louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00995618: Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
Official title: A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Febuxostat Compared With Tranilast Alone and Febuxostat Alone in Healthy Subjects With Hyperuricemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Hyperuricemia
Keywords: Gout
Hyperuricemia
Lead sponsor: Nuon Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and PD as measured by reduction in serum uric acid levels.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 to 70
* Subjects with hyperuricemia who are otherwise healthy

Exclusion Criteria:

* Pregnant or nursing
* Known history of gout
* Clinically significant infection at Screening
* Known sensitivity to tranilast or febuxostat

Primary outcomes:
measure: Mean decrease in serum uric acid levels
timeFrame: Seven days
Secondary outcomes:
measure: Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination
timeFrame: 7 days
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Nuon Investigative Site
state: Hawaii
city: Evansville
country: United States
facility: Nuon Investigative Site
state: Indiana
city: Dallas
country: United States
facility: Nuon Investigative Site
state: Texas
Study officials:
affiliation: Nuon Therapeutics, Inc.
name: Director, Nuon Clinical Trials Group
role: STUDY_DIRECTOR
References:
Clinical trial NCT05674318: The Effect of Alpha-lactalbumin on Microbiota Composition
Official title: Evaluation of Prebiotic Effects of Alpha-lactalbumin on Microbiota Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alpha-lactalbumin
Microbiota
Dysbiosis
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2023-01-06
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effects on microbiota composition after the administration of an oral supplementation based on Alpha-lactalbumin in subjects with dysbiosis.


Eligibility criteria: Inclusion Criteria:

* condition of dysbiosis

Exclusion Criteria:

* antibiotic treatment within 1 month
* probiotic or prebiotic treatments
* concomitant inflammatory intestinal diseases
* pregnancy
* neoplastic diseases
* allergy to milk protein (Alpha-lactalbumin)
* substance abuse

Primary outcomes:
measure: Improvement of microbiota composition
timeFrame: Change from baseline microbiota composition to 30 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Viterbo
country: Italy
facility: Centro Polispecialistico Giovanni Paolo I°
state: Rome
Study officials:
References:
Clinical trial NCT05463718: Virtual Reality Versus Balance Beam on Spastic Hemiplegic Cerebral Palsy
Official title: Virtual Reality Versus Balance Beam on Walking Performance in Children With Spastic Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Balance Problems in Spastic Hemiplegic Children
Walking Performance in Spastic Hemiplegic Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 75
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Is there any difference between the use of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children?

Detailed description: To compare the effect of Virtual reality and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.

To compare the effect of Balance beam and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.

To compare the effect of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children.

Eligibility criteria: Inclusion Criteria:

* Age ranges from 7 to 11 years old, from both genders.
* Modified Ashworth scale adopted from, (Bohannon and Smith,1987) was used to select the patients with grade 1 and 1+ of Spasticity.
* They were able to stand and walk.
* Gross motor function measure scale GMFM (level I \&II). (Russell et al. ,2013).
* Children with good mentality to understand the evaluation steps.

Exclusion Criteria:

* Children who have orthopedic surgery or Botulinum Toxin-A injection in the last 6 months.
* Children who have any spinal deformities.
* Children with severe muscle contracture.

Primary outcomes:
measure: Balance it will be assist by HUMAC Balance Assessment system
timeFrame: 6 month
measure: Walking ability
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Physical Therapy
city: Cairo
country: Egypt
facility: Physical Therapy
Study officials:
References:
Clinical trial NCT00707018: Immobilization in External Rotation After First Time Anterior Shoulder Dislocation
Official title: Immobilization in External Rotation After First Time Anterior Shoulder Dislocation: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2008-06-30
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.

Detailed description: The purpose of this study is to compare immobilization in internal versus external rotation after first time anterior shoulder dislocation, and thereby increase our knowledge about the best standard of care.

Eligibility criteria: Inclusion Criteria:

* 14 to 30 years of age
* Willing to participate in follow-up for at least two years
* Acute, first-time, traumatic, isolated anterior dislocation of the shoulder

Exclusion Criteria:

* Previous instability of the affected shoulder
* A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder
* Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments
* Incompetent or unwilling to consent
* A medical condition making the patient unable to wear a sling
* Significant associated fracture (Exception Hill Sachs of \>20% or bony Bankart lesions\>10%)
* Neurovascular compromise of the affected limb
* Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.

Primary outcomes:
measure: Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.
timeFrame: 24 months
Secondary outcomes:
measure: Patient self reported outcome measures
timeFrame: 24 Months
measure: Time to return to work or sport
timeFrame: 24 Months
Other outcomes:
Locations:
city: Boulder
country: United States
facility: CU Sports Medicine
state: Colorado
city: Winter Park
country: United States
facility: St. Anthony Hospitals
state: Colorado
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Akron
country: United States
facility: Summa Healthcare
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Pullman
country: United States
facility: Inland Orthopaedics
state: Washington
Study officials:
affiliation: University of Colorado, Denver
name: Eric C McCarty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06065618: Characteristics of Hospitalized Patients With Community-acquired Pneumonia
Official title: A Retrospective Study on Disease Characteristics of Hospitalized Patients With Community-acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Community-acquired Pneumonia
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients aged over 14 years with community-acquired pneumonia were confirmed by imaging.

Brief summary: At present, the epidemiological characteristics and the distribution of pathogens of community-acquired pneumonia in Shandong Province are not clear. In order to understand the characteristics of community-acquired pneumonia, the distribution of pathogens and the risk factors of complications in Shandong Province, it is necessary to carry out investigation and study, which will provide the basis and support for the future prospective cohort study of pulmonary infection.


Eligibility criteria: Inclusion Criteria:

* Age \> 14 years.
* In the community.
* Chest X-ray showed patchy, patchy infiltrative shadows or interstitial changes with or without pleural effusion (in or out of hospital) .
* Pneumonia-related clinical manifestations: 1) recent cough, expectoration or respiratory disease symptoms aggravated, and the emergence of purulent sputum, with or without chest pain. 2) fever: armpit temperature ≥37.3℃ or hypothermia: armpit temperature \<36℃. 3) signs of pulmonary consolidation and/or Wet Rales. 4) white blood cell \> 10 × 10\^9/L or \< 4 × 10\^9/L with or without left shift of nucleus. Comply with 1,2,3 above plus any one of 4 above.

Exclusion Criteria:

* The patients were initially diagnosed with pulmonary neoplasms, tuberculosis, non-infectious interstitial disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophil granulocyte infiltration and pulmonary vasculitis.
* Human Immunodeficiency Virus.
* The patient was readmitted within 72 hours of discharge and was classified as a single hospitalization.

Primary outcomes:
measure: The prevalence of CAP
timeFrame: Up to 12 months
Secondary outcomes:
measure: Severity Assessment: Curb-65
timeFrame: Up to 12 months
measure: Sputum culture
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
state: Shandong
Study officials:
References:
Clinical trial NCT01449318: Predictors of Postoperative Pain
Official title: Predictors of Postoperative Pain Following Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Pain
quantitative sensory testing
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to prove that pain scores generated from painful stimuli applied preoperatively may help identify the inter-individual variability in pain perception.

Detailed description: Psychological factors and experimental pain models such as as electrical, pressure, heat, or cold stimuli have been identified as predictors of pain intensity and opioid consumption postoperatively. This study will investigate, in addition to the factors described above, the ability of pain scores generated from painful stimuli postoperatively in predicting postoperative pain.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing abdominal hysterectomy through a pfannenstiel incision
* American Society of Anesthesiologists (ASA)Class I-III

Exclusion Criteria:

* Patients with a history of psychiatric disease
* Diabetic or alcoholic patients who may have impaired sensation due peripheral neuropathies
* chronic opioid or nonsteroidal antiinflammatory drug use
* chronic pain conditions

Primary outcomes:
measure: pain scores from IV insertion
timeFrame: 15 minutes prior to induction
Secondary outcomes:
measure: Anxiety
timeFrame: 24 to 48 hours before surgery
measure: Pain from thermal stimuli
timeFrame: 24 to 48 hours before surgery
measure: Suprathreshold Thermal pain intensity
timeFrame: 24 to 48 hours before surgery
measure: suprathreshold thermal unpleasantness intensity
timeFrame: 24 to 48 hours before surgery
measure: Expectation about pain
timeFrame: 24 to 48 hours before surgery
measure: postoperative pain
timeFrame: within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery
measure: Morphine consumption
timeFrame: within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American Unversity of Beirut Medical Center
city: Beirut
country: Lebanon
facility: AUBMC
Study officials:
affiliation: American University of Beirut Medical Center
name: Marie T Aouad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02874118: Search for Fragility Indicators Among People Aged 50+ With Chronic HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail in HIV Population
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 510
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The frailty and frail elderly was defined in 2001 by Fried as a physiological state of heightened vulnerability to external shocks. 5 criteria for classifying the elderly in 3 categories: frail, pre-frail and not frail. The prevalence of frailty in the general population was estimated to be 7%, 10% and 20% for over 65 years and 45% for over 85 years. This concept is explored in some chronic diseases, in order to prevent the loss of autonomy and tailor the treatment. In the carrier population of HIV, a North American retrospective study showed the frailty syndrome manifested as early as 10 years before, than in the general population. Furthermore various studies show in this specific population, increased incidence of diseases linked to age, suggesting an accelerated and premature aging.

objectives: The objective of this study is to determine the prevalence of frailty defined Fried syndrome in a population of subjects aged 50 and over Holders of chronic HIV infection.


Eligibility criteria: Inclusion Criteria:

* Patient with HIV and followed in the southeastern France area

Exclusion Criteria:

* In patient HIV infected patient
* HIV patient disabled (spastic)
* HIV infected for less than a year

Primary outcomes:
measure: Number of frailed patient among the HIV population folloxed in southeastern France area
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Ureielle DESALBRES
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hôpitaux de Marseille
name: Nathalie PETIT, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02235818: Determining the Immediate Effects of Counterforce Bracing Versus Kinesiotaping in Patients With Tennis Elbow
Official title: Immediate Effectiveness of Counterforce Bracing Versus Kinesiotaping During Activity: A Randomized Crossover Trial in Patients With Lateral Epicondylosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tennis Elbow
Keywords: tennis elbow, treatment, lateral epicondylitis, immediate effects
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the immediate efficacy of Counterforce brace versus kinesiotaping on patients with lateral epicondylosis/tennis elbow with respect to a repetitive physical task. The investigators hypothesized that there would be difference in the outcomes with respect to interventions and activity. Patient came for one hour long Single occasion testing session and were not followed up after the testing was complete.

Detailed description: This was a cross over randomized control trial. Thirty patients with clinical diagnosis of lateral epicondylosis/tennis elbow were recruited from a local community and were tested on single occasion (one time testing session) before and after a five minute upper extremity repetitive task first with control and then brace and kinesiotape assigned in cross-over design. The testing session was one hour long and there was no follow up of patients following the testing. The patients were recruited between Jan-June 2013.

Eligibility criteria: Inclusion Criteria:

1. Age (18-70 years)
2. Ability to provide written informed consent to participate
3. Were at least three weeks from onset of symptoms
4. Complaints of discomfort or pain at the lateral elbow region for a minimum of three weeks and tenderness with palpation of the lateral epicondyle
5. Provocation of lateral elbow pain with one of the following test - resisted middle finger extension, resisted wrist extension or passive stretch of wrist extensors

Exclusion Criteria:

1. History of surgery on affected elbow
2. History of cortisone injections on the affected elbow in the past 4 weeks
3. Any physical or mental limitations that precluded performance of the study testing
4. Allergy to adhesive tapes

Primary outcomes:
measure: Pain free grip strength
timeFrame: initial visit
Secondary outcomes:
measure: Pressure Pain Threshold
timeFrame: initial visit
Other outcomes:
measure: Pain levels
timeFrame: initial visit
Locations:
city: London
country: Canada
facility: The Hand and Upper Limb Centre, St. Joseph's Health Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Joy C Macdermid, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University, Canada
name: Pritika Gogia, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03417518: Effects of Anesthesia With Propofol Versus Desflurane in Obese Patients
Official title: Effects of General Anesthesia With Propofol Versus Desflurane on Oxidative Stress and Inflammation in Obese Patients Scheduled for Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Obesity
Keywords: Oxidative stress
Bariatric surgery
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 40
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: BASIC_SCIENCE

Brief summary: Evaluate the effects of propofol compared with desflurane on oxidative stress and inflammation markers in obese patients undergoing scheduled bariatric surgery.

Detailed description: Obese patients have a high level of oxidative stress and inflammation activity. Desflurane is an anesthetic gas often used for obese patients. Propofol, another anesthetic agent, has shown an antioxidant property. The aim of the study is to compare the effects of propofol with desflurane on oxidative stress and inflammation markers in obese patients.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) \>35
* scheduled gastric by pass surgery
* American Society of Anesthesiologists (ASA) \<III

Exclusion Criteria:

* Allergic to anesthesia agent
* patient refusal

Primary outcomes:
measure: Malondialdehyde (MDA) level in blood sample
timeFrame: up to 24 hours post bariatric surgery
Secondary outcomes:
measure: C-Reactive Protein (CRP) in blood sample
timeFrame: up to 24 hours post bariatric surgery
measure: Monocyte level in blood sample
timeFrame: up to 24 hours post bariatric surgery
measure: Pain assessed by Visual Analog Scale (VAS)
timeFrame: up to 48 hours after surgery
measure: Side-effects (nausea, vomiting, somnolence, respiratory depression)
timeFrame: up to 48 hours after surgery
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Universite libre de Bruxelles (ULB)
name: Panayota Kapessidou
role: STUDY_DIRECTOR
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre)
name: Livia Di Marco, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skalicky J, Muzakova V, Kandar R, Meloun M, Rousar T, Palicka V. Evaluation of oxidative stress and inflammation in obese adults with metabolic syndrome. Clin Chem Lab Med. 2008;46(4):499-505. doi: 10.1515/CCLM.2008.096.
citation: Del Rio D, Stewart AJ, Pellegrini N. A review of recent studies on malondialdehyde as toxic molecule and biological marker of oxidative stress. Nutr Metab Cardiovasc Dis. 2005 Aug;15(4):316-28. doi: 10.1016/j.numecd.2005.05.003.
citation: Murphy PG, Myers DS, Davies MJ, Webster NR, Jones JG. The antioxidant potential of propofol (2,6-diisopropylphenol). Br J Anaesth. 1992 Jun;68(6):613-8. doi: 10.1093/bja/68.6.613.