louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02056171: Efficacy of Quetiapine for Pediatric Delirium
Official title: Efficacy of Quetiapine for Pediatric Delirium
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Delirium
Keywords: delirium
pediatrics
critical care
quetiapine
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 6
Sex: ALL
Minimum age (years): 1
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.

Detailed description: Many children in the ICU become confused, due to their underlying illness or treatment effects. The medical term for this confusion is delirium. In adults, a medication called quetiapine has been effective in treating delirium. This is considered an "off label" use as the FDA has not approved quetiapine for this indication.

Pediatricians have been using quetiapine to treat delirium in children as well, but there is currently no data proving that it is effective in children. This study is being done to determine if quetiapine is effective for the treatment of ICU delirium in children.

Eligibility criteria: Inclusion Criteria:

- Any patient in the PICU aged 1 year to 21 years old who is diagnosed with delirium

Exclusion Criteria:

* Age \<1
* Richmond Agitation Sedation Scale (RASS) score of -4 or -5 (deeply sedated or unarousable).
* current treatment for alcohol withdrawal
* hepatic encephalopathy
* pregnancy
* diagnosis of major depressive disorder or bipolar disorder
* diagnosis of movement disorder
* diagnosis of diabetic ketoacidosis
* baseline QTc \>500 milliseconds
* non-English speaking subjects and/or parent/guardian

Primary outcomes:
measure: Time to First Resolution of Delirium
timeFrame: Within the first 10 days after study enrollment
Secondary outcomes:
measure: Total ICU Days With Delirium
timeFrame: Within 10 days after study enrollment
Other outcomes:
measure: Change in Delirium Severity
timeFrame: Baseline and 3 days of study drug initiation
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: NY Prebyterian Hospital/Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Chani Traube, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05371171: Management of Skin Graft Donor Site Wound in Aged Patient
Official title: Management of Skin Graft Donor Site Wound in Aged Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Regrafting; Donor Site of Skin Grafting; Vancouver Scar Scale
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The complication of donor site in skin grafting often acts as a causing factor for extended treatment period. The elderly individuals tend to be afflicted by impaired wound healing. Herein, the investigators presented the outcome of skin regrafting in the elderly patients.


Eligibility criteria: Inclusion Criteria:

1. All patient who need to perform skin grafting surgery

Exclusion Criteria:

1. All patient who cannot be half or general anesthetized
2. severe comorbidities

Primary outcomes:
measure: healing time
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Wan Fang Hospital
Study officials:
References:
Clinical trial NCT02567071: Natural Microbiota Restoration After C-section Birth
Official title: Retablissement Du Microbiote Naturel Apres Naissance Par Cesarienne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insufficient Intestinal Microbiota Diversity After C-section Birth
Keywords: C-section
Microbiota
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2015-10-02
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the 1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%. The use of C-section continues to grow in every countries of the world despite that current knowledge leads us to think that the vaginal birth, retained through millennia during mammalian evolution, guarantees the implementation of the best suited intestinal microbiota to build immunity and beneficial protective functions under the balanced mutual association between the host and its microbiota. Oral administration of a previously impregnated swab, by vaginal and maternal perineal secretions, following birth by planned C-section, would restore the normal development of the newborn intestinal microbiota mimicking exposure to these secretions during vaginal delivery.

The expected benefit is the establishment of a rich and diverse microbiota in individuals in the intervention group and by extension improving the overall health of these individuals.


Eligibility criteria: Inclusion Criteria:

* over the age of legal majority
* delivery by planned C-section at term or vaginal delivery at term
* registered at a social security service

Exclusion Criteria:

* HIV or other STD patients
* immunocompromised patients
* known streptococcus B carriers
* known vaginal or perineal herpes infections
* chronic disease patients (obesity, diabetes, IBD)
* IMC before pregnancy \> 30 kg/m²
* antibiotic treatments one month before delivery
* emergency C-section
* Premature delivery (\<37 amenorrhea weeks)
* hospitalized for more than one week before delivery
* known HVC infections
* for the newborns: every diagnosed anomaly
* patients who do not understand the research procedures or those that are institutionalized, or those unable to give informed consent
* patients deprived of ther liberty by legal or administrative decisions
* patients under an exclusion period from another study

Primary outcomes:
measure: Diversity of the intestinal microbiota
timeFrame: 1 year
Secondary outcomes:
measure: Health status
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Gynécologie-Obstétrique, Groupe Hospitalier Pitié-Salpêtrière
Study officials:
affiliation: APHP
name: Jacky Nizard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02125071: Study on the Pharmacokinetic Characteristics of I.V. Hepabig Injection Used for Prevention of Hepatitis B Relapse After Liver Transplantation
Official title: An Exploratory Clinical Trial to Evaluate the Pharmacokinetic Characteristics of I.V. Hepabig Injection Used for Prevention of Hepatitis B Relapse After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Chronic Hepatitis B
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Green Cross Corporation
First posted: 2014-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who receiving I.V. Hepabig injection for prevention of hepatitis B relapse after liver transplantation

Brief summary: An exploratory clinical trial to evaluate the pharmacokinetic characteristics of I.V. Hepabig injection used for prevention of hepatitis B relapse after liver transplantation.


Eligibility criteria: Inclusion Criteria:

* Male or female ≤18 years old
* Patients who understand the informed consent form and signed the form voluntarily
* Patients who underwent liver transplantation due to HBV related disease and will be treated for prevention of hepatitis B relapse after liver transplantation

Exclusion Criteria:

* Multi-organ recipient or reimplantation
* IgA Deficiency
* Serious nephropathy
* Serious cardiovascular system failure within 6 months
* Ischemic or hemolytic anemia
* Condition of immunosuppression and immunodeficiency
* Hypersensitivity or allergic to blood products
* HIV or HCV positive
* Participation to other clinical trial within 3 months
* Pregnancy or breast feeding
* Those who the investigator determines inappropriate to participate

Primary outcomes:
measure: anti-HBs titer
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University, Seoul St Mary Hospital
Study officials:
affiliation: The Catholic University, Seoul St Mary Hospital
name: Dong Gu Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01179971: n-3 and n-6 Fatty Acids in Rheumatoid Arthritis
Official title: Incorporation of n-3 Long Chain Polyunsaturated Fatty Acids and Gamma Linolenic Acid in Plasma Lipids, Cholesteryl Esters, and Erythrocyte Membranes and Their Influence on Disease Activity in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: n-3 fatty acids
n-6 fatty acids
anti-inflammatory action
clinical trial
randomized double-blinded
incorporation of fatty acids
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University of Jena
First posted: 2010-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: To investigate into the differential effects of polyunsaturated fatty acids as compared to standard control therapy (olive oil) on disease activity and biochemical parameters in patients with rheumatoid arthritis (RA), resp. psoriasis arthritis (PA).

Detailed description: Methods: Double-blinded, four-armed randomised controlled trial with 3.0 g/d of either n-3 long chain polyunsaturated fatty acids (LC-PUFA) or gamma linolenic acid (GLA), resp. the combination of 1.5 g/d of each, resp. 3.0 g/d of olive oil over 12 weeks. Outcome parameters disease activity score (DAS28), C-reactive protein, concentrations of n-3 LC-PUFA, resp. GLA in plasma lipids (PL), cholesterol esters (CE), and erythrocyte membranes (EM), and serum concentrations of arachidonic acid (AA). Conventional antirheumatic and immunosuppressive therapies could be changed only within defined limits.

Eligibility criteria: Inclusion Criteria:

* Rheumatoid or Psoriasis arthritis

Exclusion Criteria:

* Severe diseases of heart, liver, lung airways
* Non-compliance

Primary outcomes:
measure: incorporation of eicosapentaenoic acid in plasma lipids
timeFrame: 12 weeks
Secondary outcomes:
measure: Disease activity score 28 (DAS28, EULAR)
timeFrame: 12 weeks
measure: C-reactive protein
timeFrame: 12 weeks
measure: International Normalized Ratio (INR)
timeFrame: 12 weeks
measure: Tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Immanuel Krankenhaus and Charite Berlin
name: Rainer Stange, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawczynski C, Hackermeier U, Viehweger M, Stange R, Springer M, Jahreis G. Incorporation of n-3 PUFA and gamma-linolenic acid in blood lipids and red blood cell lipids together with their influence on disease activity in patients with chronic inflammatory arthritis--a randomized controlled human intervention trial. Lipids Health Dis. 2011 Aug 4;10:130. doi: 10.1186/1476-511X-10-130.
Clinical trial NCT02512471: The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block
Official title: The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supraclavicular Brachial Plexus Block
Keywords: minimum effective volume
ropivacaine
ultrasound-guided supraclavicular block
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the minimum effective volume of local anesthetic (ropivacaine 0.275% and 0.325%) required to produce an effective double-injection USG-SCB for surgical anesthesia in 90% of patients (MEV90) in young group (18-40 years) and in middle aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal to the shoulder.

Detailed description: The study is based on biased coin design, and the volume of LA for the next patient is determined by the result of the last one. In the case of block failure, the volume will be increased by 2ml. Conversely, block success will result in either a reduction in volume by 2ml (probability 11%) or no change in volume (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous nerves) at 10-min intervals up to 30 min after completion of the block. Finally, MEV90 is calculated by isotonic regression.

Eligibility criteria: Inclusion Criteria:

1. age between 18 and 65 years
2. ASA 1-3
3. body mass index between 18 and 35kg/m2

Exclusion Criteria:

1. inability to consent to the study
2. pregnancy
3. allergy to local anesthetics
4. preexisting neuropathy or coagulopathy
5. prior surgery in the supraclavicular region

Primary outcomes:
measure: The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
name: Ailin Luo, MD.,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01681771: Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression
Official title: Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression A Randomised Controlled Study of Short and Long Term Effects on Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Depressive Symptoms
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 50
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: The purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in patients with chronic heart failure and depression.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* have time to participate in the study,
* treatment for HF according to the European Society of Cardiology guidelines2
* stable HF (NYHA class I-III) and not being hospitalized for HF the latest month
* signs of suffering of depressive symptoms (Patient Health Questionnaire-9 \>9 points

Exclusion Criteria:

* severe HF (NYHA IV) or another severe chronic life threatening disease.
* severe depression assessed to need hospital care

Primary outcomes:
measure: Depressive Symptoms
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Deparment of Cardiology, University Hospital of Linköping
Study officials:
affiliation: Department of Cardiology, University Hospital of Linköping and Department of Cardiovascular Medicine, Faculty of Health Sciences. University Hospital of Linköping
name: Peter Johansson, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lundgren JG, Dahlstrom O, Andersson G, Jaarsma T, Karner Kohler A, Johansson P. The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial. J Med Internet Res. 2016 Aug 3;18(8):e194. doi: 10.2196/jmir.5556.
Clinical trial NCT02858271: Study to Assess the Absorption, Metabolism, Excretion and Pharmacokinetics of [14C]-AKB-9778
Official title: An Open-Label, Single-Dose, Phase 1 Study to Assess the Absorption, Metabolism, Excretion, and Pharmacokinetics of [14C]-AKB-9778 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Aerpio Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-08-08
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of \[14C\]-AKB-9778 in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* BMI 18 - 33 kg/m2

Exclusion Criteria:

* Significant cardiovascular, pulmonary, or renal disease

Primary outcomes:
measure: Percent of radioactive dose recovered in urine and feces
timeFrame: 7 days
measure: Concentration of total radioactivity in blood and plasma
timeFrame: 7 days
measure: Cmax of AKB-9778 and any major metabolites identified
timeFrame: 7 days
measure: Tmax of AKB-9778 and any major metabolites identified
timeFrame: 7 days
measure: AUC of AKB-9778 and any major metabolites identified
timeFrame: 7 days
measure: t1/2 of AKB-9778 and any major metabolites identified
timeFrame: 7 days
measure: Elimination rate of AKB-9778 and any major metabolites identified
timeFrame: 7 days
Secondary outcomes:
measure: Incidence of adverse events and change in vital signs and laboratory values
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Aerpio Therapeutics
name: Akshay Buch, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02447471: Agreement of the Nexfin™ Monitor With Non-invasive Blood Pressure Measurement
Official title: Agreement of the Nexfin™ Non-invasive Cardiac Output Monitor With Non-invasive Blood Pressure Measurement in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: a Pilot Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure Measurement
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BC Women's hospital parturients

Brief summary: Currently, BP is measured using an inflatable cuff wrapped around the patient's upper arm. This can be set to inflate every minute, but measurement may fail due to patient movement or shivering. Failed measurement occurs in up to 38% of patients.

This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.

Detailed description: This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.

Eligibility criteria: Inclusion Criteria:

* Healthy female pregnant patients
* ≥19 years old
* Undergoing elective Cesarean section under spinal or combined spinal-epidural anesthesia

Exclusion Criteria:

* Contraindication to wearing Nexfin cuff (upper limb vascular disease, amputated digits)
* Obesity (BMI \> 38 kg/m2)
* Use of arterial line for BP measurement
* Inability to read and understand English

Primary outcomes:
measure: Nexfin bp vs NIBP
timeFrame: During cesarean delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Vit Gunka, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204971: Enteral Glutamine in Neurologically-injured Patients
Official title: Randomized, Placebo-controlled Clinical Trial of Enteral Glutamine Supplementation in Neurologically-injured Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neurologic Injury
Traumatic Brain Injury
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Nutrition is an important part of the recovery process after having a head injury so that subjects can gain strength and fight off infection. Liquid nutrition formulas are often given to patients through a tube that has been placed into the intestines for feeding when they are unable to eat on their own. Some reports suggest that nutrition with extra amounts of the amino acid called glutamine may decrease infections and hospital stay in severely injured patients.The purpose of this study is to evaluate if giving extra amounts of an amino acid called glutamine with liquid nutrition formulas will decrease the risk of infection and length of stay in the intensive care unit after having a head injury.


Eligibility criteria: Inclusion Criteria:

* Males
* Nonpregnant females
* Aged 18-75 years old
* Glasgow Coma Scores of 3-12
* Injury Severity Scores greater than or equal to 20
* Requiring enteral nutrition for a minimum of 5 days

Exclusion Criteria:

* Documented hepatic dysfunction
* Acute renal failure (creatinine clearance \< 15 mL/min)
* Gastrointestinal malabsorptive disorder
* Infection at time of admission

Primary outcomes:
measure: Nosocomial infections
timeFrame: throughout study
Secondary outcomes:
measure: Multiple organ dysfunction syndrome
timeFrame: throughout the study
measure: Nutritional outcome parameters
timeFrame: throughout the study
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Gordon S Sacks, PharmD
role: PRINCIPAL_INVESTIGATOR
References: