louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01587690: Immune Regulation in Multiple Sclerosis: MicroRNA and Antigen-Presenting Cells
Official title: Immune Regulation in Multiple Sclerosis: MicroRNA and Antigen-Presenting Cells
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: human subjects will be enrolled in New Brunswick, NJ

Brief summary: MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in many human diseases. The purpose of this pilot study is to determine if microRNA expression is changed in untreated and interferon-beta-treated patients with multiple sclerosis.

Detailed description: MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in many human diseases. The purpose of this pilot study is to determine if microRNA expression is changed in untreated and interferon-beta-treated patients with multiple sclerosis. The expression of microRNA will be analysed in cell subsets separated from peripheral blood mononuclear cells.

Eligibility criteria: Inclusion Criteria:

* 18-60 year-old healthy subjects or patients with RRMS/CIS

Exclusion Criteria:

1. Any treatment with steroids in the last 30 days prior to the blood draw or any immunosuppressive or Disease-modifying treatment (DMT) other than Glatiramer Acetate in the last 90 days
2. Presence of other disorders that may be associated with immune-deficient or autoimmune process (e.g., HIV, lymphoma, lupus) or demyelinating disease other than MS (e.g., Lyme, B12 deficiency)
3. Pregnancy
4. Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting (Expanded Disability Status Scale (EDSS) score greater than 5.5 )

Primary outcomes:
measure: Relative MicroRNA expression in B cells
timeFrame: one time (baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers-RWJMS
state: New Jersey
Study officials:
affiliation: Rutgers-RWJMS
name: Konstantin Balashov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01729143: Impact of Black Pepper on Energy Expenditure and Substrate Utilization
Official title: A Randomized, Cross-Over Trial to Evaluate the Acute Effects of Black Pepper on Energy Expenditure and Fat Oxidation in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: black pepper
metabolic chamber
respiratory chamber
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Appalachian State University
First posted: 2012-11-20
Enrollment: 18
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: As obesity rates worldwide continue to increase, there is a focus on identifying active food ingredients which increase metabolic rate which can be used as a dietary supplement in the treatment of overweight and obesity. Promising animal and cell studies have suggested a role for black pepper and an active component of black pepper, piperine, in energy expenditure. However, the effects of black pepper have not been determined in humans. The investigators hypothesis if that consumption of 1.5g black pepper (0.5g in each of three meals over one day) will result in an elevation in 24-h resting energy expenditure when contrasted to a control day (no black pepper, same diet intake).


Eligibility criteria: Inclusion Criteria:

* Woman
* Postmenopausal
* Aged 50-65 years
* BMI 25-35kg/m2
* Not taking blood pressure or anti-inflammatory medications or any other medications that may impact the results
* Thyroid hormone profile within the normal reference range
* No medical condition which may impact the results (e.g. diabetes)
* Accustomed to eating regular meals including breakfast

Exclusion Criteria:

* Smoker
* Heavy exerciser (defined as \>150 minutes/week for more than 3 months)
* Abuses alcohol or drugs
* Vegetarian

Primary outcomes:
measure: Energy expenditure and substrate oxidation
timeFrame: 24-hours
Secondary outcomes:
measure: Gut peptides
timeFrame: 30 minutes after lunch
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: UNC Chapel Hill Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill Nutrition Research Institute
name: Andrew G Swick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swick AG, Orena S, O'Connor A. Irisin levels correlate with energy expenditure in a subgroup of humans with energy expenditure greater than predicted by fat free mass. Metabolism. 2013 Aug;62(8):1070-3. doi: 10.1016/j.metabol.2013.02.012. Epub 2013 Apr 8.
Clinical trial NCT06364943: Tear Ferning Test for Dry Eye Diagnosis
Official title: Application of Tear Ferning Test for Clinical Dry Eye Diagnosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye Syndromes
Keywords: Dry Eye diagnosis
Tear ferning
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Application of tear ferning test for clinical dry eye diagnosis

Detailed description: Comparing dry eye patients' tear ferning structure with non-dry eye patients' to develop a protocol for easy and costless diagnosis in ophthalmology.

Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 65 years
* For dry eye disease group:
* Schirmer's test results between 5 - 10 mm
* Tear Film Break Up Time less than 10 seconds
* Ocular Surface Disease Index of more than 25

Exclusion Criteria:

* Those have diabetes, hypertension or other chronic diseases
* No evident ocular diseases such as cornea disease, cataracts, vitreous degeneration, glaucoma, and retinopathy.
* Belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)

Primary outcomes:
measure: Schirmer's test
timeFrame: 5 minutes
measure: Tear film breakup time
timeFrame: 20 seconds
measure: Ocular surface health evaluate
timeFrame: 3 minutes
Secondary outcomes:
measure: Ocular surface disease index
timeFrame: 20 minutes
measure: Intraocular pressure
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Taichung,
country: Taiwan
facility: Jen-Ai Hospital
Study officials:
References:
Clinical trial NCT00611143: Atorvastatin for Prevention of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery
Official title: The Effects of Atorvastatin on the Occurrence of Postoperative Atrial Fibrillation After Off-Pump Coronary Artery Bypass Grafting Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass
Keywords: Off-pump coronary artery bypass graft
Atorvastatin
Postoperative atrial fibrillation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.

Detailed description: Atrial fibrillation after cardiac surgery is the most common arrhythmic complication that may increase incidence of congestive heart failure, renal insufficiency, and stroke, which increase the length of hospital stay, the rates of re-hospitalization, and cost of care. Its pathogenesis is multifactorial, and its prevention and management remain suboptimal. Recently, observational evidence has suggested that patients who have undergone previous statin therapy have a lower incidence of postoperative atrial fibrillation.

The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.

Eligibility criteria: Inclusion Criteria:

* consecutive patients scheduled for the elective off-pump CABG surgery

Exclusion Criteria:

* prior statin use
* previous episodes of atrial fibrillation
* impaired renal function with serum creatinine \>2mg/dL
* serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
* a malignancy or inflammatory disease

Primary outcomes:
measure: the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG
timeFrame: in-hospital period
Secondary outcomes:
measure: major adverse cardiac and cerebrovascular events rate, including cardiovascular death, postoperative stroke, myocardial infarction, or persistent atrial fibrillation,and identification of predictive markers for postoperative atrial fibrillation
timeFrame: 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Cardiac and Vascular Center; Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Young Keun On, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song YB, On YK, Kim JH, Shin DH, Kim JS, Sung J, Lee SH, Kim WS, Lee YT. The effects of atorvastatin on the occurrence of postoperative atrial fibrillation after off-pump coronary artery bypass grafting surgery. Am Heart J. 2008 Aug;156(2):373.e9-16. doi: 10.1016/j.ahj.2008.04.020. Epub 2008 Jun 17.
Clinical trial NCT04797143: Impact of a Multidisciplinary Consultation Program on Drug Adherence in First Oral Anticancer Treatment
Official title: Impact of a Multidisciplinary Consultation Program on Drug Adherence in First Oral Anticancer Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multidisciplinary Consultation Program
Adherence to Oral Anticancer Treatment
Drug Related Toxicity
Securing Medication Management
Keywords: Multidisciplinary consultation program
adherence to oral anticancer treatment
drug related toxicity
securing medication management
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with standard treatment or after implementation of a MCP The MCP was divided into 3 steps: the first step involved a consultation with an oncologist, the second step involved a consultation with an oncology pharmacist, and the third step involved a meeting with a coordinating nurse CN. The CN put in place a regular telephone follow-up with the patient, a few days later (7 to 15 days), to ensure adherence and tolerance of the OAT.

Brief summary: Oncology management has changed dramatically over the last decade with the approval and rapid adoption of newly targeted oral oncology medications. The movement to oral oncology medications has altered the balance of risks and adverse effects (AEs) in the treatment of cancer care. These treatments are associated with a different constellation of AEs and drug interactions. Patients receiving treatment with oral anticancer treatment (OAT) encounter several barriers to adherence, which may include limited access to specialty medications, severe adverse effects, complex medication regimens, and special handling precautions. Medication nonadherence not only reduces the efficacy of drug therapy but also has the potential to increase healthcare expenditures due to disease-related hospitalizations. The purpose of this study is to evaluate the drug adherence in cancer patients, using the medication possession ratio (MPR), before and after the implementation of a multidisciplinary consultation program (MCP), on initiation of OAT.


Eligibility criteria: Inclusion Criteria:

* French speaking patients with a newly diagnosed or relapsed cancer, regardless of location and introduction of oral anticancer treatment

Exclusion Criteria:

* patients treated with hormone therapy only
* Patient with severe psychiatric disorders
* patient who does not speak the French language

Primary outcomes:
measure: medication possession ratio (MPR)
timeFrame: two months
measure: medication possession ratio (MPR)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03470038: Interaction Between NGF and Acute Exercise-induced Ischemia
Official title: The Interaction Between NGF-induced Muscle Sensitivity and Acute Exercise-induced Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hyperalgesia
Pain Response
Healthy Subjects
Keywords: NGF-induced pain
Ischemia-induced pain
Hyperalgesia
NGF pain model
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate pain evoked responses and facilitation of NGF-induced mechanical muscle hyperalgesia over time following an acute exercised-induced ischemic condition in a NGF-sensitized muscle.

Detailed description: Assessing evoked pain responses and muscle hyperalgesia following contractions during acute ischemia in a NGF-sensitized muscle may clarify whether an interaction between NGF sensitization and acidic stimulation exist.

It is hypothesized that acute ischemic exercise with the NGF-sensitized TA muscle, in contrast to ischemic exercise in a non-sensitized would: 1) potentiate pain-evoked responses, and 2) facilitate NGF-induced muscle hyperalgesia.

Eligibility criteria: Inclusion Criteria:

* Healthy and pain free volunteers

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, mental illnesses, or psychiatric diseases.
* Past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage, connective tissue)
* Participation in other pain trials throughout the study period
* Lack of ability to cooperate
* Taking any analgesic 24 hours before the injections
* Performing any strenuous leg exercise through out the study period causing sore muscles

Primary outcomes:
measure: Muscle sensitivity
timeFrame: Change from baseline at 1 week
Secondary outcomes:
measure: Ischemic-induced pain intensity
timeFrame: Assessed right after the dorsiflexions have been performed
measure: Functional muscle pain
timeFrame: Change from baseline at 1 week
measure: Muscle pain diary
timeFrame: Change from baseline at 1 week
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
affiliation: Aalborg University
name: Line Bay Sørensen, Ph.d stud.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorensen LB, Gazerani P, Graven-Nielsen T. Nerve growth factor-induced muscle hyperalgesia facilitates ischaemic contraction-evoked pain. Eur J Pain. 2019 Nov;23(10):1814-1825. doi: 10.1002/ejp.1455. Epub 2019 Aug 5.
Clinical trial NCT00990938: Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
Official title: A Phase 1, Multi-center, Randomized, Double-Blind, Placebo-controlled, Dose-escalation Safety Assessment Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C, Treatment Naïve, Genotype 1 Patients
Lead sponsor: Idera Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 63
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: Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo and RBV arm (3 patients).

Detailed description: This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard ribavirin or placebo plus ribavirin. Each cohort will be randomized 4:1 to receive the investigational treatment arm or placebo and ribavirin. Three varying dose levels of IMO-2125 will be included. In both arms, ribavirin will be dosed based on patient weight.

Approximately 50 patients will be enrolled in France and Russia. Patients will provide informed consent prior to any screening procedures being performed. Screening will occur within 21 days prior to randomization. Enrolled patients who qualify and proceed successfully through the screening period will be randomized to receive 4 weeks of either the investigational treatment arm (IMO-2125 and ribavirin) or placebo and ribavirin, with a 4 week follow-up period.

Patients who are randomized to the investigational treatment arm will receive one of 3 dose levels of IMO 2125 SC once weekly; each patient will receive the same dose throughout the 4 weeks of treatment. In addition to IMO-2125 treatment they will also receive daily ribavirin, which will be given based on the patients weight and will be taken twice daily for a total of 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Documented genotype 1
* HCV-positive with documented detectable plasma viral concentration \> 10,000 IU/mL

Exclusion Criteria:

* Positive test for HIV or HbsAg
* Inadequate bone marrow, liver, and renal function
* Treatment with any IFN-based or other experimental or antiviral therapies - prior or current
* Other significant medical disease
* Concurrent or planned treatment during the study

Primary outcomes:
measure: At Least 1 TEAE
timeFrame: From first dose of study treatment to day 59 (end of study)
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
Study officials:
References:
Clinical trial NCT03089138: Efficacy and Safety of Regan Tangjiang for Treating the Common Cold With Wind-heat Syndrome
Official title: Efficacy and Safety of Regan Tangjiang for Treating the Common Cold With Wind-heat Syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cold
Lead sponsor: Beijing Da-an Bio-technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 120
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: TREATMENT

Brief summary: Efficacy and Safety of Regan Tangjiang for treating the common cold with wind-heat syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study


Eligibility criteria: Inclusion Criteria:

* Diagnosis of common cold according to Western Medicine，with symptoms onset and fever less than 24 hours prior to randomization；
* After the onset of the disease, with the following symptoms: sore throat and axillary temperature between 38.5 and 38.9°C inclusive.
* Diagnosis of wind-heat syndrome according to TCM；
* Aged between 18 to 65 years；
* Willingness to participate and to sign the informed consent form.

Exclusion Criteria:

* Participants with Pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute and chronic sinusitis, pulmonary tuberculosis and other diseases;
* White blood cell count \>11.0×109/L, or neutrophil percentage\>75%;
* Participants with liver function 1.5 times higher than the normal upper limit or serum creatinine higher than the normal upper limit;
* Participants with severe primary diseases of cardiovascular, brain, lung, liver, kidney and hematopoietic system , such as viral hepatitis, hemophilia, diabetes, psychosis and so on;
* Participants who had used other drugs to treat common cold after the onset of the disease, including antivirals, antibiotics and traditional Chinese medicine.
* Women who are pregnant or breast-feeding;
* Allergic condition (refer to history of allergy to two or more drugs or food) or allergy to the drug composition(s);
* Participation in another clinical study of an investigational drug within 3 months
* Participants who are not suitable for the trial decided by the researchers for any reason, such as pregnancy, frequently changes in work or living environments.

Primary outcomes:
measure: Time to fever relief
timeFrame: day 1 to day 3
Secondary outcomes:
measure: Time to fever clearance
timeFrame: day 1 to day 3
measure: Time to symptom disappearance
timeFrame: day 1 to day 3
measure: Disappearance rate of symptoms
timeFrame: day 1 to day 3
measure: Efficacy in TCM symptom and sign scores
timeFrame: day 1 to day 3
measure: Usage of emergency medicines
timeFrame: day 1 to day 3
Other outcomes:
Locations:
Study officials:
References: