louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03969940: Thermotherapy of Buruli Ulcer at Community Level in the Health District of Akonolinga
Official title: Thermotherapy of Buruli Ulcer at Community Level in the Health District of Akonolinga
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Buruli Ulcer
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: University Hospital Heidelberg
name: Centre International de Recherches, d'Enseignements et de Soins
First posted: 2019-05-31
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include inhabitants of all health areas of the Akonolinga health district or coming from other BU endemic areas of Cameroon.

Brief summary: The project rolls out combined innovative low-tech thermotherapy of Buruli ulcer (BU) with heat packs and WHO recommended wound management in a BU endemic district of Cameroon.

Detailed description: The project translates available clinical research findings at the secondary health care level into clinical practice at the primary health care and community level. The string of previous work from the development of the BU thermotherapy-wound management-package to the proof of its efficacy provides all necessary procedures, tools and documents to immediately proceed into practical and integrated community application.

Main objective:

To determine in patients with early BU lesions the effectiveness and acceptability of thermotherapy treatment at health post and community level.

Specific objectives:

1. To monitor and evaluate clinical and biological responses to thermotherapy in patients receiving up to 8 weeks of thermotherapy
2. To assess within 6 months after completion of heat treatment wound closure ("primary cure") and/or absence of BU specific features in included patients according to WHO healing criteria
3. To measure the BU recurrence rate in included patient within 12 months after completion of heat treatment' ("definite cure").
4. To assess the compliance rate of included patients
5. To assess the withdrawal rate of included patients
6. To assess the ability and comfort of health personnel to use the thermotherapy device

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed BU patients with a single WHO category I and II lesion

Exclusion Criteria:

- inappropriate lesion size (category III patients), location and patients with multiple lesions

Primary outcomes:
measure: Primary cure: wound closure and/or no BU features according to WHO guideline
timeFrame: 6 months
measure: Definite cure: No recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Acceptability
timeFrame: 2 years
measure: Acceptability
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Heidelberg
name: Thomas Junghanss, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06625840: A Study of MK-1167 in Healthy Elderly Participants (MK-1167-004)
Official title: A Randomized, Double-Blind Clinical Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MK-1167 in Healthy Elderly Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-03
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to learn how safe MK-1167 is in healthy elderly adults and how well people tolerate it.


Eligibility criteria: The main inclusion criteria include but are not limited to the following:

* Be in good health

The main exclusion criteria include but are not limited to the following:

* History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* History of cancer (malignancy).

Primary outcomes:
measure: Number of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to approximately 41 days
measure: Number of Participants Discontinuing Study Treatment due to an AE
timeFrame: Up to approximately 16 days
measure: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-1167 after Multiple Doses
timeFrame: Predose and at designated timepoints up to 24 hours postdose on days 1, 8 and 16
measure: Maximum Concentration (Cmax) of MK-1167 after Multiple Doses
timeFrame: Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16
measure: Concentration at 24 hours (C24) of MK-1167 after Multiple Doses
timeFrame: 24 hours postdose on days 1, 8 and 16
measure: Time to reach maximum concentration (Tmax) of MK-1167 after Multiple Doses
timeFrame: Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16
measure: Apparent Clearance (CL/F) of MK-1167 after Multiple Doses
timeFrame: Predose and at designated timepoints up to 600 hours postdose on day 16
measure: Volume of Distribution (Vz/F) of MK-1167 at Steady State after Multiple Doses
timeFrame: Predose and at designated timepoints up to 600 hours postdose on day 16
measure: Apparent Half Life (t½) of MK-1167 after Multiple Doses
timeFrame: Predose and at designated timepoints up to 600 hours postdose on day 16
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International (Site 0001)
state: California
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00742040: Rapid Versus Prolonged Inpatient Up-Titration of Captopril
Official title: Rapid Versus Prolonged Inpatient Up-Titration of Captopril: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Disease
Keywords: up-titration
captopril
pediatric
cardiac patients
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2008-08-27
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to establish a safe and effective method of up-titration of captopril for hospital inpatients.

Detailed description: Angiotensin converting enzyme inhibitors (ACEi) are one of the most frequently prescribed pediatric cardiac medication and overall their safety in children is widely accepted. Pediatric formulary recommendations for ACEi suggest starting with a low initial dose (0.1 mg/kg), to avoid hypotension, and up-titration for a maintenance dose. However, side ranges are quoted for maintenance doses and no guidance is given as to the best method of up-titration, The physician is left uncertain of the optimal dose and how best to achieve it.

The ultimate goal of this study is to be in a position to provide physicians caring for children with heart disease information about how to safely up-titrate this widely used medication, and by doing so to improve dosing in the wider pediatric population.

Eligibility criteria: Inclusion Criteria:

* Pediatric cardiology in-patients at The Hospital for Sick Children
* Primary physician has decided to commence ACEi (the division has agreed that our institutional choice will be to start patients on captopril and up-titrate to optimal dose before converting to other ACEi)
* Patients who have been initiated on captopril within the prior 24 hours, but have not yet started up-titration, will be eligible to be randomized

Exclusion Criteria:

* Known sensitivity to ACEi
* Infants on the neonatal intensive care unit
* Treatment with any ACEi for more than 24 hours within the preceding 6 months
* Age \> 18 years

Primary outcomes:
measure: The number of patients reaching a target dose of 1mg/kg/dose (given three times a day).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Paul Kantor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roche SL, Timberlake K, Manlhiot C, Balasingam M, Wilson J, George K, McCrindle BW, Kantor PF. Angiotensin-Converting Enzyme Inhibitor Initiation and Dose Uptitration in Children With Cardiovascular Disease: A Retrospective Review of Standard Clinical Practice and a Prospective Randomized Clinical Trial. J Am Heart Assoc. 2016 May 20;5(5):e003230. doi: 10.1161/JAHA.116.003230.
Clinical trial NCT01522040: Pilot Study of Magnesium Infusions in Pediatric Asthma
Official title: A Pilot Study of Magnesium Infusions (Drips) for Moderate-to-Severe Pediatric Asthma Exacerbations
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Asthma
Keywords: Asthma
Magnesium
Adrenergic Receptor
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized pilot study that seeks to address the research question: In children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from patient presentation until PICU discharge?

Detailed description: This study will be a double-blind, prospective randomized pilot study. Subjects will be randomized on a 1:1 basis to receive routine asthma care with or without a magnesium drip.

Eligibility criteria: Inclusion Criteria:

* Age 2 years 0 days up to 20 years 364 days
* Clinical diagnosis of asthma including both of the following:

  * Attending physician's primary working diagnosis is status asthmaticus
  * Results of a modified International Study of Asthma and Allergies in Children (ISAAC) diagnostic questionnaire consistent with an asthma diagnosis
* Planned PICU admission for moderate-to-severe asthma exacerbation persisting despite standard first-tier therapy (systemic corticosteroids and at least a one-hour treatment with nebulized albuterol/ipratroprium or equivalent) as evidenced by an asthma score of 7 or greater
* IV access or equivalent
* Ability to understand and give informed consent/assent in English

Exclusion Criteria:

* Prior enrollment in this study
* Prior adverse reactions to magnesium
* Use of systemic corticosteroids or magnesium in preceding 2 weeks, or administered at a transferring facility more than 3 hours prior to enrollment
* Admission for inpatient asthma care in preceding 2 weeks
* Hemodynamic instability, impending respiratory failure or intubation
* Inability in children age 7 years or older to give assent due to a developmental delay or altered mental status
* Significant renal or cardiac disease
* Sickle cell anemia
* Significant, active non-asthma pulmonary disease

Primary outcomes:
measure: Time to discharge
timeFrame: Duration of hospital stay, typically 3-5 days
Secondary outcomes:
measure: Beta receptor haplotype
timeFrame: Once on enrollment
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Keith Cross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01384240: Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
Official title: Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Colon Polyps
Colonic Dysplasia
Anal Dysplasia
Keywords: colon polyps
colonic dysplasia
anal dysplasia
microendoscopy
Lead sponsor: Anandasabapathy, Sharmila, M.D.
Sponsor class: INDIV
First posted: 2011-06-29
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.


Eligibility criteria: Inclusion Criteria:

* surveillance of polyps or disease of the colon
* screening colonoscopy
* anoscopy for suspected or known anal dysplasia or neoplasia

Exclusion Criteria:

* unfit for standard colonoscopy or anoscopy
* unable to provide informed consent

Primary outcomes:
measure: to determine whether tissue in nepoplastic or non-neoplastic
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Sharmila Anandasabapathy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang SS, Shukla R, Polydorides AD, Vila PM, Lee M, Han H, Kedia P, Lewis J, Gonzalez S, Kim MK, Harpaz N, Godbold J, Richards-Kortum R, Anandasabapathy S. High resolution microendoscopy for classification of colorectal polyps. Endoscopy. 2013 Jul;45(7):553-9. doi: 10.1055/s-0032-1326502. Epub 2013 Jun 18.
Clinical trial NCT03213340: Effects of Phytonutrients Upon Muscle Perfusion in Response to Feeding
Official title: A Pilot Study to Explore the Acute Effects of Phytonutrients Upon Muscle Microvascular Blood Flow (Perfusion) in Response to Feeding in Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biological Aging
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 39
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 3 cohorts, crossover within cohort
Primary purpose: OTHER

Brief summary: This is a random order cross over design trial to evaluate the efficacy of select nutritional ingredients on enhancing muscle perfusion in response to an acute meal stimulus.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) 18-30 kg/m2
* Free from active metabolic disease
* Normotensive

Exclusion Criteria:

* Habitual gym use or formal exercise (more than once a week) or other routine strenuous physical activity
* Smokers
* Surgery within past 3 months
* Active cardiovascular disease
* Taking beta-adrenergic blocking agents
* Cerebrovascular disease:
* Active respiratory disease
* Active metabolic disease
* Active inflammatory bowel or renal disease
* Active Malignancy or until confirmed remission
* Clotting dysfunction
* History of DVT
* Significant musculoskeletal or neurological disorders
* Family history of early (\<55y) death from cardiovascular disease
* Known sensitivity to Sonovue contrast agent
* Known allergy or intolerance to any of the study ingredients
* Current use of any of the study ingredients

Primary outcomes:
measure: muscle microvascular blood flow
timeFrame: Baseline to 240 minutes
Secondary outcomes:
measure: muscle macrovascular blood flow
timeFrame: Baseline to 240 minutes
measure: central vascular blood flow
timeFrame: Baseline to 90 minutes
measure: cerebral blood flow
timeFrame: Baseline to 120 minutes
measure: endothelial function
timeFrame: Baseline to 120 minutes
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: Abbott Nutrition
name: Suzette Pereira, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02212340: Comparison Between Propofol-remifentanil Total Intravenous Anesthesia and Desflurane-remifentanil Balanced Anesthesia With Regard to Post-anesthetic Functional Recovery Measured With QoR-40 in Vitrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitrectomy Operation Under General Anesthesia
Keywords: propofol
desflurane
quality of recovery
vitrectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely used, and there are many clinical trials comparing these on various aspects of anesthesia. However, there have not been studies comparing the quality of recovery from the different methods of general anesthesia in vitrectomy. In this study, the investigators compare the functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40 questionnaire in vitrectomy.


Eligibility criteria: Inclusion Criteria:

1. Patients (20-80 years old) scheduled for vitrectomy surgery undergoing general anesthesia.
2. ASA 1-3

Exclusion Criteria:

1. Patients with allergy to anesthetic agents
2. Anticipated difficult airway
3. BMI \> 30 kg/m2
4. Chronic obstructive pulmonary disease
5. Heart failure 6. Unstable angina

Primary outcomes:
measure: QoR-40 score
timeFrame: at 6 hours later after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT05631340: The Effects Of Discharge Education Program On Recovery And Quality Of Life After Cardiac Surgery
Official title: The Effects Of Discharge Education Program On Recovery And Quality Of Life After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Surgery, Heart Surgery, Discharge Education, Nursing, Telenursing, m-Health, Quality of Life, Recovery
Keywords: Cardiac Surgery, Heart Surgery, Discharge Education, Nursing, Telenursing, m-Health, Quality of Life, Recovery
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: same follow up time
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to build a new discharge education, booklet and mobile application based, and assess it's efffects on recovery and quality of life in cardiac surgery patients. This is a randomised control trial. 12 weeks follow up will be done by phone calls.

Detailed description: Patients following cardiac surgery will be part of the study. Patients will be randomized in control and case groups. Control group receive standart discharge eduation from the nurses of the hospital, they will be interviewed by the researcher to gather general information and also information about recovery and quality of life. Case group will be given a discharge education by the researcher before discharge. After education patients will be given a booklet and a mobile application with the neccasary discharge information. Both groups will be followed for 12 weeks by monthly phone calls. In the last call recovery and quality of life will be reassesed.

Eligibility criteria: Inclusion Criteria:

* To agree to participate in the research,
* Open heart surgery patients
* Being 18 years or older,
* Being able to read, write, understand and communicate in Turkish,
* No vision, hearing and perception problems,
* Being conscious, oriented, cooperative and open to communication.

Exclusion Criteria:

• Having surgery other than open heart surgery

Primary outcomes:
measure: Recovery status after cardiac surgery
timeFrame: 12 weeks
measure: Quality of Life after cardiac surgery
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Univesity-Cerrahpasa Florence Nightingale Faculty of Nursing
state: Şişli
Study officials:
affiliation: Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing
name: Ayfer Özbaş
role: STUDY_CHAIR
References:
Clinical trial NCT00602940: Acupuncture for Polycystic Ovarian Syndrome
Official title: The Influence of Acupuncture on Ovulation and Reproductive Hormones
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
ovulation
hormones
women
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized control trial of acupuncture for women with polycystic ovary syndrome. The study is triple-blinded.


Eligibility criteria: Inclusion Criteria:

* ages 18-43
* confirmation of PCOS through the study
* signed informed consent
* able to receive study treatment at Virginia study sites
* agree not to use hormonal medications for the 5 months of the study

Exclusion Criteria:

* pregnant
* use of hormonal drugs 30/60 days before the study entry
* acupuncture for ovulatory disorders 30 days prior to study entry

Primary outcomes:
measure: ovulation in 2 out of 5 months of study participation
timeFrame: monthly
Secondary outcomes:
measure: changes in follicle stimulating hormone and luteinizing hormone
timeFrame: baseline vs. 2 months vs. 5 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: UVA OB/GYN Department
name: Lisa M Pastore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pastore LM, Patrie JT, Morris WL, Dalal P, Bray MJ. Depression symptoms and body dissatisfaction association among polycystic ovary syndrome women. J Psychosom Res. 2011 Oct;71(4):270-6. doi: 10.1016/j.jpsychores.2011.02.005. Epub 2011 Mar 23.