linjc16/ctgov huggingface dataset:
To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.

Detailed Description
-----------------
Randomized, double-masked, vehicle-controlled, phase 2 study evaluating the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of signs and symptoms of Dry Eye Disease (DED). The subjects will be followed for approximately 2-3 months from screening to the last visit.

Official Title
-----------------
A Randomized, Double-Masked, Vehicle-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-Term Treatment of Signs and Symptoms of Dry Eye Disease (DED)

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: OTX-DED
* Drug: OTX-DED
* Drug: OTX-DED


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry Eye Disease diagnosis VAS eye dryness severity score ≥ 40. Exclusion Criteria: Are unwilling to discontinue use of contact lenses Are unwilling to withhold use of artificial tears.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTX-DED 0.2mg<br>Approximately 50 subjects | Drug: OTX-DED<br>* 0.2mg dexamethasone ophthalmic insert<br>|
| Experimental: OTX-DED 0.3mg<br>Approximately 50 subjects | Drug: OTX-DED<br>* 0.3mg dexamethasone ophthalmic insert<br>|
| Placebo Comparator: Hydrogel Vehicle (HV)<br>Approximately 50 subjects | Drug: OTX-DED<br>* Hydrogel vehicle ophthalmic insert<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center). | The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia [evaluated by the central reading center (CRC)] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia. | Change from baseline (Day 1) at Visit 4 (Day 15) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dexamethasone ophthalmic insert
TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure

Study Overview
=================
Brief Summary
-----------------
This study evaluates the link between genetic polymorphisms as r7903146, rs12255372 of TCF7L2 gene and the risk of developing hyperglycemia during Intensive care unit stay

Official Title
-----------------
TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure

Conditions
-----------------
Genetic Predisposition to Disease, Hyperglycemia, Intensive Care Unit Syndrome, Multiple Organ Failure

Intervention / Treatment
-----------------
* Genetic: genetic analysis
* Biological: blood and stools samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission in ICU>48h at least one organ dysfunction Exclusion Criteria: age< 18 years pregnant women admission less than 48h

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| intensive care patients<br>patients with a least one organ dysfunction | Genetic: genetic analysis<br> <br> Biological: blood and stools samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| value of the odds ratio associated with the relationship between a polymorphism TCF7L2 gene and the occurrence of hyperglycemia | find a link between genetic polymorphism of TCF7L2 and the risk of developing hyperglycemia in intensive care patients with a least one organ dysfunction. the hyperglycemia is defined fasting glucose> 1.26 g / l twice or need for treatment with insulin) | one year after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in inflammatory markers |  | one year after inclusion | 
| Changes in serum lipid profile | Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides | one year after inclusion | 
| Changes in liver enzymes | Changes in total alanine transaminase (ALT) total gamma-GT total aspartate transaminase (AST) | one year after inclusion | 
| Insulin Resistance (HOMA) | Calculated using the updated homeostasis model assessment (HOMA) calculator.Higher numbers indicate higher insulin resistance. There are no established cutoffs indicating impaired resistance. | one year after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biobank, hyperglycemia, Multiple Organ Failure, diabetes
Prospective Genomics Initiative on Multiple Synchronous Lung Cancer (PGI-MSLC)

Study Overview
=================
Brief Summary
-----------------
This prospective study is to characterize the genomic landscape and genetic heterogeneity of multiple synchronous lung cancer (MSLC) in correlation with comprehensive clinical, histopathological and medical imaging information, in order to improve disease diagnosis and tailored treatment for MSLC patients.

Detailed Description
-----------------
To initiate a prospective registry of MSLC patients with high-quality clinical samples and detailed medical data. To define the clonal relationship, genomic landscape and potential driver alterations of MSLC using whole-genome sequencing. To determine the intrapatient and intratumor genetic heterogeneity of MSLC. To correlate molecular features with clinical parameters and patient outcome. To serve as a continuous infrastructure for a large variety of research purposes including: A. Diagnostic research B. Prognostic research C. Biological research D. Interventional trial design testing new therapies in MSLC.

Official Title
-----------------
Prospective Genomics Initiative on Multiple Synchronous Lung Cancer (PGI-MSLC)

Conditions
-----------------
Multiple Synchronous Lung Cancers (MSLCs)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Confirmed diagnosis of multiple synchronous lung cancers (MSLCs) without metastatic disease Signed informed consent Exclusion Criteria: Medical or psychiatric condition that would preclude informed consent History of known high-risk infections With metastatic tumors except lung

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 |
| --- | --- | --- |
| Genomic characters of synchronous lessions in each MSLC patient | Whole-genome sequencing reveals the mutation, copy number variation and structure variation of MSLCs. We will analysis the genomic characters of synchronous lesions in each MSLC patient. | November 30, 2021 |
Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma

Official Title
-----------------
Open-Label, Multicenter, Phase Ⅱ Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: Docetaxel and Cisplatin and Nimotuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proved nasopharyngeal carcinoma; stage IVc according to Union for International Cancer Control (UICC) edition VIII,or recurrent disease after chemotherapy and/or radiotherapy; 18 years or older; without other malignancy; proper functioning of the major organs. Exclusion Criteria: allergic to docetaxel or cisplatin or Nimotuzumab ; female within gestation period or lactation; patients received drug of other clinical trail within 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel and Cisplatin and Nimotuzumab<br> | Drug: Docetaxel and Cisplatin and Nimotuzumab<br>* All patients enrolled in the study will accept docetaxel combined with cisplatin and Nimotuzumab as their firstline chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5-years |
Study Evaluating the Safety, Tolerability and Activity of One Dose of PAZ-417 Given to Healthy Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of PAZ-417 after administration of ascending single oral doses to healthy young Japanese male and healthy elderly Japanese male subjects.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of PAZ 417 Administered Orally to Healthy Young Japanese Male and Healthy Elderly Japanese Male Subjects

Conditions
-----------------
Alzheimer Disease, Healthy

Intervention / Treatment
-----------------
* Drug: PAZ-417
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Men aged 20 to 45 years inclusive (healthy young male subjects) and ≥65 years inclusive (healthy elderly male subjects) Nonsmoker or smoker of fewer than 10 cigarettes per day. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG). Exclusion Criteria Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Subjects who are identified as being at risk for hypercoagulability Use of any investigational or prescription drug within 30 days before test article administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Male

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAZ-417<br> | Drug: PAZ-417<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer Disease
Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in Premature Population

Study Overview
=================
Brief Summary
-----------------
Autonomic nervous system (ANS) is an essential regulator for the homeostasis, circulatory and respiratory systems. Heart rate variability, under the dependence of the parasympathetic and orthosympathetic arms is a peripheral witness of its well functioning. Activity ANS indices are technically measurable from the birth by non invasive cardiac monitoring: in given environmental conditions. According to the individualized care given to the baby, we can easily observe by frequential analysis, modifications of ANS level activity; If for a full-term newborn, the balance of ANS allows him to adapt its cardiac frequency to its internal and external environment (thermoregulation, baroreflex, sinus arrhythmia, awakening state) , the premature birth is at the origin of a prolonged defect of global ANS maturation, probably induced by external environmental and stress factors (pain, stimulations, aggressive noise and lights). This disrupted maturation profile in case of prematurity, was confirmed in two preliminary studies on premature babies reaching term for gestational age. We hypothesis that adapted sensorimotor care could decrease this stress and optimize the ANS activity profile. In a prospective study, by a non invasive real-time measure, we analyse impact of stress on ANS activity in a premature population, hospitalized in our neonatal intensive care units.

Official Title
-----------------
Evaluation of Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in a Premature Population : a Prospective Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premature birth hospitalized in the intensive care unit or in the neonatology unit or in the reanimation unit of the Pediatric Hospital of SAINT-ETIENNE Exclusion Criteria: arrhythmias general anaesthesia three weeks before the records

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 6 Weeks

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premature, newborn, heart rate variability, individualized sensorimotor care, noise
Hormone Changes in Women With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Receiving Erlotinib

Study Overview
=================
Brief Summary
-----------------
Studying samples of blood in the laboratory from patients receiving erlotinib may help doctors learn more about the effects of erlotinib on hormone levels. This clinical trial is looking at hormone changes in women with stage IIIB or stage IV non-small cell lung cancer receiving erlotinib.

Detailed Description
-----------------
Patients undergo a dermatology evaluation and complete the Polycystic Ovarian Syndrome (PCOS) research study questionnaire once. Blood samples are collected after an overnight fast. Samples are analyzed for circulating levels of total and bioavailable testosterone, dehydroepiandrosterone sulfate, and sex hormone binding globulin. Serum luteinizing hormone, follicle stimulating hormone, fasting glucose, and insulin levels are also assessed.

Official Title
-----------------
Evaluation of Hormonal Changes in Women on Erlotinib Therapy

Conditions
-----------------
Advanced Nonsmall Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Histologically confirmed non-small cell lung cancer Stage IIIB (effusion) or stage IV disease Must be receiving daily erlotinib hydrochloride for more than 3 months Must have hirsutism, acne, androgenic alopecia, amenorrhea, truncal weight gain, or other clinical phenotype associated with syndrome of androgen excess

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| questionnaire and laboratory biomarker analysis<br>Subjects with advanced non-small cell lung cancer and take erlotinib as part of their anticancer therapy for at least 3 months. Subjects have had some changes in hair growth, acne or menses (periods) that might be a side effect of erlotinib. Subjects will complete a questionnaire and blood collected for biomarker analysis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of hyperandrogenemia | We will determine if hyperandrogenemia is present in women with nonsmall cell lung cancer who are taking erlotinib. | One approximate 30 minute visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatologic manifestations | We will describe the dermatologic manifestations of erlotinib in women | One approximate 30 minute visit | 
| Changes in body habitus and patterns of hair loss | We will describe changes in body habitus and patterns of hair loss from women on erlotinib. | One approximate 30 minute visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced nonsmall cell lung cancer
Psychological Profile of Dental Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this descriptive investigation was to evaluate the psychological profile of dental patients in three levels: global level, the dimensional level, and the discrete symptom level and to compare it with a control group.

Detailed Description
-----------------
Many people is afraid of dental treatment specially local anesthesia and do not refer to dental clinics until they are obliged due to dental pain. There are so many articles in the literature about dental phobia and fear of anesthetic injection. Due to these evidences, dental people are supposed to show elevated psychological dimensions such as anxiety, and somatization. We are going to know which psychological dimensions of dental patients may be elevated when they refer to dental clinics.

Official Title
-----------------
Psychological Profile of Dental Patients. A Case Control Study

Conditions
-----------------
Indication for Modification of Patient Psychological Status

Intervention / Treatment
-----------------
* Other: Psychological Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must: be ≥ 18 years old and have high school degree or higher Exclusion Criteria: insufficient verbal capacity to comprehend the items of the questionnaire.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Dental patients group<br>Psychological measurement is done when they refer to a dental clinic. | Other: Psychological Measurement<br>* Measurement of psychological status in three levels: discrete symptom level, dimensional level, global level as measured by the scale<br>* Other names: psychological assessment of the subjects;|
| Control group<br>Psychological measurement is done when they refer to a dental clinic. | Other: Psychological Measurement<br>* Measurement of psychological status in three levels: discrete symptom level, dimensional level, global level as measured by the scale<br>* Other names: psychological assessment of the subjects;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nine psychological dimensions measured using a self-administered scale (SCL-90-R) | The subjects are supposed to consider the last week and answer all questions of psychological questionnaire. | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental patients, Psychological Profile