louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04963829: Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer
Official title: Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Ulcer
Healing Ulcer
Keywords: Healing Ulcer
Chronic Ulcer
Musa sapientum
Lemongrass
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twenty-five people, regardless of gender, participated in this study. The patients were divided into 3 groups (Control 1, Control 2 and, Study Group). The Control Group 1 (CG1) consisted of seven participants who were subjected to a standardized treatment (collagenase ointment was selected for this treatment), the Control Group 2 (CG2) accounted for seven participants who used a gel made of 10% peel powder of unripe banana (M. sapientum), and the Study Group (SG) involved eleven participants who used the abovementioned gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration.
Primary purpose: TREATMENT

Brief summary: To evaluate the activity of a gel composed of 10% peel powder of unripe banana (Musa sapientum) combined with lemongrass (Cymbopogon citratus) oil, at 0.1% concentration, in patients with chronic ulcers.

Detailed description: Purpose: To evaluate the activity of a gel composed of 10% peel powder of unripe banana (Musa sapientum) combined with lemongrass (Cymbopogon citratus) oil, at 0.1% concentration, in patients with chronic ulcers. Methods: This is a clinical, individual, analytical, interventional, longitudinal, prospective, controlled study with convenience sampling. Three groups will be used, as follows: control group 1 (CG1) with 7 participants will be treated with collagenase, control group 2 (CG2) with 7 participants will be treated with a gel composed of 10% unripe banana peel powder, and study group (SG) with 11 patients will be treated with the abovementioned gel combined with lemongrass oil at 0.1% concentration. The ulcer areas will be analyzed once a week for 4 weeks. Afterward, wound areas will be measured and the obtained data will be subjected to statistical analysis.

Eligibility criteria: Inclusion Criteria:

* presence of chronic ulcers,
* 18 years of age and older

Exclusion Criteria:

* Patients who had any type of allergic reaction to the study products during treatment

Primary outcomes:
measure: Delimitation of the wound area
timeFrame: 3 month
Secondary outcomes:
measure: Digitalizing drawing wounds measurements
timeFrame: 3 months
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Vale do Sapucaí University
state: Minas Gerais
Study officials:
affiliation: Vale do Sapucaí University
name: Adriana R dos Anjos Mendonça, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02319629: Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery
Official title: Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Keywords: Morbid obesity,
Cholelithiasis
Bariatric surgery
Ursodiol
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Risk factor of cholelithiasis is rapid weight loss after bariatric surgery and change in the gallbladder function which is secondary to surgery. Many observational studies support this fact, and a high incidence of 28% -71% after gastric bypass surgery (RYGB) was reported in them. According to another publication, the incidence of gallbladder diseases is 5-36% after jejunoileal bypass surgery and 2.8-36% after gastric bypass surgery.

Detailed description: Study format: Prospective, randomized, blinded study. 266 candidates for sleeve gastrectomy or gastric bypass surgery due to morbid obesity with BMI range of 40-50 and aged 18-65 will be studied.

The patients will be randomly divided into two groups (according to the last digit of the identity card number):

1. Treatment group will receive preventive therapy with Ursodiol 600 mg per day as of day 10 after the surgery (at the first routine visit after the surgery) and for six months or until the formation of gallstones.
2. Placebo group will receive placebo as of day 10 after the surgery (at the first routine visit after the surgery) and for six months or until the formation of gallstones.

Eligibility criteria: Inclusion Criteria:

* Candidates for sleeve gastrectomy or gastric bypass surgery due to morbid obesity with BMI range of 40 to50.
* Aged 18 to 65.
* No presence of gallstones.
* Patients who have signed the consent form.

Exclusion Criteria:

* Minors,
* Pregnant women,
* Age over 65,
* Sensitive to Ursodiol,
* Gallstones,
* Biliary tract pathologies,
* Gallbladder wall thickening,
* Patients after cholecystectomy,
* Patients participating in another clinical trial.

Primary outcomes:
measure: Incidence of gallstones formation after bariatric surgery
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: surgery department A
Study officials:
affiliation: Technion - Israel Institute of Technology, Faculty of Medicine
name: Nasser Sakran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sakran N, Dar R, Assalia A, Neeman Z, Farraj M, Sherf-Dagan S, Gralnek IM, Hazzan R, Mokary SE, Nevo-Aboody H, Dola T, Kaplan U, Hershko D. The use of Ursolit for gallstone prophylaxis following bariatric surgery: a randomized-controlled trial. Updates Surg. 2020 Dec;72(4):1125-1133. doi: 10.1007/s13304-020-00850-2. Epub 2020 Jul 14.
Clinical trial NCT00724529: Post Marketing Surveillance of Remicade
Official title: Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ankylosing Spondylitis
Keywords: Crohn's Disease
Ankylosing Spondylitis
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 938
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of subjects will mainly be taken from the digestive or rheumatoid departments of internal medicine in university or general hospitals, where patients with Crohn's Disease and Ankylosing Spondylitis are generally treated. The period of surveillance is from 23 AUG 2005 to 22 AUG 2011.

Brief summary: The purpose of this study is to understand the safety and effectiveness of infliximab when used in clinical practice. This is a post-marketing surveillance study.

Detailed description: The investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Remicade approval.

Eligibility criteria: Inclusion Criteria:

* Severe active Crohn's disease: the patients with severe active Crohn's disease who do not show any response to the treatment with corticosteroid or immunosuppressive agents, have no drug tolerance, or are contraindicated to such treatments.
* Fistula-type active Crohn's disease: the patients with fistula-type active Crohn's disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant.
* Ankylosing spondylitis: the patients with ankylosing spondylitis who do not show adequate response to general treatments, and with increased serological indices related to severe axial symptoms and inflammation.

Exclusion Criteria:

* None

Primary outcomes:
measure: To evaluate the safety of Remicade Injection (Infliximab) when used in clinical practice
timeFrame: The maximum period for observation in this surveillance would be 30 weeks (6 administrations) for patients with Crohn's disease and 24~30 weeks (6 administrations) for patients with Ankylosing spondylitis.
Secondary outcomes:
measure: To evaluate the efficacy of Remicade Injection (Infliximab) when used in clinical practice
timeFrame: The maximum period for observation in this surveillance would be 30 weeks (6 administrations) for patients with Crohn's disease and 24~30 weeks (6 administrations) for patients with Ankylosing spondylitis.
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT03905629: Validation of the Hospital Frailty Score in France
Official title: Validation of the Hospital Frailty Risk Score in Combination With Charlson/Elixhauser Comorbidity Coding Algorithms on French Hospital Databases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly
Emergency Hospitalization
Frailty
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 1000000
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients considered will be all patients aged 75 years and older hospitalized as an emergency over a one year period ranging from January to December 2017.

According to a preliminary extraction, we expect to include approximately one million patients.

Brief summary: Older people are increasing users of health care globally. Constraints in bed capacity and resources raise important challenges with regards to management of older people with complex needs, which usually require assertive and holistic assessment. It is important, therefore, to identify aged patients most likely to benefit from such frailty-attuned approaches of care. A previous study using national Hospital Episodes Statistics conducted in the United Kingdom (UK) showed that patients aged over 75 years with characteristics of frailty and at risk of adverse health-care outcomes can be identified using routinely collected data (Gilbert T et al., Lancet 2018). This study lead to the development of the Hospital Frailty Risk Score (HFRS), which is based on International Statistical Classification of Diseases and Related Health Problems 10 (ICD-10) diagnosis codes and has the potential to be used in other countries worldwide, using the ICD-10 coding framework, to identify patients at risk of frailty at the hospital and commissioners levels, as well as for database research purposes. This score has successfully been validated in Canada, Australia and Switzerland. The aim of the present study is to evaluate the ability of the HFRS to predict 30-day in-patient mortality of patients aged 75 years and older admitted to French hospitals as an emergency.


Eligibility criteria: Inclusion Criteria:

* age 75 years or over (on the day of the index admission)
* hospitalized as an emergency (i.e. after visit to ED)

Exclusion Criteria:

* none

Primary outcomes:
measure: 30-day in-patient mortality
timeFrame: In-patient mortality within 30 days from admission (index hospitalization)
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: service de court séjour gériatrique, Hôpital Lyon Sud
Study officials:
References:
citation: Gilbert T, Cordier Q, Polazzi S, Bonnefoy M, Keeble E, Street A, Conroy S, Duclos A. External validation of the Hospital Frailty Risk Score in France. Age Ageing. 2022 Jan 6;51(1):afab126. doi: 10.1093/ageing/afab126.
Clinical trial NCT05153629: Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy
Official title: Noninvasive Electrical Stimulator as an Adjunct for Pain Control After Ureteroscopic Stone Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Ureteral Calculi
Nephrolithiasis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 41
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: TREATMENT

Brief summary: The investigators will assess the use of Transcutaneous Neurostimulation (TENS), a pharmacological alternative, for treatment of ureteral stent pain post-ureteroscopy. The primary aim for the investigators is to determine if use of a TENS unit will reduce post-operative pain and nausea associated with the ureteral stent. Secondary aim will be to assess if it can help minimize narcotic use.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing standard of care ureteroscopy and laser lithotripsy for urinary stone disease
* Patients receiving a stent following their ureteroscopy and laser lithotripsy

Exclusion Criteria:

* Children
* Pregnant patients
* Patients unable to answer pain questionnaire
* Patients undergoing PCNL
* Patients being treated for Urologic malignancy with ureteroscopy
* Patients who require long term or chronic ureteral stent management
* Patient with implantable stimulators
* Patient with epilepsy
* Patients undergoing laser lithotripsy without stent placement

Primary outcomes:
measure: Pain on 11-point Visual Analog Score Scale (VAS)
timeFrame: Assessed daily until removal of stent, approximately 3-10 days after placement
measure: Difference in Pain on 11-point Visual Analog Score Scale (VAS)
timeFrame: Assessed daily until removal of stent, approximately 3-10 days after placement
Secondary outcomes:
measure: Total Opioid Consumption
timeFrame: Until stent removal (up to 10 days)
measure: Difference in Total Opioid Consumption
timeFrame: Until stent removal (up to 10 days)
measure: Ureteral Stent Discomfort Test (USDT) Scale Score
timeFrame: Assessed at removal of stent, approximately 3-10 days after placement
measure: Patient Satisfaction Survey
timeFrame: End of study (day 3 to 10)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Simon Conti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03806829: The Acute Effects of Commercially Available Drinks on the Endothelial Function of Humans Following a High-fat Meal
Official title: Pilot Study: The Acute Effects of Commercially Available Drinks on the Endothelial Function of Humans Following a High-fat Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Keywords: antioxidants
polyphenols
flow-mediated dilatation
Lead sponsor: University of the Highlands and Islands
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 7
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: High fat diets are associated with impaired endothelial function and increased cardiovascular disease risk amongst our population. These negative effects are likely caused by triglyceride induced suppression of nitric oxide, which is produced from the endothelium, and/or an increase in oxidative stress.

Interestingly, previous studies have found that some beverages that are high in polyphenols and antioxidants may suppress the impairment in endothelial function observed following high fat meals/diets. Typically, these studies have investigated the ingestion of red wine, orange juice or green tea on outcome measures (typically flow mediated dilatation (FMD) of the brachial artery). Despite this previous research, no study has compared the effects of different beverages on endothelial outcomes following a high-fat meal within the same participants.


Eligibility criteria: Inclusion Criteria:

* Females to be postmenopausal and not on hormone replacement therapy
* 25 \> BMI \< 35
* Sedentary to light activity lifestyle.

Exclusion Criteria:

* History of cardiovascular disease (Hypertension, Atherosclerosis, endothelial issues etc).
* History of diabetes (Type 1 or type 2)
* Vegan or with food allergies or intolerances.
* Taking any antioxidants over the counter (Vit C, E or polyphenol supplements)
* Taking prescription medication for hypertension.

Primary outcomes:
measure: Endothelial (dys)function
timeFrame: 2 hours post-prandial
Secondary outcomes:
measure: Plasma Nitrite
timeFrame: 2 hours post-prandial
measure: Plasma antioxidant capacity
timeFrame: 2 hours post-prandial
measure: Plasma ox-LDL
timeFrame: 2 hours post-prandial
Other outcomes:
Locations:
city: Inverness
country: United Kingdom
facility: University of the Highlands and Islands
Study officials:
affiliation: University of the Highlands and Islands
name: Ian Megson, Megson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06218329: TIMECARD(TaIwan Network of Post-arrest ManagEment for CARDiac Arrest)IIRegistry
Official title: TIMECARD (TaIwan Network of Post-arrest ManagEment for CARDiac Arrest) II Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiology, Critical Care Medicine, Emergency Medical Service
Keywords: Prognosis, post-cardiac arrest syndrome, Sudden Cardiac Arrest, registry database, predictive model
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 1000
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: This study will enroll patients with who arrived at the emergency department with non-traumatic and admitted to the ICU.

Brief summary: This study aims to collect the post-cardiac arrest patients with ICU admission.

Detailed description: The purpose of this study is to establish protocolized and standard post-arrest care as well as constitute a multicenter registry of post-arrest survivors, and thus to develop the Taiwan predictive model of cardiac arrest survivors. The registry system may help evaluate the severity of disease illness and improve the post-arrest care.

Eligibility criteria: Inclusion Criteria:

* non-traumatic cardiac arrest patients
* Admitted to the ICU

Exclusion Criteria:

* Below 18 year old
* Pregnant
* Terminal illness or not receiving medical treatment
* When emergency ICU crowded can not provide Critical Care

Primary outcomes:
measure: Number of cases
timeFrame: 2024/12/31
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Emergency Medicine, National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01803529: Deep Friction Massage for Intercostal Pain in Patients With Heart Disease
Official title: Standard Heat-pack With or Without Deep Friction Massage for Intercostal Pain in Patients With Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Pain
Keywords: thorax
Intercostal Muscles
massage
heat-pack
hot temperature
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2013-03-04
Enrollment: 29
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: Studies show that chest pain is a common complaint presented in both general practice and in emergency units. Musculoskeletal causes are common, but frequently overlooked. No studies about treatment of chest pain from the intercostal muscles were found by search in medical literature databases. The purpose of this study is to evaluate the effect of two different physical therapy interventions on intercostal pain in patients with stable heart disease.

The hypothesis was that deep friction massage combined with heat-pack is more effective than heat-pack only.


Eligibility criteria: Inclusion Criteria:

* increasing chest pain during a cardiac rehabilitation class
* stable coronary disease
* new re-vascularisation is not planned

Exclusion Criteria:

* unstable coronary disease
* not able to perform the study
* abuse of drugs or alcohol
* participating in other ongoing study

Primary outcomes:
measure: pain
timeFrame: 3 months
Secondary outcomes:
measure: quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs University Hospital
Study officials:
affiliation: St Olavs University Hospital
name: Stig A Slørdahl, md prof
role: STUDY_DIRECTOR
References:
citation: Berg AT, Stafne SN, Hiller A, Slordahl SA, Aamot IL. Physical therapy intervention in patients with non-cardiac chest pain following a recent cardiac event: A randomized controlled trial. SAGE Open Med. 2015 Apr 16;3:2050312115580799. doi: 10.1177/2050312115580799. eCollection 2015.
Clinical trial NCT00255229: Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea
Official title: Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: irinotecan
5FU
amino acids
heat shock protein
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2005-11-18
Enrollment: 130
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: Irinotecan (7-ethyl-10- {4(-1-piperidino)-1-piperidino} carbonyloxy camptothecin) is a semisynthetic camptothecin derivative introduced in the 1980's. Irinotecan is a prodrug metabolized by carboxylesterases to an active metabolite 7-ethyl-10-hydroxy-camptothecin (SN38). SN38 exerts its cytotoxic effect by forming stable complexes with topoisomerase I and DNA. These complexes collide with replication forks and cause breaks in DNA. Studies substantiated irinotecan's activity in 5FU resistant colorectal cancer and led to its approval for treatment of 5FU resistant colorectal cancer in the United States, Canada and Europe.Colorectal cancer studies demonstrated that single agent irinotecan's dose limiting toxicity was diarrhea occurring 5 to 6 days after its administration. High dose loperamide at first occurrence of diarrhea has decreased the incidence of diarrhea but the incidence of grade 3/4 diarrhea remains high at 28 to 40%.


Eligibility criteria: Inclusion Criteria:

* metastatic colorectal cancer to be treated with FOLFIAT chemo

Exclusion Criteria:

* severely abnormal liver and kidney function

Primary outcomes:
measure: Reduction in diarrhea.
timeFrame: Study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Michael Sawyer, MD
role: PRINCIPAL_INVESTIGATOR
References: