Kornimate/medical-research-clean huggingface dataset:
triamcinolone with vitamin d synergistic efficacy in psoriasis

Conditions: Plaque Psoriasis; Vitamin D3

Summary: these studies are designed to assess the synergistic efficacy of topical 0.1% triamcinolone cream paired with 40,000 iu of oral vitamin d3 daily in treating mild to moderate psoriasis. the study is designed to have all subjects treated with triamcinolone cream (tac) for 4 weeks, then will be randomized 1:1 into vitamin d3 or placebo for an additional 12 weeks. at that time, the study will become open-label and all subjects will be placed on (or continue) vitamin d3 for an additional 12 weeks. the study will take place over 28 weeks total.


Eligibility criteria:
inclusion criteria: * age 18 and older * mild to severe plaque psoriasis (2% or greater body surface area; psoriasis area and severity score of 2 or greater; investigator grade assessment of mild-severe) exclusion criteria: * currently taking medication that alters the normal ion balance of low-dose in blood. * no calcium supplements 1 month prior to baseline (not including multivitamins). * unstable or uncontrolled illness, including but not limited to cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or psychiatric disease at screening. * abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect patient safety or data integrity. * not on systemic non-biologic therapy (including, but not limited to, oral psoralen plus ultraviolet a \[photochemotherapy (puva)\] light therapy; cyclosporine; corticosteroids; methotrexate; oral retinoids; apremilast; tofacitinib; mycophenolate mofetil; thioguanine; hydroxyurea; sirolimus; tacrolimus; azathioprine; leflunomide; fumaric acid derivatives; or 1, 25 dihydroxy vitamin d3 and analogues) within 28 days prior to baseline. * no phototherapy (including either oral and topical puva light therapy, ultraviolet b, excimer laser, or self-treatment with tanning beds or therapeutic sunbathing) within 28 days prior to baseline. * no topical treatment (including, but not limited to, corticosteroids \[upper mid strength or lower potency topical steroids are permitted on the intertriginous areas and face\], crisaborole, anthralin, calcipotriene, topical vitamin d derivatives, retinoids, tazarotene, pimecrolimus, tacrolimus, emollients and other nonprescription topical products containing urea, \>3% salicylic acid, alpha- or beta-hydroxyl acids, or medicated shampoos \[for example those that contain \>3% salicylic acid, corticosteroids, coal tar, or vitamin d3 analogues\]) within 14 days prior to baseline. * no biologic agents within 8 weeks or three half-lives, whichever is greater prior to baseline. * history of renal impairment. * history of renal stones. * history of parathyroid abnormalities * osteoporosis * history of severe arthritis * ongoing use of tanning bed or other uv device or excessive sunlight * unable to understand/complete informed consent.
a study to assess the efficacy, safety and tolerability of once-daily (q.d.) qva149 in patients with moderate to severe chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to provide pivotal efficacy and safety data for qva149 in patients with moderate to severe copd.


Eligibility criteria:
inclusion criteria: * male or female adults aged ≥40 yrs * smoking history of at least 10 pack years * diagnosis of copd (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2008) * post-bronchodilator fev1 \< 80% and ≥ 30% of the predicted normal value and post-bronchodilator fev1/fvc (forced vital capacity) \<70% exclusion criteria: * patients who have had a respiratory tract infection within 4 weeks prior to visit 1 * patients with concomitant pulmonary disease * patients with a history of asthma * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular co-morbid conditions * patients with a known history and diagnosis of alpha-1 antitrypsin deficiency * patients in the active phase of a supervised pulmonary rehabilitation program * patients contraindicated for inhaled anticholinergic agents and β2 agonists * other protocol-defined inclusion/exclusion criteria may apply

Keywords: qva149, copd, combination bronchodilator, indacaterol, glycopyrronium bromide
functional prognosis of post-operative patients with cerebral small vascular disease(csvd)

Conditions: Cerebral Small Vessel Diseases; Long Term Adverse Effects

Summary: the investigators perform a retro-prospective exploratory cohort study among patients 65 to 85 years old with pre-operative head mri result after thoracic surgery in renji hospital affiliated to shanghai jiaotong university from november 2020 to december 2021. perioperative data were collected, including preoperative general condition, laboratory examination, auxiliary examination (blood routine, blood coagulation, liver and kidney function, etc.), perioperative indicators （use of anesthetics, anesthetic time, blood pressure, etc.）, postoperative cerebral function follow-up and occurrence of cerebral vascular complications (brain infarction, brain bleed, etc.) of patients.


Eligibility criteria:
inclusion criteria: * 65≤age\<85 * after thoracic surgery * finish pre-operative brain mri exclusion criteria: * mental illness * existing dementia and other diseases: alzheimer disease, dementia, parkinson's disease, huntington's disease, systemic lupus erythematosus, etc. * previous cerebral infarction or hemorrhage
studying students at risk for covid-19

Conditions: Covid19

Summary: the goal of this longitudinal observational study is to learn about how the covid-19 has impacted and continues to impact students at the university of michigan. we hope to determine whether a combination of (1) continuous heart rate obtained from wearable devices, (2) self-reported data from surveys and symptom logs, and (3) saliva samples can be used to help students self-monitor for infection and eventually be able to create a predictive model to detect illness early.

the study was originally intended to last one year, however, it was expanded to follow the study participants over several years. during this study, participants will be asked to: * provide a baseline self-collected saliva sample * download and use a suite of mobile apps (e.g., fitbit, social rhythms, roadmap 2.0) * complete surveys online * wear non-invasive fitbit smartwatch * grant the study team access to their university academic records (optional) the study will use these tools to monitor participants' physical activity and mental health over the course of at least three years. the study will also examine whether there is a connection between mental health and academic performance.

Eligibility criteria:
inclusion criteria: * students at the university of michigan who have moved back to ann arbor or who are completing schooling completely online. * for those completing school online, must be able to provide a mailing address within the united states where they can receive study tools * possession of a smartphone (apple or andriod) * ability to understand and demonstrate willingness to sign a written informed consent. exclusion criteria: * unwilling or unable to comply with the study procedures.

Keywords: wearable sensors, students
68ga-jh12 pet/ct: dosimetry and biodistribution study

Conditions: Malignant Neoplasm

Summary: 68ga-jh12 is a novel radiotracer targeting c-x-c motif chemokine receptor 4 (cxcr4). in this study, we observed the safety, biodistribution, and radiation dosimetry of 68ga-jh12 in patients with different types of cancer.

c-x-c motif chemokine receptor 4 (cxcr4) is highly expressed in patients affected with malignant tumors and ex-vivo analyses provided evidence that the expression level on the tumor cell surface is tightly linked to the proliferation index. in recent years, the diagnostic pet agent 68ga-pentixafor targeting this chemokine receptor has been extensively validated in haematological malignancies and solid tumors. 68ga-jh12, a novel radiopharmaceutical targeting cxcr4, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. in this study, the safety, biodistribution, and radiation dosimetry of 68ga-jh12 in patients with various cancers were observed to evaluate the dosimetric characteristics of 68ga-jh12.

Eligibility criteria:
inclusion criteria: * various solid tumors with available histopathological findings * signed informed consent exclusion criteria: * pregnant or lactational women * who suffered from severe hepatic and renal insufficiency
weekly topotecan in the second-line treatment of small cell lung cancer

Conditions: Lung Cancer

Summary: in this phase ii trial, we will evaluate the weekly schedule of topotecan in the second-line treatment of patients with small cell lung cancer

upon determination of eligibility, all patients will be receive: * topotecan

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * small cell lung cancer * progression after one previous regimen * measurable or evaluable disease * able to perform activities of daily living with assistance * adequate bone marrow, liver and kidney function * no more than three previous courses of radiation therapy * accessible for treatment and follow up * must give written informed consent prior to study entry exclusion criteria: you cannot participate in this study if any of the following apply to you: * central nervous system involvement * serious or active infection * serious underlying medical condition * other active neoplasms please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
exciflex for chronic wound therapy

Conditions: Chronic Wound; Diabetes; Spinal Cord Injury; Ischemic Wound

Summary: objectives: the study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (soc) for ischemic wounds and will involve participants who are veterans with lower extremity ischemic wounds. research plan: the study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use. methodology: all participants with chronic ischemic wounds treated at lscdvamc will be potentially eligible for the study. primary target populations will include veterans with sci who are inpatients or residents of the on-site long term care unit and veterans with diabetes being followed by the podiatry service for wound care. in addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1)age less than 18 years and (2)pregnancy. clinical significance: chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many veterans. the exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. the overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.

the study will employ a randomized repeated measures design to assess the therapeutic effectiveness of the exciflex bandage in clinical use. progressive changes in wound size, indicative of wound healing, will be determined using 3d digital stereophotogrammetry (lifeviz 3d system, quantificare inc., san mateo, ca) together with wound swabs to collect wound bed fluid. the study cohort will comprise veterans with ischemic wounds. a parallel-group randomization will be used and participants will be randomly assigned to one of two groups: the experimental or investigation group (group a) or the control group (group b). random allocation software will be used to produce qualified lists for parallel group assignment a priori and ensure that participants are randomized into groups that result in equal sample sizes each will have a 50% chance of being assigned to either group. group a will include eight (8) participants using the study device. group b will include eight (8) participants undergoing standard of care treatment (soc) with no study device.

Eligibility criteria:
inclusion criteria: * all participants with chronic ischemic wounds treated at lscvamc will be potentially eligible for the study * primary target populations will include veterans with sci who are inpatients or residents of the on-site long-term care unit and veterans with diabetes being followed by the podiatry service for wound care exclusion criteria: in addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include: * age less than 18 years. * pregnancy
role of oral chlorhexidine gel in prevention of ventilator associated pneumonia

Conditions: Ventilator Associated Pneumonia

Summary: the purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.

ventilator associated pneumonia as the name suggests refers to pneumonia occurring in the setting of mechanical ventilation. it accounts of 86% of nosocomial pneumonia and in contrast to other more common nosocomial infections is accompanied by a mortality rate of upto 76% in certain settings. a number of preventive methods have been studied to reduce the rate of vap but a consensus is lacking with regards to appropriate preventive strategies. studies in adults have shown a beneficial effect of oral mucosal application of chlorhexidine but similar studies in pediatric population are not available. this research project aims at addressing the gap.

Eligibility criteria:
inclusion criteria: 1. patients in picu requiring mechanical ventilation 2. above the age of 3 months 3. oro or nasotracheal intubation exclusion criteria: 1. known hypersensitivity to chlorhexidine 2. inability to access the oral cavity for any reason 3. patients with tracheostomy 4. mechanical ventilation for more than 24 hours prior to picu admission. 5. death or extubation within 24 hours of icu admission.
eeg slow wave activity in hypoxic brain injury

Conditions: Hypoxic-Ischemic Encephalopathy; Cardiac Arrest

Summary: brainicu is a prospective observational study investigating the eeg slow wave activity in comatose cardiac arrest survivors under propofol anesthesia and its association with neurological outcome.

brainicu is a prospective observational study investigating the eeg slow wave activity in comatose cardiac arrest survivors under propofol anesthesia and its association with neurological outcome. comatose adult patients admitted to intensive care unit (icu) after cardiac arrest are included. patients with previous neurological disease expected to affect substantially the eeg are excluded. the patients' relatives are asked for an informed written consent to participate. in the intensive care, the patients are sedated using continuous infusion of propofol while receiving temperature management/hypothermia treatment following the icus' common practice. eeg is recorded within the first 24h after icu admission. if possible, the recording is repeated on the second and third day i.e. 48h and 72h after icu admission, respectively. to induce the maximum effect of propofol on eeg, additional boluses of propofol during the eeg recording may be given until the burst suppression level is reached. slow wave activity is calculated offline from the eeg recordings. the neurological recovery of the patients is defined 6 months after cardiac arrest from patient documents and/or by phone call to the patient/ relative using cerebral performance category. after the follow-up period patient or the relative is also asked to fill a survey (sf-36) to estimate the health and quality of life.

Eligibility criteria:
inclusion criteria: * comatose patients admitted to intensive care after cardiac arrest exclusion criteria: * previous neurological disease expected to affect eeg substantially

Keywords: eeg intensive care propofol
phase i/ii study of jr-441 in patients with mucopolysaccharidosis type iiia

Conditions: Mucopolysaccharidosis III-A

Summary: a phase i/ ii, open-label, randomized, 2-arm study, designed to evaluate the safety and explore efficacy of the study drug in development for the treatment of mps iiia patients.


Eligibility criteria:
inclusion criteria: * chronological age of ≥1 year and ≤18 years. * confirmed diagnosis of mps iiia. * body weight ≥ 10 kg. exclusion criteria: * prior experience to gene therapy or hsct with successful engraftment. * past use of another investigational drug or product in last 4 months or 5 half-lives (whichever is longer) before signing icf. * current participation in a clinical trial or past participation (within 30 days of enrolment into this study) in a study involving invasive procedures. * past use of genistein or kineret (anakinra) within 4 months before signing icf. * serious drug allergy or hypersensitivity. * contraindication for lumbar puncture or mri. * history of bleeding disorder or current use of medications that, in the opinion of the investigator, place them at risk of bleeding following lumbar puncture. the above information is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.
vim dbs respiratory modulation: n-of-1 trial

Conditions: Essential Tremor; Dystonic Tremor

Summary: research from our group has demonstrated modulation of pefr in patients with stn and pag stimulation. however, the effect of vim (motor thalamus) stimulation remains to be investigated. our group has also been involved in research that indicates that vim stimulation may reduce perception of breathlessness. however, methodological factors limit the conclusions that can be drawn from this prior work. n-of-1 trials, organised as a randomised multiphase crossover design, are uniquely well suited for dbs research where stimulation can be switched on and off, and with simple tests that can be done quickly, multiple times. pefr and breath-holding are simple tests that we will test in this way. other respiratory tests will be carried out along side, as optional, in a single phase design. we aim to offer this study to a continuous cohort of patients scheduled to undergo vim (et/dt) dbs at our institution. we will establish a pre-operative baseline of respiratory function, and then perform the n-of-1 trial post-operatively, soon after the patient returns to hospital to receive their dbs programming.


Eligibility criteria:
inclusion criteria: * scheduled for vim dbs * diagnosis of et or dt exclusion criteria: * none
evaluation study on corneal lens for vision correction

Conditions: Astigmatism

Summary: the objective of this study is to evaluate the fitting and visual outcomes of nexis lens, made of silicone commonly used in the contact lens industry, on healthy eye with or without astigmatism.


Eligibility criteria:
inclusion criteria: 1. patient with good corneal health 2. age 18-65. 3. patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements. 4. best corrected visual acuity of 20/20 or better in the study eye/s exclusion criteria: 1. any other anterior segment abnormality. 2. no previous corneal procedures, including laser vision correction. 3. any abnormalities associated with the eye lids. 4. clinically significant inflammation or infection within six (6) months prior to study. 5. uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the investigator. 6. participation in any study involving an investigational drug or device within the past 30 calendar days, or ongoing participation in a study with an investigational material except studies using corneal lenses. 7. intolerance or hypersensitivity to topical anesthetics, fluorescein, or components of the material. 8. specifically known intolerance or hypersensitivity to contact lenses. 9. any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
a study to test the effectiveness and safety of mk0893 in combination with other drugs used to treat type 2 diabetes (0893-015)

Conditions: Diabetes Mellitus, Type 2

Summary: this study will test the effectiveness and safety of treatment with mk-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.


Eligibility criteria:
inclusion criteria: * participants who have type 2 diabetes mellitus, with suboptimal glucose control, while either not on aha (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy exclusion criteria: * participants have a history of type 1 diabetes mellitus * participants taking insulin or thiazolidinediones (tzds: peroxisome proliferator-activated receptor \[ppar\]-gamma agonists) * participants who have a contraindication to metformin or sitagliptin
a non-randomized, open-label study to evaluate the safety and effectiveness of insight® pro device for evaluating lymphatic and venous disorders (volga)

Conditions: Lymphedema; Chronic Venous Insufficiency; Edema; Venous Insufficiency of Leg

Summary: to demonstrate that the insight pro device is safe and effective for use in detecting lymphatic and venous disorders.

6. clinical hypotheses 1. the insight pro device can detect a difference in extracellular fluid volume through bioimpedance and dielectric constant measurement. 2. the insight pro device can detect a difference in skin hardness or fibrositis through a durometer measurement. 3. the insight pro device is safe for use as assessed by adverse events.

Eligibility criteria:
inclusion criteria: test group - * males and females ≥ 18 years of age * willing to sign the informed consent and deemed capable of following the study protocol * subjects must have primary or secondary unilateral or bilateral upper or lower extremity edema * at the time of initial evaluation, individuals must be at least 3 months post-surgery, chemotherapy and/or radiation treatment for cancer if applicable control group - * males and females ≥ 18 years of age * willing to sign the informed consent and deemed capable of following the study protocol * subjects must not have primary or secondary edema and self-describe general healthy exclusion criteria: * ● inability or unwillingness to participate in all aspects of the study protocol and/or failure to provide informed consent * patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.) * diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy, or primary surgery for the cancer) * patients with cardiac arrhythmia with pacemakers or other implanted electronic equipment * patients must not have implanted metal hardware in the limbs * patients undergoing external defibrillation * diagnosis of acute infection (in the last four weeks) * diagnosis of acute thrombophlebitis (in last 2 months) * diagnosis of pulmonary embolism or deep vein thrombosis within the previous 2 months * diagnosis of congestive heart failure (uncontrolled) * diagnosis of chronic kidney disease with acute renal failure * women who are pregnant, planning a pregnancy or nursing at study entry * participation in any clinical trial of an investigational substance or device during the past 30 days