louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00336908: Inflammatory Responses to Lipid Emulsions in Children Before and After Open Heart Surgery
Official title: Inflammatory Responses of Intravenous Fish Oil, Soybean Oil and Medium Chain Triglyceride Fat Emulsions in Young Children Before and After Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Inflammation
Cardiac Surgical Procedures
Keywords: Intensive Care,Neonatal
Parenteral nutrition
Fat emulsions,Intravenous
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Stollery Children's Hospital Foundation
First posted: 2006-06-14
Enrollment: 32
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a blinded, randomized, controlled prospective trial comparing immune response (sepsis, inflammatory response, pulmonary vasoconstriction) in 2 groups of infants less than 3-month old receiving pre and post cardiopulmonary bypass surgery. The infants will receive 1 out of the 2 following intravenous lipid preparations: Soybean Oil (n-6), or a combination of Medium Chain Triglyceride i.e. coconut oil, Long Chain Triglyceride i.e. Soybean Oil, and Fish Oil (MCT:LCT:FO). There will be 16 subjects in each group.


Eligibility criteria: Inclusion Criteria:

* 36 weeks gestation
* 3 months corrected age
* appropriate for gestational age (AGA)
* admitted for surgical correction of congenital heart defects (single ventricle, tetralogy of Fallot, truncus and complex biventricular repairs)
* enteral nutrition at 30 kcal/kilogram/day

Exclusion Criteria:

* 5 minute Apgar score of 4
* major congenital defect other than heart defect
* presence of significant neonatal morbidity (intraventricular hemorrhage (IVH) grade 3 or greater, necrotizing enterocolitis (NEC) and surgical abdomen)
* any metabolic disorder
* any endocrine disorder
* medications which alter eicosanoid metabolism including indomethacin, acetylsalicylate (with exception of steroids which will be analyzed independently)

Primary outcomes:
measure: To determine whether incidence of sepsis and degree of inflammatory response is altered
Secondary outcomes:
measure: To characterize serum arachidonic acid and eicosapentaenoic acid levels, leukotriene B 4/leukotriene B 5 levels and incidence of nosocomial infection
measure: To characterize incidental findings as a result of attaining complete fatty acid and cytokine profiles
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: John E Van Aerde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larsen BM, Goonewardene LA, Joffe AR, Van Aerde JE, Field CJ, Olstad DL, Clandinin MT. Pre-treatment with an intravenous lipid emulsion containing fish oil (eicosapentaenoic and docosahexaenoic acid) decreases inflammatory markers after open-heart surgery in infants: a randomized, controlled trial. Clin Nutr. 2012 Jun;31(3):322-9. doi: 10.1016/j.clnu.2011.11.006. Epub 2011 Dec 3.
Clinical trial NCT04873908: Effects of Modified Constraint-Induced on Chronic Stroke Patients
Official title: Comparison of the Effect of Proprioceptive Training Therapy or Modified Constraint-Induced Movement Therapy on Upper Extremity Physical Functions in Chronic Stroke Patients - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Keywords: Modified constraint-induced therapy
Proprioceptive Training
conventional rehabilitation
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the present study, it was aimed to compare the proprioception training applied in addition to conventional treatment and Modified Constraint-Induced Movement Therapy treatment in patients with chronic strokes and to investigate the effects on proprioception, spasticity, functional motor skills and daily living activities in the upper extremity.


Eligibility criteria: Inclusion Criteria:

* Post stroke hemiparetic patients of six months
* spasticity ≤ Grade -3 on modified Ashworth scale
* those patients capable of extension of at least 10º each at Metacarpophalangeal (MCP), Proximal Interphalangeal (PIP) and Distal Interphalangeal (DIP) joints and 20º at wrist joint
* a score of 24 or higher on the Modified Mini-Mental State Examination
* no excessive pain in the affected upper limb, as measured by a score of 4 or higher on a 10-point visual analog scale

Exclusion Criteria:

* Patients with history of previous stroke,
* angina,
* uncontrolled hypertension, on medication that could impair neuromuscular performance,
* wrist or finger pathologies, significant visual or hearing impairment,
* balance problems which may compromise safety during sound upper limb constraint,
* unwilling to participate

Primary outcomes:
measure: Fugl-Meyer assessment test
timeFrame: Score change after 6 weeks of intervention compared to baseline
measure: Action Research arm test
timeFrame: Score change after 6 weeks of intervention compared to baseline
measure: Motor Activity Log
timeFrame: Score change after 6 weeks of intervention compared to baseline
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: Score change after 6 weeks of intervention compared to baseline
measure: thumb localizing test
timeFrame: Score change after 6 weeks of intervention compared to baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University
Study officials:
References:
Clinical trial NCT01565408: Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis
Official title: Safety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Rheumatoid Arthritis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid arthritis (RA).


Eligibility criteria: Inclusion Criteria:

* A diagnosis of RA, meeting the 2010 ACR-EULAR (American College of Rheumatology-European League Against Rheumatism) or the 1987 ACR classification criteria, made at least 4 months prior to trial drug administration
* Active RA, characterised by a DAS28-CRP equal to or above 4.5 and at least 5 tender and 5 swollen joints
* Methotrexate (MTX) treatment for at least 16 weeks (dose equal to or above 7.5 mg/week and equal to or below 25 mg/week) at a stable dose for at least 6 weeks prior to dosing
* Female subjects not pregnant and not nursing

Exclusion Criteria:

* Subjects with chronic inflammatory autoimmune disease other than RA
* Any active or ongoing chronic infectious disease requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
* Body mass index (BMI) below 18.0 or above 35.0 kg/m\^2

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: From first administration of trial product (week 1) and up until week 27
Secondary outcomes:
measure: Change in serum levels of total IL-21 from first administration of trial product
timeFrame: Week 1, week 27
measure: Change in disease activity score 28 calculated using C-reactive protein (DAS28-CRP)
timeFrame: From week 1 to week 9 (8 weeks after initiation of treatment)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Wagner F, Skrumsager B, Fitilev S. Safety and tolerability of NNC0114-0006, an anti-IL-21 monoclonal antibody, at multiple s.c. dose levels in patients with rheumatoid arthritis. Arthritis and Rheumatology; 66 (10 (Supplement)): Abstract 1492
Clinical trial NCT05964608: The Effect of Behavioral Therapy Given to Men and Their Partners'
Official title: The Effect of Behavioral Therapy Given to Men With Premature Ejaculation on Symptoms and Their Partners' Sexual Functioning and Sexual Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Ejaculation
Sexual Function Disturbances
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Premature ejaculation involves not only sexual problems but also relationship and communication difficulties, and behavioral approaches to the treatment of premature ejaculation are promising.

Detailed description: Introduction and hypothesis: Premature ejaculation potentially affects not only men but also their partners negatively. The null hypothesis for this study is Behavioral therapy given to men with premature ejaculation has no effect on the symptoms and their partners' sexual functions and quality of sexual life.

Methods: A quasi-experimental study. The current study was conducted in 84 men and their partners. The "Personal Information Form", "Premature Ejaculation Diagnostic Tool (PEDT)", "Female Sexual Function Index (FSFI)", and "Sexual Quality of Life-Female (SQOL-F)" were used to collect data. Behavioral therapy, consisting of a total of 6 sessions of 45 minutes, was applied once every two weeks.

Eligibility criteria: Inclusion Criteria:

* Willingness to participate
* Having no communication barriers
* Literacy
* Age 18-45 years
* Having no diagnosis of sexual dysfunctions
* Having no medical illnesses (psychiatric diseases, pelvic anatomical disorder, post-menopause, etc.) that might affect the sexual function
* Having a spouse diagnosed with premature ejaculation according to DSM-5 criteria
* Having a spouse without any prior behavioral therapy for premature ejaculation
* Being a man diagnosed with lifelong premature ejaculation according to the ISSM criteria.
* Being married

Exclusion Criteria:

-Men and their partners who did not meet all inclusion criteria were excluded from the present study.

Primary outcomes:
measure: Premature Ejaculation Diagnostic Tool (PEDT)
timeFrame: six weeks
Secondary outcomes:
measure: Female Sexual Function Index (FSFI)
timeFrame: six weeks
measure: Sexual Quality of Life-Female (SQOL-F)
timeFrame: six weeks
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: ECE
Study officials:
affiliation: Istinye University
name: Kazım Doğan, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04348708: Long-Term Follow Up Study of Subjects Previously Administered HMI 102
Official title: An Open-Label, Long-Term Follow Up Study of Safety and Efficacy in PKU Subjects With PAH Deficiency Previously Administered HMI 102
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Phenylketonuria
PAH Deficiency
Keywords: PKU
Phenylketonuria
PAH Deficiency
Phenylalanine
Adeno Associated Virus
AAVHSC15
Lead sponsor: Homology Medicines, Inc
Sponsor class: INDUSTRY
First posted: 2020-04-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with PAH Deficiency who were previously administered HMI-102

Brief summary: An Open-Label, Long-Term Follow Up Study of Safety and Efficacy in PKU Subjects with PAH Deficiency Previously Administered HMI 102

Detailed description: This Long-Term Follow Up Study will evaluate the safety and efficacy of PKU Subjects with PAH Deficiency Previously Administered HMI 102. Subjects will have already received a single dose of HMI-102 administered intravenously

Eligibility criteria: Inclusion Criteria:

* Subject was previously administered HMI 102.
* Subject is able to understand the purpose and risks of the study and is willing to provide informed consent.
* Subject is able to comply with all study procedures and long-term follow-up.

Exclusion Criteria:

* Participation in the study is not in the subject's best interest, in the opinion of the Investigator.

Primary outcomes:
measure: Incidence and severity of adverse events of special interest (AESIs) and serious adverse events (SAEs) related to HMI 102
timeFrame: Baseline to year 5
Secondary outcomes:
measure: Plasma Phe Concentration
timeFrame: Baseline to year 5
measure: Phe-restricted diet
timeFrame: Baseline to year 5
measure: Phenylketonuria Quality of Life Questionnaire (PKU-QOL
timeFrame: Baseline to year 5
measure: Protein intake
timeFrame: Baseline to year 5
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
References:
Clinical trial NCT04619108: Thrombosomes for Expanded Access Use
Official title: Thrombosomes for Expanded Access Use
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Bleeding
Lead sponsor: Cellphire Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Expanded use of Thrombosomes where a clinical trial with Thrombosomes is not an option, Cellphire may elect to provide the Sponsor/Investigator (S/I) expanded access to its investigational product, Thrombosomes.


Eligibility criteria: Inclusion Criteria:

1. Subject has presented with WHO Grade 2 or higher bleeding which requires treatment with platelet therapy and there is limited availability of platelets or no other approved clinical alternative.
2. Evidence from the facility blood bank/Medical Director that there are no approved platelet products available for transfusion, or the patient is refractory to platelet transfusion.

   Exclusion Criteria:
3. Clinical circumstances of a history of thrombosis, thromboembolism, or vascular occlusion/ischemia in the prior six months such as defined by a past history of current diagnosis of one or more of the following:

   * arterial or venous thromboembolic disease including acute coronary syndrome
   * peripheral vascular disease
   * arterial or venous thrombosis (except when a prior history of central line thrombosis has resolved)
   * myocardial infarction (MI)
   * stent placement
   * valve replacement and/or repair
   * sinusoidal obstruction syndrome (veno-occlusive disease)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05517408: Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.
Official title: Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Gastric Ulcer
Intestinal Polyps
Intestinal Cancer
Keywords: sedation
gastrointestinal endoscopy
obese patient
ciprofol
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ciprofol is a new anesthetic, which combines with γ- Aminobutyric acid-a (GABAA) receptor. Ciprofol has shown equivalent anesthetic efficacy of propofol at 1/4 to 1/5 of the dosage. Ciprofol has the pharmacodynamic characteristics of rapid onset, stable and rapid recovery. Phase III clinical results showed that the incidence of injection pain and respiratory and circulatory depression of ciprofol was lower than that of propofol. Therefore, ciprofol has a good application prospect in sedation for gastrointestinal endoscopy, especially for obese patients. In the current study, we would explore the proper dose of Ciprofol in sedated gastrointestinal endoscopy in obese patients.


Eligibility criteria: Inclusion Criteria:

1. Age, ≤18 and ≤60 years, no gender limit
2. Undergoing routine gastrointestinal endoscopic diagnosis and treatment
3. American Society of Anesthesiologists (ASA) classification I-II
4. Body Mass Index(BMI) ≥28kg/m\^2
5. Clearly understand and voluntarily participate in the study; provide signed informed consent

Exclusion Criteria:

1. Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)
2. Drug abuse history within 3 months before the screening period
3. People who are known to be allergic to eggs, bean products, opioids and other drugs, propofol, etc
4. The researcher believes that patients should not participate in this trial

Primary outcomes:
measure: Calculating the the median effective dose (ED50) of ciprofol for sedation gastrointestinal endoscopy in obese patients.
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
measure: Calculating the the ED95 of ciprofol for sedation gastrointestinal endoscopy in obese patients.
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
References:
Clinical trial NCT05559723: Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients
Official title: Effect of Electromagnetic Field Therapy on Sciatica and Postural Control in Lumbar Disc Prolapse Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disc Herniation
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to investigate the effect of electromagnetic field therapy on sciatica and postural control in lumbar disc prolapse patients BACKGROUND: lumbar disc prolapse is a clinical condition resulting from compression of lumbar nerve roots resulting in decreased postural control and alleviating sciatic pain Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. Historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders

Detailed description: Thirty-four patients with lumbar disc prolapse The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks. The evaluation methods by Visual analogue scale for pain (VAS-P), ) multidirectional reach test, McGill pain Questionnaire, time up and go test and Oswestry Low Back Pain Disability Questionnaire

Eligibility criteria: Inclusion Criteria:

1. Age ranging from 30:45
2. sciatica due to lumbar disc prolapse mild to moderate disc prolapse according to magnetic resonance image (MRI).
3. Body mass index (18.5 to 29.9) Kg/m2.

Exclusion Criteria:

* The patients will be excluded if they have one of the followings:

  1. lumbar myelopathy.
  2. Patients with previous spinal surgery.
  3. Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis
  4. Any other neurological or musculoskeletal disorders of the spine or upper extremity.
  5. Patient with cardiopulmonary disease or diabetes mellitus

Primary outcomes:
measure: visual analogue scale
timeFrame: 4 weeks
measure: Multi-Directional Reach test
timeFrame: 4 weeks
measure: time up and go test
timeFrame: 4 weeks
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: The McGill Pain Questionnaire
timeFrame: four weeks
Other outcomes:
Locations:
city: Al Jīzah
country: Egypt
facility: Lama S Mahmoud
state: Select State
Study officials:
affiliation: October 6 University
name: Lama Saad El-Din Mahmoud, PHD
role: STUDY_CHAIR
affiliation: October 6 University
name: KEROLOS AWAD HABIB SAEED, masters
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02949323: Etiological Diagnosis of Urinary Stone in Chinese Children
Official title: Etiological Diagnosis of Urinary Stone in Chinese Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Stone
Keywords: children
renal stone
metabolic evaluation
Mutational analysis
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with urinary stones

Brief summary: The incidence of nephrolithiasis in children has been reported to increase by approximately 6-10% annually, and the incidence is currently 50 per 100,000 children with high recurrent rate. Investigators aimed to determine the metabolic risk factors in Chinese children through metabolic evaluation.

In order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western country wether adapt to Chinese children, investigators aim to determine normal urine levels of oxalate and citrate in children without kidney stone.

Detailed description: Investigators aimed to determine the metabolic risk factors in 200 Chinese children with urinary stones through metabolic evaluation.

In order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western country wether adapt to Chinese children, investigators aim to determine normal urine levels of oxalate and citrate in children without kidney stone.

Eligibility criteria: Inclusion Criteria:

* Children with urinary stones

Exclusion Criteria:

* Anatomic urinary system abnormality, vesicoureteral reflux, urinary tract infection (temperature \>38°C and/or positive urine culture), solitary kidney, and renal insufficiency

Primary outcomes:
measure: Urinary oxalate;
timeFrame: urine collected in 24 hours
Secondary outcomes:
measure: Urinary citrate;
timeFrame: urine collected in 24 hours
measure: Urinary calcium
timeFrame: urine collected in 24 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Hongquan Geng, M.D
role: STUDY_CHAIR
affiliation: Department of Pediatric urology,Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Lei He, M.D
role: PRINCIPAL_INVESTIGATOR
References: