linjc16/ctgov huggingface dataset:
Study PIEB vs PIEB: the Dose is it Variable According to the Patients

Study Overview
=================
Brief Summary
-----------------
the main objective of this study is to compare the effectiveness of three groups of epidurals with three different programmed intermittent epidural bolus (PIEB)settings.

Detailed Description
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In a PIEB, the concentration of local anesthetics administered is standardized in the services according to the recommendations. What is left to the judgement of the clinician, taking care of the patient during the work, is the administered dose. This often varies according to clinician deductions that take notice of height, weight, previous pregnancies In the CHU of Rennes, three dosages are used in common practice. The objective by comparing these three dosages is to show if there is a significant difference between the groups.

Official Title
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Study Programmed Intermittent Epidural Bolus (PIEB) vs PIEB: the Dose is it Variable According to the Patients

Conditions
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Anesthesia, Epidural, Pregnancy

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patient over 18 years old. Pregnant patient, during labor, live fetus, for whom a PIEB is desired / programmed. Patient not objecting to their participation in the study. Exclusion Criteria: Hemostasis disorder contraindicated the epidural Eclampsia Caesarean section straightaway Patient under legal protection (guardianship, curatorship, safeguard of justice).

Ages Eligible for Study
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Minimum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Groupe 5-5<br>Patients for whom the clinician has prescribed local anesthetics in the epidural: fixed dose administered every hour in a systematic way : 5 ml dose to be administered every hour by the patient : 5 ml | |
| groupe 6-6<br>Patients for whom the clinician has prescribed local anesthetics in the epidural: fixed dose administered every hour in a systematic way : 6 ml dose to be administered every hour by the patient : 6 ml | |
| groupe 7-7<br>Patients for whom the clinician has prescribed local anesthetics in the epidural: fixed dose administered every hour in a systematic way :7 ml dose to be administered every hour by the patient :7 ml | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of additional injections during work. |  | two days after infclusion |
Adherence to Preventive Care for Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
In the United States, the highest incidence of cervical cancer occurs in inner city urban centers, rural areas, the deep South, Appalachia and the U.S.-Mexico border. The goal of this study is to study predictors of adherence among patients seeking care at an inner city medical center in New York City and the U.S. Mexico border for cervical cancer prevention, namely, Pap smears and colposcopy exams.

Detailed Description
-----------------
Because there are multiple pathways through which a person is influenced to seek and receive care, the investigators will conduct interviews with patients seeking care for cervical cancer prevention at an inner city medical center. The investigators will ask questions related to previous screening, diagnostic, and treatment practices as well as barriers experienced in seeking such care. The investigators will also explore patients' level of resiliency and coping as predictors of adherence to timely care. Furthermore, among immigrants, questions about acculturation and discrimination will be asked. Additional measures of socioeconomic status, such as education, income and occupation will also be collected.

Official Title
-----------------
Adherence to Screening and Follow-up Diagnostic and Treatment Services for Cervical Cancer Prevention

Conditions
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Cervical Cancer, Cervical Precancer, Adherence

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: women who are at least 21 years old are seeking care for a Pap smear exam are seeking care for a colposcopy exam for the first time are not pregnant by self-report are able to provide informed consent Exclusion Criteria: women who do not meet the above eligibility criteria women who have no prior history of a hysterectomy women who have previously participated in this study

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

Accepts Healthy Volunteers
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No

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to screening, colposcopy and follow-up treatment | A survey will be administered to patients who present for a routine Pap smear exam, a follow-up colposcopy exam. Medical records will be reviewed to document adherence to treatments post-colposcopy | 1-2 hour interview during clinic visit and review of patients' medical records during surveillance period (up to 2 years) |
Value of Oesophagal Videocapsul and Oeso-gastro-duodenal Fiber Endoscopy for the Screening of Oesophagal Varix for Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the equivalence or not of diagnosis ability of oesophagal videocapsul versus oeso-gastro-duodenal fiber endoscopy in the screening of oesophagal varix.

Official Title
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Comparision of Diagnostic Value of Oesophagal Videocapsul (VCO) and Oeso-gastro-duodenal Fiber Endoscopy (OGDFE) for the Screening of Oesophagal Varix (OV) for Cirrhotic Patients

Conditions
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Cirrhotic Patient With Suspicion of Portal Hypertension and in a OV Screening Context

Intervention / Treatment
-----------------
* Device: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: 18< age< 80 Diagnosis of a cirrhosis suspicion of portal hypertension without known diagnosis of a cirrhosis Able to give an inform consent Exclusion Criteria: Related to pouplation case history of cancer or oesophagal surgery case history of an ORL cancer case history of evolutive cancer Related to pathology Previous fiberoptic endoscopy with OV diagnosis Less than 6 month since last fiberoptic endoscopy Related to tested device clinical suspicion of oesophagal stenosis for a patient presenting a dysphagia to solids Zenker diverticuls attested clinical suspicion of small intestinal stenosis patient with pace-maker or any other inter device pregnant women deglutition troubles withfalse passage and/or conscience troubles

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: videocapsul and OGDFE<br>Each patient have a Fiberoptic endoscopy by videocapsul, followed by one traditional oeso-gastro-duodenal fiberoptic endoscopy | Device: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy<br>* each patient receive one OVC and one OGDFE the same day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or not of oesophagal varix |  | each fiberoptic endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of OV with red signs |  | each exam | 
| Presence of big VO or VO with red signs diagnosed by the two exams |  | each patient | 
| Discrimination threshold for OV prediction |  | each exam | 
| analogical visual scale for tolerance of each exam |  | 30 days after last exam |
Decisions of Young Women With Breast Cancer Regarding Fertility Preservation Before Cancer Treatment and Family Building After Treatment

Study Overview
=================
Brief Summary
-----------------
This study will help the researchers learn more about factors that affect the decisions about fertility preservation and family building made by young women with breast cancer.

Official Title
-----------------
Decisions of Young Women With Breast Cancer Regarding Fertility Preservation Before Cancer Treatment and Family Building After Treatment

Conditions
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Fertility Preservation, Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: web-based questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer, Stage 0-III Female 18-45 years of age at time of diagnosis Patients that completed their primary breast cancer treatment (surgery, chemotherapy, radiation therapy). Patients can still be on endocrine therapy, trastuzumab and/or pertuzumab therapy. Received education and counseling by MSK Fertility Nurse Specialist before beginning cancer treatment from 2009 through 2018 Exclusion Criteria: Unable to read English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Women with Breast Cancer<br>This is a cross-sectional survey of young women with breast cancer (YWBC) who received a consultation with an MSK Fertility Nurse Specialist before starting cancer treatment. | Behavioral: web-based questionnaire<br>* Participants will complete a web-based questionnaire examining the decisions patients made about fertility preservation before and after treatment, the factors that influenced their decisions, and the ways in which patients pursue family building after treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcome questionnaire - Fertility Preservation Questionnaire | Number of patients reporting that fertility tools were recommended to them following their breast cancer diagnosis | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Web-based questionnaire, 18-461
Metabolomic Profiling in Adolescents With Obesity and Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify unique metabolite signatures associated with the development of Type 2 diabetes and diabetic kidney disease in children. We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A) in the urine of adolescent females with polycystic ovarian syndrome.

Official Title
-----------------
Metabolomic Profiling in Adolescents With Obesity and Diabetes

Conditions
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Obesity, Metabolomics, Diabetes, Diabetic Nephropathies

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Age of 13-19 years Gender: male and female Ethnic background: any Obesity will be defined as BMI >95th percentile for age/gender Diagnosis of diabetes will be defined by current American Diabetes Association criteria Diabetes duration < 2.5 years Absence of pancreatic autoimmunity (GAD65 and ICA512 and Insulin autoantibody) Adult caregiver willing to actively support study participation Signed parental informed consent form and adolescent assent form For PCOS substudy, the diagnosis of PCOS will be defined according to the 1990 US National Institute of Health (NIH) criteria (oligomenorrhea, clinical or biochemical signs of hyperandrogenism, and exclusion of other known disorders) Exclusion Criteria: Creatinine clearance <60 mL/min (calculated from estimated GFR) Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation. For PCOS substudy, use of medications that effect androgen levels in the blood (i.e. oral contraceptive pills, or metformin) for the last 3 months prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 19 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 |
| --- | --- |
| Obese adolescents with type 2 diabetes<br>No intervention | |
| Obese adolescents without diabetes<br>No intervention | |
| Healthy non-obese adolescents<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in metabolite concentrations measured by mass spectrometry, comparing blood and urine samples from obese adolescents with type 2 diabetes, obese adolescents without diabetes, and age-matched healthy non-obese controls. |  | 2 years |
Comparison of Fatigue in Varying Hot Environments

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the impact of varying hot environments on physiological and perceptual fatigue during work.

Detailed Description
-----------------
After providing written informed consent and screening, subjects will complete two experimental visits during which they will complete treadmill work in either a hot/dry or warm/humid environment.

Official Title
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Comparison of Fatigue in Varying Hot Environments

Conditions
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Hyperthermia

Intervention / Treatment
-----------------
* Other: Hot/Dry
* Other: Warm/Humid


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: 18-39 y old men and women Self-reported to be healthy Exclusion Criteria: History of any cardiovascular, neurologic, renal, or metabolic disease Current tobacco use or regular use within the last 2 years Current musculoskeletal injury Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.) Currently pregnant or breastfeeding, or planning to become pregnant during the study Inability to follow the rules of the protocols or understand the consent form Contraindications of consuming a core temperature monitoring pill

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, counterbalanced crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hot/Dry<br> | Other: Hot/Dry<br>* Work is completed in a hot/dry environment.<br>|
| Experimental: Warm/Humid<br> | Other: Warm/Humid<br>* Work is completed in a warm/humid environment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoothness of movement | The variable, jerk, determines smoothness or unevenness of physical movement during work. This is measured using accelerometers placed along the spine, ankle, and shoulder. | 90 minutes | 
| Energy Expenditure | The amount of energy the body is expending during work. This is measured using indirect calorimetry. | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceptual fatigue | The degree of fatigue that the subjects perceive during work. This is measured using a subjective likert 0-10 scale named the Fatigue Scale with 0 indicting no fatigue at all and 10 indicating completely fatigued. | 90 minutes |
Detection in Peripheral Blood of Circulating Tumor Cells in Patient With Head and Neck Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The dissemination of individual tumor cells is a common phenomenon in solid cancers. Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic situation is of high prognostic significance. The objective of our study was to detect circulating tumor cells in two different method in patient with head and neck squamous cell carcinoma .

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Other: Circulating Tumor Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patient with head and neck squamous cell cancer stage III or IV histologically proven Patient naive to any prior therapy Patient with operate cancer and resectable tumor Hemoglobin ≥ 10g / dL Performance status ≤ 2 Ability to provide written informed consent Patient's legal capacity to consent to study participation Exclusion Criteria: Other previous histology tumors Medical conditions or acute or chronic severe psychiatric disorders Deprived of liberty or under supervision

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br> | Other: Circulating Tumor Cells<br>* Patients with stage III and IV head and neck squamous cell carcinoma undergoing surgery were enrolled in this study 5 and 7.5 ml of peripheral venous blood will be taken before the surgery, just at the end of surgery and one week after surgery Analysis was performed by RT-PCR and the CellSearch™ method using immunomagnetic and fluorescence approaches. Patients will be followed every 3 months for two years.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating tumor cells in peripheral blood during head and neck surgery | The number of circulating tumor cells detected per milliliter of peripheral blood will be evaluated on the day before, the day of surgery and 7 days after the surgery. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between RT-PCR and CellSearch™ method | The comparison between RT-PCR and CellSearch™ method will be the positivity sample rate | 1 day | 
| Prognostic marker of relapse | Local recurrence, regional or metastatic head and neck cancer in the two years | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
circulating tumor cell, CellSearch™ method, RT-PCR
Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemotherapy in Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The primary object of this study is to determine tumor major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer who subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy and molecular biomarkers related to the clinical response.

Official Title
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Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemotherapy in Non-small Cell Lung Cancer: Clinical Response and Biomarkers Analysis

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Able to understand the nature of this trial and provide written informed consent. 2.18 years ≤ age ≤ 80 years 3.Histologically documented non-small cell lung cancer 4.NSCLC with resection option for potential cure.This may include clinical stage IB, II and IIIA. 5.Subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy according to disease evaluation. 6.Measurable disease by RECIST v1.1 7.Tumor tissue sample and/or alveolar lavage fluid must be available for biomarker evaluation before operation. Exclusion Criteria: Subjects are excluded if they are enrolled in any other interventional studies. Administration of chemotherapy, device therapy or any other cancer therapy in 4 weeks before the study drug administration. Subjects are excluded if they have an active, known or suspected autoimmune disease requiring systemic treatment (e.g.corticosteroids or other immunosuppressive medications) in 2 years before the study drug administration. substitution therapy ( e.g. thyroxine, insulin) are permitted. Subjects with active concurrent malignancies are excluded i.e. cancers other than NSCLC. History of allergy to study drug components Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results. Any other conditions that, in the Investigator's opinion, unfit to attend this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| molecular biomarkers related to clinical response | molecular biomarkers related to tumor major pathological response (MPR) and pathologic complete response (pCR) in stage IB-IIIA non-small cell lung cancer who subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy | change from baseline to postoperation, an average of 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-small cell lung cancer, neoadjuvant, biomarker