linjc16/ctgov huggingface dataset:
High Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of the combination of surgery, conventional chemotherapy, sequential high-dose chemotherapy with peripheral blood stem cell transplantation and reduced dose radiation therapy in high-risk PNET brain tumors.

Official Title
-----------------
Treatment Protocol for High-Risk PNET Brain Tumors in Children With Surgery, Sequential Chemotherapy, Conventional and High-Dose With Peripheral Blood Stem Cell Transplantation and Radiation Therapy

Conditions
-----------------
Medulloblastoma, Brain Tumors, Neuroectodermal Tumors, Primitive

Intervention / Treatment
-----------------
* Drug: Etoposide, carboplatin, melphalan, cisplatin, thiotepa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medulloblastoma in patients less than 5 years of age Brain PNET in patients less than 10 years of age Histologically documented diagnosis Body weight of > 8 kg Exclusion Criteria: Parents' refusal

Ages Eligible for Study
-----------------
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Etoposide, carboplatin, melphalan, cisplatin, thiotepa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of medulloblastoma metastases to the chemotherapy regimen in children less than 5 years of age |  |  | 
| Progression-free survival of children less than 10 years of age with brain PNET |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival of children less than 5 years of age with metastatic medulloblastoma |  |  | 
| Toxicity |  |  | 
| Long term sequelae |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain PNET
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.

Official Title
-----------------
Phase III, Open Label, Randomized, Multicenter Study to Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, Compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream for the Treatment of Bacterial Vaginosis and Candidiasis Isolatedly or in Association (Mixed-Type Vaginosis)

Conditions
-----------------
Candidiasis, Bacterial Vaginosis

Intervention / Treatment
-----------------
* Drug: Clindamycin 100mg and Ketoconazole 400mg
* Drug: Tetracycline 100mg and Amphotericin B 50mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mixed-type vaginosis Bacterial vaginosis Candidiasis Exclusion Criteria: Pregnancy Vaginal bleeding History of recurrent vaginosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clindamycin 100mg and Ketoconazole 400mg<br> | Drug: Clindamycin 100mg and Ketoconazole 400mg<br>* 1 vaginal capsule once a day at night<br>|
| Active Comparator: Tetracycline 100mg and Amphotericin B 50mg<br> | Drug: Tetracycline 100mg and Amphotericin B 50mg<br>* One full applicator, once a day at night<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy based on cure rate evaluated by clinical and laboratory criteria. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability based on adverse events reports and patient's information |  | 7 days | 
| Safety based on adverse events reports and laboratory criterion |  | 7 days |
Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients

Study Overview
=================
Brief Summary
-----------------
This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.

Official Title
-----------------
Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients

Conditions
-----------------
HIV-1 Infection

Intervention / Treatment
-----------------
* Biological: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged from de 18 to 80 years Patient starting a DTG-regimen Patients agreeing to use methods of birthcontrol while on the study and during the 6 weeks after stopping DTG treatment Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening Exclusion Criteria: Women who are pregnant or breastfeeding HBV or HCV coinfection Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted An active AIDS-defining condition at Screening Documented resistance to DTG Allergy or intolerance to the study drugs or their components or drugs of their class Any acute or verified Grade 4 laboratory abnormality (with the exception of Grade 4 lipids) at Screening. Coadministration with Dofelitide

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dolutegravir<br> | Biological: Blood samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Proviral HIV-1 DNA at Week 48 |  | baseline (Day 0) and Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dolutegravir pharmacokinetic (dolutegravir pharmacological blood levels) |  | Week 4, Week 24 and Week 48 | 
| Quantification of biomarkers of immune activation | CRPus, IL-6, neopterin, D-dimer, CD14s | baseline (Day 0), Week 24 and Week 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dolutegravir, Proviral HIV-1 DNA, Reservoir
Cannabinoids, Learning, and Memory

Study Overview
=================
Brief Summary
-----------------
The overarching goal of this study is to characterize the effects of cannabinoids on working and episodic memory.

Detailed Description
-----------------
This study will be achieved by studying the acute effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive component of cannabis and a cannabinoid-1 receptor (CB1R) agonist, on a wide range of memory tasks in healthy human subjects.

Official Title
-----------------
Cannabinoids, Learning, and Memory

Conditions
-----------------
Cannabis, Psychotic Disorders

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18 and 55 years (extremes included) on day of first dosing Exposed to cannabis at least once in their lifetime Exclusion Criteria: Cannabis naive Positive pregnancy screen during screening Hearing deficits

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: THC<br>Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes. | Drug: THC<br>* Active THC (0.0015-0.03 mg/kg) administered over 20 minutes.<br>Drug: Placebo<br>* Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.<br>|
| Placebo Comparator: Placebo<br>Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes. | Drug: THC<br>* Active THC (0.0015-0.03 mg/kg) administered over 20 minutes.<br>Drug: Placebo<br>* Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rey Auditory Verbal Learning Test (RAVLT) | a measure of verbal episodic memory | +35 minutes after infusion | 
| N-Back Task | a measure of working memory | +65 minutes after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered Dissociative Symptoms Scale (Total Score) |  | Baseline, +10, +85, and +240 minutes after the first infusion | 
| Visual Analog Scale (Total Score) | a measure of THC intoxication | Baseline, +10, +85, +240 minutes after the first infusion |
Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Patients with ST-segment elevation myocardial infarction (STEMI) that have suffered a major anterior wall infarction or where coronary blood flow is less than normal in spite of successful percutaneous coronary intervention (PCI) have a poor prognosis. There are today no medical treatments that specifically reduce risk in these patients. The acute inflammatory reaction in conjunction with a STEMI and reperfusion by PCI determines the final size of the infarction and the signals leading to left ventricular remodelling. This study is designed to assess the efficacy and safety of single intravenous injection with ATH3G10, a fully human IgG1 antibody against phosphorylcholine, in high-risk subjects with STEMI. ATH3G10 aims to reduce inflammation and thereby infarction size and remodeling.

Official Title
-----------------
A Phase IIa, Placebo-controlled, Double Blind, Randomised Multicentre Pilot Study to Investigate the Efficacy, Safety and Tolerability of the Monoclonal Antibody ATH3G10 in Patients With ST-elevation Myocardial Infarction

Conditions
-----------------
ST Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: ATH3G10
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myocardial infarction with ST elevation at the J-point in two contiguous leads Start of PCI less than 4 hours after symptom onset. Exclusion Criteria: Cardiogenic chock, non-compensated acute heart failure and/or pulmonary edema. Previous major vascular intervention within the last 4 weeks. History of an infarct in the same artery that is currently affected. Conditions contraindicating MRI

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATH3G10<br>Phosphorylcholine human monoclonal antibody (ATH3G10) | Drug: ATH3G10<br>* intravenous<br>* Other names: PC-mAB;|
| Placebo Comparator: Placebo<br>Placebo to ATH3G10, 0.9% sodium chloride | Drug: Placebo<br>* intravenous<br>* Other names: 0.9% sodium chloride;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular remodelling | Change in Left Ventricular End-Diastolic Volume index (LV EDVi) | From Visit2 (day 3) to visit 3 (day 90) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Salvage index (MSi) | Effects on myocardial salvage index (MSi) measured by MRI | Visit 2 (day 3) |
Body Water Content in Cyanotic Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial natruretic peptide (proANP) which most likely results in chronic dehydration, leading to reduced oxygen transport to tissues and shortness of breath with activity. The purpose of this study is to characterize adults with cyanotic congenital heart defects with respect to their body composition (water and fat-free mass) and resting metabolic rates. The study consists of several measures of how much body water, fat and lean tissue a subject has, and measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic congenital heart disease will be recruited along with healthy noncyanotic control subjects matched for age, gender, and body weight.

Conditions
-----------------
Heart Defects, Congenital

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resting blood pressure below 140/90

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 60 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cyanotic Congenital Heart Disease
HeRO Vascular Access Device Post Market Procedural Survey Protocol

Study Overview
=================
Brief Summary
-----------------
Post market observational survey of a vascular access device for access-challenged patients. Data collection efforts focused on patient medical and access history and implant procedure results.

Detailed Description
-----------------
Evaluation Design: This is a multi-center post market observational survey designed to collect procedural data on a minimum of 50 HeRO™ patients in the commercialization phase. Data will be collected retrospectively for patients already implanted with the HeRO™ device in the commercialization phase or prospectively for patients that receive the HeRO™ Device during the data collection period. No special patient screening, testing, or procedures are required. There is no required patient follow-up. Subject Population: Any patients the investigator deems/deemed eligible for HeRO™ implant with complete procedural data are eligible for inclusion in this post market observational survey. Endpoints: None Inclusion/Exclusion Criteria: There are no formal screening criteria other than patients must have all required procedural data points available for recording on the case report form.

Official Title
-----------------
HeRO Vascular Access Device Post Market Procedural Survey Protocol

Conditions
-----------------
End Stage Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: None Exclusion Criteria: None
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 |
| --- | --- | --- |
| Device placement success |  | End of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End stage renal disease, Bacteremia, HeRO Vascular Access Device, Access challenged, Catheter dependent, End stage renal disease requiring vascular access. See HeRO device instructions for use for appropriate patient population
Evaluation of a New Coating in Cement Less Femoral Stems

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.

Detailed Description
-----------------
60 patients eligible for total hip replacement will be randomized in to two groups, receiving either femoral stems with plasma sprayed hydroxyapatite coating or stems with electrochemically deposited hydroxyapatite. This patients will be followed for at least 5 years. The outcome is evaluated by comparing stability measured by RSA and periprosthetic bone remodeling measured by bone densitometry.

Official Title
-----------------
No Mid-term Advantage by Electrochemical Deposition of Hydroxyl-apatite in Cementless Femoral Stems. 5-year RSA and DXA Results From a Randomized Controlled Trial

Conditions
-----------------
Hip Osteoarthritis

Intervention / Treatment
-----------------
* Device: Taperloc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants Exclusion Criteria: infection, revision surgery, severe morbidity and obvious bone loss
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bonemaster<br>Cement-less femoral stems with electrochemical deposition of hydroxyapatite | Device: Taperloc<br>* Femoral stem with electrochemical deposition of hydroxyapatite<br>|
| Active Comparator: Hydroxyapatite<br>Cement-less femoral stems with plasmasprayed hydroxyapatite | Device: Taperloc<br>* Femoral stem with electrochemical deposition of hydroxyapatite<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early and intermediate periprosthetic bone remodeling | Bone densitometry measured by DXA | 5 years | 
| Early and intermediate femoral stem stability | Radiostereometric analysis of femoral stem movements relative to bone | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical function | Hip questionares, Harris Hip Score and Oxford Hip Score | 5 years | 
| Radiographic signs of loosening | Conventional x-ray | 5 years |
IRIS Alfa Clinical Trial A Monocentric, Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device.

Study Overview
=================
Brief Summary
-----------------
To perform a safety study on the prototype IRIS vitrectomy device.

Detailed Description
-----------------
to determine the safety and effectiveness of the device.

Official Title
-----------------
IRIS Alfa Clinical Trial. A Safety Study of a Prototype of a New Vitrectomy Device.

Conditions
-----------------
Vitrectomy

Intervention / Treatment
-----------------
* Device: IRIS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that are scheduled for vitrectomy surgery, regardless of the indication Both vitrectomy-only and combined phaco-vitrectomy surgeries Primary or repeat vitrectomy General or local anesthesia, or combination All ages Informed consent (from parents in patients <18 years old) Exclusion Criteria: Unable to obtain informed consent from patient (or from parents in children) No post-operative 8 week visit is anticipated

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRIS vitrectomy device<br>all subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device | Device: IRIS<br>* prototype IRIS vitrectomy device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of intra-operative adverse events that determine the safety of the surgery | complications VTX: iatrogenic tear, lens touch, choroidal/subretinal/vitreous hemorrhage, infusion suprachoroidal, iatrogenic retina trauma, posterior capsule tear, corneal eptihelial damage, hyphema, corneal edema, iris trauma, nucleus fragment in vitreous, posterior capsule tear, retinal incarceration, zonulae rupture with vitreous prolapse, subretinal PFCL, suprachoroidal silicone oil, zonulae dialysis, lens exchange required, other IOL problem | Intraoperative (surgery day) |