louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00851344: Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo
Official title: A Randomised, Double-blind, Placebo-controlled, 4-period Incomplete Block Crossover Study of Single Oral Dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and Placebo to Evaluate the Efficacy and Safety Using an Environmental Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Proof-of-Concept
Allergic Rhinitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis


Eligibility criteria: Inclusion Criteria:

* Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
* Male
* Aged 18 - 60
* Weight 50kg+, BMI 19-32 kg/m2
* Exhibit response to Challenge Chamber and skin prick test.
* Non-smoker
* Capable of giving informed consent

Exclusion Criteria:

* No nasal structural abnornmality/polyposis, surgery, infection.
* any respiratory disease, other than mild asthma or seasonal allergic rhinitis
* participated in another clinical study within 30 days.
* Subject has donated a unit of blood within 1 month
* Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
* History of sensitivty to drug
* History of alcohol/drug abuse within 12 months.
* Positive Hepatitis B antibody test
* Positive HIV antibody test
* Risk of non-compliance with study protocol
* Perenial allergic rhinitis
* Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
* Past or present disease that may affect outcome, as judge by investigator
* Specific Immunotherapy within 2 years

Primary outcomes:
measure: Change from baseline in total nasal symptom score 0-4 hours post dose
timeFrame: 0-4 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Daley-Yates P, Ambery C, Sweeney L, Watson J, Oliver A, McQuade B. The efficacy and tolerability of two novel H(1)/H(3) receptor antagonists in seasonal allergic rhinitis. Int Arch Allergy Immunol. 2012;158(1):84-98. doi: 10.1159/000329738. Epub 2011 Dec 29.
Clinical trial NCT05810844: Comparison Of Effects of MRP Vs NDT For Balance and Gait in Chronic Ischemic Stroke Patients RCT
Official title: Comparison Of Effects of Motor Relearning Program (MRP) Versus Neuro Development Treatment (NDT) For Balance and Gait in Chronic Ischemic Stroke Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine the comparison between effects of Motor Relearning Program (MRP) and Neuro-Development Treatment (NDT) on balance and gait in chronic ischemic stroke patients.


Eligibility criteria: Inclusion Criteria:

1. Chronic ischemic stroke Patients more than 6 months. (55)
2. Patient with good cognitive status minimum 20 or greater out of 30 in Mini mental state examinations.(56)
3. Age between 45-65 years.(57)
4. Patient with limb spasticity equal to 2 or less than 2 on Modified Ashworth scale.(56)
5. Both male and female patients.(58)

Exclusion Criteria:

1. History of neurologic disease(59, 60)
2. History of lower limb fracture.(61)
3. History of spinal cord fracture.(61)
4. Patient with skin discoloration, skin ulcers and skin allergy.(62)
5. Patients with a history of the recurrent stroke. (63)
6. Patients with any peripheral vascular disease.(60)

Primary outcomes:
measure: Effects of Motor Relearning Program Techinique, Neuro Development Treatment Techinique
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01084044: Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery
Official title: Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Occlusive Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ulinastatin reduce the amount of bleeding and fibrinolysis in high risk patients undergoing off-pump coronary bypass surgery (OPCAB).


Eligibility criteria: Inclusion Criteria:

* Eighty high risk patients undergoing OPCAB (High risk patients: Euro score ≥ 6 , acute coronary syndrome, preoperative CK-MB increased over 5 times than normal value and high sensitivity CRP ≥2.0)

Exclusion Criteria:

* The patients who receive additional operations, the patients who don't agree to participate in this trial, the patients who has a past hypersensitive experience on Ulinastatin

Primary outcomes:
measure: ulinastatin
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01145144: Dehydroepiandrosterone Supplementation for Poor Responder Patients During in Vitro Fertilization Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Stimulation
Keywords: Dehydroepiandrosterone
DHEA
IVF outcome
long protocol IVF
poor-responder
recombinant LH
embryo quality
pregnancy rate
live birth rate
poor response to ovarian stimulation
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-06-16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the effect of dehydroepiandrosterone supplementation on in vitro fertilization performance and outcome among poor-responder patient.


Eligibility criteria: Inclusion Criteria:

* previous poor response to ovarian stimulation in IVF.

Exclusion Criteria:

* patients over the age of 42
* patients who received DHEA at any time.

Primary outcomes:
measure: peak estradiol level.
measure: number of retrieved oocytes.
measure: Embryos that were graded as a top quality (according to the number of cells and percent of fragmentation)
measure: number of embryos reserved for transfer.
Secondary outcomes:
measure: pregnancy rate.
measure: live birth rate.
Other outcomes:
Locations:
city: kfar Saba
country: Israel
facility: Meir Medical center IVF unit
city: Kfar Sava
country: Israel
facility: Meir Medical Center
Study officials:
References:
citation: Wiser A, Gonen O, Ghetler Y, Shavit T, Berkovitz A, Shulman A. Addition of dehydroepiandrosterone (DHEA) for poor-responder patients before and during IVF treatment improves the pregnancy rate: a randomized prospective study. Hum Reprod. 2010 Oct;25(10):2496-500. doi: 10.1093/humrep/deq220. Epub 2010 Aug 21.
Clinical trial NCT02803944: Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years
Official title: Long Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: azithromycin
cystic fibrosis
pulmonary function
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 2055
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The eligible population consists of patients over 7 years old with CF followed in Resource Centres and Competence for Cystic Fibrosis (CRCM) France.

Brief summary: Azithromycin is an antibiotic currently prescribed continuously in cystic fibrosis patients. It was shown that this treatment taken every day or every week for 12 months, can improve the respiratory state of patients. From the second year of treatment, it would appear there is more profit to continue such treatment.

The main objective is to study the association between continuous use of azithromycin and lung function measured by Forced expiratory volume in one second (FEV1), after two years of treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with Cystic Fibrosis (whatever the genetic form)
* Age ≥ 8 years
* FEV ≥ 30% the year of azithromycin (N0)
* Continuous treatment with azithromycin for at least 2 years.

Exclusion Criteria:

-

Primary outcomes:
measure: Forced expiratory volume in one second (FEV1).
timeFrame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
measure: Number of IV antibiotics cures
timeFrame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
measure: Pseudomonas aeruginosa colonization
timeFrame: yearly recorded, 2 years before initiation of Azithromycin and 4 years after initiation of Azithromycin
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Study officials:
affiliation: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
name: Isabelle DURIEU, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00411944: Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients
Official title: Prospective Study of the Influence of CYP3A4/CYP3A5 and MDR1 Gene Single Nucleotide Polymorphisms on Long-Term Tacrolimus Disposition in Renal Allograft Recipients: a Five Year Follow-up Study Using Abbreviated Concentration-Time Measurements.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplantation
Keywords: tacrolimus pharmacokinetics
CYP3A4 - CYP3A5
P-glycoprotein
single nucleotide polymorphisms
renal transplantation
calcineurin-inhibitor-associated nephrotoxicity
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2006-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: An evaluation of the effects of genetically determined variant metabolizing and transporting proteins involved in the disposition of the immunosuppressive drug tacrolimus in renal transplant recipients. In a five year follow-up study tacrolimus dose-corrected exposure changes significantly and the effect(s) of single nucleotide polymorphisms of the CYP3A4/CYP3A5 and MDR1 genes on the latter is assessed in this study.

Detailed description: A 5-year pharmacokinetic follow-up study in 95 renal allograft recipients assessing tacrolimus exposure using repeated abbreviated Area-Under-the-Concentration-time (AUC) curve measurements at regular time points after grafting. The effects of the CYP3A5\*1, CYP3A4\*1B, MDR1 G2677T/A and C3435T single nucleotide polymorphisms on the evolution of tacrolimus disposition are studied over 5 years in order to clarify the interrelationship between CYP3A5, CYP3A4 and MDR1 genotypes, time-dependent exposure and tacrolimus-related toxicity.

Eligibility criteria: Inclusion Criteria:

* Primary or secondary single kidney transplantation
* Age older than 18 yrs

Exclusion Criteria:

* Combined organ transplantation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Nephology and Renal Transplantation
Study officials:
affiliation: Dpt Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium
name: Dirk R Kuypers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuypers DR, Claes K, Evenepoel P, Maes B, Coosemans W, Pirenne J, Vanrenterghem Y. Time-related clinical determinants of long-term tacrolimus pharmacokinetics in combination therapy with mycophenolic acid and corticosteroids: a prospective study in one hundred de novo renal transplant recipients. Clin Pharmacokinet. 2004;43(11):741-62. doi: 10.2165/00003088-200443110-00005.
citation: Kuypers DR, Claes K, Evenepoel P, Maes B, Vanrenterghem Y. Clinical efficacy and toxicity profile of tacrolimus and mycophenolic acid in relation to combined long-term pharmacokinetics in de novo renal allograft recipients. Clin Pharmacol Ther. 2004 May;75(5):434-47. doi: 10.1016/j.clpt.2003.12.009.
Clinical trial NCT03044444: The Effect of a Citrus Extract on Exercise Performance in Moderately Trained Athletes
Official title: Establishing the Effect of Long-term Citrus Extract Supplementation on Exercise-specific Performance in Moderately Trained Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Performance
Keywords: performance
polyphenols
nutrition
sports
Lead sponsor: BioActor
Sponsor class: INDUSTRY
First posted: 2017-02-07
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, the effect of citrus extract on exercise performance will be investigated. The study consists of three groups: one group will receive a high dose citrus extract, one group will receive a low dose citrus extract and the last group will receive a placebo. After four and eight weeks the effects on performance are measured through a Wingate cycling test. It is expected that exercise performance will increase in the citrus extract groups, compared to the placebo group.


Eligibility criteria: Inclusion Criteria:

* healthy idividuals
* Participants are amateur or (semi-) professional athletes in resistance or interval sports (engage in \>4 hours of intense physical activity per week).

Exclusion Criteria:

* Use of creatine supplements and/or anabolic steroids.
* Allergy to test product/placebo
* Allergy to citrus fruits
* BMI lower than 18 or higher than 30
* Recent muscle injury in less than one month before the start of the study.
* Cardiovascular complications
* Use of medication that may interfere with the study results
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study.
* Abuse of products; alcohol (\> 20 alcoholic units per week) and drugs.

Primary outcomes:
measure: peak force output Wingate
timeFrame: 8 weeks
Secondary outcomes:
measure: jumping height
timeFrame: 8 weeks
measure: peak force output Handgrip
timeFrame: 8 weeks
measure: force output Jump
timeFrame: 8 weeks
measure: anaerobic capacity
timeFrame: 8 weeks
measure: running time
timeFrame: 8 weeks
Other outcomes:
measure: lactate
timeFrame: 8 weeks
Locations:
city: Sittard
country: Netherlands
facility: High Performance Center
state: Limburg
Study officials:
affiliation: Maastricht University
name: Freddy Troost, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Iersel LE, Stevens YR, Conchillo JM, Troost FJ. The effect of citrus flavonoid extract supplementation on anaerobic capacity in moderately trained athletes: a randomized controlled trial. J Int Soc Sports Nutr. 2021 Jan 6;18(1):2. doi: 10.1186/s12970-020-00399-w.
Clinical trial NCT01332344: Outcomes in Patients Taking Fluticasone Propionate/Salmeterol Combination or Other Inhaled Corticosteroids
Official title: Comparison of Healthcare Utilization and Costs in Patients With Asthma Who Fluticasone/Salmeterol Inhalation Powder Versus Other Inhaled Corticosteroid(s) in Typical Clinical Practice Using Health Insurance Claims Data.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: fluticasone propionate/salmeterol combination
Asthma
inhaled corticosteroids
outcomes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 5180
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study intends to identify subjects with asthma treated with inhaled corticosteroids

Brief summary: The objective of this study is to compare healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg ("FSC 100/50") or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care database.


Eligibility criteria: Inclusion Criteria:

* Subjects with asthma as determined by ICD-9 codes and asthma drug use
* at least 12 years of age
* treated with inhaled corticosteroids

Exclusion Criteria:

* Subjects with COPD or treatment for COPD

Primary outcomes:
measure: To assess the difference in asthma related exacerbations
timeFrame: 90 days post index
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01988844: Upper Limbs Assessment in Children With Cerebral Palsy
Official title: Manual Dexterity and Upper Limbs Functionality Assessment in School Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Children
Keywords: functionality
Cerebral palsy
Handwriting
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 31
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: School children with cerebral palsy.

Brief summary: Cerebral palsy is the leading cause of physical disability among children. Manual dexterity and upper limbs functionality is limited between these children. The purpose of this study is to stablish a specific profile of school children with cerebral palsy based on the upper limbs assessment.

Detailed description: While the rates of perinatal and infant mortality have declined toward the end of the last century,the rate of cerebral palsy has remained at 2 to 2.5 per 1,000 live births. A high percentage of children with cerebral palsy have difficulty keeping up with the handwriting demands at school. The neurological impairments in children with cerebral palsy frequently limit the functionality of these children taken in to account the upper limbs variables. It should be interesting to describe a clinical profile based on this assessment.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy diagnosis.
* Aged between 6 and 10 years old.
* Children attending a school.

Exclusion Criteria:

* Severe cognitive impairment.

Primary outcomes:
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: baseline
measure: Upper limbs functionality
timeFrame: baseline
Secondary outcomes:
measure: Manual dexterity
timeFrame: baseline
measure: Executive function
timeFrame: baseline
measure: Handwriting assessment
timeFrame: baseline
measure: Range of motion
timeFrame: baseline
measure: Upper limbs strength
timeFrame: baseline
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03778944: Enhancing Renal Graft Function During Donor Anesthesia
Official title: Renal Graft Functional Enhancement During Donor Anesthesia: A Comparative Study of 3 Modalities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Failure Chronic
Transplant;Failure,Kidney
Anesthesia
Keywords: Mannitol
Dopamine
Perfusion
Renal graft donor
Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using computer \& sealed envelope randomization, patients are assigned to receive either Mannitol \[M group; n=20\], Dopamine \[D group; n=20\] or adequate hydration \[C group; n=20\]
Primary purpose: SUPPORTIVE_CARE

Brief summary: Renal transplantation is now recognized as the treatment of choice for patients with end-stage renal disease. An optimum anesthetic regimen should enhance the function and perfusion of the transplanted kidney. The aim of this study is to assess \& compare the effectiveness of 3 different modalities in this respect: Mannitol, Dopamine and adequate hydration.


Eligibility criteria: Inclusion Criteria:

* end-stage renal disease, for living-donor kidney transplantation

Exclusion Criteria:

* severe cardiac or hepatic dysfunction
* coagulopathy

Primary outcomes:
measure: Post-operative creatinine clearance
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al-Ainy Hospital, Cairo University
Study officials:
affiliation: Kasr Al-Ainy Hospital, Cairo University
name: Nazmy E Seif, MD
role: STUDY_CHAIR
affiliation: Kasr Al-Ainy Hospital, Cairo University
name: Ahmed M Elbadawy, MD
role: STUDY_DIRECTOR
References: