louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03918577: Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
Official title: Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Body Dysmorphic Disorders
Illness Anxiety Disorder
Keywords: Caloric Vestibular Stimulation
Insight
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, controlled crossover study
Primary purpose: OTHER

Brief summary: This study investigates whether caloric vestibular stimulation can modulate a measure of insight in obsessive-compulsive spectrum disorders.

Detailed description: Obsessive-compulsive and related disorders (OCRD), including obsessive compulsive disorder and body dysmorphic disorder, are chronic and disabling conditions characterized by recurrent intrusive thoughts and associated compulsive behaviors that affect millions of individuals in the US each year. Individuals affected by OCRD differ in insight, or the degree to which they understand their intrusive thoughts to reflect illness. Impairments in insight limit individuals' motivation to engage in care and predict worse outcome in those who access treatment.

This study seeks to explore whether unilateral stimulation of the vestibular system, which activates cortical areas hypothesized to underlie clinical insight, may beneficially modulate insight in individuals with OCRD.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Primary diagnosis of Obsessive-Compulsive Disorder, Body Dysmorphic Disorder, Illness Anxiety Disorder or Somatic Symptom Disorder (excluding "with predominant pain")
* Strongly held OCRD-related concerns meeting BABS score criterion.
* No recent change in psychopharmacological treatment, if any
* Capacity to provide informed consent

Exclusion Criteria:

* Psychiatric or medical conditions (eg, vertigo, history of otological surgery) that might make participation unsafe
* Pregnant or nursing women
* Active or recent substance use

Primary outcomes:
measure: change in clinical insight as measured by the Brown Assessment of Beliefs (BABS).
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Peter J van Roessel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04933877: Serratus Anterior Plane Block Versus Erector Spinae Plane Block. for Thoracotomy in Pediatric Patients
Official title: Serratus Anterior Plane Block Versus Erector Spinae Plane Block For Thoracotomy In Pediatric Patients: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: Erector spinae block
Pediatric
serratus anterior plane block
Thoracotomy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Misr University for Science and Technology
First posted: 2021-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controled trial is designed to compare efficacy and safty of serratus anterior plane block versus erector spinae plane block for thoracotomy in pediatric patients.


Eligibility criteria: Inclusion Criteria

* Age 1 to 10-year-old
* ASA I, II, and II

Exclusion Criteria

* Patients whose parents or legal guardians refusing to participate.
* Preoperative mechanical ventilation.
* Preoperative inotropic drug infusion.
* Known or suspected coagulopathy.

Primary outcomes:
measure: post-operative fentanyl consumption
timeFrame: 9 month
Secondary outcomes:
measure: intraoperative fentanyl consumption
timeFrame: 24 hours
measure: FLACC score at 1,2,4,8,12,24 hours postoperatively
timeFrame: 24 hours
measure: patient satisfaction
timeFrame: 24 hours
measure: RASS score
timeFrame: 24 hours
measure: time of first rescue analgesi
timeFrame: 24 hours
measure: Quality of Recovery-15 (QoR-15) scale at 24 h postoperatively.
timeFrame: 24 hours
measure: PONV
timeFrame: 24 hours
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr University For Science And Technology
Study officials:
References:
citation: Gaballah KM, Soltan WA, Bahgat NM. Ultrasound-Guided Serratus Plane Block Versus Erector Spinae Block for Postoperative Analgesia After Video-Assisted Thoracoscopy: A Pilot Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1946-1953. doi: 10.1053/j.jvca.2019.02.028. Epub 2019 Feb 21.
citation: Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11.
Clinical trial NCT00304577: Bilateral Recession or Unilateral Recession-Resection as Surgery for Infantile Esotropia
Official title: A Randomized Comparison of Bilateral Recession With Unilateral Recession-Resection as Surgery for Infantile Esotropia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strabismus
Keywords: Strabismus
Esotropia
Surgical techniques
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2006-03-20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Infantile esotropia is corrected in most cases by bilateral recession of the medial rectus muscles (BR) or by unilateral recession of the medial rectus muscle and resection of the lateral rectus muscle (RR). We compared the outcome of these techniques in a randomized prospective study.

Detailed description: We randomly assigned 124 patients (average age 5.8) from twelve participating clinics in Germany and the Netherlands to either BR or RR. Patients did not have demonstrable binocular vision at baseline. The angle of strabismus was measured pre- and postoperatively in a standardized fashion. The primary parameter to assess difference between BR and RR was the variation of the latent angle of strabismus at distance at three months postoperatively, secondary outcomes were reduction of convergence excess and binocular vision.

Eligibility criteria: Inclusion Criteria:

* Eligible were all children aged three to eight years with a normal psychophysical development, and onset of esotropia before age one who visited one of the clinics during the study period.

Exclusion Criteria:

* previous strabismus surgery, an angle of strabismus larger than 24° or smaller than 10°, any normal binocular vision, convergence excess with angle of strabismus at near fixation 1.5 times larger than the angle at distance, more than 1 line Logmar acuity difference between the two eyes, hypermetropia over 6 diopters or myopia over 3 diopters, up- or downshoot in (25°) adduction more than 8°, V-pattern (25° up and down gaze) over 8°, A-pattern (25° up and down gaze) over 5° and manifest vertical strabismus over 4°

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Dept. Ophthalmology
city: Erlangen
country: Germany
facility: Dept. Ophthalmology
city: Essen
country: Germany
facility: Dept. Ophthalmology
city: Frankfurt
country: Germany
facility: Dept. Ophthalmology
city: Freiburg
country: Germany
facility: Dept. Ophthalmology
city: Hamburg
country: Germany
facility: Dept. Ophthalmology
city: Heidelberg
country: Germany
facility: Dept. Ophthalmology
city: Regensburg
country: Germany
facility: Dept. Ophthalmology
city: Tuebingen
country: Germany
facility: Dept. Ophthalmology
city: Maastricht
country: Netherlands
facility: Dept. Ophthalmology
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: Dept. Ophthalmology
Study officials:
affiliation: Erasmus MC, Rotterdam
name: Huib J. Simonsz, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00465777: Improved Management and in-Hospital Mortality
Official title: Reduced in-Hospital Mortality After Improved Management of Patients Hospitalised With Malaria. A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mortality
Malaria
Keywords: malaria
mortality
hospital
incentive
personnel
paediatric
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
Collaborators: name: Statens Serum Institut
name: World Health Organization
First posted: 2007-04-25
Enrollment: 950
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward.

Detailed description: Mortality at the national paediatric ward in Guinea-Bissau is very high. During a civil war in 1998/1999 the hospital case fatality (CF) decreased by more than 40%, increasing again after the the war. This was attributed to the available free drugs from the humanitarian aid and food incentives to the personnel. Free emergency kits for treatment of severe malaria was introduced, however the CF did not decline. Therefore, the ward was split into two groups of rooms: intervention and control. All the staff of the ward was trained in the use of a standardised guideline for treatment of severe malaria and randomly assigned to one of the groups. All children hospitalised for malaria received the drug emergency kits. The only difference in the intervention group were the small financial incentives and supervision for strict adherence to the guidelines procedures.

Eligibility criteria: Inclusion Criteria:

* Hospitalization due to malaria
* Non per os

Exclusion Criteria:

* Consent from parent/caretaker declined

Primary outcomes:
measure: In-hospital case-fatality
Secondary outcomes:
measure: Cumulative post-discharge mortality on day 28 and length of hospitalisation
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project
Study officials:
affiliation: Bandim Health Project
name: Peter Aaby, DMSc
role: STUDY_CHAIR
References:
citation: Biai S, Rodrigues A, Gomes M, Ribeiro I, Sodemann M, Alves F, Aaby P. Reduced in-hospital mortality after improved management of children under 5 years admitted to hospital with malaria: randomised trial. BMJ. 2007 Oct 27;335(7625):862. doi: 10.1136/bmj.39345.467813.80. Epub 2007 Oct 22.
Clinical trial NCT04967677: Establishing of the Inter-rater Reliability and Variability of Selected Standardized Tests Performed in Czech Language
Official title: Establishing of the Inter-rater Reliability and Variability of Selected Standardized Tests Performed According to New Czech Extended Manuals
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Motor Activity
Keywords: standardized test
occupational therapy
fine motor skills
Nine Hole Peg Test
Purdue Pegboard Test
Box and Block Test
inter-rater reliability
variability
Czech language
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Czech healty occupational therapy students

Brief summary: The main aim of the pilot project is to establish inter-rater reliability, internal variability and variability of results got in two different ways of the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test administered according to the new Czech extended versions of their manuals.

Detailed description: New Czech manuals for the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test were made by back-translation method. They were updated and extended by new rules for unification of their performing. The manuals include instructions for performing three trials of each subtest.

At least 30 occupational therapy students will be tested by those three tests according to those new Czech manuals. Video of students' performance will be obtained.

The inter-rater reliability, internal variability and variability of results got in two different ways will be established.

Eligibility criteria: Inclusion Criteria:

* Czech language as a mother tongue
* age from 20 to 65 years
* occupational therapy student

Exclusion Criteria:

* diagnosed pathology of the upper limbs or diseases that negatively affect the dexterity of their limbs
* use of drugs affecting attention
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to read or write
* inability to complete complete testing
* failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague

Primary outcomes:
measure: results from the Nine Hole Peg Test
timeFrame: 10 minutes
measure: results from the Purdue Pegboard Test
timeFrame: 25 minutes
measure: results from the Box and Block Test
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Study officials:
affiliation: Charles University And General University Hospital In Prague
name: Kateřina Rybářová, Mgr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00972777: Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis
Official title: A Study to Evaluate the Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% BID Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bacterial Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 474
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.


Eligibility criteria: Inclusion Criteria:

* Subjects who are at least one year of age.
* Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
* Subjects who are willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

* Subjects who have any uncontrolled systemic disease or debilitating disease.
* Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
* Subjects who are expected to require treatment with any disallowed medications.

Primary outcomes:
measure: Clinical Resolution
timeFrame: Visit 2
measure: Microbial Eradication
timeFrame: Visit 2
Secondary outcomes:
measure: Clinical Resolution
timeFrame: Visit 3
measure: Microbial Eradication
timeFrame: Visit 3
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Michael R Paterno, OD
role: STUDY_DIRECTOR
References:
citation: Haas W, Gearinger LS, Hesje CK, Sanfilippo CM, Morris TW. Microbiological etiology and susceptibility of bacterial conjunctivitis isolates from clinical trials with ophthalmic, twice-daily besifloxacin. Adv Ther. 2012 May;29(5):442-55. doi: 10.1007/s12325-012-0023-y. Epub 2012 May 25.
citation: DeLeon J, Silverstein BE, Allaire C, Gearinger LS, Bateman KM, Morris TW, Comstock TL. Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children. Clin Drug Investig. 2012 May 1;32(5):303-17. doi: 10.2165/11632470-000000000-00000.
citation: Silverstein BE, Allaire C, Bateman KM, Gearinger LS, Morris TW, Comstock TL. Efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study in adults and children. Clin Ther. 2011 Jan;33(1):13-26. doi: 10.1016/j.clinthera.2010.12.004.
Clinical trial NCT04465877: Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
Official title: Single-blind, Randomized, Placebo-controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JTT-662 Administered for 28 Days in Subjects With Type 2 Diabetes Mellitus on Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: JTT-662
Diabetes
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-10
Enrollment: 37
Sex: ALL
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: This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM) who are receiving metformin monotherapy


Eligibility criteria: Inclusion Criteria:

* Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit
* Currently treated with a stable oral dose of metformin monotherapy for at least 12 weeks prior to the Screening Visit and until Day -3
* Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the Screening Visit
* Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening Visit and on Day -3
* Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)

Exclusion Criteria:

* Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes of the Young or secondary forms of diabetes
* Known medical history or presence of diabetic complications
* Have taken anti-diabetic medications (other than metformin) or medications that act mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior to the Screening Visit or from the Screening Visit to Day -3
* Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or diastolic blood pressure of at least 95 mmHg) at the Screening Visit
* Have impaired renal function (estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2)

Primary outcomes:
measure: Number of Subjects With Treatment-emergent Adverse Events
timeFrame: 6 Weeks (from Day -1 to the follow-up visit on Day 42)
measure: Number of Stools and Type of Stools Based on Bristol Stool Chart
timeFrame: 7 Weeks (from Day -6 to the follow-up visit on Day 42)
measure: Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
timeFrame: 28 Days
measure: Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28
timeFrame: Days 1, 14 and 28
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
Study officials:
References:
Clinical trial NCT03096977: Use of the Nine Holes Peg Test in Multiple Sclerosis: Participation of Elementary Neurological Components in the Functional Evaluation of Manual Dexterity
Official title: Use of the Nine Holes Peg Test in Multiple Sclerosis: Participation of Elementary Neurological Components in the Functional Evaluation of Manual Dexterity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Hand dexterity
Multiple sclerosis
Nine Holes Peg
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study lies in the continuity of the study with identification number NCT02805634. It will be performed on the same group of patients and will aim to assess the manual dexterity, in order to better assign kinesitherapy treatments and increase the utilisation capacity of the hand.


Eligibility criteria: Inclusion Criteria:

* All patients included in the NCT02805634 study

Exclusion Criteria:

* None

Primary outcomes:
measure: Scale for the assessment and rating of ataxia (SARA)
timeFrame: 1 year
measure: Prehension force
timeFrame: 1 year
measure: Tuned fork result
timeFrame: 1 year
measure: Sermes and Weinstein test
timeFrame: 1 year
measure: Weber test
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Bernard Dachy, MD
role: PRINCIPAL_INVESTIGATOR
References: