louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02286934: Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol
Official title: A Clinical Trial to Investigate the Influence of Cytochrome P450 2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamics Characteristics of Carvedilol in Healthy Korean Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Carvedilol
CYP2D6
Isoproterenol Sensitivity Test
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Food and Drug Safety Evaluation, Korea
First posted: 2014-11-10
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol

Detailed description: This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;

To evaluate the change of the result of Isoproterenol Sensitivity Test according to Cytochrome P450 2D6 genotype after the multiple administration of carvedilol

Eligibility criteria: Inclusion Criteria:

* Healthy Subjects aged 20 - 45 years
* A body mass index (BMI) in the range 18.0 kg/m2 (inclusive) - 27.0 kg/m2 (inclusive).
* Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

Exclusion Criteria:

* Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Carvedilol, Isoproterenol).
* Subject judged not eligible for study participation by investigator.

Primary outcomes:
measure: AUC (area under the plasma concentration-time curve) of carvedilol
timeFrame: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose
measure: Cmax (Maximum plasma concentration) of carvedilol
timeFrame: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyounggi
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Kore
name: Jae-Yong Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung E, Ryu S, Park Z, Lee JG, Yi JY, Seo DW, Lee J, Jeong HS, Kim JM, Oh WY. Influence of CYP2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamic Characteristics of Carvedilol in Healthy Korean Volunteers. J Korean Med Sci. 2018 May 23;33(27):e182. doi: 10.3346/jkms.2018.33.e182. eCollection 2018 Jul 2.
Clinical trial NCT00966134: Ghrelin, Growth Hormone and Growth Factors at High Altitude
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Growth Hormone
Keywords: mountain medicine
ghrelin
growth hormone
hypoxia
physiology of hormonal adaptation to high altitude
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-08-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Caucasians from an Alpinist association

Brief summary: Regulation of ghrelin, growth hormone and growth factors at high altitude and their change during ascent to high altitude has not been studied in depth yet. The study includes 33 volunteers (12f) investigated at sea level, 4 days after ascent to 3440m and 14 days after ascent to 5400-5900m.

The investigators hypothesized that during ascent growth hormone levels would increase to compensate for the higher energy needs at high altitude.


Eligibility criteria: Inclusion Criteria:

* Healthy and good physical fitness

Primary outcomes:
measure: Ghrelin, growth hormone, insulin-like growth factor I (IGF-I), IGF binding protein 1 (IGFBP1), IGF binding protein 2 (IGFBP2), IGF binding protein 3 (IGFBP3), acid-labile subunit (ALS), insulin, prolactin
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03471234: Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE
Official title: LATIn American sTUdy to Investigate the Clinical Performance of Sirolimus-eluting Stent With Abluminal-only bioDEgradable Polymeric Coating (Inspiron TM) in the Treatment of Native Coronary Artery Lesions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary disease
drug eluting stent
Inspiron
Lead sponsor: Scitech Produtos Medicos Ltda
Sponsor class: INDUSTRY
First posted: 2018-03-20
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lesions in native coronary arteries measuring between 2.5 and 4.0 mm in diameter and 34 mm length treated only with Inspiron Sirolimus-Eluting Stent.

Brief summary: Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.

Detailed description: Prospective, multicenter, single arm registry to assess the safety and performance of Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer for the treatment of "real world" patients.

Eligibility criteria: Inclusion Criteria:

* All individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with Inspiron Sirolimus-Eluting stent.

Exclusion Criteria:

* Saphenous vein grafts or Mammary lesions;
* Individuals who have been treated within the last 6 months with another stent;
* Acute myocardial infarction with ST segment elevation;
* Chronic Total Occlusion

Primary outcomes:
measure: MACE (major cardiac events)
timeFrame: 12 months
Secondary outcomes:
measure: Acute success
timeFrame: up to 24 hours
measure: Stent Thrombosis
timeFrame: 24 months
measure: MACE
timeFrame: 24 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: São Paulo
country: Brazil
facility: Instituto do Coração - INCOR
Study officials:
References:
Clinical trial NCT05703334: Kt and Myofascial Release in Exc Asthma
Official title: Kinesio Tape Versus Myofascial Release of Respiratory Muscles on Athletes Performance With Exercise Induced Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Induced Asthma
Keywords: Pulmonary function test
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: seventy male athletic subjects with exercise induced asthma, their age ranged from 18-30 years old in this study , with group (A) mean age (21.03+3.6 years), and mean BMI values (27.6+.9 kg/m2) ,and group (B) mean age (21.9+3.8 years),and mean BMI values (27.8+1.3 kg/m2), and group (C) mean age(22+3.1 years), and mean BMI values (27.8+1.3 kg/m2).

Subjects were assigned randomly into tow study groups and one control group:Group(A) 30 subjects were treated by kinesio tap therapy 2sessions per week,Ground(B) 30 subjects were treated by myofascial release therapy 3 sessions per week ,Group (C) 10 subjects were not recieved treatment.
Primary purpose: TREATMENT

Brief summary: Purpose of this study was to compare between the effects of kinesio tap and myofascial release of respiratory muscles on exercise induced asthma

Detailed description: seventy male athletic subjects with exercise induced asthma, their age ranged from 18-30 years old in this study , with group (A) mean age (21.03+3.6 years), and mean BMI values (27.6+.9 kg/m2) ,and group (B) mean age (21.9+3.8 years),and mean BMI values (27.8+1.3 kg/m2), and group (C) mean age(22+3.1 years), and mean BMI values (27.8+1.3 kg/m2).

Subjects were assigned randomly into tow study groups and one control group:Group(A) 30 subjects were treated by kinesio tap therapy 2sessions per week,Ground(B) 30 subjects were treated by myofascial release therapy 3 sessions per week ,Group (C) 10 subjects were not recieved treatment.

Eligibility criteria: Inclusion Criteria:

* Seventy male athlete with ages ranging from 18 to 28 years old. Their Body Mass Index ranged from "18.5" to "24.9". They have the same level of good aerobic fitness, muscular strength and endurance, and flexibility according to tests results; running or jogging test, push up or sit up test, and sit-and-reach test respectively.

Exclusion Criteria:

1. Pulmonary disorders.
2. Metabolic disorders (e.g. Diabetes Mellitus).
3. Coronary artery disorders .
4. Neurological disorders.
5. Recent musculoskeletal injuries.
6. Renal disorders.
7. Hepatic disorders.
8. Skin hypersensitive.
9. Smokers

Primary outcomes:
measure: Pulmonary function test
timeFrame: 2 months
Secondary outcomes:
measure: Cooper's 12 minute run test
timeFrame: 2 months
Other outcomes:
measure: pulse oximeter
timeFrame: 2 months
measure: IFIS
timeFrame: 2 months
Locations:
city: Port Said
country: Egypt
facility: Khaled mohamed Ahmed zaki
state: Port Said/el Manakh
Study officials:
References:
Clinical trial NCT00188734: Early Lung Cancer Detection Using Computed Tomography
Official title: Lung Cancer Screening in High-risk Smokers Using Low-dose Computed Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung Cancer
Eary Diagnosis
Screening
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 5000
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: high risk current and former smokers

Brief summary: Early detection of lung cancer may improve treatment outcomes. Risk factors have been identified, suggesting a population which might benefit from regular screening. Lung cancer screening using low-dose computed tomography (LDCT) has experienced a recent renaissance with reported sensitivity for detection of lung cancer of 2.7% in high-risk populations. The purpose of this study is to evaluate the utility of LCDT for the early diagnosis of lung cancer in Ontario.


Eligibility criteria: Inclusion Criteria:

55 years or older at least 10 pack-year history of smoking general good health

Exclusion Criteria:

any prior cancers except non-melanotic skin cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Heidi C Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02402634: Inflammatory Gene Polymorphism and Prolonged Mechanical Ventilation After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Postoperative Mechanical Ventilation After Liver Transplantation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 141
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20-65 years old, scheduled for liver transplantation.

Brief summary: Mechanical ventilatory lung care is essential for postoperative care in liver transplantation recipients, for such patients are under massive fluid challenge and hemodynamic alterations perioperatively. Some of the recipients experience difficulty in weaning off from the mechanical ventilator due to various causes. This study is to investigate the relationship between the inflammatory gene polymorphism, known for acute lung injury, and the duration of mechanical ventilatory care for such liver transplantation recipients.


Eligibility criteria: Inclusion Criteria:

1. 20-65 years old
2. scheduled for liver transplantation

Exclusion Criteria:

1. Patients under mechanical ventilation prior to surgery
2. patients with muscular skeletal disorder, probable cause for respiratory depression
3. patients not able to read, or understand the consent form
4. ethnicity, other than asian
5. patients refusal

Primary outcomes:
measure: total duration of postoperative ventilator care
timeFrame: an expected average of 2-3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01330134: Comparison of Two Lidocaine Administration Techniques
Official title: Comparison of Two Lidocaine Administration Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: procedural
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 481
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 objective of our study is to determine if technique of lidocaine administration can decrease pain perception.

Hypothesis: There will be a significant difference in pain perception between patients who are given lidocaine on the skin surface prior to subcutaneous injection and patients who are given only subcutaneous injection by standard approach.

Detailed description: This is a single center prospective, randomized, blinded study assessing pain perception following 2 different lidocaine administration techniques in subjects who have planned medical procedures requiring local injection of lidocaine. Subjects will be approached and consented to participate in the study. They will be interviewed after the scheduled medical procedure to assess their pain using validated pain scores. An investigator who is not present for the procedure and blinded to the randomization will gather data regarding perceptions of pain from the entire procedure.

Eligibility criteria: Inclusion Criteria:

* Adult patients refered to the University of Chicago Medical Centers Procedure Service for a planned medical procedure requiring local injection of lidocaine.

Exclusion Criteria:

* Patient who lack decisional capacity to consent
* Patients who lack the ability to answer questions in english using pain scales

Primary outcomes:
measure: Pain Assessment: Overall
timeFrame: post procedure (day 1)
Secondary outcomes:
measure: Pain Assessment: Lidocaine Injection
timeFrame: post procedure (day 1)
measure: Pain Assessment: During Procedure
timeFrame: post procedure (day 1)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: Univeristy of Chicago
name: John P Kress, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel BK, Wendlandt BN, Wolfe KS, Patel SB, Doman ER, Pohlman AS, Hall JB, Kress JP. Comparison of Two Lidocaine Administration Techniques on Perceived Pain From Bedside Procedures: A Randomized Clinical Trial. Chest. 2018 Oct;154(4):773-780. doi: 10.1016/j.chest.2018.04.018. Epub 2018 Apr 24.
Clinical trial NCT04433234: Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
Official title: A Phase II, Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne muscular dystrophy
DMD
Oligonucleotides, antisense
Exon skipping
DS-5141b
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 8
Sex: MALE
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, long-term, extension, phase 2 study to evaluate the safety and efficacy of long-term treatment with DS-5141b in patients with DMD who have completed DS5141-A-J101.


Eligibility criteria: Inclusion Criteria:

* Has competed a study of DS5141-A-J101

Exclusion Criteria:

* Significant safety issues in a study of DS5141-A-J101
* Patient who does not consent to use appropriate contraception
* Patient not appropriate to participant in the study as determined by the Investigator

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: From first injection to after the last injection of DS-5141b in this study (within approximately 2 years)
measure: Change in distance walked during 6-minute walk test (6MWT)
timeFrame: Every 3 months (within approximately 2 years)
measure: Change in time to stand (TTSTAND)
timeFrame: Every 3 months (within approximately 2 years)
measure: Change in time in Timed up and go test
timeFrame: Every 3 months (within approximately 2 years)
measure: Change in time in 10-meter Run/Walk test
timeFrame: Every 3 months (within approximately 2 years)
measure: Change in score in the North Star Ambulatory Assessment (NSAA)
timeFrame: Every 3 months (within approximately 2 years)
measure: Change in score in the Performance of Upper Limb (PUL)
timeFrame: Every 3 months (within approximately 2 years)
measure: Change in Left Ventricular Ejection Fraction percentage (LVEF %)
timeFrame: Every 6 months (within approximately 2 years)
measure: Change in in Forced Vital Capacity (FVC) (percent predicted)
timeFrame: Every 6 months (within approximately 2 years)
measure: Change in Muscle Strength Measured by Quantitative Muscle Strength Assessment
timeFrame: Every 3 months (within approximately 2 years)
Secondary outcomes:
measure: Concentration of DS-5141a in plasma
timeFrame: Every 3 months (within approximately 2 years)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: National Center of Neurology and Psychiatry
state: Kodaira-Shi
city: Hyōgo
country: Japan
facility: Kobe University Hospital
Study officials:
affiliation: Daiichi Sankyo Co., Ltd.
name: Clinical Study Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT05040334: Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation
Official title: Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Antibiotics Causing Adverse Effects in Therapeutic Use
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1;receiving antibiotic prophylaxis Group 2; Not receiving antibiotics
Primary purpose: PREVENTION

Brief summary: To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.

Detailed description: Patients will be randomized to receive either prophylactic antibiotic \[a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)\] or placebo using identical sealed envelopes.Included cases are those with early miscarriage (within the first trimester 12 6/7 weeks of gestation) , missed or incomplete miscarriage, undergoing surgical management will be included in the study.

Technique:

The investigators will prepare 138 identical envelops, half of them filled with a label group(1) who are the group to receive the antibiotic prophylaxis with all instruction details, while the other half filled with a label identifying ( group 2) who are the placebo group. All envelops will be prepared by the investigator and sealed before starting enrollment. After enrollment, each participant will be allowed to choose one envelop to determine to which group the patient will be assigned to.

Eligibility criteria: Inclusion criteria:

* Maternal age :18-35 years
* Gestational age: up to 12 6/7 weeks of gestation (confirmed by a reliable date for the last menstrual period or /and 1st trimester ultrasound scan).
* Singleton miscarriage
* Type of miscarriage: Incomplete or Missed miscarriage
* Surgical evacuation will be done within 2 weeks of diagnosis of miscarriage .

Exclusion criteria:

* Maternal age: younger than 18 years
* Induced miscarriage of pregnancy
* Septic miscarriage
* Evidence of infection
* Morbid obesity (BMI≥40kg/m2)
* Allergy to prophylactic antibiotics (i.e., doxycycline or metronidazole)
* Antibiotics use within 7 days before randomization

Primary outcomes:
measure: Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis.
timeFrame: 2 weeks from surgery
Secondary outcomes:
measure: Change in the risk of severe puerperal sepsis following the surgical procedure
timeFrame: 2 weeks from surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Obstetrics and Gynecology, Kasr Al-Ainy University Hospital, Cairo University.
Study officials:
affiliation: Cairo University
name: Marwa Mo Eid, Ass.prof.
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Nihal Mo El-Demiry, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02862834: Screening for Genes in Patients With Poikiloderma
Official title: Towards an Improvement in Diagnosis and Genetic Counselling in Syndromic Poikiloderma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Poikiloderma
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with poikiloderma

Brief summary: In the context of this study, the investigators wish to take advantage of high-throughput genetic techniques (microarray and high-throughput exome sequencing) to identify new genes implicated in syndromic poikiloderma so as to improve the diagnostic decision tree in these syndromes, opportunities for genetic counselling for patients and their families and the follow-up of patients, notably with regard to the risk of tumours.

This study will make it possible to identify new genes implicated in syndromic poikiloderma and improve the diagnostic strategy proposed to patients with these syndromes, and to propose to patients a confirmed diagnosis, appropriate follow-up, notably with regard to the risk of tumours, genetic counselling to families and eventually an antenatal diagnosis to couples who would like to have one for future pregnancies.

The identification of new genetic causes of syndromic poikiloderma will also make it possible to complete the current classification of these syndromes


Eligibility criteria: Inclusion Criteria:

patients with syndromic poikiloderma, defined by the association of poikiloderma with other extradermatological clinical signs,

* normal array-CGH, screening for chromosomal rearrangements,
* absence of mutations in the genes RECQL4, KIND1 or C16orf57,
* sporadic or familial involvement.

Exclusion Criteria:

* None

Primary outcomes:
measure: Identification of novel genes involved in syndromic poikiloderma
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: