louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02583945: Prevention of Postoperative Acute Kidney Injury
Official title: Effect of a Kidney Bundle on the Occurence of Postoperative Acute Kidney Injury in Patients at Risk
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
hemodynamic stabilisation
nephrotoxic medication
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A protocol for the improvement of the hemodynamic situation and a standardized proceeding in hemodynamic monitoring, consequent avoidance of nephrotoxic substances, regular measurement of creatinine and urine output, as well as normoglycemia. The primary goal is to determine if the consequent application of the KDIGO-bundle leads to a prevention of the occurrence of AKI in patients at risk after non-cardiac surgery.

Detailed description: All patients included in the study will be treated with the KDIGO-bundle (hemodynamic stabilization, avoidance of nephrotoxic substances, normoglycemia and measurement of creatinine in serum and urine output). 12 h, 24h as well as on day 2, 3, 5 and 10 after admission on ICU the occurence of AKI (according to KDIGO) will be assessed.

Eligibility criteria: Inclusion criteria:

* Age \> 65 years
* chronic kidney disease
* diabetes mellitus, chronic heart, lung or liver disease
* hemodynamic instability (intra and/or post-operative)
* trauma, burn injury, major surgery, usage of x-ray contrast and sepsis.

Exclusion criteria:

* Age \< 18 years
* pregnancy
* kidney graft recipient
* chronic renal disease with or without renal replacement therapy and cardiac surgery.

Primary outcomes:
measure: Incidence of postoperative AKI
timeFrame: until day 5 after surgery
Secondary outcomes:
measure: Intensive care unit mortality
timeFrame: 28 days and 90 days after surgery
measure: hospital mortality
timeFrame: up to 100 days after surgery
measure: usage of renal replacement therapy (hours)
timeFrame: up to 30 days after surgery
measure: length of invasive respirator therapy (hours)
timeFrame: up to 30 days after surgery
measure: creatinine in serum
timeFrame: 12 hours, day 2, 3, 5 and 10 after surgery
measure: urine output (total ml)
timeFrame: after 12 hours, on day 2 (in 24hour), 3 (in 24hour), 5 (in 24hour) and 10 (in 24hour) after surgery
measure: length of hospital stay
timeFrame: up to 100 days after surgery
measure: length of ICU stay
timeFrame: up to 100 days after surgery
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg, Dep. of Anesthesiology
Study officials:
affiliation: University of Wuerzburg
name: Christian Wunder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01823445: Xylitol Disk Use in Adults With Dry Mouth
Official title: XyliMelts Ability to Reduce Mutans Streptococci in Adults With the Perception of Dry Mouth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mutans Streptococci
Xerostomia
Keywords: Xylitol
Dental caries
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate whether decay causing bacteria are reduced when adhesive xylitol disks are used intraorally three times a day for two weeks in adults with dry mouth.

Detailed description: Xylitol,an FDA approved sugar substitute, has been shown to reduce tooth decay. Patients who experience dry mouth may be more susceptible to dental decay because they lack the protection provided by an adequate flow of saliva. These patients are likely to have high levels of the decay causing bacteria, mutans streptococci.

The purpose of this research is to test the ability of a novel xylitol delivery vehicle to reduce mutans streptococci in patients with dry mouth over a two week period. The delivery vehicle is a slowly dissolving xylitol disk (lozenge) that adheres to soft tissues inside the mouth. Participants will place disks on both sides of the mouth three times a day.

Eligibility criteria: Inclusion Criteria:

* Adults 21 years old or older
* Daily use of at least 2 prescription medications known to cause dry mouth
* Current report of dry mouth

Exclusion Criteria:

* Antibiotic use in the last month
* Topical oral antimicrobial (e.g. Chlorhexidine rinse) use in the last month
* Change in medication or dose within the last month
* Use of mouthwash within the last week
* Use of lozenges or chewing gum with 500 mg or more of xylitol on a habitual basis
* History of gastrointestinal disease

Primary outcomes:
measure: Mutans streptococci levels
timeFrame: One week
measure: Mutans streptococci levels
timeFrame: Two weeks
Secondary outcomes:
measure: GRIX measure of xerostomia
timeFrame: One week
measure: GRIX measure of xerostomia
timeFrame: Two weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington, School of Dentistry, Regional Clinical Dental Research Center
state: Washington
Study officials:
affiliation: University of Washington
name: Peter Milgrom, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01117545: Psychological Symptom Change in Veterans After Six Sessions of EFT (Emotional Freedom Techniques)
Official title: Psychological Symptom Change in Veterans After Six Sessions of EFT (Emotional Freedom Techniques): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: veterans,
PTSD,
EFT (Emotional Freedom Techniques),
depression,
anxiety
Lead sponsor: Soul Medicine Institute
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: EFT (Emotional Freedom Techniques) has been shown to significantly reduce post-traumatic stress disorder (PTSD) and other psychological symptoms such as anxiety and depression in a variety of clinical trials. This study examines the effect of a six session EFT protocol on the symptoms of veterans with clinical scores on the PTSD Checklist-Military (PCL-M). Subjects in the experimental group receive EFT coaching supplemental to, and supportive of, the "usual care" treatment provided by their primary care provider. Subjects in the wait list control group receive usual care for a month, with pre and posttests, after which they also receive the EFT coaching protocol. Subjects are followed at three month intervals to determine if gains are maintained, and whether the symptom reductions are similar to those observed in other trials of EFT.


Eligibility criteria: Inclusion Criteria:

* Military Service
* The ability to follow instructions, complete written forms, and provide informed consent.
* Remaining under the care of a primary care provider such as a VA hospital throughout the entire period of the study
* Between 18 and 90 years old

Exclusion Criteria:

* Participants with a score of more than 3 on questions 34 and 35 of the Symptom Assessment-45 Questionnaire (SA-45) will receive phone/skype sessions, not office visits

Primary outcomes:
measure: PTSD Scores on the PCL-M Assessment
timeFrame: One Month Before, At Start, After 3 and 6 Sessions, After 3 and 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Rosa
country: United States
facility: Soul Medicine Institute
state: California
Study officials:
References:
citation: Church D, Hawk C, Brooks AJ, Toukolehto O, Wren M, Dinter I, Stein P. Psychological trauma symptom improvement in veterans using emotional freedom techniques: a randomized controlled trial. J Nerv Ment Dis. 2013 Feb;201(2):153-60. doi: 10.1097/NMD.0b013e31827f6351.
Clinical trial NCT02399345: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults
Official title: An Open-Label, Treatment Duration-Ranging Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/ Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Naive Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Virus (HCV Infection Genotype 1)
Keywords: Treatment naive
Hepatitis C Genotype 1
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-03-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis


Eligibility criteria: Inclusion Criteria:

1. Male or female at least 18 years of age at time of screening
2. Chronic Hepatitis C virus (HCV) infection prior to study enrollment
3. Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only
4. Absence of cirrhosis and advanced bridging fibrosis

Exclusion Criteria:

1. Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency virus (HIV) positive immunoassay
2. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject an unsuitable candidate for this study or treatment with Ribavirin (RBV) in the opinion of the investigator
3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a Metavir score \> 2 or an Ishak score \> 3
4. Use of medications contraindicated for ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir, or ribavirin (RBV; for those that receive RBV), within 2 weeks or 10 half-lives whichever is longer, prior to study drug administration
5. Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV agents

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
timeFrame: 12 weeks after the last actual dose of study drug
Secondary outcomes:
measure: Percentage of Subjects With On-treatment Virologic Failure
timeFrame: 6 weeks
measure: Percentage of Subjects With Post-treatment Relapse
timeFrame: Up to 12 weeks after last actual dose of active study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Eric Cohen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04805645: Risk Factors for Mortality for COVID-19 Admitted to an Intensive Care Unit
Official title: Clinical Characteristics & Risk Factors for Mortality of COVID-19 Patients Admitted Into Intensive Care Unit in Hospital Queen Elizabeth
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid19
Critically Ill
Keywords: COVID-19
Critically ill
Mortality Day 28
Lead sponsor: Clinical Research Centre, Malaysia
Sponsor class: OTHER
Collaborators: name: Hospital Queen Elizabeth, Malaysia
First posted: 2021-03-18
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the ICU in Hospital Queen Elizabeth, Kota Kinabalu between 1st October 2020 until 31st January 2021, which confirmed to have via PCR testing or Rapid Test Antigen are positive for PCR

Brief summary: Studying clinical characterization of critically ill COVID-19 patients in a single center Studying Risk factors for Day 28 Mortality in COVID-19 patients admitted to intensive care unit

Detailed description: An observational study looking into clinical characterization of the novel Coronavirus Disease 2019 (COVID-19) in patients admitted, critically ill, into Intensive Care Unit of Hospital Queen Elizabeth between 1st October 2020 until 31st January 2021. Analysis also would be looking into the risk factors into Day 28 mortality of these patients

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the ICU in Hospital Queen Elizabeth, Kota Kinabalu between 1st October 2020 until 31st January 2021
* Confirmed COVID-19 Positive using RT-PCR or RTK-Ag either before or during admission in ICU

Exclusion Criteria:

* Patients that were admitted in ICU suspected to have COVID-19 and died in ICU which subsequently to be COVID-19 negative

Primary outcomes:
measure: Mortality
timeFrame: 28 days
Secondary outcomes:
measure: Oxygen supplementation requirement
timeFrame: day 28
Other outcomes:
Locations:
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
Study officials:
affiliation: Hospital Queen Elizabeth, Malaysia
name: Kean Khang Fong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02000245: Effects of Sympathy and Touch on Anxiety of Patients Undergoing Fiberoptic Bronchoscopy
Official title: Effects of Sympathy and Touch on Anxiety of Patients Undergoing Fiberoptic Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: bronchoscopy
anxiety
touch
sympathy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 267
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of verbal expression of sympathy and touch on anxiety of patients undergoing fiberoptic bronchoscopy


Eligibility criteria: Inclusion Criteria:

* adult patients undergoing diagnostic fiberoptic bronchoscopy
* hospitalized patients

Exclusion Criteria:

* patients who have undergone fiberoptic bronchoscopy
* not hospitalized patients
* cognitive impairment
* refusal to enroll

Primary outcomes:
measure: change of visual analogue scale (VAS) for anxiety
timeFrame: baseline (arrival at the test room), and follow-up (at least 10 min after baseline, right before undergoing bronchoscopy
Secondary outcomes:
measure: Satisfaction of patients after fiberoptic bronchoscopy
timeFrame: within 6 hours after bronchoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Internal Medicine, Seoul National University Hospital
name: Jae-Joon Yim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02903745: Knowledge Attitudes Beliefs and Practices Regarding HIV Among Teenagers in French Guiana
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 1603
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: randomly selected teenagers attending the public school system of french guiana

Brief summary: French Guiana is the French territory where the prevalence of HIV is highest. in order to determine the knowledge attitudes, beliefs, and practices among the target group of teenagers attending the public school system a survey was conducted in 2011. schools and classrooms were randomly selected, and a structured questionnaire was administered. Descriptive statistics were obtained and multivariate logistic regression was used to determine predictors of main outcomes such as age at first sex.

the results will be used to guide prevention of HIV and sexually transmitted infections though the school system.


Eligibility criteria: Inclusion Criteria:

* attending the public school system of french guiana

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: knowledge, attitudes, behaviours, and practices relative to HIV/AIDS and sexually transmitted infections
timeFrame: when the interview was conducted
Secondary outcomes:
Other outcomes:
Locations:
city: Cayenne
country: France
facility: Centre Hospitalier de Cayenne
state: French Guiana
Study officials:
References:
Clinical trial NCT02043145: Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperhidrosis
Muscle Spasticity
Glabellar Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 727
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.

Brief summary: This post marketing surveillance study in Korea will evaluate the safety and efficacy of BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)
timeFrame: 4 Years
measure: Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale
timeFrame: Pre-dose (Baseline), Post-dose (Up to 4 Years)
measure: Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale
timeFrame: Pre-dose (Baseline), Post-dose (Up to 4 Years)
measure: Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale
timeFrame: Pre-dose (Baseline), Post-dose (Up to 4 Years)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01642745: Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness
Official title: Mannitol and Methacholine Responsiveness: Effects of Deep Inhalations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine.


Eligibility criteria: Inclusion Criteria:

* stable controlled asthma

Exclusion Criteria:

* pregnancy
* use of asthma therapies other than bronchodilator therapy

Primary outcomes:
measure: Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing
timeFrame: Visit 1 (Day 1)
measure: airway responsiveness (PD15) to inhaled mannitol
timeFrame: Visit 2 = up to 13 days
measure: Airway responsiveness (PC20) to deep inhalation methacholine
timeFrame: Visit 3 = up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References:
citation: Davis BE, Stewart SL, Martin AL, Cockcroft DW. Low levels of fractional exhaled nitric oxide and deep inhalation bronchoprotection are associated with mannitol non-responsiveness in asthma. Respir Med. 2014 Jun;108(6):859-64. doi: 10.1016/j.rmed.2014.03.005. Epub 2014 Mar 20.
Clinical trial NCT04377945: Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components
Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dyskinesias
Parkinson Disease
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-05-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a two-part, double-blind, placebo-controlled, randomized, multicenter Phase 2 clinical trial of JM-010 in patients with Parkinson's Disease.

Detailed description: This is a two-part, Phase 2, double-blind, placebo-controlled, randomized, multicentre study.

Subjects with a diagnosis of PD and dyskinesias in PD will complete a Screening Visit to assess eligibility to participate in the study.

Eligibility criteria: Inclusion Criteria:

* Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.
* Is male or female, between 18 and 85 years of age at Screening Visit.
* Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
* Has experienced dyskinesia
* Has stable peak-effect dyskinesia
* Has more than one hour of "ON" time with troublesome dyskinesia

Exclusion Criteria:

* Has undergone surgery for the treatment of PD
* Has a current diagnosis of Substance Use
* Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
* Has current seizure disorders requiring treatment with anticonvulsants.

Other criteria related to other medical conditions to be referred to the protocol.

Primary outcomes:
measure: Unified Dyskinesia Rating Scale (UDysRS)
timeFrame: Week 12
Secondary outcomes:
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Week 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bukwang Investigator site
state: Florida
city: Detroit
country: United States
facility: Bukwang Investigator site
state: Michigan
Study officials:
affiliation: Bukwang Pharmaceutical
name: Sooyeon Park
role: STUDY_DIRECTOR
References: