louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05524636: Effects of Peripheral Magnetic Stimulation
Official title: Effects of Abdominal Wall Muscle Training With or Without Additional Peripheral Magnetic Stimulation on Subcutaneous Fat, Muscle Strength and Postural Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: subcutaneous fat, magnetic stimulation, abdominal muscles
Lead sponsor: University of Primorska
Sponsor class: OTHER
Collaborators: name: Fotona d.o.o.
First posted: 2022-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental and control group
Primary purpose: TREATMENT

Brief summary: Interventional study of the effectiveness of peripheral magnetic stimulation of the abdominal wall muscles in healthy individuals.

Detailed description: Interventional 8-week study of the effectiveness of peripheral magnetic stimulation of the abdominal wall muscles in healthy individuals. The study will include an experimental and a control group.

Eligibility criteria: Inclusion Criteria:

* healthy adults
* BMI between 25,0 and 29,9 kg/m2
* stable body mass with maximal variation of body mass of 2.2 kg a month prior to the inclusion in the study
* waist circumference above 80 cm for females and above 90 cm for males

Exclusion Criteria:

* invasive fat reduction procedures (e.g., liposuction and mesotherapy)
* weight loss supplements in the month prior to the participation in the study
* metal implant
* active implanted electrical device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system

Primary outcomes:
measure: Change in subcutaneous fat
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement
measure: Change in maximum isometric peak torque
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement
measure: Change in sitting postural control
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska
state: Primorska
Study officials:
affiliation: Fakulteta za vede o zdravju
name: Nejc Šarabon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00121849: Safety Study to Evaluate the Leish-111f + MPL-SE Vaccine in the Prevention of Cutaneous Leishmaniasis in Healthy Subjects Previously Exposed to the Leishmania Parasite
Official title: A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Leish-111f + MPL-SE Vaccine in Montenegro Skin Test-Positive Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cutaneous Leishmaniasis
Keywords: Leishmaniasis,
Subunit Vaccine,
Prevention,
T cell
Lead sponsor: Access to Advanced Health Institute (AAHI)
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2005-07-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult subjects with a previous exposure to the Leishmania parasite (but without current or past history of leishmaniasis).

Detailed description: Cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of Leishmania disease. All available medical therapies require weeks of treatment and cause significant toxicity. It appears that Leishmania infections can be eliminated or prevented by T helper 1 immune responses. These findings argue that a vaccine that generates a T helper 1 response against the parasite will prevent the infection and disease. This is a phase 1, open-label study to evaluate the safety, tolerability and immunogenicity in Montenegro skin test (MST)-positive healthy adults of an investigational vaccine being developed for the prophylaxis of cutaneous leishmaniasis. The vaccine, identified as Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f, 10 μg) together with the adjuvant MPL-SE (25 μg). The vaccine will be given to each study subject three times at 4 week intervals.

Eligibility criteria: Inclusion Criteria:

* Must have positive Montenegro skin test (reaction \>5 mm)
* Must be in good general health with normal lab values
* Negative for HIV, hepatitis B and C

Exclusion Criteria:

* History of leishmaniasis or exposure to Leishmania vaccine or MPL-SE.
* Pregnant or nursing female

Primary outcomes:
measure: Adverse events
measure: Dose-limiting toxicities: hematology and serum chemistries at Screening and Days 7, 35, 63, and 84
Secondary outcomes:
measure: IgG and T-cell responses to the Leish-111f protein: immunological evaluations at Days 0, 84, and 168
measure: Skin test reactivity to the Leish-111f protein at Days 0, 84, and 168
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Programa de Estudio y Control de Enfermedades Tropicales (PECET)
Study officials:
affiliation: PECET, Medellin, Colombia
name: Iván D Vélez Bernal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01913249: Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula
Official title: Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula, a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anorectal Fistula
Keywords: Anorectal fistula
LIFT
Seton
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare short term (3 week) with long term (6 months) treatment with seton prior to LIFT surgery. The main end-points are recurrence rates and complication rates after surgery.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 65 years
* Complex anal fistula defined as

  * anterior fistulas in women
  * branched fistulas
  * fistulas in patients with anal incontinence
  * fistulas traversing more than 30% of the anal sphincter and therefore unsuitable for simple division.

Exclusion Criteria:

* Crohn's disease in the rectum
* Previous LIFT surgery on same side
* Patient already treated with seton \> 3 weeks
* Not able or willing to sign informed consent

Primary outcomes:
measure: Recurrence rate
timeFrame: 1 year
measure: Complication
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hamar
country: Norway
facility: Sykehuset Innlandet
Study officials:
References:
Clinical trial NCT02467049: ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip
Official title: ECG Versus Ultrasound-guided Positioning of the Peripherally Inserted Central Catheter (PICC) Tip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Cancer
Malnutrition
Keywords: ECG
Ultrasound
Peripherally Inserted Central Catheters
PICC
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 10
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: In the prevention of thrombosis related to catheter placement it is important to have a right position of the catheter tip. Therefor we want to assess which technique is the most successful in the placing of a PICC.

Detailed description: This is a randomised prospective single blinded study. All adult patients with an indication for PICC placement can be included. Patients will be randomised into two groups, one with ECG-guided placement followed by ultrasound control and the other with only ultrasound guided placement. After placement, in both groups, control radiography of the chest will be done which will be interpreted by an independent radiologist. For the ECG-guided group the ultrasound control of the tip position will be done by an independent, blind operator, after placement. For the only ultrasound guided placement group, the ultrasound will be done by a second operator during placement.

Eligibility criteria: Inclusion Criteria:

* All adults with indication for PICC

Exclusion Criteria:

* Age \<18y
* Pregnant women

Primary outcomes:
measure: Number of participants with correct placement in the superior caval vein during PICC insertion, after either ECG or ultrasound guided insertion
timeFrame: Whitin 5 minutes after catheter-placement
Secondary outcomes:
measure: Duration of PICC-placement by ECG-guidance versus ultrasound-guidance
timeFrame: within 5 minutes
measure: frequency of necessity of replacement after chest-x-ray control
timeFrame: 1 day
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
affiliation: Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
name: Lucie Choustoulakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
name: Jan Poelaert, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Anaestesiology and Perioperative Medicine Acute and Chronic Pain Therapy.
name: Matthias Raes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02309749: CAP Pilot Study for Obstructive Sleep Apnea (OSA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sleep laboratory, DME supplier

Brief summary: This is a pilot to review the feasibility of a program that assists patients towards therapy compliance by scheduled intervention through the first month of therapy. The hypothesis of this study is that the trial program will function as intended and average patient adherence will be over 4 hours per night.


Eligibility criteria: Inclusion Criteria

* 21 to 75 years of age
* Diagnosed with OSA (AHI \>5 events/hour) and eligible for Continuous Positive Airway Pressure (CPAP) treatment under local requirements
* Must be initiated on program (i.e. received their device) within 12 weeks of CPAP titration study
* Naïve to CPAP therapy, i.e have not been prescribed CPAP in the past
* Access to a cellphone

Exclusion Criteria:

* Contraindicated for CPAP therapy
* Medically unstable condition/diagnosis that is not yet under control
* Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
* Periodic Leg MOvement Arousal Index greater than 15/hr
* Home titration of longer than 5 days

Primary outcomes:
measure: Accuracy of delivery of SMS messages to participant
timeFrame: 30 days
Secondary outcomes:
measure: Participant CPAP Adherence
timeFrame: 30 nights
Other outcomes:
Locations:
city: St Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: San Antonio
country: United States
facility: Sleep Therapy Research Center
state: Texas
Study officials:
References:
Clinical trial NCT00972049: Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects
Official title: A Phase I, Single-centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics After Oral Single Ascending Doses of AZD2516 in Young and Elderly Japanese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
AZD2516
pain
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose to Japanese healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Weight between 45 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2
* Japanese males aged between 20 to 45 years old (young) and Japanese males or females aged between 65 to 80 years old (elderly)

Exclusion Criteria:

* History of previous or ongoing somatic or psychiatric disease/condition
* Abnormalities in ECG that may interfere with interpretation of data.

Primary outcomes:
measure: Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG
timeFrame: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 3 and follow up visit 3
Secondary outcomes:
measure: Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects
timeFrame: Blood sampling at defined timepoints during residential period and follow-up
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Södertälje
name: Anders Neijber, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kyusyu Clinical Phramacology Research Clinic
name: Shunji Matsuki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06077149: Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF)
Official title: A Comparison of Immunogenicity of Licensed RSV Vaccines in Residents of Long-Term Care Facilities (LTCF) to Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Respiratory Syncytial Virus (RSV)
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 152
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This clinical trial is studying the newly licensed RSV vaccines in adults over age 60 years living in long-term care facilities (nursing homes) by comparing the immune response to their vaccine to adults over age 60 years living in the community.


Eligibility criteria: Inclusion Criteria:

* ≥60 years of age who live in skilled nursing facilities or reside independently in the community
* Life expectancy of \>6 months, as assessed by the investigator
* Able to sign informed consent or to provide consent via a legally authorized representative (LAR)

Exclusion Criteria:

* History of a current immunosuppressive condition or receipt of chemotherapy or other immunosuppressive or cytotoxic therapy, including chronic prednisone use of ≥ 20 mg/day for more than 14 days within 3 months of study vaccination
* History of hypersensitivity or reaction to any vaccine component
* Simultaneous administration of another vaccine (influenza, SARS-CoV-2) or within a 14-day window before or after intervention
* Previous receipt or intended receipt of an RSV vaccine outside the study
* Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
* Documented RSV infection within 2 months prior to study intervention.

Primary outcomes:
measure: mean peak serum neutralizing antibody against RSV
timeFrame: 1 month
Secondary outcomes:
measure: mean peak serum binding antibody to RSV prefusion F protein against RSV A & B
timeFrame: 1 month
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05351749: Implementing Prescriber-Pharmacist Collaborative Care for Evidence-based Anticoagulant Use
Official title: Implementing Prescriber-Pharmacist Collaborative Care for Evidence-based Anticoagulant Use
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Venous Thromboembolism
Atrial Fibrillation
Keywords: Prescribing alerts
Anticoagulation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-04-28
Enrollment: 306
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The researchers hypothesize that existing-prescription notifications directed to pharmacists are more likely to lead to a prescription change than existing-prescription notifications directed to prescribers. Furthermore, the researchers hypothesize that the availability of a pharmacist referral option is associated with a higher rate of prescription changes for initial-prescription alerts that are directed to the prescriber at the time of initial-prescribing errors.

Findings from this project will establish a framework for implementing prescriber-pharmacist collaboration for high risk medications, including anticoagulants

Detailed description: Please note that the 3rd and 4th outcome measures are conditional on the outcomes of the 1st and 2nd outcome measures respectively.

Please note that enrollment of 300 will provide sufficient power to study.

Eligibility criteria: Prescribers:

Inclusion Criteria:

* Michigan Medicine provider with prescribing privileges
* Providers in ambulatory care settings
* Prescribe DOAC to patients 18 years and older

Exclusion Criteria:

* Providers in inpatient settings
* Providers who are members of the study team

Primary outcomes:
measure: The number (proportion) of notifications (in the existing-prescription notification conditions) that are addressed within 7 days.
timeFrame: Up to 7 days
Secondary outcomes:
measure: The number (proportion) of alerts (in the newly prescribed DOAC alert conditions) that are addressed within 7 days.
timeFrame: Up to 7 days
measure: Change in effect size for the existing-prescription notification over time
timeFrame: Month 0, Up to 18 months
measure: Change in effect size for the initial alert over time
timeFrame: Month 0, Up to 18 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Geoffrey Barnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884649: Fetuin A in Hashimoto Thyroiditis
Official title: Fetuin A as a New Marker of Inflammation in Hashimoto Thyroiditis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hashimoto Thyroiditis
Keywords: Acute phase reactant, fetuin A, Hashimoto thyroiditis
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 97
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients ≥ 20 years of age being followed up at the outpatient clinics of the Internal Medicine Department in Medeniyet University Goztepe Training and Research Hospital and fulfilling the below mentioned criteria were included in the study

Brief summary: Fetuin-A levels are reported to be low as a negative acute phase reactant in systemical inflammatory situations. Hashimoto thyroiditis is characterized with inflammation. In this study, we hypothesised that the serum fetuin A levels could be found to be low due to inflammation in patients with Hashimoto thyroiditis

Detailed description: Patients ≥ 20 years of age being followed up at the outpatient clinics of the Internal Medicine Department in Medeniyet University Goztepe Training and Research Hospital and fulfilling the eligibility criteria will be included in the study. Approval of the local ethics committee and informed consent of the participants will be received for the study. The study is conducted in accordance with the Declaration of Helsinki. Demographic characteristics, concomitant diseases, smoking and alcohol drinking habits, concomitant medication usage, anthropometric and biochemistry data of the eligible patients will be recorded. Patient group will consist of patients with newly diagnosed Hashimoto thyroiditis and the control group will consist of healthy volunteers.

Groups will be compared according to their demographic, an¬thropometric and biochemistry data and serum fetuin-A levels. In order to detect the relationship between the serum fetuin-A levels and clinical features, correlation analyses will be done.

Eligibility criteria: Inclusion Criteria:

* patients newly diagnosed with Hashimoto thyroiditis

Exclusion Criteria:

* Acute infection
* Acute or chronic inflammatory disease
* Anti-inflammatory treatment (non-steroidal anti-inflammatory, corticosteroids etc.)
* Hypoxic situations (chronic obstructive pulmonary disease etc.)
* Severe heart, kidney and liver disease
* Pregnancy
* Endocrine disorders
* Malignancy
* Usage of drug that affects thyroid hormone levels

Primary outcomes:
measure: Comparison of serum fetuin A levels between patients with Hashimoto thyroiditis and healthy subjects
timeFrame: 1 day (The blood samples were obtained on the same day participants arrived to outpatient clinics.)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: