louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05465668: Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of DWP16001 Drug A and C
Official title: A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug C in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 43
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.

Detailed description: The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.

Eligibility criteria: Inclusion Criteria:

- Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2

☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2

Exclusion Criteria:

* musculoskeletal diseases
* mental diseases
* hemato-oncologic diseases

Primary outcomes:
measure: Cmax,ss of DWP16001
timeFrame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
measure: AUClast of DWP16001
timeFrame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Secondary outcomes:
measure: Tmax of DWP16001
timeFrame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
measure: T1/2 of DWP16001
timeFrame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
measure: CL/F of DWP16001
timeFrame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
measure: Vd/F of DWP16001
timeFrame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA unuversity bundang medical center
Study officials:
References:
Clinical trial NCT00216268: Treatment of Japanese Encephalitis
Official title: Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Japanese Encephalitis
Lead sponsor: Indian Council of Medical Research
Sponsor class: OTHER_GOV
First posted: 2005-09-22
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Japanese encephalitis is the single largest cause of viral encephalitis in the world today. It occurs in yearly post monsoon outbreaks in Uttar Pradesh and other parts of India and south east Asia. There is presently no antiviral drug of proven benefit for this illness and treatment is mostly supportive. The drug Ribavirin is already in the market in use for other indications. It has been found useful in West Nile encephalitis and various hemorrhagic fevers caused by related arboviruses. This is a double blind placebo of Ribavirin in Japanese encephalitis. To the best of our knowledge, this is the first such trial in the world. The study hypothesis is that children treated with ribavirin will be no different from those getting placebo in terms of mortality, length of hospital stay, days to return to consciousness and oral feeds, days to become afebrile and convulsion free and in 3 month sequelae rate.


Eligibility criteria: Inclusion Criteria:

* Child between 6 months and 12 years age
* Acute febrile encephalopathy
* Positive IgM ELISA test for Japanese encephalitis in serum

Exclusion Criteria:

* Consent not obtained

Primary outcomes:
measure: Mortality during hospital stay
Secondary outcomes:
measure: Sequelae at 3 months
measure: Duration of hospital stay
measure: Days to return to oral feeds
measure: Days to become convulsion free
measure: Days to become afebrile
Other outcomes:
Locations:
city: Lucknow
country: India
facility: King George Medical University
state: UP
Study officials:
affiliation: King George Medical University, Lucknow INDIA
name: Rashmi Kumar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar R, Tripathi P, Baranwal M, Singh S, Tripathi S, Banerjee G. Randomized, controlled trial of oral ribavirin for Japanese encephalitis in children in Uttar Pradesh, India. Clin Infect Dis. 2009 Feb 15;48(4):400-6. doi: 10.1086/596309.
Clinical trial NCT06396468: Sevoflurane and Intravenous Anesthesia in Hypospadias Repair
Official title: Emergence Delirium in Pediatric Age Group: Comparison Between Sevoflurane and Intravenous Anesthesia in Hypospadias Repair: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emergence Delirium
Intravenous Anesthesia
Sevoflurane
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In group Sevoflurane, anesthesia was maintained with sevoflurane (1-1.2 MAC) with oxygen /air 1:1.

In group propofol , anesthesia was maintained continuous infusion of 100-400 mcg/kg /min of propofol and fentanyl 0.1 ug / kg/ min with oxygen /air 1:1.
Primary purpose: PREVENTION

Brief summary: Emergence agitation (EA), a phenomenon observed at the time of recovery from general anesthesia (GA).The cause of ED appears to be multifactorial in origin. Use of volatile anesthetics, prolonged duration and type of surgery, pain, and rapid emergence are some factors known to increase its incidence

Detailed description: The pathogenesis of postoperative EA is still undefined, but sevoflurane has intrinsic effects that may share in emergence agitation like its different electroencephalogram pattern from halothane, and its degradation to inorganic fluoride ions and compound A which may have a role in the occurrence of EA Sevoflurane now is the inhalational anaesthetic agent of choice for pediatrics, as it is non-pungent, with minimal airway irritation characters, and its cardiac adverse effects are minimal like cardiac depression and dysrhythmias.

Total intravenous anesthesia (TIVA) using propofol and fentanyl appears to have a smooth recovery profile

Eligibility criteria: Inclusion Criteria:

* ages 1 to 8 years
* American society of anesthesiologists (ASA) physical status I and II, scheduled for hypospadias repair

Exclusion Criteria:

* children with a history of active airway disease,
* sleep apnoea, developmental delay,
* psychological,
* neurological disorder,
* cardiovascular abnormality or requirement of post-operative ventilation,
* hepatic impairment, and renal insufficiency, with active upper respiratory tract infection

Primary outcomes:
measure: Emergence delirium
timeFrame: 24 hours
Secondary outcomes:
measure: FLACC
timeFrame: Postoperatively at 24 hours
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Benha University
Study officials:
affiliation: Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
name: Ramy Saleh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01864668: the Influence of Tidal Volume to Lung Strain
Official title: the Influence of Different Tidal Volume to Lung Strain of ARDS Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Acute Respiratory Distress Syndrome
Keywords: Acute respiratory distress syndrome
lung strain
small tidal volume
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critical patients diagnosed with acute respiratory distress syndrome

Brief summary: Measure the lung strain in different tidal volume in ADRS patients to find the relationship between tidal volume and lung strain and find the most suitable tidal volume for each patient.

Detailed description: Purpose:Find the relationship between tidal volume and lung strain in ARDS patients.Then find the most suitable tidal volume for each patient according to the dividing value.

Methods:Measure the lung strain in the tidal volume of 6mL/kg,8mL/kg,10mL/kg and 12mL/kg in each ARDS patient.

Hypothesis:With the increase of the tidal volume,the lung strain develops.In the patient with larger lung compliance,the strain of the group of conventional tidal volume is less than 0.27 and there is no obvious difference between the group of small tidal volume.

Eligibility criteria: Inclusion Criteria:

1. Age:18-85,gender is not limited
2. Needing Invasive ventilation
3. Fit the definition of ARDS in 2012 "Berlin Definition"
4. Sign the paper of informed consent

Exclusion Criteria:

1. pregnancy and at the end stage of tumour
2. the COPD patients
3. less than 24h of mechanical ventilation
4. more than 5 days of mechanical ventilation
5. FiO2\>80%
6. presence of air leaks
7. organ dysfunction and hemodynamic instability
8. including in other research

Primary outcomes:
measure: the strain in different tidal volume
timeFrame: 2 hours
Secondary outcomes:
measure: 28 days mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Zhongda Hospital of Southeast University
state: Jiangsu
Study officials:
References:
citation: Xie J, Jin F, Pan C, Liu S, Liu L, Xu J, Yang Y, Qiu H. The effects of low tidal ventilation on lung strain correlate with respiratory system compliance. Crit Care. 2017 Feb 3;21(1):23. doi: 10.1186/s13054-017-1600-x.
Clinical trial NCT06345768: The Effect of the Stress Ball Applied Before Colocystectomy Surgery on Patients; Surgical Fear, Anxiety and Comfort.
Official title: Effect of Stress Ball Applied Before Cholecystectomy Surgery on Surgical Fear, Anxiety and Comfort of Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Stress
Fear
Comfort
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 90
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: Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.

Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.

In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort.

Detailed description: This study was planned to examine the effect of a stress ball applied to patients before laparoscopic cholecystectomy on preoperative anxiety, surgical fear and comfort. Patients were given a stress ball before the procedure, and the other group received routine care.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalised in surgical wards and undergoing cholecystectomy,
* Patients who voluntarily agree to participate in the study will be included.

Exclusion Criteria:

* Mental retardation and any psychiatric disorder,
* Alcohol and drug addiction,
* Dementia, Alzheimer's disease etc. affecting cognitive functions,
* Patients who will undergo other operations other than cholecystectomy surgery.

Primary outcomes:
measure: Fear of surgery
timeFrame: 30 minutes before surgery
measure: Fear of surgery
timeFrame: Just before surgery
measure: Comfort
timeFrame: 30 minutes before surgery
measure: Comfort
timeFrame: Just before surgery
measure: Stress
timeFrame: 30 minutes before surgery
measure: Stress
timeFrame: Just before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun Üniversitesi Klinik Araştırma Etik Kurulu
state: Merkez
Study officials:
affiliation: Kocaeli University
name: Hatice Merve Alptekin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02872168: Identification of a New Metabolite of Furosemide in Humans
Official title: Identification of a New Metabolite of Furosemide in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment by Furosemide
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 30
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: Heart failure patients treated by furosemide

Brief summary: Recent in-vitro and in-vivo studies performed by one of the investigators (ESO, ICMPE, UPEC, France) have recently allowed to synthetize a new and easy-to-synthesized chemical compound of the furosemide (pyridinium furosemide) during furosemide degradation by electro-Fenton or bioconversion. The biological properties of pyridinium furosemide are currently under investigation. Furosemide is a diuretics currently used in the treatment of patients with heart failure. The goal of the investigators is to assay pyridinium furosemide in urine of patients treated by furosemide to demonstrate that pyridinium is or not a metabolite of furosemide in humans. This study will contribute to assess the fate of pharmaceutical residues of furosemide in the environment.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Written informed consent
3. Affiliation to social security
4. Known heart failure
5. Treatment by furosemide

Exclusion Criteria:

None

Primary outcomes:
measure: Assay of furosemide and pyridinium furosemide in urine of heart failure patients treated by furosemide
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03771768: Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease
Official title: Active Control,Randomized,Double- Blinded Clinical Trial of BD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autoimmune
Behcet Syndrome
Keywords: Oral ulcers
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1
Primary purpose: TREATMENT

Brief summary: Laser therapy is increasingly showing promising results in dental field including oral ulcers.This trial will assess the usefulness of Diode Laser compared to corticosteroid on oral ulcers of patients diagnosed with Behcet's disease.

Detailed description: The enrolled patients will be divided randomly into two groups.one group will receive Diode Laser (power:100 milli Watt,wavelength:980 mmm, delivery system:biostimulation probe) and other group will receive topical corticosteroids(Kenacort A Orabase: triamcinolone acetonide 0.1% 5 gram adhesive paste - Dermaphor) four times daily.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with Behcet's Disease according to International Criteria for BD.
* patients with active oral ulcers.
* patients free from any visible oral lesions other than the oral ulcers of BD.
* patients who agreed to take the supplied interventions.
* patients who will agree to participate in the study.
* patients who will accept to sign the informed consent.

Exclusion Criteria:

* patients not physically able to participate in survey or clinical oral examination.
* patients with organ or life-threatening disease.
* patients with history of a severe or chronic medical condition including tuberculosis, hepatitis and human immunodeficiency virus.
* patients under immunosuppressive drugs.
* patients with organ transplantation.

Primary outcomes:
measure: Oral ulcer activity index
timeFrame: One month
Secondary outcomes:
measure: Oral health - related quality of life
timeFrame: One month
measure: Pain associated with oral ulcer
timeFrame: One month
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Sherin Ali Hassan, MD
role: STUDY_DIRECTOR
References:
citation: Prasad R S, Pai A. Assessment of immediate pain relief with laser treatment in recurrent aphthous stomatitis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Aug;116(2):189-93. doi: 10.1016/j.oooo.2013.02.011. Epub 2013 Apr 23.
citation: Hatemi G, Merkel PA, Hamuryudan V, Boers M, Direskeneli H, Aydin SZ, Yazici H. Outcome measures used in clinical trials for Behcet syndrome: a systematic review. J Rheumatol. 2014 Mar;41(3):599-612. doi: 10.3899/jrheum.131249. Epub 2014 Feb 1.
citation: Nagieb CS, Harhash TA, Fayed HL, Ali S. Evaluation of diode laser versus topical corticosteroid in management of Behcet's disease-associated oral ulcers: a randomized clinical trial. Clin Oral Investig. 2022 Jan;26(1):697-704. doi: 10.1007/s00784-021-04047-8. Epub 2021 Jul 2.
Clinical trial NCT04584268: Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents
Official title: A Randomized Controlled Trial of a Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout
Keywords: burnout
medical residents
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This was a single-site RCT to assess the effect of a longitudinal mindfulness intervention on burnout for first-year (PGY-1) internal medicine (IM) and pediatrics residents. The primary outcome was Maslach Burnout Inventory MBI) scores at baseline and 12 month follow-up. Secondary outcomes were feasibility and perceived benefit of the intervention.


Eligibility criteria: Inclusion Criteria:

* Washington University (WUSM) first year residents in internal medicine and pediatrics

Exclusion Criteria:

* none

Primary outcomes:
measure: Maslach Burnout Inventory (MBI)
timeFrame: 1 year
measure: feasibility of intervention in graduate medical education
timeFrame: 1 year
Secondary outcomes:
measure: evaluation of intervention
timeFrame: 1 year
measure: effect on mindfulness practice
timeFrame: 1 year
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT01072968: BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.
Official title: Efficacy and Safety of BF2.649 in Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea (OSA) Refusing the Nasal Continuous Positive Airway Pressure (nCPAP) Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea
Excessive Daytime Sleepiness
Keywords: Multicenter
Randomized
Double-blind
Efficacy and safety study
BF2.649 versus placebo
Patients suffering from Obstructive Sleep Apnea
Complaining from Excessive Daytime Sleepiness
Refusing nasal Continuous Positive Airway Pressure
Lead sponsor: Bioprojet
Sponsor class: OTHER
First posted: 2010-02-22
Enrollment: 268
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: Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.

This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.

Detailed description: The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo.

The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.

Eligibility criteria: Inclusion Criteria:

* Patients with OSA still complaining EDS,refusing nCPAP
* ESS score ≥ 12

Exclusion Criteria:

* Patients suffering from insomnia without OSA
* Co-existing narcolepsy
* Patient with sleep debt not due to OSA
* Acute or chronic severe disease

Primary outcomes:
measure: ESS (Epworth Sleepiness Scale) change from baseline
timeFrame: From baseline to week 12 and week 51
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble
Study officials:
affiliation: Bioprojet
name: Evelyne De Paillette, MD
role: STUDY_DIRECTOR
References:
citation: Dauvilliers Y, Verbraecken J, Partinen M, Hedner J, Saaresranta T, Georgiev O, Tiholov R, Lecomte I, Tamisier R, Levy P, Scart-Gres C, Lecomte JM, Schwartz JC, Pepin JL; HAROSA II Study Group collaborators. Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial. Am J Respir Crit Care Med. 2020 May 1;201(9):1135-1145. doi: 10.1164/rccm.201907-1284OC.