Kornimate/medical-research-clean huggingface dataset:
banded versus conventional laparoscopic roux-en-y (gaby)

Conditions: Morbid Obesity Requiring Bariatric Surgery

Summary: banded versus conventional laparoscopic roux-en-y gastric bypass (gaby). the aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance. the study will not investigate the gabp-ring as medical product but the effect of the gabp-ring on weight loss in comparison to gastric bypass alone.

gaby is designed as an international, multi center, open, prospective, randomized study to compare two methods of bariatric surgery: banded versus conventional laparoscopic roux-en-y gastric bypass. at least 16 international high volume centres of excellence in bariatric surgery and at least 384 patients (24 patients at each center) in total will be included into this study. at least 320 patients must have completed the study after 5 years. surgery will be performed according to standardized operating protocol. the group a (control group) will follow the worldwide golden standard of bariatric surgery (gastric bypass). patients randomised to group b will receive in addition a restrictive silastic ring. the ring is a launched medical product and is registered in the european community.

Eligibility criteria:
inclusion criteria: * bmi ≥ 40 kg /m2 to ≤ 50 kg/m2 * eating habit: sweet eater and volume eater * signed informed consent * patients with one or more of the following comorbidities: hypertension, diabetes mellitus type 2, hyperlipidemia, hyperuricemia, sleep apnea, degenerative diseases of: spine osteochondrosis, hip, knee, feet exclusion criteria: * history of obesity surgery * history of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy) * patients not eligible to implement silastic ring size 6.5 cm * history of drug or alcohol abuse * history of major psychiatric illness conflicting with patient's compliance * history of recent or chronic steroid medication * autoimmune disease * inflammatory bowel disease or malabsorptive disease * liver cirrhosis (child b + c) * active viral or bacterial disease (e.g. hiv, hepatitis b or c, tbc etc.) * pregnant women or women with childbearing potential without efficient contraception * history of cancer in the last five years * need of long-term anticoagulant medication for any reason * any medication with ingredient asa

Keywords: bariatric surgery obesity roux-en-y gastric medical device bypass adiposity gabp-ring bmi banded laparoscopic
dod regulating together intervention

Conditions: Autism Spectrum Disorder; Emotion Regulation

Summary: our long-term goal is to validate regulating together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation.

144 children ages 8-12 years old with autism spectrum disorder will be enrolled in the study and randomized to regulating together (rt) or achieving independence and mastery in school (aims) groups. participants will complete assessments at five time points: screen (t1) week 0 - where they will complete consent; baseline (t2); week 7: post active treatment (includes semi-structured interviews) (t3); week 16: post generalization (t4); week 29: final outcome visit (t5). participants will receive 5 weeks of intervention, twice per week, following the t2 visit.

Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder (asd) * a full scale iq score of 65 or greater on the weschler abbreviated scale intelligence (wasi-ii) or other previous weschler iq test * concern of emotion dysregulation (ed) as measured by a score of 6 or greater on the emotion dysregulation inventory-reactivity (edi-r). * caregivers and child are fluent in speaking english * child functional verbal communication, confirmed via appropriateness for an autism diagnostic observation schedule (ados-2) module 3. * family willing to keep prescribed medication and outside interventions stable * willing to participate in twice weekly 90-minute sessions of either regulating together (rt) or achieving independence and mastery in school (aims). * the guardian must provide written informed consent on behalf of the participant and the participants ages 11-12 years old must provide written informed assent to participate. exclusion criteria: * initiation of new psychosocial intervention within 30 days prior to randomization/first day of treatment. * any physical aggression toward other children outside the home in the past 2 weeks that resulted in serious injury * presence of comorbid major neuropsychiatric illness warranting other treatment approaches. * presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss

Keywords: regulating together
vardenafil odt versus placebo in males with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: this study investigates the safety and efficacy of a new dosage form of vardenafil, an orodispersible tablet (odt), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. after a 4-week unmedicated phase, patients will receive vardenafil odt or matching placebo for 12 weeks. safety will be determined by laboratory and other evaluations. efficacy will be determined by the results of different questionnaires and the patient diary that will be used.


Eligibility criteria:
inclusion criteria: * males 18 years-of-age or older * stable, heterosexual relationship for at least 6 months * a history of erectile dysfunction (ed) for at least 6 months exclusion criteria: * any underlying cardiovascular condition, including unstable angina pectoris * history of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1 * uncontrolled atrial fibrillation / flutter at screening * history of surgical prostatectomy for prostate cancer * hereditary degenerative retinal disorders * history of loss of vision because of non-arteritic anterior ischemic optic neuropathy (naion), temporary or permanent loss of vision * presence of penile anatomical abnormalities * subjects who have been confirmed with phenylketonuria (pku) * spinal cord injury * resting or postural hypotension or hypertension * subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong qt interval, human immunodeficiency virus (hiv) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin * use of any treatment for ed within 7 days of visit 1 * history of congenital qt prolongation * history of syncope within the last 6 months prior to entry into the study

Keywords: erectile dysfunction
evaluation of ivermectin mucoadhesive nanosuspension as nasal spray in management of early covid-19

Conditions: Covid19

Summary: ivermectin showed a strong viricidal effect upon covid19 virus in vitro as proved by many authors according to many studies , covid virus stay in postnasal space for 4 days before starting general manifestation, so ivermectin mucoadhesive nanosuspension sprayed inside the nose and post nasal space may help in early management of covid19 and may play a great rule in prophylaxis as well

150 patient with early covid is devided into two groups first group will receive regular protocol of drugs second group will receive ivermectin nasal spray in addition to regular protocl of drugs

Eligibility criteria:
inclusion criteria: * early covid19 pateints exclusion criteria: * children and pregnant women

Keywords: ivermectin intranasal spray in covid19
opioid misuse in patients with cancer

Conditions: Cancer; Opioid Use; Opioid Misuse; Pain; Cancer Pain

Summary: the success of opioid treatment in terminally ill cancer patients set the stage for extending the same treatment principles to the treatment of all chronic pain conditions including chronic non-cancer pain and chronic pain in cancer, where survival and long-standing chronic disease trajectories are getting more prevalent due to increasing survival rates. in this context, opioid misuse as such has been highly neglected - especially in palliative care, but also in cancer pain management in general. previous studies have explored the literature on opioid misuse among adult cancer patients, noting that the available evidence is still in its early stages. limited prospective studies with a wide range of definitions and methodologies for assessing misuse exist. therefore, it seems highly relevant and justified to study the prevalence of opioid misuse risk in patients with cancer. the hypothesis of this study is that opioid misuse is not uncommon in danish patients in treatment with opioids for cancer-related pain. thus, the prevalence of opioid misuse risk among patients with cancer in danish palliative care units will be investigate.

this is a prospective and cross-sectional study, in which opioid misuse is defined according to national institute on drug abuse (usa) as the use of prescription opioids in a manner other than as directed by a doctor (e.g., for other purpose than pain relief, in greater amounts, more frequently, longer, using someone else's prescription). the aims are: 1. investigate the prevalence of opioid misuse risk by the pain medication questionnaire (pmq) and the opioid risk tool (ort) among patients with cancer in palliative care units in denmark. 2. determine whether there is a correlation between the pmq and ort scores and opioid consumption, use of short-acting opioids (prn-dosing), tobacco smoking, alcohol consumption, previous consumption of illicit drugs and/or consumption of benzodiazepines and benzodiazepine-like hypnotics, and information provided by the physician regarding the patient's opioid misuse. 3. investigate the association between opioid misuse risk (pmq and ort scores), depression and anxiety (patient health questionnaire for depression and anxiety, phq-4), and health-related quality of life (eortc-qlq-c15-pal).

Eligibility criteria:
inclusion criteria: * outpatients ≥ 18 years, * patients who are treated with opioids due to cancer-related pain. exclusion criteria: * patients who do not master the danish language in speech and writing, * patients who have severe cognitive dysfunction, * patients who are not treated with opioids, * patients who refused to participate in the study.
prospective evaluation of effectiveness and safety of closed-loop spinal cord stimulation in treating patients with chronic pelvic pain

Conditions: Chronic Pelvic Pain Syndrome

Summary: spinal cord stimulation (scs) is an effective treatment for patients with chronic pelvic pain. the investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord.


Eligibility criteria:
inclusion criteria: the investigators will include all adult patients (18 or older) with pelvic pain more than 6 months that has not responded to conservative medical management exclusion criteria: * major untreated medical comorbidities (uncontrolled diabetes mellitus, severe obesity, uncontrolled cardiopulmonary disease, etc.) * secondary causes of pelvic pain that can be treated with appropriate medical or surgical interventions * major untreated psychological comorbidities * anatomical challeneges to place spinal cord stimulator * ongoing legal or disability claims
the impacts of the different anesthesia methods on patients of transbronchial cryobiopsy

Conditions: Transbronchial Cryobiopsy; Anesthesia; Tracheal Intubation; Rigid Bronchoscopy; Safety

Summary: to evaluate the difference between the tracheal intubation (ti) and rigid bronchoscopy (rb) under general anesthesia on patients with transbronchial cryobiopsy.

to evaluate the difference between the tracheal intubation (ti) and rigid bronchoscopy (rb) under general anesthesia on patients with transbronchial cryobiopsy. comparing the difference between two groups in the operating duration, extubation duration, total anesthesia time, heart rate, blood pressure and arterial blood gas analysis. this is a prospective, randomized, controlled trial.

Eligibility criteria:
inclusion criteria: 1. the patients are admitted in the institution as ild, while undefined after thorough history collection, laboratory examination and radiological data. 2. transbronchial cryobiopsy(tbcb) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed. 3. blood gas analysis, routine blood test, ecg examination, coagulation function, immunological examination, chest hrct, and liver/kidney function test have been completed exclusion criteria: 1. the radiological data indicates non-ild 2. the clinical examinations mentioned above are not completed. 3. the patient cannot endure or does not agree the procedure.

Keywords: transbronchial cryobiopsy anesthesia tracheal intubation rigid bronchoscopy safety interstitial lung disease
micronized dehydrated human amniotic membrane suspension in the treatment of lateral epicondylitis

Conditions: Epicondylitis, Lateral Humeral

Summary: the purpose of this study is to determine whether micronized dehydrated human amniotic membrane (dhacm) suspension is more effective in reducing inflammation than conservative measures alone when used to treat acute/early lateral epicondylitis.


Eligibility criteria:
inclusion criteria: * at least 18 years old. * medicare patients may be selected. * both male and female patients will be selected. * a negative x-ray of the elbow * diagnosis of lateral epicondylitis by history and exam with symptoms for no longer than one year. * females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence). * patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen. * patient has read and signed the irb/iec approved informed consent form before screening procedures are undertaken. exclusion criteria: * prior surgery at the site * site exhibits clinical signs and symptoms of infection. * history of chronic soft tissue inflammation of more than 6 months. * a positive x-ray for fracture or significant anatomic abnormality including fracture, advanced arthritis, excessive calcification, etc. * no history of corticosteroid injection within the past 30 days. * joint instability * no rheumatologic conditions involving the elbow. * no evidence of significant neurological entrapment or neurological disease of the forearm * concurrent cervical radiculopathy * the presence of comorbidities that can be confused with or can exacerbate the condition including: * previous elbow trauma * previous elbow surgery * patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. (i.e. a one month "washout period" for these drugs.) * patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening. * history of radiation at the site. * known history of having acquired immunodeficiency syndrome (aids) or hiv. * patients who are unable to understand the aims and objectives of the trial. * presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment. * pregnant or breast feeding. no pregnancy within the past 6 months.
treatment of covid-19 with opaganib in patients with pneumonia requiring oxygen

Conditions: COVID-19; Lung Infection

Summary: patients diagnosed with covid-19 infection will be offered treatment with opaganib, 500 mg q12 hours. opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks).

patients diagnosed with covid-19 infection by nasopharyngeal viral swab, classified as severe disease, category 5, by the who ordinal scale for clinical improvement (who require oxygen support by high flow nasal cannula but do not require mechanical ventilation) at the time of initiation of therapy will be offered treatment with opaganib, 500 mg q12 hours. opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks), upon voluntary withdrawal is initiated by the patient or when the physician decides that it is not in the patient's best interest to continue.

Eligibility criteria:
inclusion criteria: 1. patients with proven covid-19 infection diagnosed by nasopharyngeal viral swab who require external oxygen support by high flow nasal cannulas (hfnc) but not mechanical ventilation. 2. pneumonia documented by chest x-ray (cxr) 3. the patient or guardian must have signed a written irb-approved informed consent. 4. a negative pregnancy test (if woman of childbearing potential). 5. acceptable liver and renal function: 1. bilirubin ≤ 1.5 times upper limit of normal (ctcae grade 2 baseline) 2. ast (sgot), alt (sgpt) ≤ 3.0 x upper limit of normal (uln), 3. serum creatinine ≤ 1.5 x uln (ctcae grade 1 baseline) 6. acceptable hematologic status: 1. absolute neutrophil count ≥1000 cells/mm3 2. platelet count ≥75,000 (plt/mm3) (ctcae grade 1 baseline) 3. hemoglobin ≥ 9 g/dl 7. clinically acceptable blood sugar control if diabetic 8. ekg showing no qtc prolongation exclusion criteria: 1. any co-morbidity that that is considered by the treating investigator as an unacceptable risk 2. pregnant or nursing women 3. unwillingness or inability to comply with procedures required in this protocol. 4. caution must be exercised in patients who are receiving drugs that were sensitive substrates of cyp450 1a2, 3a4, 2c9, 2c19 or 2d6, or strong inhibitors or inducers of all major cyp450 isozymes that cannot be stopped or replaced with another appropriate medication or not given for the duration of the clinical study. these patients must be discussed with the sponsor in order to determine appropriateness for opaganib therapy. 5. patients who are taking warfarin, apixaban, argatroban or rivaroxaban 6. patients with qtc prolongation

Keywords: therapeutic use
efficacy of dlbs-32 in subjects with type-ii diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to investigate clinical efficacy and safety of dlbs 32 in the management of subjects with type-ii-diabetes mellitus and to determine the minimal effective dose of dlbs 32 for subjects with type-ii-diabetes mellitus.


Eligibility criteria:
inclusion criteria: * fasting capillary blood glucose of 127-249 mg/dl at screening * bmi \>= 18.5 kg/m\^2 or waist circumference of \>= 90 cm (male) or \>= 80 cm (female) * normal liver function * normal renal function * oha-naive type-ii-diabetic patients exclusion criteria: * symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia * uncontrolled hypertension * history of or current treatment with insulin * current treatment with systemic corticosteroids or herbal (alternative) medicines * history of renal and/or liver disease * pregnant or breast feeding females

Keywords: diabetes mellitus dlbs-32 fasting plasma glucose insulin resistance
lma cuff pressure and lma-induced complications

Conditions: Sore Throat; Dysphagia; Dysphonia

Summary: the purpose of this study is to determine if using 20 ml b.braun syringes to inflate lmas and allowing them to recoil will put the pressure of the lma cuff within the safety range. it will also determine if remaining within this safety range has an effect on complications after surgery..


Eligibility criteria:
inclusion criteria: * registered mayo clinic in florida patients scheduled to undergo a surgery * planned use of lma during surgery * between the ages of 18-99 * short duration (\<2 hours elective surgery) exclusion criteria: * recent history of upper respiratory tract infection * intra-cavitary or laparoscopic procedure * risk of pulmonary aspiration * known difficult airway * history of gastric reflux * bmi \> 40 * lateral or prone positions * oral or nasal surgery

Keywords: overinflation of lmas
study of methyl aminolaevulinate photodynamic therapy with and without er:yag laser in actinic cheilitis

Conditions: Actinic Cheilitis

Summary: methyl aminolaevulinate photodynamic therapy (mal-pdt) is advantageous in that it has few cosmetic side effects and minimises patient discomfort. however, its relatively low efficacy prevents its application to the treatment of actinic cheilitis(ac). er:yag ablative fractional laser (afl) treatment removes the stratum corneum to increase mal uptake and may improve efficacy. however, no studies have directly compared the efficacy of mal-pdt with and without er:yag afl in treating ac

actinic cheilitis (ac) is a keratinocytic neoplasm of the lip, especially the lower lip, is confined to the epidermis, and results from chronic or excessive ultraviolet exposure. ac is an early manifestation of lip squamous cell carcinoma (scc), and scc of the lip is usually associated with an identifiable pre-existent ac. furthermore, the likelihood that ac will progress to scc is higher than actinic keratosis (ak). consequently, early identification and treatment of ac is recommended. pdt involves the activation of a photosensitizer by irradiation with 400- to 700-nm light to create cytotoxic oxygen and free radicals that kill dysplastic cells. methyl aminolaevulinate photodynamic therapy (mal-pdt) is advantageous in that it has few cosmetic side effects and minimises patient discomfort. however, its relatively low efficacy prevents its application to the treatment of actinic cheilitis(ac). erbium:yttrium-aluminium-garnet (er:yag) ablative fractional laser (afl) therapy has been used frequently to improve treatment efficacy of pdt. er:yag afl can ablate stratum corneum with minimal penetration depth and producing minimal thermal injury. this approach creates microscopic vertical holes in the ablated tissue, surrounded by thin layers of coagulated tissue. er:yag afl does not injure the entire thickness of the epidermis; therefore, healing times are minimised. erbium:yttrium-aluminium-garnet (er:yag) ablative fractional laser (afl) has been proven in recent studies to facilitate the delivery and uptake of topical mal deep into the skin, enhancing porphyrin synthesis and photodynamic activation. the aim of our study was to compare efficacy, recurrence rate, cosmetic outcome, and safety between er:yag afl-assisted mal-pdt (er:yag afl mal-pdt) and standard mal-pdt in patients with ac.

Eligibility criteria:
inclusion criteria: * korean patients ≥ 18 years of age who had biopsy-confirmed ac lesions exclusion criteria: * porphyria * known allergies to the mal cream or lidocaine * pregnancy * lactation * any active systemic infectious disease * immunosuppressive treatment * personal history of malignant melanoma * tendency towards melasma or keloid formation * prior treatment of the lesions within 4 weeks * any indication of poor compliance

Keywords: actinic cheilitis er:yag ablative fractional laser methyl aminolevulinate photodynamic therapy