Kornimate/medical-research-clean huggingface dataset:
rapamycin+estradiol- vs. rapamycin-eluting stents to reduce restenosis (isar-peace)

Conditions: Coronary Heart Disease

Summary: the purpose of this study is to evaluate whether adding estradiol to rapamycin better prevents coronary artery reblockage after drug-eluting stent implantation.

coronary artery reblockage remains still a drawback of percutaneous coronary interventions even in the era of drug-eluting stents (des). dess working principle consists of the delivery of controlled amounts of antiproliferative agents at the local level, which results in the suppression of neontimal proliferation, the main cause of lumen re-narrowing after stent implantation. at present, several des platforms have been developed and evaluated for clinical use. they differ between them with regard to the stent type, anti-proliferative drug, presence or absence of polymers employed for drug storage and modification of drug-release kinetics as well as type of polymer used for this purpose. although their mid-term efficacy has been well-established, there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with dess. based on animal and human pathological data, investigators have linked the above-mentioned concerns to the presence of permanent polymers in dess, which have a proinflammatory and prothrombogenic potential, and sometimes may induce a hypersensitivity reaction. on the other hand, lack of or delayed reendothelialization is considered an important factor for development of coronary reblockage. estradiol has been shown to promote rapid reendothelialization of the stent and to reduce the restenosis after pci. this trial will compare the anti-restenotic efficacy of the polymer-free rapamycin plus 17β estradiolvalerat -eluting stent with that of the polymer-free rapamycin-eluting stent in patients with coronary artery disease. the isar stent is a rough surface stainless steel stent which allows coating without the need of polymer (pf isar stent) in the cath lab.

Eligibility criteria:
inclusion criteria: * patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels. * written, informed consent by the patient or her/his legally-authorized representative for participation in the study. exclusion criteria: * target lesion located in the left main trunk or bypass graft. * in-stent restenosis. * acute st-elevation myocardial infarction. * cardiogenic shock. * malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. * known allergy to the study medications: aspirin, clopidogrel, rapamycin, estradiol, stainless steel. * pregnancy (present, suspected or planned) or positive pregnancy test. * previous enrollment in this trial. * patient's inability to fully cooperate with the study protocol.
efficacy and safety of a single low-dose primaquine for the clearance of gametocytes

Conditions: Plasmodium Falciparum

Summary: the purpose of this study is to assess efficacy and safety of a single low-dose primaquine added to standard artemether/lumefantrine treatment for the clearance of plasmodium falciparum gametocytes among patients with uncomplicated malaria aged 1 year and above regardless of their g6pd status.

the current gained successes in malaria control are accredited partly to the availability of efficacious and fast acting artemisinins which are also potent against p. falciparum young gametocytes. nonetheless, mature gametocytes may persist after treatment, contributing to malaria transmission. conversely, artemisinin resistance is confirmed in south-east asia, and it may spread to africa. new control tools have to be integrated to sustain the gained successes, further reduce transmission and curb the spread of resistance. primaquine has strong gametocytocidal effect against mature gametocytes and when added to schizonticidal drugs such as artemether-lumefantrine (al), it rapidly shorten gametocytes carriage duration, halting disease transmission. nonetheless, its wide scale use has been hampered by a dose-dependent acute hemolytic anemia it causes in glucose-6-phosphate dehydrogenase (g6pd) deficient individuals. conversely, artemisinins potentiate primaquine activities, thus a low dose of primaquine would be able to clear falciparum gametocytes. the world health organization recommends addition of 0.25 mg/kg single-dose primaquine to artemisinin based combination therapies in malaria endemic areas including africa without testing for g6pd status. nonetheless, the recommendation, relies on historical data from south-east asia and among african americans in the united states. therefore, this study plans to assess safety and efficacy of 0.25 mg/kg single-dose primaquine added to a standard al treatment against p. falciparum gametocytes clearance among patients with uncomplicated malaria aged 1 year and above regardless of their g6pd status..

Eligibility criteria:
inclusion criteria: * age of 1 year and above and neither pregnant nor breast feeding. * weight over 10 kg. * body temperature ≥37.5°c) or history of fever in the last 24 hours. * p. falciparum mono-infection. exclusion criteria: * evidence of severe illness malaria or danger signs. * known allergy to study medications. * hemoglobin \<8 g/dl. * antimalarials taken within last 2 weeks. * blood transfusion within last 90 days and evidence of recent use (within 14 days)of or will be taking other drugs known to cause hemolysis in g6pd deficient subjects.

Keywords: efficacy safety primaquine artemether-lumefantrine gametocytes
effect of yoga on mood and quality of life in patients with refractory epilepsy

Conditions: Depression; Anxiety

Summary: the purpose of this study is to learn if a structured yoga program can reduce anxiety, improve depression, and improve quality of life in patients with medication resistant epilepsy (mre).


Eligibility criteria:
inclusion criteria: * diagnosis of unilateral or bilateral temporal lobe epilepsy * presence 3 or more seizures per month * no medical contraindications to yoga * willing and able to perform simple non strenuous yoga exercises * ability to get on the floor and up again without assistance * ambulatory * ability to travel to the yoga class twice a week exclusion criteria: * any yoga in the last 6 months * inability to perform yoga exercises * history of epilepsy surgery within the last year * currently pregnant or less than 6 week postpartum

Keywords: epilepsy
quality of life in patients with primary sclerosing cholangitis

Conditions: Primary Sclerosing Cholangitis

Summary: the purpose of this study is to assess the healthcare-related quality of life (hrqol), the impact of risk of liver transplant and risk of malignancy on hrqol, and the complementary and alternative medicine use in patients with psc.

a cohort of adult (age ≥ 18) patients with a diagnosis of psc will be identified. the patients will be approached about participating in the study while at their appointment, either by the investigators or someone else known to the patient. if the patient agrees, the investigators or other key personnel will then provide information about the study and obtain their informed consent to participate. the patients who consent to participate will be sent home from the clinic with a survey to complete and return via mail in a provided addressed, stamped envelope. the survey consists of the short form-36 (sf-36), the chronic liver disease questionnaire (cldq), questions from the promis sexfs v2.0, questions regarding perceived risk for liver transplant, cholangiocarcinoma, and colorectal carcinoma, as well as perceived overall life expectancy, and questions regarding complementary and alternative medicine use. demographic information and clinical data will also be obtained from the patient's electronic medical record. the study will be cross-sectional in nature, and there will be no follow-up with the subjects after the survey is completed.

Eligibility criteria:
inclusion criteria: * adult (age ≥ 18) patients with psc, confirmed by laboratory tests, imaging, and/or liver biopsy exclusion criteria: * patients \<18 * patients who have undergone liver transplant, patients with frank hepatic encephalopathy * patients with active inflammatory bowel disease (ibd) flares * patients with malignancies * patients unable to understand english * patients refusing to participate or provide informed consent

Keywords: primary sclerosing cholangitis
evaluating color perception under led red/green and green dominant light

Conditions: Color Blindness, Acquired

Summary: the investigators are testing a light-emitting diode (led) flashlight from first-light™ usa called the tomahawk mc tactical light to determine the range of colors people are able to see with these flashlights at night. the flashlight has been designed to reduce visibility of the user and uses a combination of green and red led lamps to achieve this. in this study investigators wish to determine how well a subject can differentiate colors at night in a quantifiable manner. investigators will use the farnsworth munsell 100 hue test which requires the user to put shades of red, green, blue and yellow into progressive color order which is scored according to the manufactures specifications.


Eligibility criteria:
inclusion criteria: * normal vision * 18-65 years exclusion criteria: * blindness * colorblind * pregnant women * prisoners * decisionally challenged
growth of infants with cow's milk allergy fed an amino acid-based formula containing two human milk oligosaccharides

Conditions: Cow Milk Allergy

Summary: the main aim of this study is to provide longitudinal growth data in infants with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides.


Eligibility criteria:
inclusion criteria: 1. full term infant (37 weeks ≤ gestation ≤ 42 weeks) 2. 2500g ≤ birth weight ≤ 4500g 3. having obtained written informed consent form the infant's parents or legally authorized representatives (lar). 4. infant aged between 1 and 8 months. 5. exclusively formula-fed at time of enrolment; or cmpa infant receiving partial breastfeeding and infant's mother having independently elected before enrolment to exclusively formula feed. 6. infants with physician-diagnosed cmpa as per standard clinical practice: exclusion criteria: 1. previous treatment with aaf \> 72 hours 2. known underlying medical condition that would impair growth (as per physician's assessment, e.g. unstable congenital heart disease, cystic fibrosis, metabolic disorder, chronic liver disease etc.) 3. demonstrated chronic malabsorption which is not due to cmpa. 4. other significant pre-natal and/or serious post-natal disease other than cmpa before enrolment (per investigator's medical decision). 5. infants whose parents or caregivers who cannot give informed consent or who cannot be expected to comply with study procedures. 6. treatment with systemic corticosteroids (oral or intravenous) for \>72 hours within 4 weeks before enrolment (topical corticosteroids allowed) 7. infants taking probiotic preparations for \> 72 hour within 4 weeks before enrolment 8. currently participating or having participated in another clinical trial since birth.
oral dydrogesterone (od) versus micronized vaginal progesterone (mvp) for luteal phase support (lps) in ivf/icsi

Conditions: Infertility, Female; Infertility; Genital Diseases, Male; Genital Diseases, Female; Progesterone; Dydrogesterone; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Progestins

Summary: female inability to conceive a child. the purpose of this prospective randomized, double-blinded, double dummy, two-arm cross-over study is to investigate the difference on histological, transcriptional and immunological level in endometrium between 3x10mg dydrogesterone oral tablets and 3x200 mg micronized progesterone intravaginal capsules for the luteal support in egg cell donors. beside that, the pharmacokinetics, the impact on the peripheral immunology (by blood sampling) and the microbiota (by genital swabs) will be investigated.


Eligibility criteria:
inclusion criteria: * oocyte donor candidates * regularly cycling * bmi ≥18 and ≤ 29 kg/m2 * signed informed consent * non-smokers. * amh \ 1,18 ng/ml (90th and 10th percentile for healthy women aged 25-29 according to the used elecsys® amh kit by roche) * prl, t and tsh within the normal limits for the clinical laboratory, or considered not clinically significant by the investigator within 6 months prior or at screening exclusion criteria: * intra-uterine device * previous enrollment * evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, heent (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery (\< 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which could limit participation in or completion of the study * acute urogenital disease during the course of the study * known allergic reactions to progesterone / dydrogesterone products (active substance or to any of the excipients) * intake of any experimental drug or any participation in any other clinical trial within 30 days prior to study start. * mental disability or any other lack of fitness, in the investigator's opinion, to preclude subjects in or to complete the study. * current or recent substance abuse, including alcohol and tobacco (patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed) * refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests. * known or suspected progestogen dependent neoplasms (e.g. meningioma) * serum progesterone level \>1.5 ng/ml at ovulation triggering
hiv results exchange mechanism on promoting hiv testing among msm

Conditions: HIV/AIDS

Summary: this will be a two-arm cluster randomized controlled trial. the control group can share their center for disease control and prevention certified online hiv results (cohiv) with another party freely through a social networking tool, while the intervention group will be asked for the cohiv before he can see the cohiv of his friend. the investigators hypothesize that the requires exchange will promote hiv testing and thus reduce hiv incidence among msm.

this will be a two-arm cluster randomized controlled trial. a wechat-based mini program has been developed to send and receive center for disease control and prevention certified online hiv results (cohiv). wechat is the ubiquitous communication and social networking tool in china. we will use the social network method for participant recruitment. a social network consists of one ego and some alters, and in this study a social network will be considered as a cluster. in a social network, ego is the msm who shares his certified hiv test results with or without exchange mechanism by the wechat mini program, while alters are recipients of the shared links. so the ego can shares his cohiv with many alters. after an ego shares the certified hiv test result with exchange mechanism (intervention group) or without exchange mechanism (control group) with their wechat contactors, the people who click the link will be candidate alters in our study. 1020 alters will be recruited as the participants and the randomization would be based on the unit of social network, which means the alters will be randomized into the same group that the ego is in. participants in the intervention group will receive his friend's cohiv and can only open it when the participants share their own in exchange. if the participant already has the cohiv, the system will lead the user to send his cohiv to the friend. if the participant does not have the cohiv, the system will guide him to make online appointment at the testing clinic. the participants in the control group will be able to receive and open the friend's cohiv entirely at the friend's discretion without the mandatory exchange requirement. the system will also guide users on how to get an hiv test by making appointments with the msm friendly clinics in the mini program. questionnaires are scheduled at baseline, month 3, 6 and 9. follow-up questionnaires will be delivered through wechat. the primary outcome is hiv testing rate of the participants in the past three months.

Eligibility criteria:
inclusion criteria: * aged more than18 years old * had anal sex with men * hiv unknown or negative * plan to live in guangzhou for the next year exclusion criteria: - cannot complete questionnaire survey due to difficulty in reading or communication

Keywords: hiv testing men who have sex with men
ibd strong peer2peer for self-management of psychological distress

Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Summary: psychological distress (pd) as a result of inflammatory bowel disease (ibd) is prevalent and associated with worse disease-related outcomes. ibd-associated psychological distress (ibd-pd) is particularly common at initial diagnosis, during disease flares, before surgery, and during transitions of care. access to evidence-based, gold-standard psychological interventions and emotional support for ibd-pd has been identified as a major care gap by persons living with ibd. the covid-19 pandemic has further exacerbated the burden of pd for persons living with chronic diseases like ibd, predisposing at-risk individuals to even greater mental struggles. studies have shown a minority of patients are asked about ibd-pd in routine clinical care and that even if asked, access to mental health care is extremely limited. ipeer2peer is an evidence-based, peer-led, virtually administered intervention for ibd-pd in the pediatric population that has demonstrated feasibility, acceptability and early effectiveness. using qualitative data derived from an extensive stakeholder engagement process, ipeer2peer has been adapted to meet the needs of adults living with ibd-pd. this program, ibd strong peer, will be studied through a randomized, wait list-controlled hybrid implementation-effectiveness trial in nova scotia. this study will provide implementation data needed to improve and adapt the intervention and implementation strategy to meet local needs, as well as provide early effectiveness data. this data will inform the design and statistical power needed for future larger, multicenter randomized control trials. ibd strong peer has significant potential to improve access to evidence-informed interventions for ibd-pd.


Eligibility criteria:
inclusion criteria: * adult ibd patient (18 years or older) * in a period of transition (newly diagnosed, transitioning from pediatric to adult care, flaring or changing medications, recently admitted to hospital, or facing the need for surgery) exclusion criteria: * screening positive for severe psychological pathology * do not speak english * diagnosis of a major comorbid psychiatric condition such as bipolar disorder or schizophrenia, * no access to the internet

Keywords: peer mentoring psychological distress ibd mental health access
a study of pgn-edo51 in participants with duchenne muscular dystrophy amenable to exon 51-skipping treatment

Conditions: Duchenne Muscular Dystrophy

Summary: the study consists of 3 periods: a screening period (up to 45 days), a multiple ascending dose (mad) period (16 weeks), and a long-term extension (lte) period (108 weeks). the primary purpose of the mad period is to evaluate the safety and tolerability of multiple ascending intravenous (iv) doses of pgn-edo51 administered to participants with duchenne muscular dystrophy (dmd). the primary purpose of the lte period is to evaluate the long-term safety and tolerability of pgn-edo51 in participants who have completed the mad period.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of dmd able to be corrected by skipping exon 51 * body weight at least 18kg at screening * performance of upper limb (pul) 2.0 entry score of at least 4 at screening (assessing upper limb function in ambulant and non-ambulant individuals with dmd) exclusion criteria: * known history or presence of any clinically significant conditions that may interfere with study safety assessments * treatment with any gene replacement therapy for the treatment of dmd at any time * current or recent systemic infection within 2 weeks prior to screening or infection requiring iv antibiotics within 4 weeks prior to screening * recent surgery requiring anesthesia within 3 months prior to screening or expected surgery requiring general anesthesia during the study

Keywords: enhanced delivery oligonucleotide peptide-conjugated phosphorodiamidate morpholino oligomer oligonucleotide exon 51 next-generation oligonucleotide cell-penetrating peptide muscular dystrophies neuromuscular disease dystrophin production splice correcting oligonucleotide endosomal escape delivery to the cell nucleus antisense oligonucleotide phosphorodiamidate morpholino oligomer (ppmo)
gabapentin in the post-cesarean pain management of buprenorphine patient

Conditions: Cesarean Delivery; Pain Management

Summary: the purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective cesarean delivery (cd).

many strategies have been suggested to improve post-cd pain management in parturients on buprenorphine. while effective pain relief can be achieved, women maintained on buprenorphine during pregnancy have been shown to require up to 50% more opioids after cd compared to women with opioid use disorder not on a maintenance regimen. the perioperative use of gabapentin has been shown to reduce pain scores and opioid consumption following a variety of surgeries, ranging from cardiac bypass to total abdominal hysterectomy. the purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective cd.

Eligibility criteria:
inclusion criteria: * singleton, term pregnancy * currently on buprenorphine maintenance therapy * scheduled for elective cd under spinal anesthesia exclusion criteria: * use illicit drugs or relapse during the last trimester of pregnancy * positive drug screen at the time of delivery * allergies to any medications used in the study * taking prescribed gabapentin at the time of admission for cd * contraindications to neuraxial anesthesia or require general anesthesia for cd * designated asa physical status 4 or above

Keywords: buprenorphine maintenance