linjc16/ctgov huggingface dataset:
Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS)

Study Overview
=================
Brief Summary
-----------------
the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.

Detailed Description
-----------------
the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.

Official Title
-----------------
Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS): an International Multicenter Study

Conditions
-----------------
Adrenal Disease, Renal Cancer, Surgery--Complications

Intervention / Treatment
-----------------
* Procedure: laparoscopic surgery for renal and adrenal diseases


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: renal diseases with indication to surgery adrenal masses Exclusion Criteria: open surgery in principle

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| complicated patients<br>patients underwent to laparoscopic renal and adrenal surgery with intraoperative complications | Procedure: laparoscopic surgery for renal and adrenal diseases<br>* type of treatment for patients underwent to laparoscopic surgery for renal and adrenal diseases with intraoperative complications<br>|
| uncomplicated patients<br>patients underwent to laparoscopic renal and adrenal surgery with no complication during surgical procedure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative complications | evaluation of intraoperative complication and their resolution | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic surgery, renal surgery, adrenalectomy, complication in laparoscopic surgery
Molecular Markers and Genetic Markers in Patients Undergoing Radiation Therapy for Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at molecular markers and genetic markers in patients undergoing radiation therapy for cancer.

Detailed Description
-----------------
OBJECTIVES: Primary Determine local-regional control in patients undergoing radiation therapy for cancer, as a function of expression of specific molecular/genetic markers. Secondary Determine complications of radiation therapy for patients undergoing radiation therapy for cancer. OUTLINE: Previously collected tissue samples are analyzed using immunohistochemical staining and other molecular/genetic study methods to detect markers, including p53, cyclin D1, HER-2-neu, bcl-2/BAX, and EGFR. Patient charts are also reviewed with emphasis on local-regional relapse.

Official Title
-----------------
Molecular and Genetic Markers in the Local-regional Management of Patients Undergoing Radiation Therapy

Conditions
-----------------
Hematopoietic/Lymphoid Cancer, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of cancer Undergoing radiation therapy for malignant disease PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific, hematopoietic/lymphoid cancer
My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)

Study Overview
=================
Brief Summary
-----------------
My Baby Biome is an observational study that will use 600 infant stool samples to determine the biomarkers associated with a healthy infant gut. Biomarkers identified in this study will be used to develop precision probiotics and LBPs for improving infant gut health outcomes to the benefit of all infants. Parents will be asked to submit follow-up questionnaires regarding infant immune health to improve insights obtained from the data.

Official Title
-----------------
My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)

Conditions
-----------------
Dysbiosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Infants under 2 weeks or over 2 months old Infants given any antibiotic or probiotic treatments Infants delivered prematurely or admitted to the NICU outside of establishment of normal feeding Infants with mothers under the age of 18 Infants with mothers known to have HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV2

Ages Eligible for Study
-----------------
Minimum Age: 0 Months
Maximum Age: 2 Months

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the composition of a healthy infant microbiome | Stool samples will be analyzed for bacterial metagenomics, metabolomics, proteomics, and transcriptomics to define biomarkers (such as bacteria or proteins) that are correlated with healthy infants as defined by the accompanying questionnaire. | 6-12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate impact of the microbiome on immune adverse events | Metadata from questionnaires regarding child immune health will be correlated with the metagenomic gut microbiome composition obtained from the stool sample to define the impact of individual strains on immune adverse events (i.e. allergies, diabetes, asthma, eczema) | 7 Years | 
| Build a library of samples and data for future research | Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata. | 6-12 Months |
Sugammadex Reversal of Neuromuscular Blockade and Postoperative Bleeding

Study Overview
=================
Brief Summary
-----------------
Sugammadex is new drug that is used for reversal of rocuronium induced muscle relaxation. benefits of reversal of neuromuscular blockade appears to be of great value in living donor liver transplant recipients. However, Few Clinical reports have investigated the anticoagulant effect of sugammadex. In this study, effects of sugammadex on bleeding profile of living donor liver transplantation will be investigated.

Conditions
-----------------
Blood Coagulation Tests ( INR, APTT)

Intervention / Treatment
-----------------
* Drug: Sugammadex intravenous
* Drug: Intravenous neostigmine and atropine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all candidates for living donor liver transplantation Exclusion Criteria: massive intraoperative bleeding manifestations of early graft dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Reversal of neuromuscular blockade will be performed using classic drugs (neostigmine 80 mic/kg and atropine 40 mic/kg) | Drug: Intravenous neostigmine and atropine<br> <br> |
| Experimental: Sugammadex group<br>Reversal of neuromuscular blockade will be performed using Sugammadex 2mg/kg | Drug: Sugammadex intravenous<br>* Intravenous Injection of sugammadex (2 mg/kg) for reversal of rocuronium induced muscle relaxation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activated partial thromboplastin tile in seconds |  | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| international normalized ratio in second |  | 30 min |
V/Q SPECT for Diagnosis of Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to assess diagnostic performance of V/Q SPECT for the diagnosis of pulmonary embolism by comparing V/Q SPECT results to a validated diagnostic strategy.

Official Title
-----------------
Performance of V/Q SPECT for the Diagnosis of Pulmonary Embolism

Conditions
-----------------
Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary embolism suspicion

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment

Study Overview
=================
Brief Summary
-----------------
Background: Pasireotide treatment is strictly associated with glucose metabolism impairment. The aim of the study was to evaluate the effect of pasireotide on β -cell and adipose function in patients with Cushing's disease (CD). Methods: Clinical and hormonal parameters, insulin secretion, evaluated by homostasis model assessment (HOMA-β) and by the area under the curve (AUC2h) of C-peptide during a mixed meal tolerance test and insulin sensitivity, evaluated by the euglycemic hyperinsulinemic clamp, were evaluated in 12 patients with active CD before and after 12 months of pasireotide. Circulating adipokines were evaluated in patients with CD compared to a matched group of 12 diabetic patients.

Official Title
-----------------
Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters

Conditions
-----------------
Cushing Disease

Intervention / Treatment
-----------------
* Drug: Pasireotide 0.6 MG/ML


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with active Cushing's disease. Exclusion Criteria: pituitary radiotherapy treatment performed less than 5 years before pasireotide, pregnancy, women taking oral contraceptives, diabetes on GLP-1 analogues, DPP4 inhibitors or sulphonylureas treatment, intolerance to SSA, risk conditions for prolonged QT syndrome and severe liver o renal insufficiency.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pasireotide<br>Pasireotide was administered in a 12 months period | Drug: Pasireotide 0.6 MG/ML<br>* The aim of the study was to evaluate the effect of pasireotide on β -cell and adipose function in patients with Cushing's disease (CD).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of circulating adipokines levels |  | Change from baseline to 12 months of therapy | 
| Change of homeostasis model assessment (HOMA-β ) |  | Change from baseline to 6 and 12 months of therapy | 
| Change of area under the curve (AUC2h) of C-peptide during a mixed meal tolerance test |  | Change from baseline to 6 and 12 months of therapy | 
| Change of M value evaluated by the euglycemic hyperinsulinemic clamp |  | Change from baseline to 12 months of therapy |
Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.

Official Title
-----------------
A Bioavailability Study of Four Experimental BMS-708163 Formulations Relative to Solubilized Capsule Formulation in Healthy Young Male Subjects

Conditions
-----------------
Alzheimer's Disease, Healthy

Intervention / Treatment
-----------------
* Drug: BMS-708163
* Drug: BMS-708163
* Drug: BMS-708163
* Drug: BMS-708163
* Drug: BMS-708163


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young healthy male subjects Exclusion Criteria: Women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A (Reference)<br> | Drug: BMS-708163<br>* Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.<br>|
| Active Comparator: Treatment B<br> | Drug: BMS-708163<br>* Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings<br>|
| Active Comparator: Treatment C<br> | Drug: BMS-708163<br>* Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings<br>|
| Active Comparator: Treatment D<br> | Drug: BMS-708163<br>* Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings<br>|
| Active Comparator: Treatment E<br> | Drug: BMS-708163<br>* Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the bioavailability of 4 experimental formulations relative to the current reference formulation |  | Day 1, up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse Events |  | Day 1, up to 3 weeks | 
| Safety: Vital Signs |  | Screening, Day 1 and Day 4 of each period | 
| Safety: ECGs |  | Screening, Day 1 of each period, up to 3 weeks | 
| Safety: Clinical Lab Tests |  | Screening, Day -1 of each period, Day 1, up to 3 weeks |
Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

Official Title
-----------------
Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis

Conditions
-----------------
Chronic Renal Failure

Intervention / Treatment
-----------------
* Drug: bixalomer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kiklin group<br>Oral | Drug: bixalomer<br>* Oral<br>* Other names: ILY101;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests |  | Baseline and 1, 2, 3, 6, 12 months after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum phosphorous levels |  | Baseline and 1, 2, 3, 6, 12 months after administration | 
| Serum albumin level |  | Baseline and 1, 2, 3, 6, 12 months after administration | 
| Serum calcium level |  | Baseline and 1, 2, 3, 6, 12 months after administration | 
| Serum intact PTH (parathyroid hormone) level |  | Baseline and 1, 2, 3, 6, 12 months after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritoneal dialysis, Bixalomer, Chronic renal failure patients with Hyperphosphatemia, Kiklin®
Efficacy and Safety of 5% Lidocaine Patch With Placebo Patch in Subjects With Herpes Zoster Associated Pain

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of 5% lidocaine patch, following placebo or active patch applications in placebo insensitive subjects.

Official Title
-----------------
An Open-Label, Single and Multiple-Dose, Two-Period, Consecutive Study in Healthy Chinese Subjects to Assess the Pharmacokinetic Profiles, Safety and Tolerability of Lidocaine Patch 5%.LIG13-CN-101 Study

Conditions
-----------------
Herpes Zoster Pain

Intervention / Treatment
-----------------
* Drug: 5% Lidocaine patch
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects 18 to 85 years of age. Subjects must have herpes zoster associated pain present for ≥1 months after healing of the acute herpes zoster skin rash and not located on the face, scalp; the diagnosis will be based on physical examination and review of available medical records confirming an episode of herpes zoster. Herpes zoster associated pain must be of at least moderate severity, defined as the average pain level ≥40 mm on a 100 mm visual analog scale (VAS slide ruler) Exclusion Criteria: Subjects with signs of cord or brainstem injury from herpes zoster. Presence of another pain problem of greater severity than their herpes zoster associated pain. Subjects who have undergone neurolytic nerve blocks or ablative neurosurgical procedures for control of herpes zoster associated pain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Active Comparator: Lidocaine<br>Active arm with administration of active 5% Lidocaine patch | Drug: 5% Lidocaine patch<br>* 5% Lidocaine patch to be placed on the site of pain<br>* Other names: Lignopad;|
| Placebo Comparator: Placebo<br>Placebo arm with administration of placebo patch | Drug: Placebo<br>* Placebo patch to be placed on the site of pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of VAS score | Mean change in the mean pain VAS score | over 24 hour from baseline to the post-treatment over time during double-blind period |
Sex Hormones & Serum Sclerostin Level

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether plasma sclerostin levels is affected by sex hormones during menstrual cycle. Blood samples will be obtained at the beginning (between 2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle. Serum sclerostin, estradiol, progesterone and testosteron levels will be measured blindly by only one investigator

Detailed Description
-----------------
This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board. This study will be completed with 40 premenopausal healthy volunteer women. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained at the beginning (between 2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle. Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of plasma will be added to Ependorf tubes and stored at -20°C. Plasma sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the manufacturer's instructions. The minimum detectable concentration of human sclerostin is typically <0.012 ng/ml. Intra-assay precision is less than 8%. Estradiol and progesterone levels will be analyzed in serum samples using an electrochemiluminescence immunoassay (Elecsys PTH, Elecsys-estradiol II; Roche Diagnostics, Mannheim, Germany) and the Cobas 601 analyzing system (Roche Diagnostics). Free testosteron levels will be analyzed in serum samples using an RIA (radio immun assay) (DSL 4900 Testosterone, Free, Active® RIA Assay kit, Beckman Coulter) and the DSL 4900 Berthold Technologies Multi Crystal LB 2111 model gama counter.

Official Title
-----------------
Effects Of Sex Hormones On Serum Sclerostin Level During Menstrual Cycle

Conditions
-----------------
Bony Sclerosis, Testicular; Hormone, C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premenopausal women healthy volunteer Exclusion Criteria: Endocrinopathies Bone disease (osteoporosis, osteomalacia, paget disease etc) Women who used hormonal drug within last six months Cognitive disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Serum sclerostin level | Changes in serum sclerostin level by sex hormons during menstrual cycle | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sclerostin, estradiol, progesterone, testosteron, sex hormones