louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04187131: An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation
Official title: An Augmented Reality Based System for Neglect Detection, Assessment, and Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Northeastern University
name: NSF
First posted: 2019-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this phase is to examine the feasibility and acceptability of the Augmented Reality (AR)-based and electroencephalography (EEG)-based neglect detection and rehabilitation tool.


Eligibility criteria: Inclusion Criteria:

* ages18 and older
* acute stroke
* admitted to inpatient rehabilitation
* presence of neglect (Behavioral Inattention Test total score \<129, or scoring below pre-defined cutoff score in at least one of the six subtests)
* more than 10/% missed targets on the Augmented Reality Screening Test
* intact vibration (positive test on Vibration Sensation Test)
* intact auditory function (positive test on Auditory Sensation Test)
* English speaking

Exclusion Criteria:

* inability to follow one-step directions at least 80% of the time
* current diagnosis of dementia, Parkinson's disease, multiple sclerosis, or space-occupying tumor
* metal in the head that causes interference with the EEG system
* self-report of previous positive photic stimulation test

Primary outcomes:
measure: Accuracy; indicated by percent agreement between participant report and EEG-based assessment of neglect
timeFrame: week 4
measure: Reliability; indicated by correlation coefficient between two consecutive sessions of EEG recording
timeFrame: week 4
Secondary outcomes:
measure: Technology Satisfaction; indicated by a mean score of 3 or higher on the Quebec User Evaluation of Satisfaction with Assistive Technology
timeFrame: week 4
measure: Program Satisfaction; indicated by mean score of 3 or greater on the Client Satisfaction Questionnaire
timeFrame: week 4
Other outcomes:
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Murat Akcakaya, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02400931: The Necessity of Routine Mask Ventilation in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 288
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The mask ventilation is a necessary procedure to provide oxygenation before the tracheal intubation although the gastric insufflation occurs during the mask ventilation. Sugammadex, which is recently introduced, enables the use of high-dose muscle relaxant without concerning the delayed recovery of neuromuscular blockade. It seems that there is no need to perform the mask ventilation in adults with normal airway if the investigators use high-dose muscle relaxant for the anesthetic induction because adequate muscle relaxation can be achieved within 1-2 minutes. Therefore, the investigators hypothesized that routine mask ventilation is not needed in adult patients with normal airway. The investigators will compare the incidence of desaturation and gastric insufflation between the patients with mask ventilation and the patients without mask ventilation.


Eligibility criteria: Inclusion Criteria:

* adult patients of age over 20 years for scheduled surgery with more than one and a half hours under general anesthesia

Exclusion Criteria:

* anticipated difficult mask ventilation,
* anticipated difficult intubation,
* ASA class 3 or 4,
* preoperative saturation less than 92%.,
* saturation less than 98% after preoxygenation
* body mass index over 35 kg/m2,
* obstructive sleep apnea,
* mass in the oral cavity or in the trachea,
* pregnant woman

Primary outcomes:
measure: Desaturation (saturation less than 95%)
timeFrame: until 2 minutes after the completion of tracheal intubation
Secondary outcomes:
measure: gastric insufflation (observe the antral area of the stomach using ultrasonography)
timeFrame: until 2 minutes after the completion of tracheal intubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04007731: New Protein Bar for Physically Active People
Official title: Effects of New Protein Bar on Biochemical and Physiological Parameters in Physically Active People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Mass
Inflammation
Regeneration Muscle
Keywords: protein bar
physical activity
muscle
Lead sponsor: University of Primorska
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Post-exercise nutrition is an important factor in a nutrition plan for physically active subjects. Focusing on that, the Serbian group is developing protein bars enriched with sports supplements. Slovenian partner group will investigate the effect of new protein bar consumption on body composition, biochemical parameters, and muscle regeneration after training. The new bar will be compared with a commercially available bar.

Detailed description: The clinical study will be performed on 10 elite handball players from Slovenia handball club. It will be designed as a crossover study. Half of the participants will consume the new bar for five days and the other half will consume the control bar. After the five-day washout period, the groups will consume the bar which was not consumed in the first period.

At baseline, at the end of every intervention and washout period, the blood samples will be withdrawn, and the body composition will be analyzed.

The analyzed biochemical parameters will be basic serum parameters, such as fasting glucose, total cholesterol, LDL, HDL, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), C-reactive protein (CRP), and parameters related to the muscle regeneration and inflammation, such as creatine kinase, lactate dehydrogenase, insulin-like growth factor (IGF), tumor necrosis factor alpha (TNF-alpha), interleukin 6 (IL-6), monocyte chemoattractant protein 1 (MCP-1).

In the second part of the study, the acute effect of consuming each bar after training will be tested. Each participant will consume both bars on separate days. The mentioned parameters will be assessed after training and immediately and 3h after bar consumption.

Eligibility criteria: Inclusion Criteria:

* daily high-intensity physical activity

Exclusion Criteria:

* smoking, cardiovascular, neurological, skeletal muscle disease, allergies

Primary outcomes:
measure: Muscle mass
timeFrame: 15 days
measure: Fat mass
timeFrame: 15 days
Secondary outcomes:
measure: C-reactive protein
timeFrame: 15 days
measure: Creatine kinase
timeFrame: 15 days
measure: Lactate dehydrogenase
timeFrame: 15 days
measure: Tumor necrosis factor alpha
timeFrame: 15 days
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
Study officials:
References:
Clinical trial NCT00564031: Hormonal Replacement Therapy and Small Artery Function
Official title: Hormonal Replacement Therapy and Small Artery Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopause
Keywords: hormone replacement therapy; endothelial function;
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2007-11-27
Enrollment: 66
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endothelial dysfunction in resistance arteries in women after the menopause is important for the development of high blood pressure and cardiovascular disease

Detailed description: We aim to study the effects of different hormone replacement therapies (HRT) on the function and morphology of resistance arteries, and to look for their mechanistic basis. We expect that HRT with estrogens or in combination with MPA may benefit the function of resistance arteries and may preserve the morphological integrity of endothelial cells by regulatory actions on the cytoskeleton.

Eligibility criteria: Inclusion Criteria:

* All women had been amenorrheic for at least 1.5 year.
* Menopausal status was confirmed by a serum concentration of follicular- stimulating hormone (FSH \> 34 IU/ml) and estradiol (E2 \<50 pmol/l).

Exclusion Criteria:

* Cigarette smokers and women with:

  * Hypertension
  * Diabetes mellitus
  * Clinical manifestations of arteriosclerosis (coronary heart disease, peripheral artery disease, or cerebrovascular disease)
  * Venous thromboembolic disease
  * Liver disorders
  * Unexplained vaginal bleeding; and
  * Personal or family history of breast cancer were excluded.

Primary outcomes:
measure: endothelium-dependent dilatation
timeFrame: 3 month
Secondary outcomes:
measure: pressure-induced tone and vascular morphology
timeFrame: 3 month
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University hospital-huddinge
Study officials:
affiliation: Karolinska University Hospital
name: Karolina Kublickiene, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04329260: Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity
Official title: Mutation of the LEPR Gene at Reunion Island: Involvement in Pediatric Obesity GRÉOL (Génétique Réunion Obésité LEPR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Childhood
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 3 to 18 years old with severe obesity (BMI\>30) and adult family members.

Brief summary: The objective of this study is to estimate the proportion of the recurrent deletion Δ6-8 of the LEPR gene in the homozygous and heterozygous state in pediatric cases with severe and early ( before the age of 6) obesity (BMI ≥ IOTF-30) on Reunion Island.

Detailed description: The study of the deletion Δ6-8 of the LEPR gene starts with a saliva sample using a swab in children aged between 3 to 18 years old.

The DNA from this sample will then be analyzed by the PCR technique. If the deletion of the LEPR gene is confirmed in the patient, his adult family members will also be screened using the same procedure.

Eligibility criteria: Inclusion Criteria:

* patient with early severe and non syndromic obesity (BMI\> IOTC-30) (before 6 years old)
* adult family members with deletion of LEPR gene
* informed consent form signed by participants or parents
* affiliation to social security scheme

Exclusion Criteria:

* patient with syndromic obesity
* patient Under guardianship or Under judicial protection

Primary outcomes:
measure: Proportion of the Δ6-8 deletion of the LEPR gene in paediatric population
timeFrame: at inclusion
Secondary outcomes:
measure: Proportion of the Δ6-8 deletion of the LEPR gene in adult family members
timeFrame: 6 months after inclusion of the paediatric population
Other outcomes:
Locations:
Study officials:
affiliation: CHU de La Réunion
name: Paul GUEGUEN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01360060: Analgesia After Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Pregnancy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 503
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: medical record review

Brief summary: Magnesium sulphate is the first line therapy for the management of preeclampsia and eclampsia in obstetrics. Perioperative administration of magnesium sulphate has been proved to be an effective as an analgesic adjuvant. The investigators evaluated the analgesic effect of magnesium in parturients undergoing Cesarean section.


Eligibility criteria: Inclusion Criteria:

* parturients undergoing Cesarean section

Primary outcomes:
measure: Change of numeric rating scale (NRS) of postoperative pain during postoperative period
timeFrame: postoperative 1, 2, 3, and 4 day
Secondary outcomes:
measure: incidence of stopping of intravenous PCA during postoperative 4 days
timeFrame: during postoperative 4 days
measure: serum magnesium level of group P
timeFrame: preoperative 1 h and postoperative 1 day
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul national university bundang hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT03263260: Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent
Official title: Prospective, Multicentric, Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent for Treatment of Patients With Native Coronary Artery Lesions (Inspiron Real Life II)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: stent, DES, Inspiron
Lead sponsor: Scitech Produtos Medicos Ltda
Sponsor class: INDUSTRY
First posted: 2017-08-28
Enrollment: 2504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years submitted to implant of the Inspiron Sirolimus Eluting Stent in native coronary arteries

Brief summary: Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of "real-world" patients.

Detailed description: Up to 5.0000 patients with native coronary arteries lesions with diameter between 2.5 and 4.0 mm and 34 mm of length treated solely with the Inspiron Sirolimus Eluting Coronary Stent.

Stent implantation should be performed according to the Instructions for Use and according to the local practice. It is recommended that ECG and cardiac enzymes are collected before and after procedure. Dual anti-platelet therapy is recommended for at least 6 months after procedure.

Patients will be followed at 30 days, 1 and 2 years after procedure.

Eligibility criteria: Inclusion Criteria:

* alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years

Exclusion Criteria:

* Safein Vein or Left Internal Mammary artery Grafts

Primary outcomes:
measure: Major Adverse Cardiac Events Rate
timeFrame: 12 months
Secondary outcomes:
measure: Target Vessel and Lesion Revascularization Rates
timeFrame: 24 months
measure: Stent Thrombosis Rate
timeFrame: 24 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS
state: Rio Grande Do Sul
Study officials:
References:
Clinical trial NCT06550960: Evaluation of SureCore Plus Biopsy System
Official title: Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate Using Standard of Care and Artificial Intelligence (AI) Analysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: BPH
Lead sponsor: Uro-1 Medical
Sponsor class: INDUSTRY
First posted: 2024-08-13
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm study of study biopsy needle and standard of care biopsy needle
Primary purpose: DIAGNOSTIC

Brief summary: This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.

Detailed description: Biopsy sampling of the prostate using TRUS or TPPB guidance is the current SoC approach for diagnosis of prostate cancer (CaP). Over the past decades the number of samples required and considered adequate has risen from 6 to 12-18 and sometimes as many as 30. Many practices routinely sample up to 20 cores of tissue. The SureCore Plus biopsy system is being to sample, obtain and retrieve prostate biopsy specimens in men undergoing scheduled diagnostic prostate biopsy and compare it with an standard of care (SoC) biopsy instrument and SoC method of specimen retrieval.

Eligibility criteria: Inclusion Criteria:

* Patient has BPH requiring a prostate biopsy
* Able and willing to provide consent

Exclusion Criteria:

* Active infection
* Subject participating in an other device study of the prostate

Primary outcomes:
measure: Procedure success
timeFrame: During the procedure
measure: Quality of biopsy tissue
timeFrame: During the procedure
Secondary outcomes:
measure: Performance of the study device
timeFrame: During the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Georgia Urology
name: Jeffrey Proctor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02150460: A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria
Official title: A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at National Eye Centre, Kaduna. Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anaesthesia
Cataract
Keywords: ophthalmic surgery, peribulbar local anaesthesia
Lead sponsor: National Eye Centre, Kaduna
Sponsor class: OTHER_GOV
First posted: 2014-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare the efficacy and safety of single injection peribulbar anaesthesia against the classic double injection technique.

This was a double blind randomized controlled trial involving two groups of consenting, adult Nigerian subjects with operable age-related cataract. An anaesthetic nurse who allocated the subjects to the two groups administered all the injections. The same surgeon operated on all the subjects while the principal investigator and a research assistant measured the outcome variables. All others were blinded as to subject allocation.


Eligibility criteria: Inclusion Criteria:

* Age 50 years and above
* Diagnosed with uncomplicated senile cataract
* Visual acuity of \<3/60

Exclusion Criteria:

* Impaired mental status
* Difficulty in speaking
* Known allergy to amide-type local anaesthetic agents and/ or hyaluronidase
* Previous surgery in the same eye
* Glaucoma
* Impaired ocular motility
* Eyelid abnormalities
* Patients with only one eye

Primary outcomes:
measure: Time Taken to Achieve Adequate Akinesia
timeFrame: 10 minutes and 15 minutes
measure: Supplementary Injection(s)
timeFrame: 5 minutes
measure: Complications of Local Anaesthetic Injection
timeFrame: 0,10 and 15 minutes
measure: Pain Score for Local Anaesthetic Injection
timeFrame: 20 minutes
measure: Pain Score for Cataract Surgery
timeFrame: 20 minutes
Secondary outcomes:
measure: Volume of Anaesthetic Drug (ml)
timeFrame: 10 and 15 minutes
measure: Total Number of Injections
timeFrame: 15 minutes
measure: Surgeon Satisfaction Score for Local Anaesthetic Block
timeFrame: 20 minutes
measure: Acceptability of the Anaesthetic Block to the Subject
timeFrame: 25 minutes
measure: Duration of Cataract Surgery (Minutes)
timeFrame: At the end of surgery
Other outcomes:
Locations:
city: Kaduna
country: Nigeria
facility: National Eye Centre
Study officials:
affiliation: National Eye Centre, Kaduna
name: Aminatu A AbdulRahman, MBBS, FWACS
role: PRINCIPAL_INVESTIGATOR
affiliation: National Eye Centre, Kaduna
name: Mahmoud B Alhassan, MBBS, FWACS
role: STUDY_CHAIR
References:
Clinical trial NCT02665260: Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum
Official title: Randomized Pilot Study Investigating the Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Molluscum Contagiosum
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 94
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids

Detailed description: This was a double-blind, placebo-controlled trial. Participants were recruited from the Pediatric Dermatology clinic at Montefiore Medical Center. One hundred eligible participants were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with occlusion, placebo, or placebo with occlusion. Treatments were applied at weeks 0 and 3 (blinded phase). At week 6, all participants were treated with open-label, topical cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label phase).

Eligibility criteria: Inclusion Criteria:

* 2-17years
* Healthy
* \<50 molluscum contagiosum lesions

Exclusion Criteria:

* Immunosuppressed
* Oral corticosteroids
* Sexually active/pregnant

Primary outcomes:
measure: Number of Subjects Who Achieve Complete Clearance at 6 Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Subjects Who Experienced an Adverse Event
timeFrame: 33 weeks
Other outcomes:
Locations:
Study officials:
References: