louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04403334: Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin
Official title: Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery With Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin Versus Levofloxacin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract Senile
Endophthalmitis
Antibiotic Side Effect
Safety Issues
Keywords: levofloxacin
moxifloxacin
prophylaxis
endophthalmitis
cataract surgery
Lead sponsor: Peregrine Eye and Laser Institute
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 114
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis

Detailed description: Randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification.

Eligibility criteria: Inclusion Criteria:

* Eyes undergoing uncomplicated cataract surgery by phacoemulsification

Exclusion Criteria:

* Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study

Primary outcomes:
measure: Endothelial Cell Count
timeFrame: 3 months
measure: Central Retina Thickness
timeFrame: 3 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 3 months
Other outcomes:
Locations:
city: Makati City
country: Philippines
facility: Peregrine Eye and Laser Instittute
state: MM
Study officials:
affiliation: Peregrine Eye and Laser Institute
name: Harvey S Uy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04974034: Movement Disorders Analysis Using a Deep Learning Approach
Official title: Movement Disorders Analysis Using a Deep Learning Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradykinesia
Parkinson Disease
Hypokinesia
Akinesia
Parkinsonian Syndrome
Parkinsonian Disorders
Keywords: Deep Learning
Bradykinesia
Parkinson Disease
Lead sponsor: Hospital Avicenne
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 50
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: All patients seen by a neurologist in the department of Neurology at Avicenne Hospital (Bobigny, France) between June 2019 and December 2020 were recorded during MDS-UPDRS examination.

The investigators also included healthy volunteers on a voluntary basis.

Brief summary: Bradykinesia is a key parkinsonian feature yet subjectively assessed by the MDS-UPDRS score, making reproducible measurements and follow-up challenging.

In a Movement Disorder Unit, the investigators acquired a large database of videos showing parkinsonian patients performing Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III protocols.

Using a Deep Learning approach on these videos, the investigators aimed to develop a tool to compute an objective score of bradykinesia from the three upper limb tests described in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years

Exclusion Criteria:

* Refusal of participation

Primary outcomes:
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hospital Avicenne
state: Seine Saint Denis
Study officials:
affiliation: Hospital Avicenne
name: Clément Desjardins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Avicenne
name: Bertrand Degos, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01266434: The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma
Official title: The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: moderate persistent asthma
Inhaled corticosteroids
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a signaling molecule for inflammation in inhaled steroid-treated asthmatics.


Eligibility criteria: Inclusion Criteria:

* mild-to-moderate persistent asthmatics
* FEV1 = OR \> 50% of predicted

Exclusion Criteria:

* Previous history of renal disease or serum creatinine is more than 2 mg/dl.
* Previous history of liver disease.
* Pregnancy or lactation.
* Are already receiving or are known to be allergic to statins or to have developed myositis.
* Have an asthma exacerbation requiring treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.
* Being treated with immunosuppressive agents.
* Unwilling to cooperate the study.

Primary outcomes:
measure: Sputum eosinophils
timeFrame: 8 weeks
Secondary outcomes:
measure: Phosphorylated p38 MAPK in sputum cells
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Division of Respiratory Disease and TB, Siriraj Hospital
state: BKK
Study officials:
affiliation: Siriraj Hospital
name: Kittipong - Maneechotesuwan, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00954434: Effects of Red Wine on Cardiovascular Risk Factors in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Subjects
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2009-08-07
Enrollment: 44
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Fifty healthy human subjects are randomized to not to consume any alcohol at all or to drink 1 glass of red wine/day for women or 2 glasses for men for three months. Outcomes are changes in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body composition.


Eligibility criteria: Inclusion Criteria:

* healthy subjects
* 25 years of age and older

Exclusion Criteria:

* alcoholic first degree relatives

Primary outcomes:
measure: effects on laboratory variables, mood and body composition
timeFrame: 3 months
Secondary outcomes:
measure: effects on liver fat amount
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Linkoping, Sweden
name: Fredrik H Nystrom, MD PhD prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05947734: Robot Assisted Total Hip Arthroplasties
Official title: A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS" Surgical Robotic System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthropathy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Qianfoshan Hospital
name: Chifeng Municipal Hospital
First posted: 2023-07-17
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled, multicenter study. According to the inclusion criteria, volunteers were recruited from patients undergoing total hip arthroplasty. After signing the informed consent, the subjects were assigned to the experimental group and the control group through the central randomization system. The researchers will complete the total hip arthroplasty for patients in the experimental group with the assistance of surgical robotic system. The patients in the control group do not use the surgical robotic system. The proportion of acetabular abduction angle and anteversion angle in the lewinnek safe area is the primary outcome measurement. The operation time, WOMAC score, Harris score, SF-36 and dislocation rate are the secondary outcome measurements. The incidence of complications, devices and other adverse events were recorded.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary hip osteoarthritis(OA), fracture of femoral neck (FFN),or secondary hip osteoarthritis due to developmental dysplasia of the hip (DDH), hip avascular necrosis (AVN), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and coxa plana

Exclusion Criteria:

* Severe vascular diseases of the lower extremity Neuromuscular diseases Infectious diseases Severe dysfunctions of major organs Severe neurosensory deficiencies caused by spinal diseases Unable to receive CT/MRI scans

Primary outcomes:
measure: Acetabular location accuracy
timeFrame: Within 1 week after surgery
Secondary outcomes:
measure: Operation time
timeFrame: Immediately after surgery
measure: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 months after surgery
measure: Harris Hip Score (HHS)
timeFrame: 6 months after surgery
measure: 36-Item Short Form Survey (SF-36）
timeFrame: 6 months after surgery
measure: dislocation rate of hip joint
timeFrame: 6 months after surgery
measure: adverse events or complications
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04808934: NOAC Portuguese Real World Study
Official title: Stroke/Systemic Embolism and Major Bleeding in Patients Newly Treated With Oral Anticoagulants: a Real World Study From Portuguese Administrative Claims Data
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke
Systemic Embolism
Major Bleeding
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients will be selected from the CCF database based on an apixaban, dabigatran, rivaroxaban or VKAs filled prescription between June 16, 2014 and December 31, 2018.

Brief summary: To determine if there is any difference in the effectiveness and safety outcomes of patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban and vitamin K antagonists


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years on the index date.
* At least 1 OAC (apixaban, dabigatran, rivaroxaban, VKAs) dispensed during the identification period.

Exclusion Criteria:

* Specialty of the physician responsible for the OAC prescription in the index date is one of the following: orthopedics, general surgery, vascular surgery or any other surgical specialty;
* Duration of OAC therapy during follow-up inferior to the cut-off defined during the feasibility assessment (except if the patient was admitted to in-hospital care during follow-up);
* The OAC dispensed in the index date was one of the following: dabigatran 75 mg or rivaroxaban 10 mg
* Hospital claims lacking a diagnosis code indicative of AF during the study period;
* Hospital claim indicating a diagnosis or procedure code indicative of pregnancy or childbirth during the study period;
* Hospital claim indicating a diagnosis or procedure code indicative of valvular heart disease, venous thromboembolism, cardiac surgery, pericarditis, hyperthyroidism and thyrotoxicity during the baseline period;
* Hospital claim indicating a diagnosis or procedure code indicative of hip and knee replacement surgery during the 6 weeks prior to the index date. Patients with past use of OAC will be excluded. Therefore, patients meeting any of the following criteria will be excluded:
* Had any OAC (apixaban, dabigatran, edoxaban, rivaroxaban, VKAs) dispensed during the 12-month baseline period;
* Had \>1 OAC dispensed on the index date.

Primary outcomes:
measure: stroke/systemic embolism event
timeFrame: between 2014 and 2018
measure: major bleeding event
timeFrame: between 2014 and 2018
Secondary outcomes:
measure: ischemic stroke event
timeFrame: between 2014 and 2018
measure: hemorrhagic stroke event
timeFrame: between 2014 and 2018
measure: systemic embolism event
timeFrame: 2014-2018
measure: major GI bleeding event
timeFrame: 2014-2018
measure: major IC bleeding event
timeFrame: 2014-2018
measure: other major bleeding event
timeFrame: 2014-2018
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01900834: Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period
Official title: An Observational Study Evaluating Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-07-17
Enrollment: 61
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with T1D, T2D and healthy subjects (HS) without personal or first degree family history of autoimmunity of diabetes. The HS will be mean age-matched with the T1D subjects.

Brief summary: This study is conducted in the United States of America (USA). The aim of this study is to assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.


Eligibility criteria: Inclusion Criteria:

* T1D
* Male or female subjects diagnosed within the last 3 years and with good general health based on medical history
* Age above or equal to 14 years and below or equal to 40 years
* Body weight above 45 kg
* T2D
* Male or female subjects diagnosed within the last 15 years with good general health based on medical history
* HbA1c between 6.5% and 10%
* Body mass index (BMI) below 45 kg/m\^2
* Age above or equal to 18 and below 65 years
* On insulin treatment
* HS
* Male or female subjects with good general heath based on medical history
* Age above or equal to 18 years and below or equal to 40 years

Exclusion Criteria:

* Any chronic disorder (besides T1D or T2D) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
* Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant

Primary outcomes:
measure: Variation in CD8 (cluster of differentiation) +T-cell specificity profiling
timeFrame: Over a one year period
Secondary outcomes:
measure: Variation in CD4 +T-cell specificity profiling
timeFrame: Over a one year period
measure: Change in stimulated C-peptide
timeFrame: Baseline, one year
measure: Fluctuation in islet autoantibodies titers
timeFrame: Over a one year period
measure: Variation in HbA1c (glycosylated haemoglobin)
timeFrame: Over a one year period
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00953134: Periconceptional Iron Supplementation in Rural Bangladesh
Official title: Periconceptional Iron Supplementation on Iron and Folate Indicators Among Pregnant and Non-pregnant Women in Rural Bangladesh.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Anemia
Keywords: periconceptional
iron
folic acid
supplementation
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 273
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that periconceptional iron supplementation to married, nulliparous women in rural Bangladesh will significantly reduce anemia and improve hemoglobin concentrations before and during pregnancy.

Detailed description: In 2007, the National Strategy for Anemia Prevention and Control in Bangladesh included adolescents and newly married women as target groups for future iron and folic acid (IFA) supplementation programs. This double-blinded RCT examined the effect of daily periconceptional IFA vs. folic acid (FA) on anemia and iron indictors before and during pregnancy among married, nulliparous women in rural Bangladesh. Biochemical indices were collected at baseline and either at 15 weeks gestation or after 9 months among non-pregnant women (NPW).

Eligibility criteria: Inclusion Criteria:

Women were eligible if they were:

* Married
* Nulliparous
* \< 40 years old
* Living in the same household as their husband

Exclusion Criteria:

Women were excluded if they were:

* Pregnant at enrollment
* Planning to move out of the region
* Using iron supplements within the previous 3 months
* Using an implant form of birth control, or had surgery to prevent pregnancy
* Women with a Hb concentration of \< 70 g/L, defined as severely anemic according to WHO definition (5), were excluded from the study and appropriately treated

Primary outcomes:
measure: Hemoglobin
timeFrame: February 2007-February 2008
Secondary outcomes:
measure: Plasma ferritin
timeFrame: February 2007-February 2008
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Brac
state: Dhaka Division
Study officials:
affiliation: The Hospital for Sick Children
name: Amina Khambalia, MSc
role: STUDY_DIRECTOR
References:
citation: Khambalia AZ, O'Connor DL, Macarthur C, Dupuis A, Zlotkin SH. Periconceptional iron supplementation does not reduce anemia or improve iron status among pregnant women in rural Bangladesh. Am J Clin Nutr. 2009 Nov;90(5):1295-302. doi: 10.3945/ajcn.2009.28350. Epub 2009 Sep 30.
Clinical trial NCT04326634: Controlled Exercises Effectiveness in Patients With Sleep Apnea
Official title: Controlled Exercises Effectiveness in Patients With Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Apnea, Sleep
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to compare a programme of controlled exercises therapy vs a programme of non controlled exercises therapy in patients with sleep apnea


Eligibility criteria: Inclusion Criteria:

* sleep apnea

Exclusion Criteria:

* neurologic disease

Primary outcomes:
measure: awake episodes
timeFrame: immediately after treatment
measure: awake episodes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03467334: Infant Colic Treatment With Probiotics
Official title: Nutritional Intervention, Multicenter, Randomized, Blind, Parallel Groups Study to Assess the Effect of Consumption of Bifidobacterium Breve CECT7263 and Lactobacillus Fermentum CECT5716 on Infant Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infant Colic
Keywords: Infant colic
Bifidobacterium breve
Lactobacillus fermentum
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
Collaborators: name: European Regional Development Fund
name: Ministerio de Ciencia e Innovación, Spain
First posted: 2018-03-16
Enrollment: 156
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.

Detailed description: Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fermentum CECT5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic.

The objective of the present study is to compare the effect of B. brevis and B. brevis\\L mixture. fermentum with respect to simethicone.

It is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.

Eligibility criteria: Inclusion Criteria:

* Infants from 3 to 12 weeks of age
* Born at least at week 34
* Birth weight equal to or greater than 2000 grams
* Fulfill the criteria of Rome III
* Informed consent signed by parents or guardians

Exclusion Criteria:

* Failure to thrive
* Antibiotic treatment less than 2 weeks before the study or during the study
* Take probiotics as a treatment, different from the one that could contain the powdered infant formula
* Abandon breastfeeding and switch to infant formula
* Failure to comply with the study protocol

Primary outcomes:
measure: Crying time
timeFrame: 4 weeks
Secondary outcomes:
measure: Responders to treatment on weeks 1, 2, 3 and 4
timeFrame: 4 weeks
measure: Gut microbiota
timeFrame: 4 weeks
measure: Stool carbohydrates
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Servicio Andaluz de Salud
Study officials:
affiliation: Specialist in Pediatrics of the Medical-Surgical UGC of Infancy of the University Hospital Complex of Granada (Spain)
name: José Maldonado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: