louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03707899: The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers Volunteers
Official title: An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension With Dyslipidemia
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-16
Enrollment: 49
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
* Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* SBP \< 90 mmHG, SBP \> 140mmHG or DBP \< 60 mmHG, DBP \> 100mmHg
* AST or ALT \> X 2 UNL
* CK \> X 2 UNL
* History of drug abuse or positive drug screening.
* Participation in other drug studies within 3 months prior to the drug administration.
* Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Primary outcomes:
measure: AUCt
timeFrame: 72 hr after baseline
measure: Cmax
timeFrame: 72 hr after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
References:
Clinical trial NCT01100099: HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Celiac Disease
Gluten
Keywords: Celiac disease.
Food intolerance.
Gluten intolerance without celiac disease.
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: University of Oslo
First posted: 2010-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will evaluate the use of an HLA-DQ2-gliadin tetramer for staining of gluten specific T cells in the diagnostics of uncertain celiac disease. Some patients have started on a gluten free diet without a diagnosis of celiac disease. Subsequent later investigation in special care is difficult as the patients often are reluctant to prolonged gluten challenge. The investigators use the HLA-DQ2-gliadin tetramers for detection of gluten specific T cells after a short gluten challenge. By this method the investigators search to discriminate between true celiac disease and clinical gluten intolerance without celiac disease, in a population of HLA-DQ2+ persons already on a gluten free diet without a formal diagnosis of celiac disease.


Eligibility criteria: Inclusion Criteria:

* HLA-DQ2+ celiacs and HLA-DQ2+ persons who have been on a gluten free diet for at least 4 weeks.

Exclusion Criteria:Pregnancy

* Other severe disease
* Refusal to participate
* HLA-DQ2 negativity

Primary outcomes:
measure: HLA-DQ2-tetramer response after gluten challenge
timeFrame: 6 days.
Secondary outcomes:
measure: Mucosal responses to 3 day gluten challenge.
timeFrame: 4 days.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Medicine, Endoscopy Unit, Rikshospitalet
Study officials:
References:
citation: Raki M, Fallang LE, Brottveit M, Bergseng E, Quarsten H, Lundin KE, Sollid LM. Tetramer visualization of gut-homing gluten-specific T cells in the peripheral blood of celiac disease patients. Proc Natl Acad Sci U S A. 2007 Feb 20;104(8):2831-6. doi: 10.1073/pnas.0608610104. Epub 2007 Feb 16.
Clinical trial NCT04348799: Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia
Official title: Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Thrombocytopenia
Preterm Infant
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bronchopulmonary dysplasia (BPD) is one of the common complications in neonatal intensive care units (NICU), mainly occurs in premature infants and is considered to be the main cause of premature death

Brief summary: To investigate the relationship between bronchopulmonary dysplasia and thrombocytopenia.

Detailed description: A prosepective case-control study ,the case were matched with 1:1according to gestational age,birth weight and admission diagnosis and divided into two groups according to the consensus definition of National Institute of Child Health and Human Development (NICHD). Platelet count, circulating megakaryocyte count, platelet activating markers (CD62P and CD63), thrombopoietin were recorded and compared in two groups, then, serial thrombopoietin levels and concomitant platelet counts were measured in infants with BPD.

Eligibility criteria: Inclusion Criteria:

1. presence of clinical and radiologic signs of BPD, according to conventional criteria (Greenough, 1992);
2. presence of peripheral arterial catheter;
3. gestation \<32 weeks;
4. birth weight \<1.5 kg;
5. requiring mechanical ventilation for the treatment of respiratory distress syndrome for at least 3 days during the first weeks of life;
6. ventilator and/or oxygen dependent at time of enrolment;

Exclusion Criteria:

1. congenital abnormalities;
2. infection (bacteria infection confirmed by positive blood culture or viral infection confirmed by serological test or viral culture)
3. evidence of complications of perinatal asphyxia including an apgar score \<3 at one or five minute after birth, evidence of hypoxic-ischemic encephalopathy, acute tubular necrosis, or transient myocardial ischemia;
4. identifiable hematologic disease;

Primary outcomes:
measure: Platelet counts and Circulating MK counts
timeFrame: up to 4 weeks
Secondary outcomes:
measure: CD62P and CD63 expression
timeFrame: up to 4 weeks
measure: TPO
timeFrame: up to 4 weeks
measure: TPO and platelet
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jie Yang
state: Guangdong
Study officials:
References:
Clinical trial NCT04399499: Percutaneous Mitral Valve Repair in Cardiogenic Shock: Mitra-Shock Study
Official title: Use of Percutaneous Mitral Leaflet Approach for Severe Mitral Regurgitation in Cardiogenic Shock: Results From a Multicenter Observational Italian Experience (the Mitra-Shock Study).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Regurgitation Functional
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CS and concomitant severe MR who underwent PMVR between 01/01/2012 to 01/01/2020 will be included in the study. Five Italian centers with high volume of MitraClip procedures will participate in the study. The number of enrolled patients will be of 30 patients. All patients will be older than 18 years old. Patients enrolled at our center (OSR) will be of 10 patients. The patients can tolerate antiplatelets and anticoagulant therapy. Inclusion criteria are: cardiogenic shock, severe mitral regurgitation, prohibitive surgical risk (STS\>10%), anatomic feasibility of PMVR with MitraClip® system. Exclusion criteria are: multiorgan failure, VA-ECMO, inadequate peripheral access because of vascular disease, not suitable mitral valve anatomy.

Brief summary: Cardiogenic shock (CS) is a medical emergency and a frequent cause of death. CS can be complicated and/or precipitated by mitral regurgitation (MR). The efficacy of percutaneous treatment of MR in patients with cardiogenic shock is unknown. The aims of the study will be to analyse the efficacy of MitraClip therapy on early (30 days) and midterm mortality (6 months) as well as the predictors of outcomes. Investigators will also report the rate of periprocedural complications such as minor and major bleeding, vessel injury and Acute Kidney Injury (AKI).

It is a multicenter retrospective observational study on CE marked medical device (MitraClip® System). Retrospective time range: from 01/01/2012 to 01/01/2020


Eligibility criteria: Inclusion Criteria:

* older than 18 years old

Exclusion Criteria:

* multiorgan failure,
* VA-ECMO,
* inadequate peripheral access because of vascular disease,
* not suitable mitral valve anatomy.

Primary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Mortality
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCSS San Raffaele
Study officials:
References:
Clinical trial NCT03252899: Current Practices of Upper Limb Rehabilitation After Stroke
Official title: Current Practices of Upper Limb Rehabilitation After Stroke: a Survey Among Stroke Survivors and Therapists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Upper Extremity Paresis
Survey
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physiotherapists and occupational therapists Stroke survivors with upper limb impairment

Brief summary: A survey was conducted among physiotherapists and occupational therapists working with stroke patients. The survey consisted out of 30 questions enquiring personal information and upper limb specific topics divided in 3 sections: (1) Passive mobilization, (2) Active exercises and (3) Immobilization. The survey took approximately 20 to 30 minutes to complete.

The survey for stroke survivors was divided in seven sections: (1) Personal information (2) Motor recovery of the upper limb and expectations on upper limb recovery; (3) Comfort, pain and quality of life (QoL); (4) Immobilization ; (5) Physiotherapy; (6) Occupational therapy; (7) Nursing (only for patients less than 6 months after stroke). The length to complete the survey was also organized to be achieved in 20 to 30 minutes.


Eligibility criteria: Stroke patients

Inclusion Criteria:

* stroke with upper limb paresis

Exclusion Criteria:

* severe language or cognitive problems which make it impossible to complete the survey

Therapists

Inclusion Criteria:

* physiotherapists
* occupational therapists
* experienced in the treatment of stroke patients

Primary outcomes:
measure: A questionnaire assessing the current practices of upper limb rehabilitation after stroke
timeFrame: Dec 2016 - March 2017
measure: A questionnaire assessing the stroke survivors view on upper limb rehabilitation
timeFrame: Dec 2016 - March 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06311799: Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy
Official title: Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Obesity, Maternal
Diabetes
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Family Health Council of Central Pennsylvania (FHCCP)
name: American Heart Association
First posted: 2024-03-15
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is being done to find out if online referrals to a food management program for Women, Infants, and Children (WIC) made by clinical teams will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and are eligible to be referred to the WIC program will be recruited. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their clinical team. Group 2 will be sent to WIC by their clinical team. The study team may help the clinical team with the referrals. Group 3 will get details about WIC from their clinical team and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their clinical team or study team and a dietitian will talk to them about heart-healthy diets and food management. Participants who talk with the dietitians will be sent kitchen utensils based on need. This study will last about 18 months and will have 240 total subjects joining at about 60 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study after they are done.


Eligibility criteria: Inclusion Criteria:

* English speaking
* Confirmed pregnancy
* Public Insurance (Medicaid) OR no insurance
* If no insurance, must meet income eligibility for WIC
* Intent to deliver at a Geisinger facility
* Able and willing to provide consent

Exclusion Criteria:

* Pre-existing WIC enrollment as a pregnant person
* Not eligible for WIC
* Private insurance
* Unwilling to participate for up to 12 months

Primary outcomes:
measure: Difference in Women, Infants, and Children (WIC) enrollment
timeFrame: 6 months
Secondary outcomes:
measure: WIC retention
timeFrame: 6 months
measure: WIC adherence
timeFrame: 6 months
measure: Prenatal clinic visit adherence.
timeFrame: 6 months
measure: Registered Dietitian/Nutritionist (RDN) visit adherence
timeFrame: 6 months
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Lisa D Bailey-Davis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00626899: Comparison Performance Vigileo vs. Continuous CCO (Vigilance) in Patients With Induced Therapeutic Hypothermia
Official title: Comparison of the Performance of a New Pulse-contour Analysis Cardiac Output Measurement (Vigileo) With the Traditional Method in Patients With Induced Therapeutic Hypothermia After Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Hypothermia, Induced
Keywords: Validation of Cardiac Output measurement in hypothermic patients
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after cardiac arrest who are treated with therapeutic hypothermia and require a PAC for hemodynamic monitoring

Brief summary: Patients resuscitated from a cardiac arrest undergo therapeutic hypothermia as a treatment option. Measuring the cardiac output in these patients is sometimes important, but difficult, as these patients require an invasive device for measurement. Recently, a non-invasive device based on pulse-contour analysis of the arterial pulse was developed (the Vigileo). Hypothermia changes the pulse contour, so the performance of the Vigileo in patients with induced therapeutic hypothermia is not known. Therefore we conduct this observational study in which the cardiac output of the patients is measured with the traditional method and the Vigileo simultaneously.


Eligibility criteria: Inclusion Criteria:

* patients who survived a cardiac arrest and are treated with therapeutic hypothermia
* pulmonary arterial catheter placed by treating physician

Exclusion Criteria:

* arterial catheter placement is contraindicated
* Aortic valve insufficiency (moderate to severe)
* placement of intra-aortic balloon pump (IABP) or a LVAD (left ventricular assist device)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Departement of Intensive Care Medicine - University Hospital Bern - Inselspital
Study officials:
affiliation: Departement of Intensive Care Medicine, University Hospital Bern, Inselspital, Bern, Switzerland
name: Matthias Haenggi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06726499: Orthokeratology Lens Decentration with Two Designs of Corneal Refractive Therapy™ Lenses: a One-year Prospective Study
Official title: Orthokeratology Lens Decentration with Two Designs of Corneal Refractive Therapy™ Lenses: a One-year Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia Progression
Keywords: myopia; orthok
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 70
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background/Objectives: To examine the trend of treatment zone (TZ) decentration over 12 months of Orthokeratology (OK) wear using two corneal refractive therapy (CRT) lens designs: standard (STD) and dual axis (DA). Methods: A prospective, randomized, longitudinal study was conducted at the Optometry Clinic of the Complutense University of Madrid. Subjects were fitted with STD or DA designs in one of the eyes, randomly. Refraction, uncorrected visual acuity (VA) and corneal topography were performed at baseline, 1-night, 1-week, 1-, 3-, 6- and 12-month of lens wear. Subjects requiring lens parameter adjustments or replacements after 3 months were excluded. Decentration was measured by subtracting pre-OK from post-OK tangential curvature maps at each visit, with decentration distance and corneal optical TZ measured using MATLAB. Correlations between decentration and visual acuity (VA) were also analyzed.


Eligibility criteria: Inclusion Criteria:

* Age between 8 to 17 years old
* Myopia up -6.00 D

Exclusion Criteria:

* Ocular diseases

Primary outcomes:
measure: contact lens centration
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: University Complutense of Madrid
Study officials:
References:
Clinical trial NCT04239599: Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer
Official title: Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2020-01-27
Enrollment: 178
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly.

Standard Fractionation: pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy over 39 fractions.

Detailed description: Half the participants will receive using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).

The other half of the participants will receive Standard fractionation using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.

Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained.
* Histologically confirmed diagnosis of adenocarcinoma of the prostate.
* Clinical stage T1-2 N0 M0, Gleason Score ≤ 7, PSA 20 - 100
* T1-2 N0 M0, Gleason Score 8 - 10, PSA ≤ 100
* T3 N0 M0, any Gleason Score, PSA ≤ 100

Exclusion Criteria:

* Patients with unilateral or bilateral hip replacement.
* Patients with active collagen vascular disease.
* Patients with active inflammatory bowel disease.
* Patients with previous radiotherapy to the pelvis.
* Patients with ataxia telangiectasia.
* Patients with nodal or distant metastases

Primary outcomes:
measure: Disease free survival
timeFrame: 5 years
Secondary outcomes:
measure: Late GI and GU toxicities
timeFrame: 6 month post completion of treatment to end of 5 year follow up
measure: Quality of life outcome: Expanded Prostate Index Composite (EPIC)
timeFrame: Baseline (start of treatment) to end of 5 year follow-up
measure: Overall survival
timeFrame: Baseline to end of 5 year follow-up
measure: Cancer specific survival
timeFrame: Baseline to end of 5 year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Patrick Cheung, MD
role: PRINCIPAL_INVESTIGATOR
References: