Kornimate/medical-research-clean huggingface dataset:
opioid analgesia for mab

Conditions: MAB; Pain

Summary: our primary objective will be to determine if a strong opioid, oxycodone, given at a dose recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared to ibuprofen and placebo in women undergoing medical abortion (mab). results of this study will help future providers understand whether prescribing opioids are an important adjunct for pain control in women undergoing mab.

this study will include 152 women undergoing mab. women will be randomized to oxycodone 10mg oral versus placebo and stratified by gestational age (\<7wks, 7-10wks). the primary outcome will be maximum reported pain score measured at 6-8 hours and 24 hours after misoprostol administration.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * seeking elective medical abortion * in good health * pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound * able and willing to receive text messages via phone * literate in english * able and willing to give informed consent and agree to the study terms * have assistance at home; no motor vehicle use while taking study medications exclusion criteria: * lack of access to cell phone and texting capabilities * early pregnancy failure * contraindications to the study medications: oxycodone, ibuprofen * contraindications to medical abortion with mifepristone or misoprostol * history of methadone or heroin use * used alcohol in the past 24 hours * used marijuana \>4 times per week * any opioid in the past 30 days * using additional pain medications
interactions of human gut microbiota with intestinal sweet taste receptors

Conditions: Obesity

Summary: the purpose of this study is to collect data to examine whether short-term consumption of non-caloric artificial sweeteners (ncass), such as saccharin, can lead to changes in blood sugar levels and in the composition of the bacteria in the large intestine.


Eligibility criteria:
inclusion criteria: 1. able to provide written informed consent 2. age 18-45 years 3. weight stable (± 3 kg) during the 6 months prior to enrollment 4. bmi ≤ 25 kg/m2 5. consumption of less than a can of diet beverage or a spoonful of ncass weekly (or each equivalent from foods) during the past month exclusion criteria: 1. known coronary artery disease, angina or congestive heart failure 2. type 1 or type 2 diabetes (a1c ≥6.5%) 3. bleeding disorders 4. hemoglobin level \< 12.5 g/dl for women; hemoglobin level \< 13.0 g/dl for men 5. acute or chronic infections 6. hepatitis and/or cirrhosis 7. severe asthma or chronic obstructive pulmonary disease 8. renal insufficiency or nephritis (creatinine \> 1.6 mg/dl) 9. prior bariatric surgery 10. inflammatory bowel disease or malabsorption 11. cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ) 12. psychiatric disorders or eating disorders 13. cushing's disease or syndrome 14. untreated or inadequately controlled hypo- or hyperthyroidism (abnormal tsh) 15. active rheumatoid arthritis or other inflammatory rheumatic disorder 16. pregnant or nursing women 17. smoking (smoking within the past 3 months) 18. less than 4 bowel movements per week 19. known hypersensitivity to saccharin, lactisole or any of its excipients. excluded medications include but are not limited to: 20. anti-diabetic agents 21. oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable) 22. antibiotic use (within the past 3 months) 23. other drugs known to affect immune or metabolic function 24. orlistat, phentermine, topiramate or other weight loss or anorectic agents (tricyclic antidepressants, atypical antipsychotics or other psychiatric drugs with effects on body weight)

Keywords: glucose sweet taste receptors artificial sweeteners
advancing pre-operative targeting for deep brain stimulation in the globus pallidus internus

Conditions: Parkinson Disease

Summary: in the proposed pilot project, mri data will be prospectively collected to show the feasibility of the segmentation algorithm and the potential relation to final lead positioning. patients will be selected from those undergoing gpi dbs placement. this pilot data will serve as a basis for pursuing funding for a larger trial evaluating the prospective ability of the 3t targeting study to improve outcomes and decrease complications in gpi dbs placement. improved outcomes and patient experience would be expected to further contribute to our facility as a center of excellence for treatment of movement disorders.


Eligibility criteria:
patient with the diagnosis of parkinson's disease selected for placement of globus pallidus internus (gpi) deep brain stimulator (dbs)

Keywords: parkinson disease deep brain stimulation diffusion tensor imaging
study to measure the impact of antibiotics on bacterial flora in adults with acute sinusitis

Conditions: Maxillary Sinusitis

Summary: the purpose of this study is to measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (ams).

the objectives of this study are: * to assess the impact of therapy with telithromycin vs. azithromycin on the oral microflora in patients with acute maxillary sinusitis at day 42 and to compare the duration of colonization with resistant oropharyngeal flora in patients treated with azithromycin vs. telithromycin. * to also compare the two treatment groups for rate of reinfection within 6 weeks and the susceptibility pattern of the organisms appearing during the reinfection and differences in development of resistance and the associated changes in symptom responses.

Eligibility criteria:
inclusion criteria: * adult patients, either males or non-pregnant females, aged 18 to 75 years of age with clinical findings of acute maxillary sinusitis (ams), who are amenable to serial sampling of the nasopharynx and oropharynx. * patients are required to have specimens of nasal and nasopharyngeal drainage collected for microbiological documentation within 24 hours prior to enrollment. all patients must produce sinus fluid drainage. * all patients will produce nasal or nasopharyngeal discharge sufficient for baseline culture. * female patients of child bearing potential must agree to use an accepted method of contraception (i.e., oral or implanted contraceptive with a barrier method, spermicide and barrier methods, or intrauterine device \[iud\]). the patient must agree to continue with the same method throughout the study. exclusion criteria: * patients with a history of recurrent sinusitis defined as more than three episodes of sinusitis which required antibiotic therapy in the preceding 12 months * patients with a history of chronic sinusitis defined as symptoms lasting greater than 28 days * patients with nosocomial acquired sinusitis (e.g., hospitalization or non-ambulatory institutional confinement including nursing homes within 2 weeks) * patients with a need for immediate surgery for maxillary sinusitis or previous sinus surgery within the past 6 months or sinus lavage within the past 7 days * patients who are long-term (\> 4 weeks) users of nasal decongestants (e.g. oxymetazoline 0.05%) * patients with a known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to, any macrolide antibiotic * impaired hepatic or renal function (creatinine clearance \[ccl\] \<20 ml/min) * severe respiratory tract infections requiring hospitalization and parenteral antibiotic therapy. * requirement for a concomitant antimicrobial agent other than topical, antiviral or antifungal agents. * treatment with any macrolide, azalide, or ketolide antimicrobial within the 30 days prior to entry into the study.

Keywords: s.pneumonia sinusitis ams azithromycin
concealed penis in pediatric age group

Conditions: Pediatric ALL; Surgery; Urologic Diseases

Summary: background: comparison between three different surgical techniques in the management of concealed penis. methods: this prospective interventional non-randomized study included 150 pediatric patients with concealed penis. they were distributed equally into three groups; group a; patients treated by phallopexy only, group b; patients treated by complete dissection and excision of dartos fascia \& group c; patients treated by both phallopexy and dartos excision.

background: comparison between three different surgical techniques in the management of concealed penis. methods: this prospective interventional non-randomized study included 150 pediatric patients with concealed penis. they were distributed equally into three groups; group a; patients treated by anchoring the penile skin dermis to buck's fascia at the penile base at 3 \& 9 o'clock points using pds 5/0 (phallopexy), group b; patients treated by complete dissection and excision of dartos fascia \& group c; patients treated by phallopexy as in group a after complete dissection and excision of dartos fascia. follow-up at the end of the 1st post-operative week and then monthly for 6 months as regards penile skin congestion and/or necrosis, wound infection, edema, and/or re-retraction was carried out.

Eligibility criteria:
inclusion criteria: * patients with a buried penis at or below the pubic skin level with a stretched penile length for all of them within the normal range according to their ages as titrated in the literature exclusion criteria: * patients with any associated anomalies like hypospadias, torsion, penoscrotal web, micropenis, mega-prepuce, or chordae were excluded from the study.

Keywords: concealed phallopexy dartos excision degloving penile re-retraction
clinical and laboratory online patient- and research database for primary immunodeficiencies in switzerland

Conditions: Primary Immunodeficiency Disease

Summary: a swiss national, multi-centre, online patient and research database will be created, using the existing esid database server system. this database contains disease-specific data from patients with primary (inborn) immunodeficiency diseases (pid).

the project aims to compile clinical and laboratory data of patients with primary immunodeficiencies (pid) in order to improve diagnosis, classification, prognosis and therapy. the online technology offers features not available in former databases such as access control,security functionality, and maintenance of data integrity during transactions and system errors, online back up, online optimization, scalability and online sql-queries as well as a long term documentation of patients. furthermore the database can be used for the submission and storage of molecular diagnostic results and thus allow the compilation of genotype and phenotype observations, which is of essential and immediate use for the patient himself and patient care. an attending physician may gain information on similar cases of a rare pid disease in switzerland and european countries and use these insights for therapy. in addition, it will be possible to obtain an insight on side effects. thus, the system also meets the requirements of an optimal platform for phase iv studies of post-licensing drug surveillance-programs.

Eligibility criteria:
inclusion criteria: * primary immunodeficiency disease (pid) exclusion criteria: * none

Keywords: primary immunodeficiency disease
hepatitis b vaccine genetics: a substudy of atn 024 and atn 025

Conditions: HIV Infection; Hepatitis B

Summary: this laboratory-based substudy of an effectiveness trial of two hepatitis b vaccines in hiv-negative youths is being done to evaluate the genetic contribution to the individualized immune response.

this laboratory-based substudy of atn 024 and 025 will evaluate the genetic contribution to highly individualized immune responses to hepatitis b vaccine in individuals and confirm the correlation of specific human leukocyte antigen (hla) alleles and haplotypes with hepatitis b virus (hvb) antibody concentrations and antibody decay kinetics in vaccinated adolescents. approximately 5 ml of whole blood will be collected from study participants at the time of the week 28 visit or at any subsequent study visit or clinic visit following successful completion of the week 28 visit. peripheral blood mononuclear cells will be obtained and qia amp blood kit will be used to extract high-quality genomic dna for polymerase chain reaction-based genotyping by the peii laboratory. the study is expected to be available for the duration of the parent studies which is approximately 2 years. this study requires one visit that may be arranged to coincide with a study or routine clinic visit. there are no follow up visits.

Eligibility criteria:
inclusion criteria: * subjects currently enrolled in atn 024 or atn 025 are eligible for enrollment in atn 052 beginning at or following completion of the week 28 visit. * subjects previously enrolled in atn 024 or atn 025 are eligible for enrollment in atn 052, unless the subject was prematurely discontinued from the study prior to the first post-vaccination serology assessment which is performed at week 28. * current pregnancy is permitted. * a signed informed assent/consent must be obtained from the subject. * written parental or guardian permission must be obtained where required by the institutional review board/ethics committee (irb/ec). exclusion criteria: * inadequate post-vaccination serology evaluation in atn 024 or atn 025. * unable to obtain informed consent and/or parental/legal guardian permission where required by the local irb/ec.

Keywords: hepatitis b vaccines hiv-infected adolescents hepatitis b infection (negative) hiv vaccine trial
cardiopulmonary testing in me/cfs to improve diagnostic accuracy

Conditions: Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Summary: circumstantial evidence suggests that patients diagnosed with myalgic encephalopathy/chronic fatigue syndrome (me/cfs) perform worse on day 2 in a 2-day consecutive cardiopulmonary exercise test (cpet). the aim of this study is to examine if cpet can distinguish between me/cfs patients and healthy controls.

myalgic encephalopathy/chronic fatigue syndrome (me/cfs) leads to a substantial reduction in activity level. cardiopulmonary exercise testing (cpet) quantifies physical performance, or functional capacity, by direct measurements of the maximal oxygen uptake (vo2max). functional capacity is the ability of an individual to perform aerobic work as defined by the vo2max, and the assessment of functional capacity reflects the ability to perform activities of daily living that require sustained aerobic metabolism. to the best of knowledge few robustly designed studies on repeated cpet in me/cfs are published, and they demonstrated a significant reduction in functional capacity expressed as vo2max and anaerobic threshold. this marked functional decline on the second test has apparently not been described for any other chronic, disabling conditions, and might represent a possible diagnostic tool for me/cfs; hence the investigators will examine this. in addition they will examine other biological markers (e.g. cytokines and anti-oxidative compounds) before and after the exercise tests to test if the groups can be further distinguished. the main aim of this study is to evaluate the use of repeated cpet as an objective diagnostic marker of me/cfs. specifically the investigators want to address the following questions: i. will patients with me/cfs demonstrate a significant reduction in vo2max compared to healthy individuals? if such a difference can be demonstrated, is it unique for patients with me/cfs classified according to the strictest criteria compared to others with longstanding fatigue? ii. what is the blood lactate profile before, during and after cpet? iii. are there any correlations between the decline in vo2max and other biological variables such as markers of oxidative stress, immune dysregulation or metabolic dysfunction? iv. is cardiac function impaired among me/cfs patients as assessed by ecco-cardiography? three groups will be included: (i) me/cfs patients; (ii) patients with fatigue, but not mf/cfs; and (iii) healthy controls.

Eligibility criteria:
inclusion criteria: * diagnosed with me/cfs according to the canadian and fukuda criteria; miid to moderately affected) * provide written consent * able to perform the test exclusion criteria: * not provided written consent * unable to perform the test

Keywords: cardiopulmonary exercise testing inflammation oxidative status
a study to evaluate the safety of empliciti® (elotuzumab) when treating patients with multiple myeloma in taiwan

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: this observational study aimed to assess the safety of elotuzumab when used in combination with pomalidomide and dexamethasone for the treatment of relapsed and refractory multiple myeloma (rrmm) in participants who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. the study will also assess the safety of elotuzumab when used in combination with lenalidomide and dexamethasone in rrmm participants who had received one to three prior therapies.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * confirmed diagnosis of rrmm * received ≥ 2 prior therapies including lenalidomide and a proteasome inhibitor * planning to receive elotuzumab in combination with pomalidomide and dexamethasone at physician's medical judgement or * age ≥ 18 years * confirmed diagnosis of rrmm * received one to three prior therapies * planning to receive elotuzumab in combination with lenalidomide and dexamethasone at physician's medical judgement exclusion criteria: * participants with therapeutic indications for which elotuzumab in combination with pomalidomide/lenalidomide and dexamethasone has not been approved in taiwan * participants who are contraindicated for treated with elotuzumab in combination with pomalidomide/lenalidomide and dexamethasone (as described in the taiwan label) * participants who participate in other interventional clinical trials
patient-controlled versus anesthesiologist-controlled propofol-remifentanil in awake craniotomy

Conditions: Awake Craniotomy for Brain Tumour Surgery

Summary: awake craniotomy for removal of brain tumour is performed because the tumour may be located close to areas of the brain that control specific functions such as movement or speech. local anaesthesia (freezing) and sedation are required to make the patient comfortable and free of pain, but also to be able to cooperate for testing of brain function (speaking, moving) in order to preserve these areas while removing the brain tumour. the patient will be administered routine anesthetic drugs (sedatives (propofol) and pain killers (remifentanil)). the amount of sedation and analgesia (pain killer) is individually tailored to each patient as each person has different requirements. the usual way to give these medications is by the anesthesiologist assessing pain level, watching the patient and monitoring blood pressure and heart rate. another way to give this medication is now available. this is with a special device, known as a patient-controlled analgesia pump (pca). this device allows the patient to push a button to give pain medicine through an intravenous line and is frequently used for pain treatment after surgery and for other types of procedures. this device may be helpful during awake craniotomy, as it would allow patient-controlled administration of pain medicine and relaxing medicine whenever required. the amount of medication can be increased by more presses of the pump. at all times during the operation, the anesthesiologist will monitor the patient.


Eligibility criteria:
inclusion criteria: 1. adult patients more than 18 years of age 2. asa i, ii or iii 3. scheduled to undergo awake craniotomy for elective supratentorial tumor resection. exclusion criteria: 1. patients with allergy to the drugs being used. 2. patients at risk for pulmonary aspiration eg patients with history of gerd, gastroparesis (eg diabetic) and obesity. 3. patients with bmi 35 or above 4. patients with severe cardiovascular or respiratory diseases (asa iv or higher). 5. patients who are pregnant. 6. patients with alcohol or substance abuse. 7. patients who could not understand the concept of pcsa. 8. patients who do not understand and are unable to follow instructions for the study due to a language barrier 9. lack of informed consent.

Keywords: awake craniotomy patient-controlled sedation analgesia anesthetist-controlled sedation analgesia remifentanil-propofol tumour surgery
optimal management of vasa previa study - a retrospective study

Conditions: Vasa Previa

Summary: this is a multicenter retrospective observational study of women diagnosed with a vasa previa during pregnancy or at delivery who delivered between 2000 and 2012. the study hopes to be able to describe techniques utilized to screen for and diagnose vasa previa as well as to describe the maternal characteristics and identify potential underlying risk factors that may provide a basis for future screening recommendations for vasa previa and treatment protocols.

this is a multicenter retrospective study of women identified as having a vasa previa during pregnancy or at the time of delivery who delivered between january 1, 2000 and december 31, 2012 at participating centers. the primary objective of the study is to describe techniques utilized to screen for and diagnose vasa previa. * in those cases that were diagnosed antenatally, to describe the different management protocols utilized, correlate these management protocols with neonatal outcomes and support the management protocol that offers optimal outcomes for both mother and neonate. * in those cases that were not diagnosed antenatally, to describe the clinical scenario surrounding delivery and the neonatal outcomes. review the ultrasound reports and maternal characteristics to identify any potential risk factors for vasa previa that could have been identified antenatally in attempt to improve neonatal outcomes in the future. * in all cases of diagnosed vasa previa (those diagnosed antepartum, intrapartum, and postpartum), to describe the maternal characteristics and identify potential underlying risk factors that may provide a basis for future screening recommendations and protocols. due to the rarity of this diagnosis, the study hopes to include 100-250 participants.

Eligibility criteria:
inclusion criteria: * patients with the diagnosed of vasa previa made either during the pregnancy via ultrasound or at time of delivery via clinical and/or pathologic investigation. * patient delivered between january 2000 through december 2012 exclusion criteria: * no diagnosis or confirmation of vasa previa * delivered either before january 1, 2000 or after december 31, 2012

Keywords: vasa previa
hemodynamic effects of spironolactone in patients with heart failure

Conditions: Congestive Heart Failure

Summary: to determine if the beneficial effect of spironolactone in patients with congestive heart failure is in part due to its intrinsic inotropic action. randomized, two group placebo controlled, single blind study.


Eligibility criteria:
inclusion criteria: * chf * 21 - 80 years * serum creatinine \< 2 mg/dl * serum potassium 2.7 - 4.5 mg/dl measured within past 4 weeks exclusion criteria: * less than 21 years * pregnancy

Keywords: congestive heart failure hemodynamics echocardiographs