linjc16/ctgov huggingface dataset:
Alcohol Consumption Relation With Nutritional Knowledge and Body Weight

Study Overview
=================
Brief Summary
-----------------
The increase of overweight and obesity in young Italian people, nowadays showed by several epidemiological data, has been related to the misuse of alcohol and to a lack in nutritional knowledge. Thus the aim of our study was to investigate if different nutritional knowledge from could affect body composition and drinking habits of a cohort of local young people. 104 healthy subjects (56 males and 54 females) were recruited using oral advertisements among the students of 18-19 years-old belonging to the Istituto Agrario and the Istituto alberghiero Raineri-Marcora of Piacenza. The subjects were asked to complete a questionnaire on alcohol consumption and another one related to nutritional knowledge. Then anthropometric data were measured: height, weight, waist and hips circumferences, waist-hips ratio and skinfolds were evaluated for each subject and body fat mass was calculated.

Official Title
-----------------
Effect of Alcohol Consumption and Nutritional Knowledge on Body Weight and Composition in a Group of Piacenza Students

Conditions
-----------------
Binge Drinking

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: students Exclusion Criteria: pregnant or breast feeding vegan or vegetarian

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 19 Years

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 |
| --- | --- | --- |
| anthropometric measures |  | 1day | 
| questionnaires on nutritional knowledge |  | 1 day |
Study to Evaluate ATP-induced Pain and ATP-induced Dermal Vasodilation by Iontophoresis (0000-118)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate ATP-induced Pain (AIP) and ATP-induced dermal vasodilation (AIDV) as target engagement tools for future development of analgesics.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Crossover Clinical Trial to Evaluate the Effects of ATP-Induced Pain (AIP) and ATP-induced Dermal Vasodilation (AIDV) by Iontophoresis in Healthy Subjects

Conditions
-----------------
Osteoarthritis Pain

Intervention / Treatment
-----------------
* Procedure: Comparator: Iontophoresis and Laser Doppler with ATP
* Procedure: Comparator: Iontophoresis and Laser Doppler with Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is in generally good health Subject is willing to abstain from smoking within 24 hours of each iontophoresis treatment and limit smoking to 5 or less cigarettes per week during the study Exclusion Criteria: Subject has a history of dermatitis, psoriasis, or eczema Subject has active asthma and/or hay fever at the time of the screening visit Subject is unable to refrain from use of analgesics within 3 days prior to each treatment period

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

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ATP | Procedure: Comparator: Iontophoresis and Laser Doppler with ATP<br>* Iontophoresis treatments with 10 mM ATP (adenosine triphosphate) solution and a current of 0.8 or 1.2 mA. Iontophoresis treatments will last 4 minutes. Laser doppler will be used during the iontophoresis treatments to measure dermal blood flow.<br>|
| Placebo Comparator: 2<br>Saline | Procedure: Comparator: Iontophoresis and Laser Doppler with Saline<br>* Iontophoresis treatments with 20 mM saline solution and a current of 0.8 or 1.2 mA. Iontophoresis treatments will last 4 minutes. Laser doppler will be used during the iontophoresis treatments to measure dermal blood flow.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of pain induced by ATP vs. saline iontophoresis |  | 4 minutes | 
| Increase in blood flow induced by ATP iontophoresis |  | 8 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-retest reproducibility and intra-subject variability of AIP and AIDV |  | 8 minutes |
A Study of Two Iodinated Contrast Agents in Renally Impaired Patients Undergoing Cardiac Angiography

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with moderate to severe renal insufficiency undergoing cardiac angiography. Serum creatinine will be measured before and up to 48-72 hours after the administration of the contrast agent to evaluate renal function.

Official Title
-----------------
Visipaque and Isovue in Cardiac Angiography in Renally Impaired Patients

Conditions
-----------------
CIN

Intervention / Treatment
-----------------
* Drug: Iopamidol 370 mgI/mL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for cardiac angiography; with a documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2 Exclusion Criteria: Unstable renal function; concurrent administration of nephrotoxic drugs, undergoing dialysis

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iopamidol 370 mgI/mL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in SCr at 48-72 hours post dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in eGFR at 48-72 hours post dose; occurrence of adverse events; effect on heart rate |  |  |
Phase I FOLFOX Combination

Study Overview
=================
Brief Summary
-----------------
A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.

Official Title
-----------------
A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.

Conditions
-----------------
Advanced Colorectal Carcinoma

Intervention / Treatment
-----------------
* Drug: ZD6474 (vandetanib)
* Drug: 5-Fluorouracil
* Drug: Leucovorin
* Drug: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV) WHO performance status 0-1 one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques Exclusion Criteria: Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment prior unanticipated severe reaction to oxaliplatin

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ZD6474 (vandetanib)|once daily oral dose|
|Drug: 5-Fluorouracil|intravenous infusion|
|Drug: Leucovorin|intravenous infusion|
|Drug: Oxaliplatin|intravenous infusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin |  | Assessed at each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ZD6474, FOLFOX, colorectal, adenocarcinoma
Duloxetine for the Treatment of Postpartum Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether the antidepressant, duloxetine, is equally effective as a treatment for subjects who have a Postpartum Onset Depression compared to subjects who have an onset of Major Depressive Disorder prior to delivery. The hypothesis is that duloxetine will be as effective in subjects with Postpartum Major Depressive Disorder as in subjects with a Major Depressive Disorder.

Detailed Description
-----------------
Study was terminated because of poor enrollment

Official Title
-----------------
Duloxetine in the Treatment of Postpartum-onset and Non-Postpartum Onset Major Depressive Disorder

Conditions
-----------------
Postpartum Depression, Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult female subjects age 18 and above if onset of depression within 4 weeks of delivery,or onset of depression antenatally either during pregnancy or before pregnancy must score greater than or equal to 12 on the Edinburgh Postnatal Depression Scale speak English or Spanish have access to a telephone provide written and verbal consent Exclusion Criteria: have current or lifetime psychosis an unstable medical condition hypertension narrow-angle glaucoma liver disease seizure disorders bulimia anorexia mania substance abuse disorders have a known hypersensitivity to duloxetine or any of the active ingredients are in need of inpatient hospital treatment with an excluded medication adolescents under the age of 18 Medication Exclusion other antidepressants antipsychotic agents quinolone antibiotics Type 1C antiarrhythmics daily benzodiazepines Treatment with a monoamine oxidase inhibitor

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

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

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: Duloxetine<br>type of experimental agent | Drug: duloxetine<br>* Total treatment period is 12 weeks 30mg po qd times 1 week 60mg po qd times 11 weeks<br>* Other names: Cymbalta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression severity compared to baseline scores on the IDS-C between the two subject groups. |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post Partum Depression
Expression and the Clinical Significance of Neutrophil PD-L1 During Sepsis

Study Overview
=================
Brief Summary
-----------------
Immunosuppression is the leading cause of death in septic patients. Neutrophils are classical components of innate immunology, but recent studies showed that neutrophils might display antigen presenting function and inhibit lymphocyte proliferation by expressing programmed cell death 1 ligand 1 (PD-L1). Whether neutrophils express PD-L1 and its role in immunosuppression during sepsis remain unclear.

Conditions
-----------------
Sepsis, Immunosuppression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with severe sepsis patients with sepsis after PCNL for infectious kidney stone patients with pancreatic cancer healthy volunteers Exclusion Criteria: patients with immunodeficient diseases patients who accept glucocorticoid or immunosuppressant patients with an age older than 18 years patients providing the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Severe sepsis<br>Patients with severe sepsis | |
| Infectious kidney stone<br>Patients with sepsis after PCNL for infectious kidney stone | |
| Tumor<br>Patients with pancreatic cancer | |
| Volunteer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD-L1 level on neutrophils | PD-L1 level on neutrophils was compared between different populations. | within 24h after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality |  | 28 days after diagnosis of sepsis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, immunosuppression, PD-L1
Outcomes of Stem Cells for Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

Detailed Description
-----------------
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 40 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.

Official Title
-----------------
Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Biological: Autologous Bone Marrow Mononuclear Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerebral palsy of any types caused by oxygen deprivation. Exclusion Criteria: Epilepsy Hydrocephalus with ventricular drain Coagulation disorders Allergy to anesthetic agents Severe health conditions such as cancer, failure of heart, lung, liver or kidney Active infections

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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: Stem cell transplantation<br>2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward | Biological: Autologous Bone Marrow Mononuclear Cells<br>* Transplantation of Autologous Bone Marrow Mononuclear Cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Score of Gross Motor Function Measure (GMFM)-88 | GMFM-88 | 3 months and 6 months after transplantation | 
| Change in Gross Motor Function Measure (GMFM)-66 Percentile | GMFM-66 percentile | 3 months and 6 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle tone | Muscle tone are assessed by Modified Ashworth Scale | 3 months and 6 months after transplantation | 
| Number of adverse events | Examples of adverse events to look for: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy | Through study completion, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Palsy, Stem Cells
Platelet Rich Plasma Study in Lower Extremity Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
The use of platelet rich plasma will decrease wound infection postop.

Official Title
-----------------
Phase 2-3 Observational Wound Care Study Comparing Application of Platelet Rich Plasma With Standard of Care Wound Closure in Vascular Patients Requiring a Groin Incision.

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vascular surgical patients scheduled for elective lower extremity bypass surgery,aortoiliac revascularizations and endovascular AAA repair requiring a groin incision Exclusion Criteria:Patients requiring emergent procedures, unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 90 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 |
| --- | --- |
| Platelet Rich Plasma<br>Group received platelet rich plasma and observed over a period of 30 days or until wound closure | |
| Standard Wound Care<br>Group was treated as per standard care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing |  | 4- 6 weeks post op |
Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique

Study Overview
=================
Brief Summary
-----------------
Cesarean section will performed via intraperitoneally and extraperitoneally. During postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel movement, discharged time will be compared.

Detailed Description
-----------------
Investigators will compared results intra and extraperitoneal cesarean section. Two groups will determine according to random numbers table. After operations, blood count, C reactive proteins, postoperative temperature, need for analgesia, ileus, bowel movement, mobilization time will compare by blind physician. Abdominal, shoulder and incisional pain at postoperative 0, 6, 12, 18, 24, 30 hours will compared by use visual analog score. Neonatal results and complications also will compare. Investigators and participants will be blind regarding technique.

Official Title
-----------------
Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique: Double Blind Controlled Study

Conditions
-----------------
Postpartum Fever, Ileus, Hemorrhage, Pain

Intervention / Treatment
-----------------
* Procedure: Extraperitoneal cesarean section
* Procedure: Intraperitoneal cesarean section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cesarean section for any reasons Exclusion Criteria: Involuntary

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extraperitoneal group<br>Extraperitoneal cesarean section will perform after rectus sheat incision and carefully bladder dissecting. | Procedure: Extraperitoneal cesarean section<br> <br> |
| Active Comparator: Intraperitoneal group<br>Conventional transperitoneal cesarean will perform | Procedure: Intraperitoneal cesarean section<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores as measured by the Visual Analog Scale |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood count |  | 2 days | 
| C reactive proteins level |  | 2 days | 
| Complications |  | 2 days | 
| Discharge time |  | 4 days | 
| Forced expiratory volume in 1 second |  | 2 days | 
| Forced vital capacity |  | 2 days | 
| Peak expiratory flow |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Forced Expiratory Volume in 1 second, Forced expiratory vital capacity, Peak expiratory flow
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.

Official Title
-----------------
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer

Conditions
-----------------
Keratitis, Corneal Ulcer

Intervention / Treatment
-----------------
* Device: T4020
* Device: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients diagnosed with one chronic keratitis/corneal ulcer Patients who signed and dated informed consent Exclusion Criteria: Patient under 18 years Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T4020<br>One drop every 2 days | Device: T4020<br> <br> |
| Placebo Comparator: Vehicle<br>One drop every 2 days | Device: Vehicle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 | Reduction in neurotrophic ulcer/keratitis area of 50% or more | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least One Treatment-emergent Adverse Event | With at least one TEAE | From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days | 
| Best Corrected Visual Acuity | Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye | Baseline and Day 28 |