louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01126723: Effects of Tai Chi on Frailty in Elderly Adults
Official title: The Effects of Tai Chi on the Nonlinear Dynamics of Frailty in Elderly Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2010-05-20
Enrollment: 66
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is determine the effects of Tai Chi exercise, as compared to an education-based control intervention, on cardiovascular and balance system function in older people at risk of developing frailty. We hypothesize that long-term Tai Chi training will improve specific nonlinear properties associated of cardiovascular and balance dynamics in this population.


Eligibility criteria: Inclusion Criteria:

* Men and women over age 70 will be included if they are able to stand and walk unassisted, are free of any acute or unstable medical conditions, and are able to understand directions and participate in the protocol.

Exclusion Criteria:

* Potential subjects will be excluded 1) if they cannot stand and ambulate unassisted, 2) are experiencing any symptomatic cardiovascular or respiratory disease, or have 3) a myocardial infarction or stroke within 6 months, 4) painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility, 5) systolic BP above 160 or diastolic BP above 100 mm Hg, 6) a cardiac pacemaker, 7) Parkinson's Disease or other neuromuscular disorder, 8) metastatic cancer or immunosuppressive therapy, or 9) have significant visual impairment.

Primary outcomes:
measure: Frailty Index
timeFrame: post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Roslindale
country: United States
facility: Hebrew Rehabilitation Center
state: Massachusetts
Study officials:
affiliation: Hebrew Rehabilitation Center
name: Lewis Lipsitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06625723: Analysis of Sleep & Recovery Following Rotator Cuff Repair Surgery
Official title: Investigating the Impact of a Sleep Aid on Sleep and Recovery Following Rotator Cuff Repair Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Rotator Cuff Injuries
Shoulder Pain
Shoulder Injuries
Shoulder Impingement
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two treatment arms, one standard postoperative protocol following rotator cuff repair surgery. The second arm with the same protocol, with the addition of the sleep assistive device.
Primary purpose: TREATMENT

Brief summary: Postoperative recovery following a rotator cuff repair surgery can be challenging. In particular, sleeping is difficult given the restrictions of the operative shoulder. This study aims to evaluate a postoperative sleep device that will allow for safe and comfortable positioning of the arm, with the anticipated effect to improve postoperative recovery and sleep.

Detailed description: Postoperative recovery following a rotator cuff repair surgery can be challenging. In particular, sleeping is difficult given the restrictions of the operative shoulder. This study aims to evaluate a postoperative sleep device that will allow for safe and comfortable positioning of the arm, with the anticipated effect to improve postoperative recovery and sleep.

Eligibility criteria: Inclusion Criteria:

* Rotator Cuff Tear

Exclusion Criteria:

* Prior ipsilateral shoulder surgery
* Ipsilateral upper extremity neurological deficit

Primary outcomes:
measure: Narcotic Use
timeFrame: Daily
measure: Patient Reported Sleep Quality
timeFrame: 3 months
Secondary outcomes:
measure: Sleep Data
timeFrame: 3 months
measure: Sleep Data
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02368223: Feasibility of the Portable YouGrabber System
Official title: Feasibility of a Home-based Interactive System for Upper Limb Therapy (YouGrabber)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Stroke
Traumatic Brain Injury
Meningomyelocele
Central Nervous System Diseases
Keywords: Children
Rehabilitation
Telerehabilitation
Upper limb therapy
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the feasibility of the portable version of the YouGrabber® system in children with central motor disorders.

Detailed description: In a feasibility trial with the portable version of the YouGrabber® system it will be determined if the technique and equipment are ready to be used in a home setting where children with central motor disorders train with assistance of caregivers but without a therapist. Furthermore, it will be examined if children and adolescents with central motor disorders accept this home-based system and if they are motivated for using it.

Eligibility criteria: Inclusion Criteria:

* Central motor disorders
* Ability to sit in an upright position for 45 minutes

Exclusion Criteria:

* Manual Ability Classification Scale (MACS) V
* Severe visual or auditory impairments
* Severe photosensitive epilepsy

Primary outcomes:
measure: User satisfaction (Questionnaire about usability, motivation, general opinion)
timeFrame: week 2
Secondary outcomes:
measure: Device usage (Total time of exercise per week; time of training session)
timeFrame: week 2
measure: Error rate (Error prone games; application problems as a home-based system)
timeFrame: week 2
Other outcomes:
Locations:
city: Affoltern am Albis
country: Switzerland
facility: University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis
Study officials:
affiliation: University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis
name: Corinna Gerber, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerber CN, Kunz B, van Hedel HJ. Preparing a neuropediatric upper limb exergame rehabilitation system for home-use: a feasibility study. J Neuroeng Rehabil. 2016 Mar 23;13:33. doi: 10.1186/s12984-016-0141-x.
Clinical trial NCT00428623: Aquacel Compared to Traditional Post Surgical Wound Dressing in Vascular Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Healing
Patient Comfort
Keywords: Patient comfort
Wound dressings
infection
vascular surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-01-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The study is a prospective randomised, controlled study of 136 patients undergoing vascular surgery. Their closed wounds were covered with either aquacel, a hydrofiber dressing, or a traditional gauze dressing.Number of changes, patient comfort,number of infections, length of hospital stay and wound complications were compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective vascular surgery, with an expected hospital stay of at least 4 days. informed consent

Exclusion Criteria:

* known hypersensitivity to the dressing materials. age under 18 years. dementia, insufficient danish language understanding, pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Vascular Surgery, Rigshospitalet
Study officials:
affiliation: professor
name: torben V Schroeder, prof,dmsc.md
role: STUDY_DIRECTOR
References:
Clinical trial NCT06861023: Review of the Literature and Serie of Patients Who Underwent Reconstruction After Wide Local Excision of Nail Apparatus for Melanoma
Official title: Review of the Literature and Retrospective, Single-centre Study of a Series of Patients Who Underwent Reconstruction After Complete Nail Resection.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone melanoma surgery in the plastic surgery department of the Pasteur Hospital

Brief summary: Melanomas of the nail bed are often diagnosed at the locally advanced stage. The standard treatment was amputation of the finger or toe, but it has now been established that enlarged excision of the nail plate is sufficient under certain conditions. Reconstruction of the nail system can be performed by several techniques. Here, the investigators present a series of patients reconstructed by INTEGRA (dermal matrix) and skin graft


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone enlarged resection of the nail apparatus with immediate or delayed reconstruction in the setting of acral melanoma of the fingers or toes.

Exclusion Criteria:

* Patients who have amputation, opposition of the pateint to the study.

Primary outcomes:
measure: Functional and cosmetic patient satisfaction
timeFrame: 3 months minimum postoperative
Secondary outcomes:
measure: Post-operative complications
timeFrame: 3 months minimum postoperative
measure: Recurrence of the disease
timeFrame: 3 months minimum postoperative
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NICE
state: Alpes Maritimes
Study officials:
References:
Clinical trial NCT02418923: HemoSonics-UVA Spinal Surgery
Official title: HemoSonics-UVA Spinal Surgery Clinical Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deformity of Spine
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: HemoSonics LLC
First posted: 2015-04-17
Enrollment: 51
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: Participants for this study will be recruited at the University of Virginia Medical Center. The subject population will be representative of the local racial and ethnic population.

Brief summary: This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients.

Detailed description: HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia.

Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.

A clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology

Eligibility criteria: Inclusion Criteria:

* • Subject is scheduled for major deformity correction spine surgery

  * Subject is older than 18 years
  * Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

* • Subject is unable to provide written informed consent

  * Subject is incarcerated at the time of the study
  * Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
  * Subjects with renal disease (defined as serum creatinine greater than 1.5 mg/dl)
  * Subjects with history of active liver disease
  * Subjects affected by Factor V Leiden mutation
  * Subjects affected by von Willebrand disease
  * Subjects with an history of thrombotic disease (more than one DVT)

Primary outcomes:
measure: assay inter-instrument variability
timeFrame: 1 day
measure: Establish normal ranges
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: UVA Anethesiology Faculty
name: Bhiken Naik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00140023: Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia
Official title: A Multi-center, Open Label Study to Evaluate the Efficacy and Safety of Azithromycin Microspheres in Subjects Identified as Having Low Risk Community Acquired Pneumonia (CAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Community-Acquired Pneumonia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will assess the clinical efficacy at Day 14-21 (Test of Cure), 14-21 days after starting the study drug; those subjects from whom a baseline pathogen is identified will also be assessed for bacteriologic response. All subjects who receive 1 dose of study medication will be assessed for safety.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years age or older, for whom oral, outpatient therapy is indicated.
* Diagnosis of CAP as manifested by at least 3 or more of the following:
* cough, pleuritic chest pain, fever (temperature of \>37.8 C to \<40 C), auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation, dyspnea, tachypnea, laboratory results of elevated total peripheral white blood count (WBC\> 10,000/mm3 or greater than 15% immature neutrophils (bands)

Exclusion Criteria:

* Known or suspected hypersensitivity or intolerance to azithromycin or other macrolides.
* Previously diagnosed disease(s) of immune function, including: subjects with baseline absolute neutrophil count \< 1,000/mm3, HIV positive subjects with CD4 count \< 200 cells/mm3, any immunoglobin or neutrophil disorder.

Primary outcomes:
measure: To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP.
Secondary outcomes:
measure: To assess bacteriological efficacy of 2.0 g single dose of azithromycin microspheres. To assess the safety and tolerability of 2.0 g single dose of azithromycin microspheres.
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Pfizer Investigational Site
state: Metro Manila
city: Mandaluyong City
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Muntinlupa City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05616923: Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
Official title: Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rosacea, Erythematotelangiectatic
Lead sponsor: Albany Research Institute, Inc.
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Each patient will receive two creams labeled "right cheek" or "left cheek", one containing the active ingredient and the other serving as vehicle control. The labels of each bottle were randomized and the contents of each remains blinded to both the subject and the investigator.
Primary purpose: TREATMENT

Brief summary: This is a prospective, vehicle controlled, double blinded study to evaluate the safety and potential efficacy of a topical formulation of a MEK inhibitor in patients with erythematotelangiectatic rosacea

Detailed description: The duration of the study will be 22 days. Subjects will use a cream with a mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor on one cheek, and a cream lacking the inhibitor (vehicle control) on the other. Patients will receive a randomized set of creams for the right and left cheek, one containing the active ingredient. Subjects will be evaluated on days 1, 8, 15 and 22. Skin appearance will be scored in each visit. A blood sample will be obtained to determine the levels of systemic drug absorption.

Eligibility criteria: Inclusion Criteria:

* Erythematotelangiectatic rosacea diagnosed by a clinician in the centrofacial and/or ocular regions.

Exclusion Criteria:

* Other concurrent diseases for which treatment is being received that would preclude the use of trametinib (i.e., pleural effusion, active infection, intracranial bleeding)
* History of skin allergic reactions or documented allergic reaction to trametinib
* Pregnancy or lactation.
* Heart failure or other heart disease
* Active use of medications with known documented interactions with trametinib (Chloroquine, Ritonavir, Loperamide, Penicillamine)

Primary outcomes:
measure: Change in dermatologic score
timeFrame: 22 days
Secondary outcomes:
measure: Systemic drug absorption
timeFrame: 22 days
Other outcomes:
Locations:
city: Albany
country: United States
facility: Samuel S. Stratton VA Medical Center
state: New York
Study officials:
affiliation: Stratton VA Medical Center
name: Jacqueline Busingye, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03153423: Basic Intermittent Exotropia and Risk Factors for Postoperative Overcorrection and Under Correction
Official title: Basic Intermittent Exotropia; is the Axial Length of the Globe One of the Prognostic Factors for Overcorrection and Undercorrection After Binocular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strabismus
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 86
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate preoperative risk factors for overcorrection and undercorrection following surgery for basic intermittent exotropia such as axial length of the globe, refractive error, age and sex


Eligibility criteria: Inclusion Criteria:

* Basic type intermittent exotropia

Exclusion Criteria:

* previous strabismus surgery restrictive strabismus

Primary outcomes:
measure: Risk factors for postoperative overcorrections and under corrections
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine - Minia University
Study officials:
affiliation: Minia University
name: Mohamed F Ibrahiem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02161523: The Impact of Lung Cancer-derived Fibroblasts on Mast Cells Activation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: mast cells, lung cancer, cancer associated fibroblasts (CAF)
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with non small cell lung carcinoma that need a surgery without connection to this experiment

Brief summary: In addition to their role in allergic inflammation, mast cells are often found at the site of tumors. They have been attributed both to pro- and anti-tumorigenic roles depending on the tumor type. Secretion of mast cell mediators such as histamine, tryptase, fibroblast growth factor (b-FGF), vascular endothelial growth factor (VEGF) and interleukin-8 (IL-8) can enhance tumor growth and angiogenesis while TNF-a and heparin act as tumor suppressors.

The non-small cell lung cancer constitutes the majority of cases of lung cancer. In lung cancer, mast cell numbers correlate with tumor angiogenesis and poor prognosis.

In this work, we are interested to determine the factors in lung cancer microenvironment that attribute to mast cell activation. Beside the tumor cells themselves, the cancer microenvironment includes other cells such as fibroblasts. The fibroblasts arising from tumor stroma, called cancer-associated fibroblasts (CAFs), undergo activation, and have different feature compared to normal fibroblasts (NFs). In this work we are interested to determine whether CAF cells derived from lung tumors, together with the lung cancer cells, or microvesicles-derived from these cells, are able to stimulate mast cells to degranulate and/ or to release various cytokines and chemokines.

For this propose, during surgery of patients with lung cancer, we will take unnecessary sample from the cancer and from normal area for purification of CAF or normal fibroblast cells. Those cells will be co-cultured with both lung cancer cell line (A-549) or microvesicles-derived from these cells, and human mast cell line (LAD2). Supernatants will be collected for determine degranulation and cytokine release from these mast cells.


Eligibility criteria: Inclusion Criteria:

Patient with non small cell lung carcinoma

Exclusion Criteria:

none

Primary outcomes:
measure: Measuring the levels of b-hexosaminidase (marker for mast cells degranulation ) and the cytokines levels
timeFrame: 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: