Kornimate/medical-research-clean huggingface dataset:
effects of pentazocine on manic symptoms

Conditions: Bipolar Disorder

Summary: the opiate neurotransmitter system is thought to be involved in many abnormal mood states. some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. one problem with most of the currently available opiate medications is that they can produce addiction/dependence. a particular kind of opiate medication known as kappa-opiates may be able to produce changes in this system with much less risk of addiction. this study looks at talwin (a combination of pentazocine and naloxone), a medication which affects the kappa and mu opiate systems. the study will examine whether two doses of talwin affect manic symptoms in people who have been admitted to the hospital. this study will give more information about the involvement of the opiate system in bipolar disorder, and give important information for use in developing new treatments.

opiates have a long history of treating mood disorders. some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. the clinical use of opiate medications has been limited by their abuse/dependence potential. studies of opiate receptor subtypes have raised the possibility that medications targeting the kappa/dynorphin system could be used to target mood symptoms with reduced/limited addiction potential. rodent studies at mclean indicate that kappa-agonists have pro-depressant effects and kappa-antagonists have anti-depressant effects. in addition, antimanic/antipsychotic medications regulate the activity of dynorphin cells. this study is a pilot open-label investigation using talwin, a combination of pentazocine and naloxone. pentazocine is a kappa agonist and mixed mu agonist. two doses of talwin will be given to acutely manic inpatients in a cumulative-dosing strategy. measurements of manic symptoms will be conducted before, during, and after administration. this study will determine whether pentazocine has an immediate or sustained impact on acute mania symptoms.

Eligibility criteria:
inclusion criteria: * young mania rating scale (ymrs) greater than 14 * inpatient exclusion criteria: * history of opiate abuse/dependence * recent history of substance abuse * pregnancy * unstable medical issues * use of opiate medications for pain management

Keywords: bipolar disorder mania manic state opiate kappa
epicardial ablation in brugada syndrome

Conditions: Brugada Syndrome

Summary: this prospective study evaluates the methodology and results of epicardial mapping/ablation in a large series of consecutive selected brs patients and to verify if rfa could normalize the consequences of a genetic disease.

the present registry is designed as a prospective, monocentric study. all patients referred to the arrhythmology department of irccs policlinico san donato milanese, university- hospital, for the management of brs and fulfilling the selection criteria will be invited to participate in the study and will be asked their written consent to the participation in the trial. mapping and rfa procedure will be performed following a standardized procedure in hospital settings. patients will be monitored for at least 3 days after procedure. before hospital discharge, echocardiography and 12-lead ecg will be performed in all patients. an ajmaline test will be systematically performed after the procedure and thereafter at 3, 6, and 12 months after ablation. patients will be followed up clinically after procedure as per normal clinical practice. follow-up visits will be scheduled at 3, 6, and 12 months. 12-lead ecg and icd interrogation will be performed at each follow-up visits. patients will be instructed to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias. documentation for intercurrent events will be requested and collected.

Eligibility criteria:
inclusion criteria: * patients affected by brugada syndrome, profiled by genetic testing, with documented spontaneous or drug-induced type i brs ecg pattern, with symptoms attributable to ventricular arrhythmias and presenting multiple documented arrhythmic episodes * patients with an icd already implanted * patients referred to the center for an electrophysiological study and indication to a potential concomitant radio-frequency catheter ablation (rfa) of ventricular arrhythmia or ventricular fibrillation * age ≥ 18 * willingness to attend follow-up examinations * written informed consent to the participation in the trial exclusion criteria: * pregnancy or breast-feeding * patients with low arrhythmic risk (brugada pattern iii) * life expectancy \< 12 months.

Keywords: radiofrequency ablation mapping sudden death syncope
short course radiotherapy in complicated bone metastases palliation

Conditions: Palliative Care

Summary: the study wants to define the maximum tolerated dose (mtd), safety and efficacy of a short course radiation treatment in patients with complicated bone metastases.

the study wants to define the maximum tolerated dose (mtd) of a conformal short course radiation treatment delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of complicated bone metastases.

Eligibility criteria:
inclusion criteria: * radiologically proven complicated bone metastasis * age \> 18 years * eastern cooperative oncology group (ecog) performance status \< 3 exclusion criteria: * prior rt to the same region

Keywords: palliative care complicated bone metastases radiotherapy pain quality of life
validation of an self administered questionnaire in french for assessment of cardio respiratory reserve

Conditions: Cardiovascular Diseases

Summary: the guidelines of the european society of cardiology (esc) for preoperative management in non-cardiac surgery make the estimation of patients' maximum oxygen uptake (vo2peak) one of the cornerstones of preoperative evaluation. indeed, below a certain threshold of vo2 peak fixed in the literature at 15 milliliters/kilogram/minutes (ml/kg/min) (or 4 metabolic equivalent of task - met), the esc recommends to carry out additional non-invasive examinations to evaluate the coronary risk of these patients. in current practice, this evaluation is performed in anesthesia consultation by non-standard interview. the question "can you go up a floor or climb a hill?" permits to classify patients with more or less vo2 peak than 4 met. however, several studies, including one published in the lancet in 2018, show that this evaluation doesn't assess correctly the vo2peak of the patients nor predict post-operative cardiac complications. in the same study, the evaluation of a standardized self-questionnaire, the duke activity status index (dasi), found a good correlation between the value of this pre-operative score and the 30-day mortality as well as the occurrence of infarction. this self-questionnaire contains a dozen questions about the physical activities of daily life that patients are able or not to perform (household, various physical activity). it has also been validated in medical patients as being well correlated with the value of vo2 peak in the case of an answer by a third party (r = 0.81, p \<0.001) and satisfactory in the case of a self-questionnaire (r = 0.58 , p \<0.001). this self-questionnaire exists in english but there is no validated translation in french. given the cultural differences, it seems necessary in order to use it in a french-speaking context to go through a scientific validation stage. a validation study of dasi in portuguese has already been published recently, serving as a methodological basis for a french translation. the purpose of this study is to carry out a validation of a standardized self-questionnaire in french. it will be distributed to patients referred for a vo2peak test as part of their standard management in the louis pradel hospital (hospices civils de lyon, lyon). the results of vo2peak predicted by the self-questionnaire will be compared to the vo2 peak measured during the examination.


Eligibility criteria:
inclusion criteria: * major patients * patients considered stable according to the judgment of the investigator * indication of a stress test with measurement of vo2max as part of its medical management exclusion criteria: * acute clinical event in the last 3 months * system illness context * absence of coverage by a social security system * safeguarding justice (tutelage, guardianship, deprivation of civil rights) * pregnant or lactating women
artificial sweeteners in breast milk

Conditions: Breastfeeding; Diabetes Mellitus; Overweight

Summary: this study will investigate how some artificial sweeteners (as) cross from blood to breastmilk in breastfeeding women after oral intake. moreover, it will be investigated whether the kinetics of as differ based on the women's body composition (bmi) and metabolic status (diabetes). this will be investigated through a clinical trial in which 60 women divided into three groups (normal weight, overweight and diabetic) will drink a beverage containing four as. over a period of six hours the women will donate blood and breast milk samples in order to investigate the presence of as.


Eligibility criteria:
inclusion criteria: * above 18 years old * able to give consent * able to produce enough amounts of breastmilk * danish/english speakers * pre-pregnancy bmi below 25 (20 subjects) * pre-pregnancy bmi above 27 (20 subjects) * diabetes type 1 or 2 (20 subjects) exclusion criteria: * under the age of 18 years old * unable to give consent * unable to produce enough amounts of breastmilk * non-danish/english speakers * if they have consumed artificial sweeteners 24 hours prior to trial

Keywords: artificial sweeteners non-nutritive sweeteners
protein expression in human neuroblastoma tumor samples

Conditions: Neuroblastoma

Summary: rationale: studying protein expression in samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors find better ways to treat neuroblastoma. purpose: this laboratory studying is looking at protein expression in tumor tissue samples from patients with neuroblastoma.

objectives: * to determine whether intersectin (itsn1) proteins are present at elevated levels in primary human tumor samples. outline: archived tumor tissue samples are analyzed for intersectin (itsn1) expression by western blot assays with enhanced chemiluminescence and exposed to x-ray film. the films are scanned, and levels of itsn1 signal are quantified by densitometry.

Eligibility criteria:
disease characteristics: * diagnosed with neuroblastoma * banked primary tumor samples from patients with stage 1, 2, 3, and 4 disease patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: disseminated neuroblastoma localized resectable neuroblastoma localized unresectable neuroblastoma stage 4s neuroblastoma
papuan indigenous model of male circumcision

Conditions: HIV Infections

Summary: the purpose of the study is: aim 1: to engage papuan community members to explore acceptability, barriers and facilitators for introducing a school-based age and culturally appropriate, comprehensive vmmc intervention to reduce hiv incidence in the papuan population. aim 2: to assess the capacity of the community health system to meet international criteria for safe comprehensive vmmc services and to ensure the availability of resources and training necessary to meet these criteria in selected clinics. aim 3: to design the pim of school-based adolescent vmmc based on information collected in aims 1 and 2 and in consultation with a community advisory board, the ministry of health and the ministry of education. aim 4: to pilot-test the school-based pim intervention of vmmc with 400 boys ages 12-18 years at two hiv high-risk papuan locations: the nabire and jayapura. primary outcomes are the proportion of adolescent males exposed to school-based pim vmmc educational and informational sessions who get circumcised and surgical event safety. secondary outcomes are satisfaction by adolescent males and parents, any sexual activity within 6 weeks after circumcision, changes in sexual risk behaviors between base-line and 12 weeks after circumcision, and perceptions of providers regarding mc training and implementation, ease of device use, and challenges encountered.


Eligibility criteria:
inclusion criteria: * resident of either nabiri or jayapura districts of papua, indonesia. able to provide informed consent if over 17 and parental consent and personal assent if less than 18. focus group and interview participants had to be either a parent, boy or girl between 12-18, teacher or administrator, or community leader. to be eligible for circumcision, a boy had to be uncircumcised, age 15 years or above, and not show signs or symptoms of an sti or any penile abnormality (e.g., hypospadias, phimosis) that made him clinically ineligible for circumcision. exclusion criteria: * unable to provide informed consent or assent. any medical condition indicating should not undergo circumcision.

Keywords: hiv prevention male circumcision papua indonesia
development training in babies born preterm

Conditions: Premature Birth

Summary: the specific purpose of this study is to determine the effect of movement training on the onset of motor skills in babies born prematurely. we hypothesize that infants who participate in movement training will show advances in motor skills, visual attention, and toy-oriented behavior.

the long term goal of this research program is to develop detailed intervention options for physical therapy treatment of very young preterm infants at risk for disability. the ability of infants to start reaching marks the beginning of an infants' ability to independently explore objects, and impacts development across multiple domains, including cognitive, language, and social. the aim of this study is to determine if bi-daily movement training will advance the reaching abilities of infants born preterm as compared to non-movement trained controls. movement training group: parents/caregivers will be instructed to improve their infants' awareness and ability to reach for toys with their arms and legs by performing two sets of 10 minutes of daily exercises with them. the first 10 minutes will focus on improving awareness of their arms and toys (such as bells on their wrists). the second 10 minutes of activity that focuses on introducing infants to a task-space they rarely experience at this age, the task-space required for midline reaching (such as moving the infant's arm to a midline toy). an experimenter will visit each family in their homes every other week (the week that is not a testing week) to assure correctness of training, encourage full participation and answer any questions. social training group: to control for increased social interaction that accompanies the enhanced training, parents of infants in this group will serve as a control group. parent/caregivers will be asked to perform 2x a day of 10 minutes face-to-face social interaction with their infants. parents and infants will receive a 10 minute audio tape of popular kids' songs. they will be instructed to place infants supine or in a bouncy seat and interact with the infant visually and verbally during this time period along with the music. after the study is completed, each group will be offered the training booklet that the opposite group received.

Eligibility criteria:
inclusion criteria: * infants born less than 33 weeks gestation (up to and including 32 6/7 weeks) * infants born weighing less than 2500 grams exclusion criteria: * orthopedic, visual or hearing impairments * fetal drug exposure

Keywords: premature birth motor skills learning reaching
nutriplant - opportunities for increasing consumption of local fruits and vegetables

Conditions: Functional Constipation; Irritable Bowel Syndrome

Summary: the effects of different foods to normal bowel function in adult population will be investigated. a randomised controlled intervention trial will be conducted on about 120 (30 per group) adult (18-70 years) subjects with functional constipation and irritable bowel syndrome with constipation according to the iv. rome criteria. at least one week before inclusion in the study, patients will stop taking laxatives and other anti-constipation medications. subjects will be randomly selected to consume one of the test foods (fresh apples, dried apples, sauerkraut) or the active control (psyllium) in the equivalent amount of 3 g of fiber per day for 4 weeks. subjects will be asked not to change their lifestyle habits, such as diet and physical activity level, and not to take oral laxatives during the period of participation in the study.


Eligibility criteria:
1. inclusion criteria: * signed informed consent of the participant to participate in the study * age between 18 and 70 years * functional constipation or irritable bowel syndrome * expressed willingness to eat the investigated food daily (sauerkraut, apples, dried apples or psyllium; period of four weeks) 2. exclusion criteria: * known allergy to the investigated foods (fresh apples, dried apples, sauerkraut or psyllium) * pregnancy or breastfeeding * previous gastrointestinal surgery with the exception of cholecystectomy and appendectomy * other gastrointestinal diseases (chronic inflammatory bowel disease, celiac disease, gastroparesis, etc.) * serious chronic diseases * introduction of extensive changes in diet or physical activity in the last 4 weeks before the inclusion examination * regular use of laxatives or inability to stop using laxatives for the duration of the study * concurrent participation in another study
a study of single ascending dose of lem-s401 in healthy participants

Conditions: Cicatrix; Scar Prevention

Summary: the primary objective of the study is to assess the safety and tolerability of single dose of lem-s401 in healthy adult subjects.

this study is designed to evaluate the safety and tolerability of lem-s401 administered as subcutaneous injection in healthy adult subjects. overall, 18 subjects will be studied in 3 groups. each subject will receive lem-s401 or placebo subcutaneously.

Eligibility criteria:
inclusion criteria: * healthy male and female subjects aged 19 to ≤ 65 years at screening exclusion criteria: * significant history or clinical manifestation of any hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, tumor, genitourinary, cardiovascular, gastrointestinal, musculoskeletal, dermatological (eg, contact dermatitis, atopic dermatitis), or other * history of drug abuse or positive urine drug screen at screening * for all female subjects, pregnant (urine-hcg positive) or breast-feeding subjects

Keywords: scars scar prevention fibrosis
observational study in cystic fibrosis patients using tobi® podhaler® or other fda approved inhaled antipseudomonal antibacterial drugs

Conditions: Pseudomonas Aeruginosa in Cystic Fibrosis

Summary: this is a multicenter, prospective, two cohort, observational study over a 5-year period in cystic fibrosis (cf) patients with chronic pseudomonas aeruginosa infection.the study will collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on microbiological and safety assessments.

this study will include cf patients chronically colonized with p. aeruginosa enrolled in the cystic fibrosis foundation (cff) portcf registry and using tobi® podhaler® or another fda-approved inhaled antipseudomonal antibiotic. no therapeutic intervention will be assigned and physicians will use their discretion in choosing a treatment regimen for their patients. sputum samples (primarily collected during routine clinical follow-up) from patients able to spontaneously produce sputum will be sent to a central laboratory for analysis. in addition, this study will include two optional sub-studies for qualifying patients in the first study year - sputum microbiology sub-study and tobi® podhaler® sputum pharmacokinetics (pk) sub-study.

Eligibility criteria:
inclusion criteria: * ≥ 6 years of age. * documented fev1 ≥ 25% predicted in the previous year. * diagnosis of cystic fibrosis. * established diagnosis of chronic p. aeruginosa infection of the lungs defined as two or more positive p. aeruginosa cultures in the previous year as documented in the subject's medical history (this may include a history of one positive culture in the year prior to enrollment and one positive culture from the specimen collected at the baseline visit). * prescribed and initiated chronic treatment with fda-approved inhaled antipseudomonal antibiotic for chronic p. aeruginosa infection (e.g. tobi® podhaler®, tobi®, cayston® and bethkis®). * actively enrolled or willingness to enroll in portcf registry. * willing and able to provide written informed consent or, parent/guardian consent and where applicable pediatric assent, for participation and use of relevant clinical data previously captured in portcf. * anticipated to have good adherence to routine visits, defined as the investigator having good knowledge that the patient has been to at least 2-3 routine visits in the previous year. exclusion criteria: * documented fev1 \< 25% predicted in the previous year. * current participation in an interventional clinical study with an inhaled antibiotic treatment. * treatment with compounded tobramycin (e.g. the use of tobramycin iv solution adapted for use by inhalation). * treatment with inhaled antipseudomonal antibacterial drug(s) that are not fda approved. * patients undergoing an early eradication regimen for cf (first line therapy).
comparing effects of beetroot juice and mediterranean diet on liver enzymes and sonography in patients with nafld

Conditions: NAFLD, Non-alcoholic Fatty Liver Disease

Summary: the goal of this clinical trial study is to investigate comparing effects of beetroot juice and mediterranean diet on liver enzymes and sonographic appearance in patients with non-alcoholic fatty liver disease (nafld) the main question\[s\] it aims to answer are: 1. beetroot juice has role in reduce liver enzymes 2. mediterranean diet has role in reduce liver enzymes

patients with nafld were identified and enrolled for this research at the par hospital in the kurdistan region of iraq. for 12 weeks, for the group members who were receiving the med, we recommended consuming mediterranean foods like fish, poultry, sources of omega-3, vegetables and colored fruits, legumes and nuts, and low-fat goods while avoiding inflammatory foods like high-fat foods, processed meats, fast food, simple sugars, chips, and soft drinks. at baseline, the participants' demographic and anthropometric information, including as gender, age, weight, height, smoking status, location of residence, and physical activity, were recorded.

Eligibility criteria:
inclusion criteria: 1. patients had to be between the ages of 19 and 73, and they had to have nafld as their main diagnosis. 2. for a nafld diagnosis, ultrasound proof of fatty liver (stage i or above) and an elevated level of liver enzymes were required. exclusion criteria: 1. history of diseases like cardiovascular, liver, chronic hepatitis c, and kidney disease 2. supplement use within the previous six months; hormone therapy; use of drugs like amiodarone, methotrexate, and corticosteroids 3. cases of starvation or inadequate nutrition; pregnancy; metabolic disorders like wilson disease and glycogen storage disease; a history of liver irradiation

Keywords: mediterranean diet beetroot juice nonalcoholic fatty liver