Kornimate/medical-research-clean huggingface dataset:
tpf induction chemotherapy for locally advanced and resectable oral squamous cell carcinoma

Conditions: Stage III Oral Cavity Squamous Cell Carcinoma; Stage IVA Oral Cavity Squamous Cell Carcinoma

Summary: induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radical surgery and/or radiotherapy. however, there are still debates on the clinical value of induction chemotherapy for patients with advanced and resectable oral squamous cell carcinoma. the hypothesis of this study is that the induction chemotherapy of tpf (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with locally advanced oral squamous cell carcinoma. the endpoints of this study are the survival rate, local control, and safety.

the primary endpoint of this study is the survival rate (2, 3, 5 years) after induction chemotherapy followed by surgery and radiotherapy. the second endpoint of this study is locoregional control rates (1, 2 years), and the safety.

Eligibility criteria:
inclusion criteria: * written informed consent prior to any study activities * age 18-75 years old * histological biopsy confirming oral squamous cell carcinoma (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region) * clinical stage iii/iva (t1-2, n1-2, m0 or t3-4, n0-2, m0, uicc 2002), resectable lesions * karnofsky performance status (kps) \> 60 * adequate hematologic function: white blood cell \> 3,000/mm\^3, hemoglobin \> 8g/l, platelet count \> 80,000/mm\^3 * hepatic function: alat/asat \< 2.5 times the upper limit of normal (uln), bilirubin \< 1.5 times uln * renal function: serum creatinine \< 1.5 x uln * life expectancy ≥ 6 months exclusion criteria: * evidence of distant metastatic disease and other cancers * surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment * previous radiotherapy for the primary tumor or lymph nodes * prior chemotherapy or immunotherapy for the primary tumor * other previous malignancy within 5 years * systematic diseases history of severe pulmonary or cardiac diseases * creatinine clearance \< 30 ml/min * legal incapacity or limited legal capacity * pregnancy (confirmed by serum or urine β-hcg) or lactation period

Keywords: oral squamous cell carcinoma induction chemotherapy surgery radiotherapy
lipoic acid supplement for cystine stone

Conditions: Cystinuria

Summary: this study evaluates how daily alpha lipoic acid supplementation affects cystine kidney stone recurrence. half of the subjects will receive 1200 mg alpha lipoic acid orally daily for three years, while the other half will receive a placebo. the funding source for this clinical trial is fda oopd.

cystinuria is a rare inherited autosomal recessive disorder of the kidney that is the result of a defect in the dibasic amino acid transporter in the renal proximal tubule and small intestine. supersaturation of cystine in the urine produces crystals that precipitate and form calculi, which can be a cause of obstruction, infection, and chronic kidney disease (chillarón 2010). one potential therapeutic is a thiol-containing compound alpha-lipoic acid (thioctic acid, 5-(1,2-dithiolan-3- yl) pentanoic acid, ala). it is an over-the-counter supplement with antioxidant property. once ala is transported into the cell, it is reduced to dihydrolipoic acid (dhla). both ala and dhla have direct antioxidant activity (scholich 1989), and they can regenerate endogenous antioxidants including ascorbic acid and vitamin e. it can also increase intracellular coenzyme q10 and glutathione levels. ala and dhla also have additional biochemical effects as metal chelators, reactive oxygen species scavengers, and modulators of signaling transduction of several pathways (gomes 2014). while the potential therapeutic effects of ala have been studied in a number of diseases including, for example, alzheimer's disease, obesity, cardiovascular disease, hypertension, and several cancers (gomes 2014), the efficacy of ala has been best studied in type 2 diabetic peripheral neuropathy (ziegler 2011). in our lab, results from a mouse model of cystinuria show that ala markedly slows the initiation of cystine stone formation as well as the growth of existing stones. given this history in clinical medicine and, most importantly, based upon our positive findings of ala effectiveness in a mouse model of cystinuria, we propose a pilot study on the use of this molecule in cystinuric patients.

Eligibility criteria:
inclusion criteria: * documented cystinuria on prior 24-hour urine collection and/or stone analysis; history of previous cystine kidney stones. * being able and willing to provide consent. exclusion criteria: * poorly controlled diabetes mellitus (hemoglobin a1c \> 8.0% for more than 1 year). * current alpha-lipoic acid administration at the time of screening or within the last year prior to screening. * vulnerable populations including incarceration status. * unable to give informed consent. * non-english primary language. * pregnancy, lactation, or child-bearing age without birth control devices. * anticipation of pregnancy during the study period. * serious illness likely to cause death within the next 5 years.

Keywords: cystinuria kidney stone alpha lipoic acid
exploratory study to evaluate the effect of syn111 (rufinamide) in patients with generalized anxiety disorder (gad)

Conditions: Generalized Anxiety Disorder

Summary: a multi-centered randomized, double-blind, placebo-controlled, phase 2, exploratory study to evaluate the effect of rufinamide on anxiety in patients with moderate to severe generalized anxiety disorder.

this was an exploratory study to evaluate the effect of 500 or 1000 mg per day for 8 weeks of rufinamide compared to placebo on measures of anxiety in patients with generalized anxiety disorder, and to determine tolerability of rufinamide in this population.

Eligibility criteria:
inclusion criteria: * outpatient 18-65 * meet diagnostic and statistical manual,(dsm) iv criteria for gad * have moderate to severe anxiety * sign irb (institutional review board) approved consent and can comply with visits and procedures * women of childbearing potential must use acceptable method of contraception exclusion criteria: * have diagnosis of adjustment disorder or anxiety disorder not otherwise specified (nos) * have diagnosis of specific phobia * have diagnosis of antisocial personality disorder or other axis ii disorder * have diagnosis of substance abuse disorder within 3 months of study entry * have diagnosis of major depressive disorder or panic disorder within 6 months of study entry * have diagnosis of ptsd, eating disorder substance dependence disorder within 12 months of study entry * have diagnosis anytime during lifetime of schizophrenia or other psychotic disorder, bipolar mood disorder, obsessive-compulsive disorder (ocd), psychosurgery * require medication to treat gad other than study medication * failed to show improvement with past treatment for gad * excessively consume caffeine * are receiving treatment with prohibited medications * uncontrolled thyroid condition * positive urine drug screen * obese * clinically significant ecg finding * participating in other clinical trial * clinically significant out of range lab value * past exposure to rufinamide * pregnant or nursing females

Keywords: gad
comparison of two types of biopsy in patients with breast lesions

Conditions: Breast Cancer

Summary: rationale: biopsy is the removal of cells or tissue for examination under a microscope. it is not yet known which type of breast biopsy is more effective for diagnosing breast lesions. purpose: randomized diagnostic trial to compare the effectiveness of two different types of biopsy in patients who have breast lesions that cannot be felt upon examination.

objectives: i. compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time and tissue loss in patients with nonpalpable breast lesions. ii. compare the cost effectiveness of these diagnostic methods in these patients. iii. demonstrate that radioactive seed localization allows for elimination of specimen x-ray in these patients. iv. demonstrate that radioactive seeds may be placed safely for 1-7 days prior to surgical removal in these patients. outline: this is a randomized study. patients are randomized to one of two diagnostic arms. arm i: patients undergo radiographic placement of a radioactive seed (either iodine i 125 or palladium pd 103) into the suspicious lesion. patients then undergo surgery to remove the lesion along with the seed and a small margin of surrounding breast tissue followed 3 months later by a postoperative mammogram. arm ii: patients undergo a needle localized breast biopsy with a specimen x-ray.

Eligibility criteria:
disease characteristics: suspicious nonpalpable breast lesion requiring breast biopsy for diagnosis or nonpalpable breast lesion that is not amenable to core needle biopsy or advanced breast biopsy instrumentation (abbi) excision hormone receptor status: not specified patient characteristics: age: 18 and over menopausal status: not specified performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: not pregnant prior concurrent therapy: not specified

Keywords: biopsy radioactive seed nonpalpable lesions
virtual reality in labor and delivery for reduction in pain

Conditions: Labor Pain; Virtual Reality; Alternative Medicine

Summary: the purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. the investigators will perform a randomized controlled trial of patients in labor at cedars-sinai medical center.

the purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. the investigators hypothesize that use of virtual reality devices will result in a reduction in pain medication use, in epidural use, and prolong the duration of time prior to the patient receiving an epidural. the study will be conducted as two parallel randomized controlled trials: one for latent labor patients and one for patients in active labor (defined by whether they are \ 6 cm). within each phase of labor, there will be 20 in the virtual reality arm and 20 in the control arm for a total of 80 patients.

Eligibility criteria:
inclusion criteria: 1. female 2. \>18 years old 3. pregnant with term gestation 4. nullipara 5. pain due to contractions rated from 4-7 6. contractions at least every 5 minutes x 30 minutes preceding 7. pain scores obtained at least every 60 minutes exclusion criteria: 1. parous 2. use of intravenous medications for pain relief prior to the intervention 3. use of an epidural 4. preterm gestation 5. pain not due to contractions 6. pain score of 3 or below or 8 or above

Keywords: labor pain virtual reality alternative medicine
the relationship between body composition and growth hormone, sirt signaling, protein turnover and insulin sensitivity

Conditions: Healthy

Summary: the purpose of this study is to investigate signaling pathways in fat and muscle, as well as turnover of protein, sugar and fat after stimulation with growth hormone and during fasting in lean and obese subjects. this will help clarify differences in the human metabolism between lean and obese subject and provide us with a better understanding of the molecular mechanisms regulating the basic metabolism during prolonged fasting.

in an evolutionary context, it is likely that "inherited" obesity provides a survival advantage when there are shortages of food, but also increases the risk of lifestyle diseases in times of prosperity. this may explain the high incidence of obesity, diabetes and cardiovascular disease in the western world today. obese individuals have high levels of free fatty acids (ffas) in the blood and ffas are both protein sparing (giving an evolutionary survival advantage) but also cause increased insulin resistance (which increases the risk of diabetes and cardiovascular disease). obesity also leads to low growth hormone (gh)-levels, whereas fasting is accompanied by high gh- and ffa-levels and increased igf-i mrna in muscle. it is likely that obese individuals are more capable of fasting than lean individuals and will lose less protein during fasting, have increased activation of gh signaling and altered activation of other signaling proteins. and obese individuals are likely to be more sensitive to growth hormone than lean individuals based on ffa-responses, intracellular signaling, protein loss and insulin sensitivity. we would like to test 3 hypotheses: (1) obese individuals are more capable of fasting than lean individuals and will lose less protein during fasting (2) activation of lipolysis is an important prerequisite for limiting protein loss during fasting in both slim as obese individuals. (3) obese individuals are more sensitive to growth hormone than lean individuals based on ffa responses and activation of intracellular signals. the hypotheses are tested in 8 lean and 8 obese healthy young men, who are studied 4 times: (i) after 12 hours of fasting (ii) after 72 hours of fasting (iii) after gh-bolus (0.005 mg/kg over 20 min.) and (iv) after 72 hours of fasting with inhibition of fat metabolism (tablet acipimox 250 mg every 4 hours) during the last 12 hours of fasting and during the study period. each study period consists of a 4-hour basal period and a 2 hour hyperinsulinemic euglycemic clamp (30 mu/m2/min). muscle- and fat-biopsies are taken and analyzed for enzyme expression and activation of various signaling pathways. the study subjects are given glucose-, amino acid-, urea- and palmitate-tracers and specific hormones and metabolites are measured for assessment of underlying molecular mechanisms regulating the basic human energy metabolism.

Eligibility criteria:
inclusion criteria: * healthy lean (bmi19-25) and healthy obese (bmi 32-40) men * written consent before study start exclusion criteria: * known medical conditions * any medication
atacicept demonstrating dose response

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosis (sle) is an autoimmune disease, meaning that the body's immune system attacks its own organs and tissues. within the immune system, b-cells and plasma cells make proteins called antibodies, which in autoimmune disease can bind to one's own tissues and are thus referred to as autoantibodies. atacicept blocks 2 factors in the body, called blys and april, which are important for the maintenance of b-cells and plasma cells, and thus the production of antibodies. this study will assess whether treatment with atacicept can reduce sle disease activity. atacicept is still an experimental drug, meaning that it is not available outside of a clinical trial, and that its potential benefits and risks have not been fully determined. a total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a 1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg, atacicept 115 mg or matching placebo, given subcutaneously once weekly for 24 weeks. the primary objective of the trial is to evaluate the efficacy of atacicept compared to placebo in reducing sle disease activity in subjects treated with standard of care (soc) therapy and to investigate the dose-response relationship. the secondary objectives of the trial are: * to evaluate the effect of atacicept in reducing corticosteroid usage * to evaluate the safety and tolerability profile of atacicept in subjects with sle * to confirm the pk and pd profiles of atacicept in sle subjects * to evaluate the changes in the medical outcomes study short form general health survey \[sf-36\].


Eligibility criteria:
inclusion criteria: * male or female of ≥18 years of age * written informed consent * diagnosis of sle satisfying at least 4 out of the 11 acr criteria during the course of their illness * disease duration of at least 6 months * sledai-2k score ≥ 6 at screening * positive test results for antinuclear antibody (ana) (hep-2 ana ≥1:80) and/or anti-double-stranded deoxyribonucleic acid (dsdna) (≥30 iu/ml) at screening * negative serum pregnancy test and highly effective method of contraception for woman of childbearing potential. exclusion criteria: * increase in dosing of corticosteroids within 2 weeks prior to screening * introduction of mmf within 3 months prior to td1 or increase in dosing within 1 month before screening * change in dosing of immunosuppressants or corticosteroids during the screening period * serum igg \< 6g/l * estimated glomerular filtration rate (gfr) \<50 ml/min/1.73m² * urinary protein:creatinine ratio \>2 mg/mg * history of demyelinating disease * breastfeeding or pregnancy * legal or limited legal capacity additional exclusion criteria also apply

Keywords: rheumatology double-blind placebo-controlled multidose dose-response phase ii systemic lupus erythematosus sle atacicept
effect of probenecid on synovial fluid atp levels in cppd

Conditions: Calcium Pyrophosphate Deposition Disease

Summary: this study will investigate the hypothesis that probenecid, a medication currently used for gout, reduces levels of atp in the joint fluid of patients with calcium pyrophosphate deposition disease (cppd), another common type of crystal-related arthritis. there is good evidence that cppd results from an excess of atp in joints. the investigators will measure levels of atp in joint fluid before and after 5 days of treatment with probenecid. this study will serve to rationalize larger studies of probenecid in cppd.

objective: the objective of this study is to determine whether pharmacologic doses of the drug probenecid significantly decrease atp and inorganic pyrophosphate (ppi) levels in the synovial fluid of patients with calcium pyrophosphate deposition disease (cppd). the investigators have considerable evidence that synovial fluid atp levels are high in patients with this disease and these high levels lead to calcium pyrophosphate (cpp) crystal formation which then produces acute and chronic arthritis. the investigators have identified the transmembrane protein known as ank as the chief regulator of atp levels in and around cartilage. probenecid blocks function of ank in vitro. the purpose of this study is to determine if probenecid used at normal doses are sufficient to block ank function in vivo and whether this results in reduced atp and ppi levels in synovial fluid. research design: this is a randomized un-controlled trial of probenecid vs. no drug in patients with a joint effusion and known cppd. methodology: power analysis based on an 80% chance to show a 20% difference in atp levels in the treatment group resulted in a sample size of 20 patients in each group. patients with known cppd and a joint effusion will have an arthrocentesis to remove 2 ml of synovial fluid from their joint. fluid will be sent to the investigators' research laboratory and atp and ppi levels will be measured. patients will be randomized to treatment with 2 grams/day of probenecid or no therapy. after 5 days, the remainder of the joint fluid will be removed and tested for atp and ppi levels. the investigators will compare differences in atp and ppi levels in the probenecid treated and the untreated group.

Eligibility criteria:
inclusion criteria: * age \>21 years, * cppd diagnosed by ryan /mccarty criteria * joint effusion in a shoulder or knee exclusion criteria: * inability to sign informed consent * age \<21 years * history of renal stones * significant renal dysfunction (ckd \>stage 2) * blood dyscrasias * current use of drugs which interact with probenecid * concurrent gout * active infection, including bacteremia and overlying cellulitis * recent joint trauma * intra-articular corticosteroids in the affected joint within three months

Keywords: atp probenecid chondrocalcinosis
safety and efficacy of phenylephrine 2.5%-tropicamide 1% microdose ophthalmic solution for pupil dilation

Conditions: Mydriasis

Summary: this study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (tr/pe) vs. phenylephrine (pe) alone and tropicamide (tr) alone. participants attended 3 visits. at each visit, after baseline measurements, 1 of the 3 drugs was administered to both eyes, then pupil dilation and safety assessments were performed at specific time intervals.

volunteer participants were screened for study eligibility during a screening visit and enrolled after signing the study-specific informed consent form. subjects meeting all inclusion/exclusion criteria were scheduled for 3 treatment visits, which were at least 2 days, but no more than 7 days apart. at each treatment visit, baseline measurements were taken, then 1 of the 3 study drugs was administered to both eyes (each participant's drug administration sequence was randomly determined). afterwards, efficacy and safety assessments were performed at 20, 35, 50, 65, 80, 120, and 180 minutes.

Eligibility criteria:
inclusion criteria: * ability to provide written consent and return for all study visits * photopic pupil diameter \<= 3.5 mm in each eye exclusion criteria: * allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride * history of benign prostatic hyperplasia * use of a benzodiazepine, monoamine oxidase inhibitor, tricyclic antidepressant, anticonvulsant, or cholinergic drug * history of closed-angle glaucoma * anatomically narrow anterior chamber angles * ocular surgery or laser treatment of any kind * history of chronic or acute uveitis * history of traumatic iritis or hyphema * history of traumatic mydriasis or angle recession * history of heterochromia * irregularly-shaped pupil secondary to ocular trauma or congenital defect. * history of neurogenic pupil disorder * history of anterior chamber intraocular lens (iol) or iris-fixated iol * history of iris surgery, iris atrophy, or iris-cornea apposition/touch * unwilling or unable to discontinue use of contact lenses at treatment visits. * current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye disease managed using artificial tears. * presence of a severe/serious ocular condition, or any other unstable medical condition that, in the investigator's opinion, may preclude study treatment and/or follow-up * pregnancy or lactation