louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02207803: A Culturally Sensitive Intervention for TBI Caregivers in Latin America
Official title: A Culturally Sensitive Intervention for TBI Caregivers in Latin America
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Brain Injuries
Caregivers
Intervention Studies
Latin America
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2014-08-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Traumatic brain injury (TBI) patients in Latin America experience high levels of disability and extremely poor functional outcomes, and their informal caregivers play a key role in their rehabilitation and care. To improve TBI rehabilitation through stronger informal caregiving, the proposed study will develop and evaluate an evidence--based and culturally sensitive Transition Assistance Program for informal caregivers of patients with TBI in Latin America during the patient's transition from hospital to home. This study will generate findings that can provide empirically supported guidance to clinicians regarding the provision of culturally tailored rehabilitation services for TBI caregivers in Latin America and in the U.S.


Eligibility criteria: TBI Patient Inclusion Criteria:

* Will be discharged home and not to a nursing home
* Give permission for their caregiver to participate
* Sign an informed consent
* Have the ability to communicate over the phone for data collection
* Are between 18-60 years of age

Caregiver Inclusion Criteria

* Have a telephone in the home or cellular phone and are able to talk on the phone
* Sign an informed consent
* Score at least a 13 on a health literacy screening tool
* Are between 18-85 years of age

Primary outcomes:
measure: Zarit Burden Interview
timeFrame: 2 months post-hospital discharge
Secondary outcomes:
measure: Exemplary Care Scale-Provide Subscale
timeFrame: 2 months post-hospital discharge
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Pontificia Universidad Javeriana Cali
city: Neiva
country: Colombia
facility: Universidad Sur Colombiana
city: Mexico City
country: Mexico
facility: National Institute of Neurology and Neurosurgery
Study officials:
affiliation: Virginia Commonwealth University
name: Paul B. Perrin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05851703: The Effects Of Instrument Cervical Manual Therapy Methods And Proprioceptive Neuromuscular Facilitation Techniques
Official title: The Effects Of Instrument-Supported Cervical Manual Therapy Methods And Proprioceptive Neuromuscular Facilitation Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: pain
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The location of neck pain is usually shown as "pain occurring between the occiput and the third thoracic vertebra". The annual incidence of mechanical neck pain is 12/1000 patients and is one of the most common reasons for visiting physicians. Neck pain usually lasts longer than 3 months and results in a high cost to society

Detailed description: Movement in one plane in the cervical spine is due to the contribution of vertebrae from other planes. This complicates the kinematics and injury mechanism of the cervical region. Considering the mechanism of injury, demographic information to be obtained from the person is very important.

Eligibility criteria: Inclusion Criteria:

* Those with neck pain
* Being between 20-60 years old

Exclusion Criteria:

* High blood pressure
* Cardiopulmonary disease
* Malignant
* Operation, injection, etc. for the neck in the last 3 months. those with a history of treatment
* Spine surgery
* Psychological disturbance
* Neurological and orthopedic deficits

Primary outcomes:
measure: Neck Disability Index
timeFrame: one day
measure: Visual Analogue Scale
timeFrame: one day
measure: Algometer
timeFrame: one day
measure: Pinchmeter
timeFrame: one day
measure: Jamar Hand Dynomometer
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ismet Yurtdsever
state: None Selected
Study officials:
References:
citation: Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
Clinical trial NCT00803803: Dose, Effects and Characteristics of Pilocarpine
Official title: Dose, Effects and Characteristics of Pilocarpine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-angle Glaucoma
Keywords: Pilocarpine
POAG
IOP
Concentration
Frequency
Primary open-angle glaucoma
Primary open-angle glaucoma suspect
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2008-12-08
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation, in which pilocarpine was given in repeated doses, was to evaluate: Part I - the effects of different concentrations of pilocarpine hydrochloride on intraocular pressure. Part II -the effects on intraocular pressure of glaucomatous patients to pilocarpine 2% when given once, twice and four daily. In addition, we studied various attributes of the eye which may serve as indicators of responsiveness of individual patients to pilocarpine.

Detailed description: In addition, we studied various attributes of the eye which may serve as indicators of responsiveness of individual patients to pilocarpine.

Eligibility criteria: Inclusion Criteria:

* Primary open-angle glaucoma
* Primary open-angle glaucoma suspect

Primary outcomes:
measure: Intraocular Pressure
timeFrame: 25 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Glaucoma Service
state: Pennsylvania
Study officials:
affiliation: Wills Eye Glaucoma Service
name: George L Spaeth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01611103: Cognitive Effects of Transcranial Direct Current Stimulation in Older Adults
Official title: Cognitive Effects of Transcranial Direct Current Stimulation in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Cognitive Enhancement
tDCS
stimulation
elderly
older adults
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 43
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities. In this research, a 9 volt battery is used to deliver very weak electrical current to the surface of the scalp while participants complete cognitive tasks. Our aim is to find out whether tDCS will improve task performance in adults over the age of 55.

Detailed description: Participants enrolled into this study may be asked to do the following:

* Grant permission for the researchers to view medical records associated with their language/cognitive difficulties (if applicable).
* Complete a questionnaire, provide a health history, and take some pencil-and-paper tests of problem-solving and memory in order to verify eligibility to participate and to able to safely undergo the experimental procedures.
* Complete several tasks (i.e., saying words out loud, naming objects, drawing designs, remembering lists of words, searching for images or letters, and/or completing puzzles) based upon a number of cognitive functions such as language, memory, vision, processing, and perception.
* Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) from a 9 volt battery for 20 to 60 minutes.
* Participate in several study conditions. The exact conditions and their order will be randomized. Under some conditions, participants may receive active stimulation (tDCS) and under other conditions, they may receive sham stimulation.
* The experimental sessions will last approximately 2 hours and participants may be asked to have more than one testing session in a day or to return for additional sessions.

Eligibility criteria: Inclusion Criteria:

* Over the age of 55
* Right Handed
* Native English speaker

Exclusion Criteria:

* History of Seizures
* Any implanted metal device or pacemaker
* Appreciable deficits in hearing or vision
* Greater than 1.5 standard deviations below demographically adjusted means on cognitive screen
* Dementia or Mini Mental Exam below 24

Primary outcomes:
measure: Cognitive Test Performance
timeFrame: The average time frame is 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Department of Neurology
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Barry Gordon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02094703: The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females
Official title: The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urinary Tract Infection
Keywords: female
age 18-65 years
storage symptoms
clinical urinary tract infection
non complicated
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Indonesia Inc.
name: Pharos Life Corporation
First posted: 2014-03-24
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary tract infection in females.


Eligibility criteria: Inclusion Criteria:

* females (18-65 years old)
* dysuria in symptomatic non complicated urinary tract infection

Exclusion Criteria:

* Pediatric Patients (\< 18 years old)
* geriatric Patients (\> 65 years old)
* pregnant Patients
* Patients with complicated urinary tract infection
* sexually transmitted infections
* Patients with pathological abnormalities in the urinary bladder, including stone/mass
* Catheter-mounted
* Neurological diseases/disorders
* patients with allergy/hypersensitivity with Levofloxacin/Solifenacin

Primary outcomes:
measure: Number of participants with storage symptoms
timeFrame: up to three days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
Study officials:
References:
Clinical trial NCT03782103: In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)
Official title: Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Skin Preparation
Lead sponsor: Zurex Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-20
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.

Detailed description: The primary objective of this study is to measure the antimicrobial effectiveness of a single investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™ as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle as a negative control. For efficacy at 30 seconds post-prep, the test article should be superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non-inferior to the active control using a margin of 0.5 log10 CFU/cm2.

Eligibility criteria: Inclusion Criteria:

* Subjects of any race
* Subjects in good general health
* Minimum bacterial baseline requirements on abdomen and groin
* Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.

Exclusion Criteria:

* Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
* Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to screening and treatment days, excluding contraception or post-menopausal treatment.
* Subjects with allergies to study materials including isopropyl alcohol or chlorhexidine gluconate.
* Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
* Subjects who are pregnant, attempting pregnancy or nursing.

Primary outcomes:
measure: Bacterial Reduction - Groin
timeFrame: 30 seconds post product application
measure: Bacterial Reduction - Abdomen
timeFrame: 30 seconds post product application
Secondary outcomes:
measure: Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region
timeFrame: 6 hours post product applcation
Other outcomes:
Locations:
city: Sterling
country: United States
facility: Microbac Laboratories, Inc.
state: Virginia
Study officials:
affiliation: Microbac Laboratories, Inc.
name: M H Bashir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01695603: Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients
Official title: Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injured Patients
Keywords: Brain injury
Controlled ventilation
Intellivent
Capnia control
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2012-09-28
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain capnia and oxgen partial pressure within predefined ranges in comparison to the control of capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in brain injured patients. Comparison of the numbers of alarms and required settings modifications observed with each ventilatory mode.


Eligibility criteria: Inclusion Criteria:

* Brain injury ( traumatic brain injury, subarachnoi8dal haemorrhage, intracerebral hemorrhage, ischemic stroke)
* Glasgow coma scale of 9 or less
* Controlled mechanical ventilation required
* Intracranial pressure monitoring required for clinical reasons

Exclusion Criteria:

* age under 16 years old
* clinical signs of brainstem lesions
* patients with withdrawal order or for whom organ donation is under discussion
* major haemodynamic instability
* High carbon dioxide alveoloarterial gradient (\>10 mmHg) and/or suffering of severe hypoxemia (PaO2/FIO2 \< 150 mmHg)
* Patients included in another interventional clinical study

Primary outcomes:
measure: Partial pressure of carbon dioxide
Secondary outcomes:
measure: Partial pressure of oxygen
measure: Number of alarms generated by the ventilator
measure: Number of settings modifications
measure: Intracranial pressure
measure: Respiratory parameters
measure: Cerebral vasoreactivity
measure: Partial pressure of oxygen in the brain tissue if available
measure: Number of therapeutic actions needed to reduce intracranial pressure
measure: Cerebral perfusion pressure
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Adult Intensive Care and Burn Unit, University hospital of Lausanne
Study officials:
affiliation: University of Lausanne Hospitals
name: Philippe Jolliet, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00961103: Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)
Official title: Assessment of Motor Development Related to Use of Orthoses in SMA II and III
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Muscular Atrophy
Keywords: spinal muscular atrophy
motor development
orthoses
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2009-08-18
Enrollment: 70
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: patients with SMA II and SMA III referred to UDGEE for rehabilitation consultation

Brief summary: Spinal Muscular Atrophy (SMA) is neurodegenerative disease of anterior horn cells of spinal cord and represents the second more frequent pathology in childhood.

According to the age of onset and the maximum motor function the disorder is classified in 4 types. Patients with SMA II and SMA III often use orthoses to achieve postural and dynamic functions.

In this retrospective observational study the investigators describe the characteristics of sitting position, standing and walking correlated to type and time of orthoses used.

Detailed description: We collect data from patients with SMA II and SMA III referred to UDGEE from jan. 1995 to dec. 2008.

We estimate to achieve informations about 50-70 patients.

Eligibility criteria: Inclusion Criteria:

* Clinical and genetics diagnosis of SMA II and SMA III

Exclusion Criteria:

* N/A

Primary outcomes:
measure: time and percentage of sitting, standing, walking achievement in SMA II and SMA III
timeFrame: aug.2009- nov.2009
Secondary outcomes:
measure: characteristics and percentage of orthoses for postural sitting control , standing and walking in SMA II and SMA III
timeFrame: aug. 2009 - dec.2009
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: UDGEE Hospital S.Maria Nuova
state: RE
Study officials:
affiliation: Hospital S.Maria Nuova Reggio Emilia Italy
name: Adriano Ferrari, MD
role: STUDY_DIRECTOR
References:
citation: Wang CH, Finkel RS, Bertini ES, Schroth M, Simonds A, Wong B, Aloysius A, Morrison L, Main M, Crawford TO, Trela A; Participants of the International Conference on SMA Standard of Care. Consensus statement for standard of care in spinal muscular atrophy. J Child Neurol. 2007 Aug;22(8):1027-49. doi: 10.1177/0883073807305788.
Clinical trial NCT05013203: NGS for Spine Surgery Patients
Official title: Next Generation Sequencing for the Detection of Clinical and Subclinical Infection in Patient Undergoing Spine Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spine Infection
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are having spine surgery who are \>18 years old for degenerative disease, infection, and malignancy.

Brief summary: During revision spinal surgery for aseptic indications, there remains a concern that the failure may have resulted from undetectable subclinical infection. In the common revision indications of hardware loosening and adjacent segment disease it is possible that bacterial colonization and low-grade infection precipitated the failure event. There is also significant controversy on the role infectious processes have in the development of degenerative disc disease (modic changes). In particular, this study will investigate whether discogenic colonization with Propionibacterium acnes (P. acnes) can be associated with modic changes. Whereas, in surgery for known spinal infection, epidural abscess and septic revisions, it is possible that standard culture techniques fail to detect polymicrobial flora or accurate speciation. This may lead to inappropriate antibiotic management that is not addressing the range of pathology present. There remains an incomplete understanding of the role that subclinical infection plays in aseptic spinal revision surgery and degenerative disc disease


Eligibility criteria: Inclusion Criteria:

* All patients \>18 years of age undergoing spinal surgery

Exclusion Criteria:

* All patients \<18 years of age undergoing spinal surgery

Primary outcomes:
measure: Postoperative complications
timeFrame: 1 year
measure: Patient Satisfaction
timeFrame: 1 year
measure: Patient pain
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01264003: Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias
Official title: Single Dose Antibiotic Prophylaxis in Lihtenstein Repair for Primary Inguinal Hernias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inguinal Hernia
Keywords: inguinal hernia, antibiotic, prophylaxis
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when prosthetic materials are used. This prospective randomized study has been set to observe if antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.

Detailed description: There are two group in the study. Control group received no antibiotic prohylaxis, whereas a single dose 1 gr. intravenous cefazoline is given to the patient in prophylaxis arm of the study. 30-days surgical site infection rates and 1 year prosthetic intervention late infection rates are observed and recorded. Side effects of antibiotic used are also recorded.

Eligibility criteria: Inclusion Criteria: inguinal hernia repair -

Exclusion Criteria: uncontrolled diabetes mellitus,

-

Primary outcomes:
measure: Surgical site infection
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Drug side effects
timeFrame: 5 days postoperatively
measure: 1-year prosthetic repair surgical site late infection rate
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: