Kornimate/medical-research-clean huggingface dataset:
multicenter tissue registry in melanoma

Conditions: Metastatic Melanoma

Summary: the prospective multicenter translational study tissue registry in melanoma (adoreg/trim; ca209-578) aimed to validate the tumor mutational burden (tmb) and the pd-l1 expression (pd-l1) from a pre-therapeutically obtained tumor tissue sample as a predictor of a subsequent systemic therapy in a large real-world cohort of metastatic melanoma patients.

the aim of the present study is to identify and validate molecular and clinical biomarkers of therapy outcome in metastatic melanoma. clinical and molecular parameters of melanoma patients and their tumors will be collected in an online-based registry (adoreg), and thereafter correlated with the outcome of subsequent systemic therapies in terms of progression-free survival, overall survival, and treatment response. systemic therapies will include all types of currently used regimens (kinase inhibitors, immune checkpoint inhibitors, chemotherapy). ffpe tissue samples will comprise different time points (primary tumors versus metastases) as well as tumor sites (lymph node versus organ metastases) to identify potential differences in the predictive value of these materials. the anticipated results from these analyses are of essential importance for future patient selection for individualized therapy strategies.

Eligibility criteria:
inclusion criteria: 1. patients with histologically confirmed melanoma stage iii or iv. 2. clinically eligible for systemic cancer therapy (immune checkpoint inhibitors, targeted agents). 3. tumor tissue biopsy already existing (metastasis tissue as recent as possible, but older tissue material or primary tumor tissue also possible). 4. patient has given written informed consent for the current study as well as for his data to be entered into the adoreg online database system. 5. patient is ≥18 years old. exclusion criteria: -

Keywords: melanoma biomarker tumor tissue systemic therapy immune checkpoint therapy targeted therapy pd-l1 tumor mutational burden
trial to confirm the clinical efficacy and safety of dasiglucagon in the treatment of hypoglycemia in subjects with t1dm

Conditions: Hypoglycemia; Diabetes Mellitus, Type 1

Summary: a randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (t1dm) compared to placebo

subjects were randomized in a ratio of 3:1 to receive a single subcutaneous dose of dasiglucagon (0.6 mg) or matching placebo. randomization also determined whether the subject was to be injected in the buttock or deltoid. during the dosing visit (visit 2), hypoglycemia was induced by a fast-acting insulin glulisine (apidra®) infusion, and trial drug was administered when the subject's plasma glucose level was 45-60 mg/dl (2.5-3.3 mmol/l). during the insulin-induced hypoglycemia, pharmacokinetic and pharmacodynamic samples were drawn, and plasma glucose levels were monitored closely at site for safety reasons. a rescue glucose infusion could be administered to ameliorate persistent hypoglycemia. subjects were followed for at least 28 days after dosing to perform an adequate immunogenicity evaluation of treatment.

Eligibility criteria:
inclusion criteria: * female or male subjects with t1dm for at least 1 year; diagnostic criteria as defined by the american diabetes association (3). * treated with insulin for t1dm for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening * hemoglobin a1c \<10%. * aged between 18 and 75 years, both inclusive. exclusion criteria: * previous participation in a clinical trial within the dasiglucagon in the rescue treatment of hypoglycemia program. * known or suspected allergy to trial drug(s) or related products. * history of anaphylaxis or symptoms of severe systemic allergy (such as angioedema). * previous participation in this trial. participation being defined by signing the informed consent document.

Keywords: glucagon
valacyclovir+temovate gel for the treatment of herpes labialis

Conditions: Herpes Labialis

Summary: a randomized study comparing the combination of valacyclovir and temovate gel (clobetasol gel) versus placebo for the treatment of recurrent herpes labialis (cold sores).

herpes simplex labialis is a common, worldwide affliction for which neither public health procedures, vaccines, nor antiviral chemotherapy have had a major impact. the present study has been proposed because it has become clear there are marked limitations to the benefit of antiviral therapy in herpes labialis. recently, a pilot trial of the combination of famciclovir and topical 0.05% fluocinonide vs famciclovir alone showed that the addition of corticosteroids to the antiviral drug treatment caused a marked and statistically significant reduction in lesion size and a trend to more aborted lesions. this study is designed as a randomized, placebo-controlled, , patient-initiated study. the objective of this study is to evaluate the safety and efficacy of oral valacyclovir 2grams bid for one day and topical temovate 0.05% gel bid for three days compared to placebo capsules and placebo gel in the episodic treatment of a single episode of recurrent herpes labialis in immunologically normal patients. subjects will be screened, randomized to study drug and instructed to start using study drug within one hour of the first sign or symptom of their next episode of herpes labialis. data on the treated lesion will be collected by clinic visits and a patient diary card.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * a history typical for recurrent herpes labialis. the subject must have experienced three or more cold sores in the last 12 months. * in general good health, without other serious medical conditions, as determined by the patient's account of his/her medical history. * signature on the informed consent document. exclusion criteria: * patients who have participated in an investigational drug study in the four-week period prior to enrollment. * previous herpes vaccine at any time. * patients with major medical conditions such as chronic heart, pulmonary, renal or hepatic diseases. * patients with immunodeficiency disorders such as hiv infection or cancer chemotherapy. * patients using topical steroids on or near the face or systemic steroids within 30 days of enrollment. * women who are pregnant, lactating or breast feeding. * women of childbearing potential not using adequate contraception as judged by the investigator. * recent history of alcohol or drug abuse, which in the opinion of the investigator, may interfere with that study patient's compliance with study requirements. * significant skin disease such as atopic dermatitis, acne, or rosacea that would interfere with the assessment of lesions. * allergy or hypersensitivity to steroids, acyclovir, penciclovir and/or other nucleoside analogues. * subjects with impaired renal function as defined as a serum creatinine above the upper limits of normal.
mri and ultrasound findings in patients with gout and normal plain radiographs

Conditions: Gout

Summary: radiographic imaging plays a key role in managing the long-term effects of hyperuricemia on the skeletal system. two of the accepted indications for prophylactic urate-lowering drugs in patients with hyperuricemia are gouty tophi and erosions. while much data exist on the plain radiographic changes that are seen in patients with chronic gout, far less is known about the changes seen on other imaging modalities, such as magnetic resonance imaging (mri) and ultrasound (us). further, there is very little data on the mri and us appearance of asymptomatic joints in patients with hyperuricemia and symptomatic gout. there is vast emerging data to suggest that mri and us are much more sensitive than plain radiographs at detecting the early stigmata of rheumatoid arthritis (ra). indeed, these imaging devices have revolutionized the treatment of ra, for the earlier detection of the skeletal changes of ra often mandates more aggressive therapy. these same changes would often be missed by plain radiographs. it is our hypothesis that mr imaging and us will detect the skeletal changes that are typical of gout much sooner than would plain radiography. we also hypothesize that these same imaging techniques will be able to detect signs of hyperuricemic silent deposition in asymptomatic joints of patients with symptomatic gout in other joints. as was the case with ra, the expected results of this study would mandate more aggressive therapy of both gout and hyperuricemia. our primary aim of this proposal would be accomplished by studying patients with known gout and normal plain radiographs. each patient would have their most frequently involved joint (index joint) analyzed by mri and us to evaluate for any destructive changes (erosions or tophi with cortical damage). any signs that may portend future joint destruction such as synovial pannus, bone marrow edema, soft tissue edema, or joint effusions will also be documented. in order to demonstrate the effects of hyperuricemic silent deposition, an asymptomatic joint from these same patients will be studied using these same imaging techniques. any evidence of erosions, tophi, synovial pannus, bone marrow or soft tissue edema, or joint effusions will be recorded. by demonstrating destructive, or potentially destructive, skeletal changes in the index joint or asymptomatic joint of a significant number of patients, we will show that patients who are left untreated on the basis of normal plain radiographs are likely to already have skeletal damage.


Eligibility criteria:
inclusion criteria: * known history of gout exclusion criteria: * history of any other inflammatory arthritis (ex. rheumatoid arthritis, psoriatic arthritis) * history of another crystal induced arthritis (ex. pseudogout) * any contraindication to receiving an mri (ex. pacemaker) * allergy to gadolinium contrast dye * inability to give informed consent * pregnant women * erosive changes on initial screening x-ray of index joint * serum creatinine \> 1.8 mg/dl at screening visit
analysis of next generation pet and liquid biopsy to monitor mcrpc treated with abiraterone: angela trial

Conditions: Prostate Cancer; Castration-resistant Prostate Cancer; Metastatic Disease

Summary: by incorporating dual-tracer pet/ct (psma and fdg) and ctdna, we aimed to evaluate lesion heterogeneity and genomic change of mcrpc patients receiving novel hormonal therapy. the relationship between treatment response and different molecular characterization, as well as imaging features would also be evaluated.


Eligibility criteria:
inclusion criteria: 1. diagnosed as mcrpc according to eau-estro-siog 2016 and psa \> 10ng/ml; 2. no previous treatment with novel hormonal therapy; 3. ecog 0-2; 4. normal organ function, wbc \>= 3000/mm3 or neutrophil \>= 1500/mm3; 5. aged 18 to 85 years old when issuing written informed consent; 6. life expectancy \> 12 months. 7. consent and able to carry out follow-up visit and cooperate with all other study procedures. exclusion criteria: 1. severe disease or other medical conditions suggesting a high risk of death within 1 year, which may interfere with follow-up. decided by investigator; 2. diagnosed with any other malignant tumor within 3 years before enrollment; 3. unable to provide necessary follow-up information; 4. other conditions that are judged as ineligible by the investigator.
clinical comparison of two daily disposable lenses among daily disposable lens wearers

Conditions: Myopia

Summary: the primary objective of this trial is to evaluate the subjective performance of two different daily disposable contact lenses in a population of daily disposable lens wearers.


Eligibility criteria:
inclusion criteria: * currently wearing any spherical daily disposable lens in daily wear, daily disposable modality for at least 3 months prior to enrollment with the exception of the 2 study products * currently wearing lenses at least 8 hrs/day and 5 days/week. * other protocol-defined inclusion criteria may apply. exclusion criteria: * eye injury or surgery within twelve weeks immediately prior to enrollment for this trial. * pre-existing ocular irritation that would preclude contact lens fitting. * currently enrolled in any clinical trial. * evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator. * any use of medications for which contact lens wear could be contraindicated as determined by the investigator. * prior history of corneal or refractive surgery. * requires monovision correction. * other protocol-defined exclusion criteria may apply.
a pharmacokinetic study of avanfil in healthy young male subjects

Conditions: Avanfil ADME; Semen Exposure; Sperm Function

Summary: the purposes of this study are to: * determine the effect of the study drug on sperm and semen of healthy young male subjects. * determine the effect of age on the amount of study drug in the blood of healthy subjects * learn about the safety of the study drug. * learn how subjects tolerate the study drug.

this single-center, open-label, non-randomized, two-cohort, single-dose pharmacokinetic study will be conducted at a single site in the united states, in which at least 18 young (18-45 years, inclusive) male subjects in cohort a and 14 elderly (65 years or older) males in cohort b will be enrolled and dosed to achieve a total of at least 14 completed young subjects and 12 elderly subjects. seminal fluid and plasma will be collected from cohort a, whereas only plasma samples will be collected from cohort b.

Eligibility criteria:
inclusion criteria: * cohort a: adult male subjects of 18 to 45 years of age inclusive cohort b: adult male subjects at least 65 years of age * all subjects must be medically healthy with no clinically significant screening results. * male subjects should be willing to use a condom and spermicide during sexual activity for 90 days after last dosing of avanafil and be willing to not donate sperm for 90 days after dosing. exclusion criteria: major exclusion criteria for all subjects include: * history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematologic, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment * any clinically significant laboratory abnormalities as judged by the investigator * systolic blood pressure \ 150 mmhg * diastolic blood pressure \ 95 mmhg * allergy to or previous adverse events with pde5 inhibitors * use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome p450 3a4 enzyme within 30 days of screening * use of any investigational drug within 30 days of screening * use of any prescription or over-the-counter drugs or herbal remedies within 14 days of screening * history of alcohol or drug abuse within 18 months, history of smoking within 6 months * positive urine alcohol test * positive urine drug screen * positive urine cotinine test, positive serology for hiv, hcv, hbsag * young males who have undergone vasectomy cannot participate in this-study * additional exclusion criteria are listed in section 4.2.

Keywords: semen sperm avanafil pharmacokinetics elderly
impact of sugammadex vs. neostigmine reversal on post-operative recovery and complications

Conditions: Obstructive Sleep Apnea

Summary: sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs (nmbd). this study will evaluate whether reversal of nmbd with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (or) in obese patients with osa undergoing bariatric surgery. half of the patients in the study will receive sugammadex and the other half of the patients will receive neostigmine.

sugammadex and neostigmine are nmbd reversal agents. neostigmine - an anticholinesterase is given to reverse nmbd; however reversal of nmbd with neostigmine may be associated with residual neuromuscular blockade in up to 64% patients postoperatively in the post anesthesia care unit. even mild degrees of residual neuromuscular blockade can have serious clinical consequences in the postoperative period. the severity of osa often worsens after surgery and patients with osa are at increased risk for early respiratory complications after extubating and in the pacu. morbid obesity is associated with critical respiratory complications in patients with osa. sugammadex is a newer nmbd reversal agent that rapidly and completely reverses rocuronium. it is a modified gamma cyclodextrin that forms a complex with the neuromuscular blocking agent rocuronium. it reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. it has been shown to more rapidly reverse residual neuromuscular blockade than neostigmine in obese patients without obstructive sleep apnea (osa). this study will evaluate whether reversal of nmbd with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (or) in obese patients with osa undergoing bariatric surgery. half of the patients in the study will receive sugammadex and other half of the patients will receive neostigmine

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * diagnosed obstructive sleep apnea patients by polysomnography * scheduled elective bariatric surgery exclusion criteria: * age\<18 years old * allergy to rocuronium * allergy to sugammadex * allergy to neostigmine * malignant hyperthermia * hepatic insufficiency * renal insufficiency * neuromuscular disease * pregnancy

Keywords: recovery time reversal of neuromuscular blockers (nmb) obstructive sleep apnea morbid obesity bariatric surgery
prevalance of temporomandibular joint disease

Conditions: Temporomandibular Joint Disorders

Summary: temporomandibular joint (tmj) disorders are common problems in the society and involve the masticator muscles, jaw joint and related structures. since tmj disorders affect functions such as eating and speaking, they can cause important problems in the daily life of the patient. therefore, its diagnosis and treatment are of great importance. in the treatment of these patients, methods such as analgesic and anti-inflammatory drugs, splint, exercise, physical therapy modalities can be applied.

although the prevalence of tmj disease detected in the community is between 40-60%, the rate of symptoms or clinical findings was reported to be 87% in a study including 1040 people. incomplete clarification of the etiology and pathogenesis, the lack of standard diagnostic and treatment approaches cause patients to learn to live with this problem, and severe pain and limitation of movement cause a decrease in quality of life and loss of workforce. specific pathologies such as systemic inflammatory diseases, tumor, fracture, developmental anomaly cause temporomandibular joint diseases. it also causes a wider group of non-specific tmb originating from the musculoskeletal system.when the literature was reviewed, no publications on the frequency of tmj joint disease were found in medical faculty students.

Eligibility criteria:
inclusion criteria: * being a medical student * being between the ages of 18-35 exclusion criteria: * students who do not want to participate in the study

Keywords: temporomandibular joint disorders
two cases of pulmonary cysticercosis manifesting as pleural effusion: case report and literature review

Conditions: Cysticercosis

Summary: isolation lung cysticercosis reports are rare in literature. most lung lesions were characterized by nodules. the investigators access one case which was characterized with pulmonary cavity and pleural effusion by gupta n, et al in 2015 from pubmed and medline. but pleural effusion and exudative lesions is reported for the first time.

cysticercosis is an important public health problem in developing countries. the major involvement sites are the central nervous system and the eyes，although striated muscles and subcutaneous tissues are frequently involved in the disseminated form of disease. pulmonary involvement in cysticercosis is very rare and ill-defined nodular shadows distributed throughout the lung is the usual radiological presentation. only one case of cysticercosis presenting as lung cavity with pleural effusion has been reported so far in literature. the investigators describe two cases in which pleural effusion due to cysticercosis were detected on x and ct.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of pulmonary cysticercosis。 2. with pleural effusion exclusion criteria: 1.no cysticercosis was found by biopsy or antibody test

Keywords: cysticercosis pleural effusion pulmonary
text messaging for weight loss

Conditions: Obesity

Summary: overweight and obese adults recruited from the primary care setting (n=150) will be enrolled in a 6-month randomized trial of the intervention versus control. both groups will receive usual medical care, printed materials, and educational text messages. the intervention group will also receive personalized coaching and feedback, as well as peer support, via text message. the investigators hypothesize that compared to those in the control group, patients in the intervention group will lose more weight and demonstrate more favorable changes in fruit and vegetable intake, exercise, and social support for weight loss.


Eligibility criteria:
inclusion criteria: * approved to participate by pcp (patients with diabetes, hypertension, or dyslipidemia will be eligible if approved by their pcp) * age ≥ 21 years * body mass index (bmi) 25 to 45 kg/m2 and weight ≤ 400 pounds * goal of losing weight (not just maintain weight) * willing to change diet, physical activity in order to lose weight. * currently uses text messaging in english on mobile phone * willing to use send and receive text messages for this study without direct compensation for cost of messages (general compensation for study participation will be provided) * have a scale at home for self-monitoring weight * fluent in english (speak, read, write) * commit to return for follow-up weight at 6 months regardless of amount of weight lost exclusion criteria: * involuntary or voluntary weight loss of ≥ 5% body weight in previous 6 months * participating in research project involving weight loss, exercise, or dietary modification in the previous 6 months * any of the following medical conditions which could affect weight or for which weight loss is contraindicated * end-stage liver disease * end-stage kidney disease * cancer within previous 2 years (except non-melanoma skin cancer) * myocardial infarction, stroke, or transient ischemic attack within previous 6 months * unstable angina * severe arthritis or other medical conditions which would prevent brisk walking * schizophrenia * hospitalization for psychiatric problems during the prior 12 months. * current use or anticipated future use (during 6 month study) of medications that could cause weight loss: * phentermine * orlistat (prescription xenical or otc alli) * topiramate * buprioprion * exenatide (byetta) * liraglutide (victoza) * prior bariatric surgery or plans for bariatric surgery in next 6 months * pregnant or breast feeding within the previous 6 months * planning to become pregnant in next 6 months * consumes \> 14 alcoholic drinks per week * current use of illicit drugs * planning to move out of the area in the next 6 months * another member of household or a close contact is participating in the study

Keywords: obesity weight loss text message