louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04819282: Mask Usage and Physical Performance During COVID-19 Pandemic in Geriatrics
Official title: Use of Surgical Masks in the COVID-19 Pandemic: Does it Affect Physical Performance in Geriatrics?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise Capacity
Geriatric
Mask
Keywords: Mask Usage
Geriatrics
Exercise Capacity
Physical Performance
Senior Fitness Test
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals over the age of 65

Brief summary: In the COVID-19 pandemic, the use of masks in daily life has become an important issue. The most important measure taken to prevent contagion is the use of masks. The aim of the study is to determine the effects of surgical masks used in every moment of life on physical performance in elderly individuals.

Detailed description: Physical performance measurements were carried out by a physiotherapist using the Senior Fitness Test (SFT). Participants were informed about the procedure of the test. All participants performed two evaluation sessions by the SFT with and without using a surgical mask. The participants were randomly selected to perform the test whether with or without the surgical mask at first. The sessions were held at least 24 hours apart to prevent fatigue.

Eligibility criteria: Inclusion Criteria:

* geriatrics who had a score of ≥24 in the Mini Mental Test
* which evaluates the cognitive levels of individuals over the age of 65
* who were sufficient to perform physical function tests
* who had not been diagnosed with COVID-19 before

Exclusion Criteria:

* participants with severe respiratory disease (tuberculosis, severe COPD or bronchiectasis),
* uncontrolled cardiac arrhythmia, unstable angina, heart failure, severe kidney disease, neurological disorders that could cause consciousness change
* whose disease could not be controlled with medication

Primary outcomes:
measure: Senior Fitness Test-Arm Curl
timeFrame: Baseline
measure: Senior Fitness Test-Chair Stand Up and Sitting
timeFrame: Baseline
measure: Senior Fitness Test-Chair Sit and Reach
timeFrame: Baseline
measure: Senior Fitness Test-Back Scratch
timeFrame: Baseline
measure: Senior Fitness Test-Eight Foot Up and Go
timeFrame: Baseline
measure: Senior Fitness Test-Two-Minute Step Test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
affiliation: Izmir University of Economics
name: Rıdvan Aktan
role: STUDY_CHAIR
affiliation: KTO Karatay University
name: Özlem Akkoyun Sert
role: STUDY_CHAIR
affiliation: KTO Karatay University
name: Melike Akdam
role: STUDY_CHAIR
affiliation: KTO Karatay University
name: Buse Kılınç
role: STUDY_CHAIR
affiliation: Dokuz Eylul University
name: Sevgi Özalevli
role: STUDY_CHAIR
References:
Clinical trial NCT03360682: Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients
Official title: Pilot Single-Arm Clinical Trial to Evaluate the Efficacy, PK Interactions and Safety of Dolutegravir Plus 2 NRTIs in HIV-1-Infected Solid Organ Transplant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV-1-infection
Solid Organ Transplant
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 20
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: The aims of this study are to obtain pharmacokinetic data on interactions between dolutegravir (DTG) and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Sirolimus and Mycophenolic acid) in solid organ transplant (SOT) recipients to provide proof of principle data that DTG plus 2 nucleosides (NUCs) is safe and effective in HIV-infected SOT recipients.


Eligibility criteria: Inclusion Criteria:

1. HIV patients \>18 years old who provide signed and dated informed consent;
2. Males and females;
3. SOT recipients (heart, liver or kidney);
4. On stable antiretroviral therapy (ART) for ≥6 months preceding the screening visit;
5. Plasma HIV RNA \<50 cop/ml for 12 months (2 tests separated by at least 12 months with no viral load \>50 between determinations);
6. Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing

Exclusion Criteria:

1. HIV patients who have stopped ART due to virological failure;
2. HIV patients who require treatment with DTG contraindicated medications;
3. History or presence of an allergy or intolerance to the study drug;
4. Active opportunistic infection;
5. Neoplasms requiring chemotherapy.
6. Pregnancy or breast feeding or planned pregnancy during the study period
7. Any other contraindication to study drugs.

Primary outcomes:
measure: Pharmacokinetic study
timeFrame: 24-hours before the switch and 24-hours 2 weeks after switching
Secondary outcomes:
measure: Viral resistance
timeFrame: week 48
measure: Changes in CD4+ cell
timeFrame: week 48
measure: Lipid profile
timeFrame: week 48
measure: Renal function
timeFrame: week 48
measure: Safety: number AEs and SAEs
timeFrame: week 48
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínico y provincial de Barcelona
Study officials:
affiliation: Hospital Clínico y provincial de Barcelona
name: Josep M Miró Meda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06743282: Senyo Health With Substance Use Disorder (SUD) in Primary Care
Official title: Senyo Health App - Connecting Primary Care to Substance Use Disorder Treatment Using a Telehealth Collaborative Care Platform
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Substance Use Disorders
Substance Abuse
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-12-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the barriers, facilitators, and optimal processes for implementing a digitally enhanced screening, brief intervention, and referral to treatment (SBIRT) model for Substance Use Disorder SUD treatment among Mayo primary care clinics.


Eligibility criteria: Inclusion Criteria:

* Ability to read, write, and understand English
* Minimum DAST (1+), audit-C score (3+)
* Access and willingness to use a mobile device for asynchronous (text) and synchronous (video) engagement with care.

Exclusion Criteria:

* Diagnosed personality pathology as the primary presenting concern based on clinical judgment, severe cognitive impairment (e.g., intellectual disability or dementia), or psychosis
* Inability to actively participate in and learn from psychotherapeutic interaction based on clinical evaluation and clinical judgment
* Needing a higher level of mental health care as demonstrated by ASAM32 assessment.
* Decline to answer suicidality questions.

Primary outcomes:
measure: Brief Substance Craving Scale (BSCS)
timeFrame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months
Secondary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Tyler Oesterle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01170182: Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition
Official title: A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study to Compare Omeprazole 40 mg DR Capsules Dr. Reddy's Laboratories Ltd.,With Prilosec® 40 mg Merck & Co., Inc.,USA Under Fed Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2010-07-27
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fed condition.

Detailed description: This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr. Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules) (manufactured by Merck \& Co., Inc., USA) in 54 healthy, adult, human subjects under fed conditions.

Eligibility criteria: Inclusion Criteria:

* Subjects who provided written informed consent.
* Subjects who were healthy within 18-45 years of age, weighing at least 50 kg.
* Body mass index of ≥18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
* Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I).
* Subjects with normal ECG, chest X-ray (PA view) and vital signs.
* Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

Primary outcomes:
measure: Bioequivalence based on Cmax and AUC parameters
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vimta Labs Limited, 142, IDA, Phase-II, Cherlapally, Hyderabad, India-500 051
name: Manoj K Bose, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06502782: Areal and Linear Comparison of Gingival Recession
Official title: Areal and Linear Comparison of the Effect of Gingival Phenotype on Gingival Recession
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gingival Recession
Keywords: Gingiva
Gingival recession
Screening
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study included 128 gingival recessions at 128 sites in 28 systemically healthy patients aged 18-45 years old. The patients were divided into two groups according to the thickness of the gingiva in the teeth with gingival recession.

Brief summary: Recent advances in digital technology have led to the emergence of precise methods for measuring gingival recession and tissue thickness. This study aimed to compare digital measurement methods and conventional periodontal probe measurements for the assessment of gingival recession influenced by the gingival phenotype.

This study involved 128 gingival recession sites from 28 systemically healthy patients aged 18-45 years. The participants were categorized into two groups on the basis of gingival thickness. The plaque index, gingival index, probing depth, clinical attachment level, gingival recession depth, and gingival recession width, and keratinized gingival thickness and width were measured using a manual periodontal probe and an intraoral optical surface scanner. Statistical analysis was performed with nonparametric tests because the data were not normally distributed. P\<0.05 indicated statistical significanct.


Eligibility criteria: Inclusion Criteria: The study included systemically healthy subjects aged 18-45 years with systemic disease or systemic disease under control.

Exclusion Criteria: The exclusion criteria were as follows:

* Patients with a history of radiotherapy,
* Patients with chemotherapy,
* Immunosuppressive use,
* Tobacco use,
* Smoking,
* Patients with labially exposed teeth and teeth with prominent root protrusions,
* Pregnancy and lactation,
* Patients with uncontrolled diabetes,
* Patients with postorthodontic extractions,
* Patients with gingival recession, .Patients with gingival enlargement caused by piercing and nail-biting habits.

Primary outcomes:
measure: keratinized gingival thickness
timeFrame: Baseline
measure: keratinized gingival width
timeFrame: Baseline
measure: Gingival recession depth
timeFrame: Baseline
measure: Gingival recession width
timeFrame: Baseline
Secondary outcomes:
measure: Plaque index
timeFrame: Baseline
measure: Gingival index
timeFrame: Baseline
measure: Bleeding on probing
timeFrame: Baseline
measure: Periodontal pocket depth
timeFrame: Baseline
measure: Clinical attachment level
timeFrame: Baseline
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal University
Study officials:
References:
Clinical trial NCT06059482: The Effect of Trunk Control on Sitting Balance and Upper Extremity Functions in Patients With Subacute Stroke
Official title: The Effect of Trunk Control on Sitting Balance and Upper Extremity Functions in Patients With Subacute Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: upper extremity
stroke
trunk control
sitting balance
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stroke

Brief summary: The study aims to examine whether trunk control affects sitting balance and upper extremity functions in patients with subacute stroke.

Detailed description: Patients who meet the inclusion and exclusion criteria will be informed about the study and the participants who agree to participate in the study will be given the "Mini-Mental Test" and "Brunnstrom Upper Extremity Staging" tests, respectively. Then, Trunk Impairment Scale, Trunk Control Test, Function in Sitting Test, and "Fugl Meyer Upper Extremity Test" will be applied respectively.

Thirty patients with stroke will included in the study. Trunk Impairment Scale and Trunk Control Test will used to assess trunk control assessment. Fugl-Meyer Assessment of the upper extremity will used to assess upper extremity. Function in Sitting Test will used to assess sitting balance. To evaluate between correlation trunk control and upper extremity and sitting balance will used to correlation analysis tests

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with stroke and being in the subacute period (stroke onset time is between 0-6 months),
* Over 18 years old,
* Mini-Mental Test score ≥ 24 points,
* Able to sit independently in a chair for 10 minutes
* To be able to understand and follow simple explanations.

Exclusion Criteria:

* Having been diagnosed with a brain stem or cerebellar stroke,
* Having neurological or orthopedic pathology,
* Having acute low back pain,
* Having undergone surgery in the last 6 months,
* Having neglect, aphasia and heminanopsis.

Primary outcomes:
measure: Trunk Impairment Scale
timeFrame: Baseline (First assessment)
measure: Trunk Control Test
timeFrame: Baseline (First assessment)
Secondary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: Baseline (First assessment)
measure: Function in Sitting Test (FIST)
timeFrame: Baseline (First assessment)
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
state: Merkez
Study officials:
affiliation: Kutahya Health Sciences University
name: Lütfiye AKKURT, PhD
role: STUDY_DIRECTOR
affiliation: Saglik Bilimleri Universitesi
name: Güllü A YAGCIOĞLU, PhD
role: STUDY_CHAIR
affiliation: Kutahya Health Sciences University
name: Cihan Caner AKSOY, PhD
role: STUDY_CHAIR
affiliation: Kutahya Health Sciences University
name: Fatıma YAMAN, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06198582: The Effect of Virtual Reality Based Task Specific Exercises in Patients With Hand Flexor Tendon Injury
Official title: Evaluation of the Effect of Virtual Reality Based Task Specific Exercises on Functional Level and Disease Related Quality of Life in Patients With Hand Flexor Tendon Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendon Injury - Hand
Flexor Tendon Rupture
Keywords: flexor tendon rehabilitation
virtual reality
task specific exercise
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 52
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: This study,the investigators aimed to investigate the effects of virtual reality-based task-specific exercises applied in addition to conventional rehabilitation program on functional level and disease-related quality of life in patients who underwent surgical repair due to flexor tendon damage due to traumatic hand injury.


Eligibility criteria: Inclusion Criteria:

* Tendon repair operation due to flexor tendon injury in one hand
* Admission to the Traumatic Hand Rehabilitation Outpatient Clinic of Ankara City Hospital Physical Medicine and Rehabilitation Hospital within the first postoperative week and enrolled in an early passive mobilization program
* Must be in the sixth post operative week

Exclusion Criteria:

* Under 18 years of age
* Concomitant extensor tendon injury
* Having any accompanying orthopedic, neurologic, rheumatologic and vascular problems in the premorbid period
* Presence of cognitive deficit
* Presence of visual field deficit
* Presence of postural instability
* Presence of epilepsy and/or cyber disease

Primary outcomes:
measure: Change in short form-36 (SF-36) scores
timeFrame: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
measure: The functional level of dexterity and coordination
timeFrame: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
measure: Dexterity-related activity limitations in activities of daily living
timeFrame: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
Secondary outcomes:
measure: Grip strength
timeFrame: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
measure: Change in active range of motion
timeFrame: Pre-intervention (postoperative sixth week), immediately after the intervention (postoperative tenth week)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
References:
Clinical trial NCT00282620: Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.
Official title: The Adjuvant Magnesium Trial (AdMag): Assessment if the Impact of Oral Magnesium on ICD Firing and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arrhythmia
Quality of Life
Hypomagnesemia
Keywords: Implantable Cardioverter Defibrillator
Magnesium
Electrocardiogram
Ventricular Arrhythmia
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2006-01-27
Enrollment: 240
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: This study is being conducted to see if magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life.

Detailed description: Not all ICD shocks are for ventricular arrhythmias. Some patients receive shocks when they have arrhythmias in the atria (top chambers of the heart). These are called inapproriate shocks, but the pain is similar to the pain patients feel with an appropriate shock (a shock for a ventricular arrhythmia). This study is being conducted to determine if taking magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life. Magnesium's impact of the electrocardiogram (ECG) and intracellular magnesium concentrations will also be studied.

Comparison: Magnesium compared to placebo in patients with ICDs to evaluate the number of ICD shocks and patient perceived quality of life.

Eligibility criteria: Inclusion Criteria:newly implanted ICD or recent ICD shock (within 6 months) -

Exclusion Criteria:inability to swallow, a non-cardiac disease with a survival prognosis of less than 12 months, hypermagnesemia, a creatinine clearance less than 30mL/min, lactic acidosis or systemic acidosis syndrome, or previous intolerance to magnesium L-lactate.

-

Primary outcomes:
measure: Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months
Secondary outcomes:
measure: Change in QTc interval in the total population and the subgroup receiving class III antiarrhythmics at baseline, 3, 6, 9, 12 months.
measure: Intracellular magnesium concentrations at baseline, 3 and 12 months
measure: Incidence of supraventricular arrhythmias, ventricular arrhythmias, and sinus tachycardias at baseline, 3,6,9,12 months.
measure: Ventricular fibrillation cycle length and the variability in VFCL at baseline, 3,6,9,12 months
measure: Adverse events at basline, 3,6,9,12 months. Total Hospital Costs and Cost-effectiveness.
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Jeffrey Kluger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05875831: Comparison Of Coughing and Active Cycle of Breathing Technique to Improve Pulmonary Functions in Post-Surgical Patients
Official title: Comparison Of Coughing and Active Cycle of Breathing Technique to Improve Pulmonary Functions in Post-Surgical Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Surgical
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To find out the Comparison Of Coughing and Active Cycle of Breathing Technique to Improve Pulmonary Functions in Post-Surgical Patients


Eligibility criteria: Inclusion Criteria:

* Both male and female between the age of 18-50 years who reported post-surgical complications related to pulmonary will be selected in this study

Exclusion Criteria:

* If patient is unresponsive, psychologically disturbed and does not want to participate, teenagers will be excluded from this study

Primary outcomes:
measure: Spirometry-related questions
timeFrame: 6 Months
measure: surgical Related Questioner
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital
state: Punjab
Study officials:
References: