louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04374981: Effect of Pineapple Juice on the Pharmacokinetics of Celecoxib and Montelukast in Humans
Official title: Effect of Pineapple Juice on the Pharmacokinetics of Celecoxib and Montelukast in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Food-drug Interaction
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pineapple (Ananas comosus) is a tropical fruit that is rich in antioxidents, enzymes and vitamins. It is used worldwide due to their anti-inflammatory and analgesic properties. The effect of pineapple Juice on the Pharmacokinetics of celecoxib and montelukast in Humans was studied.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects (body mass index between 21 to 25 kg/m2).

Exclusion Criteria:

* Smokers.
* Drug abuse.
* Abnormal level of kidney or liver functions.

Primary outcomes:
measure: Maximum Plasma Concentration [Cmax]
timeFrame: 12 weeks
measure: Time to reach plasma peak concentration [Tmax]
timeFrame: 12 weeks
measure: Time to reach maximum plasma concentration [Tmax]
timeFrame: 12 weeks
measure: The area under the concentration-time curve from zero to infinity (AUC0-∞)
timeFrame: 12 weeks
measure: The terminal elimination half-life (t1/2)
timeFrame: 12 weeks
Secondary outcomes:
measure: Clearance (CLT/F)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Faculty of Pharmacy-Damanhour University.
Study officials:
affiliation: Damanhour University
name: Sally Helmy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06948981: Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
Official title: A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hematological Malignancy (Leukemia- Lymphoma)
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2025-04-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective single-arm open-labled phase I/II clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed/refractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 34 subjects will be enrolled in this study.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

   -
2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

   -
3. CD19 positivity confirmed by flow cytometry and/or histopathology.

Exclusion Criteria:

1. Primary immunodeficiency.

   -
2. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.

   -
3. Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;

Primary outcomes:
measure: Incidence and severity of adversed events per CTCAE 5.0
timeFrame: 3 years
Secondary outcomes:
measure: Objective response rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Chinese Academy of Medical Sciences Hematology Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT03934281: Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient
Official title: Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabete Mellitus
Amputation
Amputation Wound
Toe (Toes); Wound
Lead sponsor: Centre Hospitalier Metropole Savoie
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 24
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: Numerous scientific publications in France and internationally have described the healing, anti-bacterial, anti-oxidant, anti-inflammatory and immuno-modulating properties of honey.

Honey is effective in the management of many infected or uninfected post-surgical wounds.

This study focuses on post surgical wounds after toe amputation in diabetic patients.

The main objective of this study is to compare the rate of epidermisation at six months for these wounds, between honey dressing and other dressing devices used according to the french Haute Autorité de Santé (HAS) recommendations


Eligibility criteria: Inclusion Criteria:

* Diabetic patients
* Patients who have had an amputation of one or more toes within four days prior to inclusion without having the second dressing rehabilitated
* Written informed consent.

Exclusion Criteria:

* Known hypersensitivity to honey, hyaluronic acid, guar gum, pectin and/or zinc oxide.
* Insipid Diabètes
* patient eligible for a dressing by Vacuum Assisted Closure therapy (VAC therapy)
* transmetatarsal amputation
* Patient with sutured wound
* Patient already included in the study, for a previous amputation for wich the wound has not healed.
* Failure to comply with protocol requirements
* Person protect by article L1121-5 to L1121-8 of the French Health Public.
* Patient include in an other clinical study

Primary outcomes:
measure: Epidermization rate at 6 months.
timeFrame: 6 months after amputation
Secondary outcomes:
measure: Epidermization rate at 12 months
timeFrame: 12 months after amputation
measure: pain during dressing change: verbal scale of pain
timeFrame: inclusion, 1month, 2 months, 3months, 4months, 5 months, 6 months,7months,8months, 8months ,9months 10months, 11months, 12 months after amputation up to cicatrization
measure: average length of wound cicatrization
timeFrame: from date of amputation until the date of the first documented complete cicatrization, assessed up to 12 months
measure: the satisfaction of professionals for the use of honey dressing
timeFrame: 12 months after amputation or at study completion, whichever came first
measure: Epidermization rate at 1 month
timeFrame: 1 month after amputation
measure: Epidermization rate at 2 months
timeFrame: 1 month after amputation
Other outcomes:
Locations:
city: Chambéry
country: France
facility: Hélène Blaise
Study officials:
References:
Clinical trial NCT02759081: Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy
Official title: A Randomized, Controlled Trial Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Intubation Time
Cap-assisted Colonoscopy
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This prospective, randomize, controlled trial will compared cap-assisted water exchange with water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis that that cap-assisted water exchange is more efficient and causes a shorter insertion time.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing fully sedated colonoscopy performed by the investigators

Exclusion Criteria:

* obstructive lesions of the colon
* massive ascites
* history of partial colectomy
* provide written informed consent

Primary outcomes:
measure: cecal intubation time
timeFrame: when the colonoscope reaches the cecum, an average of 14 minutes
Secondary outcomes:
measure: Dose of propofol
timeFrame: The end of colonoscopy, an average of 14 minutes
measure: adenoma detection rate
timeFrame: One week after colonoscopy
Other outcomes:
Locations:
city: Chia-Yi
country: Taiwan
facility: Dalin Tzu Chi General Hospital
Study officials:
affiliation: Dalin Tzu Chi Hospital. Tzu Chi medication Foundation
name: Yu-Hsi Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
citation: Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.
citation: Kondo S, Yamaji Y, Watabe H, Yamada A, Sugimoto T, Ohta M, Ogura K, Okamoto M, Yoshida H, Kawabe T, Omata M. A randomized controlled trial evaluating the usefulness of a transparent hood attached to the tip of the colonoscope. Am J Gastroenterol. 2007 Jan;102(1):75-81. doi: 10.1111/j.1572-0241.2006.00897.x. Epub 2006 Nov 13.
citation: Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56.
Clinical trial NCT04403581: Egyptian Doctors Stresses, Knowledge and Attitude During COVID-19 Pandemic
Official title: Cross-sectional Descriptive Study: Egyptian Doctors Stresses, Knowledge and Attitude During COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Keywords: stresses
covid-19
doctors
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 384
Sex: ALL
Minimum age (years): 23
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Working doctors in different specialties

Brief summary: Doctors are at high risk of corona virus infection (COVID-19) during pandemic. The investigators are aiming to explore the emotions, perceived stressors, knowledge and coping strategies of doctors who are working during COVID-19 pandemic in different specialties and in different hospitals by a self assessment questionnaire that was designed and modified from two previously published articles (mentioned in the references), including 7 sections with 88 questions.

Detailed description: Background

Corona virus disease 2019 (COVID-19), an infectious respiratory disease caused by a newly discovered corona virus in December 2019, has been recognized as a serious threat to global health. Since the WHO declared COVID-19 a pandemic in early March 2020, the WHO and the Center for Disease Control and Prevention (CDC) have been considered the most reliable sources of information for the COVID-19 global pandemic. The CDC listed moderate to severe asthma, especially if not well controlled, as high-risk for severe illness from COVID-19.

A large number of cases occurred among health care workers (HCW), which were contracted within the health care facilities. Some of the HCWs even died from the COVID-19 disease. Moreover, it was reported that unrecognized, asymptomatic patients transferred to their family or close contacts. All these factors were alarming and potentially distressing for the hospital staff who worked during the pandemic.

The severe acute respiratory syndrome (SARS) epidemic in 2003 also involved disease transmission to HCWs. Even though the fatality rates for SARS were lower than for COVID-19 infection, nonetheless, they were a cause of significant stress, emotional turmoil, and concern for all the SARS healthcare providers.

The emotions, perceived stressors, complete knowledge assessment and coping strategies of HCWs especially doctors during COVID-19 have not been explored. These issues were the intended focus of the study.

Eligibility criteria: Inclusion Criteria:

* doctors from different specialties

Exclusion Criteria:

* doctors who stopped working in the pandemic

Primary outcomes:
measure: Cross-sectional descriptive study: Egyptian Doctors Stresses, Knowledge and Attitude during COVID-19 Pandemic
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ainshams university
name: Riham H Raafat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02424981: Efficiency of Inspiratory Muscle Training in Elderly People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficiency of inspiratory muscle training in elderly people. Outcomes are lung function, muscle strength and chest expansion.


Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* pulmonary diseases
* cognitive disorders

Primary outcomes:
measure: lung function will be measured by spirometry
timeFrame: One month
measure: chest expansion will be measured by a tape measure
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
Study officials:
References:
Clinical trial NCT06064981: BE Intervention for Naloxone Uptake
Official title: Behavioral Economic Approaches to Increase Naloxone Aquisition and Carrying in an Urban Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Harm Reduction
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The overall objective of this study is to use behavioral economics interventions to increase naloxone acquisition and carrying among participants who attend an opioid overdose reversal training.

Detailed description: This study aims to use behavioral economics interventions to increase naloxone acquisition and carrying among participants who attend opioid overdose reversal training. The study consists of two distinct randomized controlled trials (Aim 2 and Aim 3) and has three primary objectives:

Aim 1: To diagnose behavioral bottlenecks to naloxone acquisition and carrying. This aim involves analyzing data from naloxone training sessions to identify barriers to acquiring and carrying naloxone. These barriers will be mapped to cognitive biases, such as optimism bias and overconfidence, and will inform the behavioral interventions in Aims 2 and 3.

Aim 2: To test the impact of a behavioral economics intervention on naloxone acquisition. This aim involves a randomized controlled trial with 60 participants. The intervention group will receive commitment pledges, acquisition plans, and tailored text message nudges to increase naloxone acquisition within one week of training. The control group will receive standard training. The primary endpoint is the time it takes for participants to acquire naloxone post-training.

Aim 3: To test the impact of a text nudge intervention on naloxone carrying. This aim also involves a randomized controlled trial, where all participants receive naloxone at the training. The intervention group will receive tailored text message nudges to encourage consistent naloxone carrying. The control group (n=30) will not receive these nudges. The primary endpoint is the consistency of naloxone carrying post-training.

Eligibility criteria: Inclusion Criteria:

* Living in the Philadelphia area
* Attended the study naloxone training.

Exclusion Criteria:

* Unable to consent

Primary outcomes:
measure: Naloxone carrying
timeFrame: Proportion of successful naloxone check-ins at 14 random time points over a 4 week period post-intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Carolyn Cannuscio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01474681: Safety and Tolerability of HSC835 in Patients With Hematological Malignancies
Official title: A First-in-human, Single-arm, Single-center, Open-label, Proof-of-concept Study to Evaluate the Safety and Tolerability of Infusing HSC835 (LFU835-expanded Umbilical Cord Blood Hematopoietic Stem Cells) in Patients With Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Myelocytic Leukemia
Acute Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Marginal Zone Lymphoma
Follicular Lymphomas
Large-cell Lymphoma
Lymphoblastic Lymphoma
Burkitt's Lymphoma
High Grade Lymphomas
Mantle-cell Lymphoma
Lymphoplasmacytic Lymphoma
Keywords: hematologic malignancies
leukemia
lymphoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 27
Sex: ALL
Minimum age (years): 10
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis that qualifies them for a DUCBT
* Absence of recent active mold infection
* Adequate organ function
* Availability of eligible donor material

Exclusion Criteria:

* Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used
* Human immunodeficiency virus (HIV) infection
* Active infection
* Extensive prior chemotherapy
* Prior myeloablative allotransplantation or autologous transplant.

Primary outcomes:
measure: Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT.
timeFrame: 32 days
Secondary outcomes:
measure: Incidence of Neutrophil Recovery Within 42 Days
timeFrame: 42 days
measure: Incidence of Platelet Recovery Within Six Months
timeFrame: 6 months
measure: Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only)
timeFrame: Day 100
measure: Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year
timeFrame: Day 100 and Month 12
measure: Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year
timeFrame: Day 100 and Monnth 12
measure: Incidence of Relapse Within One Year
timeFrame: Month 12
measure: Overall Survival (OS) Within One Year
timeFrame: Month 12
measure: Disease Free Survival (DFS) Within One Year
timeFrame: Month 12
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03620981: Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Official title: A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Agitation Associated With Dementia of the Alzheimer's Type
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-08
Enrollment: 410
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the safety of brexpiprazole and identify the optimum dose.


Eligibility criteria: Inclusion Criteria:

* Patients who satisfy both of the following diagnostic criteria:

  1. Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-5.
  2. Diagnosis of "Probable Alzheimer's Disease" according to NINCDS-ADRDA.
* Hospitalized patients or care facility patients or care at home patients
* Patients with an MMSE score of 1 to 22
* Patients who have the agitation defined according to the "Consensus provisional definition of agitation in cognitive disorders" from the International Psychogeriatric Association (IPA)

Exclusion Criteria:

* Patients who have dementia other than dementia of the Alzheimer's type
* Patients diagnosed with delirium between 30 days before the screening examination and baseline evaluation according to DSM-5.
* Patients diagnosed with any of the following disorders according to DSM-5:

  * Schizophrenia spectrum and other psychotic disorders
  * Bipolar and related disorders
  * Major depressive disorder

Primary outcomes:
measure: Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.
timeFrame: Baseline and 10 weeks first dose, on average 10 weeks
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.
timeFrame: Baseline and 10 weeks first dose, on average 10 weeks
measure: Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.
timeFrame: Baseline and 10 weeks first dose, on average 10 weeks
Other outcomes:
Locations:
city: Shirakawa
country: Japan
facility: Jisenkai Nanko Psychiatric Institute
Study officials:
References: