linjc16/ctgov huggingface dataset:
Postprandial Blood Cell Transcriptome of Normal Weight and Obese Subjects to 3 Caloric Doses of a High-fat Meal

Study Overview
=================
Brief Summary
-----------------
The study will quantitatively evaluate the metabolic response of normal weight and obese subjects to three high-fat meals differing in caloric dose by analysing the postprandial blood transcriptome.

Official Title
-----------------
Identification of Nutritional Health Biomarkers for Metabolic Flexibility in Blood - a Randomized, Postprandial, Caloric Dose-response Strategy

Conditions
-----------------
Obesity, Nutritional Intervention

Intervention / Treatment
-----------------
* Other: high-fat meal A
* Other: high-fat meal B
* Other: high-fat meal C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for normal weight subjects: age 25-50 20<BMI>25 waist circumference <94cm Inclusion Criteria for obese subjects: age 25-50 30<BMI>40 waist circumference >102cm Exclusion Criteria for both groups: physiological or psychological diseases allergies to food or intolerance to high-fat meal vegetarians, vegans chronic intake of drugs smokers diabetes mellitus type I and II debiliating kidney disease debiliating liver disease clinically established coronary heart diseases ingestion of vitamins or dietary supplements during the course of the study

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 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: normal weight subjects<br> | Other: high-fat meal A<br> <br> * Other names: high-fat meal consisting of 500 kcal;Other: high-fat meal B<br> <br> * Other names: high-fat meal B consisting of 1000 kcal;Other: high-fat meal C<br> <br> * Other names: high-fat meal C consisting of 1500 kcal;|
| Experimental: obese subjects<br> | Other: high-fat meal A<br> <br> * Other names: high-fat meal consisting of 500 kcal;Other: high-fat meal B<br> <br> * Other names: high-fat meal B consisting of 1000 kcal;Other: high-fat meal C<br> <br> * Other names: high-fat meal C consisting of 1500 kcal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood cell transkriptome/ gene-expression | differently expressed genes between normal weight and obese subjects at baseline changes in gene-expression 2, 4 and 6h after consumption | 0h, 2h, 4h, 6h |
Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction

Study Overview
=================
Brief Summary
-----------------
Multiple sclerosis (MS), debilitating disease involving primarily the central nervous system, may cause cardiovascular dysfunction, due to autonomous nervous system dysfunction, physical invalidity, increased oxidative stress, and systemic inflammatory status, but the detailed mechanisms are not elucidated. The investigators aimed to assess left and right ventricular (LV and RV) function, left atrial (LA) function, arterial function, and atrial-ventricular-arterial coupling in patients with MS, compared to control subjects. LV systolic and diastolic function and RV function were assessed by 2D- and 3D- echocardiography, tissue Doppler, and speckle tracking echocardiography. LA function was assessed by LA volume index and LA strain. Arterial remodeling and stiffness were assessed by intima media-thickness, pulse wave velocity, and parameters of wave intensity and endothelial function

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: NO intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 65 years; patients with confirmed MS diagnosis, both newly diagnosed or already under immunomodulatory treatment; informed consent signed. Exclusion Criteria: MS treated with mitoxantrone; patients with known cardiovascular disease; presence of other neurological conditions; any renal, pulmonary, hepatic or hematological disease; diabetes mellitus; any degree of arterial hypertension; pregnancy; and difficult acoustic window

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

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 |
| --- | --- |
| Multiple sclerosis patients<br>patients with confirmed multiple sclerosis, diagnosed according to the revised McDonald's criteria | Other: NO intervention<br> <br> |
| Control subjects<br>control subjects, matched for age, gender, and presence of cardiovascular risk factors | Other: NO intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricle systolic dysfunction - by echocardiography |  | 1 year | 
| Right ventricle systolic dysfunction- by echocardiography |  | 1 year | 
| Left ventricular diastolic function - by echocardiography |  | 1 year | 
| arterial function - by vascular echography |  | 1 year |
Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
Research Populations: Male patients scheduled for laparoscopic colorectal surgery Study Method: Questionnaire and function tests Hypothesis: A laparoscopic nerve-sparing operation is not inferior to reported open surgery in preserving urinary and sexual function.

Detailed Description
-----------------
There have been some reports that laparoscopically assisted rectal resection is associated with a higher rate of male sexual dysfunction compared with the open approach. But these reports are studied retrospectively. We examine the frequency of bowel, urinary and sexual dysfunction prospectively in patients who received laparoscopic colorectal surgery. We examine before operation, 7 days after, 3 months after, 6 months after and 12 months after operation, by questionnaires (International Index of Erectile Function (IIEF) 、Short Form-8 (SF8)、International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)、International Prostate Symptom Score(IPSS)、Gastro-Intestinal Functional Outcome(GIFO)) and function tests (uroflowmetry and US).

Official Title
-----------------
Outcome Study of Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery, Using Questionnaire and Function Tests

Conditions
-----------------
Surgery, Laparoscopic, Sexual Dysfunction, Physiological, Colorectal Surgery

Intervention / Treatment
-----------------
* Procedure: laparoscopic colorectal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Laparoscopic right colon resection/laparoscopic rectal surgery 20-80 years old ECOG performance status (PS) 0-2 Exclusion Criteria: Emergent operation Previous proctectomy Severe urinary dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| colon<br> | Procedure: laparoscopic colorectal surgery<br>* laparoscopic colorectal surgery<br>* Other names: endoscopic surgery;|
| rectum<br> | Procedure: laparoscopic colorectal surgery<br>* laparoscopic colorectal surgery<br>* Other names: endoscopic surgery;|

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
-----------------
Laparoscopic, Colon, Rectal, Surgery, Urinary function, Sexual function, Bowel function, Male
Manhattan HIV/Hepatology Brain Bank

Study Overview
=================
Brief Summary
-----------------
Description: The Manhattan HIV/Hepatology Brain Bank (MHBB) was established in 1998 as a resource for the AIDS research community. The MHBB was created to act as a center for the provision of pre- and post-mortem tissues and body fluids from HIV infected persons. It has recently expanded its goals to assist in the elucidation of liver disease-induced nervous system disorders. The MHBB is dedicated to improving the understanding of HIV and Hepatitis C and thereby, improving the lives of patients living with HIV and/or Hepatitis C. Participation is voluntary and can be stopped at any time. Benefits: This is an observational study; no experimental procedures, devices or drugs are used. All enrolled patients undergo regular examinations by physicians, nurses, and neuropsychologists who specialize in the problems that HIV and HCV can cause. Taking part in this study may result in the detection of brain, muscle, or spinal cord disease for which treatments may be available. Participants may receive no direct benefit from this study. However, knowledge gained from this research may, in the future, help others who suffer from HIV/AIDS and/or liver disease. Participants agree to autopsy and organ donation upon demise by signing an Anatomical Gift Consent document.

Official Title
-----------------
Manhattan HIV/Hepatology Brain Bank

Conditions
-----------------
HIV, Hepatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD4 < 50 on two occasions >12 weeks apart. Hemoglobin <10 G/dL. Albumin <3.2 G/dL. CMV end-organ disease Disseminated MAC PML AIDS Dementia Complex Wasting (>30% of lean body mass) Visceral Kaposi's sarcoma Lymphoma-systemic of CNS CHF Major systemic illness with poor prognosis (as determined by primary physician). Exclusion Criteria: - <18 years old Not willing to sign an Anatomical Gift Consent for autopsy and organ donation upon demise.

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 |
| --- | --- | --- |
| Viral Load blood level | Plasma viral load level | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 cell blood level |  | Baseline |
The Rechallenge of ADCs in MBC Patients

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of ADC rechallenge

Official Title
-----------------
A Multicenter, Real-world Study of the Efficacy and Safety of Antibody-drug Conjugates (ADCs) Rechallenge in Patients With Prior Exposure to ADCs Metastatic Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: ADC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years old. Diagnosed with Metastatic Breast Cancer. Patients with prior exposure to ADC (either in the adjuvant setting or metastatic disease are allowed). Patients plan to or have received ADCs for the second or more time. Complete medical history was available. Exclusion Criteria: Medical history was incomplete

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1<br> | Drug: ADC<br>* Patients with prior exposure to ADC (either in the adjuvant setting or metastatic disease are allowed).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Response Rate | 6 weeks | 
| CBR | Clinical Benefit Rate | 6 weeks | 
| DoR | Duration of Response | 6 weeks | 
| Adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 6 weeks | 
| OS | Overall Survival | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibody-drug conjugates, Metastatic Breast Cancer
Changes of Bone Turnover Markers and Bone Mineral Density After Osteoporosis Treatment

Study Overview
=================
Brief Summary
-----------------
To examine the changes of bone mineral density and bone turnover markers after Bonviva treatment in osteoporotic patients

Official Title
-----------------
Changes of Bone Turnover Markers and Bone Mineral Density After Treatment in Osteoporotic Patients

