louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01131182: Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)
Official title: An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 1147
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: This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.

Detailed description: This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Eligibility criteria: Inclusion Criteria:

* Muslim men and women with type 2 diabetes
* Participants who intend to fast during the month of Ramadan
* Participants who have been on a stable dose of sulfonylurea for at least three months

Exclusion Criteria:

* Participants with type 1 diabetes mellitus
* Pregnant or breast feeding women
* Participants with hypersensitivity or contraindication to dipeptidyl peptidase (DPP-4) treatment
* Participants on insulin
* Participants on any class of oral diabetic therapy other than sulfonylurea or metformin

Primary outcomes:
measure: Proportion of Participants With at Least One Symptomatic Hypoglycemic Event
timeFrame: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)
Secondary outcomes:
measure: Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event
timeFrame: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Al Sifri S, Basiounny A, Echtay A, Al Omari M, Harman-Boehm I, Kaddaha G, Al Tayeb K, Mahfouz AS, Al Elq A, Radican L, Ozesen C, Katzeff HL, Musser BJ, Suryawanshi S, Girman CJ, Davies MJ, Engel SS; 2010 Ramadan Study Group. The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial. Int J Clin Pract. 2011 Nov;65(11):1132-40. doi: 10.1111/j.1742-1241.2011.02797.x. Epub 2011 Sep 27.
Clinical trial NCT04425382: Darunavir/Cobicistat vs. Lopinavir/Ritonavir in COVID-19 Pneumonia in Qatar
Official title: Efficacy and Safety of Darunavir/Cobicistat vs. Lopinavir/Ritonavir in the Management of Patients With COVID-19 Pneumonia in Qatar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
COVID
Pneumonia
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patient who were admitted to HMC hospitals with laboratory confirmed 2019-nCoV infection who meet the inclusion criteria during the review period will be included.

Brief summary: Coronavirus Disease 2019 (COVID-19) is a disease caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. It was first isolated in Wuhan, China in December 2019 and then rapidly spread to the rest of the world posing a severe threat to global health.

Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Protease inhibitors are one of the proposed agents, but their use is limited to their significant drug interactions and side effects.

The aim of this study is to compare the efficacy and safety outcomes of Darunavir/Cobicistat versus Lopinavir /Ritonavir in the treatment of patients with COVID-19 pneumonia in Qatar.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥18 years of age
* Laboratory confirmed 2019-nCoV infection as determined by the PCR of the nasopharyngeal/oropharyngeal swab.
* Radiologically confirmed pneumonia (Based on the chest x-ray or CT scan imaging).
* Have received either Darunavir/Cobicistat or Lopinavir/Ritonavir as part of the treatment regimen for COVID-19 pneumonia

Exclusion Criteria:

* No exclusion criteria will be applied

Primary outcomes:
measure: Time to Clinical Improvement and/or Virological Clearance (Composite Endpoint)
timeFrame: Up to 90 days
Secondary outcomes:
measure: Percentage of Virological Clearance
timeFrame: At day 14, day 21, and day 28.
measure: Percentage of Clinical Deterioration
timeFrame: Up to 28 days
measure: Incidence of Adverse Events
timeFrame: Up to 28 days
measure: Length of Hospital Stay
timeFrame: Up to 90 days
measure: All-cause Mortality
timeFrame: At 30 days
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Hamad Medical Corporation
name: Dr. Eman Elmekaty, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elmekaty EZI, Alibrahim R, Hassanin R, Eltaib S, Elsayed A, Rustom F, Mohamed Ibrahim MI, Abu Khattab M, Al Soub H, Al Maslamani M, Al-Khal A. Darunavir-cobicistat versus lopinavir-ritonavir in the treatment of COVID-19 infection (DOLCI): A multicenter observational study. PLoS One. 2022 May 4;17(5):e0267884. doi: 10.1371/journal.pone.0267884. eCollection 2022.
Clinical trial NCT03540082: Safe Landing Strategy in Older Adults
Official title: Safe Landing Strategy in Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fall Prevention
Fall Injury
Fall Safety
Keywords: Aging
Older Adults
Fall prevention
Fall safety
Safe landing
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purposes of this project to examine whether older adults can learn safe landing strategy during a fall. The research hypotheses are three-fold: 1) To determine whether older adults can learn a safe landing strategy to reduce impact severity of falling; 2) To examine whether the training effect on the right side falls can be transferred to the left side falls; and 3) To examine 1-week and 3-month retention effect of fall strategy training in older adults.


Eligibility criteria: Inclusion Criteria:

* BMI 18.5-30 kg/m2
* Healthy bone mass (2.5 SD of young)
* No tumbling experience

Exclusion Criteria:

* \> 70 years old
* Bone fracture within 3 years
* Osteoporosis
* Blood thinners

Primary outcomes:
measure: Safe Landing Strategy
timeFrame: 1-week and 3-months post
Secondary outcomes:
measure: Retention effects
timeFrame: 3-months post
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02832882: RFA for Small HCC With No-touch Technique Using Octopus Electrode
Official title: Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus Electrode and No-touch Technique: Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: HCC
RFA
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 118
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method with the same device.


Eligibility criteria: Inclusion Criteria:

* Child-Pugh class A
* patient with 1cm-2.5cm sized HCC
* 1 or 2 HCCs
* being referred for curative purpose of RFA
* sign informed consent

Exclusion Criteria:

* maximum tumor diameter greater than 2.5cm
* Child-Pugh class B or C
* more than 3 HCC lesions
* invisible tumor even after US/CT or US/MR fusion
* presence of vascular tumor thrombosis or extrahepatic metastasis
* severe coagulopathy (PLT \< 50K, PT \< 50% of normal range)

Primary outcomes:
measure: 12 month local tumor progression (LTP) rate
timeFrame: 12 month after RFA
Secondary outcomes:
measure: tumor seeding rate
timeFrame: 12 months after RFA
measure: Complication rate related with RFA
timeFrame: 1 month
measure: Technical success rate
timeFrame: 1 months
Other outcomes:
measure: Ablation time
timeFrame: 3 days after RFA
measure: Intrahepatic distant mets
timeFrame: 12 months after RFA
measure: Extrahepatic distant mets
timeFrame: 12 months after RFA
measure: Technical efficacy 1
timeFrame: 2 days after RFA
measure: Technical efficacy 2
timeFrame: 2 days after RFA
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00830882: Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol
Official title: A Proof of Concept Study to Evaluate the Peak Bronchoprotection Conferred by Single and Chronic Dosing With Levosalbutamol and Racemic Salbutamol in Persistent Asthmatics.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Asthma
Keywords: asthma
levosalbutamol
genotype
bronchoprotection
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2009-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the peak dose relative bronchoprotection offered by levosalbutamol and racemic salbutamol in mild to moderate asthmatics preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms.


Eligibility criteria: Inclusion Criteria:

1. Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent
2. Methacholine responsive PC20\< 4 mg/ml
3. \>1dd change in methacholine PC20 after the administration of racemic Salbutamol.
4. Male or female 18-65
5. Informed Consent
6. Ability to comply with the requirements of the protocol

Exclusion Criteria:

1. Severe asthmatics as defined by an FEV1≤ 60% or PEF variability \> 30% or with continual daytime or nocturnal symptoms.
2. The use of oral corticosteroids within the last 3 months.
3. Recent respiratory tract infection (2 months).
4. Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
5. Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol.
6. Any significant abnormal laboratory result as deemed by the investigators
7. Pregnancy, planned pregnancy or lactation
8. Known or suspected contra-indication to any of the IMP's
9. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.

Primary outcomes:
measure: Methacholine challenge
timeFrame: Before and 30 mins after drug administration, and after 2 weeks of chronic treatment
Secondary outcomes:
measure: Salbutamol pharmacokinetics
timeFrame: over 30 minutes after drug administration, one day 1 and 14 of a 2 week study period
measure: Spirometry
timeFrame: before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing
measure: potassium
timeFrame: before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Asthma and Allergy Research Group
state: Angus
Study officials:
affiliation: Asthma and Allergy Research Group
name: Karine L Clearie, MBBS, MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Asthma and Allergy Research Group
name: Brian J Lipworth, MBchB
role: STUDY_DIRECTOR
References:
Clinical trial NCT06094582: Knowledges and Use of Cannabidiol in Older Adults
Official title: Knowledges and Use of Cannabidiol in Older Adults Aged 65 Years and Over in France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aging
Frailty
Keywords: older adults
cannabidiol use
frailty
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: older adults

Brief summary: The use of non-medical cannabidiol (CBD) has been growing recently in France and in the world, in young but also older adults. Few data are available on the use of cannabidiol in older adults. A better knowledge of the use of cannabidiol in older adults, and of their own knowledges of the molecule, is necessary to guide and follow the CBD uptake in this population and avoid potential adverse events.

Detailed description: Cannabidiol may be used by patients because it may have beneficial pharmacological effects (including anxiolytic, analgesic, anti-inflammatories or antioxidant effects). Older adults aged 65 years and over, are more frequently at risk of multimorbidity and loss of autonomy, and may present with several symptoms like pain, anxiety, sleep disturbances, that may potentially respond to CBD. The molecule is often marketed as devoid of adverse effects. Nevertheless, with ageing, reduction in liver and kidney function, may have an impact on the metabolism and elimination of CBD and increase the risk of side-effect. As well, the risk of interaction with drugs frequently prescribed in older adults such as CYP3A4 inhibitors (verapamil, ketoconazole ...), CYP3A4 inducers (phenytoin, carbamazepine, ...) or CY92C19 inhibitors or inducers (fluoxetine ...), may increase the risk of side effects. Our hypothesis is that the use of CBD has increased last years in older adults, but that they are insufficiently informed about this molecule. There is a need to assess the prevalence of CBD use in older adults in France, to assess the knowledges of CBD users about this substance, and to better characterize CBD users.

Eligibility criteria: Inclusion Criteria:

* admitted to the frailty clinic, in Toulouse University Hospital during the recruitment period.

Exclusion Criteria:

* major cognitive disorder with Mini Mental State Examination \<20
* being under legal supervision or guardianship.

Primary outcomes:
measure: Prevalence of CBD use (having consumed CBD at least once)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Sandrine SOURDET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00148382: Study of the Blood Levels and Effects of ATL-962 on Fat Excretion in Obese Subjects
Official title: Randomized, Double Blind, Parallel Group, Repeat Dose Pharmacokinetic and Pharmacodynamic Study of Four Doses of ATL-962 (40mg, 80mg, 120mg 240mg) in Otherwise-Healthy Obese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Alizyme
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the amount of metabolites of ATL-962 in the blood and to investigate the effect of ATL-962 on the amount of fat that is excreted in the faeces in subjects who are obese

Detailed description: Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction.

Eligibility criteria: Inclusion Criteria:

* Obese, otherwise-healthy subjects
* Body mass index 30-45kg/m2

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Any drug treatment within 2 weeks of commencement of dosing in this study

Primary outcomes:
measure: Pharmacokinetics of metabolites of ATL-962
Secondary outcomes:
measure: Effect of ATL-962 on faecal fat excretion
measure: Safety and tolerability of ATL-962
Other outcomes:
Locations:
city: Miami
country: United States
facility: SFBCI
state: Florida
Study officials:
affiliation: SFBCI
name: Lawrence Galitz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05003882: Radicle ACES: A Study of Commercially Available CBD Used in the Real-world Setting
Official title: A Randomized, Open-label Study of Commercially Available, Orally Ingestible, Cannabidiol (CBD) Products Used in the Real-world Setting for Pain, Sleep, and Anxiety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Sleep Disturbance
Anxiety
Lead sponsor: Radicle Science
Sponsor class: INDUSTRY
First posted: 2021-08-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults (21 yo and older) living in the USA

Brief summary: A randomized, open-label study of commercially available, orally ingestible, Cannabidiol (CBD) products used in the real-world setting for pain, sleep, and anxiety.

Detailed description: Radicle ACES is a real-world evidence study that aims to determine the effect of CBD on overall well-being, anxiety, sleep, and pain over a 28-day period in treatment groups compared to a waitlist control group.

Eligibility criteria: Inclusion Criteria:

* Participants must be 21 years of age
* Live in the USA
* Endorse symptoms of anxiety, chronic pain, or sleep disturbances as a primary reason for taking a CBD product
* Must have regular access to a computer, mobile device, and/or the internet to complete surveys

Exclusion Criteria:

* A person pregnant, trying to become pregnant or breastfeeding
* Anyone diagnosed with liver disease or considered a heavy drinker
* Anyone taking medication that warns against grapefruit consumption

Primary outcomes:
measure: Greater increase in overall well-being from baseline
timeFrame: 4 weeks
measure: Improvement in overall well-being from baseline
timeFrame: 4 weeks
measure: Change in overall well-being from baseline
timeFrame: 4 weeks
Secondary outcomes:
measure: Improvement in sleep from baseline
timeFrame: 4 weeks
measure: Change in sleep from baseline
timeFrame: 4 weeks
measure: Change in anxiety from baseline
timeFrame: 4 weeks
measure: Less anxiety from baseline
timeFrame: 4 weeks
measure: Decrease in anxiety from baseline
timeFrame: 4 weeks
measure: Less pain relative to baseline
timeFrame: 4 weeks
measure: Change in pain from baseline
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Radicle Science
state: California
Study officials:
affiliation: Radicle Science
name: Kelsey Laird, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03788382: Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer
Official title: Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer: a Real Life Scenario
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Malignant Neoplasm Primary
Keywords: Failure Adjuvant Therapy
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to Pancreatic Resection for Pancreatic Cancer

Brief summary: This study aims to evaluate the rate of patients submitted to pancreatic resection for pancreatic cancer, who fail to access to adjuvant therapy or do not complete adjuvant therapy. The purpose is to give an overview concerning the most frequent conditions and/or reasons associated with failure or omission of adjuvant therapy.

Detailed description: This prospective observational study will evaluate all patients submitted to pancreatic resection for pancreatic cancer.

The rate of omission to adjuvant therapy and rate of failure of completion of adjuvant therapy will be evaluated as primary outcomes. As secondary outcomes, survival analyses will be performed to investigate whether these factors influence prognosis, that will be evaluated through a disease free survival analysis at 18-months. Epidemiological and perioperative data will be analyzed to identify conditions associated with the primary outcomes.

Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of pancreatic cancer

Exclusion Criteria:

* Non exocrine pancreatic tumors
* Periampullary malignancies

Primary outcomes:
measure: Rate of patients who fail to receive adjuvant therapy and reasons for that
timeFrame: 6 months
measure: Rate of patients who fail to complete adjuvant therapy and reasons for that
timeFrame: 9 months
Secondary outcomes:
measure: Disease free survival of patients enrolled
timeFrame: 18 months
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University of Verona Hospital
Study officials:
References: