Kornimate/medical-research-clean huggingface dataset:
chidamide plus sintilimab for chemotherapy-refractory advanced high-grade neuroendocrine neoplasm

Conditions: Neuroendocrine Tumors; Neuroendocrine Tumor Grade 3; Neuroendocrine Carcinoma; Neuroendocrine Neoplasm

Summary: the purpose of this study is to explore the efficacy and safety of chidamide combined with sintilimab in chemotherapy-refractory advanced high-grade neuroendocrine neoplasm.

this study is a single-arm, multi-center, two-stage, phase ii clinical trial conducted in china. this study adopts simon's two-stage design, and the inclusion criteria and exclusion criteria of the two stages were consistent. six patients with high-grade neuroendocrine neoplasm will be enrolled in the first stage. if more than one complete or partial responses were seen at planned interim analysis, the additional 17 patients will be recruited in the second stage and a total of 23 patients will be treated.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. histologically confirmed advanced and metastatic high-grade neuroendocrine neoplasm; 3. receive ≤ 2 types of chemotherapy for high-grade neuroendocrine tumors and had tumor progression; 4. ecog ≤ 2; 5. have at least one measurable lesion according to recist version 1.1; 6. absolute neutrophil count ≥ 1.5×109 / l, platelet count ≥ 100×109 / l, hemoglobin ≥ 90 g/l; 7. provide tumor samples for pathological diagnosis and pd-l1 biomarker detection; 8. have ability to sign a written informed consent. exclusion criteria: 1. small cell lung cancer; 2. have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment; 3. previous use of hdac inhibitors; 4. previous use of pd-1/pd-l1/pd-l2/ctla-4 inhibitors; 5. allergy to related drug components; 6. have a medical history of immune deficiency diseases, or organ transplantation; 7. have active autoimmune diseases requiring treatment or a medical history of autoimmune diseases in the past 2 years; 8. have uncontrolled or significant cardiovascular disease; 9. abnormal liver function (total bilirubin \> 1.5×upper limit of normal); transaminases (alt/ast) \>2.5×upper limit of normal (\>5x upper limit of normal for patients with liver metastases), abnormal renal function (serum creatinine \> 1.5×upper limit of normal); 10. pregnancy ; 11. receive any live or live attenuated vaccine within 4 weeks before enrollment; 12. have serious diseases that may endanger the safety of patients, or affect patients to complete the research; 13. any serious mental or cognitive disorder; 14. patients are currently enrolled in another drug clinical trial within 4 weeks prior to enrollment; 15. any other condition which is inappropriate for the study in the opinion of the investigators.

Keywords: histone deacetylase inhibitors chidamide neuroendocrine neoplasm pd-1 sintilimab
a digimed oncology pharmacotherapy registry

Conditions: Colon Cancer; Breast Cancer; Rectal Cancer

Summary: digimeds™ are medications with fda-approved ingestible sensors (is), a wearable sensor patch (patch), and a mobile app, which records time-stamped medication type and dose alongside biometric activity. the aim of this registry is to collect and analyze data on the use of digimeds™ and a digital feedback system on medication adherence, patient-provider communication, and data-driven optimization of therapy for cancer patients.

patients will be prescribed the dmp and digimeds™ (capecitabine or supportive medications) by their healthcare provider. the pharmacy will co-encapsulate the prescribed medication with a sensor. the actual doses of digimeds™ will be based on standard of care as prescribed by treating physician. patients will be instructed in the use of the digimeds™ and the dmp based on standard of care plus use of the dmp system. every effort should be made to take the digimeds™ as prescribed. patients in this study will be given the option to use their personal smartphone or will be provided a provisioned ipad to use for the duration of the study. each patient will receive a starter kit comprised of two wearable sensor pods, adhesive strips, and instructions. additionally, some kits may contain the provisional ipad mini and charger for those without an approved smart device. should a device malfunction occur, such as a broken pod, the patient can replace it with their spare pod. broken pods should be returned to proteus as soon as possible and all pods must be returned to the clinic upon completion of the study.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * prescribed treatment with digimeds™ * have an android or ios-enabled device (e.g., iphone, ipad, samsung) or be willing to use a proteus issued ios device * signed consent form exclusion criteria: * receiving palliative or hospice care services (i.e., proxy for \<12 months life expectancy) * not proficient in the english language * have impaired cognitive ability * for women: current pregnancy * have skin sensitivity to adhesives or active/chronic dermatitis

Keywords: digimeds capecitabine standard of care
observational study to evaluate the safety while using levemir®

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in africa. the aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin levemir® under normal clinical practice conditions in egypt.


Eligibility criteria:
inclusion criteria: * after the physician decision has been made to use insulin detemir, any subject with type 1 or type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. the selection of the subjects will be at the discretion of the individual physician. exclusion criteria: * subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit; * subjects currently being treated with insulin detemir; * subjects who previously enrolled in this study * subjects with a hypersensitivity to insulin detemir or to any of the excipients * pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. (adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)
comparison of the efficacy and safety between pioglitazone and placebo added to combination therapy in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this trial is to study the efficacy and safety of pioglitazone added to combination therapy of sulfonylurea plus metformin with placebo in patients with type 2 diabetes.

pioglitazone hydrochloride, a thiazolidinedione compound, is a new therapeutic agent for the treatment of type 2 diabetes that reduces insulin resistance by enhancing insulin action in skeletal muscle, liver, and adipose tissue. in the study of diabetes, pioglitazone reduced the hyperglycemia, hyperinsulinemia, and hypertriglyceridemia characteristic of insulin-resistant states. the metabolic changes induced by pioglitazone result in increased responsiveness of insulin-dependent tissues and are observed in numerous models of insulin resistance. in the present randomized, double-blind, parallel study, we aim to compare the efficacy and safety of pioglitazone added to combination therapy of sulfonylurea plus metformin with those of sulfonylurea plus metformin for the treatment of type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: 1. male or female, aged \> 25 years and had been diagnosed as type 2 diabetes for at least 3 months before study entry. 2. subjects have taken sulfonylurea plus metformin therapy for at least 3 months before study entry. 3. subjects have to take daily metformin 500\~2000mg tolerable dosages and sulfonylurea (such as the usage dose of glimepiride ≧4mg; dose of gliclazide≧160mg; dose of glipizide ≧20mg; dose of glyburide≧4mg) for at least 1 months. 4. those subjects with hba1c historical levels between 7.0% and 11.0% within 3 month prior to study entry. 5. bmi between 20-35 kg /m2. 6. each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document. 7. subjects have been under stable diet control for at least 1 month before study entry. 8. subjects are willing to stick to current diet and sulfonylurea plus metformin treatment plan during this trial. exclusion criteria: 1. pregnant women or lactating mothers. 2. type 1 dm(iddm), or diabetes caused by pancreas damage、secondary forms of diabetes, i.e., cushing's syndrome or acromegaly. 3. a history of acute metabolic complication within 3 months before study entry, i.e., ketoacidosis or hyperosmolar state (coma). 4. there are significant macrovascular complications (i.e. unstable angina or acute myocardial infarction) or renal impairment (serum creatinine higher than 1.5 mg/dl). 5. have a known allergy to pioglitazone. 6. other medications can be taken if their use had been instituted before study entry, but agents that can interfere with study evaluations, including other oral antidiabetic agents and corticosteroids, were not allowed.
a pilot trial of modafinil for treatment of methamphetamine dependence

Conditions: Methamphetamine Addiction

Summary: patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. modafinil (d, l-2-\[(diphenylmethyl) sulfinyl\] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimilar to cns stimulants such as the amphetamines, methylphenidate, and pemoline. it is well tolerated and has low abuse liability compared to cns stimulants. modafinil is fda approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when co-administered with intravenous methamphetamine. we will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence. specific aims: 1. determine the safety of modafinil in the treatment of methamphetamine dependence. 2. determine the efficacy of modafinil in the treatment of methamphetamine dependence. 3. assess the effect of modafinil on cognitive function in methamphetamine users. 4. assess the effect of modafinil on methamphetamine withdrawal symptoms. 5. compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring. hypotheses: 1. modafinil will be as safe and well tolerated as placebo in a comparison group from another study. 2. subjects given modafinil will use less methamphetamine than subjects given placebo. 3. subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo. 4. subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo. 5. adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.


Eligibility criteria:
inclusion criteria: * age between 18 and 50 years * patient is agreeable to conditions of study and signs consent form * fluency in english contact site for additional information.

Keywords: amphetamine methamphetamine addition treatment study drug use modafinil
creative therapy to affect stroke outcomes

Conditions: Stroke

Summary: stroke is one of the common diseases in the elderly. it is the third ranking cause of death and affects health care system in our country. the focal brain lesions encountered in patients with stroke can result in impairments in motor function, language, cognition, sensory processing, cognition and emotional disturbances. all of these conditions affect performance of functional activities. the abrupt change in the life situation of the stroke survivor impacts all phases of care. this may reduce a patient's quality of life. many innovative therapy techniques have been developed to help the restoration of lost functions and to aid in prevention and treatment of depression. music and art therapy has been used in rehabilitation settings to stimulate brain functions involved in movement, cognition, speech, emotions, and sensory perceptions. however many research studies on the use of music and art therapy in rehabilitation of acquired brain injury have suffered from small sample size, making it difficult to achieve statistically significant results. in addition, differences in factors such as study designs, methods of interventions, and intensity of treatment have led to varying results.

our study focuses on the use of creative therapy with a patient diagnosed with stroke. creative therapy refers to a group of techniques include art therapy, writing, movement therapy, role play, and music therapy that are expressive and creative in nature. the aim of creative therapies is to help patients find a form of expression beyond words or traditional therapy, such as cognitive or psychotherapy. these therapies use arts modalities and creative processes during intentional intervention in therapeutic, rehabilitative, community, or educational settings to foster health, communication, and expression.

Eligibility criteria:
inclusion criteria: * stroke patients * duration of stroke \>=1 month * age \>=50 years * ability to follow command and communicable exclusion criteria: * unstable medical conditions, including fever, uncontrolled hypertension * serious contact diseases, for example aids, tb * severe dementia or uncontrolled psychiatric problems

Keywords: stroke art therapy music therapy creative therapy efficacy
effect of peep on lung regional ventilation and perfusion

Conditions: Mechanical Ventilation Complication; Respiratory Failure; Hypoxia

Summary: investigate effects of peep on pulmonary regional ventilation and perfusion assessed by eit

1. when the research team was available, adult patients within 7days who were sequentially admitted to the department of critical care medicine and required central venous catheters and mechanically ventilation were eligible for the study. 2. written informed consent was obtained from all patients or next of kin before data were included in the study. 3. information collected at enrollment included demographic characteristics, such as age, sex. 4. the blood pressure（bp）,heart rate（hr）, pulse o2（spo2）,tidal volume and lung regional ventilation and perfusion were collected at peep 0 centimeter h2o column and peep 12-15 centimeter h2o column. 5. indicator-based eit method: rapidly inject 10ml 10% sodium chloride（nacl） through central venous catheter during a 8s respiratory hold, and the curve of impedence change was collected by eit machine

Eligibility criteria:
inclusion criteria: 1. have been placed central venous catheter based on patient's condition 2. under mechanically ventilation 3. under sedation and control ventilation mode 4. year\>18 exclusion criteria: 1. pneumothorax 2. pregnancy 3. severe chest wall wound 4. severe hypernatremia

Keywords: eit pulmonary perfusion ventilation
topical dexamethasone and tacrolimus for the treatment of oral chronic graft-versus-host disease

Conditions: Oral Chronic Graft-versus-host Disease

Summary: the purpose of this research study is to determine the effectiveness of topical steroid therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment of oral chronic graft-versus-host disease (cgvhd)

* because no one knows which study option is best, participants will be "randomized" into one of two study groups: topical dexamethasone or topical tacrolimus. * participants will take the medication by mouth rinse four times a day for 5 minutes at a time. after rinsing they will spit out the medication and will not be able to eat or drink for 15 minutes. * participants will also take anti-fungal medication (fluconazole) orally once a week. * after two weeks on study treatment, participants will have a blood drawn to monitor tacrolimus levels. * after the final treatment (4 weeks), participants will have the following tests and procedures: clinical examination; questionnaire; blood tests; oral culture; optional tissue biopsy.

Eligibility criteria:
inclusion criteria: * patients with oral chronic graft-versus-host disease * patients 4 years of age or older * stable cgvhd medication regimen for the four weeks prior to study enrollment exclusion criteria: * patients already on topical steroid or tacrolimus therapies

Keywords: tacrolimus dexamethasone oral rinse
a study of ngm621 in participants with geographic atrophy

Conditions: Geographic Atrophy

Summary: this is a multi-center evaluation of ngm621 in a randomized, double-masked, sham-controlled study in participants with geographic atrophy secondary to age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * male or female (non-pregnant, non-lactating) subjects ≥ 55 years * standard luminance bcva score of 34 letters or better using etdrs charts at the starting distance of 4 meters (approximately 20/200 snellen equivalent or better) in study eye * clinical diagnosis of ga secondary to amd: 1. total ga area must be ≥ 2.5 and ≤ 17.5 mm² 2. if ga is multifocal, at least one focal lesion must be ≥ 1.25 mm² (0.5 da), with the overall area of ga ≥ 2.5 and ≤ 17.5 mm² 3. well demarcated ga with no anatomical evidence of current or prior cnv in the study eye exclusion criteria: study eye * ga secondary to a condition other than amd in either eye (e.g., monogenetic macular dystrophies like stargardt disease, cone rod dystrophy, or toxic maculopathies) * any history of or active choroidal neovascularization (cnv) both eyes * any history of or active bacterial, viral, fungal, or parasitic infection in either eye in the 3 months prior to randomization
a postural study comparing sitting on the floor versus sitting in a chair while playing video games.

Conditions: Scoliosis

Summary: to determine if sitting in a chair or sitting on the floor lends itself to better posture while playing video games.

upon completion of the parental consent form, each test subject will be instructed to flip a two-sided coin to determine the sitting position of the test subject. if the flip reveals a "heads", the child will be instructed to sit in a chair; chairs will be appropriately sized to allow the child to rest his/her feet on the ground. if the flip reveals a "tails", the child will be instructed to sit on a small carpet piece that measures 2-feet by 2-feet. each test subject will be taken to their gaming station which will sit approximately 8 feet away from a 55-inch flat screen television that will be on a 30-inch table and handed a wireless controller. two gaming stations will be available with one featuring the game lego batman and the other featuring lego indiana jones with both gaming stations testing simultaneously. the test subjects will be told they can play for 5 minutes with a physical therapist at each station to monitor and record the test subjects' positioning.

Eligibility criteria:
inclusion criteria: * english and spanish speaking exclusion criteria: * non-english or non-spanish speaking

Keywords: posture analysis video gaming forward head position rounded shoulder position spine posture
ruxolitinib for chuvash polycythemia

Conditions: Erythrocytosis, Familial, 2

Summary: chuvash polycythemia (cp) is a rare form of congenital polycythemia caused by mutations in the vhl gene. currently, there are no therapies that have proven effective for cp. recent studies have demonstrated that vhl (von hippel-lindau tumor suppressor) regulates the activity of jak2 (janus kinase 2). in mouse models, inhibition of jak2 reverses the cp phenotype. therefore, the investigators hypothesize that jak2 inhibition may have significant clinical benefits for cp patients.

study involvement will last for 48 weeks. there will be approximately 11 visits through week 48. visits may take up to 2-3 hours to complete and occur every 4 weeks for the first 24 weeks, then every 12 weeks until week 48. during each study visit, any or all of the following procedures may occur: * list current medications and participant general health * obtain blood pressure, body weight, body temperature, respiratory rate and heart rate * measure spleen by examination * obtain an abdominal mri to evaluate spleen and any pre-existing or new blood clots * obtain blood samples for safety tests and to monitor kidney/liver function. * questionnaires for participant to complete regarding symptoms related to disease. * ruxolitinib dosing may be increased after 4 weeks if needed. the dose of the ruxolitinib may be reduced related to side effects.

Eligibility criteria:
inclusion criteria: * diagnosis of chuvash polycythemia exclusion criteria: * unable to comprehend or unwilling to sign an informed consent form.

Keywords: polycythemia
a natural history study of fibrodysplasia ossificans progressiva (fop)

Conditions: Fibrodysplasia Ossificans Progressiva

Summary: fibrodysplasia ossificans progressiva (fop) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and ligaments. flare-ups begin early in life and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza infections. recurrent flare-ups progressively restrict movement by locking joints leading to cumulative loss of function and disability. this 3-year, non-interventional, two-part, natural history study is designed to gain insight into total body ho, fop disease progression, the impact of fop on subjects' physical functioning, and clinical features and biomarkers that may be useful in the diagnosis and monitoring of disease progression. this natural history study will also provide important information to inform the design of subsequent interventional trials.

this is a multi-center, natural history, non-interventional, longitudinal study in subjects with classic fop. a thorough baseline examination will be performed to determine the current status of disease in each subject. in part a, two imaging modalities assessed total body ho at baseline, and the optimal method (low-dose whole body ct scan \[excluding head\]) will be employed in part b for the balance of the study. progression will be assessed at annual in-clinic visits (ie, at months 12, 24, and 36) at which time the procedures conducted at the baseline visit will be repeated. in addition, site personnel will telephone subjects midway between the annual visits (ie, at months 6, 18, and 30). during the 36-month follow-up period, at least one new flare-up (with a maximum of one per year) will be carefully studied. an in-clinic visit will be performed within 14 days following the subject's identification of his/her flare-up. additional visits at day 42 and day 84 (after the initial flare-up clinic visit) will be performed. an additional future visit may be scheduled after day 84 at the discretion of the principal investigator (pi) for prolonged flare-ups. however, subjects with an eligible flare-up may elect to participate in an ongoing clementia interventional study rather than continue in this natural history study.

Eligibility criteria:
inclusion criteria: - subjects clinically diagnosed with classical fop with documented r206h mutation or believed to carry the r206h mutation exclusion criteria: - participation in an interventional clinical research study within the 4 weeks prior to enrollment

Keywords: natural history study non-interventional study observational study heterotopic ossification fibrodysplasia ossificans progressiva fop disease progression fop flare-up progression clementia myositosis ossificans progressiva munchmeyer's disease fop palovarotene