louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02962206: The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction
Official title: The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Point-of-care Ultrasound, Distal Radius Fracture
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
First posted: 2016-11-11
Enrollment: 22
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: Distal radius (Colle's) fractures in adult patients are commonly reduced in the emergency department before casting. Standard of care currently requires that x-rays be performed before and after fracture reduction, and inadequate reductions may be subject to repeat attempts and are at a higher risk to require surgery. This study will assess the use of point-of-care ultrasound (POCUS) in addition to standard care as a tool to decrease the angulation at the fracture site after a reduction is performed. If this angulation is decreased, it would suggest that POCUS for distal radius fracture reduction could decrease the number of failed reduction attempts and therefore the number of repeated reduction attempts.


Eligibility criteria: Inclusion Criteria:

* radiographically confirmed distal radius fracture

Exclusion Criteria:

* patients who do not consent
* patients with multiple acute injuries, open fractures, or other local fractures evident (a simple ulnar styloid fracture will not be considered an exclusion criterion)
* patients with neurovascular compromise
* patients with bilateral distal radius fractures
* patients with minimally displaced distal radius fractures that do not require closed reduction before casting

Primary outcomes:
measure: Residual dorsal angulation
timeFrame: Collected at the same-day post-reduction xray. Data will be aggregated over 1 year
Secondary outcomes:
measure: Need for orthopaedic surgery within 6 weeks of injury
timeFrame: To be assessed 6 weeks post-injury. Data will be aggregated over the 1 year study period
measure: Physician satisfaction: post-reduction questionnaire
timeFrame: Questionnaire to be administered immediately after reduction. Data to be aggregated during the 1 year study period
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care London
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT03796806: Methods Validation Assessment for Study of Inflammatory Skin Disease
Official title: Methods Validation Assessment for Study of Inflammatory Skin Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lichen Planus
Keywords: lichen planus
proteomics
xenograft model for lichen planus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic patients with active lichen planus and residing within a 50-mile radius of Mayo Clinic-Rochester.

Brief summary: 1. Assess validity of methods involved in molecular studies of the skin in inflammatory skin disease
2. Assess feasibility of methods for grafting fresh human skin (normal and diseased with inflammatory skin disease) onto an established xenograft murine model.

Detailed description: The use of fixed tissue specimens for research studies is attractive, because a large number of relevant specimens can be collected quickly from tissue registry. There is a current lack of knowledge regarding to what extent formalin fixation alters the identification of proteins in the skin with inflammatory dermatoses. This information would be important to assess when determining the limitations (or potentially lack thereof) of using fixed specimens in research.

Collaborators have successfully developed a murine model that can accept human skin xenografts. While those investigators have successfully demonstrated transplantation of healthy skin onto mice, it is unknown whether skin affected by inflammatory disease can be transplanted and, if so, whether the inflammatory skin disease remains, whether it spreads to involve host skin, or whether it resolves. Determining feasibility of transplanting inflamed human skin using this model, as well as observing the course of this inflammation, are the next steps in advancing this potentially invaluable research modality.

Eligibility criteria: Inclusion Criteria:

- Adults \>18 years with active cutaneous lichen planus with capacity to consent.

Exclusion Criteria:

* Concurrent skin infection
* Wound healing disturbances
* Patients on systemic immunosuppressive medications.
* Lidocaine allergy
* Platelets \<10,000

Primary outcomes:
measure: Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue.
timeFrame: 8 months
measure: Viability of human inflammatory skin (lichen planus) graft in a xenograft murine model
timeFrame: 8 months
measure: Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Julia S Lehman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00069706: Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients
Official title: Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: open-angle
glaucoma
ocular
hypertension
POAG
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-10-06
Enrollment: 118
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: The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Diagnosis of open-angle glaucoma or ocular hypertension.
* LogMAR visual acuity not worse than 0.6.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Clinically relevant ophthalmic or systemic conditions.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Intraocular Pressure (IOP)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05170906: Cerebral Oxygenation During Vojta Therapy in Healthy Adults Using Near-infrared Spectroscopy
Official title: Cerebral Oxygenation During Vojta Therapy in Healthy Adults Using Near-infrared Spectroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Brain
Keywords: Adult
Vojta Therapy
Oxigenation
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A randomized clinical trial on a cohort of healthy subjects of legal age, both sexes, recruited from the university community and who will be randomly distributed into two groups (experimental and control).

The objective is to assess neurophysiological activation by measuring oxygenation in the supplementary motor and premotor areas of oxygenation in the supplementary motor and premotor areas, through near infrared spectroscopy (NIRS) in healthy subjects spectroscopy (NIRS) in healthy subjects during the application of Vojta Therapy.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old.
* Under 40 years old.
* Full cognitive capacity.

Exclusion Criteria:

* Subjects with neuro-muscular pathologies that affect the abdominal muscles, previous surgeries in the area or any chronic neurological or organic disorder that may alter the results.
* Vaccinated in the 10 days prior to the intervention
* Fever

Primary outcomes:
measure: Near Infrared Spectroscopy (NIRS)
timeFrame: 15 minutes per patients
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Juan Luis Sánchez González
Study officials:
References:
Clinical trial NCT04608006: Epidural Analgesia and Delivery of Second Twin
Official title: Epidural Analgesia and Delivery of Second Twin: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidural
Analgesia
Labor Pain
Keywords: Epidural
Analgesia
Labour
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 124
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with twins pregnancy planned for trial of vaginal delivery and gave birth

Brief summary: Over an 8-year period, 124 twin pregnancies at gestational age ≥32 weeks with both twins presenting as a vertex and eligible for vaginal delivery were reviewed. Excluded were patients with the following intrapartum factors which may affect mode of delivery of second twin: 1. Presentation of the 2nd twin: breech or other than vertex; 2. Monochorionic twins; 3. Induction of labour; 4. difference in foetal weight between twin B and twin A ≥25%. The chi-square statistic was used to compare differences in the incidence of retained second twin between the groups.

Detailed description: The investigators conducted this prospective study in women with twins pregnancy planned for trial of vaginal delivery and gave birth between January 2014 and December 2019, in the Department of obstetrics and Gynaecology of the Sabah Maternity Hospital, Sabah Specialized Area, Kuwait. The Sabah Maternity Hospital is a tertiary care hospital for the country of Kuwait with approximately 12500 deliveries per year. The study protocol was approved by the Ethics Committee.

Eligibility criteria: Inclusion Criteria:

.gestational age of 32 weeks, determined by an early ultrasound performed in the second trimester or certain last menstrual period; (2) both twins viable; (3) eligibility for vaginal delivery as defined by twin A being cephalic; and (4) no previous cesarean section.

Exclusion Criteria:

* underwent an elective or repeat cesarean section
* presentation of twin B at delivery other than cephalic (breech, oblique or transverse presentation
* induction of labour
* the difference in foetal weight between twin B and twin A at delivery ≥25% .Neonates were excluded if one was stillborn or had major congenital malformations.

Primary outcomes:
measure: Delivery of First twin
timeFrame: 24 hours
measure: Delivery of Second twin
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university faculty of medicine
Study officials:
affiliation: Assiut University
name: Abdelrady S Ibrahim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexander JM, Sharma SK, McIntire DD, Leveno KJ. Epidural analgesia lengthens the Friedman active phase of labor. Obstet Gynecol. 2002 Jul;100(1):46-50. doi: 10.1016/s0029-7844(02)02009-4.
Clinical trial NCT06188806: Investigation of the Effect of Proximal and Distal Adductor Canal Block in Knee Replacement Surgery
Official title: Investigation of the Effect of Proximal and Distal Adductor Canal Block on Pain Control and Functional Mobility in Total Knee Prosthesis Surgery Performed Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: adduktor canal block,knee artroplasti,postoperative pain
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-03
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three groups Group 1: proximal ACB (n:26) Group 2: distal ACB(n:26) Group 3: Control group (n:26)
Primary purpose: TREATMENT

Brief summary: to investigate the effect of adductor canal block applied with two different approaches in the treatment of pain after TKA surgery on pain control and functional mobility.

Detailed description: This prospective randomized trial is randomly divided into 3 groups using the method. Total knee arthroplasty is performed by the same surgical team.

is applied. The patients were divided into proximal ACB applied, distal ACB applied and control groups.

Eligibility criteria: Inclusion Criteria:

* Medications for unilateral TKA surgery

  * Patients aged 18-85
  * ASA 1-3

Exclusion Criteria:

* Patients under 18 years of age and over 85 years of age
* Patients with ASA 4 and above
* Patients with cognitive impairment
* Patients with application site infection
* Patients allergic to local anesthesia
* Patients receiving anticoagulant therapy
* Patients with bleeding diathesis
* Patients with chronic opioid or substance use
* Patients with insulin-dependent diabetes mellitus
* patients with neuropathy

  * patients with hepatic or renal failure
* Patients who do not accept the procedure to be applied

Primary outcomes:
measure: VISUAL ANALOGUE SCALE(VAS)
timeFrame: POSTOPERATIVE 6, 12 AND 24 HOURS
Secondary outcomes:
measure: first mobilization time
timeFrame: within postoperative 24 hours
measure: length of hospital stay
timeFrame: ONE WEEK
measure: opioid use
timeFrame: within postoperative 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Education and Research Hospital
state: Umraniye
Study officials:
References:
Clinical trial NCT03657706: Tunneling Technique in Treatment of Miller's Class III Gingival Recession
Official title: Analysis of the Aesthetic Outcome After Root Coverage Using Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Modified Free Gingival Graft in Miller's Class III Recession Defect: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several surgical techniques have been proposed to correct recession defect and attain root coverage. Though, the majority were executed on Miller Class I and II recession defects. Moreover, Analysis of literature revealed only a few studies that treated miller class III recession defects.

In the current study, a new modification in the free gingival graft is proposed to provide the patient with more esthetic outcome, less pain and postoperative trauma. Likewise, the proposed graft modification will combined both FGG and CTG benefits, overcome the limitations of the FGG and enhances the advantages of CTG.

Detailed description: In the current study, patients with Miller's class III will be randomly allocated in two groups. In the first group, gingival recession will be treated by tunneling technique with subepithelial connective tissue graft (sCTG). the tunnel preparation will be performed in the recession site then the sCTG will be harvested from the palate and inserted in the prepared tunnel and sutured in a coronally advanced position.

Equally , the second group will be treated with modified free gingival graft (mFGG). Initially, after tunnel preparation in the recession site and harvesting of the free gingival graft,the proposed modification is performed by mimicking the recession defect shape and size leaving the rest of the free gingival graft deepithelialized and inserted in the prepared tunnel. then, suturing will be performed in a coronally advanced position.

Eligibility criteria: Inclusion Criteria:

1. Patients with healthy systemic condition.
2. Buccal recession defects classified as Miller class III.
3. Clinical indication and/or patient request for recession coverage.
4. O'Leary index less than 20%.

Exclusion Criteria:

1. Pregnant females.
2. Smokers as smoking is a contraindication for any plastic periodontal surgery.
3. Unmotivated, uncooperative patients with poor oral hygiene
4. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.

Primary outcomes:
measure: root coverage aesthetic score (RES)
timeFrame: 6 months
Secondary outcomes:
measure: recession depth
timeFrame: 6 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT00228306: The Effect of Aerobic Exercise on Learning After Stroke
Official title: Effect of Cardiovascular Fitness on Motor Learning and Executive Function in Individuals After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2005-09-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Determine if attaining aerobic fitness is beneficial in producing cortical neuroplasticity in individuals with chronic stroke.

Detailed description: Crossover clinical trial. Experimental group undergoes 3x/wk/6 months of aerobic conditioning. Control group performs usual daily activities. All participants will be assessed with cognitive and motor behavioral testing at baseline, 3, 6, 9 and 12 months.

