Kornimate/medical-research-clean huggingface dataset:
study to evaluate the overall performance of the zalviso system™ (sufentanil sublingual tablet system) 15 mcg

Conditions: Moderate-to-severe Acute Pain

Summary: study to evaluate the overall performance of the zalviso system™ (sufentanil sublingual tablet system) 15 mcg

320 adult postoperative in-patients, who met all study entry requirements, and were expected to require opioid analgesia for at least 24 hours, and up to 72 hours, after surgery were enrolled. patients used the zalviso™ (sufentanil sublingual tablet system) 15 mcg to self-administer a tablet of study drug as needed for pain. the system was evaluated for usability and functionality for up to 72 hours.

Eligibility criteria:
inclusion criteria: 1. male or female patients who were 18 years of age or older. 2. patients who were scheduled to undergo surgery under general or spinal anesthesia that does not include intrathecal opioids during the operation. 3. patients classified as american society of anesthesiologists (asa) class i - iii (appendix i). 4. female patients of childbearing potential must have been using an effective method of birth control at the time of screening visit and for 30 days following the end of the study period. acceptable methods of birth control included oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (iud), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. the reason for non-child bearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for \> 1 year, was specified. patients using hormonal forms of contraception were also willing to use a barrier method of contraception from screening through 30 days following the study period. 5. post-surgical patients who had been admitted to the pacu, and were expected to have acute pain requiring opioids for 24 - 72 hours after surgery. exclusion criteria: 1. patients who had taken an opioid for more than 30 consecutive days, at a daily dose of 15 mg or more of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of vicodin®, norco®, lortab® with 5 mg hydrocodone per tablet). 2. patients who were currently taking monoamine oxidase inhibitors (maois) or had taken maois within 14 days of the first dose of study drug. 3. patients with current sleep apnea that had been documented by a sleep laboratory study or were on home continuous positive airway pressure (cpap). 4. patients with an allergy or hypersensitivity to opioids. 5. patients who were currently taking monoamine oxidase inhibitors (maois) or had taken maois within 14 days of the first dose of study drug. 6. patients with current sleep apnea that had been documented by a sleep laboratory study or were on home continuous positive airway pressure (cpap). 7. patients who were receiving oxygen therapy at the time of screening.
a study to compare adjuvant concurrent chemoradiation (ccrt) to adjuvant radiation therapy (rt) in grade 2 and 3 extremity soft tissue sarcomas

Conditions: Sarcoma,Soft Tissue

Summary: the aim of the study is to retrospectively evaluate the outcome of adjuvant concurrent chemoradiation delivered to patients with high grade non-metastatic soft tissue sarcomas of the extremities at the investigators institution paired with patients treated by adjuvant radiation therapy


Eligibility criteria:
inclusion criteria: * all patients consecutive enrolled from 1990 to 2004 with soft tissue sarcomas located either in the limbs or girdles, superficial or deep, grade 2 or 3 (fnclcc), who were first treated with radical conservative surgery and adjuvant rt atto a minimum biologically equivalent dose of 45 gy, with or without concurrent adjuvant chemotherapy. exclusion criteria: * a patient record captured outside the time frame from 1990 to 2004 with trunk, retro-peritoneum, and head and neck localisations, grade 1 histology and, ps≥3, were excluded as well as and those plus patients who had received neoadjuvant treatment. differentiated liposarcomas, dermatofibrosarcomas protuberans, extraskeletal ewing's sarcomas, primitive neuroectodermal tumors and osteosarcomas were also excluded due to specific treatment strategies.
stellate ganglion nerve block in treating women with hot flashes

Conditions: Hot Flashes

Summary: rationale: a stellate ganglion nerve block may help relieve hot flashes in women. purpose: this clinical trial is studying how well a stellate ganglion nerve block works in treating women with hot flashes.

objectives: * to evaluate the impact of stellate ganglion blockade on hot flash scores. * to evaluate the toxicity of stellate ganglion blockade. outline: patients undergo fluoroscopic-guided stellate ganglion blockade using bupivacaine hydrochloride in week 1. patients complete a hot flash diary daily and a symptom experience diary weekly in weeks 1-7 and the profile of mood states questionnaire in weeks 1 and 7. after completion of study treatment, patients are followed at 2 months and then monthly for 1 year.

Eligibility criteria:
disease characteristics: * presence of hot flashes for ≥ 1 month prior to study registration * hot flashes considered bothersome (defined by their occurrence of ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention) * use of more conventional hot flash treatments (including newer antidepressants and gabapentin) have failed to control hot flashes (as defined by the patient) patient characteristics: * ecog performance status 0-1 * life expectancy ≥ 6 months * not of childbearing potential, as judged by the attending clinician * able to complete questionnaires alone or with assistance * no evidence of an active malignancy * no von willebrand's disease or other bleeding disorders * no allergy to chlorhexidine or bupivacaine prior concurrent therapy: * more than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents * tamoxifen, raloxifene, or aromatase inhibitors allowed provided the patient has been on a constant dose for ≥ 4 weeks and continues to receive medication during study treatment * more than 10 days since prior and no concurrent anticoagulants (e.g., aspirin, clopidogrel, ticlopidine, or warfarin) * concurrent heparin flushes for venous catheter allowed * no concurrent use of other agents (e.g., megestrol acetate, soy, clonidine, or bellergal) for treating hot flashes * vitamin e, gabapentin, or antidepressants allowed provided the patient has been on a stable dose for \> 30 days and continues to receive medication during study treatment

Keywords: hot flashes
magnetic seizure therapy for bipolar mania

Conditions: Bipolar Disorder, Manic

Summary: this trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (mst) and its safety for bipolar mania. half of the participants will receive mst, while the other half will receive electroconvulsive therapy (ect).

magnetic seizure therapy (mst) is likely to be an alternative options to electroconvulsive therapy (ect). widespread stimulation of cortical and subcortical regions is inevitable for ect since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. in addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. as a consequence, mst are able to generate focus stimuli on superficial regions of the cortex while ect can't, which may give mst the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects.

Eligibility criteria:
inclusion criteria: 1. dsm-5 diagnosis of bipolar i disorder and currently in a manic episode; 2. convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics; 3. the young mania rating scale (ymrs) score ≥ 10; 4. informed consent in written form. exclusion criteria: 1. primary diagnosis of other mental disorders; 2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency; 3. present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants; 4. failure to respond to an adequate trial of ect lifetime; 5. are pregnant or intend to get pregnant during the study; 6. unremovable metal implants. 7. other conditions that investigators consider to be inappropriate to participate in this trial.

Keywords: magnetic seizure therapy electroconvulsive therapy bipolar mania cognition randomized controlled trial
study of elotuzumab in combination with lenalidomide and dexamethasone in subjects with multiple myeloma and various levels of renal function

Conditions: Multiple Myeloma

Summary: the purpose of the study is to assess the concentration of elotuzumab in myeloma patients with very low kidney function including patients on dialysis.


Eligibility criteria:
inclusion criteria: * subjects with multiple myeloma (mm) and renal function fitting one of three categories: 1. severe renal impairment: estimated creatinine clearance (crcl) \<30 ml/min, but not requiring dialysis 2. end-stage renal disease: requiring hemodialysis 3. normal renal function: estimated crcl ≥90 ml/min * documented evidence of symptomatic mm, either newly diagnosed or relapsed/refractory * prior lenalidomide exposure is permitted only if the subject did not discontinue lenalidomide due to a grade ≥3 related adverse event (ae) exclusion criteria: * monoclonal gammopathy of undetermined significance (mgus), waldenstrom's macroglobulinemia, or smoldering myeloma * active plasma cell leukemia * all adverse events of any prior chemotherapy, surgery, or radiotherapy not resolved * poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * acute renal failure
pre-operative therapy in breast cancer

Conditions: Breast Cancer

Summary: this is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer.


Eligibility criteria:
inclusion criteria: * female, aged ≥18 years * histologically confirmed primary breast cancer * plan to receive pre-operative therapy * adequate organ function exclusion criteria: * history of neurological or psychological disease, including epilepsy or dementia * not suitable to participate in this study judged by investigators
orantinib in combination with transcatheter arterial chemoembolization in patients with unresectable hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to compare the overall survival (os) for orantinib in combination with transcatheter arterial chemoembolization (tace) versus placebo in combination with tace in patients with unresectable hepatocellular carcinoma (hcc).

this is a randomized, multi-center, double-blind, placebo-controlled phase iii trial of orantinib administered in combination with tace in patients with unresectable hcc. patients will be randomly assigned (1:1) to receive tace given in combination with either orantinib (200 mg orally, twice per day) or placebo. oriental:orantinib investigation on tace combination trial.

Eligibility criteria:
inclusion criteria: * patients must be diagnosed as hcc. * patients has no indications for treatment with curative hepatic resection or curative percutaneous local therapy. * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1. * patients are able to receive oral medication.
j-valve compassionate use

Conditions: Aortic Valve Disease; Aortic Valve Insufficiency; Aortic Valve Stenosis

Summary: j-valve tf compassionate use cases approved on a case by case basis by the fda

the j-valve is designed to treat patients with aortic valve disease requiring replacement. there are certain patient subsets that the j-valve tf is uniquely able to treat and where there are no good alternative treatments for patients at high surgical risk. physicians have applied for individual approval to treat patients with the j-valve in certain clinical conditions.

Eligibility criteria:
inclusion criteria: - exclusion criteria: -
phase i/ii study of amplitude-modulated electromagnetic fields in the treatment of advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma

Summary: the goal of this study is to investigate the safety and feasibility of treating patients with advanced hepatocellular carcinoma with a noninvasive device administering low level of amplitude-modulated electromagnetic fields.


Eligibility criteria:
inclusion criteria: * advanced biopsy-proven hcc * performance status ecog 0-1 * patients with child pugh a and b cirrhosis scores * absence of medical or psychiatric contraindication which, in the opinion of the treating investigator, would make the patient's participation in this trial inappropriate. * presence of one or more measurable lesion(s) according to the recist criteria. * lesions treated with chemoembolization or ablation by means of radio frequencies will not be considered measurable in this study. * patients on a liver transplant waiting list may be included * patient must not have curative treatment options other than liver transplant * patient may have been treated with intrahepatic treatment (chemoembolization or intrahepatic chemotherapy) or conventional chemotherapy or sorafenib or other experimental therapies prior to study entry. there is no limit for the number of prior therapies * extra hepatic metastases do not constitute an exclusion criterion, except for active cns metastases. * at least 4 weeks must have elapsed since administration of any anti-cancer treatment. * other anti-cancer treatments are not permitted during this study * patients must be more than 18 old and must be able to understand and sign an informed consent. * patient must agree to be followed up according to the study protocol. * patients may have either stable disease or disease progression according to the principal investigator assessment. * patients who carry a pacemaker or any other implantable electronic device are not allowed in the study exclusion criteria: * suspected or biopsy confirmed brain metastases * patients with hepatic cirrhosis with child-pugh class c * patients who have received a liver transplant. * patients who had a surgical resection of the disease and who do not have measurable disease. * pregnant women * patients who still show objective response (complete or partial response) according to the recist criteria due to the last anti-cancer therapy * patients diagnosed with another type of cancer (excluding basal cell carcinoma) during the last five last years or whose cancer diagnosed previously is not in remission
parent intervention to reduce binge drinking

Conditions: Alcohol Consumption

Summary: parent and peer interventions to reduce student drinking

parent and peer interventions to reduce student drinking: efficacy; mediation: moderation

Eligibility criteria:
inclusion criteria: * varsity athlete in high school exclusion criteria: * not a varsity athlete in high school

Keywords: parents peer basics college student drinking
antibiotic prophylaxis when removing ureteric stent after stone surgery

Conditions: Ureteric Stent After Stone Surgery

Summary: is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents cystoscopically after stone surgery?

many patients undergoing stone surgery receive a ureteric stent that should be removed after 14 days. this stent is removed cystoscopically and today this is done without giving antibiotics. some patients get urinary tract infections subject to this. however the investigators do not know how many of these patients get uti as most are followed by their primary care doctor. with this study the investigators would like to find out whether it is possible to avoid such infections and also find out how many actually do get infected.

Eligibility criteria:
inclusion criteria: * stone surgery patients with ureteric stent that should be removed after 14 days exclusion criteria: * ongoing antibiotic treatment, allergy to trimetoprim-sulfa
study of the effects strengthening exercises in individuals with als

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is the most common motor neuron disease mnd) among adults. motor neurons in the spinal cord, brain stem, and cerebral motor cortex degenerate and create a variety of upper (umn) and lower motor neuron (lmn) clinical signs and symptoms, with the most frequently presenting symptom being focal weakness beginning in the leg, arm, or bulbar muscles, occurring in more than 70% of patients. despite the high incidence of muscle weakness in patients with als, only two case studies evaluating the effects of specific muscle strengthening and endurance exercise programs in this patient population have been published, and the effects of resistive exercise programs in patients with als have not been well studied. some have discouraged exercise programs in patients with als because of fear of overuse weakness. yet, in patients with other neuromuscular diseases, resistive exercise programs have been shown to be beneficial and have not produced overuse weakness. the purpose of this study is to determine the effects of six months strengthening program on strength, function, fatigue and quality of life in individuals with als.

the specific aims of this preliminary, prospective randomized study of individuals with als are to determine variability, describe trends over a 6-month time frame and to estimate differences between individuals with als who perform an upper and lower extremity strengthening program three times per week and a control group of individuals with als with respect to the following outcomes: 1. an increase in muscle strength (maximum voluntary isometric contraction) as measured by quantitative muscle testing. 2. an increase in functional activities as measured by the amyotrophic lateral sclerosis functional rating scale (alsfrs)7 and the schwab and england rating scale (sers). 3. a decrease in fatigue as measured by the fatigue severity scale. 4. an increase in quality of life as measured by the sf-36.subjects will be randomized into two groups - experimental and control. subjects in the control group will perform a daily stretching exercise program for a period of six months. subjects in the experimental groups will perform a strengthening exercise program three times per week for a period of six months. all subjects will be evaluated at baseline and then monthly using the following outcome measures: (1) maximum voluntary isometric contraction; (2) amyotrophic lateral sclerosis functional rating scale; (3) schwab and england rating scale; (3) fatigue severity scale; (4) forced vital capacity; and, (5) the sf-36.

Eligibility criteria:
inclusion criteria: * definite and/or probable diagnosis of als * early stages of the disease exclusion criteria: * history of neuromuscular dysfunction not related to als * active, confounding medical conditions * unwillingness or inability to comply with the protocol * fvc of less than 90% predicted * alsfrs score of less than 30

Keywords: amyotrophic lateral sclerosis exercise
comparative effects of gun massager and transverse friction massage in patients with plantar fasciitis

Conditions: Plantar Fascitis

Summary: to compare the effects of massage gun and transverse friction massage on management of pain and disability in patients with plantar fasciitis.


Eligibility criteria:
inclusion criteria: * patients complaining of morning heel pain with taking first step. * patients with limited range of motion and diagnosed with plantar fasciitis. * patients who are willing to participate. exclusion criteria: * patient with heel fracture and surgeries will be excluded. * patient with sign of local and generalized infection or sepsis. * patient with foot deformities will be excluded

Keywords: plantar fasciitis foot and ankle disability index numeric pain scale deep friction massage gun massager
perioperative immunonutrition, phagocytic and bactericidal activity of blood platelets in gastric cancer patients

Conditions: Gastric Cancer

Summary: perioperative immunonutrition in gastric cancer patients can reduce perioperative morbidity and may improve quality of their life. patients with gastric cancer will be divided into four groups depending on the type of artificial nutrition. group i (enteral feeding) and ii (enteral feeding and parenteral nutrition with glutamine) will be administered nutritional therapy during the postoperative period, group iii (oral arginine) and iv (parenteral immunonutrition) patients will be treated nutritionally both prior to and after the surgery. the lymphocytes and their subpopulations, interleukin il-1b,-6,-23, and the phagocytic, and bactericidal activity of blood platelets will be determined before and after nutritional therapy.

surgical treatment of gastric cancer is associated with a high risk of perioperative complications. morbidity of cancer patients increases in concert with the clinical stage of the malignancy. it is postulated that a reduction in perioperative morbidity and improved quality of life of patients with advanced gastric cancer can be achieved by proper preparation to surgery, among others. one of such methods is the implementation of immunostimulating nutritional therapy during the perioperative period.the stage of cancer will be graded according to tnm classification. the patients will be randomly assigned to four clinical groups based on the type of nutritional therapy implemented.

Eligibility criteria:
inclusion criteria: * gastric cancer exclusion criteria: * for group iii constituted gastric cancer associated with severe gastrointestinal obstruction

Keywords: malnutrition, perioperative artificial nutrition, immunonutrition, gastrectomy, lymphocytes, interleukin, blood platelets, phagocytic and bactericidal activity of blood platelets