linjc16/ctgov huggingface dataset:
Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)

Study Overview
=================
Brief Summary
-----------------
This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase (rASNase) for first-line treatment of infants (< 1 year of age at diagnosis) with de novo acute lymphoblastic leukaemia

Official Title
-----------------
Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial

Conditions
-----------------
Acute Lymphoid Leukemia

Intervention / Treatment
-----------------
* Drug: recombinant asparaginase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria. Morphological verification of the diagnosis, confirmed with cyto¬chemistry and immunophenotyping. Age < 1 year at diagnosis. Written informed consent of the parents or other legally authorised guardian of the patient. Treatment according to protocol INTERFANT 06 Exclusion Criteria: Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL. The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells. Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible. Known allergy to any ASNase preparation. Pre-existing known coagulopathy (e.g. haemophilia). Pre-existing pancreatitis. Liver insufficiency (bilirubin > 50 µmol/L; SGOT/SGPT > 10 x the upper limit of normal).

Ages Eligible for Study
-----------------
Maximum Age: 364 Days

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: recombinant asparaginase<br> | Drug: recombinant asparaginase<br>* 10 000 Units/m² adjusted to age, 6 i.v. infusions (day 15, day 18, day 22, day 25, day 29, day 33) during the induction therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with hypersensitivity reactions to rASNase |  | within 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacodynamic of rASNase |  | within 33 days |
Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Determine whether copies of the cystic fibrosis gene (pGT-1) can be delivered to the cells lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated gene transfer.

Detailed Description
-----------------
PROTOCOL OUTLINE: Under direct visualization, patients receive lipid/DNA formulation (pGT-1 lipid complex) by syringe instillation over 30 minutes to the right inferior nasal turbinate. Patients are followed daily for 7 days, twice a week for 3 weeks, every 2-3 weeks for 10 weeks, then every 3 months thereafter.

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

Intervention / Treatment
-----------------
* Genetic: pGT-1 gene lipid complex


Participation Criteria
=================
Eligibility Criteria
-----------------
Cystic fibrosis patients Not pregnant Fertile patients must use effective contraception

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: pGT-1 gene lipid complex|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
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
NOX4 and Related Biomarkers in ADPKD

Study Overview
=================
Brief Summary
-----------------
To determine the value of NOX4, markers of mitochondria injury and function, and oxidative stress as real-time biomarkers to assess disease severity in patients with early autosomal dominant polycystic kidney disease (ADPKD).

Detailed Description
-----------------
This will be a cross sectional study and will include male and female, young (15-40-years) well characterized patients with early (eGFR>70mL/min/1.73m2) ADPKD. Patients with different classes of disease severity will be selected using the ADPKD imaging classification. The study will include 60 class-1 (A-E) patients (N=12 per each sub-class).

Official Title
-----------------
NOX4, Mitochondria and Related Biomarkers in Autosomal Dominant Polycystic Kidney Disease

Conditions
-----------------
Autosomal Dominant Polycystic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADPKD (based on Ravine et al. criteria) Class 1 A-E according to imaging classification Male and female subjects 15 - 40 years of age Estimated GFR> 70 mL/min/1.73 m2 (CKD-EPI) Ability to provide written, informed consent Exclusion Criteria: Class 2 according to imaging classification Concomitant systemic disease affecting the kidney Diabetes mellitus Predicted urine protein excretion in >1 g/24 hrs Use of antioxidants i.e. vitamins, Nrf2 activators Abnormal urinalysis

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with a previous diagnosis of ADPKD<br>Patients that have been diagnosed with ADPKD and are classified as Class 1A, 1B, 1C, 1D and 1E. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NOX4 levels | Determination of NOX4 levels from urine and plasma samples | Baseline | 
| mtDNA copy number | Determination of mtDNA copy number from urine and plasma samples | Baseline | 
| Tricarboxylic Acid (TCA) cycle metabolites | Determination of TCA cycle metabolite concentration from urine and plasma samples | Baseline | 
| REDOX status | Determination of REDOX from urine and plasma samples | Baseline | 
| Total kidney volume (TKV) | Determined by MRI | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Glomerular Filtration Rate (eGFR) | Estimated by CKD-epi equation | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxidative Stress, Mitochondria injury and function, NADPH oxidase 4
Ultrasonography vs Conventional Methods for Prediction of Difficult Airway in Adult Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study to assess and compare between methods of prediction of difficult airway including Mallmpati score , thyromental distance and us measured distance from skin to epiglottis(DES) t the level of thyrohyoid membrane in adult patients requiring endotracheal intubation for an elective surgical procedure.

Official Title
-----------------
Ultrasonography(Distance From Skin to Epiglottis) vs Conventional Methods (Mallampati Score & Thyromental Distance) for Prediction of Difficult Airway in Adult Patients

Conditions
-----------------
Difficult Intubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anaesthesia class 1,2and 3. elective surgical procedure requiring endotracheal intubation. Age 18_60 years old. BMI less than 40kg/meter square. Exclusion Criteria: patients refusal. Unable to give consent. Preexisting airway malformations or pathology. History of difficult intubation. Pregnancy. Patients with tracheostomy tube. BMI more than 40 kg/meter square.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| easy intubation<br>Cormack _Lehane : 1&2 | |
| difficult intubation<br>Cormack _Lehane : 3&4 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of difficult airway | Assess which method is better for prediction of difficult airway DES or conventional | Preoperative |
The Impact of Tibial Tubercle-trochlear Groove Distance and Patellar Height on the Outcome of Isolated Medial Patellofemoral Ligament Reconstruction

Study Overview
=================
Brief Summary
-----------------
The investigators plan to perform a prospective observational cohort study of patients undergoing MPFL reconstruction for the treatment of episodic patellar instability in the absence of significant degenerative disease. The investigators will follow these study subjects for a minimum of two years to monitor their functional and clinical outcome.

Official Title
-----------------
The Impact of Tibial Tubercle-trochlear Groove Distance and Patellar Height on the Outcome of Isolated Medial Patellofemoral Ligament Reconstruction

Conditions
-----------------
Patellar Dislocation

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MPFL Reconstruction Exclusion Criteria: Trochleoplasty Required Prior ipsilateral knee surgery Iwano grade 2+ CHondral injury requiring surgical treatment beyond debridement Major ligamentous injury to the knee

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 90 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 |
| --- | --- |
| MPFL Reconstruction<br>Subjects undergoing MPFL Reconstruction | Other: Observational<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Dislocation | Recurrent Dislocation | 2 years |
Bedside Sleep Medicine

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to evaluated the role of bedside sleep medicine in an cardiology intensive care unit. The patients will be submitted to a overnight polysomnography. Those individuals with sleep apnea will be treated with CPAP during the ICU admission. Also, the investigators will identify the factors that compromise the sleep and will act to minimize them to improve the sleep quality. After the interventions, the investigators will evaluate if there are reduced days of hospital admission, major cardiovascular events (infarction, reinfarction, heart failure and stroke) and overall mortality.

Detailed Description
-----------------
At the hospital discharge and after at 1, 3 and 12 months we will evaluate the occurrence of major cardiovascular events (infarction, reinfarction, heart failure and stroke) and overall mortality.

Official Title
-----------------
Intensive Cared Bedside Sleep Medicine

Conditions
-----------------
Sleep Disorders, Sleep Apnea, Acute Myocardial Infarction, Acute Decompensated Heart Failure

Intervention / Treatment
-----------------
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myocardial infarction Acute decompensated heart failure Age > 18 years-old Cardiology intensive care unit admission Exclusion Criteria: Intravenous sedation Invasive mechanical ventilation hemodynamic instability use of intravenous vasoactive drugs acute respiratory failure

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: CPAP<br>Patients with apnea will be treated with CPAP during the night. | Device: CPAP<br>* CPAP - continuous positive air pressure in patients with sleep apnea<br>|
| No Intervention: Control<br>One arm group will be control and will not receive CPAP treatment during the ICU admission. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of admission | Days of admission in the cardiology intensive care unit | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combination of acute myocardial infarction, reinfarction, heart failure and stroke |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep medicine, Sleep apnea, Acute myocardial infarction, Heart failure, CPAP
Manchester Antenatal Vascular Service

Study Overview
=================
Brief Summary
-----------------
25-30% of women with preexisting vascular disease (chronic hypertension/diabetes/obesity) will develop pre-eclampsia and or growth restriction. In addition, the frequency of stillbirths in this group is dramatically increased over the general population. Pregnancy complications in this very heterogeneous group are likely to be a combination of a failure of the maternal vasculature to adapt to pregnancy and/or a failure of placental development. The relative contribution of these two mechanisms is poorly understood and current preventative strategies (aspirin) in this group only prevent a small number of adverse outcomes. This important and complex group have been inadequately investigated to date mainly because of the diversity of their underlying disease complicating prospective research studies. The evolution of tools which allow more detailed assessments of both uteroplacental blood flow and maternal vascular function will enable us to perform prospective studies in these women and to develop targeted preventative measures. Recent biomarker studies have also identified a number of biomarkers which have not yet been assessed in these high risk groups.

Official Title
-----------------
Manchester Antenatal Vascular Service

Conditions
-----------------
Vascular Disease

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with preexisting vascular disease: chronic hypertension BP ≥140/90 at ≤14 weeks chronic hypertension requiring antihypertensive treatment ≤ 14 weeks pre gestational diabetes with evidence of vascular complications (hypertension, nephropathy) history of ischemic heart disease previous early onset pre-eclampsia (delivery < 32 weeks) Obesity (BMI ≥ 40) with any history of hypertension or booking BP≥130/80 Exclusion Criteria: Women who do not meet the inclusion criteria
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation<br>No intervention | Other: no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular compliance |  | At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation | 
| Uteroplacental assessment |  | At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, vascular disease, pregnancy, chronic hypertension, diabetes
SOOTHER Trial to Treat Rectal Itch

Study Overview
=================
Brief Summary
-----------------
Longitudinal, observational, single-arm trial of a novel, composite Lidocaine ointment to treat rectal itch (pruritus ani)

Official Title
-----------------
SOOTHER Trial: Study of an Over-the-Counter Ointment to Treat Rectal Itch

Conditions
-----------------
Pruritus Ani

Intervention / Treatment
-----------------
* Drug: Lidocaine Ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of pruritus ani (anal itch/discomfort) for at least 2 weeks, and a compatible physical exam. Exclusion Criteria: Inability to understand informed consent, history of inflammatory bowel disease, known venereal disease, or immunodeficiency disease, history of or current anal or perianal abscess, anal or rectal surgery within the past 12 weeks, pregnancy or breastfeeding female, or signs of other rectal diseases such as anorectal fistula, infection, perianal eczema or tumors.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pruritus ani patients<br>Adult patients with pruritus ani (rectal itch) treated with lidocaine ointment | Drug: Lidocaine Ointment<br>* Composite over-the-counter lidocaine ointment administered twice daily for 2 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom assessment | SOOTHER Symptom assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst | 2 weeks | 
| Visual ano-rectal exam | Visual ano-rectal exam assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pruritus ani, rectal itch, anal itch
An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018

Study Overview
=================
Brief Summary
-----------------
This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.

Detailed Description
-----------------
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind studies 6002-EU-007, 6002-US-013 or 6002-US-018 are eligible to enter into this 1-year, long-term open safety study with a starting istradefylline dose of 40mg per day.

Official Title
-----------------
A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Istradefylline ( KW-6002)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of study 6002-EU-007, 6002-US-013 or 6002-US-018 Non-pregnant and either not of childbearing potential or using specified contraception Exclusion Criteria: History of psychotic illness Variant/atypical Parkinson's disease Cancer within 5 years of enrollment ALT/AST levels > 1.5 times ULN Seizure disorder Neuroleptic malignant syndrome

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Istradefylline ( KW-6002)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, levodopa, end of dose wearing off, OFF time