louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05681897: Comparing Platelet-Rich Plasma (PRP) Centrifugation Methods on Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia
Official title: Comparing Platelet-Rich Plasma (PRP) Centrifugation Methods on Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia: A Preliminary, Randomized, Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alopecia, Androgenetic
Keywords: Androgenetic Alopecia
Centrifugation
Platelet-rich plasma
Thrombocyte
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 30
Sex: MALE
Minimum age (years): 25
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is a preliminary, randomized, double blind clinical trial, which will examine the differences in PRP preparation methods, a single-spin centrifugation of 3000 rpm in 15 minutes compared to a double-spin centrifugation of 1500 rpm in 6 minutes followed by 2500 rpm in 15 minutes, on the results of Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia.

Detailed description: Several examinations will be performed in every visit, including history taking, physical examination, trichoscopy and trichoscan. Laboratory evaluations (complete blood count) for the measurement of the thrombocyte for baseline and PRP will be performed for all assented subjects on the first visit. Each subject will be instructed to apply 5% topical minoxidil twice a day everyday as primary therapy during the study

Eligibility criteria: Inclusion Criteria:

* Met the criteria of androgenic alopecia (Hamilton Norwood grade III-IV)
* Men between ages 25-59 years old
* Have stopped taking topical anti-androgen or minoxidil for at least one month, or oral anti-androgen or minoxidil for at least three months

Exclusion Criteria:

* alopecia of any other type
* subject with a history of keloid or blood coagulation disorders underwent anticoagulant therapy
* subjects on Non-Steroidal Anti-Inflammatory Drugs (NSAID) medications in seven days prior to the study
* subjects who had hair treatment using growth factors, including PRP and microneedling within at least six months prior to the study.

Primary outcomes:
measure: Thrombocyte Count in PRP and Whole Blood
timeFrame: 6 weeks
measure: Clinical Improvement of Androgenetic Alopecia
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: DKI Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: Jakarta
Study officials:
References:
Clinical trial NCT03123497: Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura (Kid's ITP Tools)
Official title: Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: Idiopathic Thrombocytopenic Purpura
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-04-21
Enrollment: 183
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with idiopathic thombocytopenic purpura, aged between 1 and 17 year

Brief summary: Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment


Eligibility criteria: Inclusion Criteria:

* children with Idiopathic thrombocytopenic purpura
* aged between 1 and 17 year
* Idiopathic thrombocytopenic purpura persistent at 12 months
* obtention of informed consent

Exclusion Criteria:

* Persistant/acute Idiopathic thrombocytopenic purpura
* concomittant chronic disease, stabilized or not
* Concomittant disease with life expectancy \< 1 year
* Person who have not belong to a social security scheme
* Secondary Idiopathic thrombocytopenic purpura

Primary outcomes:
measure: quality of life score according to type of treatment
timeFrame: at inclusion visit
Secondary outcomes:
measure: number of hospitalisation and consults per year
timeFrame: at inclusion visit
measure: description of general quality of life
timeFrame: at inclusion visit
measure: description of general quality of life
timeFrame: at inclusion visit
measure: description of awareness of parent and patient about Idiopathic thrombocytopenic purpura
timeFrame: at inclusion visit
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
Study officials:
affiliation: chu
name: Isabelle Pellier, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01659697: Diabetes Prevention in Prediabetic Patients
Official title: Diabetes Prevention in Patients Aged 25-55 From Ethiopian Origin With Prediabetes: Evaluation of Feasibility and Efficacy of Intensive or Less Intensive Lifestyle Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ethnic Group
Young Adults
Prediabetes
Community Health Services
Keywords: lifestyle
diabetes prevention
BMI
physical activity
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2012-08-08
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged 25-55 from Ethiopian origin leaving in Israel with pre diabetes

Brief summary: This study will evaluate the feasibility and efficacy of two interventions of lifestyle ( intensive and less intensive) to prevent diabetes in patients from Ethiopian origin, aged 25 to 55 years old with prediabetes living in Israel and insured by Clalit Health Services in the Central district, using resources existing in this Health Care system (HMO).


Eligibility criteria: Inclusion Criteria:

* prediabetes
* age 25-55
* ethiopian origin

Exclusion Criteria:

* diabetes
* age under 25 or above 55
* non ethiopian origin

Primary outcomes:
measure: occurence of diabetes
timeFrame: two years period
Secondary outcomes:
measure: change in Body Mass index and Physical activity
timeFrame: two years
Other outcomes:
Locations:
city: Rishon Le Zion
country: Israel
facility: Central district Clalit Health Services
Study officials:
affiliation: Meir Medical Center
name: Joelle A Singer, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Meir Medical Center
name: Dalia Blumenthal, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01971697: Socio-Economic Survey in Uganda
Official title: Short Term Socio-economic Impact Due to Blunt Orthopedics Trauma on the Victims in Uganda
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopaedic Injury
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Urgent care patients. Patients coming to the ER with a orthopaedic injury.

Brief summary: This study will be conducted at Mulago Teaching Hospital. Patients coming to the ER with an orthopaedic injury will be approached. If a patient consents to be part of the study, they will complete a questionnaire. Participation in the study will end as soon as the questionnaire is completed.

Detailed description: All patients will be recruited from the orthopedics inpatient wards and emergency department at Mulago National Referral Hospital. Only patients who have sustained an orthopedics injury will be included in this study, and the severity will be recorded for future references. No Protected Health Information (PHI) will be collected throughout the study.

Steps

1. Identify patients from Mulago Teaching Hospital
2. Enrollment of patients into survey study
3. Administer survey to patients at 1st meet up
4. Administer survey to doctor-in-charge?
5. Compilations of survey results into excel spreadsheet. Participants will be assigned an ID. The study team does not intend to collect any PHI.
6. Statistical Analysis.

Eligibility criteria: Inclusion criteria:

* Subject is a male or female 18 years old or older.
* all patients presented at Mulago National Referral Hospital with orthopedics trauma injuries regardless of age and gender.

Exclusion criteria:

- patients presented with all other conditions other than orthopedics related injuries that may require long term care. Some examples are head injuries leading to long term damage, loss of sights, etc.

Primary outcomes:
measure: Immediate social-economic impact of orthopedics trauma as measured by socio-Economic Questionnaire
timeFrame: approximately 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Kampala
country: Uganda
facility: Mulago National Referral Hospital
Study officials:
affiliation: Duke University
name: William Richadson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01537497: A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers
Official title: Phase 1 Four-Arm Parallel Group, Placebo-Controlled Study To Evaluate The Effects Of Single Doses Of PF- 05175157 At Three Dose Levels On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 1
Single Doses
Pharmacodynamics
Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-02-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. In addition, subjects must have normal pulmonary function tests and normal ocular findings.
* Women must be of non-childbearing potential.
* Body Mass Index (BMI) of 19.5 35.5 kg/m2, and a total body weight of \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
* Evidence or history of any chronic ongoing or current pulmonary disease.
* History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day -7.
* Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.

Primary outcomes:
measure: Modulation of carbohydrate and lipid metabolism
timeFrame: 24 hours
Secondary outcomes:
measure: Cmax of PF-05175157 after single oral doses
timeFrame: 24 hours
measure: Tmax of PF-05175157 after single oral doses
timeFrame: 24 hours
measure: Area under the curve (AUC) of PF-05175157 after single oral doses
timeFrame: 24 hours
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03280797: Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases
Official title: Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study will assess the feasibility of using cytokine expression profiles in blood samples as a method for evaluating rheumatoid polyarthritis


Eligibility criteria: Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient is at least 18 years old
* Subjects included as patients have rheumatoid polyarthritis according to ACR EULA 2010, DAS28\>3.2 criteria
* Subjects included as controls are healthy volunteers who have no overexpression of cytokines

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient has had at least 3 months of specific treatment that can potentially impact cytokine profile

Primary outcomes:
measure: Dosage of cytokines between groups
timeFrame: Day 0
Secondary outcomes:
measure: Creation of biobank
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
References:
Clinical trial NCT03933397: Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
Official title: A Comparison of Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sickle Cell Disease
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-05-01
Enrollment: 328
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: The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency department. This is called weight based treatment. The other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. This is called patient specific treatment.


Eligibility criteria: Inclusion Criteria:

* All adult (18 years or older);
* Sickle Cell Disease patients with the following genotypes: Hgb SS (sickle cell anemia), SC(Sickle hemoglobin-c) , and SB+(sickle Beta-Plus thalassemia) and SB-(sickle Beta zero thalassemia)

Exclusion Criteria:

* determined to not benefit from opioids and therefore won't receive opioids in any future Emergency Department visit.

Primary outcomes:
measure: The Change in Pain Score
timeFrame: baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first
Secondary outcomes:
measure: Length of Index ED (Emergency Department) Stay
timeFrame: From bed placement to discharge or 6 hours whichever comes first
measure: Length of Care
timeFrame: up to 6 hours
measure: Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment
timeFrame: Up to 7 days post enrollment
measure: Number of Participants Experiencing Side Effects
timeFrame: Bed placement to discharge or 6 hours, whichever comes first
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Cleveland
country: United States
facility: Case Western University
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Duke University
name: Huiman Barnhart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University School of Nursing
name: Paula Tanabe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03701997: Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
Official title: All-comers Registry Monitoring the Safety and Effectiveness of the Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventricular Dysfunction
Ventricular Dysfunction, Left
Ventricular Dysfunction, Right
Lead sponsor: Berlin Heart, Inc
Sponsor class: INDUSTRY
First posted: 2018-10-10
Enrollment: 62
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric (0-21 years) who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric

Brief summary: The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric. This surveillance includes an "all-comers" prospective cohort of pediatric (\<22 years of age) patients implanted according to the IFU with the EXCOR® Pediatric.

Detailed description: The Advanced Cardiac Therapies Improving Outcomes Network (Action) database will be used for the surveillance. The network was developed to determine best practice and improve quality in the pediatric mechanical circulatory support field. The registry Protocol and Manual of Operations will be followed by participating pediatric transplant hospitals. Quality assurance of the data will be monitored by the registry's data coordinating center.

Eligibility criteria: Inclusion Criteria:

* Transplant eligible
* Implanted with EXCOR Pediatric per IFU

Exclusion Criteria:

* Having any contradictions for user per IFU

Primary outcomes:
measure: Stroke rate
timeFrame: Until discontinuation of device support or 180 days
Secondary outcomes:
measure: Adverse Events
timeFrame: Until discontinuation of device support or 180 days
measure: Device effectiveness
timeFrame: Until discontinuation of device support or 180 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Sites per Action network
state: Ohio
Study officials:
affiliation: Berlin Heart, Inc
name: Robert M Kroslowitz, BS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01698697: Comparison of Two Insulin Aspart Formulations in Healthy Volunteers
Official title: A Single Centre, Randomized, Balanced Double-blind, Cross-Over Trial Investigating the Bioequivalence of a Continuous Subcutaneous Infusion of a Marketed NovoRapid Formulation Containing 100 U/ml and a New NovoRapid Formulation Containing 200 U/ml in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).


Eligibility criteria: Inclusion Criteria:

* Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
* Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant
* Body mass index (BMI) 18-26 kg/m\^2 (both inclusive)
* Weight 60-90 kg
* Non-smoker

Exclusion Criteria:

* Any condition requiring the regular use of any medication
* Known or suspected allergy to the trial product or related products
* Family history of type 1 diabetes mellitus

Primary outcomes:
measure: Area under the curve (AUC)
measure: Area under the glucose infusion rate curve
Secondary outcomes:
measure: Cmax (maximum plasma concentration)
measure: Time to reach maximum (tmax)
measure: Terminal half-life (t½)
measure: Incidence of hypoglycemic events
measure: Adverse events
measure: GIRmax: The maximal GIR (glucose infusion rate)
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: