linjc16/ctgov huggingface dataset:
Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to implement a support interdisciplinary program(oncologists, pharmacists, physicians, nurses, leagues against cancer) of medication adherence to oral oncology treatments. The aim is to ensure continuity of care between professionals,effectiveness of treatment and patient safety.

Detailed Description
-----------------
80 patients will be included in swiss-romande hospitals and private oncologists and followed by thirty study pharmacies. Each refusal and drop-out will be documented. Follow-up duration is 48 weeks, with a motivational interviewing at least every three months. Patient adherence will be assessed electronically by MEMS (Medication Event Monitoring System).

Official Title
-----------------
Collaborative and Seamless Care in Oncology : a Study in Primary Care to Measure and Reinforce Safety and Adherence to Oral Cancer Treatment

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Treated for a cancer with oral medication (letrozol, exemestan,imatinib, sunitinib, nilotinib, everolimus, deferasirox) French speaking Exclusion Criteria: - None

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 |
| --- | --- |
| Study population<br>Adults (18 years old or more) with one of the following oral oncology treatments: letrozole, exémestane, imatinib, sunitinib, nilotinib, evérolimus, déférasirox | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Medication adherence | MEMS data, completed by informations given in motivational interviewing | 3 months, 6 months, 9 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program implementation | Evaluating the implementation of the program in pharmacies | 1 year | 
| Oncologists, nurses, pharmacists and patients satisfaction | By questionnaire and interviews | 1 year | 
| Effect of Adverse Drug Reaction (ADR) on medication adherence | By MEMS data and motivational interviewing informations | 1 year | 
| Change in Adverse Drug Reaction (ADR) | To evaluate the frequency and severity of ADR and the pharmacist's contribution to their management. Data from motivational interviewing. | 3 months, 6 months, 9 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medication Adherence, Patient Compliance, Patient Acceptance of Health Care, Administration, Oral, Cancer, Letrozol, Exemestan, Imatinib, Sunitinib, Nilotinib, Everolimus, Deferasirox
Can Pretreatment MRI be Used to Predict Intra-arterial Chemotherapy Response in Retinoblastoma?

Study Overview
=================
Brief Summary
-----------------
Retinoblastoma is the most frequent intraocular tumor in children and represents 6% of all pediatric cancers before the age of 5 years-old. The outcome is now excellent with 95 to 97% of 5-years survival rate. Conservative treatments are being more and more used, and intra arterial chemotherapy is one of the adjuvant treatments proposed to the children. The treatment is efficient in most cases, but a small proportion of children will have an early progression after treatment. MRI is used for the diagnosis of retinoblastoma. We aim to find prognostic factors using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for early identification of children response to intra arterial chemotherapy.

Official Title
-----------------
Prediction of the Response Using Dynamic Contrast-enhanced Magnetic Resonance Imaging Before Intra-arterial Chemotherapy in Children With Retinoblastoma

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Device: Dynamic contrast-enhanced MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: grade B to D retinoblastoma prescription of intra arterial chemotherapy Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Dynamic contrast-enhanced MRI|Dynamic contrast-enhanced perfusion sequences added to MRI examination performed at the beginning of intra arterial chemotherapy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response to chemotherapy | Persistence of ocular scarring (= favorable outcome)18 months after the end of the treatment by intra-arterial chemotherapy. | 18 months |
Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Four methods are routinely used to monitor CO2 in patients. End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia. CO2 is also monitored in other healthcare settings transcutaneously (TCO2), via finger stick capillary CO2 (CapCO2), and arterial blood gas (ABG). The purpose of this study is to perform all four measurements simultaneously during general anesthesia to identify which measure provides the most accurate data with the least amount of patient risk.

Official Title
-----------------
Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: End tidal CO2 (EtCO2)
* Device: Transcutaneous CO2 (TCO2)
* Diagnostic Test: Capillary CO2 (CapCO2)
* Diagnostic Test: Arterial blood gas (ABG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype) Hemodynamically stable undergoing general anesthesia for a scheduled procedure Exclusion Criteria: Patients not diagnosed with CF CF patients undergoing anesthesia for emergency procedures
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CF<br>Cystic fibrosis patients undergoing general anesthesia. | Other: End tidal CO2 (EtCO2)<br>* End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.<br>Device: Transcutaneous CO2 (TCO2)<br>* Continuous and noninvasive real-time monitoring of transcutaneous CO2.<br>* Other names: The SenTec Digital Monitoring System (SDMS);Diagnostic Test: Capillary CO2 (CapCO2)<br>* Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.<br>Diagnostic Test: Arterial blood gas (ABG)<br>* Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of CO2 Levels | Looking at the accuracy of CO2 levels assessed via end tidal CO2 (ETCO2), capillary CO2 (Cap-CO2), and transcutaneous CO2 (TCCO2) compared to arterial blood gas (ABG) which is the gold standard. | Immediately following induction of anesthesia |
Biomarkers of the Response to Osteopathic Manipulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify non-invasive biomarkers of the physiologic response to Osteopathic Manipulative Treatment (OMT).

Official Title
-----------------
Identification of Biomarkers for Investigating Osteopathic Manipulative Treatment

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

Intervention / Treatment
-----------------
* Other: Osteopathic Manipulation
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults between the ages of 21 and 60 Exclusion Criteria: Eating or drinking anything but water or chewing gum within an hour of the appointment Rib fracture History of unstable cardiac arrhythmia or symptoms related to the chest cavity (difficulty breathing, chest pain) Symptoms suggestive of bowel obstruction (abdominal bloating with pain, nausea and vomiting, diarrhea) Pregnancy History of Sjogren's Syndrome

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic Manipulation<br>Standardized OMT procedure | Other: Osteopathic Manipulation<br>* Standardized rib raising protocol<br>|
| Placebo Comparator: Placebo<br>Light touch placebo procedure | Other: Placebo<br>* Light touch control procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary amylase levels |  | baseline, 10 minutes post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OMT, biomarker, Manipulation, osteopathic
The Diagnosis Value of Serum Marker in Stroke Associated With Nonvalvular Atrial Fibrillation.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the diagnostic value of serum NT - proBNP in stroke associated with nonvalvular atrial fibrilltion.

Detailed Description
-----------------
All included in the cases in 7 days of blood samples, the detection of serum NT - proBNP.Through the single factor analysis to determine the serum NT - proBNP central source sex stroke prediction values.

Official Title
-----------------
The Diagnosis Value of Serum Marker in Stroke Associated With Nonvalvular Atrial Fibrillation

Conditions
-----------------
Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 ≤ Age ≤ 85; Meet the clinical diagnostic criteria for acute ischemic stroke; onset within 7 days; Exclusion Criteria: Severe systemic disease (chronic inflammation, infection, blood system diseases, cancer, kidney failure, liver failure,heart failure); Nearly a month history of myocardial infarction; pregnant; Serious neurological disease that the diagnosis is unclear;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| The diagnostic value of serum NT - proBNP in stroke associated with nonvalvular atrial fibrilltion | All included in the cases in 7 days of blood samples , the detection of serum NT - proBNP.Through the single factor analysis to determine the prediction values of serum NT - proBNP in stroke associated with nonvalvular atrial fibrilltion. | 34 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, NT-proBNP, Cardioembolic Stroke
Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia who are not considered to be suitable for standard chemotherapy.

Official Title
-----------------
A Phase I, Open Label, Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1152 in Japanese Patients With Acute Myeloid Leukaemia.

Conditions
-----------------
Acute Myeloid Leukaemia

Intervention / Treatment
-----------------
* Drug: AZD1152


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission Newly diagnosed Acute Myeloid Leukemia who are not considered suitable for other treatments. Exclusion Criteria: Administration of anticancer agents (other than hydroxyurea) within 2 weeks prior to first dose of study drug, and administration of hydroxyurea within 24 hours prior to first dose of study drug Participation in any other trial with an investigational product within the previous 30 days. Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD1152|intravenous|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis |  | assessed at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the pharmacokinetics of AZD1152 |  | assessed after dose administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myeloid Leukaemia, Phase 1, AZD1152
Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES

Study Overview
=================
Brief Summary
-----------------
The present study is designed to determine the mutational status of markers (TET2 and PLCb2, cytogenetic aberrations) together with methylation status of the above genes using bone marrow and matched buccal cell samples from MDS patients who necessitate to start a treatment (i.e. EPO, Lenalidomide, Azacytidine). All patients included in the study will be followed for at least 2 years.

Official Title
-----------------
Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES

Conditions
-----------------
Myelodysplastic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Patients diagnosed with MDS according to FAB, WHO and IPSS classifications All clinically treatable MDS patients with EPO or Lenalidomide or 5-Azacytidine; Hb < 10 g/dL Age ≥ 18 years Gender: Male or Female Sufficient amount of biological samples for molecular studies Exclusion Criteria: Age <18 years Patients who do not require treatment on watch and wait strategy Insufficient amount of biological samples for molecular studies

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 |
| --- | --- |
| Patients with MYELODYSPLASTIC SYNDROMES<br>Patients diagnosed with MDS according to FAB, WHO and IPSS classifications. Patients who necessitate to start a treatment (i.e. EPO, Lenalidomide, Azacytidine). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze the incidence of TET2 gene mutations and Validation of the prognostic potential of TET2 mutations and MPLA screening | Analyze the incidence of TET2 gene mutations in a series of MDS patients and describe the clinical status of patients carrying mutations Validation of the prognostic potential of TET2 mutations and MPLA screening on: Response rate to treatment with Epo, Lenalidomide and Azacitidine Progression Free Survival (PFS ) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the prognostic potential of TET2 mutations | Validation of the prognostic potential of Tet2 mutations on: Overall Survival; Validation of MLPA analyisis in the identification of cytogenetic abnormalities in MDS patients as a complementary screening tool; Validation of the prognostic relevance of MLPA analysis | 2 years |
Fascia Iliaca Compartment Blocks for Pain Control in Hip Fractures

Study Overview
=================
Brief Summary
-----------------
This study is comparing the use of a peripheral nerve block and standard opioid pain medications in pain control in hip fractures prior to surgery. A peripheral nerve block is a procedure that injects numbing medicine around a nerve to help decrease the pain, motion, and sensation around the painful site temporarily. The purpose of this study is to evaluate if peripheral nerve blocks are more effective for pain control than just standard opioid pain medication while decreasing the amount of side effects from opioid medication.

Official Title
-----------------
Fascia Iliaca Compartment Blocks to Improve Preoperative Pain Control in Elderly Hip Fractures

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Procedure: Nerve Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 50 or older, low energy hip fracture, acute hip fracture Exclusion Criteria: On anticoagulants, hardware present near injection site, preexisting nerve injury.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non nerve block<br>Receives no nerve block | |
| Experimental: Nerve block<br>Receives nerve block | Procedure: Nerve Block<br>* This group will receive a nerve block consisting of 20mL of 5mg/mL ropivicanine and 0.1mL of 10mg'mL dexamethasone.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Baseline Pain score on Visual analogue scale at initial encounter | pain is measured 1-10, 1 being the lowest and 10 being the highest | 0-60 minutes | 
| Mean Change from baseline pain score on the visual analogue scale | pain is measured 1-10, 1 being the lowest and 10 being the highest | 3-8 hours after initial encounter |
Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify the effectiveness of the investigational product through Subjective Assessment and answered by volunteers.

Official Title
-----------------
Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women

Conditions
-----------------
Female Dry Genital Mucosa

Intervention / Treatment
-----------------
* Device: KL029 Intimate Lubricant Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged between 45 to 65 years old Sexually active volunteers, with a minimum of 1 intercourse per week In menopause for at least 6 months; Intact skin in the product analysis region; No prior reactions to topical products Reading, understanding, agreement and signature of the informed consent form Exclusion Criteria: Use of anti-inflammatory and immunosuppressive ( in the last 30 days and during the study) Active skin diseases (local or disseminated) in the evaluation área; Diseases that cause imune suppression; Endocrine disorders such as thyroid, ovarian or adrenal gland disorders; Any infection in the region where the product will be analyzed diagnosed at enrollment; Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Device: KL029 Intimate Lubricant Gel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the product's efficiency as a moisturizer through subjective evaluation |  | 40 days |