linjc16/ctgov huggingface dataset:
Isoflurane at Subanesthetic Concentrations - 6

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.

Official Title
-----------------
Isoflurane at Subanesthetic Concentrations

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: 40% Nitrous oxide
* Other: Sham comparator
* Drug: 0.2% isoflurane
* Drug: 0.4% isoflurane
* Drug: 0.6% isoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 34 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 0% isoflurane<br> | Drug: 40% Nitrous oxide<br>* Used as pain assay positive control<br>Other: Sham comparator<br>* 0% isoflurane in oxygen<br>|
| Active Comparator: 0.2% isoflurane<br> | Drug: 40% Nitrous oxide<br>* Used as pain assay positive control<br>Drug: 0.2% isoflurane<br> <br> |
| Active Comparator: 0.4% isoflurane<br> | Drug: 40% Nitrous oxide<br>* Used as pain assay positive control<br>Drug: 0.4% isoflurane<br> <br> |
| Active Comparator: 0.6% isoflurane<br> | Drug: 40% Nitrous oxide<br>* Used as pain assay positive control<br>Drug: 0.6% isoflurane<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain response | Effects of inhaled isoflurane on pain from immersion of subject's arm in ice cold water. Nitrous oxide (40%) was used as a positive control to confirm sensitivity of the pain assay. | Post inhalation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
isoflurane, general anesthetic, inhalant, subjective effects, healthy volunteer
The Importance of Muscle Function in Patients With Disseminated Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
This study investigates if reduced muscle mass and muscle function predispose to poor completion of oncological treatment in patients with bladder cancer (including cancer of the renal pelvis, ureter and urethra) and if muscle mass and muscle function change during oncological treatment in these patients. It also evaluates biomarkers for sarcopenia.

Official Title
-----------------
The Importance of Muscle Function in Patients With Disseminated Bladder Cancer

Conditions
-----------------
Urinary Bladder Neoplasm

Intervention / Treatment
-----------------
* Other: Evaluation of muscle mass and muscle function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Age ≥ 18 år Histologically verified cancer of the renal pelvis, ureter, bladder or urethra regardless of type of histology ECOG performance status 0 - 3 Meet the requirements for receiving oncological treatment (neoadjuvant chemotherapy for localized disease, chemotherapy or immunotherapy for disseminated disease). Exclusion Criteria: Age < 18

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 |
| --- | --- |
| Included patients<br>One-arm study. All included patients will have muscle mass and muscle function evaluated | Other: Evaluation of muscle mass and muscle function<br>* Included patients have their muscle mass and muscle function evaluated before start on and after completion of oncological treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass | We will describe if muscle mass at baseline is correlated to completion of planned systemic oncological treatment | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | We will describe if muscle strength at baseline is correlated to completion of planned systemic oncological treatment | Up to 36 months | 
| Muscle mass changes during systemic oncological treatment | We will describe if muscle mass change during systemic oncological treatment | Up to 36 months | 
| Muscle strength changes during systemic oncological treatment | We will describe if muscle mass change during systemic oncological treatment | Up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary Bladder Neoplasm, Urothelium Neoplasm, Oncology, Muscle function, Sarcopenia
Pancreatic Cancer Registry: For Any Person With a Personal or Family History

Study Overview
=================
Brief Summary
-----------------
The NFPTR was established in 1994 to find the causes of pancreatic cancer. In brief, the investigators are interested in both the genetic and non-genetic causes of pancreatic cancer. The investigators are particularly interested in finding the genes that cause pancreatic cancer to cluster in some families. Up to 10% of pancreatic cancer patients have another close relative who has also developed pancreatic cancer. This clustering of pancreatic cancers in families has yet to be explained; however, the investigators continue to identify new familial pancreatic cancer genes that explain this clustering in subsets of families. For example, in 2009 and 2012 the investigators discovered that mutations in the PALB2 and ATM genes jointly account up to 5% of the clustering of pancreatic cancer in families.

Official Title
-----------------
National Familial Pancreas Tumor Registry

Conditions
-----------------
Pancreatic Cancer, ATM, BRCA, Hereditary Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: personal or family history of pancreas tumors Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| participants<br>individuals with a personal or family history of pancreas tumors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pancreatic cancer |  | 35 years |
Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy

Study Overview
=================
Brief Summary
-----------------
Many patients undergoing flexible bronchoscopy (FB) experience anxiety and discomfort during the procedure. The investigators want to evaluate whether an additional Lorazepam premedication would improve patient satisfaction for FB.

Detailed Description
-----------------
The enrolled patients are randomized to either the control or Lorazepam groups according to a random sample chart of numbers. The patients complete questionnaires about baseline anxiety level and satisfaction for FB within 24 hours after the FB.

Official Title
-----------------
Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy

Conditions
-----------------
Patient Satisfaction for Bronchoscopy

Intervention / Treatment
-----------------
* Drug: Lorazepam
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (aged 18 years or older) admitted to the Respiratory Department Exclusion Criteria: outpatient procedures therapeutic bronchoscopy expected operation or discharge within 24 hours after the FB sedative premedication endotracheal intubation with mechanical ventilation inability to speak Korean

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Placebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB | Drug: Control<br>* Placebo 1T po at night one day before FB and placebo 1T po 30min before the FB<br>|
| Experimental: Lorazepam<br>Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB | Drug: Lorazepam<br>* Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction |  | within 24 hr of bronchoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relationship between patient satisfaction and sleep quality, anxiety level |  | 24hr before and after bronchoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fiberoptic Bronchoscopy, Patient, Satisfaction, Lorazepam
Using Tailored Emails to Motivate Healthy Behavior Among Employees

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to evaluate the efficacy of a multi-component email health promotion program on employee adoption of health promoting behaviors and secondarily on health status, work productivity and health care costs.

Detailed Description
-----------------
The Specific Aims are: To demonstrate the feasibility and assess the acceptability of email health promotion among diverse employee groups; To evaluate short and intermediate-term changes in health behaviors (e.g., daily fruit/vegetable intake, weekly physical activity) at 6 and 12 months; To assess change in health status (SF-12), work productivity, and healthcare costs among email program users and controls; To identify person predictors of sustained voluntary participation in a 6 month email health promotion program among the workforce population; To disseminate the results to maximize influence on e-health promotion, employer health promotion programs, health insurance policy, and research.

Official Title
-----------------
Using Tailored Emails to Motivate Healthy Behavior, Improve Health Status, & Reduce Health Care Costs in Employee Populations: A Randomized Trial

Conditions
-----------------
Health Behavior

Intervention / Treatment
-----------------
* Behavioral: Sequential emails and web support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult employee of participating worksite Access to desktop computer Exclusion Criteria: Under 18 years of age

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Sequential emails and web support|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity |  |  | 
| Fruit and Vegetable intake |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antecedents to behavior change |  |  | 
| Health status |  |  | 
| Work productivity |  |  | 
| Costs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
email, internet, health promotion, behavior change, health status, work productivity, healthcare cost, employee
Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.

Official Title
-----------------
Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity : Observational Study (COFTASD)

Conditions
-----------------
Spinal Deformity

Intervention / Treatment
-----------------
* Behavioral: Quality of life questionnaires
* Procedure: Radiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years-old Diagnosis of Adult Spinal Deformity with any of the deformity characteristics following: Scoliosis with a Cobb angle ≥ 20 ° Vertical sagittal axis (SVA) ≥ 5 cm Pelvic tilt ≥25 °, Thoracic kyphosis with a Cobb angle ≥ 60 ° Eligible for surgery Having given their participation agreement Affiliate or beneficiary of a social security scheme Exclusion Criteria: Age under 18 years-old Patient unlikely to comply with follow-up Patient with long-term complete paraplegia Patient unable to understand and answer questionnaires in due to language difficulties or cognitive impairment Pregnant or breastfeeding woman Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

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 |
| --- | --- |
| Spinal deformity operated patients<br> | Behavioral: Quality of life questionnaires<br>* Oswestry Disability Index Scoliosis Research Society-22R Short Form 36 Health Survey Questionnaire Tobacco, Alcohol, Prescription medication, and other Substance use Core Outcome Measures Index : back and neck<br>Procedure: Radiography<br>* Spinal radiography : full, face, profile<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with improved oswestry disability score | The factors associated with an improvement in the ODI score, 1 year after surgery, will be sought among the initial characteristics (before surgery) and within 3 months after surgery. An improvement in ODI score is defined as a decrease in score at 1 year of at least 10 points from baseline. | 15 years |
Application of Telemedicine to the Management of Aggressive Lymphomas

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.

Official Title
-----------------
Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Other: AMA (Assistance for ambulatory patients)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a recent diffuse large B cell lymphoma (LBDGC), histologically proven, with treatment not started a priori likely to be treated by rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) for 8 cycles or rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP). Index international prognosis (IPI) measurable (IPI-aa), adjusted for age. Any IPI-aa is eligible. accepting the study Exclusion Criteria: Patient with another type of lymphoma (including transformed follicular forms) Patient having already started his treatment. Life expectancy <3 months. Carcinologic history Serum positive for HIV or hepatitis B virus (HBV).

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AMA group<br>Patient with telephone follow-up modality called AMA (Assistance for ambulatory patients) | Other: AMA (Assistance for ambulatory patients)<br>* telephone follow-up modality<br>|
| No Intervention: Control group<br>Patient with standard follow-up with no specific assistance for ambulatory patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose-relative intensity (RDI) | reduction of RDI | through study completion, an average of 2 years |
To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion

Study Overview
=================
Brief Summary
-----------------
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution). The study also aim to evaluate the impact of washing the application site on the absorption of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous solution).

Official Title
-----------------
A Phase I Trial to Determine the Impact of Application of Antiperspirant and Deodorant as Well as Washing the Application Site, on the Pharmacokinetics of Testosterone Following Single Dose Applications of 2% Testosterone MD-Lotion® (Cutaneous Solution)

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosterone MD-Lotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy premenopausal female subjects ≥18 and ≤45 years of age with qualifying general medical health. Exclusion Criteria: Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br> | Drug: Testosterone MD-Lotion<br> <br> |
| Active Comparator: Group 2<br> | Drug: Testosterone MD-Lotion<br> <br> |
| Active Comparator: Group 3<br> | Drug: Testosterone MD-Lotion<br> <br> |
| Active Comparator: Group 4<br> | Drug: Testosterone MD-Lotion<br> <br> |
| Active Comparator: Group 5<br> | Drug: Testosterone MD-Lotion<br> <br> |
| Active Comparator: Group 6<br> | Drug: Testosterone MD-Lotion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution). Also to evaluate the impact of washing. |  | April 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application. |  | April 2009 |
Mesenchymal Stem Cells: Alterations in Genome

Study Overview
=================
Brief Summary
-----------------
The aim is to study small genetic alterations induced by cell culture in human mesenchymal stem cells in GMP condition.

Official Title
-----------------
MESenchymal Stem Cells: Alterations in GEnome

Conditions
-----------------
Pened Chest Surgery for Programmes Coronary Bypass

Intervention / Treatment
-----------------
* Procedure: harvest of a small bone marrow sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 old age < 75 old opened chest surgery for programmed coronary bypass

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: harvest of a small bone marrow sample|harvest of a small bone marrow sample during open chest surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of small genetic alteration in mesenchymal stem cells |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
celle therapy, cell culture, mesenchymal stem cells