louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02791529: Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release
Official title: Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release - Randomized, Controlled Open-Label Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2016-06-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).

Detailed description: The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).

Eligibility criteria: Inclusion Criteria:

* Age 18 - 60 years
* Scheduled to undergo open carpal tunnel release (OCTR) by a study group member
* Gives informed consent
* diagnosis of chronic carpal tunnel syndrome

Exclusion Criteria:

* -Any current underlying systemic illness or condition that may affect wound healing (e.g. diabetes or chronic vascular disease)
* History of severe systemic or focal illness (e.g. previous myocardial infarction, chronic obstructive pulmonary disease)
* Chronic skin condition in the affected upper limb (e.g. psoriasis)
* Pregnancy
* Inability to comprehend the consent form (in Finnish) or inability to give consent
* Previous surgery or scar in the palmar aspect of the affected wrist
* Recurrent carpal tunnel syndrome
* Previous significant trauma of the affected upper extremity (including distal radius fracture) or suspicion of acute onset carpal tunnel syndrome

Primary outcomes:
measure: Pain on visual analogue scale
timeFrame: First postoperative day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00905229: Comparing Different Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bleeding
Complications
Keywords: hip fracture
warfarin
vitamin k
Phytonadione
INR level
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2009-05-20
Enrollment: 0
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: It is well known that femoral neck fractures carry a significant increase in patients' mortality and that surgical intervention is the preferred treatment.

Any delay in operating on such patients would inevitably increase their risk of developing complications. One of the reasons for such unintentional delay would be the hypercoagulative status of patients taking warfarin. The CHEST 2008 guidelines suggest reversing warfarin with Vitamin K for patients who need urgent operation. The aim of this study is to compare different roots and doses of Vitamin K.


Eligibility criteria: Inclusion Criteria:

* hip fracture patients on warfarin

Exclusion Criteria:

* pregnancy
* vitamin k sensitivity

Primary outcomes:
measure: International normalized ratio (INR) </= 1.2
timeFrame: 3 days
Secondary outcomes:
measure: Bleeding
timeFrame: 6 weeks
measure: Complications
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
References:
citation: Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):160S-198S. doi: 10.1378/chest.08-0670.
citation: Al-Rashid M, Parker MJ. Anticoagulation management in hip fracture patients on warfarin. Injury. 2005 Nov;36(11):1311-5. doi: 10.1016/j.injury.2005.05.004.
citation: Lubetsky A, Yonath H, Olchovsky D, Loebstein R, Halkin H, Ezra D. Comparison of oral vs intravenous phytonadione (vitamin K1) in patients with excessive anticoagulation: a prospective randomized controlled study. Arch Intern Med. 2003 Nov 10;163(20):2469-73. doi: 10.1001/archinte.163.20.2469.
Clinical trial NCT06766929: A Phase I Clinical Study of VSA012 in Healthy Volunteers
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VSA012 After Single Ascending Doses in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Visirna Therapeutics HK Limited
Sponsor class: INDUSTRY
First posted: 2025-01-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The complement system is an important component of the innate immune system. Abnormal activation, inadequate regulation and control of the complement system, as well as impaired and dysfunctional effector functions, underlie complement mediated diseases. VSA012 targeting complement system has the potential to treat a variety of diseases associated with abnormal activation of the complement system (e.g. PNH) .The purpose of VSA012-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VSA012 Injection in adult healthy volunteers (HVs). HVs will receive a single dose of VSA012 or placebo.


Eligibility criteria: Inclusion Criteria:

* Willing to provide written informed consent and to comply with study requirements
* Participants must be non-pregnant/non-lactating
* Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine.
* Body Mass Index (BMI) between 18.0 and 30.0 kg/m2
* No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the Investigator, could adversely impact participant safety or adversely impact study results.

Exclusion Criteria:

* History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses
* History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations
* Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
* History of meningococcal infection

Primary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
timeFrame: up to Day 180
Secondary outcomes:
measure: Pharmacokinetics (PK) of VSA012: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to 48 hours post-dose
measure: PK of VSA012: Time to Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to 48 hours post-dose
measure: PK of VSA012: Area Under the Plasma Concentration Versus Time Curve
timeFrame: Up to 48 hours post-dose
measure: Change from Baseline in Serum Complement Factor B (CFB)
timeFrame: Up to Day 180
measure: Change from Baseline in Serum Complement Alternative Pathway (CAP)
timeFrame: up to Day 180
measure: The incidence of ADA
timeFrame: up to Day 180
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04113629: Simplified Monitoring Myanmar SM2 Study
Official title: Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (Simplified Monitoring Myanmar SM2 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Liver Cirrhoses
Liver Inflammation
HIV Infections
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: University of Public Health, Myanmar
First posted: 2019-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sequential Assignment
Primary purpose: DIAGNOSTIC

Brief summary: The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.

Detailed description: A total of 200 HIV/HCV co-infected patients who plan to commence DAA therapy at Specialist Hospital Waibargi and Mingaladon, will be enrolled by simple random sampling.

In addition to standard of care medical procedures, each participant will complete a questionnaire and have blood taken for standard HCV RNA testing.

They will also have a finger-stick capillary blood sample collected for a HCV point of care test, using the the Xpert HCV Assay performed in the GeneXpert point of care machine.

Dried blood spot collection (DBS) for HCV core antigen and HCV RNA testing will be collected as a research sample. Concordance between standard of care method and new DBS method will be evaluated.

The proportion of patients reaching SVR will be calculated.

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to participate in this study.

1. Have voluntarily signed the consent form.
2. 18 years of age or older.
3. HCV antibody positive.
4. HIV antibody positive.

Exclusion Criteria:

Subjects who meet any of the exclusion criteria are not to be enrolled in this study.

1. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the subject treatment, assessment or compliance with the protocol.
2. Creatinine clearance (CLcr) \< 30mL/min at screening.
3. Pregnant or nursing female.
4. Use of prohibited concomitant medications.
5. Inability or unwillingness to provide informed consent or abide by the study requirements.

Primary outcomes:
measure: Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
timeFrame: 12 weeks post completion of commenced treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: The Kirby Institute, University of New South Wales Australia
state: New South Wales
Study officials:
References:
Clinical trial NCT04792229: Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy
Official title: Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Diplegia
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will help to determine the beneficial effects of high frequency vibration on children with diplegic cerebral palsy in improving balance ,spasticity, strength of lower limb and quality of life and a comparison between the effect of simple conventional treatment and conventional management with the usage of vibrational therapy in cp patients.

Detailed description: A study "Effect of whole body vibration training on mobility in children with cerebral palsy "states Whole body vibrational therapy induce an improvement in independent ambulation and mobility of lower limb by strengthening of muscles along with the refinement of walking pattern ,gait speed and stride length in children with cerebral palsy. On the basis of our study a better treatment protocol can be designed for future in diplegic spastic cerebral palsy children.

Eligibility criteria: Inclusion Criteria:

* Gross motor function classification level II-III
* Modified Ashworth Scale of 1-2

Exclusion Criteria:

* Auditory/ visually impaired
* Other neurological conditions e.g. spina bifida etc.
* Lower limb contractures
* Children with history of lower limb surgery in last 6 months

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: 4 weeks
measure: Pediatric Balance Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Manual Muscle Testing
timeFrame: 4 weeks
measure: CP QoL
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tarbela
country: Pakistan
facility: Meshal School of Special Children
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Riphah International University
name: Mirza Obaid Baig
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04252729: Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study
Official title: Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope
Keywords: Psychotherapy
Syncope
Quality of life
Psychoanalytic psychosomatics
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recurrent vasovagal syncope although presenting a benign prognosis in terms of survival, is associated with significant impairment of quality of life. The impaired emotional status is also related to the recurrence of the events, closing a negative cycle for the evolution of the disease. This study aims to evaluate the effect of psychotherapy on the quality of life and in the number of syncope and pre-syncope events during one year of follow-up of patients with recurrent vasovagal syncope.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of vasovagal syncope with positive TILT TEST and recurrent episodes (≥2 episode within 6 months)
* Signed Free and Informed Consent Form

Exclusion Criteria:

* Severe comorbidity with life expectancy \<1 year
* Age \<18 years
* Current psychotherapeutic follow-up
* Cardiac or neurological syncope
* Pregnancy

Primary outcomes:
measure: Quality of life analysis performed by the Short Form 36 Instrument
timeFrame: 1 week
measure: Quality of life analysis performed by the Short Form 36 Instrument
timeFrame: 6 months
measure: Quality of life analysis performed by the Short Form 36 Instrument
timeFrame: 12 months
Secondary outcomes:
measure: Demographic data
timeFrame: 12 months
measure: Number of comorbidities
timeFrame: 12 months
measure: Use of concomitant medication
timeFrame: 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
References:
citation: de Barros E Silva RLA, Volich RM, de Barros E Silva PGM, da Costa Darrieux FC, Scanavacca MI, Hachul DT. Effect of psychotherapy on recurrence of events and quality of life in patients with vasovagal syncope. Sci Rep. 2022 Apr 6;12(1):5745. doi: 10.1038/s41598-022-09513-1.
Clinical trial NCT06960629: The Effect of ROCK Inhibitors on Corneas of Patients With Glaucoma and Pseudophakic Bullous Keratopathy (PBK)
Official title: The Effect of Topical Rho-kinase (ROCK) Inhibitors on Corneas of Patients With Glaucoma and Pseudophakic Bullous Keratopathy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pseudophakic Bullous Keratopathy
Glaucoma
Keywords: Glaucoma
Topical ROCK inhibitors
Netarsudil/latanoprost
corneal edema
pseudophakic bullous keratopathy (PBK)
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of both sex, age between 40 and 90 years with glaucoma and pseudophakic bullous keratopathy.

Brief summary: The goal of this clinical trial is to learn if topical netarsudil/latanoprost works to treat pseudophakic bullous keratopathy in patients with glaucoma. The main questions it aims to answer are:

Does topical netarsudil/latanoprost improves visual function in patients with glaucoma and pseudophakic bullous keratopathy? Does topical netarsudil/latanoprost affects the central corneal thickness (CCT) in patients with glaucoma and pseudophakic bullous keratopathy? Researchers will compare topical netarsudil/latanoprost to a placebo (a look-alike substance that contains no drug) to see if topical netarsudil/latanoprost works to treat pseudophakic bullous keratopathy (PBK).

Participants will take topical netarsudil/latanoprost or a placebo every day for 3 months and visit the clinic once every two weeks for checkups and tests.

Detailed description: Patients with glaucoma and pseudophakic bullous keratopathy will be randomly divided in two groups. Group 1 will take topical netarsudil/latanoprost 1x daily for 3 months and group 2 will take topical placebo (artificial tear substitute) 1x daily for 3 months. Visual acuity (VA) will be evaluated using Snellen chart and converted to logarithm of the minimum angle of resolution (LogMAR). Central corneal thickness (CCT) measurements will be performed using ultrasound pacymetry (Micro Medical devices, Inc, CA). Information about adverse effects will be recorded during the study. Patients will visit every two weeks for checkups and measurements for 3 months.

Eligibility criteria: Inclusion Criteria:

* both sex,
* age between 40 and 90 years
* pseudophakic bullous keratopathy
* glaucoma

Exclusion Criteria:

* other anterior segment pathology (corneal opacities);
* ocular surface inflammation
* retinal diseases affecting visual acuity

Primary outcomes:
measure: Visual acuity (VA)
timeFrame: 3 months
Secondary outcomes:
measure: Central corneal thickness (CCT)
timeFrame: 3 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
Study officials:
affiliation: University Hospital Dubrava
name: Josip Pavan, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02177929: Study About Acting of Adaptive Sport in Musculoskeletal, Cardiovascular System and the Quality of Life of Individuals With Spinal Cord Injury Through Biomedical Instrumentation
Official title: Study About Acting of Adaptive Sport in Musculoskeletal, Cardiovascular System and the Quality of Life of Individuals With Spinal Cord Injury Through Biomedical Instrumentation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adaptive Sport in Spinal Cord Injury
Keywords: Spinal cord injury,
adaptive sport,
dynamometry,
electromyography,
force platform.
Lead sponsor: Universidade do Vale do Paraíba
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 45
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis is to the fulfillment of canoeing, handbike and conventional physiotherapy activities the groups could show improvement in muscle strength of the arms, decreased resistance of the lower limbs (spasticity), improved trunk balance and movements of the upper limbs, improves cardiovascular function, bone health, and consequently improve the quality of life.


Eligibility criteria: Inclusion Criteria:

* aged 15-40 years
* of both sexes
* with injury time over 8 months, who present spasticity in the lower limbs up to grade 2 according to the scale of Ashwoth modified patient with paraplegia or paraparesis in thoracolumbar level (lower than T2) levels.

Exclusion Criteria:

* age over 40 years
* lesion less than 8 months
* above T2 lesions
* musculoskeletal disorders such as deformity
* severe contracture
* previously diagnosed cardiovascular abnormalities or risk factors such as hypertension
* diabetes and obesity, use of medications and cardiopressant cardioestimuladoras, smoking and alcoholics.
* For individuals who participate in the group canoeing and by adapting the pool will still include the following exclusion criteria:

  * decubitus ulcers
  * fungal infections
  * urinary incontinence
  * inflammatory processes and neoplasms.

Primary outcomes:
measure: Evaluate of torque
timeFrame: Data collection for 11 months.
measure: Evaluation of resistance to stretching of the flexors and extensors knee
timeFrame: For 11 months
measure: Electromyography of knee extensors
timeFrame: 11 months
measure: Electromyography of erector trunk
timeFrame: 11 months
measure: Evaluation of trunk balance
timeFrame: 11 months
measure: kinematic analysis
timeFrame: 11 months
measure: Analysis of heart rate varibilidade
timeFrame: 11 months
measure: Evaluation of quality of life
timeFrame: 11 months
Secondary outcomes:
measure: Data Analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: São José dos Campos
country: Brazil
facility: Universidade do Vale do Paraíba
state: São Paulo
Study officials:
References:
Clinical trial NCT04504929: The Effectiveness of Dynamic Taping in Preventing Muscle Fatigue
Official title: The Effectiveness of Dynamic Taping in Preventing Muscle Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue; Muscle, Heart
Shoulder Pain
Sport Injury
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of dynamic tape in prevent shoulder muscle fatigue.

Detailed description: After being informed about the study and the potential of risk, all participants will undergo a screening to determine eligibility for study entry and giving written informed consent.

We will include 20 participants who have pitch 100 times with dynamic taping or shame taping in randomized sequence. There must be more than 2 weeks resting between 2 test. We will test maximal force in shoulder flexion, extension, abduction and adduction before and after test. We also record spins and speed of baseball for performance outcome.

To our hypothesis, we suggest dynamic taping could decrease the arm fatigue after long-term pitching.

Eligibility criteria: Inclusion Criteria:

* more than 20 years old
* amateur baseball player
* could tolerate pitching 100 times

Exclusion Criteria:

* shoulder pain who could not tolerate 100 pitching
* upper limb surgery history
* Allergy to topical agent

Primary outcomes:
measure: Change from baseline in shoulder force after pitching
timeFrame: baseline and 2 weeks
Secondary outcomes:
measure: Change of pitching velocity during pitching
timeFrame: baseline and 2 weeks
measure: Change of pitching spin rate during pitching
timeFrame: baseline and 2 weeks
measure: Change of delayed onset muscle soreness after pitching
timeFrame: baseline, 1 Day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: YuHsaun Cheng, Master
role: PRINCIPAL_INVESTIGATOR
References: