Kornimate/medical-research-clean huggingface dataset:
kf2022#3-trial: effect of tea and cola beverage on absorption of risperidone oral solution

Conditions: Psychosis; Food-drug Interaction

Summary: risperidone is widely used in the treatment of schizophrenia, bipolar disorder, and aggression associated with moderate or severe alzheimer's dementia. in vitro studies have shown that constituents of tea and cola beverages can result in insoluble complex formation with risperidone, potentially reducing risperidone oral absorption. the purpose of this study is to investigate the effect of tea and cola beverage on the pharmacokinetics of risperidone oral solution. in an open three-phase, randomized, crossover study with 12 healthy volunteers, the subjects will receive a 1 mg dose of risperidone oral solution with either water, tea or cola beverage. blood samples will be collected and risperidone's pharmacokinetics will be monitored up to 48 hours postdose. primary endpoint is area under the plasma concentration-time curve of risperidone. recruitment starting date is december 4, 2023.


Eligibility criteria:
inclusion criteria: * written informed consent * age 18-45 * healthy * systolic blood pressure ≥110 mmhg * heart rate ≥ 50/min * normal ecg * accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). negative pregnancy test result (serum human chorionic gonadotropin) for women. exclusion criteria: * significant disease * mood disorder or suicidality * smoking * using oral contraception pills or other regular medication * pregnancy (current or planned) or nursing * participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study * donation of blood within three months prior to the entry into this study * significant overweight / small or hard-to-find veins * bmi \< 18.5 kg/m2 * insufficient finnish language skills
assisted reproductive techniques (art) with sperm donation : an inclusive model of art for all women

Conditions: Fertility Issues

Summary: this is a monocentric, retrospective, non-interventional study. the main objective is to describe the populations requesting assisted reproductive techniques (art) with sperm donation ; and compare them between groups depending on their parental project.. the secondary objectives are to describe the center support process in the context of art with sperm donation, to determine the initial/final orientation of support and the time to care the statistical analysis will be carried out to compare these parameters between groups depending on their parental project the study is taking place in the reproductive medicine department of the regional university hospital centre in nancy.

descriptive analysis of a new map population since the update of bioethics legislation in august 2021 this study is a descriptive analysis of the population requesting assisted reproductive techniques (art) with sperm donation since update of bioethics legislation in august 2021 ; and compare them in groups depending on their parental project. the main objective is to describe the different populations requesting art with sperm donation (number and evolution of requests, age, history, geographical origin, infertility delay, parenthood context). the secondary objectives are to describe the center support process in the context of art with sperm donation, to determine the initial/final orientation of support and the time to care and compare them between groups depending on their parental project the statistical analysis will be carried out to compare these parameters between groups depending on their parental project this research contributes to our knowledge of patients with a parental project. it may lead to improve their medical care the study is monocentric, retrospective, non-interventional and does not involve human subjects. this research is based on existing data, extracted from patient files in the médifirst software. this is taking place in the reproductive medicine department of the regional university hospital centre in nancy.

Eligibility criteria:
inclusion criteria: * single women consulting the reproductive medicine service for a parenthood project by sperm donation between january 2021 and june 2023. * women in relationship with women consulting the reproductive medicine service for a parenthood project by sperm donation between january 2021 and june 2023 exclusion criteria: * minors * person under guardianship

Keywords: parenthood assisted reproductive techniques
sinusys patency of frontal recess and sphenoid sinus ostia study

Conditions: Sinusitis

Summary: the goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of sinusys dilation system when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.

a multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (crs).

Eligibility criteria:
inclusion criteria: * diagnosis of crs * subject in in need of frontal recess and/or sphenoid sinus dilation exclusion criteria: * pregnant or breastfeeding females * previous treatment site intervention * cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation
physical workload identify in chest compression position using surface electromyogram

Conditions: Cardiopulmonary Resuscitation; Cardiac Arrest

Summary: the chest compression depth decreases over time after starting continuous chest compression due to the rescuers' fatigue. the investigators hypothesized that the frequency parameters from surface electromyogram from each muscle during chest compression may reflect the muscle fatigue of the rescuers. then investigators can identify which of the body are mainly used and get tired by continuous chest compression using surface electromyogram.


Eligibility criteria:
inclusion criteria: * doctors with american heart association basic life support (aha bls) provider certification * healthy, experienced health-care providers exclusion criteria: * physical pain (ex. low back, wrist) * heart disease
adriamycin, vinblastine, dtic and revlimid in elderly hodgkin lymphoma patients

Conditions: Hodgkin Lymphoma

Summary: the purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (mtd) of lenalidomide in combination with avd should be.


Eligibility criteria:
inclusion criteria: * hodgkin lymphoma, intermediate or advanced stage * age \>60 and \<75 years * ecog 2 or better * no major organ dysfunction * ability to take aspirin or lmw heparin exclusion criteria: * hl as composite lymphoma * prior use of lenalidomide * prior use of chemo- or radiotherapy
acupuncture treatment of dry eye

Conditions: Keratoconjunctivitis Sicca; Xeropthalmia

Summary: the purpose of this study is to determine the safety and efficacy of acupuncture in the treatment of moderate to severe dry eye by replicating the study design of the previous protocol and to see the study through to its completion.


Eligibility criteria:
inclusion criteria: * military healthcare beneficiary * male and female patients, at least 18 years of age * diagnosis of keratoconjunctivitis sicca or xerophthalmia (dry eyes) in one or both eyes * persistent signs and symptoms despite conventional therapy for at least three months exclusion criteria: * contact lens wear * intraocular surgery or laser in the study eye within 90 days prior to enrolling in the study * history of any medical condition or circumstance that would preclude scheduled visits or completion of the study * known history of adverse reaction to acupuncture * pregnancy or breast feeding
effect of sitagliptin on short-term metabolic dysregulation of oral glucocorticoid therapy

Conditions: Pre-diabetes; Impaired Fasting Glucose; Impaired Glucose Tolerance

Summary: the investigators hypothesize that sitagliptin will significantly reduce impairments in insulin secretion and insulin resistance resulting from short-term oral glucocorticoid therapy.

the investigators plan to conduct a prospective, randomized, double-blind, placebo-controlled parallel arm crossover study comparing insulin secretion and insulin resistance in subjects with impaired fasting glucose on oral glucocorticoid therapy + placebo versus subjects on oral glucocorticoid therapy + sitagliptin. for the oral glucocorticoid therapy, we plan to use dexamethasone (dex) 2.5 mg daily. we chose dex for known glycemic effects, improved compliance, and once daily dosing. previous studies have shown that in humans, glucocorticoid-induced insulin resistance develops within 4 hours with infused drug at high dose (methylprednisolone 500 mg x single infusion) and does not change with duration of drug therapy of up to 3 months.10 furthermore, more modest doses over a short duration (dex 2.0 mg orally daily x 2 days) have been shown to decrease insulin-mediated glucose disposal.11 12 thus, studying acute effects of oral dex at 2.5 mg daily x 7 days should be more than adequate to achieve impaired glucose-mediated insulin secretion and impaired insulin-mediated glucose disposal. in order for sitagliptin to have the desired effect, drug should be administered for at least 7 days (5 half-lives plus 40% more for margin of error). we plan to study subjects with impaired fasting glucose or impaired glucose tolerance as they would likely be candidates for dpp-iv therapy in the future and would be likely to have impaired insulin secretion and impaired glucose disposal amenable to dpp-iv therapy. a total of 10 participants were enrolled in this study. participants were given 2.5 mg dexamethasone daily plus either placebo tablet or sitagliptin daily for 8 days with a washout period prior to crossover. the order of study drug administration was randomized. participants underwent blood sampling, mixed meal testing (mmt), and intravenous glucose tolerance testing (ivgtt) before and after each study period.

Eligibility criteria:
inclusion criteria: * men and women * impaired fasting glucose * we will stratify for weight and age. exclusion criteria: * known type 2 dm * severe disease preventing participation in study * on chronic steroids for any reason * already taking dpp-4 inhibitor

Keywords: pre-diabetes impaired fasting glucose impaired glucose tolerance steroid-induced hyperglycemia
cinacalcet hydrochloride in treating men with recurrent prostate cancer

Conditions: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer

Summary: this phase ii trial is studying how well cinacalcet hydrochloride works in treating men with recurrent prostate cancer. cinacalcet hydrochloride may be effective in lowering prostate-specific antigen (psa) levels in patients with recurrent prostate cancer that has not responded to previous treatment

primary objectives: i. to test the hypothesis that once-daily treatment with 30 mg of cinacalcet hydrochloride (sensipar) will reduce the rate of rise of serum prostate-specific antigen (psa) compared to pre-treatment psa values in subjects with biochemically recurrent prostate cancer after failed definitive local therapy. outline: patients receive cinacalcet hydrochloride orally (po) once daily (qd) for 20 weeks in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up for 4 weeks.

Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed adenocarcinoma of the prostate * for patients who have recurrent disease following surgery as first line therapy ("surgical failures") * psa requirement is 0.2 ng/ml or above * for patients who have recurrent disease following radiation as first line therapy, the eligibility follows the "phoenix criteria", that is, a rise of 2 ng/ml over the psa nadir * eastern cooperative oncology group (ecog) performance status =\< 2 * granulocytes \>= 1000/ul * serum creatinine =\< 2.0 mg/dl * total serum calcium \> 9.0 and \< 10.5 mg/dl * total bilirubin =\< 2.0 mg/dl * platelet count \>=100,000/ul * hemoglobin (hgb) \>= 9 g/dl * total testosterone \>= 50 ng/dl * ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative) exclusion criteria: * serious medical illness which would limit survival to less than 3 months * active, uncontrolled bacterial, viral or fungal infection * hemorrhagic disorder * any radiographic evidence of metastatic disease including positive bone scan or computed tomography (ct) abdomen/pelvis * history of hypocalcemia or seizure disorder * patients with known hypersensitivity to any of the components of cinacalcet (cinacalcet hydrochloride)
comparing vasopressin and adrenaline in patients with cardiac arrest

Conditions: Cardiac Arrest

Summary: the effectiveness of medications in cardiac arrest has been greatly debated and questioned. historically intravenous adrenaline has been the drug of choice since 1906. there have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field. thus the purpose of this study is to compare vasopressin and adrenaline in the treatment of cardiac arrest to answer the question whether there is an improvement in survival between vasopressin and adrenaline.

the effectiveness of medications in cardiac arrest has been greatly debated and questioned. historically intravenous adrenaline has been the recommended drug of choice since 1906. there have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field. more recently, vasopressin has been used in patients with cardiac arrest. in human studies on vasopressin, clinical trials have produced conflicting results. the current study compared vasopressin and adrenaline in the treatment of cardiac arrest in patients presenting to the emergency department (ed). specific outcomes included return of spontaneous circulation (rosc) (as measured by the presence of a palpable pulse at any time during resuscitation), survival to hospital admission, survival to discharge from hospital, and functional status at discharge and at one year (as measured by the glasgow-pittsburgh outcome categories).

Eligibility criteria:
inclusion criteria: * patient with cardiac arrest as confirmed by the absence of a pulse, unresponsiveness and apnea * age above 16 (age 21 and above for cgh only) exclusion criteria: * traumatic cardiac arrest * age 16 and below (age 20 and below for cgh only) * cpr is contraindicated

Keywords: vasopressin adrenaline survival return of spontaneous of circulation
alpha radiation emitters device for the treatment of advanced pancreatic cancer

Conditions: Pancreatic Cancer; Unresectable Pancreatic Cancer; Metastatic Pancreatic Cancer; Pancreatic Adenocarcinoma

Summary: a unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer.

this is a prospective, single-center, open label, single arm study. the study is designed to evaluate the feasibility, safety and preliminary efficacy of intratumoral alpha radiation mediated treatment with alpha dart seeds for the treatment of advanced pancreatic cancer. the study will be comprised of a screening period, dart insertion visit, acute follow-up phase of 4-6 weeks and a long-term follow up phase of 24 months. the total duration of the study will be 24 months from the dart insertion procedure. 30 patients with advanced pancreatic cancer will be recruited by the investigational site. eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of dart seeds insertion. the patients will be monitored for a period of 24 months post insertion.

Eligibility criteria:
inclusion criteria: * histologically and/or cytologically proven locally advanced (stage ii or iii) or metastatic (stage iv) pancreatic, adenocarcinoma * inoperable pancreatic cancer due to at least one of the following: a) unresectability, b) metastatic disease, c) medically unfit for surgery * ecog performance status ≤ 2 * measurable lesion per recist (version 1.1) criteria * maximum lesion of 4cm in the longest diameter (including primary tumor and regional lymph nodes) * ≥ 18 years of age * estimated life expectancy of at least 12 weeks * women of childbearing potential (wocbp) will have evidence of negative pregnancy test * subjects are willing to sign an informed consent exclusion criteria: * prior chemotherapy does not exclude the patient * prior abdominal radiation therapy * concomitant chemotherapy or immunotherapy * borderline resectable pancreatic cancer and medically fit for surgery * connective tissue disease (scleroderma, lupus) * patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.) * patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids * volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of dart * high probability of protocol non-compliance (in opinion of investigator) * patients not willing to sign an informed consent form * women who are pregnant or lactating

Keywords: pancreatic cancer unresectable pancreatic cancer metastatic pancreatic cancer pancreatic adenocarcinoma pancreas neoplasm alpha radiation pancreas cancer pancreas metastases
anal cytology collection procedures in predicting high-grade anal dysplasia in men who have sex with men

Conditions: Anal Carcinoma; HIV Infection; Human Papillomavirus Infection

Summary: this clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (msm). it also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. this study may help doctors develop better screening for high-grade anal dysplasia in msm in order to identify those who need to return for additional screening and treatment.

primary objectives: i. evaluate the sensitivity \& specificity, predictive positive value (ppv), \& predictive negative value (pnv) (test characteristics) \& cellularity, beta-globin, deoxyribonucleic acid (dna), ribonucleic acid (rna), \& protein (quality measures) from nylon-flocked (nf)- \& dacron-swab protocols to detect biopsy-detected high-grade anal intraepithelial neoplasia (hg-ain) \& human papillomavirus (hpv)-infections, using randomized-controlled study design. ii. evaluate the test characteristics for anal cancer screening algorithms that incorporate sequentially or simultaneously performed high-threshold molecular hpv tests, with \& without cytology, to predict hg-ain. iii. evaluate the cost-effectiveness \& relative cost of single- \& multiple-test anal cancer screening algorithms. outline: patients undergo anal cytology collection using 2 nf swabs and 1 dacron swab for analysis via papanicolaou (pap) staining, hpv genotyping, and polymerase chain reaction (pcr).

Eligibility criteria:
inclusion criteria: * males who self-identify as having had or currently having sex with men; both human immunodeficiency virus (hiv)-infected and hiv-uninfected subjects are being enrolled
an exploratory study to evaluate the safety of brimonidine intravitreal implant in patients with retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: this exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of brimonidine intravitreal implant in one eye of patients with retinitis pigmentosa.


Eligibility criteria:
inclusion criteria: * retinitis pigmentosa in both eyes * visual acuity between 20/40 to count fingers exclusion criteria: * growth of new blood vessels in the eye * any intraocular surgery or laser in either eye in the last 6 months prior to screening visit or between the screening visit and day 1 * any ocular disease that can interfere with diagnosis and or assessment of disease progression * significant near-sightedness * hiv * female patients who are pregnant, nursing, or planning pregnancy
assesment of the efficiency and safety helicobacter pylori therapy with or without saccharomyces boulardii

Conditions: Helicobacter Pylori Infection

Summary: this study assesses the effect of quadruple therapy for h. pylori, with the addition of probiotics saccharomyces boulardii. in addition, he assesses whether this combination reduces the frequency of adverse effects of eradication therapy, and whether it affects the compliance.

standard triple therapy for h. pylori infection proved to be insufficiently effective, primarily due to antibiotics resistance.therefore, the latest maastricht consensus suggests using bismuth-quadruple or non-bismuth-quadruple therapy, in regions with high clarithromycin resistance. the addition of probiotics with eradication therapy has never become a standard treatment. however, the maastricht consensus suggest that the addition of probiotics could increase the effectiveness of quadruple therapy. the study was designed as a prospective, double-blind, randomized, case-control intervention study.

Eligibility criteria:
inclusion criteria: * dyspepsia * patients not treated for h. pylori * age of 18-50 years * positive urea breath test exclusion criteria: * alarm symptoms (anemia, persistent vomiting, hematemesis, dysphagia, significant weight loss, palpable mass in abdomen) * gastric cancer * immunosuppressive therapy * use of acetylsalicylic acid * severe renal failure * severe liver failure * immunodeficiency * proven malignant disease * penicillin allergy * allergy to any component of dietary supplement (saccharomyces boulardii and vitamin d) * chronic alcoholism * pregnancy * lactation

Keywords: helicobacter pylori saccharomyces boulardi eradication therapy
analysis of tclt in tbi patients: a prospective, randomized controlled trial

Conditions: Brain Injury; Cognitive Deficits

Summary: the purpose of this study is to evaluate the early and late effects of transcranial led therapy (tltc) in memory and executive functions in patients with moderate and severe tbi history (tbi time longer than 3 months).

in the current study patients in the outpatient center - neurotrauma unit at university of são paulo (hcfmusp) diagnosed with moderate / severe blunt head trauma that meet the inclusion criteria will be divided randomly and blindly in two groups: group a (n = 18) will receive stimulation through active helmet and group b (n = 18) given placebo stimulation or sham through the inactive helmet. all patients will be subjected to 3 times of neuropsychological assessment: study 1 (e1) - up to 4 weeks before the start of tltc sessions; study 2 (e2) - a week after the end of tltc; and study 3 (e3) - three months after the intervention. the evaluations will take in order to verify the early and late effects of tltc in attention, memory and executive functions in patients with moderate and severe tbi.

Eligibility criteria:
inclusion criteria: * clinical and radiological diagnosis of traumatic brain injury * must be able to sign the informed consent form * patients with tbi beginning three months after injury exclusion criteria: * impairment of language and / or limiting engine * extensive cranial vault defects * presence of uncontrolled post-tbi epilepsy

Keywords: traumatic brain injury cognitive