linjc16/ctgov huggingface dataset:
Exploratory Study of Propofol and Fentanyl Pharmacodynamics

Study Overview
=================
Brief Summary
-----------------
Exploration of the hypothesis that general anesthesia is not a singular threshold but is a continuum of central nervous system depression dependent on interpretation of nociceptive stimuli.

Official Title
-----------------
An Open Label, Exploratory Study of Propofol and Fentanyl Pharmacodynamics

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Drug: propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesia (ASA) classification score I-II male and female volunteers Normal healthy individual by medical history and physical examination Uncomplicated airway anatomy Body Mass Index (BMI) between 18-29 Subject willing to give consent and comply with evaluation and treatment schedule 18-55 years of age (inclusive) Negative durg screen for marijuana, cocaine, ecstasy, phencyclidine (PCP), amphetamines, benzodiazepines, opiates and methamphetamines Woman of childbearing age byst be utilizing reliable means of contraception Able to read, speak and understand English Exclusion Criteria: Physical of psychological condition which would impair study participation as determined by the principal investigator Known or suspected neurological pathologies as assessed by the principal investigator History of significant alcohol or drug abuse, a history of allergy to opioids or propofol, or a history of chronic drug requirement or medical illness that is known to alter pharmacokinetics or pharmacodynamics of fentanyl and/or propofol Known or suspected hypersensitivity to any study drug Taken any medication within 2 days prior to study drug administration, with the exception of oral contraceptives Baseline tolerance above 50 mA on TES Pregnancy or lactation Consumed food within 8 hours or liquids within 4 hours prior to study drug administration Participation in any other investigational device or durg study within 30 days of enrollment Diagnosis of sleep apnea Current prescription to anti-depressant or anti-anxiety 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: proprofol<br> | Drug: propofol<br>* peripheral IV of propofol at increasing dose levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between Modified Observers Assessment of Alertness (MOAAS) and transdermal electrical stimulation (TES) | MOAAS and TES assessment of increasing level(s) of sedation | 1 day |
Tow Maxillary Hybrid Expanders Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study

Study Overview
=================
Brief Summary
-----------------
in this study i will use to different designs of t maxillary hybrid expanders that consists of HYREX supported with tow miniscrews to treat the collapsed maxilla in Yonge adolescents

Detailed Description
-----------------
the maxilla is expanded by tow diffrent designs of maxillary hybrid expanders

Official Title
-----------------
Comparison of Tow Maxillary Hybrid Expanders -Perpendicular Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study

Conditions
-----------------
Cross Bite

Intervention / Treatment
-----------------
* Device: hybrid expanders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically free male or female patients Patients that necessitated maxillary expansion due to constricted maxillary arch shown by a unilateral or bilateral posterior crossbite. The patient should have no missing teeth except third molars. Age ranged from 12 to 18 years old. The patient should have a good gingival condition. The patient should have a good periodontal condition. Exclusion Criteria: 1-hisory of previous orthodontic treatment. 2- Lack of cooperation. 3- Mental problems. 4- Skeletal open bite. 5- TMJ problem. -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group (1)<br>tow perpendicular miniscrews supported hybrid expanders | Device: hybrid expanders<br>* tow maxillary hybrid expanders supported anteriorly with tow miniscrews<br>|
| Experimental: group (2)<br>tow angulated miniscrews supported hybrid expanders | Device: hybrid expanders<br>* tow maxillary hybrid expanders supported anteriorly with tow miniscrews<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in maxillary width | millimeter | 12 weeks following end of treatment |
Comparison of CL Wear Between Two Allergy Drops

Study Overview
=================
Brief Summary
-----------------
Comparison of two allergy drops for enhancing comfort and performance of contact lens wear

Detailed Description
-----------------
Contact lens patients will instill allergy drops and subjective and objective tests will be performed

Official Title
-----------------
Comparison of CL Wear Between Epinastine Hydrochloride and Olopatadine Hydrochloride

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: epinastine HCL and olopatadine HCL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females > 18 years old Mild to moderate dry eye symptoms Likely to complete all study visits and able to provide informed consent Exclusion Criteria: Current use of topical cyclosporine Known contraindications to any study medication or ingredients Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable) Ocular surgery within the past 3 months

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: epinastine HCL and olopatadine HCL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact lens objective and subjective clinical performance testing |  | up to 3 months |
Determinants of Health Status and Quality of Life in Patients With Primary Immunodeficiencies Inhereted Diagnosed During Childhood

Study Overview
=================
Brief Summary
-----------------
Background: Most children with primary immune deficiency (PID) now reach adulthood. However, few studies have evaluated their health status and health related quality of life (HRQoL). Objective: To investigate long-term morbidity, the French Reference Center for PIDs initiated a prospective multicenter cohort: the F-CILC (French Childhood Immune deficiency Long-term Cohort). The data collected will be used to assess the physical health condition of patients who reached adulthood and the impact on their quality of life. Methods: Patients are asked to complete health status questionnaires. A severity score (grade1 [mild] to grade 4 [life-threatening]) is assigned to each health condition. The HRQoL of patients is compared to age- and sex-matched French normal values using the SF36 HRQoL questionnaire. Capsule summary. This will be the first study of adult survivors of childhood PID describing how the burden of health conditions affect their quality of life.

Official Title
-----------------
Determinants of Health Status and Quality of Life in Patients With Primary Immunodeficiencies Inhereted Diagnosed During Childhood

Conditions
-----------------
Primary Immune Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with primary immune deficiency diagnosed during childhood Exclusion Criteria: Patients not willing to answer to quality of life questionnaires
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 |
| --- | --- | --- |
| Numbers of patient with PID diagnosed during childhood experiencing a heavy burden of health conditions affecting their quality of life |  | 3 years |
Prospective Clinical and Biologic Study of Secondary Cutaneous Effects in Targeted Cancer Therapies

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to do a descriptive analysis of the cutaneous toxicity observed in patients treated using targeted therapies in order to have a better understanding of the skin pathophysiology.

Official Title
-----------------
Prospective Clinical and Biologic Study of Secondary Cutaneous Effects in Targeted Cancer Therapies

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Procedure: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cancer beginning a targeted therapy Patients able to follow the protocol Age >/= 18 years old Signed inform consent Exclusion Criteria: Patient unable to follow the protocol, having a non cooperative behavior or unable to come to follow up visits or unable to complete the study Pregnant or breastfeeding woman

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: Patients having received targeted therapies<br>Patients treated using targeted therapies | Procedure: Biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of clinical secondary effects bind to targeted therapies | Dermatological exam including questionnaire, clinical examination and photographies | Every 28 days up to 5 years |
Assessment of Factors Influencing Parents' Attendance Time During Feeding Time of Premature Infants Born Before 35 Weeks of Amenorrhea in Besançon University Hospital

Study Overview
=================
Brief Summary
-----------------
The precise description of parental presence and the associated factors will make it possible to construct an intervention in order to correct potentially low parental participation. The demonstration of the effectiveness of such an intervention will be the subject of a larger study (PHRIP type). Ultimately, the investigators want to personalize the daily support for parents to offer optimal support for parenting.

Detailed Description
-----------------
Considering the importance of the bond of attachment, and in particular the emotional tuning between the adult and the premature baby and the particularly important interactions during feeding, it seemed essential to us to make an evaluation of the parental presence during the meals. , which sheds light on the factors influencing this presence. The presence time seems to vary depending on: the child's background, the profile of the parents, the profile of the child and environmental factors. Knowing the factors influencing this presence is essential in order to understand the obstacles to the arrival of parents, to think as a team and to offer personalized support in order to allow them to be more present with their baby.

Official Title
-----------------
Assessment of Factors Influencing Parents' Attendance Time During Feeding Time of Premature Infants Born Before 35 Weeks of Amenorrhea in Besançon University Hospital

Conditions
-----------------
Premature Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature newborn under 35 weeks of amenorrhea (AS), hospitalized at Besançon University Hospital, Newborn baby whose parents: expressed their non-opposition to participate in the study, are affiliated to a social security scheme, are of age, express themselves easily in French. Exclusion Criteria: Newborn baby whose parents object to participating in the study, Newborns presenting severe malformative anomalies, or malformations of the oral sphere, Newborn baby whose transfer is scheduled before the end of hospitalization (excluding birthing pool at the CHU de Besançon).

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 10 Days

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 |
| --- | --- | --- |
| The time of parental presence | Quantify the time of parental presence during the meals of premature children born before 35 weeks of amenorrhea (AS) | Up to 6 months |
Pelvic Microbiomes of Benign and Malignant Ovarian Diseases

Study Overview
=================
Brief Summary
-----------------
This case-control study aims to compare the pelvic microbiomes of benign ovarian diseases and ovarian malignancies by 16s RNA techniques and culture. Discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube are collected from age and menopausal status matched patient before and during procedures of laparoscopies. The discharges/flushing fluid would be sent for 16s RNA analysis and microculture respectively, and the results would get self-contrasted comparison and case-control comparison.

Official Title
-----------------
The Role of Pelvic Microbiomes During the Malignant Transformation of Benign Ovarian Diseases

Conditions
-----------------
Microbiota, Ovarian Neoplasms, Ribosome Alteration

Intervention / Treatment
-----------------
* Diagnostic Test: microbiomes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopy procedures Specific pathological diagnosis Exclusion Criteria: Previous history of pelvic surgeries Evidences of pelvic inflammation diseases
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Benign ovarian disease<br>The group consists of patients of benign ovarian diseases and health conditions (eg infertility), who would accept the tests of pelvic microbiomes. | Diagnostic Test: microbiomes<br>* 16s RNA analysis and microculture of discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube<br>|
| Malignant ovarian disease<br>The group consists of patients of high grade serous carcinoma, who would accept the tests of pelvic microbiomes. | Diagnostic Test: microbiomes<br>* 16s RNA analysis and microculture of discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of species distribution of microorganism according to 16s RNA analysis | The difference of species of microorganism distribution according to 16s RNA sequencing analysis between control group and study group, and between different sampling sites in each arm | 2 years | 
| Difference of species distribution of microorganism according to microculture outcomes | Difference of species distribution of microorganism according to microculture outcomes between control group and study group, and between different sampling sites in each arm | 2 years |
Mitochondria Inborn Errors of Metabolism and ANT Defects in Mitochondria Diseases

Study Overview
=================
Brief Summary
-----------------
The objective of this research protocol is to continue investigation of the nature and prevalence of mitochondria disease and to aid patients and health care providers in the understanding of these complex disorders. This research study brings together many clinical sub-specialists to address the etiology of these disorders and to develop more effective approaches for their diagnoses and more reliable prognoses.

Detailed Description
-----------------
The non-invasive device named Diffuse Optical Spectroscopy developed at the Beckman Laser Institute is to be used to measure various physiological parameters. Since mitochondria produce most of the energy necessary for cellular function, their efficacy is most important for systems with a high energy demand like the brain, heart, skeletal muscle, kidney, liver, and endocrine tissues. As a result, mitochondria diseases usually manifest as complex, multi-organ disorders, requiring multispecialty investigations.

Official Title
-----------------
Investigation of the Nature and Prevalence of Mitochondria Disease

Conditions
-----------------
Mitochondrial Disease

Intervention / Treatment
-----------------
* Device: Diffuse Optical Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female all ages group with diagnosis of mitochondrial disorder Exclusion Criteria: Subjects with visual, auditory and/or neurological problems known to result from toxic or environmental effects

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Diffuse Optical Spectroscopy|mitochondria|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Mitochondrial diseases |  | Up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mitochondrial
Observational Study on the Management of Patients With Non Small Cell Lung Cancer Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to determine the proportion of patients with M + mutation status among patients with Non Small Cell Lung Cancer adenocarcinoma.

Detailed Description
-----------------
MSD

Official Title
-----------------
Observational Study on the Management of Patients With Non Small Cell Lung Cancer (NSCLC) Adenocarcinoma Tested for the Activating Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase (EGFR TK)

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with lung cancer (Non Small Cell Lung Cancer adenocarcinoma) Patient for whom a search for the mutational status of EGFR (EGFR-M +, M- or Mx) has been done or is being analyzed Exclusion Criteria: Assessment of mutational status of EGFR is not done

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main objective of the study is to determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma |  | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the therapeutic management according to the mutational status (EGFR M +, EGFR M- and Mx). |  | 12 months / At each visit | 
| Describe the therapeutic management of patients with EGFR M +. |  | 12 months / At each visit | 
| Describe the clinical course of patients EGFR-M +, treated for first-line treatment, and then 2nd line treatment, until 31-AUG-2012 |  | 12 months / At each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
M + mutation, Non Small Cell Lung Cancer adenocarcinoma, To determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma
Prediction of Acute Rejection in Renal Transplant

Study Overview
=================
Brief Summary
-----------------
Acute rejection is still a major risk factor affecting the prognosis of kidney transplant patients. Alloreactive cells of the recipient infiltrate the kidney graft and cause inflammatory reaction which damages the graft structure and function. Conventional diagnosis of acute rejection is based on clinical symptoms and kidney biopsy examination. The clinical symptoms are a result of the kidney damage, which occurs days after the initiation of the rejection reaction. Kidney biopsy is an invasive and expensive procedure. It has been wished to have new parameters that can replace/supplement the conventional procedures. Chemokines are small molecules that attract inflammatory cells. Changes of chemokine levels in the urine may correlate with the immune status in the kidney. A systematic study to evaluate the chemokine levels in urine and correlation with the kidney biopsy pathology will answer the question whether monitoring of urinary chemokines would be useful in predicting graft rejection/damage.

Official Title
-----------------
Prediction of Acute Graft Rejection by Examining Urine Chemokines in Patients With Kidney Transplant

Conditions
-----------------
Kidney Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One hundred subjects undergoing kidney biopsy for suspected rejection Forty subjects that have stable graft function with normal level of blood creatinine (No biopsy is needed at the time of sample collection). Exclusion Criteria: Subjects under the age of 18 Gender of potential subjects male or female Age Limits greater than 18 years of age

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kidney biopsy pathology |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary chemokines |  | 1 year |