linjc16/ctgov huggingface dataset:
Sweden Cancerome Analysis Network - Breast Recurrence (SCAN-B-rec)

Study Overview
=================
Brief Summary
-----------------
Prospective multicenter observational study to assess molecular drivers of metastatic breast cancer and disease evolution upon therapeutic pressure. The main aim is to develop and validate prognostic, predictive and pathogenic markers in clinically well-characterized population-based material of breast cancer tumors and the corresponding normal tissue.These data will be used to characterize recurrent breast cancer on a molecular level, study tumor evolution, develop biomarkers of response/resistance to targeted therapy in the metastatic setting, enroll patients on targeted treatment clinical studies and to elucidate mechanisms of resistance to therapy.

Official Title
-----------------
SCAN-B-rec: Infrastructure, Technology Platform and Clinical Research Development to Profile and Monitor Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Biopsies, blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pathologically confirmed advanced breast cancer (ABC), including locally advanced inoperable disease and stage IV disease. Age > 18 years. Performance status according to Eastern Cooperative Oncology Group (ECOG) ≤ 2. ABC must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination, computerized tomography (CT-scan), magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography (PET). Patients must have a radiological evaluation done maximum 6 weeks prior to inclusion. Signed informed consent according to ICH/GCP, and national/local regulations. Exclusion Criteria: Untreated psychiatric disorders that will impair the patient's ability to comply with study treatment or protocol.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Biopsies, blood|We will perform targeted exon sequencing on paraffin embedded tissues from metastatic breast cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Prospective recording of treatment interventions and molecular characteristics in metastatic breast cancer patients until the date of Death. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic breast cancer, Molecular profiling, Circulating tumor DNA, Circulating tumor cells
Australian Trial in Acute Hepatitis C Recall Study

Study Overview
=================
Brief Summary
-----------------
A single long-term follow up assessment of an established multi-centre, prospective longitudinal cohort study of patients for clinical, psychosocial, immunovirological outcomes 4 to 8 years after previous treatment for recently acquired hepatitis C virus infection.

Detailed Description
-----------------
The study aims are: To evaluate the effect of successful prior treatment or spontaneous clearance of recently acquired HCV infection on long-term quality of life, social functioning, injecting behaviour, mental health and liver health. To assess the incidence of HCV re-infection following prior treatment induced clearance or spontaneous clearance of recently acquired chronic HCV infection. To determine predictors of HCV re-infection following recently acquired HCV infection treatment. To determine frequency and predictors of new mixed and superinfections in ATAHC subjects with persistent viraemia. To add to a tissue repository of serum and PBMCs from well-characterised patients treated for recently acquired HCV infection to allow future examination of the role of other variables that may potentially impact on the prognosis and outcomes of early HCV treatment.

Official Title
-----------------
Long-term Outcomes Following Treatment of Recently Acquired Hepatitis C Virus Infection.

Conditions
-----------------
Acute Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous enrolment in the Australian Trial of Acute Hepatitis C Virus Infection (ATAHC) Study. Provision of written, informed consent. Exclusion Criteria: In the opinion of the investigator that the patient is not able to provide informed consent. Inability or unwillingness to comply with study collection requirements.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Long-term effects of HCV clearance | Health related quality of life (measured by SF-12) Social functioning (measured by OTI survey) Injecting behaviour Mental health (measured by DASS and MINI) Liver health (measured by FibroScan and biochemical markers) | 4 to 8 years from initial infection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of HCV re-infection | Rate of HCV RNA positivity in patients previously HCV RNA negative. | 4 to 8 years from initial infection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, acute, early chronic
Naproxen Versus Tramadol for Post Cesarean Pain Control

Study Overview
=================
Brief Summary
-----------------
Oral naproxen might be more efficacious for post-cesarean pain-control and have better side-effects profile than oral tramadol.

Official Title
-----------------
Oral Naproxen Versus Oral Tramadol for Analgesia After Cesarean Delivery - A Randomized Controlled Trial

Conditions
-----------------
Pain, Cesarean Section

Intervention / Treatment
-----------------
* Drug: Naproxen Tramadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients after cesarean section Exclusion Criteria: emergent CS hypersensitivity to drug drug abuse
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Active Comparator: Tramadol at fixed intervals<br> | Drug: Naproxen Tramadol<br> <br> |
| Active Comparator: Tramadol on request<br> | Drug: Naproxen Tramadol<br> <br> |
| Active Comparator: Naproxen at fixed intervals<br> | Drug: Naproxen Tramadol<br> <br> |
| Active Comparator: Naproxen on request<br> | Drug: Naproxen Tramadol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain control after cesarean section
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Venous Leg Ulcers

Study Overview
=================
Brief Summary
-----------------
This is a Phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC (7 subjects per treatment arm).

Detailed Description
-----------------
To assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC (7 subjects per treatment arm).

Official Title
-----------------
A Phase II, Randomized, Controlled, Two-Center Pilot Study of the Safety and Efficacy of Topically Applied MEBO® Wound Ointment Compared to Standard of Care in Subjects With Venous Leg Ulcers

Conditions
-----------------
Ulcers

Intervention / Treatment
-----------------
* Drug: MEBO Wound Ointment (MEBO)
* Procedure: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥18 years of age. Able and willing to provide informed consent. Able and willing to comply with protocol visits and procedures. A full-thickness VLU that has been open continuously for ≥4 weeks and ≤1 year. Exclusion Criteria: Ulcer of a non-venous hypertensive pathophysiology. Known or suspected allergy to any of the components of MEBO. Malignancy on target ulcer limb. Received another investigational device or drug within 30 days of enrollment. Non-compliance in the screening or run-in period.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEBO Wound Ointment (MEBO)<br>Topical application once a day | Drug: MEBO Wound Ointment (MEBO)<br>* Topical application once a day<br>* Other names: MEBO;|
| Active Comparator: Standard of Care<br>Application of Profore multilayer compression bandage system | Procedure: Standard of Care<br>* Application of Profore multilayer compression bandage system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete healing of the target ulcer within the 8-week treatment period. |  | 8 week treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous Leg Ulcers, VLU
The Italian Coronary Artery Aneurysm and Ectasia In Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The ITACA study is a prospective, observational no profit registry enrolling patients with Acute Coronary Syndrome and angiographic evidence of coronary aneurysms and/or ectasia.

Detailed Description
-----------------
The ITACA study is aimed at evaluating short and long term outcomes in patients with acute coronary sindrome and angiographic evidence of coronary aneurysm and/or actasia. Data regarding safety and effectiveness of invasive and pharmacological treatment strategies will be also collected.

Official Title
-----------------
ITAlian Coronary Artery Aneurysm and Ectasia Observational Study in Patients With Acute Coronary Syndrome: The ITACA Registry

Conditions
-----------------
Ectasia, Acute Coronary Syndrome, Angiographic Evidence if Coronary Aneurysms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signature of informed consent; Patients aged ≥18 years; diagnosis of ACS (ST-elevation myocardial infarction, non ST-elevation myocardial infarction, unstable angina), in accordance with the definition provided in the latest guidelines; diagnosis of ectasia or coronary aneurysm according to the definitions contained in this protocol, either in the culprit vessel of the SCA than in another vessel. Coronary pseudoaneurysms are excluded. Exclusion Criteria: impossibility or unwillingness to provide signed informed consent; contraindications to dual antiplatelet therapy; contraindications to anticoagulant therapy; active bleeding or severe anemia (Hb <6 g / dl); life expectancy <12 months; female patients with potential pregnancy;

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Major adverse cardiac events | A composite endpoint of myocardial infarction, stroke, cardiovascular death, myocardial revascularization and hospitalisation due to cardiovascular events | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aute Coronary Syndrome, Coronary Artery Artery, Ectasia
Sour Taste and Cold Temperature in Dysphagia

Study Overview
=================
Brief Summary
-----------------
The objective is to establish the effect of sour taste and cold temperature on the pharyngeal swallowing transit time after ischemic hemisphere stroke.

Detailed Description
-----------------
Over the past decade there were many studies over normal and pathological swallowing that discuss the influence of taste and temperature. Nevertheless there were many questions on the issue that remains to be solved, including the hemispheric lateralization of lesions dysphagic patients remains also to be fully understood.Swallowing disorder is defined as oropharyngeal dysphagia in presence of alterations in any phase of the complex swallowing dynamics. It could be congenital or acquired, affecting nutritional aspects, hydration, lung function and the individual's social integration [1]. Stroke, has a high incidence among neurological diseases, and cause disturbs on swallowing dynamics presenting signs of dysphagia in at least 50% of cases.A study that analyzed swallowing dynamics by videofluoroscopy in individuals with history of one or more stroke episodes with oropharyngeal dysphagia shows shorter pharyngeal and oropharyngeal transit times with cold stimulus than without them. Other study of heterogeneous neurological diseases such as cerebral palsy, brain trauma, stroke, and Alzheimer's disease, concluded that sour taste improved swallowing, minimizing laryngotracheal penetration and aspiration in individuals with neurological damaged. Chen et al. in an analysis of 42 healthy individuals with several taste bolus found that awareness and arousal could also influence the swallowing function.

Official Title
-----------------
Sour Taste and Cold Temperature Effects on Pharyngeal Transit Time After Ischemic Stroke:Anatomic and Functional Bases.

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of stroke Exclusion Criteria: instability clinic

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Sour Taste and Cold Temperature in Dysphagia |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke; sour taste; cold temperature; pharyngeal swallowing
Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the implantation of foldable intraocular lenses.

Detailed Description
-----------------
Intraocular Lenses (IOL) Cartridge is made up of polypropylene material with coating. This cartridge is used as lens delivery system for foldable lens implantation while doing cataract surgery. The coating is made up of medical grade polyurethane and biocompatible. This coating would be useful for smooth delivery of intraocular lens.

Official Title
-----------------
Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: cartridge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40 to 60 Senile cataract Nuclear Sclerosis grade I and grade II Exclusion Criteria: Inherent zonular weakness Shallow anterior chamber PXF Traumatic cataract Uveitis and Complicated cataract Dense PSCC and PPC

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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 |
| --- | --- |
| single group<br>the intra ocular lenses will be loaded in the cartridge. | Procedure: cartridge<br>* IOL cartridge coated with polymer material may ensure smooth delivery of IOL during cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra operative complication | to asssess the incidence of cartridge related post operative complications occurring in the anterior chamber on day 1 | post operative day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cartridge IOL
Bioequivalence Study in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial oral suspension of candesartan cilexetil (1 mg/mL) and a single 32 mg dose of the candesartan cilexetil oral suspension (1.6 mg/mL) used in the paediatric program.

Official Title
-----------------
A Single Dose, 2-Period, Cross-over, Bioequivalence Study in Healthy Subjects to Evaluate the Proposed Commercial Oral Suspension of Candesartan Cilexetil

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Candesartan cilexetil
* Drug: Candesartan cilexetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study specific procedures Body mass index (BMI) 19-27 kg/m2 calculated from height and weight at the Screening visit Clinically normal physical findings including ECG and safety laboratory values at the Screening visit and on Day -1 of each treatment period, including negative results for drugs-of-abuse, alcohol, Hepatitis B, Hepatitis C and HIV. Exclusion Criteria: History of significant mental, cardiac, renal, hepatic or significant gastrointestinal disease (that may affect the rate and extent of absorption of the IP), as judged by the Investigator Any condition which could modify the absorption of the IPs Previous randomisation of treatment in the present study History or symptoms and signs of ongoing severe allergic disease/hypersensitivity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Candesartan cilexetil 1mg/mL | Drug: Candesartan cilexetil<br>* Formulation:Oral suspensionStrength:1 mg/mLDose: 32 mg, single dose<br>|
| Experimental: B<br>Candesartan cilexetil 1.6mg/mL | Drug: Candesartan cilexetil<br>* Formulation:Oral suspensionStrength:1.6 mg/mLDose: 32 mg, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK (Candesartan cilexetil) |  | Collected at pre-dose and at selected time points; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30 and 36 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, ECG, vital signs, safety laboratory) |  | During the whole treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Candesartan, Bioequivalence
Natural History of Infantile Neuroaxonal Dystrophy

Study Overview
=================
Brief Summary
-----------------
This is a retrospective and cross-sectional review of the natural history of INAD.

Detailed Description
-----------------
After obtaining informed consent, the study participants' relevant medical records will be collected and reviewed. If needed, a telephone or video conference will be scheduled with the patient's family to confirm and clarify information in the medical record. Deceased patients may be eligible for inclusion the retrospective registry if medical records are sufficient and indicate eligibility. Data will be pooled and presented in aggregate, without identification of individual subjects.

Official Title
-----------------
A Retrospective Review of the Natural History of Infantile Neuroaxonal Dystrophy

Conditions
-----------------
Infantile Neuroaxonal Dystrophy, INAD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 months to 10 years of age Medical history consistent with the symptoms of classic INAD (onset of symptoms between the ages of 6 months and 3 years) Homozygous for PLA2G6 deficiency (variant alleles may be mixed heterozygotes) Signed informed consent form (ICF) prior to entry into the registry Exclusion Criteria: Diagnosis of atypical NAD (ANAD) Unwilling or unable to allow medical record review

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 10 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 |
| --- | --- | --- |
| To describe the natural history of infantile neuroaxonal dystrophy (INAD). | Overall analysis | Birth to time of enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To look for trends in disease progression of INAD that may be helpful in planning future interventional trials in INAD. | Overall analysis | Birth to time of enrollment. | 
| Evaluating and potentially validating a Assessment of Severity by Parent or Caregiver questionnaire. | In the questionnaire parents/caregivers are asked to score the child on a scale of 1 to 4 based on how often the child can perform 33 various activities of daily living. The individual scores are then added up to form a composite score of disease severity, with lower scores indicating higher severity and higher score indicating less disease progression. | At time of enrollment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infantile Neuroaxonal Dystrophy, INAD, PLA2G6