Eligibility criteria: Inclusion Criteria:

* Single ischemic stroke occuring 6-72 months prior
* Fugl-Meyer score (upper + lower extremity) 45 or greater
* Mini mental status score of \>23
* approval of the subject's medical doctor

Exclusion Criteria:

* already performing \>20 min of cardiovascular exercise 3x/wk or more
* alcohol consumption of \>2 oz. liquor, 8 oz. wine or 24 oz beer/day
* cardiac history of unstable angina, recent myocardia infarction within the last 3 months, congestive heart failure, significant valve dysfunction
* medical history of recent hospitalization (\> 3 months) for medical illness
* symptomatic peripheral arterial occlusive disease
* orthopedic or chronic pain conditions restricting exercise
* pulmonary or renal failure
* active cancer
* unstable hypertension (\>160/100 mmHg)
* diabetes mellitus (fasting glucose \> 180 NG./dk, HgA1C \> 10%) that is unable to be controlled \< month
* receptive or expressive aphasia as indicated on MMSE
* multiple strokes or other neuromuscular conditions
* major depression that is untreated using the Beck depression inventory

Primary outcomes:
measure: Motor learning behavioral measures; executive function behavioral measures.
timeFrame: Baseline, 8 weeks, 12 weeks
Secondary outcomes:
measure: Peak V02 and other aerobic capacity measures. Physical disability measures.
timeFrame: Baseline, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Barbara Quaney, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04760106: Learning Curves of Gastric Ultrasound for Novel
Official title: The Feasibility of Ultrasound for the Qualitative Assessment of Gastric Content, and Determine the Reliability of This Novel Tool in Gastric Volume Measurements When Performed by Novice Gastric Sonographers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Ultrasound
Learning Curve
Novel in Gastric Ultrasound
Keywords: Gastric ultrasound
Learning curve
Accuracy
Reliability
Novel in gastric ultrasound
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty healthy volunteers

Brief summary: Various studies have shown that gastric sonography can reliably provide information on both qualitative (nature of content) and quantitative (volume) aspects of gastric content. A recent study has suggested that a minimum of 33 scans is needed to achieve a 95% success rate in the qualitative assessment of gastric ultrasound. However, as the risk and severity of aspiration are also influenced by gastric volume, further study concerning quantitative assessment is warranted.

Detailed description: This study are conducted to affirm the feasibility of ultrasound for the qualitative assessment of gastric content, and determine the reliability of this novel tool in gastric volume measurements when performed by novice gastric sonographers. Two novels in gastric ultrasound learn from online materials, including educational videos and picture library through www.gastricultrasound.org and www.usra.ca. 1-hour lecture with discussion and 1-hour interactive hands-on with expert in gastric ultrasound. Then the novels were tested for the accuracy and reliability of their skills from 50 volunteers gastric ultrasound assessment.

Eligibility criteria: Inclusion Criteria:

* age between 18 to 70 years old with an American Society of Anesthesiologist physical status class I to II

Exclusion Criteria:

* BMI \> 40 kg/m2; pregnancy; diabetes mellitus; a history of upper gastrointestinal tract disease (including hiatal hernia and gastric tumors); and previous surgical procedures on the esophagus, stomach, or upper abdomen.

Primary outcomes:
measure: The accuracy of qualitative ultrasound assessment of gastric content in novel gastric sonographers
timeFrame: 3 months
Secondary outcomes:
measure: An interrater reliability of the quantitative ultrasound assessment of the gastric volume
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Siriraj Hospital
name: Pawinee Pangthipampai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tankul R, Halilamien P, Tangwiwat S, Dejarkom S, Pangthipampai P. Qualitative and quantitative gastric ultrasound assessment in highly skilled regional anesthesiologists. BMC Anesthesiol. 2022 Jan 3;22(1):5. doi: 10.1186/s12871-021-01550-z.