louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01532206: IL-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction
Official title: Interleukin-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Remote ischemic preconditioning
inflammation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 1
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: Remote ischemic preconditioning has proven beneficial in patients undergoing percutaneous coronary intervention and coronary artery bypass surgery. Animal studies suggest remote ischemic preconditioning increases levels of interleukin 10. The investigators aim to determine whether remote ischemic preconditioning results in an increase in IL-10 levels in patients following acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

- Acute myocardial infarction

Exclusion Criteria:

- Cardiogenic shock Active ischemia

Primary outcomes:
measure: Interleukin 10 levels
timeFrame: 24 hours following RIPC
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steven P Schulman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00961506: Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy
Official title: Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gallbladder Disease
Keywords: cholecystectomy
gallbladder
laparoscopy
laparoendoscopic
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2009-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and recovery compare to laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* gallbladder disease Age: 18-99

Exclusion Criteria:

* intolerance to laparoscopy

Primary outcomes:
measure: Body image scale
timeFrame: 1 months
Secondary outcomes:
measure: pain VAS
timeFrame: 10 days
measure: Analgesic requirement
measure: time to return to work
measure: scar scale
timeFrame: 1 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Pascal Bucher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05401006: Effect of Acitretin Versus Narrowband Ultraviolet B on Neopterin Level in Psoriatic Patients .
Official title: Evaluation of the Effect of Acitretin Versus Narrowband Ultraviolet B on Serum Neopterin Level in Psoriatic Patients .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate effect of acitretin versus Narrowband UVB on serum level of neopterin in psoriatic patients.


Eligibility criteria: Inclusion Criteria:

* Patients with psoriasis diagnosed clinically Aged (15-60).

Exclusion Criteria:

* Patient with history of skin cancer.
* Patient with history of photosensitivity.
* Pregnancy and lactation.
* Liver failure.
* Renal failure.
* Patient with psoriatic artheritis.
* Patient with allergy to product or any of its components.
* Patient with poorly controlled dyslipidemia.
* Patient receiving tetracyclines.

Primary outcomes:
measure: Serum Neopterin in psoriasis
timeFrame: 3 Months
Secondary outcomes:
measure: Treatment of psoriasis
timeFrame: 3 Months
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University
Study officials:
References:
Clinical trial NCT04314206: VNRX-5024 Safety and PK in Healthy Adult Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-5024 Administered Orally for 10 Days in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-03-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 2-part dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study after safety assessments and PK samples are collected. In the multiple dose part of the study, subjects will receive multiple doses of VNRX-5024 for 10 days.


Eligibility criteria: Inclusion Criteria:

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
4. Normal blood pressure
5. Normal lab tests

Exclusion Criteria:

1. Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
3. Use of antacid medications
4. Abnormal ECG or history of clinically significant abnormal rhythm disorder
5. Positive alcohol, drug, or tobacco use/test

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: Day 19
Secondary outcomes:
measure: Part 1: AUC0-tau
timeFrame: Days 1-2
measure: Part 2: AUC0-tau
timeFrame: Days 3-12
measure: Part 1: Cmax
timeFrame: Days 1-2
measure: Part 2: Cmax
timeFrame: Days 3-12
measure: Part 1: tmax
timeFrame: Days 1-2
measure: Part 2: tmax
timeFrame: Days 3-12
measure: Part 1: CLr
timeFrame: Days 1-2
measure: Part 2: CLr
timeFrame: Days 3-12
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences - Early Development Services
Study officials:
References:
Clinical trial NCT03176706: Assessment of Dried Blood Spot Thyroglobulin and Urinary Iodine Concentration in Pregnant Women
Official title: Assessment of Dried Blood Spot Thyroglobulin in Pregnant Women to Redefine the Range of Median Urinary Iodine Concentration That Indicates Adequate Iodine Intake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iodine Deficiency
Pregnancy Related
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 2900
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant women aged from 18 to 44 years, living since 12 months or longer in the respective country.

Brief summary: To avoid iodine deficiency and its consequences in pregnant women and their offspring, women should reach a sufficient iodine intake long before conception. To monitor iodine status, median urinary iodine concentration (UIC) is widely used in pregnant women (PW). Thyroglobulin (Tg) us another marker used to assess iodine status . In this study, urine samples as well as dried blood spots will be collected to measure UIC and Tg (as well as other hormones to define thyroid function) in PW. The results shall be used to reassess the threshold which defines iodine status in PW according to UIC.


Eligibility criteria: Inclusion Criteria:

1. Generally healthy
2. No major medical illness, no thyroid disease, and taking no chronic medication
3. No use of iodine containing dietary supplements
4. No use of iodine-containing X-ray /CT contrast agent or iodine containing medication within the last year
5. Aged between 18 and 44 at enrollment
6. Singleton pregnancy
7. Non-smoking
8. Residence at study site since 12 months or longer

Primary outcomes:
measure: Urinary iodine concentration and Thyroglobulin concentration in pregnant women.
timeFrame: June 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Dunedin
country: New Zealand
facility: University of Otago
state: Otago
Study officials:
References:
Clinical trial NCT00113906: Melatonin Treatment After Laparoscopic Cholecystectomy
Official title: The Effect of Melatonin Treatment on Postoperative Fatigue and Sleep Disturbances: A Placebo Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Complications
Fatigue
Dyssomnias
Keywords: melatonin,
fatigue,
sleep quality,
circadian,
postoperative
Postoperative fatigue
postoperative sleep disturbance
general wellbeing
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2005-06-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep disturbances and general wellbeing.

Detailed description: Postoperative fatigue and sleep disturbances occur after minimally invasive surgery. The pathophysiological background is unknown, but several studies have shown disturbed melatonin secretion after surgery. It is unknown whether melatonin substitution will improve general wellbeing, fatigue or sleep disturbances after laparoscopic cholecystectomy. We set out to study in a randomized clinical trial to investigate the effect of 5 mg melatonin versus placebo, on postoperative sleep disturbances, fatigue and general wellbeing.

Eligibility criteria: Inclusion Criteria:

* Operation for gall bladder disease
* Age over 18 years

Exclusion Criteria:

* Known preoperative sleep disturbance
* Anticoagulant therapy
* Psychiatric disease
* Lack of written informed consent
* Treatment with hypnotics within one week prior to surgery

Primary outcomes:
measure: Fatigue
Secondary outcomes:
measure: Sleep quality
measure: general wellbeing
measure: pain
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: University Hospital of Glostrup
state: Copenhagen
city: Hellerup
country: Denmark
facility: Copenhagen University Hospital, Gentofte
state: Copenhagen
Study officials:
affiliation: Copenhagen University Hospital, Gentofte
name: Ismail Gögenur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04385706: Joint Planning in Paediatric Rehabilitation
Official title: The Effectiveness of Joint Planning in Paediatric Rehabilitation: Parent and Child Related Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children With Developmental Delay
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 8
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group pre-test post-test design to evaluate a coaching model
Primary purpose: TREATMENT

Brief summary: We will use one group, pretest-posttest research design. The intervention will have a 6-month timeframe. Up to 18 participants will be selected from active caseloads of the three to six participating healthcare providers in the Early Childhood Rehabilitation Program at the Alberta Children's Hospital, Child Development Centre site in Calgary Alberta. All data will be collected in Alberta using remote measures. Parents and therapists will complete surveys in an online portal. One measure needs to be completed in conjunction with the therapist and parent and will be done in person using an online portal. The researchers will have a local investigator (Debra Teitelbaum) in Calgary who works on-site to help manage data collection and recruitment in person if necessary.


Eligibility criteria: Inclusion Criteria:

* Receiving care for developmental delay

Exclusion Criteria:

* Cannot speak or read english

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure (COPM)
timeFrame: Change in COPM performance and satisfaction between baseline and 6-months.
Secondary outcomes:
measure: Measure of Processes of Care (MPOC)
timeFrame: Change in MPOC (satisfaction) between baseline and 6-months.
measure: PedsQL Family Impact Module
timeFrame: Change in PedsQL Family Impact Module between baseline and 6-months
measure: Parent Stress Index
timeFrame: Change in Parenting Stress Index between baseline and 6-months
measure: Self-efficacy Visual Analog Scale
timeFrame: Change in self-efficacy between baseline and 6-months
measure: Therapist perceived parent efficacy Visual Analog Scale
timeFrame: Change in efficacy between baseline and 6-months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital - Early Childhood Rehabilitation
state: Alberta
Study officials:
affiliation: Western University
name: Laura K Brunton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05836506: A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult Participants
Official title: Assessment of the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: ABBV-903
Healthy Volunteer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-05-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess the relative bioavailability and pharmacokinetics of ABBV-903 in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.
* Negative test result for SARS-CoV-2 infection at screening visit and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Approximately 44 days
measure: Maximum Plasma Concentration (Cmax) of ABBV-903
timeFrame: Up to approximately 14 days
measure: Time to Cmax (Tmax) of ABBV-903
timeFrame: Up to approximately 14 days
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-903
timeFrame: Up to approximately 14 days
measure: Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903
timeFrame: Up to approximately 14 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903
timeFrame: Up to approximately 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 254926
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03722706: Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook
Official title: Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-10-29
Enrollment: 246
Sex: ALL
Minimum age (years): 30
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this research is to evaluate the effectiveness of an educational handbook for parents of children with atopic dermatitis (AD) in improving clinical outcomes for pediatric patients with AD and their parents. The handbook was developed by an interdisciplinary team of healthcare providers to facilitate therapeutic patient education as a routine component of care for pediatric patients with atopic dermatitis (AD). Patient education is an important element of practice management guidelines for AD, particularly given complex treatment plans and high rates of non-adherence in this population. Parents of children with AD will be randomized into either the handbook arm (handbook provided as an adjunct to standard AD management with a healthcare provider at Boston Children's Hospital) or the control arm (standard management alone). Participants will complete study measures at two time points: baseline (prior to a clinic visit appointment for AD care at Boston Children's Hospital), and 3-month follow-up. Data will be analyzed for change on study outcome measures (AD symptoms, AD severity, quality of life) and satisfaction with the handbook.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of atopic dermatitis
* Scheduled for clinic visit for evaluation/management of atopic dermatitis at Boston Children's Hospital

Exclusion Criteria:

* Parent is Spanish speaking
* Parent is foster parent

Primary outcomes:
measure: Patient-Oriented Eczema Measure (POEM)
timeFrame: baseline to 3-month follow-up
Secondary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: baseline to 3-month follow-up
measure: Infant's Dermatitis Quality of Life Index (IDQOL)
timeFrame: baseline to 3-month follow-up
measure: Children's Dermatology Life Quality Index (CDLQI)
timeFrame: baseline to 3-month follow-up
measure: Dermatology Family Impact Questionnaire (DFI)
timeFrame: baseline to 3-month follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jennifer S LeBovidge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03961906: Physiotherapy in Hereditary Spastic Paraplegia
Official title: Design and Validation of a Modular Physiotherapy Concept for the Treatment of Hereditary Spastic Spinal Paralysis (HSP) - a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hereditary Spastic Paraplegia
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Goal of this study is to develop and evaluate a physiotherapy concept that is focused on bilateral leg spasticity and aims to reduce spastic gait disturbance and to improve mobility in patients suffering from HSP.

Detailed description: This is a randomized single-center parallel study with a control group design. A blinded block randomization in groups of four was performed in equal parts toward the treatment (TPC) or the control (regular standard-of-care) group using randomization.com. Group assignment was kept in a closed envelope which was opened by the participant at the end of the baseline visit. Therefore both, the movement disorder specialist as well as the physiotherapist, were blinded to the randomization result for the baseline assessment up to the beginning of the first physiotherapy training session.

Therapeutic effects were evaluated at follow-up visits after 12 weeks (first visit, short-term effect) and after 26 weeks (second visit, long-term effect) comparing standard-of care with the TPC. Clinical evaluation is stated in detail below. Primary outcome assessment of this study was the change between baseline and follow-up assessment in treatment to control group in the spastic paraplegia rating scale (SPRS) score as a validated measure of disease severity (see Reference). Secondary outcome assessment was the change in walking distance in the Three-Minute-Walking test (3MW). Further exploratory outcome assessments were evaluated as effect sizes as specified below.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of hereditary spastic paraplegia
* manifest spastic gait disturbance
* remaining walking ability of at least 100m in three minutes,
* no botulinum toxin treatment during the entire study and three months prior to study inclusion
* no functional electronic stimulation during the study period.

Exclusion Criteria:

* see above

Primary outcomes:
measure: Change in total Spastic paraplegia rating scale (SPRS) score
timeFrame: 12 weeks and 26 weeks
Secondary outcomes:
measure: Change in Three Minute Walk
timeFrame: 12 weeks and 26 weeks
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen, Center for Neurology
Study officials:
References:
citation: Schule R, Holland-Letz T, Klimpe S, Kassubek J, Klopstock T, Mall V, Otto S, Winner B, Schols L. The Spastic Paraplegia Rating Scale (SPRS): a reliable and valid measure of disease severity. Neurology. 2006 Aug 8;67(3):430-4. doi: 10.1212/01.wnl.0000228242.53336.90.