louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04521647: Effects of Menthol in E-cigarettes on Smoking Behaviors
Official title: Effects of Menthol in E-cigarettes on Smoking Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nicotine Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-08-20
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The overall goal of this proposal is to understand the relationship between nicotine metabolism and menthol flavor in e-cigarettes on smoking behavior in smokers.


Eligibility criteria: Inclusion Criteria:

* At least 21 years of age
* Able to read and write English.
* Smoking at least 1 menthol cigarettes/cigars/little cigars per day
* Report regular menthol cigarette use
* Have at least 200ng/ml urine cotinine
* Willing to abstain from combustible tobacco products 12 hrs prior to each experimental session.
* not planning a smoking quit attempt.
* Have not stopped use due to COVID.
* used e-cigarettes at least 10 times in the past six months.
* Fully vaccinated against COVID-19.
* must report history of JUUL and other nicotine salt/pod devices (i.e., JUUL-like)

Exclusion Criteria:

* Use of psychoactive drugs including anxiolytics, antidepressants, and other psychostimulants unless prescribed and stable for two months.
* Current diagnosis of any severe psychiatric disorder
* Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, pulmonary or hepatic pathology that would increase risk or would interfere with/mimic tobacco abstinence.
* Known hypersensitivity to propylene glycol and nut allergies.
* Pregnant or lactating females.
* current criteria for moderate or severe cannabis and alcohol use disorder per DSM-5 criteria.
* current criteria for other substance use disorders per DSM-5 criteria.
* Seeking treatment to stop smoking.
* individuals who do not want to use e-cigarettes.
* Uncontrolled asthma (defined as \<20 on Asthma Control Test) AND/OR endorsement of "yes" to environmentally induced bronchospasm that requires prescription Epipen)
* blood pressure \>170/\>100 and heart rate \>100
* vaping of CBD/THC or marijuana related products in the past 3 months
* For current THC vapers: Any report of mild or great EVALI-related symptoms (i.e. cough, shortness of breath, chest pain, nausea, vomiting, stomach pain, diarrhea, fever, chills, or weight loss) without non-EVALI reasonable and proximal cause

Primary outcomes:
measure: Plasma nicotine levels
timeFrame: up to 3 weeks
measure: Nicotine Metabolic Rate
timeFrame: up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
References:
Clinical trial NCT02851147: Slit Lamp Model SL-D-301 and DC-4 Digital Camera Attachment
Official title: Slit Lamp Model SL-D-301 and DC-4 Digital Camera Attachment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Images
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2016-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subject population will consist of a maximum number of 30 volunteer subjects consenting to undergo a slit lamp eye exam and to have digital images of their eyes obtained with the DC-4 and the SL-D301.

Brief summary: The purpose of the evaluation is to confirm operability and usability of the SL-D301 Slit Lamp and the DC-4 digital camera attachment by conducting a usability evaluation and subsequently submitting a questionnaire and hold an interview with the operator.

Of special interest for the study is to confirm whether the illumination level of SL-D301 is enough to perform an eye exam since the maximum illumination level on the SL-D301 is lower than other existing Topcon digital ready slit lamps due to regulations that limit the maximum light intensity on the human eye. The SL-D301 will be compared against the predicate device SL-3G.

Detailed description: An eye care professional familiar with the use of slit lamps and experienced with other Topcon and other manufacturer's slit lamps will evaluate operability and usability of SL-D301 and DC-4 digital camera attachment instrument performing routine eye examinations and image capture on volunteer subjects using above mentioned instruments. Similar evaluations will be performed with the SL-3G Slit Lamp and a comparative evaluation will be drawn between the two instruments. At the end of the evaluation, the evaluator will be presented with a questionnaire on specific points regarding the performance and features of the instruments and interviewed. The responses will then be evaluated by Topcon.

Eligibility criteria: Inclusion Criteria:

* Any Willing Subject

Exclusion Criteria:

* Subjects unwilling to participate

Primary outcomes:
measure: Image Comparison of DC-4 to the SL-D301
timeFrame: 1 Hour
Secondary outcomes:
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: Glassman Eye Associates
state: New Jersey
Study officials:
affiliation: Topcon Corporation
name: Ricardo Almiron
role: STUDY_CHAIR
References:
Clinical trial NCT06758947: Use of Selective JAK Inhibitor in ILD and Skin Tightness of Systemic Sclerosis Versus MMF
Official title: Upadacetinib Versus MMF in SSc-ILD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Interstitial Lung Disease Due to Systemic Disease (Disorder)
Keywords: ILD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised double blinded clinical trial
Primary purpose: TREATMENT

Brief summary: Systemic sclerosis (SSc) is a systemic autoimmune disease with heterogeneous clinical presentation and prognosis. JAK inhibitors reduced cutaneous and pulmonary fibrosis in mice models of SSc. Clinical data regarding the efficacy and safety of JAK inhibitors in SSc patients are scarce

Detailed description: Systemic sclerosis (SSc) is a systemic autoimmune disease with heterogeneous clinical presentation and prognosis. JAK inhibitors reduced cutaneous and pulmonary fibrosis in mice models of SSc. Clinical data regarding the efficacy and safety of JAK inhibitors in SSc patients are scarce. Upadacitinib mechanism of action JAK-STAT pathways are composed of four JAK kinases and seven STATs (STAT1-6, including homologs STAT5a and STAT5b). A cytokine binding to its receptor initiates the signaling cascade as well as the subsequent association/rearrangement of the receptor subunits. This rearrangement enables JAK activation by transphosphorylation and, upon activation, JAKs phosphorylate the receptors.

Eligibility criteria: Inclusion Criteria:

* all patients are systemic sclerosis disease duration more than 3 years limited and diffuse types ground glass at HRCT DLCO\< 80% decline in FVC \>10% in last 12months

Exclusion Criteria:

* associated other CT diseases disease duration \< 3 years kidney disease

Primary outcomes:
measure: forced vital capacity
timeFrame: 52 week
Secondary outcomes:
measure: High resolution chest computed tomography
timeFrame: 52 week
measure: modefided Rodnan skin score
timeFrame: 52 week
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Medicinr
state: Alabama
Study officials:
affiliation: Assiut University
name: Manal Hassanien, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06579547: Evaluating Replacement of Standard-of-care Low Dose Computer Tomography (CT) Scans With Radiation-free Bone Imaging by Deep-learning Augmented Zero Echo Time (DL-ZTE) Magnetic Resonance Tomography (MRT)
Official title: Single-center Prospective Comparison of Diagnostic Performance of Deep-learning Agumented UTE/ZTE MRI Sequences and Standard-of-care Low Dose CT for Rheumatologic Patients With Musculoskeletal Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Joint Diseases
Joint Inflammation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to determine how effectively bone structures of the human skeleton can be visualized using Deep Learning (DL) augmented Magnetic Resonance Imaging (MRI) in individuals with inflammatory and degenerative joint changes, compared to Computed Tomography (CT). MRI is a technique that operates without the use of X-rays. The main question it aims to answer is:

1. Can DL MRI accurately depict bone structures as well as CT?
2. Can DL MRI be used as an alternative to CT to avoid exposure to X-rays in the future?

Researchers will compare DL MRI scans to CT scans to see if DL MRI can effectively replace CT in visualizing bone structures without the use of radiation.

Participants will:

1. Undergo MRI scans of their skeletal system that will then be processed using DL.
2. Undergo CT scans of the same body region for comparison purposes.


Eligibility criteria: Inclusion Criteria:

* Referral for a clinically indicated MRI examination of the musculoskeletal system to assess inflammatory and degenerative joint changes.
* Willingness to sign the informed consent form.
* No contraindications for a CT examination (e.g., claustrophobia).

Exclusion Criteria:

* No signed informed consent form.
* Patients under 18 years of age.
* Pregnant women.
* The calculated effective dose of the CT examination exceeds 5 mSv.

Primary outcomes:
measure: Total score for bone erosions
timeFrame: one day (day of MRI and CT examination)
measure: Total score for joint space narrowing
timeFrame: one day (day of MRI and CT examination)
measure: Visibility of cortical bone
timeFrame: one day (day of MRI and CT examination)
measure: Visibility of trabecular bone
timeFrame: one day (day of MRI and CT examination)
measure: Visibility of soft tissue calcifications
timeFrame: one day (day of MRI and CT examination)
measure: Contrast to noise ratio
timeFrame: one day (day of MRI and CT examination)
measure: Signal to noise ratio
timeFrame: one day (day of MRI and CT examination)
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT01623947: Effects of Sustamine(TM) on Cycling Time Trial Performance
Official title: Effects of Sustamine(TM) on Cycling Time Trial Performance Following Prolonged Cycling
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: glutamine
cycling performance
mental function
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Kyowa Hakko Bio Co., Ltd.
First posted: 2012-06-20
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Acute supplementation of Sustamine(TM), a combination of two amino acids, will improve cycling performance and mental acuity in a dose-dependent response.


Eligibility criteria: Inclusion Criteria:

* Competitive cyclist or triathlete
* Male (VO2max \>= 55 ml/kg/min) or Female (VO2max \>= 45 ml/kg/min)
* Healthy
* Blood pressure below 140/90
* Non-smoker

Exclusion Criteria:

* Anti-depressant medications
* Inconsistent regular medications
* Consumption performance-enhancing substances
* Type I or Type II diabetes
* Renal, hepatic or cardiac disease Current infectious disease

Primary outcomes:
measure: Improved Time Trial Performance
timeFrame: After 2.5 hr interval cycling
Secondary outcomes:
measure: Improved Mental Function
timeFrame: After time trial
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: John L. Ivy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02160977: Proprioception of the Knee Post MIS TKA and MIS-QS TKA
Official title: Prospective Randomized Comparative Study on the Proprioception of the Knee Post MIS TKA (Minimally Invasive Surgery Total Knee Arthroplasty) and MIS-QS(Quadriceps Sparing ) TKA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Surgical procedures
Minimally invasive
Arthroplasty
Knee
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 90
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: If the proprioception of the affected knee post total knee arthroplasty (TKA) can recover earlier, it will accelerate the regaining of motion control ability and motion control accuracy of the TKA patients. This study compared the proprioception difference of the post operation knees between the MIS-QS TKA group and the MIS TKA group.The differences of proprioception recovery were analyzed following the two different TKA procedures and the advantages of MIS-QS TKA in the recovery of knee. proprioception were discussed.

Detailed description: Patients were scheduled prospectively to undergo total knee arthroplasties were randomly assigned to receive either a MIS-QS TKA or a MIS TKA. Proprioception of the knee position sense was assessed by the knee angle reproduction test (10\~20 degree, 30\~40 degree, 80\~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation. Paired two-tailed t tests with a level of significance of p \< 0.05 were used to assess the effect of the different arthroplasty procedure on the postoperative knee joint proprioception for all subjects.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of osteoarthritis
* Indication of TKA

Exclusion Criteria:

* Bilateral total knee replacements
* Rheumatoid arthritis
* Genu valgus over than 10 degrees and genu varum over 15 degrees
* ROM (Range of motion) of preoperative knee joint less than 100 degree.

Primary outcomes:
measure: Proprioception of the Knee Post Operation
timeFrame: six months
Secondary outcomes:
measure: HSS(Hospital for Special Surgery) Score of the Knee Joint
timeFrame: 6 months
measure: VAS(Visual Analogue Scale/Score) of the Knee Joint
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing City
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: JIa-Kuo Yu, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00776477: The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atherosclerosis
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2008-10-21
Enrollment: 300
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: Clopidogrel is a antiplatelet agent and is effective at reducing intimal hyperplasia in animal models of thrombosis.Several large clinical trials have demonstrated that clopidogrel with aspirin can reduce ischemic events and mortality in patients with atherosclerotic disease,therefore the combination of two antiplatelets might be useful to prevent patients received coronary artery bypass graft surgery from Saphenous vein graft disease. the aim of this study is to estimate the safety and efficacy of clopidogrel and aspirin therapy versus aspirin alone in patients after CABG.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts, with or without the use of cardiopulmonary bypass.

Exclusion Criteria:

* Emergency surgery
* Valve surgery
* Redo CABG
* Left ventricle ejection fraction \< 30%
* Preoperative use of clopidogrel (with the exception of the current admission)
* Preoperative use of warfarin
* Allergy to aspirin or clopidogrel
* History of cerebrovascular accident
* History of severe liver disease
* Morbid obesity
* Current malignancy

Primary outcomes:
measure: Vein graft patency examined by CT scan
timeFrame: three months after surgery
Secondary outcomes:
measure: Incidence of major adverse coronary events Incidence of major bleeding events
timeFrame: two years following surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of cardiovascular diseases,Fuwai hospital
state: Beijing
Study officials:
References:
citation: Gao G, Zheng Z, Pi Y, Lu B, Lu J, Hu S. Aspirin plus clopidogrel therapy increases early venous graft patency after coronary artery bypass surgery a single-center, randomized, controlled trial. J Am Coll Cardiol. 2010 Nov 9;56(20):1639-43. doi: 10.1016/j.jacc.2010.03.104.
Clinical trial NCT04663477: Development and Validation of the Patient-completed Caprini Risk Score
Official title: Patient-Completed Caprini Risk Score for Venous Thromboembolism Risk Assessment Developed and Validated From 1017 Medical and Surgical Patients: a Diagnostic Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Thromboembolism
Keywords: VTE risk
Caprini
Patient-complete
Validation
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 1017
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators will recruite nearly 500 inpatients from the surgical unit and nearly 500 inpatients from the medical unit between January 1 and December 31, 2019

Brief summary: The investigators aimed to test the reliability and validity of the Chinese version of patient-completed CRS in hospitalized patients and to evaluate whether this form can be widely used in clinical practice instead of only health care workers' evaluation.


Eligibility criteria: Inclusion Criteria:

* patients older than 18 years
* patients with first admission to the medical and surgical units within 24 hours
* willingness to participate in the study

Exclusion Criteria:

* patients with a diagnosis of PTE or DVT on admission
* patients with cognitive impairment
* inability to read or write
* patients with mental diseases
* patients with visual impairment
* refusal to cooperate

Primary outcomes:
measure: Question-to-question agreement between patient-completed and nurse-completed CRS
timeFrame: one year
Secondary outcomes:
measure: Correlation and difference between the scores calculated by patient-completed and nurse-completed CRS
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Frendship hospital
Study officials:
References:
Clinical trial NCT00538577: Outcome and Related Factors of Necrotizing Fasciitis of the Limb
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotizing Fasciitis
Keywords: Necrotizing fasciitis
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Patients with diagnosis of necrotiying faciitis

Brief summary: Soft tissue necrotizing fasciitis of limbs are lethal infections and associated with high morbidity and mortality rates. The purpose of this study is to determine the clinical manifestations and factors affected the treatment outcome to predict the prognosis and make timely decision for appropriate management and prevent limb loss.

Detailed description: Patients that are admitted to hospital with the diagnosis of necrotizing fasciitis of a limb will be entered to this study. A questionnaire will be completed for each patient included demographic data, admission and diagnosis date, treatment onset, medical history for diabetes mellitus, HIV infection, use of immunosuppressor drugs, peripheral vascular disease, cancer, renal disease, intravenous drug abuse, and disease outcome that can be recovery, amputation or death.

Eligibility criteria: Inclusion Criteria:

* Necrotizing fasciitis of the limb

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Operative Theater of Orthopedic Surgery Department- Imam Khomeini Hospital
Study officials:
affiliation: Imam Khomeini Hospital- Tehran University of Medical Sciences
name: Ramin Espandar, MD
role: PRINCIPAL_INVESTIGATOR
References: