louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01225939: A Study Conducted Over 3 Periods to Look at the Drug in the Body
Official title: A Randomised, Open-label, Three-way Cross-over, Phase I Study in Healthy Subjects to Assess the Pharmacokinetics of AZD8329 After Single Doses of the Oral Solid Formulation and the Oral Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Healthy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study conducted over 3 periods to look at the drug in the body.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5
* suitable veins for cannulation or repeated venepuncture
* Subjects should have a body mass index (BMI) between 18 and 30 kg/m2

Exclusion Criteria:

* Abnormal vital signs (blood pressure and pulse) after 10 minutes supine rest, as judged by the investigator
* Prolonged QTcF \>450 msec or shortened QTcF \<350 msec or family history of long QT syndrome
* Suspicion of known Gilbert's disease
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

Primary outcomes:
measure: Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329.
timeFrame: Information will be collected during 48h after each dose.
Secondary outcomes:
measure: Explore the effect of food on the pharmacokinetics (Tmax, T1/2 and CL/F) of AZD8329 oral solid formulation.
timeFrame: Information will be collected during 48h after dose.
measure: Investigate the safety and tolerability of AZD8329 administered as two different oral formulations.(Safety variables: Adverse events, Vital Signs, Clinical chemistry, Electrocardiogram (p ECG))
timeFrame: Adverse event will be collected from first dose to last visit . Clinical chemistry, Vital Signs and pECG's will be collected at all 5 visits
Other outcomes:
Locations:
city: London Bridge
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Quintiles Drug Research Unit at Guy's Hospital
name: J Ritter, BM BCh, MRCP, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Mölndal
name: Dr. Mirjana Kujacic
role: STUDY_CHAIR
affiliation: AstraZeneca Sweden
name: Jan Eriksson, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05219539: Questionnaire Survey of the Advanced Training Program for Laparoscopic Radical Gastrectomy
Official title: Outcomes of the National Advanced Training Program for Laparoscopic Radical Gastrectomy: a Survey Based on Follow-up Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 1355
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From September 2009 to July 2021, Fujian Medical University Union Hospital have carried out 113 ATP-LRG courses, training a total of 1,447 trainees nationwide. In order to reduce recall bias, this study used an electronic questionnaire to conduct a return visit to 875 trainees who participated in the ATP-LRG for one year from January 2015 to October 2020.

Brief summary: This study aims to evaluate the outcomes of the advanced training program for laparoscopic radical gastrectomy (ATP-LRG). The research subjects are the trainees who participated in this training program.

Detailed description: Written informed consent is not required because of the observational and anonymous nature of this study. ATP-LRG is a national training program carried out by Fujian Medical University Union Hospital. Each training lasts about 1.5 days, which includes 1) detailed technique description; 2) prevention and solving of intraoperative complications; 3) live surgery performance; 4) theory and practice of clinical research; 5) comments on trainees' videos; and 6) questions, answers and discussions. In this study, 875 trainees who participated in ATP-LRG from January 2015 to October 2020 were interviewed using electronic questionnaires. Using a repeated-measures design to examine differences in outcomes before and after participating in the training. Questionnaire Star (Changsha Ranxing Information Technology Co., Ltd), a most widely used professional online questionnaire software platform in China, was used to design and create a link to the questionnaire. The questionnaire's link was sent to each trainee via WeChat (Tencent Holdings Limited), the most commonly used social networking software in China.

Eligibility criteria: Inclusion Criteria:

* Participated in ATP-LRG between January 2015 and October 2020
* Have contact information

Exclusion Criteria:

* Repeated participation in ATP-LRG
* Refuse to fill out the questionnaire

Primary outcomes:
measure: Change of general surgical skills score
timeFrame: One year after participating in ATP-LRG
Secondary outcomes:
measure: Changes of laparoscopic gastrectomy acceptance score
timeFrame: One year after participating in ATP-LRG
measure: Changes of clinical research possibilities score
timeFrame: One year after participating in ATP-LRG
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT00668239: Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser
Official title: Treatment of Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone and Laser Photocoagulation: Randomized Clinical Trial With Morphological and Functional Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Edema
Keywords: diffuse macular oedema
type 2 diabetes mellitus
laser therapy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2008-04-29
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the use of intravitreous triamcinolone and laser therapy to treat maculopahty in patients with type 2 diabetes mellitus in a short-tem period of 6 months

Detailed description: The purpose of this double blind randomized clinical trial was to compare the treatment of diffuse diabetic macular oedema with intravitreal triamcinolone and laser in patients with type 2 diabetes mellitus (DM), using a morphofunctional assessment. Patients with clinically significant diffuse macular oedema, previously untreated and with a macular thickness \>250 μm at optical coherence tomography (OCT) were randomized for treatment with Laser or intravitreal injection of Triamcinolone acetate. Optical coherence tomography (OCT), biomicroscopy, fundoscopy, fluorescein angiography, tonometry, scotometry, visual acuity and contrast acuities were performed at 0, 1, 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

* patients with type 2 DM, diffuse macular oedema secondary to diabetic retinopathy, seen at the Centre of Reference for Diabetic Retinopathy at Hospital de Clinicas de Porto Alegre (HCPA) and at the Ophthalmology Outpatient Clinic at HCPA,

Exclusion Criteria:

* patients with type 2 DM and previous treatment of diffuse macular oedema secondary to diabetic retinopathy

Primary outcomes:
measure: diffuse macular oedema
timeFrame: 1, 3 and 6 months
Secondary outcomes:
measure: morphofunctional assessment of retina
timeFrame: 1,3 and 6 monts
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Porto alegre
country: Brazil
facility: HOspital de Clínicas de Porto alegre
state: RS
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Alberto L Gil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gil AL, Azevedo MJ, Tomasetto GG, Muniz CH, Lavinsky J. Treatment of diffuse diabetic maculopathy with intravitreal triamcinolone and laser photocoagulation: randomized clinical trial with morphological and functional evaluation. Arq Bras Oftalmol. 2011 Sep-Oct;74(5):343-7. doi: 10.1590/s0004-27492011000500007.
Clinical trial NCT03630939: A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 in Subjects With Plaque Psoriasis
Official title: A Multicenter, Double-Blind, Randomized, Vehicle-Controlled Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 Gel in Subjects With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psoriatic Plaque
Lead sponsor: Escalier Biosciences B.V.
Sponsor class: INDUSTRY
Collaborators: name: Innovaderm Research Inc.
First posted: 2018-08-15
Enrollment: 104
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: This is a multicenter, double-blind, randomized, vehicle-controlled, parallel-group proof-of-concept study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of topically applied ESR-114 following twice daily (BID) application for 42 days (6 weeks).


Eligibility criteria: Inclusion Criteria:

* Subject has a history of plaque psoriasis for at least 6 months.
* Subject has PGA of mild (2) or moderate (3) at Day 1.
* Subject has total LSS of ≥6 at Day 1.
* Subjects with plaque psoriasis-affected BSA to be treated of 1% to 15% at Screening and Day 1.

Exclusion Criteria:

* Subject has non-plaque psoriasis at Screening and Day 1.
* Subject has a history of skin disease or presence of skin condition that, in the opinion of the Investigator, would interfere with the study assessments at Screening and Day 1.
* Subject has used any topical therapy to treat psoriasis within 2 weeks prior to Day 1.

Primary outcomes:
measure: Change in Total Lesion Severity Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of subjects with clear or almost clear on the Physician Global Assessment
timeFrame: 6 weeks
measure: Proportion of subjects with PASI75
timeFrame: 6 weeks
measure: Change from Baseline in erythema score over time
timeFrame: 6 weeks
measure: Change from Baseline in induration score over time
timeFrame: 6 weeks
measure: Change from Baseline in desquamation score over time
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Study Site 19
state: California
city: Tampa
country: United States
facility: Study Site 16
state: Florida
city: Fridley
country: United States
facility: Study Site 17
state: Minnesota
city: Raleigh
country: United States
facility: Study Site 14
state: North Carolina
city: Austin
country: United States
facility: Study Site 12
state: Texas
city: College Station
country: United States
facility: Study Site 11
state: Texas
city: Houston
country: United States
facility: Study Site 15
state: Texas
city: San Antonio
country: United States
facility: Study Site 18
state: Texas
city: Peterborough
country: Canada
facility: Study Site 13
state: Ontario
city: Montréal
country: Canada
facility: Study Site 10
state: Quebec
Study officials:
affiliation: Escalier Biosciences B.V.
name: Allison Luo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05804539: The Recovering Strategy on Forward Head Posture in Chinese Adolescents: Tai Chi and Manual Therapy
Official title: The Recovering Strategy on Forward Head Posture in Chinese Adolescents With Explainable Artificial Intelligence: Tai Chi and Manual Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forward Head Posture
Keywords: forward head posture
Lead sponsor: Northeast Normal University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 65
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Forward head posture (FHP) is a prevalent deformity that can cause various health issues in adolescents. The programs combining manual therapy (MT) and stability exercises (SE) have shown better effectiveness than stability exercises and home exercises in recovering FHP. However, the effectiveness of the therapy program consisting of Tai Chi and MT for recovering FHP remains unclear. Therefore, this study aimed to investigate the effects of Tai Chi with MT on FHP recovery. Meanwhile, with a particular focus on personalized medicine, we utilized explainable artificial intelligence (XAI) to predict if individuals would reverse to healthy posture based on different interventions.


Eligibility criteria: Inclusion Criteria:

1. who was diagnosed as FHP;
2. whose age was between ten to nineteen years old.

Exclusion Criteria:

1. who had nervous system disease or musculoskeletal system disease;
2. who had congenital scoliosis or congenital malformation disease;
3. who participated in other sports training;
4. who participated in other training program in the past of three months before the beginning of the study.

Primary outcomes:
measure: Using photogrammetry to calculate the cranial vertebral angle of participants before and after the intervention.
timeFrame: Month 3
measure: Using universal goniometer to calculate the cervical range of motion of participants before and after the intervention.
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: Chinese Center of Exercise Epidemiology
state: Jilin
Study officials:
References:
Clinical trial NCT03727139: Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
Official title: AZILECT Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-11-01
Enrollment: 1021
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease treated with Rasagiline 1 mg tablets as part of routine medical care.

Brief summary: The purpose of this survey is to evaluate the long-term safety of Rasagiline (AZILECT) in patients with Parkinson's disease in daily clinical practice and also collect efficacy information.

Detailed description: The drug being tested in this survey is called rasagiline tablet. This tablet is being tested to treat people with Parkinson's disease.

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the rasagiline tablet in the routine clinical setting. The planned number of observed patients will be approximately 1000.

This multi-center observational trial will be conducted in Japan.

Eligibility criteria: Inclusion Criteria:

-Patients with Parkinson's disease should be surveyed.

Exclusion Criteria:

-Participants who have contraindications on package insert of rasagiline.

Primary outcomes:
measure: Number of Participants Who Had One or More Adverse Events
timeFrame: 24 months
measure: Number of Participants Who Had One or More Adverse Drug Reactions
timeFrame: 24 months
Secondary outcomes:
measure: Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Baseline, Up to Month 24 (Final Assessment Point)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02033239: A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacodynamic Response of FIAsp in 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: 2014-01-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: 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 pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)

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 at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Primary outcomes:
measure: Area under the glucose infusion rate curve
timeFrame: From 0 to 12 hours
Secondary outcomes:
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 12 hours
measure: Maximum glucose infusion rate
timeFrame: Within 0 to 12 hours after dosing
measure: Maximum observed serum insulin aspart concentration
timeFrame: Within 0 to 12 hours after dosing
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Stender-Petersen K, Hovelmann U, Jacobsen JB, Nosek L, Zijlstra E, Haahr H. Pharmacokinetic and Pharmacodynamic Properties of Faster-Acting Insulin Aspart versus Insulin Aspart Across a Clinically Relevant Dose Range in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2017 Jun;56(6):649-660. doi: 10.1007/s40262-016-0473-5.
citation: Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. Faster Onset and Greater Early Exposure and Glucose-Lowering Effect with Faster-Acting Insulin Aspart vs. Insulin Aspart: A Pooled Analysis in Subjects with Type 1 Diabetes. Diabetes. 2016; Suppl. 1: A239. doi:10.2337/db16-861-1374 http://dx.doi.org/10.2337/db16-861-1374
citation: Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017 May;56(5):551-559. doi: 10.1007/s40262-017-0514-8.
Clinical trial NCT02684539: Autonomous Syncope Onset Prediction and Prevention
Official title: Autonomous Syncope Onset Prediction and Prevention An Open-label, One-centre Pilot Study on Healthy Subjects With the Erigo Tilt Table
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Syncope
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2016-02-18
Enrollment: 0
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: syncope prediction on tilt table

Detailed description: A tilt table is used to provoke syncope. syncope prediction is achieved through sensor measurements (ECG, ICG, SpO2, breathing rate, BP, NIRS, GSR, oculography).

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

-

Primary outcomes:
measure: clinical sign of syncope
timeFrame: 1 session of 90 minutes duration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00743639: Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy
Official title: Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dilated Cardiomyopathy
Keywords: Cardiomyopathy
stem cell
cardiac failure
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2008-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class III or NYHA.


Eligibility criteria: Inclusion Criteria:

* Diagnosis made at more than one year and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
* Left ventricular ejection fraction (LVEF) less than 35% by echocardiogram
* Age below 70 years
* Absence of neoplasm
* Abscence of hematologic disease or systemic disease
* No previous cardiac intervention

Exclusion Criteria:

* Episodes of tachycardia or ventricular fibrillation
* Severe or moderated mitral insufficiency
* Any other valvulopathies
* Previous cardiac surgery

Primary outcomes:
measure: Increase of the ejection function of the left ventricle
timeFrame: twelve months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Institute of Cardiology of Rio Grande do Sul / FUC
state: Rio Grande do Sul
Study officials:
affiliation: Institute of Cardiology of Rio Grande do Sul / FUC
name: Renato AK Kalil, MD, PhD
role: STUDY_DIRECTOR
References: