louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04417439: The Effect of Acute Phase Treatment Approaches on Creatine Kinase and the Musculoskeletal System in Different Types of Burns
Official title: Turgut Özal Medical Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn Injury
Keywords: Acute-phase burn
Creatine Kinase, MM Form,
Musculoskeletal Development
Treatment Effectiveness
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 37 individuals, including 10 females and 27 males

Brief summary: There are very few studies indicating the effect of acute phase treatment approaches on creatine kinase and the musculoskeletal system in the physiotherapy and rehabilitation process. Rehabilitation in burn patients is a benchmark due to return to pre-burn life. Therefore, this study was conducted to determine the effect of acute phase treatment approaches on creatine kinase and the musculoskeletal system in different types of burns.

Detailed description: In the literature, there are very few objective and quantitative studies comparing the effects of standard wound care and rehabilitation period on different burn types in burn patients. Thus, our study was designed to investigate the effects of acute phase treatment approaches on creatine kinase and the musculoskeletal system in different types of burns.

Eligibility criteria: Inclusion Criteria:

* the study were being aged between 18-65 years and having different burn types, and flame, scald, and electrical burns were included in the study.
* The burn percentage and mortality percentage were calculated, and patients with a burn percentage of less than fifty percent were included.

Exclusion Criteria:

* the study were having a systemic disease, having substance abuse, and having a burn percentage of more than fifty percent.

Primary outcomes:
measure: universal goniometer
timeFrame: three weeks
measure: A tape measure with a width of 7 mm
timeFrame: three weeks
measure: The biochemical examination of CK (creatine kinase)
timeFrame: three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Malatya İnönü University
city: Malatya
country: Turkey
facility: Turgut Özal medical center
Study officials:
References:
citation: Flores O, Tyack Z, Stockton K, Ware R, Paratz JD. Exercise training for improving outcomes post-burns: a systematic review and meta-analysis. Clin Rehabil. 2018 Jun;32(6):734-746. doi: 10.1177/0269215517751586. Epub 2018 Jan 10.
citation: Goverman J, Mathews K, Goldstein R, Holavanahalli R, Kowalske K, Esselman P, Gibran N, Suman O, Herndon D, Ryan CM, Schneider JC. Adult Contractures in Burn Injury: A Burn Model System National Database Study. J Burn Care Res. 2017 Jan/Feb;38(1):e328-e336. doi: 10.1097/BCR.0000000000000380.
Clinical trial NCT01982539: Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute
Official title: An Open-Label Study of the Safety and Efficacy of Zipsor® (Diclofenac Potassium) Liquid Filled Capsules in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pain
NSAID
moderate pain
mild pain
acute pain
mild acute pain
moderate acute pain
mild or moderate acute pain
Lead sponsor: Depomed
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.

Detailed description: Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate acute pain for up to 4 days.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects between 12-17 years of age.
* Subjects must be post-op, having mild or moderate acute pain.

Other inclusions apply.

Exclusion Criteria:

* Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.
* Subject has been taking analgesic for 48-72 hours prior to Screening.
* Subject has a history of any GI event greater than 6 months before Screening.
* Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.
* Subject has previously participated in another clinical study of Zipsor or taking Zipsor for any other indication.
* Subject is requiring treatment for pre-existing hypertension.

Other exclusions apply.

Primary outcomes:
measure: Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years
timeFrame: First dose to 30 days after the last dose
Secondary outcomes:
measure: Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration.
timeFrame: From Baseline to 1st and 2nd hour
measure: Percentage Difference of Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration.
timeFrame: From Baseline to 1st and 2nd hour
Other outcomes:
Locations:
city: Sheffield
country: United States
state: Alabama
city: Stanford
country: United States
state: California
Study officials:
References:
Clinical trial NCT04452539: Gender Influence on Morbi-mortality in Pediatric Cardiac Surgery.
Official title: Gender Influence on Mortality and Major Morbidity After Pediatric Cardiac Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cardiac Surgery
Gender
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 1500
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing paediatric cardiac surgery with cardiopulmonary bypas at our institution from jan 2006 to dec 2019.

Brief summary: Recent studies show an important influence of gender on inflammatory reactions. Cardiac surgery is associated with a major systemic inflammatory response. The investigators want to evaluate the gender influence on morbi-mortality in pediatric cardiac surgery patients.

Detailed description: Gender plays an important role in the inflammatory response. This is due to hormonal influences, but also different genetic regulation of pro-inflammatory cytokines, as nuclear facto kapp B. it is also know that cardiac surgery, especially under cardiopulmonary bypass, is associated with a major inflammatory response. This response is even more marked in pediatric cardiac surgery. The investigators hypothesise that there is a gender influence on mortality and major morbidity in paediatric patients undergoing cardiac surgery. The investigators will do a retrospective cohort study, analysing the local database of all paediatric cardiac surgery cases from jan 2006 to dec 2019. Primary outcome will be any difference in mortality and /or major morbidity according to gender.

Statistical analysis:

The investigators will use a propensity score on 11 pre-operative variables clinically judged relevant. Both group will be matched until a absolute standardised difference \< 15% is obtained. This type of matching, contrary to a P value, is independent of sample size. Variables will be presented as mean, standard deviation or percentage for frequency distributions. After propensity score matching, logistic regressions will be performed on binary variables and linear regressions on continuous variables. A Bonferroni correction will be used for multiple comparisons.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Jehova's witness

Primary outcomes:
measure: Mortality
timeFrame: Beginning of the operation until 5 days postop
measure: Morbidity
timeFrame: Beginning of the operation until 5 days postop
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire des Enfants Reine Fabiola
Study officials:
affiliation: CHU Brugmann
name: Denis Schmartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05504239: Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin and Metformin
Official title: A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin and Empagliflozin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 235
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin and metformin


Eligibility criteria: Inclusion Criteria:

* Patients with Type II diabetes mellitus aged 19 years or older
* Subjects with 7.0%≤HbA1c≤10.5% at screening visit
* Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit

Exclusion Criteria:

* Subjects with type 1 diabetes mellitus or secondary diabetes
* Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit
* Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin)
* Body mass index greater than 40 kg/m2 at the screening visit
* Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment

Primary outcomes:
measure: Changes from baseline HbA1c at week 24
timeFrame: Baseline (week 0) and week 24
Secondary outcomes:
measure: Changes from baseline FPG at week 24
timeFrame: Baseline (week 0) and week 24
measure: Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24
timeFrame: Baseline (week 0) and week 24
measure: Changes from baseline in BMI at week 24
timeFrame: Baseline (week 0) and week 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03822039: WHO Checklist- Based Infection Prevention Guidelines in Mulago Hospital
Official title: Compliance Levels With WHO Checklist-based Infection Prevention Guidelines and Associated Surgical Site Infection Following Caesarean Delivery in Mulago Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Site Infection
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 768
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mothers undergoing Caesarean Deliveries in Mulago National Referral Hospital, Kawempe labour suite and gynaecology theatre.

Brief summary: This prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days .

Detailed description: To determine the level of compliance with WHO checklist-based infection prevention guidelines following caesarean delivery in Mulago National Referral Hospital, Kawempe.

To determine the association between compliance with WHO checklist-based infection prevention guidelines and surgical site infection following caesarean delivery in Mulago Hospital, Kawempe.

This prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days of in-hospital stay for the purpose of documentation of surgical site infection. Data will be collected using the checklist expansion for antisepsis and infection control questionnaire.

Eligibility criteria: Inclusion Criteria:

* Mothers undergoing elective and emergency caesarean deliveries in Mulago National Referral Hospital, Kawempe in labour suite and gynaecology theatre.

Exclusion Criteria:

* Patient who is unconscious and unknown patient

Primary outcomes:
measure: Level of compliance with WHO checklist-based infection prevention guidelines following caesarean delivery among health care workers in Mulago Hospital, Kawempe
timeFrame: 24Hours
Secondary outcomes:
measure: surgical site infection within 30 days of operation
timeFrame: 30 days
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago hospital
state: Mulago Hospital
Study officials:
affiliation: Makerere University
name: Anne Mbiya, Mbchb
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04794439: Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing
Official title: Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque, Dental
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate and compare plaque removal efficacy of four dentifrices following a single timed tooth brushing. Prior to each evaluation visit of the four-way cross-over study, subjects will abstain from all oral hygiene for 24 hours. At each evaluation visit, subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.

Detailed description: This study is a randomized, single-brushing, examiner-blinded, 4-cell cross-over design that enrolled approximately 70 subjects to ensure that at least 60 subjects to complete the study. This 4-week cross-over study will evaluate plaque removal following a single brushing with the assigned dentifrices. Qualified subjects will have sufficient plaque (Lobene-Soparkar Modification of Turesky Plaque Index). Subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.

Eligibility criteria: Inclusion Criteria:

1) 18 to 69 years

Exclusion Criteria:

1. Have any known allergies or sensitivities to marketed dentifrice or oral hygiene products.
2. Have fixed or removable orthodontic appliances, peri/oral piercings, or removable partial dentures.
3. Evidence of poor oral hygiene, rampant dental caries, presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.

Primary outcomes:
measure: Mean change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research, Inc.
state: Indiana
Study officials:
References:
Clinical trial NCT02186639: Breath Analysis in Chronic Obstructive Lung Disease (COPD)
Official title: Exhaled Breath Analysis in Patients With COPD by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: exhaled breath
volatile organic compounds (VOCs)
SESI-MS
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2014-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited in primary, secondary and tertiary care clinics. Healthy controls will be recruited from a community sample.

Brief summary: To answer the question whether a disease specific profile of breath in patients with COPD can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.

Detailed description: This is an observational study comparing the volatile organic compounds (VOCs) in exhaled breath between COPD patients and matched control subjects (age, gender, smoking-state). 40 COPD patients (20 non-frequent, 20 frequent exacerbators) and 40 matched controls will be examined by SESI-MS on the composition of exhaled breath for identification of COPD specific markers.

Eligibility criteria: Inclusion Criteria:

* confirmed COPD GOLD stage I-IV, based on a post-bronchodilator spirometry (FEV1/FVC \< 0.7) performed within the last 6 months
* age between 18 and 80 years at study entry
* healthy controls: normal spirometry

Exclusion Criteria:

* COPD exacerbation within the last 6 weeks
* any lung disease other than COPD
* acute inflammatory disease (e.g. common cold) within the last 6 weeks
* acute or chronic hepatic disease
* renal failure or renal replacement therapy

Primary outcomes:
measure: COPD-specific mass spectrometric exhaled breath pattern
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
affiliation: University Hospital Zurich, Pulmonary Division
name: Malcolm Kohler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaugg MT, Nussbaumer-Ochsner Y, Bregy L, Engler A, Stebler N, Gaisl T, Bruderer T, Nowak N, Sinues P, Zenobi R, Kohler M. Real-Time Breath Analysis Reveals Specific Metabolic Signatures of COPD Exacerbations. Chest. 2019 Aug;156(2):269-276. doi: 10.1016/j.chest.2018.12.023. Epub 2019 Jan 24.
Clinical trial NCT06467539: Novel Augmentation of DAOIB and Antioxidant for Early Dementia
Official title: Novel Augmentation of DAOIB and Antioxidant for Early Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous studies found that some NMDA-enhancing agents were able to improve cognitive function of patients with early-phase dementia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of dementia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
* MMSE between 10-26
* CDR 1 or 0.5

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major depressive disorder
* Major physical illnesses
* Severe visual or hearing impairment

Primary outcomes:
measure: Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
Secondary outcomes:
measure: Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
timeFrame: week 8, 16, 24
measure: Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24
timeFrame: week 0, 24
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: