louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03672812: The Use of Liraglutide in Brain Death
Official title: Randomized Clinical Trial to Evaluate the Use of Liraglutide in Individuals With Brain Death and Anti-inflammatory and Anti-apoptotic Effects on Organs to be Transplanted
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain Death
Keywords: liraglutide
brain death
inflammation
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is evidence of the association of brain death and inflammation, affecting outcomes of transplanted organs, but in a way not fully understood. Observational studies suggest that the use of target-guided therapies has a beneficial effect in reducing the rate of donor loss due to cardiac arrest and increasing the rate of donor-picked organs, which will be tested through the randomized clinical trial. However, no study so far has directly tested the effect of drugs with anti-inflammatory and anti-apoptotic properties administered to the donor in encephalic death in reducing inflammation of organs to be transplanted. This study aims to evaluate the use of liraglutide in patients with brain death in relation to their ability to attenuate the inflammation induced by encephalic death by means of a randomized clinical trial.

Detailed description: The intervention group will be composed of individuals deceased in brain dead, after the conclusion of the brain dead protocol by the teams responsible for the Intensive care and will receive liraglutide. The control group will be composed of the same population of individuals who died in brain dead of the intervention group, but will receive a placebo.

Eligibility criteria: Inclusion Criteria:

* individuals deceased more than 18 years after the end of the brain death protocol

Exclusion Criteria:

* Pregnant women, patients with advanced renal failure on hemodialysis, with hepatic insufficiency or allergy known to liraglutide

Primary outcomes:
measure: change inflammation
timeFrame: from 6 hours to 24 hours
Secondary outcomes:
measure: change inflammation with liraglutide
timeFrame: from 6 to 24 hours
measure: change inflammation liraglutide group
timeFrame: from 6 to 24 hours
measure: change inflammation intervention group
timeFrame: from 6 to 24 hours
measure: change inflammation
timeFrame: from 6 to 24 hours
Other outcomes:
Locations:
city: Blumenau
country: Brazil
facility: Hospital Santa Isabel
state: Santa Catarina
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Cristiane Leitao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00366912: Unloading Respiratory Muscles During NIV: Comparison of a Spontaneous and Auto-adjusting Controlled Mode
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Failure
Keywords: work of breathing
pressure time product
muscle pressures
Lead sponsor: Krankenhaus Kloster Grafschaft
Sponsor class: OTHER
First posted: 2006-08-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Measurement of Work of breathing (WOB), as well as pressure time product (PTP) of transdiaphragmatic pressures to evaluate the degree of muscle activity and muscle unloading during non-invasive ventilation.

The study makes comparison of a new developed auto adjusting controlled mode and a regular spontaneous mode.

Detailed description: Non-invasive ventilation (NIV) reduces carbon dioxide in hypercapnic respiratory failure by unloading the respiratory muscles. Spontaneous modes of NIV are usually being used in these situations. Spontaneous modes have the disadvantage, that the patient has to trigger the ventilator. The work to activate the trigger (WT) is estimated to be as high as up to 50% of the total work of breathing dependent on the underlying disease. Elimination of WT would increase the degree of respiratory muscle unloading.

A new pressure controlled mode incorporated into the ventilogic mechanical ventilator (Weinmann, Germany) is capable of self adjusting respiratory parameters in a preset range according to the patient requirements.

After a short period where the patients spontaneous respiratory parameters are being analyzed, the ventilator slowly implements a pressure controlled mode that matches the patients requirements.

This study intends to investigate if this new mode achieves a higher degree of respiratory muscle unloading compared to a spontaneous mode.

Eligibility criteria: Inclusion Criteria:

* Healthy voluntary individuals
* PFT within normal limits

Exclusion Criteria:

* Disease of the upper GI-tract
* Any form of lung disease or disease of the upper airways
* Any form of muscular disease, especially neuromuscular disease pregnancy

Primary outcomes:
measure: Work of breathing, pressure time product
Secondary outcomes:
measure: comfort
Other outcomes:
Locations:
city: Schmallenberg
country: Germany
facility: Fachkrankenhaus Kloster Grafschaft
state: NRW
Study officials:
affiliation: Fachkrankenhaus Kloster Grafschaft
name: Dominic Dellweg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03063112: Radiofrequency and Chemical Neurolysis of Thoracic Splanchnic Nerve for Abdominal Cancer Pain
Official title: Comparative Study Between Radiofrequency Thermocoagulation and Chemical Neurolysis of Thoracic Splanchnic Nerve Bilaterally for the Management of Abdominal Cancer Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Cancer
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study compares between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation and chemical neurolysis of bilateral thoracic splanchnic nerves in the management of refractory pain which developed in patients suffering from upper abdominal cancer.

Detailed description: Radiofrequency thermocoagulation of splanchnic nerves was done bilaterally at level of thoracic vertebra T10 and T11 ( there were no enough studies done to test the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of splanchnic nerves at level of T10 ). Aim of the Study is to compare between the efficacy, safety and impact on the quality of life of radiofrequency thermocoagulation of bilateral thoracic splanchnic nerves at level T10 and T11 vertebra and chemical neurolytic block of them at level of T11 vertebra only in the management of upper abdominal cancer pain.

Eligibility criteria: Inclusion Criteria:

1. Patients suffering from upper abdominal cancer pain.
2. Visceral pain with visual analogue pain score ≥ 4.
3. Normal coagulation profile.
4. Positive diagnostic test.
5. Written informed consent from the patients .

Exclusion Criteria:

1. Patients with organ failure.
2. Coagulation disorders.
3. Local infection at the puncture site or sepsis.
4. Allergy to the contrast dye or alcohol.
5. Severe displacement of intra-abdominal structures.
6. Pregnant women.
7. Documented metastatic lesions.
8. Psychiatric illness affecting cooperation.
9. De-compensated cardiac disorders.
10. Liver and renal dysfunction.

Primary outcomes:
measure: Pain relief
timeFrame: 3 months
Secondary outcomes:
measure: Decrease the need for analgesic drugs
timeFrame: 3 months
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer Institute
state: Assuit governrate
Study officials:
affiliation: Head of the department
name: Samy A Erfan, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01149512: Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program
Official title: Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2010-06-23
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

Brief summary: The majority of data documenting the outcomes for the adjustable gastric band (LAGB) originate from non-publicly funded surgical centres. The investigators aim to investigate the clinical outcomes of LAGB from a publicly funded Canadian obesity management program. This program recognized obesity as a chronic disease, providing extensive pre-operative multidisciplinary assessment and long term patient follow-up. Patients are selected for surgical management carefully by a multidisciplinary team and the LAGB is presented as one option to surgical management. Further, the investigators will investigate the operational impacts, including direct and indirect costs related the LAGB, to determine long term impacts on publicly funded hospitals within Canada.


Eligibility criteria: Inclusion Criteria:

* All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.

Exclusion criteria:

* Patients who have undergone selection for surgery outside this process, or who have had surgery elsewhere.

Primary outcomes:
measure: Mean Percentage Total Body Weight Loss
timeFrame: baseline to 1 year, baseline to 2 years, baseline to 3 years
Secondary outcomes:
measure: % of Excess Body Weight Loss
timeFrame: baseline to 1 year, baseline to 2 years, baseline to 3 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Center for the Advancement of Minimally Invasive Surgery & Weight Wise Program
state: Alberta
Study officials:
References:
Clinical trial NCT00568412: A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis
Official title: A Multicenter, Randomized, Double-blind Clinical Study to Examine the Efficacy and Safety of Zarzenda in Comparison to Elidel in the Management of Mild to Moderate Atopic Dermatitis in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mild to Moderate Atopic Dermatitis
Keywords: atopic dermatitis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis


Eligibility criteria: Inclusion Criteria:

* male and female children and adolescents (aged 2 - 17)
* mild to moderate atopic dermatitis
* patients in whom a treatment with topical corticosteroids in not recommended or possible
* wash out periods to be observed

Exclusion Criteria:

* known allergy to one of the two treatments
* known immunodeficiency
* known hepatic or renal insufficiency
* acute skin infections

Primary outcomes:
measure: Investigator's Global Assessment
timeFrame: End of study compared to baseline
Secondary outcomes:
measure: EASI
timeFrame: End of study compared to baseline
measure: Affected body surface area
timeFrame: End of study compared to baseline
measure: Patient's assessment of itch, quality of sleep, and global assessment
timeFrame: End of study compared to baseline
measure: Children's Dermatological Life Quality Index
timeFrame: End of study compared to baseline
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01040312: An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors
Official title: A Prospective Observational Study of the Efficacy and Safety of CPT-11 Plus Platinum Analogues Regimens for UGT1A1 Genotype Guided Patients With Several Solid Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Cell Lung Cancer
Non-small Cell Lung Cancer
Cervical Cancer
Ovarian Cancer
Gastric Cancer (Inoperable and Recurrent)
Keywords: UGT1A1, irinotecan
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2009-12-29
Enrollment: 321
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in Japan with small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer treated with CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) in clinical practice

Brief summary: The purpose of this study is to examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Has small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer
* Has UGT1A1 genotype \*1/\*6, \*1/\*28, \*6/\*6, \*28/\*28 and \*6/\*28
* Is receiving CPT-11 plus platinum analogue (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents)

Exclusion Criteria:

* Has contraindication for CPT-11
* Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 3-4

Primary outcomes:
measure: Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues
timeFrame: within 6 months
Secondary outcomes:
measure: Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues
timeFrame: within 6 months
measure: Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype
timeFrame: within 6 months
Other outcomes:
Locations:
city: Tokorozawa
country: Japan
facility: Department of Obstetrics and Gynecology, National Defense Medical College Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT06635746: Dose Escalation Study of Vinpocetine in Healthy Volunteers
Official title: Phase I, Open Label, Dose-Escalation Study for Maximum Tolerated Vinpocetine Dose in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Fetal Alcohol Spectrum Disorders
Keywords: Cognition
Vinpocetine
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine whether vinpocetine is safe when taken at higher doses.

Detailed description: The planned study seeks to provide preliminary data to assess the benefits and safety for vinpocetine to address cognitive problems in two groups of patients. One group are patients with epilepsy in whom cognitive problems are common, but there is currently no specific treatment available. Vinpocetine has been shown to improve memory in animals and also has anticonvulsant activity. The other group are people who suffer cognitive/behavioral problems from fetal exposure to alcohol or anticonvulsant drugs. In animals, vinpocetine has been shown to mitigate these deficits. We propose to extend our prior preliminary studies by conducting a Phase I study in healthy volunteers, a Phase I study in adolescents with cognitive impairments from fetal alcohol exposure, then Phase II studies in patients with epilepsy and in adolescents/adults with cognitive impairments from fetal alcohol or antiseizure medication (e.g., valproate) exposure. The proposed investigations are guided by prior PK and PD studies in animals and humans. They are designed to provide data on the dosages needed to provide levels comparable to effective animal studies and provide data on the potential efficacy and safety of vinpocetine in improving cognition in order to direct more definitive randomized trials in the future.

Specific Aim: To determine the maximum tolerated oral dose of vinpocetine in healthy adult volunteers and develop data on pharmacokinetic response curve for vinpocetine effects.

Eligibility criteria: Inclusion Criteria:

1. Healthy adults 18-40 years old.
2. Proficient English.
3. Use of appropriate contraception if woman of childbearing potential.

Exclusion Criteria:

1. Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression).
2. Those who score \>18 overall on the BDI-II or \>0 for item #9 (suicidal thoughts) at screening.
3. Use of centrally active medications.
4. History of allergy to vinpocetine.
5. IQ\<80.
6. BMI≥30.
7. Pregnancy or lactation.

Primary outcomes:
measure: Adverse Events
timeFrame: Approximately weekly treatments across ~4-6 visits per participant.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01797146: Effectiveness of Catheter Reminder and Evaluation Program
Official title: Effectiveness of Catheter Reminder and Evaluation (CARE) Program in Reducing the Catheter-day and Prevention of Catheter-associated Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: All Hospitalized Patients
With and Without Catheter
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 874
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators will conduct a cluster randomized controlled trial to evaluate the efficacy of Catheter Reminder and Evaluation program (CARE) in reducing the duration of catheter use and the number of infection relating to catheter use.


Eligibility criteria: Inclusion Criteria:

* All hospitalized adults in 6 general medical wards at Siriraj Hospital
* With or Without catheter

Exclusion Criteria:

* None

Primary outcomes:
measure: Urinary catheter day
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
measure: CA-UTI
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
References:
Clinical trial NCT01140412: Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
Official title: Open-Label, Fixed-Sequence, Crossover Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: maraviroc
fosamprenavir
drug interaction
pharmacokinetics
HIV
AIDS
CCR5
protease inhibitor
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2010-06-09
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>45 kg (99 lbs).

Exclusion Criteria:

* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Known hypersensitivity or history of allergy to sulfonamides.

Primary outcomes:
measure: Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20
timeFrame: 25 days
measure: Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 2, Day 10 and Period 2, Day 20
timeFrame: 25 days
Secondary outcomes:
measure: Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.
timeFrame: 25 days
measure: Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.
timeFrame: 25 days
measure: Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments.
timeFrame: 25 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00789646: Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients
Official title: Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Corneal Ulcer
Keywords: corneal ulcer
painless
subconjunctival injection
antibiotics
antifungal
lidocaine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2008-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due to subconjunctival antibiotic and antifungal injection.


Eligibility criteria: Inclusion Criteria:

* The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features.

  1. corneal epithelial defect with stromal infiltration
  2. reaction in anterior chamber
  3. positive for bacteria or fungus
* The patients have to receive subconjunctival antibiotic injection twice at least.
* The patients must be informed consent.

Exclusion Criteria:

* The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs.
* The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection.
* Unable to cooperate with the treatment.
* Pregnant women

Primary outcomes:
measure: Numeric rating scale
timeFrame: immediately after injection
Secondary outcomes:
measure: Side effects
timeFrame: 24 hours after injection
Other outcomes:
Locations:
Study officials:
References: