linjc16/ctgov huggingface dataset:
Effects of Retinoids on CYP2D6 Activity During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Prospective drug interaction study during pregnancy.

Detailed Description
-----------------
A randomized pharmacokinetic study to evaluate CYP2D6 activity with and without vitamin A administration during pregnancy and compared to postpartum control.

Official Title
-----------------
Effects of Retinoids on CYP2D6 Activity and Variability in Special Populations

Conditions
-----------------
CYP2D6 Polymorphism

Intervention / Treatment
-----------------
* Drug: Vitamin A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancies Extensive metabolizers Exclusion Criteria: Chronic or persistent cough accompanying asthma, smoking or chronic obstructive pulmonary disease Productive cough Fever Known kidney disease Known liver disease Diabetes Obesity Bipolar disease Attention deficit disorder Social phobia Allergy or history of adverse event with dextromethorphan Drugs, foods, beverages or dietary supplements that interact with CYP2D6 or dextromethorphan dextromethorphan Unable to give written informed consent Inability to fast Concurrent use of vitamin A supplementation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, parallel group study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin A<br>Subjects will receive 3-4weeks of vitamin A | Drug: Vitamin A<br>* vitamin A daily X3-4 weeks<br>|
| No Intervention: Control<br>Subjects will receive no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CYP2D6 activity: dextromethorphan metabolic ratio | dextromethorphan metabolic ratio change from baseline during pregnancy | 4 weeks |
Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if the two different formulations of exemestane (Aromasin), oral and injectable, are equivalent in terms of pharmacodynamics and pharmacokinetics, i.e., if ultimately both formulations have the same efficacy in postmenopausal women with metastatic breast cancer who have failed previous antiestrogens therapy and are equally safe.

Official Title
-----------------
Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women With Advanced Breast Cancer Having Progressed on Tamoxifen.

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: exemestane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: other diagnosed with breast cancer estrogen receptor positivity Postmenopausal status advanced disease progression to previous tamoxifen therapy Exclusion Criteria: more than 1 chemotherapy and / or more than 1 hormonotherapy for advanced disease previous hormonotherapy other than Tamoxifen

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: exemestane|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacodynamic equivalence at steady state of the IM formulation of exemestane with the oral formulation in terms of plasma estrone sulphate inhibitory effect in postmenopausal women with advanced breast cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to characterize the pharmacodynamic profile of the two formulations in terms of estrogens, androgens, and sec hormone binding globulin |  |  | 
| to characterize the pharmacokinetics of exemestane and 17 hydroexemestane after administration of the two formulations |  |  | 
| to evaluate the relationships between pharmacokinetics and pharmacodynamics after intramuscular and oral administration of exemestane |  |  | 
| to evaluate the efficacy (as tumor response) |  |  | 
| to evaluate the incidence and severity of systemic toxicities and of the local tolerability of the injectable formulation |  |  | 
| to evaluate the effect on serum bone turnover markers |  |  |
Newborn Feeding and Infant Phenotype

Study Overview
=================
Brief Summary
-----------------
Breast feeding is believed to be beneficial to long-term health but how these effects are mediated is unknown. I suggest that this may be through effects on body composition and metabolism. I will compare adipose tissue and liver fat deposition in healthy, full term breast and formula fed infants babies shortly after birth and around 12 weeks.

Official Title
-----------------
Newborn Feeding and Infant Phenotype

Conditions
-----------------
Breast Feeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy baby Term baby Appropriate weight for gestational age (UK - WHO 2009 growth charts) Exclusion Criteria: Infants of diabetic mothers Infants of smokers Infants fed non-commercial or non-cows milk based infant formulae

Ages Eligible for Study
-----------------
Maximum Age: 4 Weeks

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 |
| --- | --- |
| Breastfed infants<br>>80% of feeds consisting of breast milk at both scanning points | |
| Formula-fed infants<br>>80% of feeds consisting of formula milk at both scanning points | |
| Mixed-fed infants<br>20%-80% of feeds consisting of breast milk. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Adipose Tissue Volume | Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging. | Between birth and 6-12 weeks age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants. | Change in regional adipose tissue distribution (ratio of internal abdominal to total subcutaneous abdominal adipose tissue) measured using whole body magnetic resonance imaging | Between birth and 6-12 weeks age | 
| Change in Intrahepatocellular Lipid Compared to Breastfed Infants. | Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy | Between birth and 6-12 weeks age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body Composition, Adipose Tissue, Intrahepatocellular Lipid, Infant, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.

Official Title
-----------------
A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction

Conditions
-----------------
Chronic Kidney Disease (CKD)

Intervention / Treatment
-----------------
* Device: Endovasccular AVF (EndoAVF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for a native surgical arteriovenous fistula, as determined by the treating physician. Adult (age >18 years old). Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis. Written informed consent obtained

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular AVF (EndoAVF)<br>The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access | Device: Endovasccular AVF (EndoAVF)<br>* The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access<br>* Other names: FLEX;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access Functionality | The functionality of the AVF will be measured based on use of the AVF with two needles for at least 75% of dialysis sessions over a 4-week period following at least a one month maturation period. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Chronic kidney disease, Arteriovenous fistula, Vascular access
Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period

Study Overview
=================
Brief Summary
-----------------
Vitamin D has pleiotropic effects. Burn patients are at risk of hypovitaminosis D and may experience post-injury osteopenia and sarcopenia. Investigators hypothesized that vitamin D supplementation during one year can improve bone and muscle health in post-burn period.

Official Title
-----------------
Effects of a One Year Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period

Conditions
-----------------
Vitamin D, Burn Injury

Intervention / Treatment
-----------------
* Drug: Cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: occurrence of injury between 2005 and 2011 burn surface area (BSA) greater than 10% Exclusion Criteria: Pregnancy, renal or liver failure, hypo or hyperparathyroidism, prior vitamin D substitution, treatment using systemic corticosteroids or antiepileptic drugs, regular exposure to ultraviolet B radiation (solarium), unstable cardiovascular disease or acute muscle or skeletal injury prohibiting physical exercise

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cholecalciferol<br> | Drug: Cholecalciferol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calcidiol blood concentration |  | at the end of the protocol (after one year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone health | bone formation and resorption markers (blood concentrations) bone mineral density measurement using dual energy X-ray absorptiometry | at the end of the protocol (after one year) | 
| muscle strength | Measurements of knee muscles strength on an isokinetic dynamometer | at the end of the protocol (after one year) |
Ropinirole in the Treatment of Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
To demonstrate efficacy and safety of Requip in in treating bipolar depression.

Detailed Description
-----------------
This study is 8 weeks long, with an optional additional 8 weeks. The study is placebo-controlled and patients are randomized to receive either ropinerol or placebo. Changes in depression, anxiety and overall psychiatric symptoms will be monitored during participation.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy of Ropinirole in the Treatment of Depression in Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: ropinirole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet DSM-IV criteria for bipolar disorder Current MADRS score > 16 Current MRS-SADS score < 10 Prior to participation in this study, each subject must sign an informed consent. All patients will be required to also take at least one other mood-stabilizing agent, defined as a standard agent (lithium, valproate, carbamazepine) or a novel anticonvulsant agent (oxcarbazepine, gabapentin, topiramate). If patients are not taking any of these agents on study initiation, they will be required to start one of these agents at study initiation. Study inclusion criteria must be met after at least 2 weeks of treatment with one of these mood-stabilizing agents. Exclusion Criteria: Any serious acute medical illness Any clinically serious evidence of suicidality or score of 3 or greater on suicide item on MADRS scale

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ropinirole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcomes will include predictors of response, such as insight into illness, comorbid anxiety symptoms, prior course of illness, previous treatment history with antidepressants, and other relevant clinical and demographic features. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bipolar disorder, ropinirole, depression
The Association Between Delivery Method and Maternal Rehospitalization

Study Overview
=================
Brief Summary
-----------------
Hypothesis: The rates of rehospitalization after cesarean section are significantly higher than those following spontaneous vaginal delivery and are due mainly to late bleeding and less to infection.

Detailed Description
-----------------
To determine if there is an association between delivery method and maternal rehospitalization rate, the type of association and the reasons for rehospitalization. The study population will consist women who were rehospitalized in the Western Galilee Hospital following cesarean section and after a vaginal delivery. Demographic data and hospitalization characteristics will be analyzed.

Official Title
-----------------
The Association Between Delivery Method and Maternal Rehospitalization

Conditions
-----------------
Hospitalization

Intervention / Treatment
-----------------
* Procedure: Cesarean section
* Procedure: Vaginal delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parturients rehospitalized after delivery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cesarean section|nan|
|Procedure: Vaginal delivery|nan|

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
-----------------
Rehospitalization, Cesarean, Vaginal delivery
Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition

Study Overview
=================
Brief Summary
-----------------
Systemic Sclerosis (SSc) is an inflammatory chronic disease that can lead to structural damage and handicap. The SSc physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the SSc mechanism, and improves the diagnosis and the treatment of the disease.

Detailed Description
-----------------
Studies show that the risk associated with high cumulative exposure to silica and organic solvents appears to be strongly increased in SSc. Moreover, exposure to silica is associated with a specific type of SSc phenotype with a worse prognosis. However, the type, intensity and probability of these expositions are unknown. The aim of the study is to precisely determine type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix.

Official Title
-----------------
Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged over 18 years old Speaking and understanding French language Being informed about the study and having given his consent Affected by SSc according to EULAR 2013 criteria Exclusion Criteria: Patient under tutorship Patient who refuse to participate

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 |
| --- | --- |
| Systemic Sclerosis patient<br>patients affected by SSc according to EULAR 2013 criteria | Behavioral: Questionnaire<br>* Questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyse type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix |  | At baseline (day 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toxic substances exposure, Organic Solvents, Silica
Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years

Study Overview
=================
Brief Summary
-----------------
A controlled, double blinded study to determine the safety and reactogenicity in healthy adults of a single dose of a trivalent cell-derived influenza vaccine administered by intramuscular injection.

Official Title
-----------------
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: Seasonal cell-derived influenza vaccine
* Biological: Placebo Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female or male subjects aged ≧18 and ≦49 years Willing and able to give informed consent Exclusion Criteria: Influenza vaccination of laboratory confirmed influenza infection within six months of informed consent, presence of any significant medical condition, a serious adverse reaction after a previous (influenza) vaccination, underlying medical conditions for which annual influenza vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP), chronic diseases requiring long-term immunosuppressive therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Seasonal cell-derived influenza vaccine<br>* 0.5 mL im, single dose<br>|
| Placebo Comparator: 2<br> | Biological: Placebo Comparator<br>* 0.5 mL im, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination. |  | 3 weeks | 
| Long-term safety |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HI antibody titers |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cell-derived subunit influenza vaccine, Safety, Reactogenicity