louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03105089: Effect of Cardiac Preconditioning Upon the Inotrope Score
Official title: Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Heart Surgery
Preconditioning
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: preconditioning of no debate has a valuable effect upon myocardial protection . pre-cardiopulmonary bypass pre-conditioning , suspected to have a role upon postoperative inotropic support

Detailed description: Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be ( ischemic ;pharmacologic or Physical) Pharmacological pc may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids etc ) Ischemic pc includes local ;remote and the idea is temporary interruption of blood supply to the organ so that liberation of protective mediators occurs The liberated mediators have favorable effects not only upon the myocardium But ;it extend to protect other organs against inflammatory activation ;ischemia reperfusion injury Inotropic score IS is already an evident predictor of postoperative cardiac mobidity and mortality

Eligibility criteria: Inclusion Criteria:

* adult patient
* valve replacement surgery
* ASA grade 2 or 3

Exclusion Criteria:

* emergency surgery
* - poor general conditions
* impaired hepatic or renal function
* peripheral vascular disease
* patient refusal

Primary outcomes:
measure: inotropic score
timeFrame: 48 hours
Secondary outcomes:
measure: renal function
timeFrame: 2 dyas
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT01543789: The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial
Official title: The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Umbilical Hernia
Keywords: Umbilical Hernia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Medri
First posted: 2012-03-05
Enrollment: 44
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 use of mesh in the repair of umbilical hernias is a gold standard. The best location of the mesh remains a matter of discussion, i.e. it might be placed inside the peritoneal cavity (open intraperitoneal onlay mesh) or between the peritoneum and the muscle layers, so not in contact with the viscera (retromuscular or preperitoneal). The Rebound mesh consists of polypropylene, i.e. the most used fabric for meshes, in combination with a nitinol memory ring. This ring allows the surgeon to position the mesh more flat, with less wrinkling and subsequently better tissue ingrowth. It also saves time for both patient's anesthesia and the surgery.

This type of mesh (one coated with PTFE for intra-abdominal use and one pure polypropylene for preperitoneal use), will be used in this multicentric trial, to evaluate the best procedure in terms of efficacy, safety and postoperative complications.


Eligibility criteria: Inclusion Criteria:

* written informed consent from the patient or his/her legal representative
* primary umbilical hernia requiring elective surgical repair
* diameter between 0 and 3 cm

Exclusion Criteria:

* no written informed consent
* incisional hernia at the level of the umbilicus
* recurrent umbilical hernia, as they have to be considered an incisional hernia
* emergency surgery (incarcerated hernia)
* pregnancy
* non-compliance

Primary outcomes:
measure: Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement.
timeFrame: Total duration of the operation with an expected average of approximately 45 minutes.
Secondary outcomes:
measure: Surgical wound morbidity complication rate.
timeFrame: Up to 1 year.
measure: Recurrence Rate
timeFrame: up to 2 years
measure: Pain evaluation
timeFrame: within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years
measure: Discomfort evaluation.
timeFrame: Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years.
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02516189: Strength Training for Elderlies and Their Effects on Muscle Fatigue and Microcirculation - Randomized Clinical Trial
Official title: Strength Training for Elderlies and Their Effects on Muscle Fatigue and Microcirculation - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Microcirculation
Electromyography
Motor Activity
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
Collaborators: name: Universidade Estadual da Paraiba
First posted: 2015-08-05
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to verify the effects of a strength training program on functional capacity, muscle performance and microcirculation in the elderly.

Detailed description: Purpose

The primary research question is:

Do muscular strength training programs can improve functional capacity, muscle performance and microcirculation in the elderly? Hypothesis: Strength training program will promote electromyographic changes during the development of peripheral muscle fatigue and microcirculatory blood flow contributing to functional autonomy.

Secondary Research Questions

1. Does the strength training program in the elderly improve the standard of electromyographic fatigue? Hypothesis: Elderly practitioners of strength exercise program showed increased neuromuscular efficiency and electromyographic fatigue index.
2. Do the strength training program in the elderly improve peripheral microcirculation? Hypothesis: A regular program of strength exercise in the elderly increases the blood flow in peripheral microcirculation changing the process of muscle fatigue. These biomechanical and physiological changes contribute to increased functional autonomy and reducing the risk of falls in the elderly.

Eligibility criteria: Inclusion Criteria:

* sedentary elderly
* individuals who have physical and medical conditions to perform strength training
* individuals who participate in the Open University Maturity Program

Exclusion Criteria:

* individuals who do not have physical and medical conditions to perform strength training

Primary outcomes:
measure: Change in elderlies's microcirculatory blood flow after 4 months
timeFrame: 4 months
measure: Change in elderlies's muscle fatigue after 4 months
timeFrame: 4 months
measure: Change in elderlies's functional capacity after 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Change in elderlies's strength after 4 months
timeFrame: 4 months
measure: Change in elderlies's functional autonomy after 4 months
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Estadual da Paraiba
name: Danilo A Vasconcelos, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Medicina Integral Professor Fernando Figueira
name: João G Alves, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00497289: Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
Official title: Double-blind, Prospective, Randomized Comparison of a Medium Chain Triglycerides (MCT)/Long Chain Triglycerides (LCT)/Fish Oil (FO) Containing 20% Lipid Emulsion With a MCT/LCT Emulsion (20%) for Parenteral Nutrition in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preterm Infants
Parenteral Nutrition n-3 Fatty Acids
Keywords: n-3 Polyunsaturated Fatty Acids (PUFA)
parenteral nutrition
preterm infant
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2007-07-06
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed by monitoring of inflammatory parameters.


Eligibility criteria: Inclusion Criteria:

* prematurity (birth weight 500 - 1500 g)
* postnatal age \<= 72 h
* need for cumulative parenteral energy supply of at least 70% during study duration
* signed informed consent form

Exclusion Criteria:

* simultaneous participation in another clinical study
* platelet count below 50000 /ml
* cumulative enteral energy supply of \> 30 % during study duration
* serious congenital infections and/or diseases
* serious metabolic disturbances
* severe cranial bleeding (Papile III, IV)
* need for administration of blood products
* contra-indication for iv lipid administration
* withdrawal of consent

Primary outcomes:
measure: Safety: Alanine Transaminase (ALT)
timeFrame: on Study day -1 & 6
measure: Efficacy: Interleukin-6 (IL-6)
timeFrame: on Study day -1 & 6
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Neonatology of the Pediatric University Hospital
state: Bavaria
city: Greifswald
country: Germany
facility: Ernst Moritz Arndt University , Childrens Hospital
Study officials:
affiliation: Dr. von Hauner Children´s Hospital, University of Munich
name: Berthold V. Koletzko, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06235489: Evaluation of Clinical Success of Bulk Fil Composite Versus Highly Viscous Glass Ionomer in Primary Class II Molars
Official title: "Evaluation of Clinical Performance of a Flowable Bulk Fill Composite Resin Versus a Highly Viscous Glass Ionomer Cement in Class II Cavities in Primary Molars: A Randomized Clinical Trial"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries Class II
Keywords: HVGIC
Proximal caries
Bulk-fil flowable composite
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluate the clinical performance of EQUIA Forte ® ( a HVGIC) and Plafique® Bulk Flow composite resin when placed in class II cavities in primary molars.

Detailed description: 1. Thorough diagnosis of patients will be done by the primary investigator. Patients with class II carious primary molars with score 4 or 5 using the International Caries Detections and Assessment Criteria (ICDAS).
2. Pre-operative bitewing radiographs will be obtained to assess the depth of the cavity. Primary molars with score D1 or D2 according to the ADA will be included in the study.
3. Each patient will be assigned to one of the two groups.

   * Group I (n= 59): Plafique Bulk Flow Composite.
   * Group II (n=59): EQUIA Forte Group.
4. Class II carious primary molars are prepared using 330 burs. The cavity will be approximately with a depth of 0.5 mm in dentin and width of at least one-third of the occlusal table. Outline of the cavity will be determined by the extent of the carious lesion. No beveling will be done in any of the cavities.
5. Matrix is placed and secured in position.
6. One of the 2 restorative materials is placed in the cavity using the manufacturer's instructions.
7. Patients will be recalled at 3, 6, and 12 months to evaluate the restoration clinically using the FDI criteria.
8. Patients will receive oral health education on how to maintain a proper oral hygiene and proper diet consumption.
9. They will be given manual tooth brushes and tooth pastes to use during the study.

Eligibility criteria: Inclusion Criteria:

* Four to 8 years old children
* Cooperative children classified as class 3 or 4 based on Frankle et al. classification.
* Presence of deep bite or any type of malocclusion or parafunctional habits.
* Children who have at least one primary molar with active proximal caries (score 4 or 5 using ICDAS).

Exclusion Criteria:

* Refusal of the parents to sign the informed consent.
* Presence of deep bite or any type of malocclusion or parafunctional habits.

Primary outcomes:
measure: clinical performance
timeFrame: one- year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain Shams University
Study officials:
affiliation: Head of Pediatric Dentistry Department, Faculty of Dentistry, Ain Shams University
name: Mariem O Wassel, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02860689: Predictive Factors for Male Sexual Dysfunction After Traumatic Spinal Cord Injury
Official title: Predictive Factors for Male Sexual Dysfunction After Traumatic Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male Sexual Dysfunction
Spinal Cord Injury
Keywords: Sexuality
Spinal cord injuries
Penile erection
erectile dysfunction
Psychological Sexual Dysfunctions
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 45 men, aged between 18 and 60 years with a clinical diagnosis of traumatic spinal cord injury, injury time less than six months heterosexual and sexually active. The study excluded patients who had erectile dysfunction attributed to endocrine or metabolic disease order, those who underwent surgery in the genital area, such as radical prostatectomy or penile implant and cognitive impairment.

Brief summary: Objective: To analyze the association between sexual function of men with spinal cord injury with possible predictive factors for dysfunction.

Detailed description: Method: Observational study (CAAE 41221414.5.0000.5208) conducted with 45 men, mean age 34 (CI 31.5 to 37.1), with spinal cord injury and active sex life. Sexual function was assessed by the International Index of Erectile Function and level and degree of injury were determined following the guidelines of the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury. Descriptive statistical techniques were applied and multivariate analysis using logistic regression adjusted to observe the association between factors, with 0.05 significance level.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of traumatic spinal cord injury, injury time less than six months heterosexual and sexually active

Exclusion Criteria:

* patients who had erectile dysfunction attributed to endocrine or metabolic disease order, those who underwent surgery in the genital area, such as radical prostatectomy or penile implant and cognitive impairment

Primary outcomes:
measure: Male Sexual Dysfunction
timeFrame: one day
Secondary outcomes:
measure: Level of neurological lesion
timeFrame: one day
measure: Degree of neurological lesion
timeFrame: one day
measure: Depression
timeFrame: one day
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Josepha Karinne de Oliveira Ferro
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Josepha KO Ferro, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01467089: The Assessment of Movement Disorders Utilizing Live Two-Way Video
Official title: The Assessment of Movement Disorders Utilizing Live Two-Way Video
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tardive Dyskinesia
Keywords: Schizophrenia
Extrapyramidal symptoms
Tardive dyskinesia
Two Way Video Assessment
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 patients with schizophrenia will be recruited via in- and outpatient psychiatry service of The Zucker Hillside Hospital.

Brief summary: The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) examinations conducted via live two-way video versus live examinations completed in-person

Detailed description: Extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) are one of the most frequent and troublesome adverse events when taking antipsychotic agents. The investigators aim in this study to determine if the investigators can conduct examinations for EPS and TD remotely using live two-way video. It is potentially beneficial for patients, especially those who are located far away from psychiatrists if they could be seen by trained clinicians and assessed for EPS and TD via two-way video in the future. Participants will be asked to have a medical assessment which consists of simple questions and some examination of their movements via two-way video and in person. The investigators will compare the results of video examinations with the results of live examinations.

Eligibility criteria: Inclusion Criteria:

* Inpatients and outpatients aged 18-75 years old who have been taking antipsychotics for longer than 6 months in their life time, and
* That have been compliant for the past week.

Exclusion Criteria:

* Patients who have medical conditions which make it difficult to perform a physical examination.
* Patients who are clinically too ill to consent and/or unable to cooperate with the examination procedures.

Primary outcomes:
measure: Abnormal Involuntary Movement Scale (AIMS) when done in-person versus via two-way video
timeFrame: Baseline
measure: Modified Simpson Angus Scale (mSAS) short version when done in-person versus via two-way video
timeFrame: Baseline
Secondary outcomes:
measure: the correlation between the short version and full version of the Modified Simpson Angus Scale (mSAS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Sandeep Kapoor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05714189: The Effect of Dietary Interventions, or no Intervention, on Pain and Quality of Life in Women Diagnosed With Endometriosis
Official title: The Effect of Dietary Interventions, or no Intervention, on Pain and Quality of Life in Women Diagnosed With Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 62
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women could chose to adhere to a diet or the control group. there was no cross-over.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This prospective pilot study was performed to explore the influence of a dietary intervention, the Low FODMAP diet or endometriosis diet, on endometriosis-related pain and Quality of Life (QoL). Participants could choose between adherence to a diet; the Low FODMAP diet or endometriosis diet, or to contribute to the control group and not adhere to a diet.

Detailed description: This prospective pilot study was performed to explore the influence of a dietary intervention, the Low FODMAP diet or endometriosis diet, on endometriosis-related pain and Quality of Life (QoL). Participants could choose between adherence to a diet; the Low FODMAP diet or endometriosis diet, or to contribute to the control group and not adhere to a diet. Women choosing to adhere to a diet were extensively guided by a dietician in training. In addition, both groups are asked to complete three questionnaires over a period of six months; once every two months.

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with endometriosis, either through radiologic imaging (transvaginal ultrasound and/or MRI) or laparoscopy
* A reported pain score of ≥ 3 (Visual Analogue Score (VAS), scale 0-10cm) in one or more of the following symptoms: dysmenorrhea, deep dyspareunia and chronic pelvic pain

Exclusion Criteria:

* about to undergo an operation within six months
* Undergone an operation in the past six weeks
* a switch in hormonal therapy within six weeks
* Women that were pregnant or breastfeeding
* women diagnosed with a malignancy
* An additional diagnosis with Coeliac Disease (CD) and/or lactose intolerance.
* Not sufficient in the Dutch or English language.

Primary outcomes:
measure: pain scores
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life (QoL)
timeFrame: 6 months
measure: Gastro-Intestinal Health
timeFrame: 6 months
measure: Adhesion to dietary intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam AMC
Study officials:
References: