louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05572281: Bioequivalence Study Between Tasimelteon Capsule Formulation and Liquid Suspension Formulation in Healthy Volunteers
Official title: An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of Tasimelteon Capsule Formulation Relative to Tasimelteon Liquid Suspension Formulation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-10-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female participants between 18 to 55 years (inclusive).
* Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.
* Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.

Exclusion Criteria:

* Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded.
* Participants with history of smoking or use of tobacco products in the last 3 months.
* Pregnant or nursing (lactating) women.

Primary outcomes:
measure: Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation
timeFrame: 8 hours
measure: Assessment of Safety and Tolerability of the liquid suspension and capsule formulation of tasimelteon
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Vanda Investigational Site
state: Missouri
Study officials:
References:
Clinical trial NCT00744081: Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)
Official title: Open-label Multicenter Trial of Glivec® (Imatinib Mesylate, Formerly Known as STI571) in Combination With Chemotherapy (MTC) in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: AML
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2008-08-29
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.


Eligibility criteria: Inclusion Criteria:

* Refractory AML after primary therapy
* First relapse after a safe previous diagnosis of de novo or secondary AML
* Age \> 18 years
* Serum bilirubin \< 2.0 mg/dl
* Serum creatinine \< 1.5 times the normal value or a creatinine clearance \> 60 ml/min
* ECG and heart echography prior to start of therapy without severe findings
* Overall condition \< 2 according to ECOG criteria
* Life expectancy \> 6 weeks
* Written informed consent by patients with full legal capacity

Exclusion Criteria:

* Serious secondary disease (clinically relevant cardiac disease, chronic- obstructive pulmonary disease, hepatic dysfunction, renal insufficiency)
* Active secondary neoplasia (exception: adequately treated basalioma or epidermoid cancer and cervical carcinoma)
* Known hypersensitivity to topoisomerase-I inhibitors
* Overall condition \> 2 according to ECOG criteria
* Pregnant/breast feeding women
* Serious intercurrent infections

Primary outcomes:
measure: To show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University of Frankfurt, Medical Dept. II
Study officials:
affiliation: University Hospital of Frankfurt, Medical Dept. II
name: Lothar Bergmann, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04468581: Characteristics of TraceTogether Users
Official title: Characteristics of TraceTogether Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
Keywords: Contact tracing
TraceTogether
COVID-19
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 505
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Representative sample of the Singapore population

Brief summary: In this protocol, we seek the understand the demographics of individuals who have used the TraceTogether mobile application. Little is known about the group of individuals who are more likely to utilise the application. Hence, this study hopes to: (1) Understand the demographics of Singaporeans who use and do not use TraceTogether, (2) Identify other behavioural habits of people who do use TraceTogether, (3) Determine if confidence in government would have any effect on TraceTogether usage


Eligibility criteria: Inclusion Criteria:

* At least 21 years
* Has stayed in Singapore for at least 2 years

Exclusion Criteria:

* Below 21 years
* Has stayed in Singapore for less than 2 years

Primary outcomes:
measure: Demographic information
timeFrame: Once during initial enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale NUS
Study officials:
References:
citation: Saw YE, Tan EY, Liu JS, Liu JC. Predicting Public Uptake of Digital Contact Tracing During the COVID-19 Pandemic: Results From a Nationwide Survey in Singapore. J Med Internet Res. 2021 Feb 3;23(2):e24730. doi: 10.2196/24730.
Clinical trial NCT06467981: Study of the Indications for Amyloid Positon Emission Tomography (PET) Scans and Their Usefulness for Patients With Suspected Alzheimer's Disease (AD)
Official title: Study of the Indications for Amyloid PET Scans and Their Usefulness in the Management of Patients With Suspected Alzheimer's Disease (AD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who had a flutemetamol amyloid PET scan with a PET request form including the indications for the examination and who received the information letter on the objectives of the research and who did not object to the use of their data.

Brief summary: The recent clinical authorization of amyloid Positon Emission Tomography (PET) in France represents a crucial step for the nuclear medicine community involved in the diagnosis of Alzheimer's disease (AD).

Detailed description: The recent clinical authorization of amyloid Positon Emission Tomography (PET) in France represents a crucial step for the nuclear medicine community involved in the diagnosis of Alzheimer's disease (AD). At the era of Amyloid, Tau, Neurodegeneration (ATN) biomarkers, amyloid PET fills a need in patients with an atypical or mixed clinical presentation, in particular young patients (\< 65 years old), when the lumbar puncture is contraindicated or not feasible for technical reasons. Importantly, a negative amyloid PET scan discards the diagnosis of AD. Furthermore, early phase imaging of amyloid PET allows to estimate the perfusion neuronal state, increasing the diagnostic value of such PET radiotracer. Its role could be further developed in routine care for the selection and monitoring of promising disease modifiers therapies.

Eligibility criteria: Inclusion Criteria:

* Patients aged = or \> 18 years
* Patients who have had an amyloid PET scan with a PET request form including the indications for the examination
* Patient informed via a newsletter and non-opposition to the use of their data for research purposes (research objectives clearly explained in the letters)

Exclusion Criteria:

* Patient opposition to the use of their data for this research

Primary outcomes:
measure: Evaluate the indications for Amyloid PET in 7 centers in France to assess the relevance of the examination
timeFrame: 1 day
Secondary outcomes:
measure: Evaluate the frequency of positive examinations for the diagnosis of AD
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre/les/Nancy
country: France
facility: Nuclear medicine department
Study officials:
References:
Clinical trial NCT01758081: Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18 (VITAL Infection)
Official title: Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infections
Human Cathelicidin Antimicrobial Peptide (hCAP-18)
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 25874
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids affect risk of infection and plasma hCAP18 levels.


Eligibility criteria: Participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Please see NCT 01169259 for lists of inclusion and exclusion criteria.

Primary outcomes:
measure: upper respiratory infection
timeFrame: one year
measure: hCAP-18
timeFrame: one year
Secondary outcomes:
measure: lower respiratory infection
timeFrame: 5 years
measure: urinary tract infection
timeFrame: 5 years
measure: cellulitis
timeFrame: 5 years
measure: antimicrobial-treated infection
timeFrame: 5 years
measure: infection-related hospitalizations
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. Contemp Clin Trials. 2012 Jan;33(1):159-71. doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2.
citation: Bassuk SS, Manson JE, Lee IM, Cook NR, Christen WG, Bubes VY, Gordon DS, Copeland T, Friedenberg G, D'Agostino DM, Ridge CY, MacFadyen JG, Kalan K, Buring JE. Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL). Contemp Clin Trials. 2016 Mar;47:235-43. doi: 10.1016/j.cct.2015.12.022. Epub 2016 Jan 6.
Clinical trial NCT01950481: Effect of Hepatic Impairment on LDK378 Pharmacokinetics
Official title: A Phase I, Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of LDK378 in Subjects With Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Normal Hepatic Function
Impaired Hepatic Function
Keywords: LDK378
pharmacokinetics
hepatic impairment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-09-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired hepatic function and healthy subjects with normal hepatic function.


Eligibility criteria: Inclusion Criteria (all groups):

* Male Subjects between 18-70 years of age
* Female subjects between 18-70 years of age who are postmenopausal or sterile
* Body Mass Index (BMI) of 18.0- 36.0 kg/m2, with body weight ≥ 50 kg.

Inclusion (group mild, moderate and severe hepatic impairment):

- Subjects with confirmed cirrhosis

Exclusion Criteria (all groups):

* impaired cardiac function
* concurrent severe and/or uncontrolled medical conditions

Exclusion Criteria (moderate, mild and severe groups):

* Clinical evidence of severe ascites
* Use of PPIs within 10 days prior to 2 days after LDK378 dosing

Primary outcomes:
measure: LDK378 pharmacokinetic parameters (Tmax)
timeFrame: 18 Days
measure: LDK378 pharmacokinetic parameters ( Cmax)
timeFrame: 18 Days
measure: LDK378 pharmacokinetic parameters ( AUClast)
timeFrame: 18 Days
measure: LDK378 pharmacokinetic parameters (AUCinf)
timeFrame: 18 Days
measure: LDK378 pharmacokinetic parameters (T1/2)
timeFrame: 18 Days
measure: LDK378 pharmacokinetic parameters (CL/F)
timeFrame: 18 Days
measure: LDK378 pharmacokinetic parameters (Vz/F)
timeFrame: 18 Days
Secondary outcomes:
measure: Number of subjects with Adverse events
timeFrame: after informed consent is signed, 30 days after last dose
measure: Plasma protein binding of LDK378
timeFrame: Day 1 predose, Day 1 6 hours postdose
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: DaVita Clinical Research-Denver
state: Colorado
city: DeLand
country: United States
facility: Avail. Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Clinical Research of Miami, INC CLDK378A2110
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06509581: Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelation Regimen
Official title: Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta-Thalassemia
Keywords: thalasssemia
vitamin E
Oxidative stress
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: repeated transfusions are the mainstay of disease management in most patients with transfusion dependent beta thalassemia.iron overload predispose to oxidative stress and tissue injury.

oxidative stress play important role in pathogenesis of anemia in beta thalassemia.

vitamin E is often depleted in thalassemia patients.

Detailed description: oxidative stress status is very important in thalassemic patients and explains the different manifestations in thalassemic patients.

vitamin E is fat soluble vitamin shown to reduce the oxidative stress in thalassemia and to reduce lipid peroxidation of red cell membranes.

therefore, this study shows the safety of oral vitamin E as adjuvant therapy to three iron chelators : desferoxamine,deferiprone and deferasirox in moderately iron overloaded children and adolescents with transfusion dependent beta thalassemia and its relation to iron overload over one year.

Eligibility criteria: Inclusion Criteria:

* Beta thalassemia patients on regular packed red blood cells transfusion,with vitamin E deficiency
* serum ferritin 1000-2500 ug/l
* cardiacT2\*\>10ms and ejection fraction \>55%

Exclusion Criteria:

* Diabetes,active hepatitis(serum transaminases \>2 times ULN)
* renal impairment (serum creatinine\>2times ULN)
* participation in previous investigational drug study with 3 months preceding screening supplementation with antioxidants or vitamins within 3 months prior to the study and patients with known allergy to vitamin

Primary outcomes:
measure: effect of vitamin E on Liver iron concentration (LIC)
timeFrame: 12 months
Secondary outcomes:
measure: effect of vitamin E on antioxidants enzymes
timeFrame: 12 months
measure: effect of vit E supplementation on SF
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbasia
Study officials:
References:
citation: Fibach E, Rachmilewitz EA. The role of antioxidants and iron chelators in the treatment of oxidative stress in thalassemia. Ann N Y Acad Sci. 2010 Aug;1202:10-6. doi: 10.1111/j.1749-6632.2010.05577.x.
Clinical trial NCT05697081: Oral Symptoms of COVID-19 Among Infected Medical Doctors
Official title: Oral Manifestations of COVID-19 Correlated to Medical History. A Survey on Infected Medical Doctors.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Respiratory Infection
Keywords: COVID-19
Dysgeusia
Xerostomia
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 312
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: any medical doctors infected with COVID-19

Brief summary: Oral symptoms of corona virus disease have been reported by many studies. The lack of direct contact between the dentist and the patient during the active disease presented an obstacle to build a strong body of evidence.

the aim of the study is to report the oral symptoms of COVID-19 and correlate the occurrence of these symptoms with various disease-related factors.

Detailed description: This is a cross-sectional web-based survey targeted Medical doctors infected with COVID-19. The survey questioned the diagnosis of the disease, the severity of the disease, the general symptoms, the oral symptoms along with drug and medical history.

The survey comprised a total of 3 main sections. The first section included demographic data and diagnostic method for COVID-19 infection. The second section included question about duration of the disease, the general manifestations of the disease, the previous medical history. History of smoking, severity of COVID-19 infection and history of hospitalization. Drug history and treatments for COVID-19. Presence of blood discrepancies during COVID-19 infection. The third section targeted detailed oral manifestations of the disease and questions about the oral hygiene and presence of previous oral lesions.

The questions about oral manifestations were designed based on a systematic search through the current literature, dated between 2019 and January 2021.

Eligibility criteria: Inclusion Criteria:

* COVID-19 infection
* Medical doctors

Exclusion Criteria:

* none

Primary outcomes:
measure: Occurrence of oral symptoms
timeFrame: 14 days of infection
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Banī Suwayf University
Study officials:
affiliation: Lecturer
name: Eman Magdy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06575010: Exparel v Dexamethasone in RCR
Official title: Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Rotator Cuff Tears
Postoperative Pain
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with their experience and are better able to participate in rehabilitation exercises during their stay in the hospital. As surgeons and health care systems in the United States find themselves in the middle of an opioid epidemic, it is necessary to discover different options to provide patients pain relief that are both effective and safe in an effort to decrease the amount of pain medication used.


Eligibility criteria: Inclusion Criteria:

* Participants having a primary rotator cuff repair
* Age 18 and older
* English speaking
* Ability to complete surveys by phone or in person
* Ability to provide informed consent

Exclusion Criteria:

* Revision rotator cuff repair (RCR) cases
* Participants having an open RCR
* Allergies and/or medical contra-indications to study medications
* Non-English speakers
* Participants who are pregnant, plan to become pregnant and do not utilize adequate contraceptive means, or are currently breastfeeding (all patients who have the potential to be pregnant are administered a urine beta-HCG pregnancy test, with suspected false-positive or equivocal urine pregnancy tests followed by a more specific serum pregnancy test)
* Rotator cuff repair needing Graft Augmentation
* Known alcohol or narcotic abuse history
* Existing contract with a pain specialist due to underlying preoperative pain syndrome
* Preoperative opioid use within the 3 months prior to surgery

Primary outcomes:
measure: Postoperative narcotic medication use
timeFrame: 14 days
measure: Postoperative pain levels
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References: