louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02453659: Women Engaging in Quitting Smoking Together
Official title: Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-05-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The long-term goal of this program of research is to develop and disseminate an efficacious, group-based distress tolerance treatment for weight concern (DT-W) that will significantly increase smoking cessation rates among women. The objective of this project is to conduct a preliminary randomized controlled trial (RCT) (N = 60) comparing DT-W to a Health Education (HE) comparison intervention, in which both groups also receive standard behavioral smoking cessation treatment (ST) including counseling and transdermal nicotine patch (TNP), and examine potential mechanisms that may underlie the efficacy of DT-W in improving smoking outcomes at 1-, 3-, and 6-month follow-ups.


Eligibility criteria: Inclusion Criteria:

female

* at least 18 years of age
* smoke 5 or more cigarettes per day
* daily smoker for at least the past year
* report motivation to quit smoking in the next month of at least 5 on a 10 point scale
* report concern of at least 50 on at least one of two 100 point scales assessing weight concern
* able to travel to study location for study appointments

Exclusion Criteria:

* current use of other smoking cessation or weight loss therapies
* current use of other tobacco products at least weekly
* diagnosis or treatment for non-nicotine substance use disorder with substance use during the past 6 months
* lifetime diagnosis or treatment of eating disorder, bipolar disorder, schizophrenia, or schizoaffective disorder
* score above established cut-offs on self-report screening measures of depressive symptomology, eating disorder symptomology, alcohol use disorder, or drug use disorder
* current suicidality or homicidality
* medical condition that is a contraindication for the use of transdermal nicotine patch
* lives at same address as current or past participant

Primary outcomes:
measure: Point prevalence abstinence from smoking: percentage of participants in each treatment group who report abstinence from smoking for the 7 days prior to each follow-up assessment
timeFrame: 6 months post-quit date
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References:
citation: Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
Clinical trial NCT00168259: Evaluation of Interferon-gamma Responses to HCMV Infection in HIV Positive Individuals
Official title: Evaluation of Interferon-gamma Responses to HCMV Infection in HIV Positive Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
CMV Infection
Keywords: Treatment Naive
HIV
Lead sponsor: The Alfred
Sponsor class: OTHER
Collaborators: name: Cellestis
First posted: 2005-09-15
Enrollment: 20
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: HIV infected patients with past CMV infection initiating antiretroviral therapy

Brief summary: The study is designed to evaluate interferon responses to CMV in HIV positive individuals and a component will look at interferon responses to CMV in HIV positive individuals over time after commencement of antiretroviral therapy. We will also look at the correlation between CD4 T cell numbers and HLA type with the interferon response.


Eligibility criteria: Inclusion Criteria:

1. HIV positive with history of documented HCV infection
2. Over 18 years old
3. HIV positive
4. Antiretroviral naive, starting on antiretroviral therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Sharon Lewin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00979459: A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)
Official title: A Single Dose Study to Compare the Pharmacokinetics of Two Probe Formulations of MK-1006
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 12
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: This study will assess the pharmacokinetics of two formulations of MK-1006. The primary hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and film coated tablet (FCT) formulations of MK-1006 will be similar.


Eligibility criteria: Inclusion Criteria:

* is a male or a female of non-child bearing potential
* has type 2 diabetes (T2D) and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent(s)
* has been a nonsmoker for at least 6 months

Exclusion Criteria:

* has a history of stroke, chronic seizures, or major neurological disorder
* has a history of major endocrine (except T2D), gastrointestinal, cardiovascular, blood, liver, immune, kidney, respiratory, or genitourinary abnormalities or diseases
* has a history of cancer, except certain skin or cervical cancers or cancer that was successfully treated more than 10 years prior to screening
* has unstable or rapidly progressing diabetic retinopathy and/or neuropathy
* has had an eye infection or other inflammation of the eye in the 2 weeks prior to screening
* has glaucoma or is blind
* has had incisional eye surgery in the last 6 months or laser eye surgery in the last 3 months (Lasik is permitted)
* has a history of type 1 diabetes
* has symptomatic coronary artery disease
* consumes excessive amounts of alcohol and/or caffeine

Primary outcomes:
measure: Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose
measure: Maximum Plasma Concentration (Cmax) for MK-1006
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose
Secondary outcomes:
measure: Number of Participants Who Experienced at Least One Adverse Event
timeFrame: Through 30 days post-dose
measure: Number of Participants Who Discontinued Study Medication Due to an Adverse Event
timeFrame: up to 8 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03637959: Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging
Official title: Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Fibrosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-08-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The Researchers are trying to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.

Detailed description: Utilizing vibrating transducer, receiver and speaker in differing sequences, while collecting ultrasound liver tissue elastography measurements during participant breath holds. Participants fast for a minimum of four hours and are positioned lying on left side with knees slightly bent.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers or patients who are scheduled for clinically indicated liver MRE for fibrosis staging.
* Age 18 to 80.

Exclusion Criteria:

* Subjects lacking capacity to consent
* Subjects with unreliable ultrasound or MRE measurements.
* Pregnant women.

Primary outcomes:
measure: Liver Stiffness Measured by MRE
timeFrame: Baseline, approximately 1 day
measure: Liver Stiffness Measured by Mechanical Vibrations With Ultrasound Shear Wave Imaging
timeFrame: Baseline, approximately 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shigao Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02482259: Assessment of Frailty in Patients With Advanced Hepatocellular Cancers
Official title: Assessment of Frailty in Patients With Advanced Hepatocellular Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Cancer
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 28
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 with Hepatocellular cancer

Brief summary: This study is looking at the feasibility of performing frailty assessments on patients with advanced hepatocellular cancer.

Detailed description: This study is primarily looking to see if it is feasible to assess frailty in patients with advanced hepatocellular cancer. It is also evaluating whether there may be any correlation between these assessments and toxicity of treatment and outcome.

The assessments include: Frailty score, nutritional assessment, comorbidity score and quality of life. In addition sarcopenia will be assessed measuring muscle mass from imaging performed as part of routine clinical care.

The assessments will be performed at baseline on entry into the study, at week 9 and week 18.

There is the option for patients to also donate a blood samples for research purposes.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of hepatocellular cancer not suitable for curative treatment
* Seen by an oncologist or hepatologist for consideration of palliative treatment and a decision regarding management already made
* WHO Performance status 0-2
* Childs Pugh Score A or B
* Written informed consent

Exclusion Criteria:

N/A

-

Primary outcomes:
measure: Percentage patients consenting for assessment out of number of patients approached
timeFrame: baseline
measure: Time taken to complete assessments
timeFrame: Baseline, week 9 and week 18
Secondary outcomes:
measure: Frailty as a predictor of grade 3/4 toxicity
timeFrame: Baseline, week 9 and week 18
measure: Muscle mass and timed get up and go as predictors of outcome
timeFrame: Baseline, week 9 and week 18
Other outcomes:
measure: Quality of Life - EORTC QCQ 30 and HCC18
timeFrame: Baseline, week 9 and week 18
measure: Biomarker assessment of frailty and associated factors
timeFrame: Baseline, week 9 and week 18
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation Trust
Study officials:
affiliation: Newcastle Unversity
name: Elizabeth R Plummer, MD, MRCP, BA, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05242159: Prevalence and Clinical Significance of Anti-annexin A2 Antibodies in COVID-19 Infection
Official title: Prevalence and Clinical Significance of Anti-annexin A2 Antibodies in COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
annexin A2
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients hospitalized in Amiens University Hospital with COVID-19 infection

Brief summary: In January 2020, researchers isolated and sequenced in China from patients with severe atypical pneumonia a novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 has rapidly spread throughout the world. SARS-CoV-2 may trigger hyperstimulation of immune system with an autoinflammatory response but also the development of an autoimmune process. These autoimmune responses may also develop through the molecular mimicry between virus and human-self components. Multiple autoantibodies have been described in COVID-19 patients.

Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator has been identified as a new autoantigen in antiphospholipid syndrome. ANXA2 has been identified as candidate autoantigen recognized by SARS patient sera. ANXA2 contributes also to pulmonary microvascular integrity. These data lead to identify anti-ANXA2 antibodies in COVID-19 patient sera and to know if the presence of these antibodies is associated with pulmonary injury or thrombosis in COVID-19 and represents a marker of severity.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* All patients hospitalized in Amiens University Hospital with COVID-19 infection

Exclusion Criteria:

* Autoimmune diseases
* Chronic viral infection by hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV)
* Immunosuppressive treatment
* Solid tumors
* Hematological malignancies

Primary outcomes:
measure: Prevalence of anti-ANXA2 antibodies in patients with COVID-19 infection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03289559: Effects of Testosterone and Fat Utilization
Official title: Testosterone Effects on Systemic Lipolysis and Whole Body Lipid Utilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Volunteers
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 13
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Evidence is accumulating that there are sex differences in energy and substrate metabolism. The positive or negative consequences of such metabolic differences between men and women need to be evaluated with respect to health outcomes. The importance of aberrant lipid metabolism in metabolic diseases such as obesity, diabetes and cardiovascular disease, makes understanding the distinction between "normal" vs aberrant critical to future treatment and prevention strategies. Sex differences in the effects of catecholamines on lipid metabolism and substrate oxidation in non-obese, healthy individuals, have been consistently observed. In addition, distinct differences in men and women exist in the distribution of body fat, with men typically having greater central adiposity than women. Accumulation of fat in the abdomen is associated with an increased risk for metabolic abnormalities such as hyperlipidemia and insulin resistance. In the current study, therefore, the role of testosterone in determining the sex differences in catecholamine mediated substrate metabolism and deposition of dietary fat into upper versus lower body adipose tissue depots will be addressed.


Eligibility criteria: Inclusion Criteria:

* normal weight (BMI of 23-29.9 kg/m2)
* not be highly trained (\< 5hrs of moderate intensity, planned exercise per week).

Exclusion Criteria:

* Patients will be excluded if they have one or more of the following out-of-range values measured on a fasting blood sample:
* glucose \<65 or \> 110 mg/dl,
* insulin \> 20 uU/ml,
* thyroid stimulating hormone \<0.5 or \>5.0 uU/ml,
* growth hormone \>2.5 ng/ml.
* Subjects who may be:
* anemic (hemoglobin \< 14.5 g/dl men ),
* have abnormal liver function tests:

  * alanine amino transferase \> 47 U/l,
  * aspartate aminotransferase, \> 47 U/l,
  * alkaline phosphatase \<39 or \>117 U/l) or
  * creatinine (\<0.6 or \>1.1 mg/dl).

Primary outcomes:
measure: Dietary fat tracer for storage of meal derived fatty acids
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Daniel Bessesen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rynders CA, Schmidt SL, Bergouignan A, Horton TJ, Bessesen DH. Effects of short-term sex steroid suppression on dietary fat storage patterns in healthy males. Physiol Rep. 2018 Jan;6(2):e13533. doi: 10.14814/phy2.13533.
Clinical trial NCT04628559: Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
Official title: Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Intravenous Anesthetic Toxicity
Keywords: Dexmedetomidine
Ketamine
Perioperative effects
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. First arm received dexmedetomidine
2. Second arm received ketamine
3. Third arm received saline solution.
Primary purpose: TREATMENT

Brief summary: This randomized double-blind study aimed to compare the effects of dexmedetomidine and ketamine on hemodynamic parameters, recovery criteria, and opioid consumption and advers effects in septorhinoplasty operations. Totally 63 patients were included.

The groups were compared in terms of hemodynamic values, recovery times, postoperative agitation, sedation, activity, modified Aldrete and pain scores, side-effects and additional analgesia requirements at postoperative 24h.

Detailed description: A total of 63 patients 18-55 years undergoing septorhinoplasty, who were graded as American Society of Anesthesiologists physical status were randomly allocated into three groups, receiving dexmedetomidine (n=21, Group D), ketamine (n=21, Group K) and saline solution (n=21, Group S). Anesthesia was induced with propofol, cisatracurium and fentanyl. Maintenance anesthesia was done with 2-2.5% sevoflurane mixture, 50-60% oxygen and N2O. The groups were compared in terms of hemodynamic values, recovery times, postoperative agitation, sedation, activity, modified Aldrete and pain scores, side-effects and additional analgesia requirements at postoperative 24h.

Eligibility criteria: Inclusion Criteria:

* Patient graded as American Society of Anesthesiologist (ASA) physical status, I or II
* Patient subjected to septorhineoplasty operation

Exclusion Criteria:

* Patient having morbid obesity,
* Patient having yypertension,
* Patient having Asthma,
* Patient having neuropsychiatric disease,
* Patient allergy to the study drugs.

Primary outcomes:
measure: Response to verbal stimulus time
timeFrame: 0-120 minutes following finishing operation
measure: Intraoperative additional fentanyl requirement
timeFrame: 0-120 minutes following initiating operation
Secondary outcomes:
measure: Heart rate
timeFrame: 0-120 minutes
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Medical School of Karadeniz Technical University, Department of Anesthesiology
Study officials:
affiliation: Medical School of Karadeniz Technical University, Department of Anesthesiology
name: Muge Muge, Assoc Prof
role: STUDY_CHAIR
References:
Clinical trial NCT00727259: Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067)
Official title: Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 1995
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol at sites in France.

Brief summary: The current gold standard for treatment of chronic hepatitis C (CHC) patients is with pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegPen. The goal of this study is to determine the satisfaction grade with this novel device.

Detailed description: Enrollment of patients will occur in a sequential order of treatment initiation.

Eligibility criteria: Inclusion Criteria:

* Adult patients with hepatitis C

Exclusion Criteria:

* According to the products' labeling.

Primary outcomes:
measure: Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months
timeFrame: The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Clinical Director
role: STUDY_DIRECTOR
References: