louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03467854: PK of Piperacillin/Tazobactam in Adults Undergoing ECMO
Official title: Pharmacokinetics (PK) of Piperacillin/Tazobactam in Adults Undergoing Extracorporeal Membrane Oxygenation (ECMO)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Respiratory Failure With Hypoxia
Keywords: ECMO
Antimicrobials
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients receiving VV ECMO for acute respiratory distress syndrome will be assessed for inclusion into the study.

Brief summary: This study is designed to provide preliminary data to determine if concentrations of piperacillin/tazobactam change in patients with severe respiratory failure receiving extracorporeal membrane oxygenation (ECMO). The investigators hypothesize that patients will have significant changes in concentration measurements, specifically an increased clearance rate and increased volume of distribution, during ECMO as compared to critically ill patients.

Detailed description: In a healthy patient, the lungs provide oxygen to the blood and remove carbon dioxide. However, in patients with severe lung failure, blood may not adequately be delivered to the lungs, or the lungs may not adequately supply blood with oxygen. In this case, patients may require assistance from a machine to help provide this oxygen. Extracorporeal membrane oxygenation (ECMO) is a device that acts as an artificial lung, allowing the patient to recover from their illness. Patients receiving support from ECMO are often put in a medically induced coma while their lungs heal. Certain drugs may stick to the internal surfaces of the machine; therefore leading to decreased concentrations. Patients receiving ECMO often require antimicrobials to treat severe infections. However, little data exist concerning the likely changes in drug concentrations from drug circuit interactions in adult patients receiving ECMO.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Initiated on VV ECMO for acute respiratory distress syndrome
* Receiving piperacillin/tazobactam

Exclusion Criteria:

* Pregnancy
* Massive blood transfusion (10 units or more of of PRBC) within a 24-hour period
* Prisoners

Primary outcomes:
measure: Change in clearance rate
timeFrame: Up to 2 days after the first dose of piperacillin/tazobactam
measure: Change in volume of distribution
timeFrame: Up to 2 days after the first dose of piperacillin/tazobactam
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Darryl Abrams, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01663454: Working Memory Training in Children With Cerebral Palsy, a Pilot Study
Official title: Computer Based Working Memory Training in Children With Cerebral Palsy, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Working Memory Training
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2012-08-13
Enrollment: 6
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to assist the preparation of a larger multi-center study. The main aim is to determine the feasibility of conducting computerized working memory training in a group of children with cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Born at term with unilateral spastic CP
* Born preterm with bilateral spastic CP

Exclusion Criteria:

* Children with Gross Motor Function Classification Scale (GMFCS) level V
* Severe visual or hearing impairments
* Photosensitive epilepsy

Primary outcomes:
measure: Changes in training index
timeFrame: Changes in training index is measured during 5 weeks of working memory training
Secondary outcomes:
measure: Neuropsychological testing
timeFrame: baseline and 2 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Harald Beneventi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01698554: Bimatoprost in the Treatment of Eyelash Hypotrichosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Eyelash Hypotrichosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 464
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 study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).


Eligibility criteria: Inclusion Criteria:

-Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).

Exclusion Criteria:

* Damage to eyelid area (scarring) that may prevent growth of eyelashes
* Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye)
* Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening
* Current eyelash implants of any kind
* Eyelash tint or dye application within 2 months of baseline
* Eyelash extensions application within 3 months of baseline
* Use of eyelash growth products within 6 months of baseline
* Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.

Primary outcomes:
measure: Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)
timeFrame: Baseline, Month 4
Secondary outcomes:
measure: Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)
timeFrame: Baseline, Month 4
measure: Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA
timeFrame: Baseline Month 4
measure: Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA
timeFrame: Baseline, Month 4
measure: Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)
timeFrame: Month 4
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
city: St. Petersburg
country: Russian Federation
city: Stockholm
country: Sweden
city: Norfolk
country: United Kingdom
state: England
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02535754: Interventions to Increase Workplace Wellness
Official title: Interventions to Increase Workplace Wellness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2015-08-31
Enrollment: 682
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Behaviour changes such as improving nutrition, increasing physical activity, and decreasing obesity are linked with lower mortality and morbidity and fewer cancers. Health promotion programs in the workplace are a promising way to reach a large segment of the population. This project evaluated the efficacy of three approaches - all of which were based on previous research and programs with demonstrated positive benefits - on cancer-related outcomes (healthy eating, physical activity, normal body weight) and work-related outcomes (absenteeism, presenteeism).

Detailed description: The project evaluated the efficacy of three health promotion interventions on cancer- and work-related outcomes. Three worksites in British Columbia were randomly assigned to one of three conditions: (1) an empirically-validated intervention directed at individual behavior change using personally-tailored messages delivered by email (ALIVE) ; (2) a comprehensive approach building on social and institutional support developed by the Canadian Cancer Society British Columbia Yukon and previously used for worksite tobacco control (CCS BCY) and (3) an intervention including both of these approaches (CCS BCY + ALIVE). The primary outcome was change in fruit and vegetable consumption from baseline to 16 months, as an indicator of healthy diet. Change in weight, physical activity, and work productivity were secondary outcomes. The investigators also conducted focus groups to assess participant perspectives on the programs which comprise another secondary outcome.

Eligibility criteria: Inclusion Criteria:

* Employee of the company
* English speaking with reading level at Flesch-Kincaid 8.5 grade level
* Ability to provide access to individual work email address

Exclusion Criteria:

* Non-English speaking without reading level at Flesch-Kincaid 8.5 grade level
* Inability to provide access to individual work email address

Primary outcomes:
measure: Change in number of fruit and vegetable servings per day
timeFrame: 16 months
Secondary outcomes:
measure: Absenteeism (days)
timeFrame: 16 months
measure: Change in body weight (lbs)
timeFrame: 16 months
measure: Physical activity efficacy (minutes)
timeFrame: 16 months
measure: Participant perspectives on the program (theme)
timeFrame: 16 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Carolyn C Gotay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02212054: A Trial on Treatments of Hirschsprung Allied Disease
Official title: A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Children With Hirschsprung Allied Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complications of Treatment
Complication of Surgical Procedure
Megacolon, Not Hirschsprung
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease

Detailed description: The present study was designed to compare the efficacy of conservative treatment,such as anal dilatation, colonic lavage and so on, to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease

Eligibility criteria: Inclusion Criteria:

* hard or firm stools for twice or less per week
* a predicting score of less than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96

Exclusion Criteria:

* functional constipation
* a predicting score of more than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96

Primary outcomes:
measure: the change of defecation frequency
timeFrame: 6~12 months
Secondary outcomes:
measure: stool pattern
timeFrame: 6~12 months
measure: controlling stool ability
timeFrame: 6~12 months
measure: complications
timeFrame: 6~12 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Pediatric Surgery
state: Hubei
Study officials:
affiliation: department of pediatric surgery
name: Qi T Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05009654: The Effect of Leucine on Carnitine Transport to Skeletal Muscle
Official title: Carnitine Supplementation and Skeletal Muscle Function in Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Loss
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
Collaborators: name: Medical University of Gdansk
First posted: 2021-08-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of the current research project is to explore whether leucine stimulates carnitine transport, and thus affecting muscle carnitine content.

A secondary aim of this project is to investigate the effect of carnitine with leucine supplementation on muscle strength and body composition.


Eligibility criteria: Inclusion Criteria:

* must be able to swallow tablets

Exclusion Criteria:

* cardiovascular disease
* liver disease
* kidney disease
* neuromuscular disease
* gastrointestinal disorders (including stomach ulcers and erosions)
* diabetes
* other severe chronic diseases

Primary outcomes:
measure: Muscle Carnitine Concentration using UPLC-MS/MS
timeFrame: 24 weeks
Secondary outcomes:
measure: Muscle Strength using Biodex System 4 Pro dynamometer
timeFrame: 24 weeks
measure: Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720).
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02901054: CSF Pharmacokinetics of Ondansetron
Official title: Investigation of Cerebrospinal Fluid (CSF) Pharmacokinetics of Ondansetron
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability that may affect that distribution.

Study procedures will include iv ondansetron administration, serial blood draws, cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 70 years old;
2. Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;
3. Ability to provide informed consent

Exclusion Criteria:

1. Not giving consent to participate in the study;
2. Patients with history of or current hepatic or renal insufficiency;
3. Patients with BMI ≥ 33;
4. Patients with heart failure or active arrhythmias;
5. Patients with severe systemic disease that is a constant threat to life;
6. Contraindication or allergy to ondansetron;
7. Pregnancy or lactation.
8. Prisoners

Primary outcomes:
measure: CSF to Plasma Concentration Ratio
timeFrame: 0-180 min from the beginning of infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Dept of Anesthesiology, Washington Univ School of Medicine
name: Simon Haroutounian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06443554: Evaluation of the Effectiveness of a Community Health Management Program for Dry Eye Disease in Middle-Aged and Elderly Individuals
Official title: Evaluation of the Effectiveness of a Community Health Management Program for Dry Eye Disease in Middle-Aged and Elderly Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: Fujian University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 182
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of a community health management program for middle-aged and elderly patients with dry eye disease (DED). By comparing the community-based health management plan with conventional treatment, the study aims to determine the impact on eye health and quality of life.


Eligibility criteria: Inclusion Criteria:

1. Patients meeting the diagnostic criteria for dry eye disease.
2. Middle-aged and elderly individuals aged 45 years and above.
3. Normal cognitive and expressive abilities.
4. Informed consent and ability to complete the survey.
5. Voluntary participation in the study.

Exclusion Criteria:

1. Patients with other ocular surface diseases, including stye, trachoma, allergic conjunctivitis, etc.
2. Patients with severe cataracts, glaucoma, uveitis, retinal detachment, optic nerve diseases, high myopia, or other conditions.
3. Patients who have undergone eye surgery or have a history of eye trauma in the past three months.
4. Patients who did not sign the informed consent form.

Primary outcomes:
measure: Goal Attainment Scaling (GAS)
timeFrame: 12 weeks
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 12 weeks
measure: Schirmer I Test
timeFrame: 12 weeks
measure: Quality of Life for Dry Eye Patients
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
state: Fujian
Study officials:
References:
Clinical trial NCT04670354: Differential Diagnosis and Cause-specific Treatment During OHCA
Official title: Differential Diagnosis and Cause-specific Treatment During OHCA - a Prospective Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: out of hospital cardiac arrest
differential diagnosis
prospective
ultrasound
blood gas analyse
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-traumatic out-of-hospital cardiac arrest patients encountered by the helicopter emergency medical services.

Brief summary: Differential diagnosis: ultrasound, blood gas analyse combined with examination of the patient and environment is used during Out Of Hospital Cardiac Arrest (OHCA) to screen possible underlying cause of cardiac arrest. Helicopter Emergency Medical Service (HEMS) in Helsinki has unraveled a protocol for performing differential diagnosis during OHCA. Our study aim is to test the feasibility of this protocol. Our study is a prospective medical record based study. The anesthesiologist operating in the HEMS unit fills a form after encounter of OHCA. Questioners focus on how long did execution of the protocol take, and the cause if the protocol was not completed.


Eligibility criteria: Inclusion Criteria:

* non-traumatic out-of-hospital cardiac arrest encountered by the helicopter emergency medical services team

Exclusion Criteria:

* return of spontaneous circulation before HEMS crew arrival
* termination of resuscitation attempt before HEMS crew arrival

Primary outcomes:
measure: Successful execution of differential diagnosis protocol
timeFrame: 60 minutes
Secondary outcomes:
measure: Rate of cause-specific treatment during resuscitation
timeFrame: 60 minutes
measure: Time needed to complete the differential diagnostics protocol
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Vantaa
country: Finland
facility: FinnHEMS 10
Study officials:
References:
Clinical trial NCT02443454: Short and Long-term Results of Arterial Stiffness and Central Aortic Pressure After Kidney Transplantation
Official title: Short and Long-term Results of Arterial Stiffness and Central Aortic Pressure After Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Calcification
Aortic Stiffness
High Blood Pressure (& [Essential Hypertension])
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 100 consecutive patients admitted to routine visin in Transplant Centre and 30 healthy subjects were included in this study.

Brief summary: Central blood pressure and pulse wave velocity were measured using a Complior Analyse device in Short and Long-term after kidney transplantation.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* functioning graft longer than 3 months to 10 years
* no clinical cardiovascular disease during the 6 months preceding entry
* stable graft function- glomerular filtration rate \> 30 ml/min/1.73 m2, creatinine concentration \<2.5 mg/dl
* medical staff (medical doctors, nurses)

Exclusion Criteria:

* not meet the above criteria
* episode of illness (for example: infection)
* pregnancy

Primary outcomes:
measure: Differences in carotid-femoral pulse wave velocity [m/s] in short and long-term postoperative period.
timeFrame: 1 day
Secondary outcomes:
measure: Differences in central aortic pressure [mmHg] in short and long-term postoperative period.
timeFrame: 1 day
measure: Differences in central aortic pressure [mmHg] and cuff blood pressure [mmHg] in short and long-term postoperative period.
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
state: Mazovian
Study officials:
affiliation: Medical University of Warsaw
name: Łukasz Czyżewski, PhD
role: STUDY_CHAIR
References:
citation: Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Comparative analysis of hypertension and its causes among renal replacement therapy patients. Ann Transplant. 2014 Nov 3;19:556-68. doi: 10.12659/AOT.891248.
citation: Czyzewski L, Wyzgal J, Kolek A. Evaluation of selected risk factors of cardiovascular diseases among patients after kidney transplantation, with particular focus on the role of 24-hour automatic blood pressure measurement in the diagnosis of hypertension: an introductory report. Ann Transplant. 2014 Apr 28;19:188-98. doi: 10.12659/AOT.890189.
citation: Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Assessment of health-related quality of life of patients after kidney transplantation in comparison with hemodialysis and peritoneal dialysis. Ann Transplant. 2014 Nov 9;19:576-85. doi: 10.12659/AOT.891265.