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Device: Ibandronic acid, vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoporosis Exclusion Criteria: Kidney, parathyroid, congenital bone metabolic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 Years

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

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

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: Osteoporosis<br> | Device: Ibandronic acid, vitamin D<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of bone mineral density | To examine the changes of bone mineral density for the purpose of the effectiveness of the drug | every 4-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of bone turnover markers | To examine the changes of bone turnover markers for the purpose of the effectiveness of the drug | Every 3-6 months |
The Influence of Lutein Supplements on Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Rationale: Age-related macular degeneration is the most common cause of blindness in the industrialized world. Macular pigment is hypothesized to protect against the vision loss in this disease. Objective: 1. To study if the macular pigment optical density can be raised by lutein supplementation. 2. To study if lutein supplementation can stop or slow down the decrease in visual functions. Study design: Randomized, double blind, placebo controlled intervention study. Study population: Eighty patients with early signs of age-related macular degeneration Intervention: The intervention group (40 subjects) receives 10 mg lutein per day, while the control group (40 subjects) gets a placebo.

Official Title
-----------------
The Influence of Lutein Supplements on Age-related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Dietary Supplement: Lutein
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AMD grade 2 or 3 visual acuity > 0.5 BMI < 30 Exclusion Criteria: using lutein supplements smoking diabetes diseases that interfere with lipid absorption other eye diseases

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: supplement<br>lutein supplement | Dietary Supplement: Lutein<br>* Lutein supplement, 10 mg daily<br>|
| Placebo Comparator: placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Pigment Optical Density |  | Baseline, 4 months, 8 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | Baseline, 4 months, 8 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular pigment, lutein, age-related macular degeneration, AMD
ERAS and Pediatric Scoliosis Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the outcomes after scoliosis surgery before and after ERAS (enhanced recovery after surgery) program inplementation in children and teenager.

Detailed Description
-----------------
Enhanced recovery after surgery (ERAS) is a multimodal approach focused on reducing the stress response and associated physiologic changes related to surgery. Over the past 20 years, ERAS programs have been found to result in reduced lenght of stay and complications in adult patients. Data in pediatric population remains very scarce.Therefore this study was designed to compare the outcomes after scoliosis surgery before and after ERAS (enhanced recovery after surgery) program inplementation in children and teenager.

Official Title
-----------------
Assesment of Enhanced Recovery After Pediatric Idiopathic Scoliosis Surgery

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Other: ERAS program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patient with age < 18 years patient scheduled for scoliosis surgery Exclusion criteria: patient with age > 18years patient with medical follow up by pediatric chronic pain departement

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| the before group<br>75 teenagers after scoliosis surgery before ERAS program implementation | Other: ERAS program<br>* ERAS program<br>|
| the after group<br>75 teenagers after scoliosis surgery after ERAS program implementation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of hospital stay | Postoperative length of hospital stay | up to 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Antalgics consumption | Antalgics consumption including opioids and non-opioids drug | up to 15 days after surgery | 
| Time to oral diet tolerance | Able to eat without abdominal discomfort, nausea, or vomiting | up to 15 days after surgery | 
| Time to first bowel motion | Able to eat without abdominal discomfort, nausea, or vomiting | up to 15 days after surgery | 
| Time to first verticalization | Able to eat without abdominal discomfort, nausea, or vomiting | up to 15 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Surgery, Rehabilitation
Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)

Study Overview
=================
Brief Summary
-----------------
To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses.

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

Conditions
-----------------
Healthy Men and Women

Intervention / Treatment
-----------------
* Drug: Flupentixol/melitracen film-coated tablet
* Drug: Flupentixol/melitracen coated tablet (Deanxit®)


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 <30 kg/m2. Women will be non-pregnant and non-lactating. Other protocol-defined inclusion and exclusion criteria may apply.

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: Flupentixol/melitracen film-coated tablet<br>test treatment - 0.5 mg/10 mg; oral as a single dose | Drug: Flupentixol/melitracen film-coated tablet<br> <br> |
| Other: Flupentixol/melitracen coated tablet (Deanxit®)<br>reference treatment - 0.5 mg/10 mg, oral as a single dose | Drug: Flupentixol/melitracen coated tablet (Deanxit®)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the flupentixol plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h) |  | Up to 72 hours post dose | 
| Maximum observed concentration (Cmax) of flupentixol |  | Up to 312 hours post dose | 
| Area under the melitracen plasma concentration-time curve from zero to 72 hours post dose (AUC0-72h) |  | Up to 72 hours post dose | 
| Maximum observed concentration (Cmax) of melitracen |  | Up to 312 hours post dose |