linjc16/ctgov huggingface dataset:
Expanded Access to REGN4461 for Patients With Lipodystrophy or Monogenic Obesity With Complications of Leptin Deficiency or Deficient Leptin Signaling

Study Overview
=================
Brief Summary
-----------------
Provide Expanded Access to REGN4461 for patients with lipodystrophy or monogenic obesity with complications of leptin deficiency or deficient leptin signaling

Detailed Description
-----------------
Expanded Access requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. Availability will depend on location.

Intervention / Treatment
-----------------
* Drug: REGN4461


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: REGN4461|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
-----------------
Leptin (LEP), Leptin Receptors (LEPR)
The Effects of Caffeine on Heart Rate and Heart Rate Variability

Study Overview
=================
Brief Summary
-----------------
In previous research we have shown that an acute caffeine dose of 5 mg/kg body mass reduces heart rate at rest and during low intensity exercise, with the effect dissipating as exercise intensity increases. If, as suspected, the effect at rest and at low intensities is due to an effect of caffeine on parasympathetic activity, this is likely to be reflected in an increase in heart rate variability (the beat-to-beat fluctuation in heart rate). The aim of this study is therefore to investigate the effect of caffeine on heart rate and heart rate variability at rest and during submaximal exercise.

Official Title
-----------------
The Effects of Caffeine Supplementation on Heart Rate and Heart Rate Variability at Rest and During Submaximal Exercise

Conditions
-----------------
Caffeine

Intervention / Treatment
-----------------
* Drug: Caffeine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trained cyclists Exclusion Criteria: Injured or a contraindicative medical condition

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caffeine<br>caffeine dose of 5 mg per kg of body mass administered orally via a gelatine capsule | Drug: Caffeine<br>* Single pill in an acute dose of 5 mg per kg of body mass<br>|
| Placebo Comparator: Placebo<br>maltodextrin (placebo) dose of 5 mg per kg of body mass administered orally via a gelatine capsule | Drug: Placebo<br>* Single pill in an acute dose of 5 mg per kg of body mass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | Change from baseline in heart rate variability measured at rest and at five different exercise intensities (40, 50, 60, 70 and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer | From baseline to completion, up to 31 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Change from baseline in heart rate measured at rest and at five different exercise intensities (40, 50, 60, 70 and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer | From baseline to completion, up to 31 days |
Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- Compatibility

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINBACK Tangerine Mix.

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age between 18 and 60 years old; Phototype Skin I,II, III e IV; Integral skin test in the region; Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; Exclusion criteria: Lactation or gestation; Personnel history of atopy; History of sensitivity or irritation for topic products; Active cutaneous disease; Use of new drugs or cosmetics during the study;

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lactic Acid | Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)<br>* Lactic Acid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. |  | Throughout the study |
Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male

Official Title
-----------------
Randomized, Open, 2-way Cross Over, Single Dose Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI: 18.0 - 27.0 kg/m2 Willingness to sign the written Informed Consent Form Exclusion Criteria: Evidence of clinically relevant pathology History of relevant drug and food allergies Positive screen on drugs of abuse Participation in a drug study within 60 days prior to drug administration.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCP 1004<br> | |
| Vimovo 500/20mg<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast, Cmax of Naproxen and Esomeprazole |  | Naproxen : 0h,30min, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72h, Esomeprazole : 0h, 10min, 20min, 30min, 45min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax, t1/2, CL/F, AUCinf of Naproxen and Esomeprazole |  | Naproxen : 0h, 30min, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72h Esomeprazole: 0h, 10min, 20min, 30min, 45min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12h |
Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study aims to evaluate frequence of acute renal insufficiency in patients with ST-segment elevation who need urgent coronary angiography in Ambroise Paré hospital. The secondary objectives are: identify factors of risks associated with the occurrence of acute renal insufficiency after coronarography. establish a preprocedure score, predicting of acute renal insufficiency after urgent coronary angiography in patients with ST+ acute coronary syndrome.

Official Title
-----------------
Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography

Conditions
-----------------
Acute Renal Insufficiency, Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient aged ≥ 18 years; evocative symptoms of myocardiac ischemia: typical chest pain; ST-segment elevation and 1 mm in two consecutive peripheral leads and 2 mm in two consecutive precordial derivations, or appearance of a bloc of left branch of novo; need urgent coronarography; Covered by french social security scheme included CMU. Exclusion Criteria: dialysed patient for chronic renal insufficiency; cardio-resporatory arrest; cardiogenic choc state; prior emergency passage to hospital; patient under tutor, gardianship; patient covered by french AME scheme; pregnant women or breastfeeding; all medical, psychological or social situation which should influents the compliance to protocol according to investigator; patient refusal.

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 |
| --- | --- | --- |
| incidence of acute renal failure | Acute renal failure is defined as an increase in plasma creatinine of at least 26.5µmol/l within 48 hours, or an increase in plasma creatinine of at least 1.5 times plasma creatinine within 48hours of hospitalisation | at baselin and at 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Renal Insufficiency, Acute Coronary Syndrome
Brain Energy and Cognition

Study Overview
=================
Brief Summary
-----------------
This proposed laboratory study will extend previous findings on relationships between cognitive function and nutritional status to conditions that more closely resemble military operations where aerobic exercise, inadequate nutritional intake and sleep deprivation combine to degrade cognitive function. The investigators will examine cognitive function, brain activity and glucose levels in volunteers who are calorie-deprived, performing high workload cognitive tests, exercising and, in one arm of the study, are sleep-deprived for approximately 48 hours. A comprehensive cognitive test battery will be repeatedly administered and several cognitive tests will be administered when volunteers are exercising. Interstitial glucose levels will be assessed and whole body nitrogen utilization determined. The effects of energy restriction and the physiological basis of the relationship between peripheral glucose levels and cognitive function will be examined using a state-of-the-art imaging technology, functional Magnetic Resonance Imaging (fMRI). This technique will allow any key brain regions affected by caloric deprivation to be identified.

Official Title
-----------------
Brain Energy and Cognition

Conditions
-----------------
Energy Restriction, Sleep Deprivation

Intervention / Treatment
-----------------
* Other: Sleep Deprivation
* Other: Energy Restriction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MUST BE ACTIVE DUTY ARMY STATIONED AT NATICK SOLDIER SYSTEMS CENTER Fluent in English (non-native English speakers can be enrolled); males and females aged 18 - 39 years. Exclusion Criteria: Not yet reached 18th birthday, metal implants - which can interfere with fMRI scanning; fear of small places; pregnant (USARIEM will test for pregnancy), Attention Deficit Hyperactivity Disorder (ADHD) - if previously documented by a waiver; acute or chronic physical limitation that would hinder performing cycle exercise; known allergies to medical adhesives.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energy Restriction<br> | Other: Energy Restriction<br>* Energy Restriction<br>|
| Experimental: Sleep Deprivation<br> | Other: Sleep Deprivation<br>* Sleep Deprivation<br>|

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
-----------------
energy restriction, sleep deprivation, cognitive performance, brain function
A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients

Study Overview
=================
Brief Summary
-----------------
The ARIES HSV 1&2 Assay is a PCR based test for the direct detection and typing of herpes simplex virus (HSV 1 & 2) DNA. The objective is to establish the diagnostic accuracy of ARIES HSV-1&2 Assay.

Detailed Description
-----------------
The ARIES HSV 1&2 Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and typing of herpes simplex virus (HSV 1 & 2) DNA in male external and internal anogenital, female external and internal anogenital (vaginal), oral and skin lesion specimens. The objective is to establish the diagnostic accuracy of ARIES HSV-1&2 Assay through a multi-site, method comparison on prospectively collected, left-over de-identified, clinical specimens (i.e. all-comers accrued at enrolled clinical sites between pre-determined dates) as an aid in the diagnosis of herpes infection.

Official Title
-----------------
A Two Arm, Multi-Site Clinical Evaluation of the ARIES HSV 1&2 Assay in Symptomatic Patients

Conditions
-----------------
Herpes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The specimen is from one of the following lesion sources: male internal and external anogenital, female internal anogenital, female external anogenital, oral or skin The specimen is collected and maintained in unexpired Copan universal transport medium Exclusion Criteria: The specimen was not properly collected, transported or stored according to instructions provided by Sponsor
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blinded, Prospective Arm<br>The diagnostic accuracy for lesions from individuals suspected of having a herpes infection will be evaluated in prospectively collected, left-over de-identified, clinical specimens accrued between pre-defined dates. | |
| Blinded, Pre-selected Arm<br>For specimen types that are less common, banked, pre-selected, positive clinical specimens will be tested. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement). |  | Within the first year of sample collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARIES HSV 1&2
Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of rectal cancer.

Detailed Description
-----------------
Rectal cancer is the second cause of mortality after lung cancer in industrialized countries and represent 28% of colorectal carcinomas. Despite major improvements in diagnosis and treatment made those last years,mortality and morbidity remains high, because of high prevalence of metastasis and local recurrence. A accurate initial staging is of paramount importance for an appropriate treatment (neoadjuvant chemiotherapy and radiotherapy, surgery). Actually, there is no international consensus concerning imaging for the staging of rectal cancer and modalities used are variable from one center to another. WB-MRI represented a attractive and promising technique for the staging of rectal cancer, free of ionizing radiation .

Official Title
-----------------
Diagnostic Value of Whole-Body MRI Compared to FDG-PET-CT for Rectal Cancer Preoperative Staging, Before and After Neoadjuvant Treatment

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rectal cancer T3 N+ or T3 or T4 Exclusion Criteria: renal failure allergy to iodinated contrast medium contraindication to MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment | We will compare for each body region the findings of the whole-body MRI to the FDG-PET-CT considered as the gold-standard and measure sensibility/specificity and diagnostic accuracy of the whole-body MRI for distant lesions of rectal cancer. | baseline and 1 week before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumoral regression after neoadjuvant treatment | Evaluate the tumoral regression after neoadjuvant treatment on the MRI by the measurement of the ADC (attenuation diffusion coefficient) increase and compare the results to the measure of the SUV (standard uptake value) decrease on the FDG-PET-CT. | baseline and six weeks after the end of the neoadjuvant treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectal cancer, Whole-body MRI, FDG-PET-CT, preoperative staging
Renal Function Measurements in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate a feasible, safe and reliable iohexol plasma clearance method in routine monitoring of the renal function (GFR) in children. Different parameters of renal function will be compared to the gold standard multiple sample points procedure of iohexol clearance.

Official Title
-----------------
Glomerular Filtration Rate in Children - a Methodological Study With Iohexol Clearance

Conditions
-----------------
Renal Function Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 18 years Clinical indication for measurement of glomerular filtration rate Exclusion Criteria: Previous serious reaction on Iohexol

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glomerular Filtration Rate, Kidney disease, Child, Iohexol, Cystatin C, Measurement of kidney function in children
Serum Biomarker HE4 During IVF Treatment

Study Overview
=================
Brief Summary
-----------------
Human epididymal secretory protein 4 (HE4) is a new biomarker for ovarian cancer. The effect of IVF stimulation will be evaluated in order to see whether severe hormonal changes in the gonadotrophin and steroid status affect the serum levels of this marker. Findings will be compared to serum concentrations of CA-125, which is currently the most often used marker for ovarian cancer. The intention is to determine the serum concentration of HE4 and CA-125 in serial samples in 20 women undergoing IVF stimulation. Samples will be taken following GnRH agonist suppression, 2-3 times during FSH stimulation, at ovum pick up and two weeks following embryo transfer at the time of the hCG-test. The ovarian follicle count and the serum estradiol concentrations are recorded throughout the treatment. The serum biomarker HE4 is expected to ba a stable marker, which does not respond significantly to hormonal stimulation.

Official Title
-----------------
Serum Concentration of HE4, a New Marker for Ovarian Cancer, Changes Little Throughout IVF Stimulation

Conditions
-----------------
IVF Treatment, Human Epididymal Secretory Protein E4

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertility treated by IVF Exclusion Criteria: pelvic tumor overweight (BMI over 35)

Ages Eligible for Study
-----------------
Minimum Age: 27 Years
Maximum Age: 39 Years

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

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
-----------------
HE4, IVF, Biomarker, Ovarian cancer, Infertility