Kornimate/medical-research-clean huggingface dataset:
single arm trial of tumor-treating fields in combination with nivolumab and ipilimumab in metastatic uveal melanoma

Conditions: Uveal Melanoma

Summary: tumor treating fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.

uveal melanoma is the most common ocular malignancy for adults and despite effective therapies, roughly 50% of patients will develop metastatic disease. currently there is no therapy to improve the prognosis of patients with metastatic disease and these patients are usually treated with regimens used for cutaneous melanoma. tumor treating fields is a new type of anti-cancer therapy approved by the fda for use in glioblastoma multiforme and mesothelioma. ttf has been shown to activate the sting pathway leading to increased levels of dendritic cells in regional lymph nodes.

Eligibility criteria:
inclusion criteria: 1. patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement 2. age 18 years or older and willing and able to provide informed consent 3. wocbp must have a negative serum pregnancy test documented with 72 hours of first administration of drug 4. sexually active and wocbp, patient and partner must agree to use adequate contraception 5. normal organ and marrow function 6. ecog 0-1 7. life expectancy of 3 months or greater exclusion criteria: 1. history of previous grade 3, life threatening immune related adverse event (irae) from prior checkpoint inhibitor therapy 2. prior treatment with anti cytotoxic t-lymphocyte-associated protein 4 (ctla-4) therapy within 90 days of c1d1 of study treatment 3. prior anti-cancer therapy (systemic, regional or radiation) within 2 weeks of c1d1 of study treatment 4. aes from prior anticancer therapies that have not resolved to grade 1 or less, other than endocrine related iraes for which patients are on appropriate replacement therapy (ie hypothyroidism, adrenal insufficiency, type 1 diabetes) 5. history of or active autoimmune disease requiring systemic corticosteroid or immunosuppressive therapy. (patients who have limited autoimmune disease not requiring systemic therapy or autoimmune disease that is unlikely to recur, such as ulcerative colitis s/p colectomy, will be allowed to enroll.) 6. serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug. 7. patient is unwilling or unable to comply with study procedures 8. patients with implanted pacemaker, defibrillator, nerve stimulator or other active electronic medical devices; sensitive to conductive hydrogels used on electrocardiogram (ecg) stickers or transcutaneous electrical nerve stimulation (tens) electrodes typically used for ttfields studies.
eswl on disintegration of renal stones

Conditions: Renal Stone

Summary: the impact of different frequencies on pattern of disintegration of renal stones

* prior to the introduction of extracorporeal shockwave lithotripsy (eswl) in 1980, the only treatment available for calculi that could not pass through the urinary tract was open surgery. since then, eswl has become the preferred tool in the urologist's armamentarium for the treatment of renal stones, , eswl is minimally invasive, exposes patients to less anaesthesia, and yields equivalent stone-free rates in appropriately selected patients. * the efficacy of eswl lies in its ability to pulverize calculi in vivo into smaller fragments, which the body can then expulse spontaneously. shockwaves are generated and then focused onto a point within the body. the shockwaves propagate through the body with negligible dissipation of energy (and therefore damage) owing to the minimal difference in density of the soft tissues. at the stone-fluid interface, the relatively large difference in density, coupled with the concentration of multiple shockwaves in a small area, produces a large dissipation of energy. via various mechanisms, this energy is then able to overcome the tensile strength of the calculi, leading to fragmentation. repetition of this process eventually leads to pulverization of the calculi into small fragments that the body can pass spontaneously and painlessly. * it is well recognized that the popularity of extracorporeal shock wave lithotripsy (swl), despite its non-invasive character, has decreased during recent years. this is partly explained by the technological achievements in endoscopy and urologists' enthusiasm for such procedures. another explanation is that many urologists have been insufficiently successful with swl. the latter effect might to some extent be a result of the performance of the lithotripter used, but in too many cases, it is evident that the principles of how shock wave lithotripsy should be carried out are poorly appliedical aspect

Eligibility criteria:
inclusion criteria: * pelvic and upper ureteric stones * stone size less than 2 cm * stone density up to 1000 hu exclusion criteria: * lower calycle stone * stone size 2 cm or more * stone denstiy more than 1000 * age group less than 18 y * uncontrolled hypertension patient and bleeding disorder * pregnancy * patients with upj obstruction, ureteral strictures, * congenital anomalies * previous stented ureter * narrow neck of the calycx less than 30 %
prediction of progression of retinal ischemia in diabetes

Conditions: Diabetic Retinopathy

Summary: diabetes mellitus (dm) is a major public health problem with significant socioeconomic implications due to its increased prevalence. diabetic retinopathy (dr) is the most frequent complication in dm patients and remains the leading cause of legal blindness in working-age populations (yau et al., 2012). differentiating patients with higher vs low risk of progression to vision-threatening complications is of paramount importance for an efficient managing of the disease to prevent vision disability. prediction is a longitudinal prospective clinical study in dmt2 patients with a higher risk of progression to explore possible imaging, functional and systemic biomarkers of progression, using non-invasive methods, commonly applied in the clinical practice. investigating the retinal vascular network (vessel density metrics with optical coherence tomography angiography) will allow a better understanding of the evolution of capillary closure and ischemia, two main risk factors for dr worsening.

patients with mild to severe npdr (etdrs drss 43-53) often progress to pdr and/or ci-dme (etdrs report). however, it is unclear which patients in this group are likely to progress. previous studies have shown that diabetic macular ischemia (dmi) is a risk factor for progression of dr. this study aims to correlate baseline octa metrics with visual function and identify risk factors for progression from npdr to pdr and/or ci-dme.

Eligibility criteria:
inclusion criteria: * dm type 2 according to 1985 who criteria. * age between 35 and 80 years. * bcva ≥ 75 letters (20 /32). * refraction with a spherical equivalent less than 5 diopters. * npdr levels 43, 47 or 53 (based on the etdrs criteria - 7 fields cfp). exclusion criteria: * cataract or other eye disease that may interfere with fundus examinations. * hba1c ≥ 12% * any eye surgery within a period of 6-months before the inclusion visit date. * other retinal vascular disease. * previous laser or intravitreal injection treatment. * dilatation of the pupil \< 5 mm.
aggrastat truncated length against standard therapies in percutaneous coronary intervention

Conditions: Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina; Percutaneous Coronary Intervention

Summary: the purpose of this study is to determine whether the efficacy of tirofiban (a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention (pci) plus two hours after the procedure) is more effective than placebo in the setting of standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing pci, as assessed by the incidence of adverse cardiac ischemic events defined as death, myocardial infarction (mi), and urgent target vessel revascularization (utvr) within 48 hours following study drug initiation. a secondary objective of this study is to assess whether tirofiban (a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a pci plus two hours after the procedure) is safe compared to placebo in the setting of standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing pci, as assessed by the incidence of non-cabg-related timi major bleeding within 48 hours following study drug initiation. patient enrollment is pending.


Eligibility criteria:
inclusion criteria: 1. age \>18 years of age 2. scheduled to undergo pci with an approved device 3. written informed consent exclusion criteria: 1. primary pci for st-elevation myocardial infarction (stemi) 2. prior pci within 30 days 3. prior gpiib/iiia use within 14 days 4. prior enoxaparin use within 4 days 5. prior stemi within 30 days 6. in non-elective subjects, a rising troponin defined as a most recent pre-pci sample greater than the sample immediately preceding it, as long as the two samples are separated by four or more hours and have been analyzed in the same hospital laboratory.
clinical trial of donepezil between the naive group and the switching group

Conditions: Alzheimer's Disease; Dementia

Summary: to compare the clinical efficacy of donepezil between the naive group and the switching group.

the purposes of this study are: 1. to compare the efficacy between switching patients with alzheimer's disease (ad) from galantamine or rivastigmine to donepezil because they were not responding adequately, and naive patients with ad who initiated therapy with donepezil 2. to help to clinicians in choosing the best treatment

Eligibility criteria:
inclusion criteria: 1. a diagnosis of probable ad according to the criteria of the nincds-adrda 2. korean version mini-mental state examination scores between 10 and 26 3. history of cognitive decline that had been gradual in onset and progressive over at least 6 months 4. a caregiver who could assist the patient with medication, attend the assessment and provide information about the patient. exclusion criteria: 1. they had evidence of any neurodegenerative diseases other than ad (i.e. parkinson's disease, huntington's disease) 2. psychiatric disorder or severe behavioral disturbances that required psychotropic medications 3. cerebral injuries induced by trauma, hypoxia, and/or ischemia 4. clinically active cerebrovascular disease; history of seizure disorder 5. other physical conditions that required acute treatment.

Keywords: naive group switching group treatment response efficacy adverse event
a rollover study to provide continued treatment for participants previously enrolled in studies of itacitinib

Conditions: Myelofibrosis; Postlung Transplant (Bronchiolitis Obliterans); Chronic Graft Versus Host Disease

Summary: this is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following incyte-sponsored studies of itacitinib: incb39110-209, incb39110-213, incb39110-214, incb39110-230, and 39110-309. eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. the original study is referred to as the "parent protocol". participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.


Eligibility criteria:
inclusion criteria: * currently enrolled and receiving treatment in an incyte-sponsored itacitinib (incb39110)-based clinical study (parent protocol). * currently tolerating treatment as defined by the parent protocol. * currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator. * has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements. * willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol. * willingness to avoid pregnancy or fathering children.. * ability to comprehend and willingness to sign an icf. exclusion criteria: * able to access itacitinib therapy commercially. * participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the protocol. * pregnant or breastfeeding women.

Keywords: itacitinib incb39110
sitagliptin versus insulin dose increase in type 2 diabetes on insulin treatment

Conditions: Diabetes

Summary: it is well established that inhibition of dipeptidyl peptidase (dpp)-iv reduces glucose levels and preserves pancreatic beta cell function in patients with type 2 diabetes. dpp-iv inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas by increasing incretin (glp-1) levels. recent studies reported that combination therapy with dpp-iv inhibitors and other oral antidiabetic medication have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. however, there have been few studies about the glucose lowering effect of dpp-iv inhibitors in patients with type 2 diabetes on insulin treatment. the researchers hypothesized that dpp-iv inhibitor add-on therapy to insulin treatment may have favorable effects on glucose control and endogenous insulin secretory function in type 2 diabetic patients. the researchers plan to compare between sitagliptin (dpp-iv inhibitor) add-on therapy and insulin dose increase therapy in uncontrolled type 2 diabetes on insulin treatment.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c ≥ 7% * age ≥ 18 * insulin treatment with or without oral antidiabetic medication exclusion criteria: * contraindication to sitagliptin * pregnant or breast feeding women * type 1 diabetes, gestational diabetes, or diabetes with secondary cause * chronic hepatitis b or c (except healthy carrier of hbv), liver disease (ast/alt \> 3-fold the upper limit of normal) * renal failure (cr \> 2.0) * cancer within 5 years * not appropriate for oral antidiabetic agent * medication which affect glycemic control * disease which affect efficacy and safety of drugs * other clinical trial within 30 days

Keywords: diabetes sitagliptin insulin c-peptide
sleep enhancement for older adults living with memory loss and their care partners

Conditions: Sleep Disturbance; Dementia

Summary: the purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.

disturbed sleep is stressful to persons living with dementia (plwd) and their caregivers. it contributes to the earlier placement of the plwd in nursing homes and increases the risk for many psychological and cognitive health issues and poor quality of life for both the plwd and the caregivers. given the potential harmful side effects of medications, non-medication alternatives, such as cognitive behavioral therapy for insomnia (cbti), may be safer to improve disturbed sleep in this population. cbti which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long term. cbti has improved sleep disturbances in plwd and their caregivers, separately. since disturbed sleep in the plwd-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons. there is no current published research on cbti when the plwd and their caregivers receive the intervention at the same time; as a result, the research team aims to examine the 1) feasibility and 2) preliminary efficacy of 6-week cbti intervention for community-dwelling plwd and their caregivers who are both experiencing sleep disturbances. plwd-caregiver dyads will participate in videoconferencing sessions. in addition, semi-structured interviews will take place to examine the acceptability and satisfaction with the intervention.

Eligibility criteria:
inclusion criteria for the plwci: * diagnosis of alzheimer's disease and related dementias (adrd), or caregiver-reported probable or possible cognitive impairment based on electronic medical records or prescribed medications or * montreal cognitive assessment (moca) score between 12 and 24; * had ≥1 sleep problem ≥3x/week on the neuropsychiatric inventory (npi)-nighttime behavior subscale; * have an eligible caregiver; * be able to participate meaningfully in an interview inclusion criteria for caregivers: * ≥18 years old, co-residing with persons living with cognitive impairment (plwci); * regularly assist the care recipient with ≥1 of 7 basic activities of daily living or * ≥1 of 7 instrumental activities of daily living for the past 6 months; * have a pittsburgh sleep quality index (psqi) of 5 or greater exclusion criteria: * plwci: moderate to severe cognitive impairment * individuals who are not yet adults * pregnant women * prisoners * individuals who are not able to clearly understand english.

Keywords: persons living with dementia (plwd) caregivers cognitive behavioral therapy for insomnia (cbti)
a study of the effectiveness and safety of mometasone furoate nasal spray (mfns, sch 032088) for the treatment of nasal polyps (p05604)

Conditions: Nasal Polyps

Summary: this study will evaluate the effectiveness and safety of mfns in improving nasal congestion/obstruction and in reducing bilateral nasal polyps.


Eligibility criteria:
inclusion criteria: * must be chinese * must have a diagnosis of bilateral nasal polyps * clinically significant nasal congestion/obstruction must be present * must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures, or compromise the participant's safety * must have negative urine pregnancy test * must be using or agree to use a medically accepted method of contraception prior to screening and during the study exclusion criteria: * have a history of seasonal allergic rhinitis within the last two years * have had sinus or nasal surgery within the past six months * have presumed fibrotic nasal polyps * have had three or more nasal surgeries * have had any surgical procedure that prevents an accurate grading of the polyps * complete (or near complete) nasal obstruction * have acute sinusitis, concurrent nasal infection or have had a nasal infection within two weeks * have ongoing rhinitis medicamentosa * have churg strauss syndrome (vasculitis, asthma, fever, and eosinophilia) * have dyskinetic ciliary syndromes, eg, young's syndrome (sinopulmonary infections and obstructive azoospermia) or kartagener's syndrome (immobile cilia) * have been treated within the last 4 weeks with intranasal steroids * have used any investigational drug in the last 30 days * have a hypersensitivity to corticosteroids or are allergic to aspirin * have an ongoing upper respiratory tract infection or had an upper respiratory tract infection within two weeks * have a nasal septal deviation needing corrective surgery * have a nasal septal perforation * have asthma that required in-patient hospitalization for asthma control within six months, required ventilator support for respiratory failure secondary to their asthma within the last five years, required admission to the hospital for management of airway obstruction on two or more occasions within the past year, or required use of more than 14 days of systemic steroid use in previous six months
venetoclax in combination with standard induction and consolidation chemotherapy in newly diagnosed young aml patients

Conditions: Acute Myeloid Leukemia

Summary: the goal of this observational study is to to evaluate the efficacy and safety of venetoclax in combination with da60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and hd-arac(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: * newly diagnosed, morphologically documented aml based on the world health organization (who) 2016 classification. * age ≥ 18 years and ≤ 59 years * have been treat with the "venetoclax in combination with standard induction and consolidation chemotherapy" therapy, and in follow-up. * be comprehensive of the research, and able to provide informed consent. exclusion criteria: * diagnosis of acute promyelocytic leukemia (apl). * prior treatment for aml, except for: leukapheresis, hydroxyurea, and growth factor/cytokine. * unable to understand or participate.
use of tilapia skin for palate repair and protection after graft removal

Conditions: Pain, Postoperative; Palate; Wound; Cicatrization

Summary: randomised clinical study to evaluate the efficacy of tilapia skin as an occlusive biological dressing on palatal wound healing after free gingival graft harvesting.

autogenous grafts are currently considered the gold standard in regenerative and reconstructive procedures. however, these procedures require a second surgical site to provide the tissue graft. in autogenous gingival grafts, the area commonly selected for graft harvesting is the palate, which is linked to great discomfort and morbidity for the patient. in order to overcome these limitations, xenogeneic and alloplastic materials have been tested as tissue substitutes, but their results are still considerably inferior when compared to autogenous grafts. faced with this superiority, another approach to favor the use of autogenous grafting is to develop materials that provide greater postoperative comfort and patient safety. since the main complaint arising from the technique is related to pain resulting from the remaining surgical wound on the palate, it is interesting to look for mechanisms to reduce this sensitivity and accelerate the healing process. for this, the use of tilapia skin as a postoperative dressing seems to be a good alternative. thus, the purpose of this study is to evaluate the use of tilapia skin, with the intention of accelerating the palate healing process, and to serve as a protector barrier during the healing process. patients treated according to two techniques for palate protection after autogenous gingival graft harvesting will be evaluated: c- use of surgical cement and t- use of tilapia skin. will be selected 60 patients of both sexes,\> 18 years old, requiring the removal of the palate graft for periodontal surgery. at the time of graft removal, palate thickness and graft dimensions will be measured. after 7, 14 and 30 days, the patient's discomfort and the difficulty in chewing and speaking will be recorded through a visual analog scale, the consumption of analgesic, and the dimensions of the surgical wound on the palate. for statistical analysis, two-way anova will be performed and t-test paired on the obtained results.

Eligibility criteria:
inclusion criteria: * patients need periodontal or peri-implant surgical procedures requiring palate gingival graft exclusion criteria: * patients with an infectious condition that compromises the procedures * users of drugs that can act on periodontal tissues or the healing process * pregnant * smokers * diabetes * irradiated