louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00159003: Analysis of Genetic Factors Related to Predisposition and Prognosis of Hematological Malignancies in Israel
Official title: Molecular Analysis of Genetic Elements Which May Influence Predisposition and Prognosis of Hematological Malignancies in Different Ethnic Groups in Israel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Keywords: drug metabolism and disposition enzymes
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Hadassah Hospital with AML or CLL.

Brief summary: There are naturally occuring variations in the genetic makeup of all of us. Some of these variations may contribute to a change in susceptibility toward different diseases or change the prognosis.

We are studying these genetic variations in patients with leukemia. The genes we are studying are those which influence detoxification of drugs and toxins.

Detailed description: We have prepared DNA on patients with leukemia (AML, CML and CLL) and we are studying the influence of polymorphisms in drug metabolism and disposition genes on predisposition and prognosis of these types of leukemia. The genes we are studying include: MDR1, CYP3A4, NQO1, NAT1/2, GST, hOCT. We plan to study other genes that may be contributory.

Study includes comparing the frequency of polymorphisms in these genes with the frequency in the general population and the study of DNA biding proteins which bind at the sites of these polymorphisms.

Eligibility criteria: Inclusion Criteria:

* diagnosis of acute myeloid leukemia or chronic lymphocytic leukemia

Exclusion Criteria:

* under 18 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Deborah G Rund, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chanock S. Genetic variation and hematology: single-nucleotide polymorphisms, haplotypes, and complex disease. Semin Hematol. 2003 Oct;40(4):321-8. doi: 10.1016/s0037-1963(03)00198-7.
Clinical trial NCT00560703: Treatment of Patients With Blepharitis and Facial Rosacea
Official title: Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blepharitis
Meibomianitis
Dry Eye
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea


Eligibility criteria: Inclusion Criteria:

* blepharitis
* facial rosacea

Exclusion Criteria:

* pregnant or nursing women
* allergy to tetracyclines
* recent eye surgery
* past or current use of isotretinoin
* patients who are achlorhydric
* patients who have had gastric by-pass surgery

Primary outcomes:
measure: Change in Bulbar Conjunctival Hyperemia
timeFrame: Baseline to Week 12
measure: Change in Ocular Surface Disease Index (OSDI)
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Pleasant Valley Ophthalmology
state: Arkansas
city: Naples
country: United States
facility: Warren Scherer, MD
state: Florida
city: Louisville
country: United States
facility: Kentucky Lions Eye Center
state: Kentucky
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lynbrook
country: United States
facility: Marguerite McDonald, MD
state: New York
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
city: Bala-Cynwyd
country: United States
facility: Anita Nevyas-Wallace, MD
state: Pennsylvania
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
Study officials:
affiliation: Galderma R&D
name: Michael Graeber, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05516303: Pharmacogenetics of Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod
Official title: Pharmacogenetic Investigation of Susceptibility to Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Fingolimod
hepatic adverse events
polymorphism
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple sclerosis (MS) patients attending out-patient neurological consultations in Caen University Hospital, with a relapsing-remitting disease course, and prescribed fingolimod as a disease-modifying drug for MS.

Brief summary: To investigate whether polymorphic differences can be identified between Multiple Sclerosis patients developing elevated liver enzymes (defined as ALT, AST, GGT or bilirubinemia levels five above the upper normal limit on at least one) compared to those not developing elevated liver enzymes after exposure to fingolimod for multiple sclerosis.

Detailed description: PURPOSE: To investigate whether polymorphic differences can be identified between Multiple sclerosis (MS) patients treated by fingolimod who had liver enzymes elevation compared to those who do not.

OBJECTIVE: To determine whether elevated liver enzyme tests (ALT, AST, GGT or bilirubinemia above the upper limit of normal) in MS patients treated with fingolimod is associated with genetic polymorphisms.

METHOD OF RECRUITMENT:

Patients will be identified through a clinic database and chart reviews. A phone call will be made to determine interest. Upon a follow-up neurological consultation, consent into study will be sought.

PROCEDURES:

Blood samples will be collected for genetic analyses, fingolimod and fingolimod-phosphate quantification and a questionnaire will be administered

Eligibility criteria: Inclusion Criteria:

* Adults (\> 18 years)
* Have a definite Multiple Sclerosis with a relapsing-remitting course (McDonald criteria)
* Treated with fingolimod
* Have given consent and signed an informed consent form

Exclusion Criteria:

* an elevated liver test result on baseline before starting fingolimod treatment
* presence of a viral, hereditary or auto-immune liver pathology
* Time of fingolimod exposure lower than three months
* Woman currently pregnant or breastfeeding

Primary outcomes:
measure: CYP4F2 polymorphism frequency in case and control groups
timeFrame: At inclusion
Secondary outcomes:
measure: Fingolimod concentrations in case and control groups
timeFrame: At inclusion
measure: Fingolimod-phosphate concentrations in case and control groups
timeFrame: At inclusion
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: University Hospital, Caen
name: Gilles Defer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00438503: Glucose in Dialysis Water in Diabetics With Chronic Renal Failure
Official title: Effect of Glucose in Dialysis Water in Diabetics With Chronic Renal Failure on Blood Pressure, Pulse Rate, Plasma Glucose, Plasma Concentrations of Insulin, Growth Hormone, Renin, Angiotensin II, Endothelin and Body Temperature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Failure, Chronic
Diabetic Nephropathies
Keywords: Hemodialysis, diabetes mellitus,
Chronic renal failure, dialysis ,
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2007-02-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purposes are 1. to measure the effect of dialysis with glucose in dialysis water on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and 2. to analyse the relationship between the changes in blood pressure and changes in vasoactive hormones

Detailed description: The relationship between blood pressure during dialysis treatment and vasoactive hormones are studied. This includes measurements of plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years,
2. Both men and women,
3. Dialysis treatment for at least three month due to diabetic nephropathy

Exclusion Criteria:

1. Heart failure,
2. Lung insufficiency,
3. Chronic liver disease,
4. Malignant disease,
5. Nephrotic syndrome,
6. Lack of compliance,
7. Unwillingness to participate

Primary outcomes:
measure: Effect og glucose in dialysis water on blood pressure, plasma glucose and hormones in plasma
Secondary outcomes:
measure: Relationship between changes in blood pressure and and changes in hormones
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Holstebro Hospital
Study officials:
affiliation: Regional Hospital Holstebro
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01773603: Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer
Official title: Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: Time-lapse
morphokinetics
blastocyst transfer
eSET
Lead sponsor: Memorial Sisli Hospital, Istanbul
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion.

This study was designed to select for the top blastocyst to be replaced, while increasing the pregnancy chance, with the local legislation regulating the number of embryos to be transferred and to establish a morphokinetic standard to be used in our clinical setting.


Eligibility criteria: Inclusion Criteria:

* patients in their first or second ART treatment cycle
* no recurrent spontaneous abortions
* age\<35 years
* BMI\<28 kg/m2
* ≥8 oocytes retrieved

Exclusion Criteria:

* severe endometriosis
* polycystic ovary syndrome
* hydrosalpynx
* uterine pathology
* severe male factor (presenting less than 5 million motile sperm cells in total in the ejaculate)
* very severe morphological sperm defects (mainly globozoospermic or macrocephalic samples)

Primary outcomes:
measure: Blastocyst formation rate
timeFrame: 5th day of embryonic development
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 7th week of pregnancy
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Memorial Hospital
Study officials:
affiliation: Sisli Memorial Hospital
name: Semra Kahraman, MD, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT04231903: Myocardial Protection in Minimally Invasive Mitral Valve Surgery
Official title: Endo-aortic Versus Trans-thoracic Clamping in Right Mini-thoracotomy Mitral Valve Repair: Outcome on Myocardial Pro-tection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Protection
Minimally Invasive Surgery
Mitral Valve Prolapse
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All comers at our Deparment with diagnosis of mitral valve disease with surgical indication for mitral valve repair through the right mini-thoracotomy approach and retrograde arterial perfusion.

Brief summary: Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (MV) surgery have evolved over time and remarkable short- and long-term results have been re-ported. However, some concerns have emerged about the adequacy of myocardial protection dur-ing the minimally invasive approach and about the role of aortic clamping strategies in this contest.

Aim of this study was to compare the efficacy, in terms of myocardial protection, of the en-do-aortic clamp (EAC) versus the trans-thoracic aortic clamp (TTC) in patients undergoing right mini-thoracotomy MV repair.

A single center, prospective observational study was performed between June 2014 to June 2018 on patients undergoing right mini-thoracotomy MV repair with retrograde arterial perfusion and EAC or TTC. The selection of one setting in respect to the other was patient orientated. Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) and cardiac Troponin T (cTn-T) blood levels immediately after the surgical procedure and at 6, 12, and 24 hours and compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* Surgical indication for mitral valve repair.
* Right mini-thoracotomy approach.
* Retrograde arterial perfusion.

Exclusion Criteria:

* Age more than 75 years.
* Cardiac ejection fraction lower than 40%.
* Previous cardiac surgery procedures for coronary artery bypass graft.
* Any degree of coronary artery disease.
* Severe peripheral vascular disease.
* Concomitant procedures for atrial fibrillation ablation.

Primary outcomes:
measure: cTn-T levels immediately after surgery
timeFrame: Immediately after surgery
measure: CK-MB levels immediately after surgery
timeFrame: Immediately after the surgery
measure: cTn-T levels 6h
timeFrame: hour 6 after surgery
measure: CK-MB levels 6h
timeFrame: hour 6 after surgery
measure: cTn-T levels 12h
timeFrame: hour 12 after surgery
measure: CK-MB levels 12h
timeFrame: hour 12 after surgery
measure: cTn-T levels 24h
timeFrame: hour 24 after surgery
measure: CK-MB levels 24h
timeFrame: hour 24 after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01174303: A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacodynamic Properties of NN5401 in Young Adults and Geriatric Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-08-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the exposure of NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)
* HbA1c (glycosylated haemoglobin A1c) maximum 10.0% by central laboratory analysis

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the Glucose Infusion Rate curve (only for NN5401)
timeFrame: from 0 to 24 hours after single-dose administration
Secondary outcomes:
measure: Area under the glucose infusion rate curve (only for biphasic insulin aspart 30)
timeFrame: from 0 to 24 hours after single-dose administration
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Brunner M, Pieber T, Korsatko S, Kojzar H, Svendsen AL, Haahr H. The Distinct Prandial and Basal Pharmacodynamics of IDegAsp Observed in Younger Adults Are Preserved in Elderly Subjects with Type 1 Diabetes. Drugs Aging. 2015 Jul;32(7):583-90. doi: 10.1007/s40266-015-0272-y.
Clinical trial NCT00902603: Ventavis® Registry Protocol
Official title: Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension
Ventavis®
iloprost
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 148
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. Data will be collected via patient interview and review of the medical record. Quarterly data collection will include capture of medications and Ventavis® adherence data.

Detailed description: The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH and who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. All data will be collected via patient interview and/or review of the medical record, as well as from I-neb® downloads using INSIGHT software. Adherence with Ventavis® will be compared before and after targeted instruction on inhalation techniques by a respiratory therapist or designee, as well as before and after participation in PAH patient support groups (if applicable). Quarterly data collection will include capture of PAH and non-PAH medications and Ventavis® adherence data; Ventavis® adherence data will also be collected one month after study entry.

Eligibility criteria: Inclusion Criteria:

1. Have a current diagnosis of WHO Group I PAH
2. Have initiated therapy with commercial Ventavis® administered via portable nebulizer at least 3 months prior to study enrollment, either with commercial product or from participation in Actelion's Clinical Study AC-063A302
3. Age \> or = 18 years old at the time of enrollment

Exclusion Criteria:

1. Meet the criteria for inclusion into WHO Groups II, III, IV or V PAH
2. Are not currently on commercial Ventavis®
3. Have initiated therapy with commercial Ventavis® administered via portable nebulizer less than 3 months prior to study enrollment

Primary outcomes:
measure: Adherence with instructions for use of Ventavis®
timeFrame: 2 years
Secondary outcomes:
measure: Persistence of use of Ventavis®
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04133103: Early Mobilisation in the Surgical Robot Assisted Spinal Surgery
Official title: A Prospective Study of Early Mobilisation in the Surgical Robot Assisted Spinal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Disease
Fracture
Keywords: early mobilisation
robot
spine
enhanced recovery
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, patients who underwent lumbar spine surgery in our hospital were included. A prospective study was conducted to investigate the effects of early mobilisation on postoperative complications, functual outcomes and patient satisfaction after robotic assisted lumbar spinal surgery.


Eligibility criteria: Inclusion Criteria:

* diagnosis of degenerative diseases or spinal fracture
* single level instrumentation sugery
* sign informed consent

Exclusion Criteria:

* multilevel instrumentaion surgery
* diagnosis of severe osteoperosis (BMD \< 60mg/cm3) by QCT
* coagulant function abnormality
* severe internal disease
* not suitable for inclusion

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: preoperative
measure: Visual Analogue Scale
timeFrame: 4 hours postoperatively
measure: Visual Analogue Scale
timeFrame: 24 hours postoperatively
measure: Visual Analogue Scale
timeFrame: 3 months postoepratively
Secondary outcomes:
measure: Japanese Orthopedic Association
timeFrame: preoperative
measure: Japanese Orthopedic Association
timeFrame: 3 months postoperatively
measure: Oswestry Disability Index
timeFrame: preoperative
measure: Oswestry Disability Index
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wei Tian
Study officials:
affiliation: Beijng Jishuitan Hospital
name: Wei Tian
role: STUDY_DIRECTOR
References: