cyrilzakka/clinical-trials huggingface dataset:
Changing Physical Activity Behavior in Individuals With Type 2 Diabetes Using Counceling and Information From Continuous Glucose Monitoring

The purpose of this study was to develop a nurse counseling intervention to increase physical activity behavior in people with type 2 diabetes and to improve their health

Diabetes affects 20.8 million Americans and is the fifth leading cause of death in the United States. Although physical activity is a cornerstone in the treatment of diabetes, it is difficult to change physical activity behaviors and up to 60% of individuals with diabetes do not participate in regular physical activity. The use of a nurse counseling intervention based on established behavior change theory with technology-derived graphical representations of glucose information created a unique opportunity to test the feasibility of motivating people with type 2 diabetes to change physical activity behaviors. The consent form described the study protocol, participant expectations, benefits, risks, and the process of maintaining participant confidentiality.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus
* Three month blood sugar test (HbA1c) \> 7.5%
* Not receiving insulin to manage diabetes
* Not engaged in a physical activity program more than 2 days per week
* Able to read and speak English

Exclusion Criteria:

* Not able to walk ¼ mile in 10 minutes
* Taking glucocoricoids
* Serious health problems, such as heart problems, found on examination.
REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)

The trial is conducted in the United Kingdom (UK), Australia, Canada, Denmark and the Netherlands. The aim is to test whether 3 years treatment with metformin added to titrated insulin therapy (towards target HbA1c 7.0%/53 mmol/mol) reduces atherosclerosis, as measured by progression of carotid intima-media thickness (cIMT), in adults with confirmed type 1 diabetes aged 40 years and over at increased risk for cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes for five years or more\*
* Age 40 years or above
* 7.0 =\< HbA1c \<10.0% (53 - 86 mmol/mol)

AND 3 or more of the following ten CardioVascular Disease (CVD) risk factors:

* BMI \>27 kg/m\^2
* Current HbA1c \>8.0% (64 mmol/mol)
* Known CVD/peripheral vascular disease
* Current smoker
* Estimated glomerular filtration rate (eGFR) \<90 ml/min per 1.73 m\^3
* Confirmed micro- or macroalbuminuria \[according to local assays and reference ranges\]
* Hypertension (BP \>=140/90 millimeters of mercury (mmHg) or established on antihypertensive treatment)
* Dyslipidaemia \[total cholesterol \>=5.0 mmol/L (200 mg/dL);OR HDL cholesterol \<1.20 mmol/L (46mg/dL) \[MEN\]; OR \<1.30 mmol/L (50 mg/dL) \[WOMEN\]; or triglycerides \>=1.7 mmol/L (150mg/dL); or established on lipid-lowering treatment)\]
* Strong family history of CVD (at least one parent, biological aunt/ uncle, or sibling with myocardial infarction or stroke aged \<60 years)
* Duration of diabetes \> 20 years

Exclusion Criteria:

* eGFR \< 45 ml/min/1.73m2
* woman of childbearing age not on effective contraception
* Pregnancy and/or lactation
* Acute coronary syndrome or Stroke/Transient Ischaemic Attack within the last three months
* NYHA stage 3 or 4 heart failure
* Significant hypoglycaemia unawareness
* Impaired cognitive function/ unable to give informed consent
* Previous carotid surgery/ inability to capture adequate carotid images
* Estimated glomerular filtration \< 45ml/min/1.73m\^2 (MDRD)
* Gastroparesis
* History of lactic acidosis
* Other contraindications to metformin (hepatic impairment, known hypersensitivity to metformin, acute illness such as dehydration, severe infection, shock, acute cardiac failure or suspected tissue hypoxia)
* Any coexistent life threatening condition including prior diagnosis of cancer within two years
* History of alcohol problem or drug abuse
Non-interventional Retrospective Multicenter Study of Patients With Bronchial Asthma During a Routine Visit to Out of Patients' Clinics

To assess asthma control in Russian patients according to the new criteria provided in the international guidelines and identify pharmacological approaches that provide a higher level of overall asthma control


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients over 18 years of age
* Patients with asthma diagnosed in accordance with the Global Initiative for Asthma (GINA \[xv\]) within 6 months before inclusion into the study. Patients with no changes in their treatment within 2 months before inclusion into the study
* Patients who signed their informed consents to collection and further processing of data on their disease course

Exclusion Criteria:

* Asthma patients with an exacerbation at the moment of inclusion.
* Patients on β-blockers.
* Patients with COPD, mucoviscidosis or bronchiectasis, Severe heart failure (NYHA functional class III-IV), Renal insufficiency, Cancer, Previous stroke.
* Pregnant women.
* Patients following a major surgery, Hepatic insufficiency.
Bryostatin 1 in Treating Patients With Myelodysplastic Syndrome

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with myelodysplastic syndrome.

OBJECTIVES: I. Determine the response rate of bryostatin 1 in patients with myelodysplastic syndrome. II. Determine the qualitative and quantitative toxic effects of bryostatin 1. III. Determine the duration of response and survival of patients receiving this therapy.

OUTLINE: This is a two stage study. Patients receive bryostatin 1 by continuous infusion over 72 hours every 14 days for 4 cycles. Responding patients may continue treatment in the absence of disease progression or unacceptable toxicity. Patients with complete response receive 2 additional cycles. Patients with no response receive 4 additional cycles. Patients are re-evaluated after every 4 cycles.

PROJECTED ACCRUAL: 14 to 27 patients will be accrued within 2 years into this 2 stage study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically diagnosed refractory anemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, refractory anemia with ringed sideroblasts, or chronic myelomonocytic leukemia with significant cytopenias of at least 4 weeks duration No more than 1 prior treatment for disease Not eligible for allogeneic bone marrow transplantation if less than 60 years of age

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hematocrit less than 26% (or requiring transfusion) for at least 4 weeks Absolute neutrophil count less than 1000/mm3 for at least 4 weeks Platelet count less than 50/mm3 for at least 4 weeks Hepatic: Bilirubin less than 1.5 mg/dL Transaminase less than 2.5 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL Creatinine clearance of at least 60 mL/min Other: Not pregnant or lactating Fertile patients must use effective contraception while on study and for 100 days afterwards No uncontrolled or life-threatening infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent treatment with growth factors Chemotherapy: At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosourea) and recovered Endocrine therapy: No concurrent use of steroids Radiotherapy: At least 4 weeks since prior radiation therapy and recovered Surgery: Not specified
Ultrasound Guided Arthrocentesis

Does ultrasound guidance improve success rate and decrease aspiration attempts for peripheral arthrocentesis?


Eligibility Criteria:
Inclusion Criteria:

* Age at or over 18
* Indication for peripheral arthrocentesis

Exclusion Criteria:

* Hemodynamic instability
* Previous arthroplasty of the joint
* Known intraarticular fracture
* Hip arthrocentesis
Laser Versus Silver Diamine Fluoride in Hall Technique in Primary Teeth

The hall technique for primary teeth depends on the idea of isolation of the carious non exposed primary tooth from all bacteria present in the oral cavity by using a stainless-steel crown which result in arresting of the caries and preventing its progress to the pulp. Recently laser and Silver Diamide Fluoride (SDF) have been used to arrest the progress of caries so in the current study we will compare the success rate of hall technique with either laser or SDF in arresting of caries

The high frequency of caries in primary teeth and its inadequate treatment are major public health problems during childhood. Nowadays, the Hall technique is one of the methods used for biological sealing in carious lesions in primary molars. Thus, the bacteria will be sealed from oral environment and the caries will be inactive. Using the Hall technique, the crown is placed without local anesthesia, caries removal, or tooth preparation. Then, the crown is fitted over the carious primary molar by either the dentist's finger pressure, or the child's biting force. The average results of many clinical trials showed that the success rates of the Hall technique were greater than the conventional restorations. However, some criteria of minor failures were seen in 26.6% of Hall crowns. Silver diamine fluoride (SDF), a clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a promising therapeutic agent for managing caries lesions in young children, its effectiveness in reducing specific cariogenic bacteria and its remineralizing potential on enamel and dentin have been reported in many studies. Recently, lasers have been proven to significantly arrest the dental caries by increasing the acid resistance of the enamel with an antibacterial effect. Diode lasers with several positive aspects, such as the small size, low cost, and ease of use in the oral cavity, were found to have a caries prevention and arrest effect on the dental enamel, particularly deciduous teeth. In the current study the success rate of Hall technique using SDF will be compared to the same technique using Diode laser in arresting the carious lesions in primary teeth.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be medically free
* Presence of asymptomatic enamel and dentin caries in one or more primary molars, which can be detected clinically and radiographically
* Periapical radiograph should show caries involving the outer half of the dentin
* There should be no signs or symptoms of pulpal pathosis

Exclusion Criteria:

* Immunocompromised patients
* Presence of any signs or symptoms of pulpal pathosis denoting irreversible pulpitis
* Parents who are not willing to come in the follow up visits
Effects of Intranasal Oxytocin and Vasopressin on Social Behavior and Decision Making

The purpose of this study is to investigate the role of a one-time intranasal administration of the oxytocin, vasopressin, or placebo on prosocial decision making such as cooperation and competition in a healthy population of student controls.


Eligibility Criteria:
Inclusion Criteria:

• healthy controls

Exclusion Criteria:

* Past or present psychiatric, neurological, endocrinological or severe chronic medical illness.
* Use of medications or drugs that would interfere with study results. This includes steroids, medications for psychiatric symptoms like anxiety or depression, stimulants, and medications for high blood pressure. Participants will be asked to tell the investigators of any medications or drugs that they are taking. The investigators will consider the drug interactions with oxytocin and vasopressin prior to study, and participants will not be able to participate in the study if the drug interactions could be dangerous.
* history of drug or alcohol addiction
* Pregnancy or Nursing Status: Because of the risk to an unborn fetus or infant, women who are pregnant or nursing are excluded from this protocol. All females will have a pregnancy test performed no more than 24 hours before each drug administration and will not be able to participate if the pregnancy test is positive.
Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

The purpose of this study is to determine whether melatonin is effective in the treatment of relapsing-remitting multiple sclerosis patients as a supplement to the main disease-modifying drugs.

Multiple sclerosis is an autoimmune chronic demyelinating disorder of the central nervous system, and the major cause of disability in the youngsters all over the world, still with no definitely known etiology and treatment. Melatonin is a hormone secreted by pineal gland famous for its role in circadian rhythm regulation, and with known antioxidant effects. It was shown that melatonin is lower in multiple sclerosis patients in the relapse phase in comparison to other diseases and is correlated with the Multiple Sclerosis Functional Composite score of the patients. Melatonin is also suggested to have an immunomodulatory role. Therefore, we hypothesize that melatonin can be effective in the treatment of relapsing-remitting multiple sclerosis patients.

Eligibility Criteria:
Inclusion Criteria:

* definite diagnosis of relapsing-remitting multiple sclerosis
* EDSS \<=5
* at least 6months consumption of interferon beta 1a

Exclusion Criteria:

* illiteracy
* evidence of Nystagmus or visual acuity lower than 5/10 in each of the eyes
* relapse in the last 3 months
* pregnancy or deciding to become pregnant during the following year
* regulatory consumption of warfarin, nifedipine, nonsteroidal anti-inflammatory drugs (NSAIDs), beta-blockers, fluvoxamine, isoniazide, progestin
* history of epilepsy, stroke, major depression, endocrine, hepatic, hematologic, and nephrologic diseases
Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography

The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:

1. To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) /MRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure
2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and
3. To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction.

Eligible patients will be adults (≥18 years old) with Stage II-III or oligo-metastatic stage IV malignancy (any histology) at high risk for RT-associated cardiac toxicity (defined as receiving ≥30 Gy (Gray) RT where the heart is in the treatment field54). The study will enroll a total of 10 subjects, recruited from Cedars-Sinai Medical Center. The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points. Blood will be collected at baseline, end of RT, and 6-months post-RT.


Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years.
* Have clinical stage II-III or oligo-metastatic stage IV malignancy (any histology) planned to be treated with thoracic radiotherapy (≥30 Gy) where the heart is in the treatment field.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
* Planning to receive standard of care radiotherapy treatment.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
* Ability to read, write, and understand English

Exclusion Criteria

* Estimated glomerular filtration rate (eGFR) \<45 mL/min/m2 or serum creatinine ≥1.5 mg/dL.
* Patients with a known or previous allergy to iodinated contrast, gadolinium contrast, and/or 18F-NaF tracer.
* Inability to receive PET tracer.
* Inability to receive MRI, requiring sedation for MRI, or prohibitive implant and/or device, including ferromagnetic implants and ferromagnetic foreign bodies.
* Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.
* Subjects that are pregnant or breastfeeding.
* Subjects unable to comply with visit instructions, including inability to lie still, hold breathe, or follow procedure instructions.
* Allergy to animal dander or animal-instigated asthma.
* Any other condition which, in the opinion of the investigator, may make the patient a poor candidate for participation in a clinical trial
Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites

Various management options for free flap donor sites that require split thickness skin grafting exist. None has proven superior from both a patient care and a cost standpoint. Major complications occurring at these surgical sites include wound breakdown, tendon exposure, and loss of function. We seek to investigate the use of the PICO single-use negative pressure wound therapy device in these surgical sites and determine if it can yield superior results to simpler methods.

Many studies have addressed the use of negative pressure wound therapy (NPWT) in free flap donor sites with mixed results. It is well established that NPWT is safe and causes no harm, and no delay in healing. A previous study performed at UAB showed that NPWT in complex Head \& Neck Surgery reconstruction is safe, including free flap donor sites. There have been studies that state the rate of tendon exposure is lower with NPWT in free flap donor sites, and studies that conclude there is no difference in complication rates. Current clinical practice is varied, often within a single institution.

While no studies of NPWT in free flap donor sites have noted inferior results with its use, a primary reason cited for not using it is cost. Traditional NPWT using canister-based vacuum devices adds significant cost. The PICO single-use NPWT device (Smith \& Nephew) is a relatively inexpensive, low-profile dressing that does not require attachment to an external canister. It is battery-powered and disposable. Empiric use on our patients undergoing split-thickness skin-grafting to free flap donor sites shows good results with minimal intra-operative effort compared to traditional bandaging. We would like to prospectively investigate the use of this low-cost NPWT device and compare it directly to the traditional post-op dressing method.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* participants are able to consent for themselves
* undergoing reconstructive surgery requiring split-thickness skin graft coverage of a free flap donor site (i.e., radial forearm free flap or fibula free flap)

Exclusion Criteria:

* \< 18 years of age
* participants are unable to consent for themselves
* undergoing reconstructive surgery that does not require split-thickness skin graft coverage of a free flap donor site
Acupoint Application With Yanqing Zhitong Ointment for Chronic Non-specific Low Back Pain

This is a non-inferiority randomized controlled trial, recruiting 150 patients with chronic non-specific low back pain. The patients will be randomly assigned either to Yanqing Zhitong Ointment acupoint application group (Treatment Group) or the acupuncture group (Control Group) in a 1:1 ratio.

This is a non-inferiority randomized controlled trial, 150 patients with chronic non-specific low back pain were randomly assigned to acupoint application group and acupuncture group in a 1:1 ratio. The main acupoints are Ashi points, Shenshu(BL23), Guanyuanshu(BL26). The primary outcome measure is the change of McGill Pain Questionnaire (MPQ) before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with non-specific low back pain
2. Aage from 18 to 65
3. VAS between 4 and 7
4. No other treatment in the past 3 months
5. No other simultaneous relevant treatment
6. Voluntarily joining this study with informed consents

Exclusion Criteria:

1. Pregnant women
2. With skin ulcers or contusion wounds
3. Past history of severe allergy to transdermal preparations
4. Complicated with serious diseases
Transcutaneous Vagal Nerve Stimulation: Influence on miRNA, Inflammation, Cerebral Resting State and Gastric Motility

Randomized, double-blind trial to investigate the influence of a single 4 hours episode of transcutaneous vagal nerve stimulation on the expression of microRNA, various cytokines, chemokines, neuropeptides, cerebral resting state and gastric motility in healthy volunteers.

Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive treatment option for epilepsy. TVNS works via electrical stimulation of the vagal nerve in the outer ear area via two steel electrodes and is performed for about 4 hours per day. Its mechanism of action is unknown. We hypothesize that expression of microRNA (miRNA), and/or release of cytokines, chemokines or neuropeptides is involved in the anticonvulsant activity. TVNS might also influence the cerebral resting state as measured by functional magnetic resonance imaging (fMRI). Due to it's anatomical connections, stimulation of the vagal nerve may furthermore result in altered gastric motility.

This study aims to detect levels of miRNA, cytokines, chemokines and neuropeptides in the blood of healthy volunteers before and after 4 hours of conventional tVNS or sham tVNS. Cerebral resting state and gastric motility will be measured by fMRI.

To this end, 60 healthy volunteers will be recruited and divided into 2 groups. 30 healthy volunteers will be treated with tVNS (25 Hz) for 4 hours (tVNS group). 30 healthy volunteers will be treated with sham tVNS (1 Hz) for 4 hours (control group).

On day 1 of the study, participants will be randomized to one of the two groups. Blood will be drawn from all participants at baseline. Both groups receive a standardized breakfast. TVNS ear electrodes will be put into place for 4 hours without electrical stimulation. Thereafter, blood will be drawn.

On day 2 of the study, blood will be drawn, and all participants receive a standardized breakfast again. Afterwards, tVNS (25 Hz) will be performed in participants of the tVNS group, and sham tVNS (1 Hz) will be performed in participants of the control group. TVNS or sham tVNS end after 4 hours. Blood will be drawn immediately after stimulation end. Thereafter, MRI will be performed in all participants (fMRT resting state, gastric motility). This ends the study for the participant.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Written informed consent

Exclusion Criteria:

* pregnancy
* active implants (like cardiac pacemaker, cochlea implant, implanted VNS)
* contraindications for MRI (e. g. metal fragments, claustrophobia)
* skin lesions in the ara of the left ear conch
* nickel allergy
* drug or alcohol abuse
* current acute disease or medical history of chronic disease
* participant is under legal guardianship