linjc16/ctgov huggingface dataset:
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309

Study Overview
=================
Brief Summary
-----------------
This study is a Phase I, open label study to determine the Maximum Tolerated Dose(MTD) and the Recommended Phase II Dose (RP2D) in patients with advanced solid tumors.

Official Title
-----------------
Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: PQR309


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of advanced solid tumor for which no therapy of proven efficacy is available. Age ≥ 18 Evidence of tumor progression with measurable or evaluable disease. Use of adequate contraceptive measures for male patients. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. Signed informed consent. Exclusion Criteria: Concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors) Patients with a history of myocardial infarction or coronary artery bypass within the last 3 years. Patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure NYHA Class 3 or 4, hypertension BP>150/100mmHg. Pre-diagnosed diabetes mellitus. Fasting glucose > 7.0 mmol/L or HbA1c > 6%.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PQR309<br>Different dose evaluation | Drug: PQR309<br>* Dosing will be orally, once a day for the duration of the trial.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) |  | In average 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine overall safety | Incidence of SAEs, incidence and severity of all AEs, changes of vital signs, physical examinations, body weight, changes of routine laboratory assessments. | 1 year |
The Effect of the Amino Acid L-Theanine on Alertness and Vigilance

Study Overview
=================
Brief Summary
-----------------
The amino acid l-theanine (the active ingredient in green tea) is considered to have a calming effect without causing sleepiness. This study evaluates whether l-theanine affects blood pressure, heart rate, alertness, and sense of well-being.

Official Title
-----------------
The Effect of the Amino Acid L-Theanine on Alertness and Vigilance

Conditions
-----------------
Theanine, (L)-Isomer

Intervention / Treatment
-----------------
* Dietary Supplement: L-theanine capsule
* Dietary Supplement: Placebo capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult able to swallow capsule Exclusion Criteria: none

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo capsule<br> | Dietary Supplement: Placebo capsule<br> <br> |
| Experimental: L-theanine capsule<br> | Dietary Supplement: L-theanine capsule<br>* L-theanine 250mg capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alertness | The average response time to identify a small rectangle shown on a computer screen. | 48 hrs | 
| Alertness | Degree of subjective alertness, measured on a visual analog scale | 48 hrs | 
| Well-Being | Sense of subjective well-being as measured on a visual analog scale | 48 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
l-theanine, alertness, well-being
Comparison of BIS and PIS in Children

Study Overview
=================
Brief Summary
-----------------
Comparison of bispectral index and patient sedation index during general anesthesia in children

Detailed Description
-----------------
the values of BIS and PSI of every 1 minute during general anesthesia in children

Official Title
-----------------
A Comparison Between Patient State Index (PSI) and Bispectral Index (BIS) as Technologies for Monitor in Depth of Anesthesia in Children: A Prospective Observational Trial

Conditions
-----------------
Depth of Anesthesia Monitor

Intervention / Treatment
-----------------
* Device: depth of anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: general anesthesia Exclusion Criteria: developmental delay IICP

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: depth of anesthesia|monitoring of depth of anesthesia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of BIS and PSI | difference of BIS and PSI values | through study completion, an average of 2 hours |
Vitamin D in Egyptian Children With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
There is an emergent evidence demonstrating the role of Vitamin D deficiency in eczema. Vitamin D supplementation with standard treatment yielded positive clinical outcomes for children and adolescents with mild and moderate AD; however, the potential benefit of vitamin D in severe cases remains unclear

Official Title
-----------------
The Impact of Vitamin D Supplementation as an Adjuvant Therapy on Clinical Outcome in Patients With Severe Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.diagnosis of severe AD according to Hanifin and Rajka criteria and the Eczema Area and Severity Index (EASI) score Exclusion Criteria: serious skin disorder other than AD. taking systemic corticosteroids or anti-inflammatory medications, prior vitamin D supplementation receiving oral or topical antibiotics or topical calcineurin inhibitors for at least one week prior to enrollment known gut absorption problem, presence of active skin infection at baseline any known hepatic and/or renal disease.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment group<br>vitamin D plus topical 1% hydrocortisone cream twice daily | Drug: Vitamin D<br>* Vitamin D plus topical 1% hydrocortisone cream twice daily<br>* Other names: plus topical 1% hydrocortisone cream twice daily;|
| Placebo Comparator: placebo group<br>placebo plus plus topical 1% hydrocortisone cream twice daily | Drug: Placebo<br>* placebo plus topical 1% hydrocortisone cream twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study |  | 12 weeks | 
| the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score | EASI 75 | 12 weeks | 
| Difference in proportion of patients with a reduction from baseline of (50 or more up to 75) in Eczema Area and Severity Index (EASI) score | EASI 50 | 12 weeks | 
| Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score | EASI<50 | 12 weeks |
Belviq Tablet® Post Marketing Surveillance Protocol

Study Overview
=================
Brief Summary
-----------------
Post-marketing surveillance of Lorcaserin

Detailed Description
-----------------
Lorcaserin(Belviq) is a selective 5-hydroxytryptamine receptor agonist, witch is used long term for weight loss in those who are obese. Lorcaserin was approved in 2015 the Republic of Korea for weigh loss in those who are obese. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of lorcaserin for weigh loss in real-world practice.

Official Title
-----------------
Belviq Tablet® Post Marketing Surveillance Protocol

Conditions
-----------------
Weight Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who use the drug as an adjuvant therapy of diet therapy and kinesitherapy for weight control are selected. Obese patients whose body mass index (BMI) is ≧30 kg/m2. Overweight patients whose body mass index(BMI) is ≧27 kg/m2 and who have other risk factors(e.g. hypertension, dyslipidemia, type II diabetes mellitus) Exclusion Criteria: Patients with a hypersensitivity reaction to the drug or the ingredient of the drug Female patients of childbearing potential and pregnant or lactating women Patients taking another weight control drug Patients with the medical history of drug abuse

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse event after this drug administration in general medical | Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline to week 12 in the Body Mass Index(BMI) | BMI is measured before administration of the drug and within 12 weeks after administration. | 12 weeks |
Double Regional Anesthesia in Video Assisted Thoracoscopy

Study Overview
=================
Brief Summary
-----------------
Monocentric, randomized, controlled, single-blind study who's aim is to demonstrate the efficacy of the association of paravertebral block and serratus plane block with paravertebral block alone

Official Title
-----------------
Double Regional Anesthesia in Video Assisted Thoracoscopy

Conditions
-----------------
Anesthesia, Video Assisted Thoracoscopy

Intervention / Treatment
-----------------
* Drug: Serratus plane block and paravertebral block
* Drug: paravertebral block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 to 75 years; Programmed for unilateral videothoracoscopy for anatomical resection (segmentectomy, lobectomy); Subject affiliated to a social security scheme; Subject having signed an informed consent Exclusion Criteria: Chronic treatment with opiates; Contraindication to administration of morphine; Allergy to local anesthetics or contraindications to the use of ropivacaine; Contraindication to the realization of paravertebral blocks and serratus; Pregnancy, breastfeeding; Severe obesity (BMI > 40 kg/m²); Renal impairment (GFR < 30 mL/min) or known severe hepatic impairment; Difficulties of comprehension preventing the collection of consent and the realization of the study;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serratus plane block with paravertebral block<br>Association of Serratus plane block and paravertebral block for anesthesia | Drug: Serratus plane block and paravertebral block<br>* Single Administration of 20 mL of ropivacaine for Serratus plane block (Intra-muscular injection) followed by a single administration of 20 ml ropivacaine for paravertebral block (T4 inter-vertebral injection)<br>|
| Active Comparator: paravertebral block alone<br>Paravertebral block for anesthesia | Drug: paravertebral block<br>* Single Administration of 20 ml of ropivacaine for paravertebral block (T4 inter-vertebral injection)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of opioids drug administrated |  | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in recovery room |  | 24 hours postoperatively | 
| Total duration of hospitalization |  | during the 28 days postoperatively |
Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to test whether Generalized Anxiety Disorder (GAD) patients that participate in a Stress Reduction Intervention show a brain activation pattern (assessed by MRI) indicative of improved emotion regulation compared to an active control intervention.

Official Title
-----------------
Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Stress Reduction Intervention
* Behavioral: Active Control intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participation in the study 'Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects by Dr. Elizabeth Hoge Exclusion Criteria: metallic implants left handed epileptic seizures head trauma weight over 350 pounds claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress Reduction Intervention<br>Stress Reduction Intervention | Behavioral: Stress Reduction Intervention<br>* eight week group program, plus daily homework practice<br>|
| Active Comparator: Active Control Condition<br> | Behavioral: Active Control intervention<br>* weekly group meetings for eight weeks, plus daily homework practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain activation and structure as assessed by MRI | BOLD functional MRI and structural MRI | Day 1 (within two weeks before the intervention) | 
| brain activation and structure as assessed by MRI | BOLD functional MRI and structural MRI | Day 2 (within two weeks after the intervention) |
Safety and Feasibility of imILT Locally Advanced Pancreatic Cancer (LAPC)

Study Overview
=================
Brief Summary
-----------------
10 Patients with Locally Advanced Pancreatic Cancer, no further responsive to neoadjuvant treatments but with a Stage-III disease will be submitted to imILT (Immunostimulating Interstitial Laser Thermotherapy). Safety and feasibility of imILT on LAPC will be evaluated as primary objective. Secondary objectives will be QoL after imILT, study of the immune reaction after imILT, oncological analysis of patients suffering from LAPC submitted to imILT.

Official Title
-----------------
Immunostimulating Interstitial Laser Thermotherapy in Patients With Locally Advanced Pancreatic Cancer: Results of a Prospective, Open, Non Comparative Study

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: immunostimulating Interstitial Laser Thermotherapy
* Device: Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of stage III locally advanced pancreatic cancer No further neoadjuvant treatments are doable Eastern Cooperative Oncology Group performance status < 1 Exclusion Criteria: No other concomitant oncological treatments (hormonal, immunotherapies, etc) Suffering from other neoplasms Suffering from HIV Suffering from autoimmune diseases Concomitant medication with steroids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imILT of pancreatic cancer<br>10 patients suffering from LAPC will be submitted to immunostimulating interstitial laser thermotherapy (imILT) in a single-arm setting | Procedure: immunostimulating Interstitial Laser Thermotherapy<br>* Through a laparotomy a laser device will be inserted into the locally advanced pancreatic cancer.<br>* Other names: imILT;Device: Laser<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The immunostimulating effects of imILT | This will be determined by measuring plasma levels of various pro and anti-inflammatory cytokines and immune-related cells | Up to 24 months | 
| Overall Survival |  | Up to 24 months | 
| Progression free survival (PFS) |  | Up to 24 months | 
| Disease specific survival (DSS) |  | Up to 24 months |
Structural Problems in Brainstem and Cervical Spine Cord in ME/CFS

Study Overview
=================
Brief Summary
-----------------
A case control study on patients with ME/CFS and healthy controls on prevalence of cervical obstructions, Cerebro spinal fluid (CSF) pressure and laboratory findings.

Detailed Description
-----------------
50 patients and 50 healthy controls will undergo clinical exams and blood test of inflammatory and other findings as well as magnetic resonance imaging (MRI) with spectroscopy. The patients will undergo csf -sampling and measurements of CSF pressure.

Official Title
-----------------
The ME-SH (Myalgic Encephalomyelitis in Stockholm-Harvard) Study: Structural Problems in Brainstem and Cervical Spine Cord in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome(ME/CFS) - a Case-control Study

Conditions
-----------------
Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: MRI
* Procedure: Spinal Tap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnose Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) according to Canada Consensus Criteria from 2003 Exclusion Criteria: Bleeding abnormality Contraindication to Magnetic Resonance Imaging MRI Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| ME/CFS patients<br>Patients diagnosed according to Canada Criteria 2003 | Diagnostic Test: MRI<br>* If possible with spectroscopy<br>* Other names: Cervical MRI, Brain MRI;Procedure: Spinal Tap<br>* together with CSF pressure estimate<br>* Other names: CFS sampling;|
| Healthy Controls<br>Age and sex matched healthy controls | Diagnostic Test: MRI<br>* If possible with spectroscopy<br>* Other names: Cervical MRI, Brain MRI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalance of cervical obstructions | MRI findings | Two days | 
| Prevalence of Intracranial Hypertension | CSF measurements | Two days |