louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00970775: AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Japanese Male and Non-Fertile Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Phase I
Japanese healthy volunteer
AZD2423
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-02
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following single ascending dose administration to healthy Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese male and non-fertile female subjects aged ≥20 to ≤55 years with suitable veins for cannulation or repeated venepuncture.
* Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2
* Clinically normal physical findings including supine blood pressure, pulse rate, orthostatic blood pressure, ECG, and laboratory assessments in relation to age, as judged by the Investigator.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 3 months of the first administration of investigational product.
* Frequent use of tobacco or other nicotine containing products. Frequent use is defined as smoking or consumption/intake of nicotine products more than two days per week during the last 12 weeks.

Primary outcomes:
measure: To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.
timeFrame: From screening period to follow-up visit, 40 days (Maximum).
Secondary outcomes:
measure: To characterize the pharmacokinetics of AZD2423 in plasma and urine.
timeFrame: Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately)
measure: Exploratory endpoints;Levels of CCL2 pre-and post dose
timeFrame: Blood sampling after dosing, 3 days
Other outcomes:
Locations:
city: Croydon
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Richmond Pharmacology Limited
name: Ulrike Lorch, MD MFPM FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00008775: Pressure Support Ventilation During CF Exacerbations
Official title: Pressure Support Ventilation During CF Exacerbations: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2001-01-18
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Chest physiotherapy is recognized as a mainstay of cystic fibrosis therapy, and is particularly important during treatment of pulmonary exacerbations. For some patients, especially those with moderate to severe compromise of lung function, this therapy may impose a high demand in the work of breathing and energy expenditure. The goal of this study is to evaluate the effectiveness of adding pressure support ventilation (PSV) during chest physiotherapy sessions in patients with cystic fibrosis with moderate to severe lung function compromise being treated for a pulmonary exacerbation.

Detailed description: The proposed study will be conducted over three years. Cystic fibrosis patients with moderate to severe pulmonary disease who are experiencing an acute exacerbation that requires hospitalization will be admitted to the GCRC. Subject participation in the study will be for the first 10 days of hospitalization. Subjects will be randomized into one of two treatment groups: usual care or usual care plus non-invasive pressure support ventilation (PSV).

Eligibility criteria: cystic fibrosis subjects with pulmonary exacerbation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT00580775: Study of Early Hormone Replacement Therapy on Risk Factors for Sudden Cardiac Death
Official title: Effects of Early Hormone Replacement Therapy on Risk Factors for Sudden Cardiac Death: Autonomic Function and Ventricular Repolarization Heterogeneity ( A KEEPS Ancillary Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopausal Women
Keywords: Menopause
Hormone Replacement Therapy
Sudden Cardiac Death
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 25
Sex: FEMALE
Minimum age (years): 42
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Self-voluntary study subjects participating in the KEEPS parent study which is randomized, double-blind, placebo controlled.

Brief summary: As an ancillary study to the KEEPS study (see ClinicalTrials.gov Identifier: NCT00154180), the primary purpose is to measure effects of estrogen vs. placebo in menopausal women, on autonomic function and repolarization; both measured non-invasively via holter monitoring.

Detailed description: The parent study KEEPS, will be a randomized, placebo-controlled double blinded, prospective trial with two active groups and one placebo group. Only patients enrolled in KEEPS will be invited to participate in this ancillary study.Duration of the KEEPS study will be for 4 years after randomization for each study subject, with assessment of the primary endpoint, carotid CIMT, twice at baseline, 12, 24, 36 and 48 months. Ancillary to the KEEPS study, patients will undergo holter monitoring at baseline, 24 and 48 months.Data will be analyzed after 24 and 48 months (corresponding to data analysis of the primary endpoints.) Holter monitors will be put on during the scheduled KEEPS visits, will be worn for 24 hours and will be returned the following day. Effects of estrogen on heart rate variability (HRV) and repolarization parameters will be evaluated, and also correlated with clinical, quality of life, sleep and mood information gathered through the parent study. Anticipated enrollment from the parent study at this site is 90 study subjects. This ancillary does not involve the use of drugs or investigational devices.

Eligibility criteria: Inclusion Criteria:

* participant of the KEEPS parent study: ClinicalTrials.gov Identifier NCT00154180

Exclusion Criteria:

* non-participants of parent study

Primary outcomes:
measure: Heart rate variability
timeFrame: 48 Months
Secondary outcomes:
measure: Repolarization parameters
timeFrame: 48 Months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine / Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Rachel Lampert, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00982475: Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
Official title: Ablation at St. George Hospital - Prospective Randomized Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: pulmonary vein isolation
robotic navigation
atrial fibrillation
Lead sponsor: Asklepios proresearch
Sponsor class: INDUSTRY
Collaborators: name: Abbott Medical Devices
name: Hansen Medical
First posted: 2009-09-23
Enrollment: 130
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients with drug refractory atrial fibrillation are not inferior to manual radiofrequency current ablation.


Eligibility criteria: Inclusion Criteria:

* paroxysmal atrial fibrillation
* persistent atrial fibrillation \< 2 month
* indication for catheter ablation
* LEF \> 50%
* diameter LA \< 50 mm

Exclusion Criteria:

* intracardial thrombus
* atrial fibrillation with underlying curable disease
* renal failure \> stage I
* contraindication for anticoagulation
* life expectancy \< 12 month
* previous PVI
* pregnancy

Primary outcomes:
measure: Freedom of AF 12 months after procedure.
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: ASKLEPIOS KLINIK St. Georg
Study officials:
References:
citation: Rillig A, Schmidt B, Di Biase L, Lin T, Scholz L, Heeger CH, Metzner A, Steven D, Wohlmuth P, Willems S, Trivedi C, Galllinghouse JG, Natale A, Ouyang F, Kuck KH, Tilz RR. Manual Versus Robotic Catheter Ablation for the Treatment of Atrial Fibrillation: The Man and Machine Trial. JACC Clin Electrophysiol. 2017 Aug;3(8):875-883. doi: 10.1016/j.jacep.2017.01.024. Epub 2017 Jun 28.
Clinical trial NCT02516475: Effects of Zinc Supplementation on Anthropometric Factors, Apelin and Inflammatory Markers in Obese Individuals
Official title: Effects of Zinc Supplementation on Weight, Body Mass Index (BMI), Waist Circumference, Fat Mass and Lean Mass, Apelin and Inflammatory Markers in Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of zinc supplement on anthropometric factors, Apelin and inflammatory markers in obese individuals, 50 obes person who referred to Diet and Nutrition clinic of Shahid Beheshti University of Medical Sciences will be randomly allocated to receive 50 mg zinc capsules or placebos for 15 weeks; both groups will be advised to adherence the investigators' diet . At the first and the end of the intervention,weight, body mass index (BMI), waist circumference, fat mass and lean body mass, concentration of zinc, albumin, hs-CRP, TNF-α and plasma apelin will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 45 years
* Non-smoking
* Body Mass Index (BMI) more than 30

Exclusion Criteria:

* Pregnancy, lactation or menopause in women
* History of liver disease, kidney, thyroid, diabetes and other metabolic diseases
* Use of drugs interfering with lipid profile, blood-thinning drugs, beta-blockers
* Patients with immune deficiency
* Use of zinc, calcium and iron supplement in the last 2 months
* Use of weight loss medication or special diet
* Following program to lose weight in recent 2 months
* Recent surgery

Primary outcomes:
measure: weight
timeFrame: 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Nutrition and Food Technology Research Institute
name: Azita Hekmatdoost, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khorsandi H, Nikpayam O, Yousefi R, Parandoosh M, Hosseinzadeh N, Saidpour A, Ghorbani A. Zinc supplementation improves body weight management, inflammatory biomarkers and insulin resistance in individuals with obesity: a randomized, placebo-controlled, double-blind trial. Diabetol Metab Syndr. 2019 Dec 2;11:101. doi: 10.1186/s13098-019-0497-8. eCollection 2019.
Clinical trial NCT01306175: Drug Interaction Study of Digoxin and BI 10773
Official title: Relative Bioavailability of a Single Oral Dose of Digoxin (0.5 mg) When Administered Alone or in Combination With Multiple Oral Doses of BI 10773 (25 mg qd) in Healthy Male and Female Volunteers (an Open-label, Randomised, Two-way Crossover Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to investigate the relative bioavailability of digoxin after concomitant multiple oral administration of BI 10773 and a single dose of digoxin in comparison to digoxin given alone to healthy male and female subjects.


Eligibility criteria: Inclusion criteria:

-Healthy male and female subjects

Exclusion criteria:

-Any relevant deviation from healthy conditions

Primary outcomes:
measure: Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞)
timeFrame: 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose
measure: Digoxin: Maximum Measured Concentration (Cmax)
timeFrame: 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose
Secondary outcomes:
measure: Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz)
timeFrame: 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1245.40.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Macha S, Sennewald R, Rose P, Schoene K, Pinnetti S, Woerle HJ, Broedl UC. Lack of clinically relevant drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and verapamil, ramipril, or digoxin in healthy volunteers. Clin Ther. 2013 Mar;35(3):226-35. doi: 10.1016/j.clinthera.2013.02.015.
Clinical trial NCT06649175: Effect of Kinetic Chain Exercises on Muscle Strength, Joint Position Sense and Quality of Life in Children with Haemophilia.
Official title: Effect of Kinetic Chain Exercises on Muscle Strength, Joint Position Sense and Quality of Life in Children with Haemophilia.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemophilia a
Muscle Strength
Joint Position Sense
Quality of Life (QOL)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 40
Sex: MALE
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if there are effect of close kinetic chain exercises on muscle strength, joint position sense and Quality of life in children with haemophilia? Null hypothesis

It will be hypothesized that:

There is no effect of close kinetic chain exercises on muscle strength, joint position sense and Quality of life in children with haemophilia.

Detailed description: Sample size estimation will be carried out to determine the recruited number of children selected randomly from Out Patient clinic of Atfal Misr hospital, Cairo governorate to participate in this study. The study targets male children with hemophilia A.

They will be selected based on the following:

Inclusion criteria:

1. Their chronological age will be 5-7yeasr.
2. All children will receive prophylaxis therapy.
3. They will able to stand and walk independently.
4. They will be able to follow instructions during evaluation and treatment.

Exclusive criteria:

The children will be excluded if they have one of the following:

1. Visual or auditory problem.
2. Radiographic changes as bone erosions, destruction, or joint subluxation, or congenital or acquired skeletal deformities in both lower limbs.
3. Surgical procedures performed six weeks prior to or during study.
4. Bleeding in joint 2 week prior to assessment.

Eligibility criteria: Inclusion Criteria:

* 1. Their chronological age will be 5-7yeasr. 2. All children will receive prophylaxis therapy. 3. They will able to stand and walk independently. 4. They will be able to follow instructions during evaluation and treatment.

Exclusion Criteria:

* The children will be excluded if they have one of the following:

  1. Visual or auditory problem.
  2. Radiographic changes as bone erosions, destruction, or joint subluxation, or congenital or acquired skeletal deformities in both lower limbs.
  3. Surgical procedures performed six weeks prior to or during study.
  4. Bleeding in joint 2 week prior to assessment.

Primary outcomes:
measure: a) Assessment of muscle strength:
timeFrame: baseline only
Secondary outcomes:
measure: b) Assessment of knee joint position sense.
timeFrame: baseline only
Other outcomes:
measure: c) Assessment of Quality of life.
timeFrame: baseline only
Locations:
city: Cairo
country: Egypt
facility: Out Patient clinic of Atfal Misr hospital
Study officials:
References:
Clinical trial NCT04944875: Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric Magnetic Resonance Imaging.
Official title: Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Solid Tumor
Pediatric Brain Tumor
Pediatric Cancer
Keywords: Magnetic Resonance
sedation
maternal voice
sedative effects
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 210
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the effects of music and maternal voice in children on sedation depth and sedative use during pediatric magnetic resonance imaging.

Detailed description: When the patients and their parents arrived in the magnetic resonance unıt about 30 minutes before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment.

Patients were categorized into 3 groups: music, maternal voice and isolation. During the procedures,the patients in the music group listened to Vivaldi's The Four Seasons violin concertos by sound isolating headphones, whereas the patients in the isolation group wore the headphones but did not listen to music.

All patients were sedated by midazolam and propofol. During the procedure, an additional propofol was administered as required

Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiologists) I-II

Exclusion Criteria:

* Patients with hearing impairment, distorted ear anatomy, recent organ or system deficiency, severe pulmonary and/or cardiovascular problems, intolerance to propofol, airway ab-normalities, or known psychiatric or mental problems were ex-cluded from the study.

Primary outcomes:
measure: amount of propofol dose used in sedation
timeFrame: during the MRI procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Özlem Öz Gergin
Study officials:
affiliation: TC Erciyes University
name: Ozlem Oz Gergin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Starkey E, Sammons HM. Sedation for radiological imaging. Arch Dis Child Educ Pract Ed. 2011 Jun;96(3):101-6. doi: 10.1136/adc.2008.153072. Epub 2010 Jul 30. No abstract available.
citation: Ahmad R, Hu HH, Krishnamurthy R, Krishnamurthy R. Reducing sedation for pediatric body MRI using accelerated and abbreviated imaging protocols. Pediatr Radiol. 2018 Jan;48(1):37-49. doi: 10.1007/s00247-017-3987-6. Epub 2018 Jan 1.
Clinical trial NCT04103775: Mechanisms of Cognitive Change
Official title: Mechanisms of Cognitive Change
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psychosis
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will determine whether targeted cognitive training, a low-cost and low-risk commercial cognitive remediation therapy, directly impacts therapeutic targets as well as secondary outcomes in college undergraduates. The active intervention will be compared to an active control condition (computer games). Participants will also attend CSU TILT (The Institute for Teaching and Learning) Academic Workshops.

Detailed description: The primary goal of this project is to investigate whether commercial cognitive remediation therapy improves cognitive functioning in college undergraduates. The secondary goal is to investigate neurophysiological, cognitive, and psychosocial mechanisms of change. The investigators will compare cognitive remediation therapy to computer games. The active control condition will allow the investigators to determine whether targeted cognitive training, as an adjunct to academic skills training provided by CSU TILT, provides significant improvement over computer games alone (which is also thought to provide some value as "brain training"). Participants who agree to enroll in the study will be randomized to one of two intervention arms: cognitive remediation (CR) or active control (AC). In the CR arm, participants will complete 20 hours of targeted cognitive training, in 30-min session, 5 days per week, over 8 weeks. The AC Arm will follow the same schedule, except that participants will complete video games (e.g., pong). All participants will repeat assessments at randomly determined midpoint, as well as after the 8 weeks of training have been completed.

Eligibility criteria: Inclusion Criteria:

* College undergraduate;
* English fluency, and the ability to complete study requirements.

Exclusion Criteria:

* College seniors (i.e., students with more than 89 credits at CSU);
* Students who are concurrently enrolled in another study investigating the efficacy or effectiveness of novel learning or cognitive development techniques (not including tutoring or other existing programs available to CSU undergraduates);
* Participants less than age 15.

Primary outcomes:
measure: MATRICS Consensus Cognitive Battery (MCCB) Verbal Learning Subscale Scores
timeFrame: Three time points (1 week pre-randomization, mid-treatment [randomly selected for each participant between the 2nd and 7th week of treatment], and 1 week post-treatment) for all participants.
Secondary outcomes:
measure: Academic Performance
timeFrame: Semester data obtained yearly up to 8 years
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
References: