louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05691946: Acute Effects of Kinesiology Taping in Handball Players
Official title: Acute Effects of Kinesiology Taping On Functional Performance And Physical Parameters In Handball Players: Randomised Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kinesiology Taping
Keywords: muscle strength
proprioception
handball players
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised placebo-controlled with pretest-posttest both groups.
Primary purpose: SCREENING

Brief summary: The aim of this randomised placebo-controlled study was to investigate the acute effect of kinesiology taping in the gastro-soleus muscle group of handball players.

Researchers compared the placebo and the kinesiology taping groups to see if there were any effects on foot plantar and dorsiflexion muscle strength, balance, proprioception, horizontal jumping and injury proneness.

Detailed description: This randomised placebo-controlled and double blinded study aimed to investigate the acute effect of kinesiology taping in the gastro-soleus muscle group, which has the key role in jumping, of handball players on foot plantar and dorsiflexion muscle strength, balance, proprioception, horizontal jumping and injury proneness. There were two groups in the study: the experimental group was applied 'Y shaped' kinesiology taping on gastro-soleus muscle group, based on facilitation technique with 25-50% stretching. The control (placebo) group was applied kinesiology taping on gastro-soleus muscle group without any stretching. Participants' muscle strength, proprioception, balance, horizontal jumping and injury proneness was measured before and two hours after taping.

Eligibility criteria: Inclusion Criteria:

* Licensed handball player
* Volunteer to participate the study

Exclusion Criteria:

* Any discomfort that is contraindicated for the measurements
* Have suffered any injury in the last 6 months

Primary outcomes:
measure: Muscle strength
timeFrame: 2 hours
measure: Proprioception
timeFrame: 2 hours
Secondary outcomes:
measure: Horizontal jump performance
timeFrame: 2 hours
measure: Balance
timeFrame: 2 hours
measure: Injury proneness
timeFrame: 2 hours
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya University
Study officials:
References:
Clinical trial NCT03726346: The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea
Official title: The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2018-10-31
Enrollment: 39
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Pulmonary Disease Specialists Research database.

Detailed description: Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F\&P Toffee mask for use in home. The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the Toffee mask in home will be 14 ± 4 days from visit two. The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 2 weeks of the beginning of the study.

Eligibility criteria: Inclusion Criteria:

* Adult (22+ years of age)
* Able to give informed consent
* Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
* Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
* Fluent in spoken and written English
* Existing OSA mask user

Exclusion Criteria:

* Inability to give informed consent
* Participant intolerant to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
* Pregnant or may think they are pregnant.

Primary outcomes:
measure: Toffee Mask Acceptability
timeFrame: 14±4 days in home
measure: Toffee Mask Comfort
timeFrame: 14±4 days in home
measure: Toffee Mask Treatment Seal Performance-Subjective
timeFrame: 14±4 days in home
Secondary outcomes:
measure: Toffee Mask Treatment Performance-Objective
timeFrame: 14±4 days in home
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Pulmonary Disease Specialists
state: Florida
Study officials:
affiliation: Research Director
name: Catherine Goodwin
role: STUDY_DIRECTOR
affiliation: Pulmonologist
name: Thomas O'Brien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002146: Safety and Efficacy of Intravenous Magnesium Sulfate in Modulating Changes in Symptoms and Divalent Cation Levels Associated With Foscavir Therapy: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Pilot Study
Official title: Safety and Efficacy of Intravenous Magnesium Sulfate in Modulating Changes in Symptoms and Divalent Cation Levels Associated With Foscavir Therapy: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cytomegalovirus Infections
HIV Infections
Hypocalcemia
Keywords: Infusions, Intravenous
Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Magnesium Sulfate
Magnesium Deficiency
Hypocalcemia
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine whether acute ionized hypomagnesemia and hypocalcemia immediately following foscarnet infusions can be lessened or eliminated by prior infusion of magnesium sulfate. To determine whether reductions in ionized magnesium, ionized calcium, and parathyroid hormone levels following foscarnet infusions are lessened by preinfusion of magnesium sulfate. To evaluate the safety of intravenous magnesium sulfate prior to foscarnet infusion by monitoring blood pressure, heart rate, and heart rhythm. To characterize the effect of magnesium sulfate on foscarnet blood levels and urinary excretion of calcium, magnesium, phosphate, and foscarnet.

Detailed description: Patients are randomized to one of four treatment groups. Intravenous foscarnet is administered for 4 days. Patients receive one of three doses of magnesium sulfate or placebo in normal saline according to one of four schedules. Sequence of doses will differ for each group.

Eligibility criteria: Inclusion Criteria

Patients must have:

* AIDS by CDC criteria.
* Documented CMV disease.
* Tolerance of foscarnet dose of 90 mg/kg bid.
* Normal serum calcium, serum creatinine, and serum phosphate.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known allergy to Foscarnet.
* In extremis or incapacitated because of underlying illness (e.g., comatose or tracheally intubated).
* Volume depletion.

Concurrent Medication:

Excluded:

* Nephrotoxic drugs such as IV pentamidine, amphotericin B, aminoglycosides, and cisplatin.
* Other investigational drugs that affect metabolic balance, such as human growth hormone.
* Oral or parenteral magnesium and calcium supplementation.

Patients with the following prior condition are excluded:

History of heart block.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma City Veterans Administration Med Ctr
state: Oklahoma
Study officials:
References:
Clinical trial NCT00724646: Perspectives on End-of-Life Care for Medically-Fragile Children and Young Adults
Official title: Direct Care Staff and Parents'/Legal Guardians' Perspectives on End-of-Life Care in a Long-Term Care Facility for Medically Fragile and Intellectually Disabled Pediatric and Young Adult Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
Keywords: parents
medically fragile
death
end-of-life care
surveys
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents/ legal guardians and habilitation assistants

Brief summary: Hattie Larlham is a specialized long-term care facility for pediatric and young adult residents who are medically fragile and intellectually disabled, whose daily care is provided by direct care staff, Habilitation Assistants (HA), in conjunction with nurses and other direct care providers. The purpose of this study is to assess the perspectives of HA and parents/legal guardians on end-of-life care in a long-term care facility for pediatric and young adult residents who are medically fragile and intellectually disabled.


Eligibility criteria: Inclusion Criteria:

* HA at Hattie Larlham between January 1, 2006 to present
* HA provided care to \> 1 resident whose death occurred between January 1, 2006 through the end of the study period
* HA provided ongoing care to the resident for at least 5 days in the last 30 days at Hattie Larlham before the resident's death
* Parent/legal guardian of a Hattie Larlham resident whose death occurred between January 1, 2006 through the end of the study

Exclusion Criteria:

* HA employed \< 30 days at Hattie Larlham or cared for resident \<5 days in last 30 days prior to the resident's death
* HA or parent/legal guardian who has not experienced a Hattie Larlham resident's death since December 31, 2005

Primary outcomes:
measure: Participants' responses to survey questions.
timeFrame: Start of Study
Secondary outcomes:
measure: Participants' responses to focus group discussions.
timeFrame: End of study
Other outcomes:
Locations:
city: Mantua
country: United States
facility: Hattie Larlham Center for Disabled Children
state: Ohio
Study officials:
affiliation: Hattie Larlham Center for Disabled Children
name: Richard Grossberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brazil K, McAiney C, Caron-O'Brien M, Kelley ML, O'Krafka P, Sturdy-Smith C. Quality end-of-life care in long-term care facilities: service providers' perspective. J Palliat Care. 2004 Summer;20(2):85-92.
citation: Contro N, Larson J, Scofield S, Sourkes B, Cohen H. Family perspectives on the quality of pediatric palliative care. Arch Pediatr Adolesc Med. 2002 Jan;156(1):14-9. doi: 10.1001/archpedi.156.1.14.
citation: Vohra JU, Brazil K, Szala-Meneok K. The last word: family members' descriptions of end-of-life care in long-term care facilities. J Palliat Care. 2006 Spring;22(1):33-9.
Clinical trial NCT01301846: Participation of Manual Wheelchair Users in the Community
Official title: Participation of Manual Wheelchair Users in the Community: The Relationship to Wheelchair Skills Capacity
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Wheelchairs
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of people who use manual wheelchairs

Brief summary: To explore the relationship between ability to do different wheelchair skills and the participation and quality of life of wheelchair users in and around their home and community. The investigators study hypothesis:

1. Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is strongly related to self-reported participation.
2. Self-reported capacity of wheelchair skills (ability to do wheelchair skills) is related to the average daily distance traveled in their wheelchair.


Eligibility criteria: Inclusion Criteria:

* have a manual wheelchair for home and community use;
* use a manual wheelchair at least once a week;
* have a minimum of 3 months experience using a manual wheelchair outside the hospital setting;
* be over the age of 18;
* be able to read and understand English and follow verbal and visual instructions;
* be competent to give informed consent;
* be willing to take part in the study, including signing the consent after carefully reading it;
* not have been under significant bed rest for the past month.

Primary outcomes:
measure: Wheelchair Skills Test Questionnaire Capacity Version
timeFrame: baseline
measure: Impact on Participation and Autonomy Questionnaire
timeFrame: baseline
measure: Average Distance Travelled
timeFrame: Up to a week time period, one time measure
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale short form
timeFrame: baseline
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Rehabilitation Centre
state: Nova Scotia
Study officials:
References:
Clinical trial NCT02245646: Distortion Product After Stapedotomy Surgery
Official title: Subjektiv Verzerrter Höreindruck Nach Stapedotomie
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distorted Sound Perception
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2014-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control group: Healthy volunteers are recruited by flyers that are displayed in the waiting zones of the ENT clinic.

Subjects with stapedotomy: Patients are being asked by the examining MD as soon as the indication for stapedotomy is proven.

Brief summary: This study aims at capturing for the first time at which frequencies and sound intensities hearing distortions are perceived after successful stapedotomy surgery. Also, the portion of patients perceiving these sound distortions and the length of time over which the distortions occur are assessed.

Detailed description: If the stapes footplate is fixed in position, e.g. by otosclerosis, rather than being normally mobile, a conductive hearing loss results. This conductive hearing loss is usually compensated with hearing aids or through stapedotomy. During stapedotomy, the diseased stapes bone is removed and is replaced with a piston prosthesis that conveys the sound stimulus from the incus to the footplate of the removed stapes.

After surgery subjects sometimes state that the quality of sound is suboptimal, even though their hearing ability has improved significantly. Some subjects subjectively hear distorted sounds, which often disappear several weeks after surgery.

This study aims at capturing for the first time at which frequencies and sound intensities these distortions are perceived. Additionally, the portion of patients perceiving these sound distortions and the length of time over which the distortions occur are assessed.

Eligibility criteria: Inclusion Criteria:

* indication for stapedotomy
* written consent given

Exclusion Criteria:

* not mentally able to give written consent

Primary outcomes:
measure: Change of distorted sound perception after stapedotomy surgery
timeFrame: 7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery
Secondary outcomes:
measure: Questionnaire on quality of hearing after Stapedotomy (APOSE)
timeFrame: 7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Zurich University Hospital, Division of Otorhinolaryngology, Head and Neck Surgery
Study officials:
affiliation: USZ
name: Alexander Huber, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT06193746: Laser Efficiency on Metabolic Parameters
Official title: Effect of Non-invasive on Lipid Metabolism and Renal Out Comes in Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: the study population selected from out patient of Berket El-haje medical center suffering from metabolic syndrome

Brief summary: Non-invasive laser therapy is laser blood irradiation improves many metabolic parameters. So, this study aims to assess the impact of Non-invasive laser therapy on lipid metabolism and renal out comes

Detailed description: The metabolic syndrome is a constellation of interrelated metabolic risk factors especially central obesity, dyslipidemia, hyperglycemia, which all affect worse their kidney function, and all of this causing mortality. This time line requires a quick procedure that will enable us to implement safe and non-invasive therapeutic instruments adjacent therapy for metabolic syndrome cases.

Eligibility criteria: Inclusion Criteria:

* The patients have Metabolic syndrome, started more than one year ago.
* BMI ranged 30- 35Kg/m2.
* They are on medical therapy for more than one year.
* Clinically stable.

Exclusion Criteria:

* taking specific drugs uncontrolled diseases
* cardiovascular instability
* sever e autonomic neuropathy
* infection wound,
* burn, allergy or another external injury
* hypothyroidism
* hemorrhagic disorders
* history of cancer
* pregnant women,
* mental illness as schizophrenia or dementia.

Primary outcomes:
measure: lipid profile change
timeFrame: 12 weeks following end of treatment
measure: glomerular function range change
timeFrame: 12 weeks following end of treatment
measure: creatinine change
timeFrame: 12 weeks following end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Toka
Study officials:
References:
Clinical trial NCT04914546: A Study of LY3819469 in Healthy Participants
Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3819469
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-06-04
Enrollment: 66
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: BASIC_SCIENCE

Brief summary: This is a 2-part study. In Part A, the main purpose is to evaluate the safety and tolerability of the study drug LY3819469 in healthy participants with high lipoprotein (a) \[Lp(a)\] levels. How the body processes the study drug and the effect of the study drug on blood Lp(a) levels will also be investigated. Part B will mainly evaluate the safety and tolerability of LY3819469 as well as how the body processes the study drug in Japanese participants. The study may last up to 53 and 29 weeks for each participant in Parts A and B, respectively.


Eligibility criteria: Inclusion Criteria:

* Female participants must not be able to get pregnant and male participants must agree to adhere to contraception restrictions
* Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²)
* For Part B, participants should be of first-generation Japanese origin

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days
* Are heavy alcohol drinkers or heavy cigarette smokers
* Have donated blood of more than 500 milliliters (mL) in the last 3 months

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Week 49
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3819469
timeFrame: Predose through Day 15
measure: PK: Maximum Observed Drug Concentration (Cmax) of LY3819469
timeFrame: Predose through Day 15
measure: Pharmacodynamics (PD): Change From Baseline in Fasting Lp(a)
timeFrame: Baseline up to Week 49
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles, Inc
state: California
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01446146: Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: Posttraumatic Stress Disorder
PTSD Treatment
Decision making
Veterans
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
Collaborators: name: South Central VA Mental Illness Research, Education & Clinical Center
First posted: 2011-10-05
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this program is to compare two different methods of matching a Veteran to a PTSD treatment.

Detailed description: Posttraumatic Stress Disorder (PTSD) is a serious disorder that affects many Veterans who have had a traumatic experience. The VA offers several different types of treatment for PTSD. We are researching different ways to match a Veteran to a type of treatment. Participants in this study will will be randomly assigned to either a 40-minute session in which they will learn about PTSD treatments and select a preferred treatment or to a 40-minute assessment interview. Those participants assigned to the assessment interview will have the opportunity to work with their Trauma Recovery Program provider to determine a plan for their PTSD treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of combat-related PTSD
* Newly enrolled in Trauma Recovery Program (TRP) at the Michael E. DeBakey VA medical center
* TRP provider approval

Exclusion Criteria:

* Previous participation in TRP treatment for PTSD

Primary outcomes:
measure: Treatment participation
timeFrame: 4 months
Secondary outcomes:
measure: Treatment satisfaction
timeFrame: 4 months
measure: Change in PTSD severity
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: MDVAMC, BCM, SC MIRECC
name: Juliette M Mott, PhD
role: PRINCIPAL_INVESTIGATOR
References: