Kornimate/medical-research-clean huggingface dataset:
a study of sotorasib (amg 510) in participants with stage iv nsclc whose tumors harbor a kras p.g12c mutation in need of first-line treatment

Conditions: Non-small Cell Lung Cancer

Summary: the main objective of this study is to evaluate the tumor objective response rate (orr) assessed by response evaluation criteria in solid tumors (recist) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (pd-l1) tumor proportion score (tps) \< 1% and/or harbor a serine/threonine kinase 11 (stk11) co-mutation, in a subgroup of participants with pd-l1 \< 1% and in a subgroup of participants with stk11 co-mutation.


Eligibility criteria:
inclusion criteria: * adult (= or \> 18 years old) with nsclc * untreated stage iv metastatic disease. participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage iv disease * pathologically documented metastatic nsclc with kras g12c mutation (local confirmation) * programmed death-ligand 1 (pd-l1) tps score \< 1% and/or serine/threonine kinase 11 (stk11) co-mutation (local confirmation) * eastern cooperative oncology group (ecog) score of 0 or 1 * no active brain metastases * measurable disease per investigator interpretation using response evaluation criteria in solid tumors (recist) 1.1 criteria exclusion criteria: * mixed small-cell lung cancer and nsclc histology * myocardial infarction within 6 months of study day 1 * use of proton-pump inhibitors (ppis), histamine (h2) receptor antagonists (h2ra), strong inducers of cytochrome p450 (cyp) 3a4 (cyp3a4) or known cyp3a4 sensitive substrates or p-gp substrates * therapeutic or palliative radiation therapy within 2 weeks of study day 1 * unable to take oral medication * unable to receive both iodinated contrast for computed tomography (ct) scans and gadolinium contrast for magnetic resonance imagine (mri) scans

Keywords: non-small cell lung cancer kras p.g12c sotorasib amg 510
oral steroid in controlling pain after tka

Conditions: Pain, Acute

Summary: to compare efficacy of oral steroid in controlling pain after tka

to compare pain and functional outcome for oral dexamethasone 16 mg, 8 mg and pacebo in patient undergoing unilateral primary total knee arthroplasy

Eligibility criteria:
inclusion criteria: * patients with osteoarthritis of the knee who undergoing unilateral tka * asa class i-iii * informed consent * good cognitive function exclusion criteria: * uncontrolled dm (hba1c \> 7) * uncontrolled ht * morbid obesity (bmi \> 40) * history of bleeding in gi tract * corticosteroid used within 6 months * sever liver or renal impairments * studied drug allergy

Keywords: oral corticosteroid postoperative pain dexamethasone total knee arthroplasty
efficacy and safety of ryanodex® (egl-4104) as adjuvant treatment in subjects with exertional heat stroke (ehs)

Conditions: Heat Stroke

Summary: study egl-4104-c-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel study of ryanodex for the adjuvant treatment of exertional heat stroke (ehs) administered intravenously (iv), to current standard of care (soc). soc for the treatment of ehs is defined as effective body cooling, which should be implemented as quickly as available after diagnosis of exertional heat stroke.

the study will take place at emergency medical facilities. due to the life-threatening nature of exertional heat stroke (ehs), rapid assessment for inclusion into the study and subsequent immediate treatment must occur. following initial triage and primary assessment of a subject, the subject's baseline status should be documented, and once a diagnosis of ehs is obtained, soc treatment will be initiated immediately, the subject will be randomized to one of two treatment arms (soc only or soc plus ryanodex). patients will be remain hospitalized for up to 72 hours after administration of the first dose of study drug and implemented soc and will receive all necessary supportive measures until resolution of symptoms. study duration: 72 hours

Eligibility criteria:
inclusion criteria: * subjects may be entered in the study if they have a core body temperature obtained rectally of ≥ 40.0°c (104°f) * recent history or suspected recent history (prior 24 hours) of performing intense physical activity (exertional activity) * the subject has an impaired consciousness level as evidenced by a gcs score \< 13 * the subject has tachycardia (heart rate ≥ 100 bpm) exclusion criteria: * the subject is diagnosed with or is suspected of having an acute clinically severe infection, which in the opinion of the investigator may increase the subject's risk for participating in the study and/or may impair the ability of performing and/or interpreting study assessments * the subject has severe hyperthermia secondary to a condition other than heat stroke (e.g., serotonin syndrome, thyrotoxicosis, pheochromocytoma, or brain hemorrhage) * there is likelihood of head trauma in the past 6 months, or other significant cardiovascular, pulmonary, hepatic, endocrine, or renal illness that in the opinion of the investigator may increase the subject's risk for participating in the study and/or may impair the ability of performing and/or interpreting study assessments * a female subject has a positive pregnancy test (urine) or evidence of active lactation * reported known use of potent cyp3a4 inhibitors * a known history of allergy or hypersensitivity to dantrolene * a history of chronic and ongoing assisted mechanical ventilation prior to the onset of ehs via an established artificial or supported airway (e.g., for severe chronic obstructive pulmonary disease \[copd\], upper airway disease, impaired respiratory function). note: endotracheal intubation and mechanical ventilation as part of supportive measures for the treatment of ehs are allowed
assessment vitamin d analogues intake pathways on the proteins which involved in metabolic rate in obese subjects

Conditions: Obesity

Summary: the aim of this double blind clinical trial study is to investigate whether alphacalcidol treatment in obese subjects can affect the resting metabolic rate. moreover, the investigators will evaluate the pathways of nesfatin-1, peroxisome proliferator-activated receptor gamma (pparγ) and eroxisome proliferator-activated receptor- coactivator-1 α (pgc1α) protein which may lead to change in metabic rate following treatment with either alphacalcidol or placebo.


Eligibility criteria:
inclusion criteria: age 22-52 years body mass index equal or more than 30 exclusion criteria: acute or chronic inflammatory disease history of hypertension alcohol or drug abuse history of any condition affecting inflammatory markers thyroid diseases malignancies current smoking diabetes mellitus sustained hypertension heart failure acute or chronic infections hepatic or renal diseases use of pparγ agonist drug

Keywords: vitamin d analogues resting metabolic rate obesity
utility and cost-effectiveness of microscopic examination of the neck dissection.

Conditions: Metastasis

Summary: most patients with cancer of the head and neck are offered surgical resection of the primary tumor. in order to determine how the tumor will eventually behave, along with the resection of the primary tumor, lymph nodes present in the neck are also dissected. different institutes have different protocol on handling of the specimen that is received by the pathology labs after dissection of the neck. the investigators intend to analyze the protocol that they use to evaluate the neck dissection specimen.

this will be a retrospective study. all neck dissections received in the histology laboratory from jan 2013 to december 2016 will be retrieved from the histopathology files by conducting a search through copath. the glass slides of all the neck dissections that fit the study criterion will be retrieved from the archives. the glass slides will be reviewed by the pathologist. at the time of review number of lymph nodes identified microscopically, presence or absence of metastasis and if the lymph nodes (ln) were palpable or not palpable will be documented. the data will be analyzed to see if the submission of extra fat yielded any additional positive lymph nodes or microscopic deposits. the cost analysis for additional slides will be also done.

Eligibility criteria:
inclusion criteria: 1. neck dissection (unilateral and/or bilateral) 2. primary squamous cell carcinoma of head and neck exclusion criteria: 1. any neck dissection performed outside ummc and case received as a consult.
intra-articular dexmedetomidine versus neostigmine after knee arthroscopy (a comparative study)

Conditions: Knee Injuries

Summary: knee arthroscopy is a minimally invasive day case procedure which may be done for diagnosis, meniscectomy or debridement. arthroscopic surgery is associated with a variable degree of postoperative pain, which is caused by an irritation of free nerve endings of the synovial tissue, anterior fat pad, and joint capsule due to surgical excision and resection

many studies were done using different intra-articular agents as local anesthetics, opioids, ketamine and alfa2- adrenergic agonists for prevention and treatment of pain after knee surgeries. dexmedetomidine is a potent and highly selective alfa2-adrenoreceptor agonist. it has sedative-hypnotic, anxiolytic, analgesic, anesthetic and sympatholytic effects. intra-articular dexmedetomidine was used in several studies to enhance postoperative analgesia after knee arthroscopy with an increased time to first analgesic request and a decreased need for postoperative analgesia neostigmine is an anticholinesterase and also has antinociceptive effects when administered intrathecally or peripherally.

Eligibility criteria:
inclusion criteria: * patients aged above 18 years * scheduled for elective arthroscopic knee surgery under intrathecal anaesthesia exclusion criteria: * absolute or relative contraindications for intrathecal anaesthesia, * allergy for the studied drugs. * patients having history of cardiovascular, cerebrovascular, and respiratory diseases, * patients receiving chronic pain treatment or hypertension treated with alfa methyldopa, clonidine or beta adrenergic blockers were excluded from the study.

Keywords: knee arthroscopy dexmedetomidine neostigmine
statin and post-interventional coronary microcirculation dysfunction

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.

development of peri-procedural myocardial infarction following percutaneous coronary intervention (pci) is not uncommon and affects long-term prognosis. clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. the mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. however the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet. in this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. at the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. percutaneous coronary intervention (pci) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. when pci is performed, fractional flow reserve (ffr) and index of microvascular resistance (imr) will be measured before and after the procedure. periprocedural myocardial infarction will be defined by post-pci cardiac biomarker. all patients will be followed for adverse cardiac events for 1 year.

Eligibility criteria:
inclusion criteria: * a. finished informed consent * b. stable angina with clinical indication of coronary angiography * c. age ≥ 21 year and ≤ 80 year exclusion criteria: * a.without informed consent * b.pci target lesion is not adequate or not indicated for ffr/imr study * c.prior myocardial infarction or interventional procedure for pci target vessel * d.myocardial infarction within 30 days * e.usage of statin, current or within 1 month * f.prior bypass surgery * g.impaired renal function (creatinine \> 2.0 mg/dl) * h.impaired left ventricular function (ejection fraction \< 40%) * i.active hepatitis or abnormal hepatic transaminase level (\> 3 uln) * j.contraindication for long-term antiplatelet agent or statin * k.planning or potential of pregnancy * l.neoplastic disease without evidence of treatment completion * m.impaired general condition
temporal relationship between motor fluctuations and nonmotor fluctuations

Conditions: Parkinson Disease

Summary: the purpose of this study is to determine the temporal relationship between motor fluctuations and non-motor fluctuations in persons with parkinson's disease. observational study case-only

objectives 1. how many patients will experience motor or nonmotor fluctuation during follow-up period? 2. in how many patients, does motor fluctuation precede nonmotor fluctuation? 3. in how many patients, does nonmotor fluctuation precede motor fluctuation? participants: persons with parkinson disease in early stage who does not have motor or nonmotor fluctuation recruitment period: 3 years from the commencement of the study follow-up period: 3 years for each participants

Eligibility criteria:
inclusion criteria: * clinical diagnosis of parkinson disease by united kingdom parkinson's disease society brain bank criteria * early stage exclusion criteria: * dementia (mmse\<26) * persons who refuse participating

Keywords: parkinson disease
an evaluation of the safety of csf-1 in presbyopic subjects

Conditions: Presbyopia

Summary: this is a multi-center, double-masked, vehicle-controlled study. the purpose of the study is to evaluate the safety of csf-1 compared with vehicle in presbyopic subjects. subjects will be treated for at least 6 weeks.


Eligibility criteria:
inclusion criteria: * subjects must have presbyopia exclusion criteria: * have any contraindications to the study medications or diagnoses that would confound the study data
tetrathiomolybdate in hormone refractory prostate cancer

Conditions: Prostate Cancer

Summary: purpose: the aim of this clinical trail is to evaluate tetrathiomolybdate (tm) in the treatment of hormone refractory prostate cancer.

tetrathiomolybdate or tm, a drug developed for wilson's disease, removes copper from the bloodstream. copper is a key factor in angiogenesis (blood vessel growth)- a process that occurs normally in the body but becomes uncontrolled in cancerous cells. tetrathiomolybdate essentially wages war against copper, which serves to choke off tumor growth. realizing the key role of copper in angiogenesis, researchers have begun exploring treatment with tetrathiomolybdate for different types of cancers. this clinical trial will evaluate the effectiveness of tetrathiomolybdate in the treatment of patients with hormone refractory prostate cancer. hormone refractory prostate cancer refers to advanced disease in which the patient no longer responding to conventional hormonal treatment.

Eligibility criteria:
inclusion: * patients must have histologic diagnosis of adenocarcinoma of the prostate with progression following hormonal therapy and antiandrogen withdrawal. * patients must have minimal disease (defined as bone metastasis or visceral disease with no impairment of organ function or pain severe enough to require narcotics for control). * adequate bone marrow and renal function * ecog (eastern cooperative oncology group) score of 0 or 1 (a measure of general well being where 1 represents asymptomatic and 5 represents death) * life expectancy of at least 16 weeks * must have completed radiation more than 4 weeks prior to registration and must have a rising psa (prostate specific antigen) and lesion outside of the radiation field exclusion: * patients with an elevated psa as the only evidence of disease * clinical evidence of spinal cord compression * history of prior malignancy within the past 5 years (with the exception of in situ carcinoma of any site or nonmelanoma skin cancer)
study evaluating rhmbp-2/cpm in open wedge osteotomies

Conditions: Osteoarthritis

Summary: to assess the feasibility of using rhbmp-2/cpm in owo as a surgical model for pharmacodynamic studies, with assessment of the following parameters: * injecting the desired volume of rhbmp-2/cpm within the defect * conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhbmp-2/cpm.


Eligibility criteria:
inclusion criteria: * male or female subjects 45 to 70 years of age * within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment oa of the knee. * female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for owo and agree to use medically approved contraception for the duration of the study. other inclusion applies. exclusion criteria: * subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results. * subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up. * subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma. other exclusion applies.

Keywords: osteoarthritis deformity of knee
potassium citrate and crystal light lemonade

Conditions: Kidney Stone

Summary: to define the effect of crystal light, potassium citrate, or both on urinary stone risk factors in patients with a history of stone and hypocitraturia/low ph


Eligibility criteria:
inclusion criteria: 1. men and women between age 18-80 years 2. willing to follow experimental protocol 3. willing to complete 24-hour urine collections (three total) 4. willing to sign the informed consent form 5. completed litholink collection with blood work with results a. hypocitraturia or aciduria i. hypocitraturics must meet definition of \< 450 mg/day for men \< 550 mg/day for women. b. low urine ph must be less than 5.6 c. potassium, bun, creatinine, egfr and hemoglobin a1c within normal limits exclusion criteria: 1. patients with severe hypocitraturia \< 200 mg/day (men or women) 2. patients with hyperkalemia, uncontrolled diabetes, chronic kidney disease, adrenal insufficiency, delayed gastric emptying (or drug induced delayed gastric emptying), peptic ulcer disease, or active uti 3. patients with distal renal tubular acidosis or medication induced rta (e.g. carbonic anhydrase inhibitor, topiramate) 4. members of vulnerable patient populations 5. allergies to ingredients in crystal light 6. patients lacking decisional capacity
safety and efficacy of buprenorphine transdermal system (btds) in subjects with chronic nonmalignant pain

Conditions: Chronic Non-malignant Pain

Summary: the objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. the double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility criteria:
inclusion criteria: * at least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy. * good, very good or excellent pain control on current opioid therapy. * willing and able to use a telephone interactive voice response service. exclusion criteria: * currently receiving daily morphine or oxycodone monotherapy. * scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period. other protocol-specific exclusion/inclusion criteria may apply.

Keywords: chronic pain opioid transdermal butrans™ [btds]
multidisciplinary intervention in chronic gvhd

Conditions: Stem Cell Transplant Complications; Graft Vs Host Disease; Coping Skills; Quality of Life

Summary: this research is being done to evaluate the feasibility and efficacy of a multidisciplinary, patient-centered intervention, horizons program, versus minimally enhanced standard care to improve quality of life, symptom burden and psychological distress of adults who received an allogeneic hematopoietic stem cell transplant and developed graft versus-host disease (gvhd).

this randomized research study is being conducted to see if the horizons program compared to usual care is manageable and effective at improving understanding of chronic gvhd and treatment, coping, and quality of life. randomization means that participants will be put into one of two groups by chance: * horizons program --individuals who receive the horizons program will attend 8 weekly 90-minute group sessions using a secure telehealth videoconferencing system * usual care --individuals who receive usual care will also receive an educational booklet. the research study procedures include: * screening for eligibility * a brief test of videoconferencing software * completion of three study assessments (after signing consent but before randomization and at 8 weeks and 16 weeks after the start of the horizons program) * individuals who receive usual care will also receive an educational booklet. it is anticipated 80 people will take part in this research study. the mgh bmt survivorship program is supporting this research study by providing funding for this project.

Eligibility criteria:
inclusion criteria: * adult patients (≥ 21 years) who underwent allogeneic hct * have moderate to severe chronic gvhd * are currently receiving their care at the mgh blood and marrow transplant clinic * have the ability to participate in an english language group intervention exclusion criteria: * patients with comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention * vulnerable patients, defined here as prisoners and pregnant women, will not be included in the intervention

Keywords: stem cell transplant complications graft vs host disease coping skills quality of life
patient engagement study to evaluate the use of biological therapies for cardiac arrhythmias

Conditions: Arrythmia

Summary: in this patient engagement study, patients and partners will attend a presentation, group meeting and responding to the survey to help the research team gage the acceptability of using a biological therapy to prevent cardiac arrhythmia. patient partners will also help to clarify which outcomes are important to patients, to ensure the selected outcomes align with patient interests.

there will be four study groups: 1. heart patients who experienced a cardiac arrhythmia while in hospital, 2. heart patients who did not experience a cardiac arrhythmia while in hospital, 3. heart patients with an upcoming procedure that have not had a cardiac arrhythmia, 4. members of the general public. there will be a presentation, two surveys and a team meeting. results will be compiled and analyzed.

Eligibility criteria:
inclusion criteria: * upcoming or previous cardiac procedure. exclusion criteria: * inability to complete an electronic survey or participate in a small group meeting.

Keywords: patient engagement