour 18F-FDG uptake |  | 3 months | 
| Difference between tumour burden as measured on CT scan and on 18F-FDG-PET |  | 3 months | 
| Difference between tumour volume as determined by manual measurement or semiautomatic measurement |  | 3 months | 
| Correlation of baseline serum LDH level with tumour volume as measured on CT scan and as measured on 18F-FDG-PET scan |  | 3 months |
The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus

Study Overview
=================
Brief Summary
-----------------
Cap assisted colonoscopy, a simple technique of fixing a transparent plastic cap to the tip of the colonoscope, was proven to increase the adenoma detection rate during screening colonoscopy by helping to depress and flatten colonic folds, thereby improving visualization and decreasing blind mucosal areas. The usefulness of cap assisted upper endoscopy (CAE) is still under investigations. The aim of this study is to compare the diagnostic yield of the CAE to the standard endoscopy in esophagus.

Official Title
-----------------
Comparison Between Standard Endoscopy and Cap Assisted Endoscopy for Diagnostic Yield in Esophagus

Conditions
-----------------
Endoscopic Diagnosis in Esophagus

Intervention / Treatment
-----------------
* Procedure: cap assisted upper endoscopy
* Procedure: standard upper endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for upper endoscopy age over 18 years ability to provide informed consent Exclusion Criteria: known or suspected upper gastrointestinal strictures upper gastrointestinal bleeding previous upper endoscopy during the last three months American Society of Anesthesiologists class III or higher

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>subjects receive standard upper endoscopy | Procedure: standard upper endoscopy<br>* standard examination without using a cap<br>|
| Experimental: Group B<br>subjects receive cap assisted upper endoscopy | Procedure: cap assisted upper endoscopy<br>* A soft plastic cap is attached to the tip of the scope to allow pressing of the folds and thus enhance the visualization.<br>* Other names: cap fitted upper endoscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield in esophagus | All endoscopic abnormalities in esophagus which are detected during the examination in both groups will be documented, analyzed and compared | 15 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall diagnostic yield in upper gastrointestinal tract. | All other endoscopic abnormalities outside the esophagus (stomach and duodenum) which are detected during the examination in both groups will be documented, analyzed and compared | 15 Minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
upper endoscopy, cap assisted endoscopy, esophagus
Vaspin Levels Compared With Serum Insulin and Blood Glucose Levels in Neonates

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate circulating concentrations of vaspin in fetal and neonatal samples from SGA, AGA and LGA with the respective insulin concentrations. Serum vaspin concentrations were determined by enzyme immunoassay in 22 SGA and 30 LGA and 30 AGA singleton full-term fetuses and neonates on cord blood and postnatal day 5.

Official Title
-----------------
Zekai Tahir Burak Maternity Teaching Hospital

Conditions
-----------------
Insulin Sensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full term healthy infant Exclusion Criteria: sepsis congenital anomaly sick infant

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 5 Days

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 |
| --- | --- |
| SGA<br>SGA (small for gestational age) | |
| LGA<br>LGA (large for gestational age) | |
| AGA<br>AGA (appropriate-for-gestational-age) | |

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
-----------------
Vaspin, LGA, SGA, Insulin, Blood glucose
Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol

Study Overview
=================
Brief Summary
-----------------
Vocal cord injuries occur not only during tracheal intubation, but also during surgery and during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less vocal cord injuries than a total intravenous anesthesia with propofol.

Detailed Description
-----------------
Volatile anaesthetics increase neuromuscular block of neuromuscular blocking drugs. We tested the hypothesis, that sevoflurane would cause less vocal cord injuries than an intravenous anaesthesia with propofol. Sixty five patients were randomly assigned to the SEVO group (anaesthesia with sevoflurane) or TIVA group (anaesthesia with propofol). Vocal cord injuries were examined by stroboscopy before and 24 and 72 h after surgery; hoarseness was assessed up to 72 h.

Official Title
-----------------
Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Anesthesia With Sevoflurane and Intravenous Anesthesia With Propofol A Randomized, Prospective, Controlled Trial

Conditions
-----------------
Vocal Cord; Injury, Superficial

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: orotracheal intubation surgery of the ear written consent ASA I-III Exclusion Criteria: preexisting pathologies of the vocal cords obesity difficult airway

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane<br>Anesthesia was maintained with sevoflurane during surgery. | Drug: Sevoflurane<br>* Maintenance of anesthesia with sevoflurane 1.0 Vol%<br>* Other names: remifentanil;|
| Active Comparator: Anesthesia with propofol<br>Anesthesia was maintained with propofol during surgery. | Drug: propofol<br>* Maintenance of anesthesia with propofol<br>* Other names: remifentanil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of vocal cord injuries | assessed by stroboscopy | 24h after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hoarseness |  | 24h after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hoarseness, sore throat, vocal cord injuries
A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ICS).

Official Title
-----------------
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: lebrikizumab (MILR1444A)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight 40 kg--150 kg Chest radiograph with no evidence of clinically significant abnormality Uncontrolled asthma Exclusion Criteria: Asthma exacerbation during screening Known malignancy Known immunodeficiency Pre-existing lung disease other than asthma Uncontrolled clinically significant medical disease Current smoker History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator Prior allergic reaction to a monoclonal antibody Patients (men and women) of reproductive potential who are not willing to use contraception Pregnancy

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: lebrikizumab (MILR1444A)<br>* Subcutaneous repeating dose<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* Subcutaneous repeating dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in forced expiratory volume in 1 second (FEV1) |  | From baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pre-bronchodilator FEV1 |  | From baseline to Week 24 | 
| Change in quality of life and symptom scores |  | From baseline to Week 12 | 
| Change in peak flow |  | From baseline to Week 1 | 
| Rate of asthma exacerbations |  | During the 24 week treatment period | 
| Change in rescue medication use |  | From baseline to Week 1 | 
| Frequency and severity of adverse events |  | Through study completion or early study discontinuation | 
| Incidence of human anti-therapeutic antibodies (ATA) |  | At the end of the follow-up period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult Asthma
Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery

Study Overview
=================
Brief Summary
-----------------
This multicentric, prospective study will evaluate the medium-term outcomes of patients implanted with GORE VIABAHN® stent grafts for popliteal artery aneurysms in scheduled elective surgery with the registry of the Research in Vascular Surgery University Association (AURC)

Official Title
-----------------
Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery: Multicenter Prospective Registry of the Research in Vascular Surgery University Association (AURC)

Conditions
-----------------
Popliteal Aneurysm

Intervention / Treatment
-----------------
* Device: Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old at time of treatment symptomatic or asymptomatic popliteal artery aneurysm needing surgery scheduled elective surgery Exclusion Criteria: life expectancy of <1 year thrombotic occlusion of popliteal artery intolerance to antiplatelet drugs (antiaggregants) known allergies to GORE VIABAHN® stent graft materials/composition emergency surgery

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 |
| --- | --- |
| Popliteal aneurysm patients with GORE VIABAHN®<br>The study population will include all popliteal aneurysm patients treated with GORE VIABAHN® stent graft in scheduled elective surgery, whether symptomatic or asymptomatic. | Device: Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery<br>* The intervention can be performed under local anesthesia (LA), regional locus (ALR) or general anesthesia (AG) (data collected) by first approach: percutaneous or conventional. The data collected are: Number of GORE VIABAHN® stent used (length and diameter of each) Embolization of collaterals and other related actions Operative complications Intraoperative fibrinolysis Collar cover> 2 cm Lack of overlap in the overlap zone (nb: between 4 and 8 cm above the joint spacing) Arteriography in profile, kink<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major limb events | Composite criterion associating Target Lesion Revascularization (TLR) and Rate of major amputation. An Echo-Doppler imaging examination will be performed and the following parameters and information should be collected: Permeability Intra-stent restenosis Systolic pressure index | 2 years of follow-up |