louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04196387: Antimicrobial Resistance Rate In Escherichia Coli And Klebsiella Pneumonia : A Retrospective Study
Official title: Antimicrobial Resistance Rate In Escherichia Coli And Klebsiella Pneumonia : A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotic Reaction
Keywords: antibiotics, urine, resistance
Lead sponsor: Al-Kindy College of Medicine
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 88
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with dysurea

Brief summary: Antibiotics are medicines used to avoid and treat bacterial infections. Antibiotic resistance is increasing to dangerous level globally.

Detailed description: Antibiotics resistance is a global health problem.

Eligibility criteria: Inclusion Criteria:

1. patients with UTI
2. patients with dysuria
3. patients with loin pain

Exclusion Criteria:

1. patients with surgery
2. patients with cancer

Primary outcomes:
measure: urine culture results
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01362387: R U OK? The Acceptability and Feasibility of New Communication Technologies for Follow-up After Medical Abortion
Official title: R U OK? The Acceptability and Feasibility of New Communication Technologies for Follow-up After Medical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Legally Induced Abortion, Complete, Without Mention of Complication
Keywords: Medical abortion
abortion follow-up
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: British Pregnancy Advisory Service
First posted: 2011-05-30
Enrollment: 999
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Purpose: This randomised trial will compare outcomes and acceptability of an alternative medical abortion follow-up protocol using standardised text messaging, on-line questionnaire, or a phone interview and a low sensitivity pregnancy test with the current standard of care which consists of either a clinic visit and ultrasound scan or a telephone call and high sensitivity pregnancy test.

Hypothesis: The use of "alternative" methods to assess outcomes after early medical abortion will achieve a higher rate of follow-up than women undergoing "standard" follow-up

Primary aim: To determine the follow-up rate after early medical abortion with an alternative protocol as compared to a standard follow-up protocol

Secondary aims:

* To assess complication rates and receipt of further treatment among women in the two study arms
* To ascertain women's preferences for mode of communication regarding their post-medical abortion status
* To determine provider opinions and preferences for different follow-up modalities


Eligibility criteria: Inclusion Criteria:

* 16 years of age or older,
* eligible for an abortion under the terms of the Abortion Act (1967),
* requesting an early medical abortion,
* willing and able to comply with the study protocol and visit schedule,
* access to either a mobile phone, intranet or telephone and willing to have communication by one of these means to assess post-medical abortion status,
* willing to have call back messages left,
* willing and able to provide valid informed consent, and
* able to communicate in English.

Exclusion Criteria:

* prior participation in this research study, or
* current participation in another research study that, in the opinion of the investigator, would interfere with the conduct of this study.

Primary outcomes:
measure: Number of women with complete clinical information on post-abortion status
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Day Care Unit
city: Chester
country: United Kingdom
facility: Chester Day Care Unit
city: London
country: United Kingdom
facility: London Central Day Care Unit
city: Luton
country: United Kingdom
facility: Luton Day Care Unit
Study officials:
affiliation: Gynuity Health Projects
name: Hillary Bracken, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00998387: Validation of the Korean Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Official title: Translation and Validation of the Korean Version of Confusion Assessment Method for the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-10-20
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to medical ICU at Seoul National University Hospital longer than 24 hours

Brief summary: The purpose of this study is to translate and validate the CAM-ICU for use in the Korean ICU setting.


Eligibility criteria: Inclusion Criteria:

* older than 18 years
* admitted to medical ICU at Seoul National University Hospital longer than 24 hours

Exclusion Criteria:

* comatose or moribund state throughout the study period
* preexisting neurologic problem

Primary outcomes:
measure: Interrater reliability of Korean CAM-ICU
timeFrame: after completion of study
measure: Sensitivity of Korean CAM-ICU for diagnosing ICU delirium
timeFrame: after completion of study
measure: Specificity of Korean CAM-ICU for diagnosing ICU delirium
timeFrame: after completion of study
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05809687: Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A
Official title: Evaluate Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A in Mixed Dyslipidemia Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Dyslipidemias
Lead sponsor: Dongkwang Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-12
Enrollment: 0
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: Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A

Detailed description: Phase 3 study to evaluate the efficacy and safety of DKP21102 in patients with mixed dyslipidemia where LDL-C is properly controlled but triglyceride and HDL-C levels are not regulated by DKP21102_A alone.

Eligibility criteria: Inclusion Criteria:

* A man or woman over 19 years old.
* Patients with coronary heart disease or risk of coronary heart disease

Exclusion Criteria:

* History of Unstable angina, myocardial infarction etc
* Uncontrolled hypo-thyroidism (TSH≥1.5XULN), Diabetes(HbA1c ≥ 9.0%)
* renal impairment (Creatinine clearance \< 60 mL/min) etc.

Primary outcomes:
measure: Percent change (%) of non-HDL-C from baseline
timeFrame: from baseline at 12weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06371287: Effect of Musical Auditory Training on Subjects With Tinnitus Disorder
Official title: Effect of Musical Auditory Training on Neuroplasticity and Perception of Subjects With Tinnitus Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: Plasticidade Neuronal
Zumbido
Processamento Auditivo Central
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Among the theories of tinnitus generation, there is that of central neuroplastic changes, which reports the association between changes and reorganization that occur in central auditory pathways and impacts on associated areas due to the altered neural signal. Auditory training modifies these altered pathways through auditory exercises, which provoke positive neuroplasticity. Musical auditory training is a proposal to stimulate auditory, cognitive and metalinguistic skills with activities focused on musicality. Therefore, the objective of this study is to verify the effect of musical auditory training (MAT) on the neuroplasticity of the auditory system and the perception of tinnitus disorder in young adults.


Eligibility criteria: Inclusion Criteria:

* Individuals of both sexes aged between 18 years and 55 years;
* Complaint of chronic tinnitus (minimum perception of six months) unilateral or bilateral;
* Hearing thresholds within normal limits bilaterally or even mild sensorineural hearing loss in the four-tone average (500, 1000, 2000 and 4000Hz);
* Annoyance score of at least four on the Visual Analogue Scale, considered a moderate symptom discomfort;
* Have normality in the Mini Mental State Examination (cognitive screening).

Exclusion Criteria:

* Apparent speech, psychiatric or neurological changes;
* History of head or brain trauma;
* Objective tinnitus (somatosensory and vascular);
* Present symptoms and/or diagnosis of middle ear involvement;
* Having started a new treatment (pharmacological or therapeutic) or having been diagnosed with a disease of any origin in the last month.
* Be carrying out another intervention for tinnitus during the research;
* Use of electronic assistive hearing devices.

Primary outcomes:
measure: Changes in latency of the long latency auditory evoked potential (LLAEP)
timeFrame: Within a month
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Universidade Federal de Santa Maria
state: RS
city: Santa Maria
country: Brazil
facility: Universidade Federal de Santa Maria
state: RS
Study officials:
References:
Clinical trial NCT00802087: Single Dose Pharmacokinetics of Egalet® Hydrocodone
Official title: A Single-Centre, Single Dose, Randomized,Open Label, Exploratory, 5-way Crossover Study Evaluating the Pharmakokinetic Profiles of Various Egalet® Hydrocodone Formulations In Healthy Volunteers Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Hydrocodone
Pharmacokinetics
Safety & Tolerability
Lead sponsor: Egalet Ltd
Sponsor class: INDUSTRY
First posted: 2008-12-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® hydrocodone formulations and compare to a marketed hydrocodone drug.

Detailed description: Outcomes:

Pharmacokinetic parameters and bioequivalence testing.

Eligibility criteria: Inclusion Criteria:

* Non-smokers
* ≥18 and ≤55 years of age
* BMI ≥19 and ≤30.0

Exclusion Criteria:

* Clinically significant abnormalities, physical or psychological illnesses or conditions contraindicating hydrocodone treatment
* History of significant abuse, dependance or addiction of alcohol, drugs or hard drugs within one year prior to screening
* Allergic to hydrocodone, hydromorphone, other opioids, or related drugs
* Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study drug administration
* Pregnant or breast-feeding

Primary outcomes:
measure: To evaluate the Pharmacokinetics of Egalet® hydrocodone formulations. PK Parameters: AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, Kel, MRT, proportion of AUC before Tmax, AUC0-12 and AUC0-24
timeFrame: Single-dose evaluation
Secondary outcomes:
measure: To evaluate safety and tolerability of Egalet® hydrocodone formulations. Hematology, biochemistry, urinalysis, ECG, vital signs (including pulse oximetry), and adverse events monitoring.
timeFrame: Single-dose evaluation
Other outcomes:
Locations:
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Egalet A/S
name: Christine Andersen, M.Sc.Pharm
role: STUDY_DIRECTOR
References:
Clinical trial NCT05574387: Metformin as Added on Therapy in Patients With Ulcerative Colitis
Official title: Metformin, The Biguanide Derivative, as Adjuvant Therapy in Patients With Ulcerative Colitis Treated With Mesalamine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Principal Investigator Mostafa Mahmoud Bahaa El-Dien Pharmacy Practice Department- Horus University
First posted: 2022-10-10
Enrollment: 46
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: Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is marked by increased intestinal motility and bloody diarrhea. The clinical value of existing therapeutic strategies of UC, including glucocorticoids, anti-tumor necrosis factor α (TNF-α), mesalamine, and thiopurines is still limited. Therefore, the discovery of new therapeutic approaches is essential to improve the effectiveness of the treatment.Adenosine monophosphate (AMP)-activated protein kinase (AMPK) is a conserved fuel-sensing enzyme that plays an important role in the regulation of cellular metabolism where it increases glucose and fatty acids uptake and activates the oxidation process to improve the cellular energy utilization


Eligibility criteria: Inclusion Criteria:

- Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception Mild and moderate UC patients diagnosed and confirmed by the endoscope

Exclusion Criteria:

- Breastfeeding Significant liver and kidney function abnormalities Diabetic patients Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids

Primary outcomes:
measure: Improvement in HRQL through changes in inflammatory bowel disease questionnaire (IBDQ) score and change in mayo scores
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine, Mansoura University
Study officials:
References:
Clinical trial NCT01758887: Antipsychotic Discontinuation in High-risk Subjects
Official title: Antipsychotic Discontinuation in High-risk Subjects
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Schizophrenia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical high risk subjects for psychosis who have been treated with antipsychotic medication so that reach to the remission.

Brief summary: * Would be there any difference in dopamine synthesis between remitted clinical high risk subjects for psychosis and healthy control?
* What would happen to dopamine synthesis after antipsychotic discontinuation in clinical high risk subjects for psychosis?
* What about the dopamine synthesis in recurred clinical high risk subjects for psychosis after the discontinuation?

Detailed description: After the antipsychotic medication discontinuation, we are going to assess the changes of the biological markers

Eligibility criteria: Inclusion Criteria:

* Diagnosed as a clinical High Risk
* Treated with antipsychotic drugs
* PSP1-5 (from SIPS criteria) \<3 (severity index)for more than 6 months
* Had not experienced a symptomatic relapse in the 6 months

Exclusion Criteria:

* Significant abnormality in laboratory tests
* History of head trauma

Primary outcomes:
measure: Presynaptic dopamine synthesis in the striatum
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Jun Soo Kwon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06262087: The Combined FIFA 11+ and Change of Direction Training
Official title: The Combined FIFA 11+ and Change of Direction Training on Knee Valgus Angle During Cutting in Male Soccer Players
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rehabilitation
Physical Therapy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study has investigated the effects of adding change of direction (COD) training to the FIFA 11+ on lower extremity performance in soccer players. The investigators are interested in knee valgus angle during cutting which is typically suggested as a critical risk of anterior cruciate ligament injury. Peak knee valgus angle during cutting is expected to reduce immediately after adding COD training to the FIFA 11+.


Eligibility criteria: Inclusion Criteria:

* Soccer players

Exclusion Criteria:

* Having experience of serious injury such as, ACL injury and chronic ankle instability
* Having experience of lower limb surgery such as, bone fracture, tendon rupture, or ligament rupture
* Having current musculoskeletal injuries such as, muscle sprain
* Attending other prevention program or similar study especially on lower extremity
* Soccer player who are unable to perform level 3 of part 2 of the FIFA 11+ prevention program

Primary outcomes:
measure: Peak knee valgus angle
timeFrame: At pre-training and immediate post-training of prevention program
Secondary outcomes:
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: FFC league in Cambodia
Study officials:
References:
Clinical trial NCT04802187: Implementation of COVID-19 Testing Strategies in Community Health Centers
Official title: Implementation of COVID-19 Testing Strategies in Community Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: implementation science
community health center
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Harvard School of Public Health (HSPH)
name: Massachusetts League of Community Health Centers
name: National Cancer Institute (NCI)
First posted: 2021-03-17
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project is part of a competitive revision to accelerate COVID-19 testing in underserved populations. The overall aim is to implement strategies to expand COVID testing in hotspot communities in MA, through 6 community health center (CHC)-community partnerships. A base strategy will be implemented at all sites. A tailored strategy unique to local populations will be added and tested in a stepped wedge design.


Eligibility criteria: Inclusion Criteria:

* Participants are patients at the intervention or control CHCs or members of the local community. The participating sites constitute one group; a set of matched control CHCs that will conduct testing as usual constitute the second group.

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage Change in Testing During the Study Compared to Tests Completed Prior to Study Start
timeFrame: 85 weeks post-implementation compared to 35 weeks pre-implementation
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts League of Community Health Centers
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elsie Taveras, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Karen Emmons, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts League of Community Health Centers
name: Susan Dargon-Hart, LICSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00621387: Study of Long-Term Antibiotic Treatment in Reactive Arthritis
Official title: Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reactive Arthritis
Keywords: reactive arthritis
antibiotics
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled trial of the effect of 3-month treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice daily on clinical course of recent-onset reactive arthritis. Patients are followed-up at regular intervals until 6 months. The main outcome measure is recovery from arthritis, and secondary outcome measures include swollen and tender joint counts, Ritchie index, joint pain, serum C-reactive protein level and blood erythrocyte sedimentation rate. The study will also address the safety and tolerability of long-term antibiotic treatment. 56 patients are enrolled and the enrollment of patients has been completed.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of acute reactive arthritis
2. Preceding infection confirmed by positive culture and/or serology, or with a history of urethritis or gastroenteritis within the preceding 2 months
3. Age 18 or older

Exclusion Criteria:

1. Allergy to quinolones or macrolides
2. Treatment with systemic corticosteroids within 2 weeks
3. Serum creatinine level elevated over the reference limit
4. Alanine aminotransferase or alkaline phosphatase levels elevated over twice the reference limit
5. Current or planned pregnancy, or lack of contraception
6. Known HIV positivity
7. Blood leukocyte count less than 4.0x109/l
8. Blood platelet count less than 100x109/l
9. Lack of co-operation.

Primary outcomes:
measure: Proportion of patients recovered from arthritis
timeFrame: 6 months
Secondary outcomes:
measure: Swollen joint count
timeFrame: 6 months
measure: Tender joint count
timeFrame: 6 months
measure: Ritchie index
timeFrame: 6 months
measure: Joint pain (visual analogue scale)
timeFrame: 6 months
measure: Serum C-reactive protein level
timeFrame: 6 months
measure: Blood erythrocyte sedimentation rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Division of Rheumatology, Department of Medicine
city: Vantaa
country: Finland
facility: Peijas Hospital
Study officials:
affiliation: Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital
name: Marjatta Leirisalo-Repo, MD
role: PRINCIPAL_INVESTIGATOR
References: