louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05422196: Evaluation of Computer-Guided Secondary Alveolar Cleft Bone Grafting With and Without Platelet-Rich Fibrin
Official title: Evaluation of Computer-Guided Secondary Alveolar Cleft Bone Grafting With and Without Platelet-Rich Fibrin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Grafting
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 12
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at investigating the role of platelet-rich fibrin in alveolar cleft secondary grafting. This grafting is done from the patient's chin using a computer-guided stent that is customized for each patient, and the cleft volume is analysed at first to estimate the needed amount of bone to be harvested.


Eligibility criteria: Inclusion Criteria:

1. Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I.
2. Patients seeking treatment and accepting to be enrolled in the study, so as their guardians.
3. Patients who will age 9-14 years old by the surgery day.
4. Patients with adequate chin bone volume that could be harvested without marked donor site morbidity, as pre-determined by cone beam computed tomography.

Exclusion Criteria:

1. Patients with systemic illness, i.e. ASA(22) classes II, III, IV, and V.
2. Patients with previously operated alveolar clefts and seeking revision for the same cleft.
3. Patients that wouldn't be able to attend the recalls.
4. Patients with other craniofacial anomalies and associated syndrome conditions.
5. Edentulous maxilla, atypical or non-described cleft diagnosis.
6. Patients with history of chemotherapy or radiotherapy.

Primary outcomes:
measure: Closure of oronasal fistula
timeFrame: Ten days postoperatively
measure: Closure of oronasal fistula
timeFrame: Six months postoperatively
measure: Volume of newly formed bone
timeFrame: Six months postoperatively
measure: Average density of newly formed bone
timeFrame: Six months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry, Mansoura University
state: Addakahlyia
Study officials:
References:
Clinical trial NCT02056496: Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Urolithins in Healthy Subjects.
Official title: Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Gut Microbiota-derived Metabolites (Urolithins) in Overweight Subjects. Comparison Between Two Pomegranate Extracts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pomegranate
Ellagic acid
Pharmacokinetics
Urolithins
Bioavailability
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Universidad Católica San Antonio de Murcia
First posted: 2014-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Both ellagic acid (EA) and urolithins can exert a number of biological activities. However, the bioavailability of ellagic acid has been reported to be very low and the existing studies are controversial so far. The investigators want to carry out a robust (cross-over, double-blind) pharmacokinetic assay in 20 healthy volunteers, using two types of pomegranate extracts (PEs). PEs with low (PE-1) and high (PE-2) punicalagin:EA ratio will be administered. The investigators will analyze blood and urine samples using UPLC-ESI-QTOF-MS/MS. The investigators will evaluate:

* The pharmacokinetics of EA.
* The effect of punicalagin:free EA ratio on the pharmacokinetics of EA and urolithins production.


Eligibility criteria: Inclusion Criteria:

* Aged 18-35 years.
* Healthy status (no illness in the previous 3-months).

Exclusion Criteria:

* Smoking.
* Pregnancy/lactation.
* Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
* Previous gastrointestinal surgery
* Recent use of antibiotics (within 1-month prior to the study)
* Suspected hypersensitivity to pomegranate or any of its components
* Consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication.
* Regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire).
* Intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.

Primary outcomes:
measure: 24-hour pharmacokinetics of ellagic acid in plasma
timeFrame: Outcome measures at 0.5, 1, 2, 3, 4, 5, 6, and 24 hours post-dose.
Secondary outcomes:
measure: 72-h accumulation of urolithins in urine
timeFrame: Changes from baseline at 24, 48 and 72 hours
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM (San Antonio Catholic University from Murcia)
Study officials:
affiliation: National Research Council (CEBAS-CSIC, Murcia, Spain)
name: Dr. Juan Carlos Espín, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02672696: Interest of Navigation for the Treatment of Pertrochanteric Fractures With the Gamma 3 Nail
Official title: Interest of Navigation for the Treatment of Pertrochanteric Fractures With the Gamma 3 Nail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoral Fractures
Fracture Fixation, Internal
Trochanteric Fractures
Keywords: Navigation
Gamma Nail
Lead sponsor: Hôpital du Valais
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 60
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 aim of the study is to compare Tip-Apex Distance values in two groups of patients after intramedullary nailing of proximal femur. The first group of patients is operated with the help of a 3D reconstruction device connected to the standard fluoroscopy allowing the surgeon to visualize directly the exact position of the tip of the trans-cervical screw while the second group (which is the reference-group) is operated with the help of fluoroscopy alone.

Detailed description: The main orthopedic complication after fixation of a proximal femoral fracture with a cephalo-medullary nail is the cut-out of the cephalic screw from femoral head resulting in a protrusion of this screw in the coxo-femoral joint, mostly during the first 6 months after the operation. In most cases, the surgeon has to remove the primary implant and perform a total hip arthroplasty to his patient, therefore rising the morbidity and social costs linked to the treatment of the initial fracture.

Baumgartner showed the importance of the position of the cephalic screw for predicting failure of the implant and proposed a new measurement to evaluate this position, the tip-apex distance which is the sum of the distance from the tip of the cephalic screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. He showed a lower TAD was associated with a lower risk of cut-out.

The aim of this study is to evaluate the help of a 3D reconstruction software linked to the standard fluoroscopy in achieving the lowest TAD and therefore minimizing the cut-out rate.

Eligibility criteria: Inclusion Criteria:

* Adult patients with a proximal femoral fracture eligible for intramedullary nailing with a Gamma 3 Nail

Exclusion Criteria:

* None

Primary outcomes:
measure: Tip-Apex distance
timeFrame: 6 months
Secondary outcomes:
measure: Cut-out of the cephalic screw
timeFrame: 6 months
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Hopital du Valais
state: Valais
Study officials:
References:
Clinical trial NCT01390896: Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery
Official title: Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 329
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese patients undergoing general surgery of the lower limb at high risk for venous thromboembolism

Brief summary: The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing general surgery of the lower limb at high risk of developing venous thromboembolism.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing general surgery of the lower limb at high risk for venous thromboembolism

Exclusion Criteria:

* Patients with a history of hypersensitivity to the ingredients of fondaparinux
* Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed)
* Patients with acute bacterial endocarditis
* Patients with severe renal impairment

Primary outcomes:
measure: The number of adverse events in Japanese subjects undergoing general surgery of the lower limb treated with fondaparinux
timeFrame: 1 month
measure: Presence of absence of venous thromboembolism after treatment of fondaparinux
timeFrame: 1 month
measure: Occurrence of adverse events of bleeding
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04362696: Improving Working Memory in Older Adults
Official title: Improving Working Memory in Older Adults by Restoring Large-Scale Cortical Interactions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Large-scale Physiological Foundations of Memory Decline in Aging Humans
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The research program will evaluate the theoretical claim that age-related memory and cognitive decline in humans result from the inefficient orchestration of rhythmic activity within large-scale cortical networks. The results will contribute to the basic science groundwork for developing future non-pharmacological interventions aimed at boosting memory and cognition in aging and clinical populations.

Detailed description: We hypothesize that aged-related memory and cognitive impairments emerge from large-scale functional dysconnectivity, and by stimulating the brain noninvasively with extremely weak levels of electrical current, we may be able to re-synchronize connectivity and stabilize or improve memory and cognitive function, measured behaviorally. The experiments of this project are proposed as between-subjects, sham-controlled, and double-blind in design, and use noninvasive electroencephalographic (EEG) measurements of rhythmic brain activity. The experimental intervention involves the application of low-intensity, high-definition, transcranial electrical current stimulation while subjects perform a variety of computer-based tasks that probe memory and cognitive function.

Eligibility criteria: The following general inclusion criteria apply to all subjects: must be between the ages of 68-80 (except for Experiment 1 where subjects must be between the ages of 18-30), have normal or corrected-to-normal vision, color vision, nonpregnant, no metal implants in head, no implanted electronic devices, no history of neurological problems or head injury, no skin sensitivity, no claustrophobia, no dementia (normal Mini Mental State Examination between 24-30; Montreal Cognitive Assessment \> 25), no depression (normal Beck Depression Inventory II \<13; Geriatric Depression Scale \< 10), and cannot be taking any psychoactive medication.

Primary outcomes:
measure: Memory performance success (sham stimulation condition)
timeFrame: During sham intervention
measure: Memory performance success (active stimulation condition)
timeFrame: During active intervention
measure: Memory performance speed (sham stimulation condition)
timeFrame: During sham intervention
measure: Memory performance speed (active stimulation condition)
timeFrame: During active intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: 677 Beacon St. Room 308
state: Massachusetts
Study officials:
References:
Clinical trial NCT04062396: Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction
Official title: Randomized Comparison Between Oxygenator Systems for the Reduction of Post-operative Delirium in Older Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
Lead sponsor: Maria Cecilia Hospital
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 154
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Age is no longer an absolute contraindication to cardiac surgery therefore there is often need for combined interventions (double valve repair/replacement, or coronary artery bypass graft and valve repair/replacement) with relative prolongation of cardiopulmonary bypass time. Prolonged cardiopulmonary bypass use causes an increase in the inflammatory response, and on the other a need for blood reinfusion and therefore lipid microemboli from the operative field. The clinical consequences for patients are post-operative delirium and post-operative cognitive impairment.

These two neurological complications involve up to 45% of elderly patients undergoing cardiac surgery and have a significant impact on quality of life, hospitalization and mortality in the short and long term. The Remowell 2 oxygenator system has demonstrated in preliminary studies that, compared to the gold standard Inspire oxygenator, it can guarantee a significant reduction of hemodilution, inflammatory systemic response and embolization of lipid microemboli and leukocytes. In light of these considerations, it is possible to formulate the hypothesis that the use of the Remowell 2 device can contribute to significantly reducing the onset of post-operative delirium and cognitive impairment. The present study is designed to validate this hypothesis in a randomized controlled scenario.


Eligibility criteria: Inclusion Criteria:

1. Signature of informed consent for participation in the study
2. Age ≥65 years
3. Patients undergoing cardiac surgery of:

   1. coronary artery bypass graft and concomitant valve replacement/repair OR
   2. double valve replacement/repair

Exclusion Criteria:

1. Any documented history of cognitive impairment estimated as a mini mental state examination \< 24 points
2. Patients who need blood prime in the cardiopulmonary bypass circuit
3. Chronic coagulopathies ( international normalized ratio \> 2 in patients without anticoagulant treatment)
4. End stage renal disease on dialysis treatment
5. Previous cerebrovascular accident
6. Active cancer or immunological diseases
7. Liver cirrhosis (platelets \<100.000/uL)
8. Decompensated diabetes
9. Severe preoperative anemia (hemoglobin \<8 g/dl).

Primary outcomes:
measure: post-operative delirium
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
Study officials:
affiliation: Maria Cecilia Hospital
name: Lorenzo Mantovani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03174496: Physical Activity Tracking in Paediatric Elective Tonsillectomy
Official title: Physical Activity Tracking in Paediatric Elective Tonsillectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tonsillectomy
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children undergoing elective tonsillectomy or tonsillotomy

Brief summary: This pilot study will investigate the feasibility of physical activity tracking in patients aged 4-16 years before and after elective tonsillectomy as an innovative tool in paediatric research. The participating patients will receive a wearable physical activity tracker (CE-certified) that will continuously measure the patients' physical activity before and after an elective tonsillectomy, in addition to their parents' documentation of their child's activity in a conventional diary.


Eligibility criteria: Inclusion Criteria:

* Age 4 to 16 years old, in 2 subgroups (4-7 years, 8-16 years)
* Inpatient surgery at University Children's Hospital Basel (UKBB), Switzerland
* Children undergoing an elective tonsillectomy or tonsillotomy. Children having additional ENT procedures, such as adenectomy, tympanostomy, etc. may be included as well.

Exclusion Criteria:

* Children with mental or physical impairment during daily-life activities.
* Children undergoing additional surgical procedures other than Ear, Nose \& Throat (ENT) procedures impacting the recovery period.

Primary outcomes:
measure: Feasibility of physical activity tracking in children
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Children's Hospital Basel
name: Victoria Ziesenitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambrechtse P, Ziesenitz VC, Atkinson A, Bos EJ, Welzel T, Gilgen Y, Gurtler N, Heuscher S, Cohen AF, van den Anker JN. Monitoring the recovery time of children after tonsillectomy using commercial activity trackers. Eur J Pediatr. 2021 Feb;180(2):527-533. doi: 10.1007/s00431-020-03900-4. Epub 2021 Jan 4.
Clinical trial NCT02036996: Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined
Official title: Official Title Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Over Weight
Sleep Disorders
Lead sponsor: EarlySense Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Different patient population will be monitored including obese, morbidly obese, patients with or without apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Brief summary: The objective of this study is to collect heart rate, respiration data and motion data of patients admitted to sleep lab and to determine the current accuracy level of the EarlySense system vs. the standard system, and predicate device for EarlySense (Embla) used in sleep lab in monitoring heart rate and respiration rates monitors (ECG, respiratory belts, oximeter) that are currently used in the sleep lab among different population (Obese, patients with or without apnea, patients with or without arrhythmia). It is emphasized that no interpretations or clinical decisions will be made based on data received from the ES study device.

Detailed description: The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Eligibility criteria: Inclusion Criteria:

* 1. Age 18 years or more 2. Is willing to sign the consent form.

Exclusion Criteria:

* Age \< 18 years
* Is not willing to sign the consent form.

Primary outcomes:
measure: Determine the detection rate and the accuracy of the EarlySense system in measuring HR and RR and motion as well as capability of system to detect patient turns, bed-exit and entries
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Asher Tal, Prof.
role: PRINCIPAL_INVESTIGATOR
References: