cyrilzakka/clinical-trials huggingface dataset:
Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis

The goal of this research is to test a novel centralized care coordinator program to assist patients with psoriatic disease in lowering their risk of cardiovascular disease through the application of standard of care approaches to improving modifiable cardiovascular risk factors.

Psoriasis patients have an increased risk of cardiovascular disease and mortality but are less likely to have traditional cardiovascular risk factors identified or adequately managed. Care coordinators have previously been demonstrated to improve outcomes in patients with chronic diseases (such as comorbid diabetes and depression) and are now routinely embedded in primary care practices in integrated health systems. The goal of this research is to test a novel centralized care coordinator program to assist patients with psoriatic disease in lowering their risk of cardiovascular disease through the application of standard of care approaches to improving modifiable cardiovascular risk factors.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide informed consent
2. Male or female aged 40-75
3. Being seen by a dermatology provider in routine care for the primary encounter diagnosis of psoriasis

Exclusion Criteria:

1. Currently taking a prescription lipid lowering medication
2. Pregnant or planning pregnancy in the next 6 months
3. Has a known history of cardiovascular disease (MI, Stroke, coronary artery, cerebrovascular, or peripheral vascular disease)
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis

To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.

To establish superiority of each active treatment over the placebo.


Eligibility Criteria:
Inclusion Criteria:

* Non-immuno compromised male or female aged 8 years and older
* Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)
* Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable.
* A diagnosis of AD for at least 3 months
* An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3)
* Affected area of AD involvement at least 5% body surface area (BSA)
* Treated with a bland emollient for at least 7 days

Exclusion Criteria:

* Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
* Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
* Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations
* History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
* History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders
* Concurrent disease or treatment likely to interfere with the study treatment or evaluations
* Known allergy or hypersensitivity to pimecrolimus or any other component of the drug products
* Not willing to minimize or avoid natural and artificial sunlight exposure during treatment
DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix

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 DX-8951f in treating women who have advanced or recurrent cancer of the cervix.

OBJECTIVES:

* Determine the antitumor activity of DX-8951f in women with advanced or recurrent squamous cell carcinoma of the cervix.
* Evaluate the quantitative and qualitative toxic effects of this regimen in these patients.
* Evaluate the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed advanced or recurrent squamous cell carcinoma of the cervix not curable by surgery or radiotherapy
* Measurable disease
* No known brain metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present)

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No active congestive heart failure
* No uncontrolled angina
* No myocardial infarction within the past 6 months

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent serious infection
* No other malignancy within the past 5 years except nonmelanomatous skin cancer
* No other life threatening illness
* No psychosis, mental disability, or incompetence

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent biologic therapy

Chemotherapy:

* At least 4 weeks since prior chemotherapy
* No more than 1 prior chemotherapy regimen (except chemotherapy for radiosensitization)
* No prior camptothecin
* No other concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy

Surgery:

* At least 4 weeks since prior surgery
* No concurrent surgery

Other:

* At least 4 weeks since other prior investigational drugs (including analgesics or antiemetics)
* No other concurrent investigational drugs during or within 28 days after final dose of study drug
* No concurrent drugs that induce or inhibit CYP3A enzyme
A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression

Investigators developed Motherly 1.0, a smartphone app designed to treat and promote maternal mental health. A 2-arm parallel-randomized controlled clinical trial (RCT) will be conducted to test the efficacy of Motherly in conjunction with brief cognitive-behavioral therapy. 70 pregnant women between 16-40 years old will be recruited. Since all interventions will be conducted online, participants will be recruited from any Brazilian state or municipality. Participants will be randomly assigned to either receive intervention via app consisting of behavioral activation and psychoeducation to promote changes in sleep, nutrition, and physical activity habits, as well as to engage in prenatal care, breastfeeding, and social support, and to stimulate child development, in addition to brief cognitive-behavioral therapy (CBT) (n=35); or to a comparison group receiving an psychoeducational app (active control) with psychoeducational content about gestation, maternal health and mental health, and child development in addition to brief CBT (n=35). Duration of treatment will be eight weeks, during which participants in both groups will be assessed at the beginning (baseline; T0), weeks 3-4 (midpoint; T1), and week 8 (endpoint; T2) in order to evaluate treatment effects. A follow-up postnatal assessment will also be conducted when the child is three months of age (T3).


Eligibility Criteria:
Inclusion Criteria:

* women aged between 16-40 years;
* having a score of \>7 on the Edinburgh Postnatal Depression Scale (EPDS);
* gestational age between 17-26 weeks;
* being literate;
* owning a functional smartphone with Android for personal use.

Exclusion Criteria:

* pregnancies classified as being at risk, fetal malformation, or congenital disease;
* visual, auditory or intellectual disabilities, or chronic diseases associated with fetal development alterations;
* severe and/or chronic mental disorder (e.g., schizophrenia, bipolar disorder, etc).
Coordinating Teams in Primary Health Care.

Patients who suffer from musculoskeletal pain often have more than one diagnosis. These patients mostly have to wait a long time for the doctor's examination and treatment, and they also often have a sick leave for a long period of time. The investigators expect that treatment and follow-up by an coordinating interdisciplinary team can improve these patients opportunity to function, increase their quality of life, and decrease their pain. The purpose of this study is to investigate if use of a coordinating interdisciplinary team in primary health care will result in reduced sick leave compared with practice as usual, and give fewer referrals to specialized health services and private rehabilitation centers. Research data will be obtained from the patients journals, questionnaires, and clinical examinations..


Eligibility Criteria:
Inclusion Criteria:

* patient in one of the participating general practices
* musculoskeletal complaints in 3 years before start of this study
* informed consent

Exclusion Criteria:

-
Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls

To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects. These subjects will also be evaluated for beta-cell function as measured by the insulin and C-peptide response to a challenge with intravenous arginine under basal and glucose enhanced conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects of non-childbearing potential between the ages of 30 and 65 years inclusive.
* Able to tolerate PET, PET/CT and MR imaging
* Estimated creatinine clearance \>= 60mL/min
* Informed consent documents signed and dated by subject
* Subjects must be willing and able to comply with all scheduled visits, treatments laboratory tests, scans and other study procedures.
* In addition, subjects must meet classification requirements for one of the following

  1. Healthy Overweight
  2. Pre-diabetes
  3. T2DM
* (T2DM only) Subjects with other chronic medical conditions (besides diabetes) that are well controlled and stable on medication are acceptable for inclusion in this study.

Exclusion Criteria:

* Subjects who are affiliated with or relatives of staff members of either the site or Pfizer directly involved in the conduct of the trial.
* Conditions which in the opinion of the study investigator may interfere with the subject's ability to participate in the study
* History of allergic reaction to drug/contrast agent or history of drug/alcohol abuse
* Subjects who have received investigational medications within the last 30 days or a radiopharmaceutical in the past 7 days.
* Pregnant or nursing females; females of childbearing potential.
A Study to Investigate the Effect of Food on Oral LBH589 Absorption in Patients With Advanced Solid Tumors

The primary purpose of this study is to evaluate the effect of food on oral LBH589 in adult patients with advanced solid tumors. This study will also evaluate the safety and efficacy of LBH589 in adult patients with advanced solid tumors


Eligibility Criteria:
Inclusion criteria:

* Patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists
* Age ≥ 18 years old
* Patients must have adequate laboratory values
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Ability to swallow capsules or tablets

Exclusion criteria:

* Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
* Patients with a second primary malignancy that is currently clinically significant or requiring active intervention
* Impaired heart function or clinically significant heart disease
* Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589
* Ongoing diarrhea
* Liver or renal disease with impaired hepatic or renal functions
* Concomitant use of any anti-cancer therapy or certain drugs
* Female patients who are pregnant or breast feeding
* Patients not willing to use an effective method of birth control

Other protocol-defined inclusion/exclusion criteria may apply
Effects of Vagus Nerve Stimulation on Central Pain Sensitivity & Parasympathetic Function in Knee Osteoarthritis

The goal of this clinical trial is to test the feasibility and effectiveness of transcutaneous vagus nerve stimulation (tVNS) to the ear on pain and autonomic function in people with knee osteoarthritis (OA). The main questions it aims to answer are: 1) whether tVNS is feasible to be used in people with knee OA; 2) whether tVNS demonstrates the trend in improving knee pain; and 3) whether tVNS has physiological effects on autonomic function (e.g., parasympathetic function) and pain perception in the central nervous system such as brain (i.e., central pain mechanisms). Participants will be asked to complete a battery of self-reported questionnaires about their demographic and behavioral information, ethnicity, pain, sleep, psychological/emotional symptoms. Subsequently, participants will complete baseline assessment where investigators will assess their knee pain severity, central pain sensitivity, and heart rate variability (a measurement for autonomic function). Then participants will receive a 60-minute tVNS. Investigators will redo the same assessment as baseline assessment after tVNS intervention to see the degree of knee pain, central pain sensitivity, and autonomic function changes. At the end of the study, investigators will assess their satisfaction level with the tVNS intervention and the feasibility of the intervention (e.g., completion rate, side effects).


Eligibility Criteria:
Inclusion Criteria:

* chronic knee pain consistent with a clinical osteoarthritis diagnosis, which does not require radiographic evidence (age ≥ 45 years, activity-related knee pain, and no knee morning stiffness lasting \>30 minutes)
* knee pain ≥ 3 months
* average pain intensity ≥ 4 on a scale from 0 to 10
* knee pain as the chief complaint
* able to understand English

Exclusion Criteria:

* current skin disease of the left ear interfering with the application of the auricular electrode for stimulation(eczema, urticarial lesion, skin infection, external otitis, etc.)
* auditory canal not adapted to the application of the ear electrode
* known history of cardiac rhythm disturbances or atrioventricular block \> 1st degree, conduction disturbances
* recurrent vagal syncope
* history of vagotomy
* use of other medical devices electrically active (pacemaker, transcutaneous electrical nerve stimulation, etc)
* serious and uncontrolled concomitant disease, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, gastrointestinal, epileptic disease or malignant diseases
* pregnant or breastfeeding woman
* numbness or sensation loss on the body sites for pain measurements (i.e., the wrist, knee, the forearm)
* any intervention procedures for knee pain in the past 3 months
* age less than 45 years old
Efficacy of Oxycodone-propofol Combination Compared With a Fentanyl-propofol Combination on Conscious Sedation Effect and Early Cognitive Function During Therapeutic Endoscopic Retrograde Cholangio-pancreatography

To evaluate and compare the sedative effect and effects on early period cognitive function of a fentanyl-propofol Combination (FP) regimen with a oxycodone-propofol(OP) combination during the endoscopic retrograde cholangio-pancreatography (ERCP) requiring conscious sedation

One hundred patients undergoing ERCP were included in this study and randomly divided into two groups of 50 people each. The patients in group FP were given fentanyl infusion of 1ug/kg intravenously 5 minutes before the process. They were given propofol infusion: a loading does of 1-2mg/kg immediately before the process then maintenance does of 1mg/kg/h. The patients in group OP were administered oxycodone of 0.1 mg/kg and 1-2mg/kg loading dose of propofol intravenously 5 minutes before the process. Then they were given 1mg/kg/h maintenance does of propofol infusion. In order to maintenan Ramsey Sedation Scale (RSS) between 3 and 4, all patients were administered 0.2\~0.5 mg/kg bolus of propofol when necessary. Time of induction of anesthesia, operation time, wake-up time, recovery time, occurrence of adverse cardiovascular events, bucking, nausea and vomiting and respiratory depression ,total dosage of used propofol were assessed.Furthermore,different time point of regional cerebral oxygen saturation (rScO2) ,serum levels of irisin and cognitive function by mini-mental state examination (MMSE) were rated.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III

Exclusion Criteria:

* cardiovascular disease
Making Effective Human Papillomavirus (HPV) Vaccine Recommendations

Coverage of HPV vaccination among US teens is low, far below Healthy People 2020 goals. A central reason for low coverage is infrequent and inadequate healthcare provider recommendation of HPV vaccine. The proposed intervention aims to train clinicians to provide effective recommendations for the vaccine using participatory or efficient communication strategies.

This study will evaluate the effectiveness of two communication trainings to increase HPV vaccination coverage among adolescent patients. We will compare HPV vaccination for pediatric and family medicine clinics receiving a participatory communication training, efficient communication training, or no training. Ten clinics will be randomly assigned to each study arm for a total of 30 clinics. The primary outcome of this study is to compare the change in clinics' levels of HPV vaccination initiation coverage among 11-12 year old adolescent patients from baseline to 6 month follow-up. Secondarily, we will compare the change in HPV vaccination initiation coverage in 13-17 year old adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Eligible clinics are pediatric and family medicine practice clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics must have at least one pediatric or family medicine physician who provides HPV vaccine to adolescents ages 11-12.

Exclusion Criteria:

* Ineligible clinics include those that have participated in a quality improvement study to increase HPV vaccination rates in the last 6 months or plan to participate in such a study in the next 6 months.
Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)

Mometasone furoate (MF) is a synthetic glucocorticosteroid that, when administered to asthma patients with a dry powder inhaler (Asmanex® Twisthaler®) at dosages of 100 to 400 mcg twice daily, has been shown to improve lung function, reduce symptoms of asthma, and reduce frequency and severity of exacerbations by reducing airway inflammation, with a relatively low potential to cause systemic side effects such as hypothalamic-pituitary-adrenal (HPA) axis suppression.

An experimental formulation of MF 100 mcg delivered twice daily via a pressurized metered-dose inhaler (MDI) also has been shown to be effective in improving lung function of asthma patients as measured by forced expiratory volume in 1 second (FEV1). This trial is designed to verify the effectiveness of twice daily MF MDI 100 mcg in treating asthma in adults and adolescents previously treated with low dosages of inhaled corticosteroids (ICS), as measured by improvement in morning FEV1 and time to first asthma exacerbation over 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* An adult or adolescent subject with a diagnosis of persistent asthma of \>=6 months duration may be selected for this study.
* Both subject (and/or parent/guardian, if appropriate) and investigator must agree that changing therapy is acceptable and poses no inherent risk.
* Subject must have been using a low daily maintenance dose of inhaled corticosteroids (ICS), with or without added long-acting β2-agonist (LABA), for \>=12 weeks prior to Screening, and must have been on a stable regimen (daily dose unchanged) for at least the last 2 weeks of that period.
* At Screening, the subject must have a prebronchodilator FEV1 between 60% and 90% of the predicted value when restricted medications have been withheld.
* To be randomized, the subjects must be symptomatic with FEV1 at Baseline must be between 50% and 85% of predicted.

Exclusion Criteria:

* A subject must not have been admitted to the hospital for management of airway obstruction within the last 3 months prior to Screening, and must not have experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication, as judged by the clinical investigator at any time from Screening to Baseline/Randomization.
* In addition, a subject must not have demonstrated a decrease in absolute FEV1 of \>20% at any time from Screening to Baseline, or a decrease in AM peak expiratory flow (PEF) below the PEF stability limit on any 2 consecutive days prior to Baseline/Randomization.
An Examination of Brown Adipose Tissue and Energy Expenditure in Infants

Excess fetal adipose tissue growth during intrauterine development increases future obesity risk. Development of brown adipose tissue, a highly thermogenic organ in utero, may affect postnatal energy expenditure, thus influencing obesity risk. This research study is designed to understand the developmental origins of energy balance by examining maternal and neonatal factors that influence neonatal brown adipose tissue and to quantify its physiological relevance to energy expenditure in human neonates.

The developmental origins of obesity begin in utero with growth and differentiation of adipose tissue. Fetal white adipose tissue accretion is highly variable and dependent on the maternal intrauterine environment. Unlike white adipose tissue, brown adipose tissue has a high capacity for thermogenesis. Brown adipose tissue is present at birth and it is believed to support the critical function of thermoregulation in early postnatal life. Therefore, Brown adipose tissue may also influence the development of neonatal energy balance. Similar to white adipose tissue, it is hypothesized that development of Brown adipose tissue in utero is also influenced by maternal factors such as prepregnancy body mass index and gestational weight gain. The research aims of this study to 1) identify maternal and neonatal factors that contribute to neonatal Brown adipose tissue and 2) to identify changes in neonatal Brown adipose tissue and to energy expenditure in response to a mild cold exposure. To achieve these aims, we will conduct a cross-sectional, observational study in up to 60 infants 0-3 weeks of age. Using state-of-the-art methodology, we will assess brown adipose tissue, body composition, and resting metabolic rate under thermoneutral and mild-cold stimulated conditions.

Eligibility Criteria:
Inclusion Criteria:

* aged 0 weeks to less than 3 weeks at visit 1
* be willing to complete MRI procedures

Exclusion Criteria:

* Unable to complete two clinic visits within 14 days
* Born with health conditions that would render the procedures unsafe
* Born earlier than 36 and 0 days gestation
* Taken a steroid drug since birth
* Implanted metal or electronic objects that render MRI unsafe