linjc16/ctgov huggingface dataset:
Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection

Study Overview
=================
Brief Summary
-----------------
Lung immune responses are regulated independently of systemic responses. Injected vaccines may induce optimal responses in blood but not at mucosal surfaces. We compared the responses in serum and lung fluid to injected pneumococcal conjugate vaccine.

Detailed Description
-----------------
We tested the hypothesis that conjugate vaccine offered less protection against pneumonia due to a reduced mucosal response compared to serum. We further hypothesized that this response would be further compromised with HIV co-infection[32] due to lack of local CD4 lymphocyte support and an altered alveolar milieu. We measured pneumococcal capsular specific immunoglobulin responses to 7-valent conjugate vaccine in both lung fluid and serum from healthy HIV infected and uninfected volunteers, together with flow cytometric assessment of the relative numbers and phenotypes of BAL T lymphocyte, B lymphocyte and macrophages.

Official Title
-----------------
Open Label Study of Lung and Serum Immunoglobulin Responses to 7-Valent Pneumococcal Conjugate Vaccine in HIV Infected and Non-HIV Infected Malawian Adults

Conditions
-----------------
HIV, Pneumonia, Meningitis, Invasive Pneumococcal Disease

Intervention / Treatment
-----------------
* Biological: 7-valent pneumococcal conjugate vaccine (Prevnar)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteer adults Exclusion Criteria: pregnant, recent illness, previous vaccination, asthma

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: 7-valent pneumococcal conjugate vaccine (Prevnar)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunoglobulin titres in bronchoalveolar fluid |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunoglobulin titres in serum |  |  | 
| Lung lymphocyte phenotype |  |  | 
| HIV viral load |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccine, Lung, Bronchoalveolar lavage, Lymphocyte, Immunoglobulin, HIV, Streptococcus pneumoniae, Conjugate vaccine
The Incidence of Metabolic Syndrome Among Obese Children in Our Region

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the prevalence of metabolic syndrome amongst obese children in our region with a body mass index (BMI) above the 95th percentile for age and sex.

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Routine laboratory tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with BMI over 95 percentile Exclusion Criteria: Obesity secondary to medication use Obesity secondary to genetic disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
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 |
| --- | --- |
| Obese children<br> | Other: Routine laboratory tests<br>* Laboratory tests to determine metabolic syndrome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of children with metabolic syndrome |  | six months |
Head and Neck Squamous Cell Carcinoma (HNSCC)PET-CT Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see how useful the information provided from Positron Emission Tomography (PET) scans can be in the actual planning and delivery of radiation treatment to patients who have head and neck cancers. Patients participating in this study, will have (in addition to their routine tests) a PET scan before and during their radiation treatment. Following the intervention, patients will be followed as per standard practice.

Official Title
-----------------
A Pilot Study of 18F-FDG PET-CT Kinetic Analysis in Head and Neck Squamous Cell Carcinoma (HNSCC)

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: 18-F FDG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-nasopharynx head and neck mucosal squamous cell carcinoma Radiologically evident gross disease Radiotherapy alone for curative intent Age equal to or more than 18 years old To be eligible for the second study PET-CT scan: FDG avid tumour (or minimum SUV of 2.5) on the first study PET-CT scan Exclusion Criteria: Nasopharynx cancer H&N SCC skin Distant metastases (already known or if found on baseline CT-thorax) Prior malignancy within the last 5 years (exclude non-H&N SCC, BCC skin) Prior chemotherapy within the last 5 years or concurrent chemotherapy/EGFR inhibitors Prior head and neck radiotherapy Inability to lie supine for study duration Pregnancy Inability to provide informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HNSCC Patients receiving RT<br> | Drug: 18-F FDG<br>* All patients enrolled in this study will receive 2 PET Scans: One prior to Radiation, and one during Radiation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure rate constant of 18F-FDG uptake in tumour and normal tissue with dynamic PET scanning before radiotherapy. |  |   2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure rate constant of 18F-FDG uptake in tumour and inflammatory tissue with dynamic PET scanning during radiotherapy . |  |   2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and Neck Squamous Cell Carcinoma, Radiation therapy, Head and Neck Cancers
Performance Evaluation of Four Pharmacokinetic-Pharmacodynamic(PKPD) Models of Propofol in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
Despite the wide use of propofol target-controlled infusion (TCI) in elderly patients, pharmacokinetic (PK) and pharmacodynamic (PD) models performance has not been prospectively assessed in this population. The aims of this study are to derive four PKPD models using previously published PK parameters sets, and to prospectively assess their performance in elderly people. With the obtained data we propose to build a specific PKPD model for this population.

Detailed Description
-----------------
After BIS® and routine monitors were placed, 14 ASA I-II elderly patients (>65 yr) will be anesthetized with plasma TCI of propofol based on Schnider model. After partial recovery from a bolus dose a remifentanil infusion was started and continued throughout surgery. All BIS and TCI data will be continuously record. Arterial blood samples for propofol assays were collected at 1, 2, 3, 5, 10, 20, 40 and 60 min post-induction, and at 0, 1, 3, 5, and 10 min after stopping the infusion. A three compartment effect site model linked to a Sigmoidal Emax PD model, will be used to fit all the data simultaneously in NONMEM. Median performance errors(MDPE), and median absolute performance errors(MDAPE) were calculated to measure bias and accuracy of each model. Comparisons between models will be performed.

Official Title
-----------------
Derivation and Prospective Validation of Four Pharmacokinetic-Pharmacodynamic Models of Propofol in Elderly Patients

Conditions
-----------------
Propofol Overdose of Undetermined Intent

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 65 years, ASA 1,2 Exclusion Criteria: Included less than 70% or more than 130% of ideal body weight Neurologic disorder Use of psychoactive medication, including alcohol intake during the last 48 hours

Ages Eligible for Study
-----------------
Minimum Age: 65 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
-----------------
PKPD, Propofol, TCI, Elderly patients
Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.

Study Overview
=================
Brief Summary
-----------------
To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.

Official Title
-----------------
Single Site Study, Phase III, for Safety Dermatological Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Teen.

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

Intervention / Treatment
-----------------
* Drug: Cetylpyridinium chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Integral buccal mucous (without oral pathologies); Normal odontological exams; Exclusion Criteria: Lactation or gestational risk or gestation; Use of Antiinflammatory or immunosuppression drugs 15 days before the study; Being in odontological treatment; Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results; Personal history of allergic disease in the area to be treated; Allergic or atopic history;

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 60 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: 1<br>Cetylpyridinium chloride during 21 consecutive days. | Drug: Cetylpyridinium chloride<br>* Cetylpyridinium chloride during 21 consecutive days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients will be evaluated according to the adverse reactions and the intensity of them. |  | 21 days |
The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep

Study Overview
=================
Brief Summary
-----------------
Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this has not been carefully studied. This research is being done to learn more about sleep function in heavy marijuana users, and to determine whether a medication approved for treating insomnia can help restore normal sleep function during brief periods of abstinence.

Official Title
-----------------
The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep

Conditions
-----------------
Marijuana Dependence

Intervention / Treatment
-----------------
* Drug: eszopiclone
* Drug: Placebo
* Drug: ramelteon
* Drug: zolpidem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current use of marijuana able to give informed consent Exclusion Criteria: dependence on drug other than marijuana current sleep disorder pregnant, breast feeding, or planning to become pregnant within the next 3 months currently seeking treatment for cannabis-related problems or otherwise trying to reduce use use of cannabis under the guidance of a physician for a medical disorder unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina) allergy to study medication

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Medication<br>Participants receive active hypnotic medication prior to sleep | Drug: eszopiclone<br>* Oral capsule at dose recommended for adults<br>Drug: ramelteon<br>* ramelteon<br>Drug: zolpidem<br>* zolpidem<br>|
| Placebo Comparator: Placebo<br>Participants receive placebo prior to sleep | Drug: Placebo<br>* Participants receive placebo prior to sleep<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marijuana Withdrawal |  | Every day during study participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Sleep Assessment |  | Every day during study participation | 
| Cognitive Performance |  | Every day during study participation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
marijuana, cannabis, dependence, withdrawal
Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)

Study Overview
=================
Brief Summary
-----------------
Multi-national, randomized, phase III, GCIG Intergroup study comparing pegylated liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in patients with epithelial ovarian cancer in late relapse. (CALYPSO)

Official Title
-----------------
Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)

Conditions
-----------------
Epithelial Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: pegylated liposomal Doxorubicin (CAELYX) & Carboplatin
* Drug: Paclitaxel & Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with epithelial Ovarian cancer in late relapse
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

| Intervention/Treatment |
| --- |
|Drug: pegylated liposomal Doxorubicin (CAELYX) & Carboplatin|Chemotherapy|
|Drug: Paclitaxel & Carboplatin|Chemotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | overall |
Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation(TMS) on Brain Derived Neurotrophic Factor (BDNF) in Depressed Patients.

Study Overview
=================
Brief Summary
-----------------
To investigate the change in brain derived neurotrophic factor (BDNF) between pre and post treatment for patients with depression with either ECT or TMS.

Official Title
-----------------
Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS) on Serum Levels of Brain Derived Neurotrophic Factor in Depressed Patients.

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MDD or bipolar disorder; current depressive episode, ham-d17>17 and ymrs<8; recommended to receive ECT or TMS as part of clinical care; male/female; age 18-65; inpatient or outpatient; comorbid dysthymic disorder, gad, or social anxiety will be included; able to give written consent and agree. Exclusion Criteria: current manic, hypomanic, or mixed episode, ymrs>7; current schizophrenia, anorexia, bulimia, substance dependence (current within past 6 months excluding caffeine and nicotine); TMS or ECT in the last 3 months; any other primary diagnosis; uncontrolled medical illness; epilepsy or severe personality disorder at the discretion of the investigators; 3 weeks prior to first blood test, antidepressants, mood stabilizers, antipsychotics can not be added or increased; pregnant women or women of childbearing potential not willing to use appropriate contraception, nursing women; known intolerance or lack of response to treatment receiving as judged by the investigator; medical conditions that would affect serum levels of BDNF; involvement in planning and conduct of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| 1<br>Electroconvulsive Therapy (ECT): blood sample taken from this group at start and after therapy; subjects not randomized to therapy option. | |
| 2<br>Transcranial Magnetic Stimulation (TMS): blood sample taken from this group at start and after therapy; subjects not randomized to therapy option. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of BDNF. |  | pre and post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the change in BDNF levels and illness severity after treatment. |  | pre and post treatment |
Impact of Hepatitis C Virus Variability on Steatosis

Study Overview
=================
Brief Summary
-----------------
Chronic infection by the hepatitis C virus (HCV) is a common cause of liver disease, which may progress to cirrhosis and eventually liver cancer. The therapeutic indication will depend mainly on the importance of liver damage (fibrosis), which can be assessed by physical techniques, blood tests and a liver biopsy. The overall objectives of the project are to understand how HCV variability may influence the severity of steatosis (accumulation of fat in the liver), studying 30 patients chronically infected with HCV (half of these patients infected by HCV genotype 3, versus the other half infected by HCV of another genotype). A small portion of the biopsy performed for the routine pathology examination will be placed in special fixation buffer for electron microscopy (EM). Counting and measuring the size of lipid droplets present in the liver by EM will be used to precisely quantify and characterize the liver steatosis. A blood sample of patients will also be collected to sequence the viral genome present in the patient and identify the amino acids involved in an increase in intracellular accumulation of lipid droplets. This work should clarify the impact of the viral variability in the severity of steatosis. Ultimately, the identification of viral sequences responsible for an increase of this phenomenon could be crucial for understanding the mechanisms involved in the steatosis.

Official Title
-----------------
Impact of the Hepatitis C Virus Variability on Liver Steatosis

Conditions
-----------------
Chronic Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic hepatitis C, naive of an antiviral treatment or after relapse or non-response for an antiviral treatment stopped for more than 1 year Liver biopsy necessary for the care of the patient Signature of informed consent Exclusion Criteria: Patients for which the liver biopsy is estimated ≤ 18 mm, so a portion of 3 mm could not be devoted for 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |