Kornimate/medical-research-clean huggingface dataset:
safety study of combination of hormone therapy, paclitaxel and radiation therapy to treat prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine if the combination therapy of hormone, paclitaxel and radiation therapy are effective in treatment of locally advanced prostate cancer


Eligibility criteria:
inclusion criteria: * any one or more of the following characteristics will qualify patient with t2/t3 prostate cancer for eligibility to current study: * biopsy proven prostate cancer with gleason score \> 7 * pathologic staging txn1 (on mri or ct) * prostate-specific antigen (psa) \> 10 ng/ml done within a month prior to study entry (the day of first hormonal ablation) and \> 10 days after prostate biopsy. in addition patients must also have: * performance status \< 2 * hemoglobin \> 11 grams per deciliter (g/dl), white blood cell (wbc) \> 4000 and platelet count \> 100.000/l * no evidence of other synchronous primary. prior malignancies does not exclude if the patient is disease free \> 5 years. * prior or concurrent basal cell or non-invasive squamous carcinoma of the skin is eligible and * received hormone therapy with any of the following combination for less than 3 months * lupron / flutamide * zoladex/ flutamide * lupron/ casodex * zoladex/ casodex exclusion criteria: * clinical stage t1n0, psa \< 10, and gleason score less than 7. * evidence of distant metastasis * previous surgery for prostate cancer (radical prostatectomy). * current treatment with ketoconazole, cimetidine or hormone therapy for more than 3 months prior to inclusion in the protocol for prostate cancer * major medical or psychiatric illness, which in the investigator's opinion may prevent completion of the study and interfere with follow up. * bilirubin \> 1.5 * prior chemotherapy is not allowed
pharmacokinetic study of levetiracetam in epileptic pediatric subjects ranging in age from 1 month to less than 4 years old

Conditions: Epilepsy

Summary: the primary purpose of this study was to document the pharmacokinetic parameters of both levetiracetam and its metabolite, ucb l057, after a single dose of 20 mg/kg of levetiracetam in epileptic pediatric subjects, aged 1 month to less than 4 years.


Eligibility criteria:
inclusion criteria: * male or female between 1 month and less than 4 years * diagnosis of any type of epilepsy * at least 5 kg body weight * using no more than two antieplieptic drugs exclusion criteria: * a treatable seizure etiology * epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease * history of status epilepticus during the 2 weeks prior to the selection visit * history of or the presence of pseudoseizures * epilepsy surgery within one year prior to the selection visit * on a ketogenic diet * taking felbamate at the selection visit

Keywords: levetiracetam keppra
a study to evaluate the efficacy and safety of sitagliptin and mk0431a in comparison to a commonly used medication in patients with type 2 diabetes (0431-068)(completed)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of sitagliptin and mk0431a in comparison to a commonly used medication in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 78 with type 2 diabetes mellitus * patient has not been on any antihyperglycemic agent (insulin or oral) in the last 3 months exclusion criteria: * patient has a history of type 1 diabetes mellitus or a history of ketoacidosis * patient has previously been treated with sitagliptin or has previously been in a study using a dpp-4 inhibitor
establishing the genetic profile of multiple hereditary exostoses (hme) in families of bc

Conditions: Exostoses, Multiple Hereditary

Summary: the purpose of this study is to establish the genetic profile of families in british columbia with hme.

the purpose of this study is to establish the genetic make-up of families and patients with hme. this will occur as the patient presents to a regular clinic visit. dr. alvarez will be introduced to interested patients and their parent(s) and a brief discussion about the project will occur. if the patient and their direct family are interested they will be entered into the study. this will involve interviewing the patients and their direct family. this interview will take about 1 hour. we are interested in identifying all affected family members as far up the family tree as possible. we ask that the idea of the study be introduced to extended family members by the participating family members and then have them call dr. alvarez to set up an appointment. each available member will be interviewed and a physical exam done to determine the location of osteochondromas. in addition, xrays will be done to determine the location of all osteochondromas. all xrays will be reviewed. no new ones will be taken unless it is part of the patient's routine care. to complete the genetic work up dna analysis will be done on all available family members. this will entail obtaining a blood sample from each family member willing to partake in the study. these blood samples will be used only for the purpose of identifying abnormalities in the genes related to osteochondromas. the blood samples will be taken at british columbia's children's hospital and processed there. dna samples will be kept confidential.

Eligibility criteria:
inclusion criteria: * diagnosed with hme

Keywords: dna sequencing ext genes hereditary multiple exostoses, also known as multiple hereditary exostoses, also known as hereditary multiple osteochondromas
incidence and progression of glaucoma in the tema eye survey cohort

Conditions: Glaucoma

Summary: aim 1: to determine the incidence of glaucoma in ghana in subjects previously found to be non-glaucomatous in the tema eye survey. aim 2: to characterise the progression of glaucoma and the outcomes of subjects diagnosed with glaucoma in the tema eye survey.


Eligibility criteria:
inclusion criteria: - glaucomatous and non-glaucomatous patients previously seen in the tema eye survey who are selected and invited to participate exclusion criteria: - patients not previously seen in the tema eye survey
pharmacokinetics and pharmacodynamics of an anti-hiv drug in israeli ethiopian and non-ethiopian populations

Conditions: HIV Infection; AIDS

Summary: the objective of this proposal is based on the assumption that the hiv infected ethiopian population responded in a different way in comparison to the caucasian subjects to lopinavir therapy. our preliminary data demonstrated that ethiopian's have different lopinavir serum concentration in comparison to non-ethiopian's. for these reasons the plan of this study is to investigate the pharmacokinetic/pharmacodynamic (pk/pd) profile in both populations. the results will allow to establish a better personalised medicine for hiv infected individuals.

the objective of this proposal is based on the assumption that the hiv infected ethiopian population responded in a different way in comparison to the caucasian subjects to lopinavir therapy. our preliminary data demonstrated that ethiopian's have different lopinavir serum concentration in comparison to non-ethiopian's. for these reasons the plan of this study is to investigate the pharmacokinetic/pharmacodynamic (pk/pd) profile in both populations. the results will allow to establish a better personalised medicine for hiv infected individuals.

Eligibility criteria:
inclusion criteria: * all hiv infected ethiopian and non-ethiopian subjects * aids diseased ethiopian and non-ethiopian individuals exclusion criteria: * individuals who are unable to sign the informed concent * individuals unable to take oral medications * individuals who described lopinavir allergy

Keywords: lopinavir pharmacokinetic pharmacodynamic ethiopian population caucasian population
evaluation of triclosan coated suture in obstetrical surgery

Conditions: Cesarean Section; Infection

Summary: a prospective comparative randomized blinded study conducted in the obstetrics gynecology department of ben arous hospital over an eight-month period between november 2020 and june 2021. the aim of this study is to evaluate effectiveness of triclosan coated suture use in obstetrical surgery.


Eligibility criteria:
inclusion criteria: * pregnant women with indicated cesarean delivery and who have signed a written consent. exclusion criteria: * cases with incomplete follow up * breach of operative protocol

Keywords: surgical site infections caesarean section healthcare costs
natural orifice transgastric endoscopic (notes) transgastric diagnostic peritoneoscopy with laparoscopic assistance

Conditions: Abdominal Adhesions

Summary: the study will document being able to successfully perform transgastric diagnostic peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.


Eligibility criteria:
inclusion criteria: men and women will be enrolled in this study who: * are willing to give consent and comply with evaluation and treatment schedule; * at least 18 years of age; * are a candidate for surgical weight loss intervention (i.e. meet asmbs and nih criteria) for an rygb procedure at the investigational site; * have a history of open abdominal surgery or laparoscopic abdominal surgery; * asa classification i, ii, or iii (appendix ii); and * have a negative serum pregnancy test (for women of childbearing potential). exclusion criteria: subjects will be excluded from the study for any of the following: * use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable); * acute cholecystitis or acute pancreatitis; * evidence of abdominal abscess or mass; * diffuse peritonitis; * use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy; * clinical diagnosis of sepsis; * co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial; * planned concurrent surgical procedure other than rygb or adhesiolysis; * prior or planned major surgical procedure within 30 days before or after study procedure; * participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints; * previously enrolled in the current series of 4 trials investigating the ees notes gen1 toolbox; or * any condition which precludes compliance with the study (investigator discretion).

Keywords: abdominal adhesions diagnostic peritoneoscopy natural orifice transluminal endoscopic surgery notes
geodon for the treatment of refractory social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (sad) who did not remit on sertraline treatment alone

this is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with sad and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.

Eligibility criteria:
inclusion criteria: * adults 18-65 years of age * primary diagnosis of sad, using diagnostic standard manual(dsm-iv) criteria * minimum clinical global impression of severity (cgi-s) score of 4 at baseline * minimum brief social phobia scale(bsps) score of 20 at baseline * written informed consent * negative serum pregnancy test for women of childbearing potential * normal ekg exclusion criteria: * current dsm-iv diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition * any current primary anxiety disorder other than sad * current primary depression * history of substance abuse or dependence within the last 3 months * suicide risk or serious suicide attempt within the last year * clinically significant medical condition or laboratory or ekg abnormality * women of childbearing potential who are unwilling to practice an acceptable method of contraception * patients needing concurrent use of psychotropic medications * history of hypersensitivity to sertraline or ziprasidone * recent (less than 2 months) initiation of psychotherapy for sad * history of failure to respond to augmentation with an adequate trial of an atypical antipsychotic * patients who are currently taking any of the following medications: erythromycin, biaxin, avelox, zithromax, amantadine, levaquin, tamoxifen, tegretol, nizoral, and levitra

Keywords: anxiety disorder sad ziprasidone sertraline antidepressant antipsychotic
safety and efficacy of dcb for the treatment of sfa ischemic vascular disease in patients with tasc c and d lesions

Conditions: PAD

Summary: the study is aimed at collecting preliminary safety and efficacy data related to the use of drug coated balloon (dcb) technology for the treatment of symptomatic superficial femoral artery (sfa) ischemic vascular disease in patients presenting with long lesions. the present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (ce marked) dcb currently available on the market.

the present study is designed as a prospective, open label, observational study. the study will collect information about the medical care patients receive during their planned procedure. no additional testing or procedures will be done. patients elected for endovascular revascularization with dcb will be asked their written consent to the use of their personal data. revascularization will be performed as per standard procedure of the sites. after discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days), 24 and 36 months (±30 days). angiographic follow-up will be performed in symptomatic patients, as clinically indicated.

Eligibility criteria:
inclusion criteria: 1. documented obstructive ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to rutherford category 2, 3 or 4 2. target lesion consists of a single solitary or multiple adjacent de novo or re-stenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm 3. target vessel is the superficial femoral artery and/or popliteal artery (p1-2-3) 4. life expectancy \>1 year in the investigator's opinion 5. written informed consent exclusion criteria: 1. patient unwilling or unlikely to comply with fu schedule 2. administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure 3. known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel 4. additional planned cardiac or peripheral percutaneous or surgical intervention including cabg within 30 days following the study procedure 5. ≥15 cm long inflow lesion (≥50% ds) 6. failure to successfully treat \< 15 cm long inflow lesion in the ipsilateral iliac artery
comparing acute aerobic and resistance exercise

Conditions: Exercise Physiology

Summary: the purpose of this study is to determine the effect of age and fitness level on the physiological response to an acute bout of resistance or aerobic exercise.

young and middle-aged to older adults who are physically active or not physically active will participate in two moderate to vigorous intensity exercise bouts: aerobic exercise and resistance training exercise. blood will be collected to assess immune function and metabolism.

Eligibility criteria:
inclusion criteria: * "young" adults: ages 18-30 * "older" adults: ages 55-75 and if a female postmenopausal * participants classified as "trained" must participate in at least 30 minutes of moderate to vigorous intensity cardiovascular activity at least 3 days per week and engage in resistance training for all of the major muscle groups approximately 2 days / week. they must have upheld this activity for the past 3 months * participants classified as "untrained" must be participating in less than 30 minutes of moderate to vigorous intensity cardiovascular activity and less than 2 days of resistance training per week for at least the last 3 months. exclusion criteria: * have any contraindications to moderate to vigorous exercise * range of motion restrictions that would prevent them from participating in aerobic or resistance training with proper form (they must be ambulatory) * aking medications (prescription or over the counter) known to influence immune function, including daily nsaid's, beta blockers, statins, bisphosphonates, or steroids. * have known cardiovascular, respiratory, metabolic, or renal disease, with the exception of controlled hypertension (as defined by resting bp below 140/90) and/or controlled asthma (self-reported). * be pregnant * be unable to complete all visits (i.e. must not be planning to leave the houston area long-term before concluding their participation in the study which will span several weeks) * fall outside of a bmi range of (18.5 - 30) * consume alcohol or recreational drugs for 24h prior to visits * older women cannot be pre-menopausal (must have not had a menses for at least 12 months) * unable to speak or read english * participants must not have scheduling conflicts that would prevent them from reporting to the laboratory of integrated physiology 4 times over the course of the study
constant current versus constant voltage subthalamic nucleus deep brain stimulation in patients with parkinson's disease

Conditions: Parkinson&#39;s Disease (PD)

Summary: to compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery.

this is a randomized, parallel controlled, multi-center study to compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery. participants will be followed for up to 12 months. approximately 180 pd participants will be recruited from up to 14 sites. participants will be randomized to current mode or voltage mode after dbs surgery and be comprehensively assessed at baseline and follow up according to the protocol developed.

Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease * aged 18 to 75, no limited sex * after bilateral stn-dbs, yet not powered on exclusion criteria: * mental disorders or dementia * pregnant, lactating women or women who are unable to take effective measures to prevent pregnancy * serious health conditions, such as tumors, liver or kidney diseases, etc. * epilepsy or other seizure disorders * patients with severely deviated electrode placement * patients who were unable to voluntarily sign an informed consent form * patients who did not agree to cooperate with follow-up
tens and heat for reducing back pain in humans

Conditions: Pain

Summary: lower back pain is one of the most common and most expensive impairments costing time and expense in the work force today. with the effects on cognitive skills and addictive side effects of opioids and other prescription pain killers, there has been increasing interest in alternative medical treatments to relieve pain. two of these that are commonly used are heat and transcutaneous electrical nerve stimulation (tens). in the present investigation, there are two objectives 1) to determine if tens needs to be continuous or can be intermittent and still achieve pain relief and 2) to see how long pain relief lasts after 4 hours of application of tens, heat or both. there will be seventy-five subjects with chronic back pain divided into 6 groups randomly; 15 subjects per group. the intervention will be either tens alone, heat alone or tens plus heat or a control group.

there will be seventy-five subjects with chronic back pain divided into 6 groups randomly; 15 subjects per group. they are between the ages of 24 and 60 years old. they will not be taking pain medications for at least 48 hours prior to the study. the groups were as follows; 1. control 2. heat only 3. tens only 4. tens and heat 5. tens for the last 15 minutes each hour plus heat 6. tens for the last 15 minutes each hour tens is at threshold intensity (12 ma) at a frequency of 20 hz either ramped continuously or for the last 15 minutes of each hour. the stimulation is 3 seconds increase to threshold, 3 seconds hold and 3 seconds ramped down followed by a 9 second rest period. pain is assessed by an analog visual pain scale and an algometer placing pressure on the back to assess the pressure that causes pain, a measure of inflammation. in addition, the oswestry lower back pain index and roland morris questionnaire are used. range of motion in the trunk where first pain is felt is also measured.

Eligibility criteria:
inclusion criteria: 1. pain for at least 3 months in the lower back 2. age range 24-60 exclusion criteria: 1. those with back pain caused by fractures or spinal damage 2. those who had undergone low back surgery within the last year 3. those with diagnosed diabetes 4. no use of opiod pain meds for at least 10 days

Keywords: heat hot temperature cutaneous electrostimulation
breast and cervical cancer education program

Conditions: Cervical Cancer; Breast Cancer; Health Behavior

Summary: the primary goal of this study is to improve cancer literacy in black women living with hiv and ultimately improve breast and cervical cancer screening uptake. this study involves an educational intervention delivered virtually and in person, depending on the participants' preference.

the aims of this study are to: 1. develop educational materials on breast and cervical cancer screening; 2. administer the intervention using a powerpoint presentation; 3. evaluate changes in breast and cervical cancer literacy levels after the intervention; and 4. assess participants'; satisfaction with the program

Eligibility criteria:
inclusion criteria: * able to read and write in english * self-identify as hiv positive - * black/african american. exclusion criteria: * acutely ill