louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05898568: Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy
Official title: Virtual Reality in Hand Peripheral Nerve Injuries Effectiveness of Based Movement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Nerve Injury, Virtual Reality, Rehabilitation
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 42
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: The aim of this study is to investigate the effectiveness of virtual reality-based motion therapy in peripheral nerve injuries in the hand.


Eligibility criteria: Inclusion Criteria:

* ıt was operated in the early period with the diagnosis of peripheral nerve injury in the postoperative hand.
* clinical impression was made.
* out patient with median, ulnar, and radial nerve repair.
* completed the 6th postoperative week.

Exclusion Criteria:

* Those who have communication problems and users
* With the musculoskeletal system, the additional passage, rheumatological, etc., where they are located.

those with the disease

- Patients with multiple traumas

Primary outcomes:
measure: Jebsen Taylor Hand Function Test
timeFrame: from baseline to the end of the treatment (4 week)
measure: visual analog scale (VAS)
timeFrame: from baseline to the end of the treatment (4 week)
measure: duruöz hand index
timeFrame: from baseline to the end of the treatment (4 week)
measure: Sammes Weinstein Monofilament Test (SWMT)
timeFrame: from baseline to the end of the treatment (4 week)
measure: Questionnaire Quick Disability of the Arm, Shoulder, and Hand (Quick DASH)
timeFrame: from baseline to the end of the treatment (4 week)
measure: Jamar dynamometer
timeFrame: from baseline to the end of the treatment (4 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
state: Arızlı
Study officials:
References:
Clinical trial NCT06239168: Citrus Extract, Sleep and Mental Wellbeing
Official title: The Effect of Citrus Extract on Sleep and Mental Wellbeing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: BioActor
First posted: 2024-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, cross-over trial investigating the effects of daily administration of citrus extract on sleep and mental wellbeing.

Detailed description: Based on epidemiological data, a substantial number of people report to have sleeping problems. This is of major concern, as poor sleep quality has been associated with impaired mental and physical health. Several pre-clinical studies have shown promising results, but evidence from human studies is still limited. Therefore, the aim of the present study is to investigate the effect of a citrus extract on sleep and mental wellbeing in healthy subjects with (minor) sleep disturbance.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals with (minor) sleep disturbance
* Age 40-70 years
* BMI 18.5 - 30 kg/m2
* Willingness to give up being a blood donor from 4 weeks before the start of the study, during the study and for 4 weeks after completion of the study

Exclusion Criteria:

* Excessive caffeine use
* Major psychiatric/mental health disorders .
* Chronic sleep disorders
* Severe sleep disturbance for more than 1 year
* Other clear causes for poor sleep quality or mental wellbeing
* Use of medication or supplements that can affect outcomes
* Nonpharmacological treatment for sleep disorders
* Flight from a time-zone with \>3 h difference ≤1 week before an intervention period
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study
* Use of pre-, pro- or synbiotics within 1 month prior to the start of the study
* Reported weight loss or weight gain of \>3 kg in the month prior to pre-study screening
* Smoking
* Abuse of products
* Known allergy to citruses
* Known pregnancy or lactation

Primary outcomes:
measure: Changes in sleep quality scores between the intervention and placebo group
timeFrame: 8 weeks of intervention
measure: Changes in sleep quality between the intervention and placebo group
timeFrame: 8 weeks of intervention
Secondary outcomes:
measure: Changes in mental wellbeing between the intervention and placebo group
timeFrame: 8 weeks of intervention
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Jogchum Plat
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Tanja Adam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04918368: Vitamin D and Sleep Disorders in Pregnancy
Official title: Do Low Vitramin D Levels Increase the Frequency of Sleep Disorders and Anxiety in the 2nd and 3rd Trimester?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorder
Pregnancy Related
Vitamin D Deficiency
Keywords: anxiety
Pregnancy,
Sleep Wake Disorders
Vitamin D
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2021-06-08
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 225 pregnant women who are in second or third trimester of pregnancy

Brief summary: Lack of sleep and poor sleep quality in pregnant women are associated with maternal depression and cognitive-sensual irregularities. These irregularities were reported worsening women's life quality and even increasing suicide ideation. It is also associated with obstetrical complications such as fetal growth deficiency, preterm birth, prolonged labor, preeclampsia and increased abdominal delivery frequency.Vitamin D also may affect the sleep indirectly through the cases with nonspecific pains. It was reported that vitamin D levels are correlated with sleep disorders such as obstructive sleep apnea and restless legs syndrome. The primary purpose of this study is to examine sleep disorders and vitamin D levels in pregnant women, and also, secondarily, vitamin D - anxiety and sleep disorders - anxiety relations were assessed.


Eligibility criteria: Inclusion Criteria:

* singletone pregnant women
* second and third trimester pregnant women

Exclusion Criteria:

* psychiatric disorder
* sleep disorder

Primary outcomes:
measure: Health Initiative Sleeplessness Scale (WHISS)
timeFrame: Through study completion, an average of 1 year
measure: State Anxiety Scale (SAS)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatma Ketenci Gencer
Study officials:
References:
Clinical trial NCT06707168: INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY
Official title: ACCURACY of DIGITAL INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY SURGERY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pars Plana Vitrectomy
Keywords: intraocular pressure
pars plana vitrectomy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Intraocular pressure is measured regularly at any and all visits with your eye doctor or optometrist.

The purpose of this study is to compare measurements of eye pressure at the end of the surgery, comparing the ability of a gloved finger or sterile cotton-tipped applicator ("Q-tip") to accurately measure intraocular pressure against a standardized instrument designed for this purpose.


Eligibility criteria: Inclusion Criteria:

1. All patients undergoing Pars Plana Vitrectomy between June 25, 2024 - and December 30, 2024, will be included.
2. Patients aged 18 years or older
3. Patients able to give informed consent

Exclusion Criteria:

1. Patients with complicated Pars Plana Vitrectomy (choroidal hemorrhage, retrobulbar hemorrhage)
2. Patients with irregular cornea surface will be excluded (keratoconus, band keratopathy, corneal edema, corneal transplant, cornea scarring)
3. Patients undergoing combined scleral buckling at time of surgery
4. Patients with previous glaucoma filtration surgery (ie. trabeculectomy or tube shunt surgery)

Primary outcomes:
measure: Intraocular pressure measurement
timeFrame: From enrolment to end of treatment at 8 weeks
Secondary outcomes:
measure: Intraocular pressure measuring agreement
timeFrame: From enrolment to end of treatment at 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Acar N, Kapran Z, Unver YB, Altan T, Ozdogan S. Early postoperative hypotony after 25-gauge sutureless vitrectomy with straight incisions. Retina. 2008 Apr;28(4):545-52. doi: 10.1097/IAE.0b013e318162b008.
citation: Wilde C, Bhardwaj P, King A, Kumudhan D, Foss A, Orr G, Zaman A. First postoperative day review in eyes undergoing pars plana vitrectomy, encirclement and endotamponade to check intraocular pressure: Is it necessary? Int Ophthalmol. 2020 Oct;40(10):2577-2583. doi: 10.1007/s10792-020-01438-w. Epub 2020 Jun 1.
citation: Alexander P, Michaels L, Newsom R. Is day-1 postoperative review necessary after pars plana vitrectomy? Eye (Lond). 2015 Nov;29(11):1489-94. doi: 10.1038/eye.2015.134. Epub 2015 Aug 28.
Clinical trial NCT06900868: The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial
Official title: The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: DME
Dental Caries
Dental
Deep Margin Elevation
Keywords: Deep margin elevation
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Deep marginal elevation usinge a bioactive dental material in deep subgingival Class II restorations, S-PRG filler-containing materials offer significant benefits due to their bioactive properties, Their ability to release fluoride, remineralization potential and acid neutralization, reducing the risk of recurrent caries, particularly at the gingival margin(Imazato et al. 2023). The antibacterial and antifungal effects help inhibit biofilm formation, enhancing the longevity of restorations. Additionally, these materials support better marginal adaptation by reducing microleakage and improving bond durability (Imazato et al. 2023) This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health(Imazato et al. 2023).


Eligibility criteria: Inclusion Criteria:

* Adults patients (20-50)
* Good oral hygiene (plaque index 0 or 1 )
* Patient approving to participate in the study
* Absence of parafunctional habits and/or bruxism
* No sign of irreversible pulpitis
* No periapical radiolucency
* Deep subgingival margin
* Molars class II with subgingival margin

Exclusion Criteria:

* • Patients with known allergic or adverse reaction to the tested materials.

  * Systematic disease that may affect participation.
  * Xerostomic patients.
  * Bad oral hygiene (plaque index 2 or 3 )
  * Heavy smokers
  * Patients undergoing or will start orthodontic treatment
  * Patients with removable prothesis

Primary outcomes:
measure: Recurrent caries
timeFrame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
Secondary outcomes:
measure: Fracture of Restoration
timeFrame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
measure: Post- operative sensitivity
timeFrame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
measure: Bleeding on Probing
timeFrame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
Other outcomes:
Locations:
Study officials:
References:
citation: Felemban MF, Khattak O, Alsharari T, Alzahrani AH, Ganji KK, Iqbal A. Relationship between Deep Marginal Elevation and Periodontal Parameters: A Systematic Review. Medicina (Kaunas). 2023 Nov 3;59(11):1948. doi: 10.3390/medicina59111948.
citation: Choudhury WR, Nekkanti S. Mechanical Properties of SDR and Biodentine as Dentin Replacement Materials: An In Vitro Study. J Contemp Dent Pract. 2022 Jan 1;23(1):43-48.
Clinical trial NCT02531568: Drug Interaction Study of Warfarin and MT-3995
Official title: A Phase I, Open-label, Single-Centre, Drug-Drug Interaction Study to Evaluate the Influence of MT-3995 on Pharmacokinetics(PK) and Pharmacodynamics of Warfarin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2015-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin

Detailed description: The purpose of this study is to evaluate the potential effects of multiple once daily doses of MT-3995 on the PK of (S)-warfarin and (R)-warfarin after single-dose administration of racemic warfarin

Eligibility criteria: Inclusion Criteria:

* Able and willing to provide written informed consent to participate in this study
* Healthy, free from clinically significant illness or disease
* White Caucasian male or female, aged 18 to 55 years
* Body weight ranging from 50 (females) and 60 (males) to110 kg (inclusive)
* Must have coagulation test results (including international normalised ratio \[INR\] and activated partial thromboplastin time \[aPTT\]) within the laboratory reference range at Screening.

Exclusion Criteria:

* Presence or history of serious adverse reaction or allergy to any medicinal product
* Known contraindication or adverse reaction to warfarin.
* Presence of Cytochrome P450 2C9 (CYP2C9) and Vitamin K epoxide reductase complex subunit 1 (VKORC1) genetic polymorphisms that are known to increase warfarin sensitivity at Screening.
* Known contraindications to heparin administration.
* Known contraindication to parenteral vitamin K administration.

Primary outcomes:
measure: Cmax of warfarin with MT-3995 versus warfarin alone
timeFrame: 8 days
measure: AUC of warfarin with MT-3995 versus warfarin alone
timeFrame: 8 days
Secondary outcomes:
measure: International normalized ratio (INR) max of warfarin with MT-3995 versus warfarin alone
timeFrame: 8 days
measure: INR AUC of warfarin with MT-3995 versus warfarin alone
timeFrame: 8 days
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: Clinical research organization
state: Wegenerstraße
Study officials:
affiliation: Nuvisan GmbH
name: Horst Heuer, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakamura T, Shimizu H, Kawaguchi A. Drug-Drug Interactions of the Nonsteroidal Mineralocorticoid Receptor Antagonist Apararenone With Midazolam, Warfarin, and Digoxin: A Phase 1 Studies in Healthy Volunteers. Clin Ther. 2020 Nov;42(11):2171-2183.e4. doi: 10.1016/j.clinthera.2020.09.002. Epub 2020 Nov 3.
Clinical trial NCT02874768: Comparison Between Dexmedetomidine and Propofol for Patients in the Intensive Care Unit After Abdominal Surgery
Official title: Comparison Between Dexmedetomidine and Propofol for Postoperative Sedation of Patients in the Intensive Care Unit After Abdominal Surgery: Microcirculation, Kidney Injury, and Intestinal Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Microcirculation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single-blind randomized clinical trial. Patients undergoing abdominal surgery will be enrolled and randomly divided into two groups: dexmedetomidine group and propofol group. In the dexmedetomidine group, patients will receive continuous intravenous infusion of dexmedetomidine (infusion dosage range: 0.1 \~ 0.7 mcg/kg/h). In the propofol group, patients will receive continuous intravenous infusion of propofol (infusion dosage range: 0.3 \~ 1.6 mg/kg/h). Hemodynamics will be continuously monitored using a non-invasive monitoring with chest bioreactance technique at preset time points (0, 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results and fluid balance will be recorded. The microcirculation will be examined by Cytocam. The following microcirculatory parameters will be investigated: total small vessel density, perfused small vessel density, microvascular flow index, and heterogeneity index. The enzyme-linked immunosorbent assays will be used to measure serum level of endocan, diamine oxidase, and neutrophil gelatinase-associated lipocalin at preset time points. The primary goal of this study is to compare the effect on microcirculation between dexmedetomidine and propofol in intensive care unit patients after abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* non-emergent major abdominal surgery with ICU admission
* the need of sedation during ICU stay

Exclusion Criteria:

* age younger than 20 years and older than 89 years
* refractory bradycardia (HR \< 60 bpm after treatment)
* severe AV block (2nd or 3rd degree)
* refractory shock (MAP \< 60 mm Hg after treatment)
* severe heart failure or NYHA 4
* new onset of myocardial infarction within 4 weeks
* receive CPR within 4 weeks
* APACHE score \> 30 before enrollment
* severe liver cirrhosis or CHILD B or C
* pregnancy
* allergic history to dexmedetomidine or propofol
* be enrolled in other clinical trials related to dexmedetomidine or propofol within 4 weeks
* non-native speakers

Primary outcomes:
measure: Total perfused small vessel density
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chang Yeh, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02600468: Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg
Official title: Outline of Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2015-11-09
Enrollment: 671
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's survival and development of malignancies after treatment discontinuation

Brief summary: The purpose of this study to collect information on the safety, especially serious infections and malignancies, and efficacy of the long-term use of ORENCIA Intravenous Infusion 250mg in patients with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Patients who are beginning to receive the treatment with ORENCIA Intravenous Infusion 250mg under the approved indications, dosage, and administration
* Have available HAQ data
* Have available DAS28-ESR or DAS28- CRP data
* Have no past or present history of malignancies
* Are expected to be followed up for 3 years

Primary outcomes:
measure: Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events
timeFrame: 3 years
Secondary outcomes:
measure: Efficacy measured by Patient's survival
timeFrame: 3 years
measure: Efficacy measured by development of malignancies after treatment discontinuation
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06189768: A Study on Pigmentation Disorders in Children
Official title: A Retrospective Study on Pigmentation Disorders in Children in a Tertiary Care Children's Hospital.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperpigmentation
Pediatric Dermatology
Keywords: Hyperpigmentation disorders
Nepal
Pediatric
Observational study
Lead sponsor: Nepal Health Research Council
Sponsor class: OTHER_GOV
First posted: 2024-01-05
Enrollment: 299
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusive of children ranging from newborns to 15 years old with hyperpigmentation due to any cause, the study excluded those admitted to wards with alternative diagnoses

Brief summary: The descriptive cross-sectional study was undertaken at Kanti Children's Hospital during the period from January 2020 to June 2021. Ethical approval for the study was obtained from the Institutional Review Board of Kanti Children's Hospital (IRB-KCH). The refence number is 59/2020-021. The study focused on children with hyperpigmentation disorders presenting at the Dermatology Outpatient Department of Kanti Children's Hospital.


Eligibility criteria: Inclusion Criteria:

* children ranging from newborns to 15 years old with hyperpigmentation due to any cause

Exclusion Criteria:

* children admitted to wards

Primary outcomes:
measure: Measure the causes of hyperpigmentation in children aged 0 to 15
timeFrame: 1.5 years
measure: Measure the age distribution of children with hyperpigmentation disorders
timeFrame: 1.5 years
measure: Measure the gender distribution of children with hyperpigmentation disorders
timeFrame: 1.5 years
measure: Measure the caste distribution of children with hyperpigmentation disorders
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Kanti Children's Hospital
Study officials:
References: