Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the brainport® vision device in subjects who are blind

Conditions: Blindness

Summary: the purpose of this study is to assess the safety of the brainport vision device and to demonstrate improved object recognition and word identification and ambulation with use of the brainport vision device in subjects who are medically documented as blind, with acuity of 20/ 5000 or worse.


Eligibility criteria:
inclusion criteria: * confirmed written medical or low vision diagnosis of no light perception or light perception * performance on the fract acuity test of worse than 20/5000 or impossible to measure. * minimum post 6 months diagnosis blindness. * previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog. * able to have read to him or her, understand, and sign the informed consent form. * daily access to an accessible computer with email for study communication, device- use logging and access to device user manual preferred. * willing and able to complete all testing, training, and follow- up evaluations required by the study protocol, after receiving a short orientation on the use of the device. exclusion criteria: * current oral health problems as determined from the oral health exam which preclude enrollment in the study in the judgment of the principal investigator. * any medical condition that would interfere with performance on the assessments. * prior use of the brainport vision device. * known neuropathies of tongue or skin tactile system. * smoke or chew tobacco products less than 12 months prior to study enrollment * any allergies to nickel or stainless steel * history of seizures or epilepsy. * if female, pregnant. women of child bearing potential must agree to use appropriate birth control to prevent pregnancy for the duration of the study. * people with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator, cochlear implant). * psychiatric disease including anxiety disorders and forms of depression (using provided beck anxiety inventory (bai) and beck depression inventory (bdi- ii) as screening tools). * any disease or condition that prevents understanding or communication of informed consent, study demands and testing protocols including the following: * cognitive decline including forms of dementia and/or progressive neurological disease * deafness or selective frequency hearing loss that prevents hearing device alarms and alerts. * does not speak english * blindness occurring due to cortical injury (i.e. stroke, traumatic brain injury, etc) * principal investigator, in his or her judgment, does not believe the subject is a good candidate for the trial.

Keywords: assistive technology non-surgical visual prosthetic sensory substitution
growth hormone in neuroendocrine dysfunction with severe fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: the purpose of this study is to evaluate the efficacy of recombinant human growth hormone (r-hgh) treatment in severe fibromyalgia subjects with growth axis dysfunction.


Eligibility criteria:
inclusion criteria: * women aged greater than or equal (\>=) 18 years * fibromyalgia diagnosed at least one year before * history of generalized pain and at least 16 positive tender points (1990 american college of rheumatology \[acr\] criteria) * body mass index (bmi) less than or equal to(=\<) 32 * normal gh stimulation test (insulin) * stable (\>= 3 months unchanged) standard treatment with amitriptyline (10-50 milligram per day \[mg/day\]) plus selective serotonin reuptake inhibitor (10-40 mg/day) plus tramadol (25-400 mg/day) * active rehabilitation program during the previous year (at least 30 minutes/day) * fibromyalgia impact questionnaire (fiq) score \>=75 * igf-1 serum level =\< 150 nanogram/milliliter (ng/ml) otherwise =\< 2 sd of the local lab normality) * normal response to igf-1 generation test * chronic fatigue symptoms (multidimensional assessment of fatigue \[maf\]) * effective anti-conception * willingness to comply with the protocol * written informed consent exclusion criteria: * major psychiatric condition * rheumatic disease, including systemic lupus erythematosus (sle) * previous or current malignancies, active or inactive * clinical history intracranial space occupying lesion * reactive or secondary (rheumatoid arthritis \[ra\], osteoarthritis) fibromyalgia syndrome (fms) * antinuclear antibody (ana) greater than or equal 1:80 * abnormal creatine phosphokinase (cpk) or aldolase serum levels * not controlled thyroid disease in the last 3 months (free thyroxine \[t4\] and thyrotrophin-stimulating hormone \[tsh\] serum levels) * diabetes mellitus * adrenal gland disease (any abnormal cortisolemia, will be confirmed by 24-hour cortisoluria) * pregnancy or breast feeding * known to be hypersensitive to somatotropin or any of the excipients
nasal mask ventilation during the induction of general anesthesia

Conditions: Mechanical Ventilation Complication; Upper Airway Obstruction

Summary: recently, the investigators demonstrated that nasal route ventilation is superior to the nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. the investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask ventilation during the induction of general anesthesia by: 1) producing a better seal than full face mask, and 2)establishing a greater airway patency and more effectively ventilate than full face mask ventilation. the investigators intend to test this hypothesis on adult patients during the induction of general anesthesia in the absence of muscle relaxation.


Eligibility criteria:
inclusion criteria: * 18-65 years of age * asa physical status classification i-ii * general anesthesia * elective surgery * who are able to breathe through both their nose and mouth while awake exclusion criteria: * patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or american society of anesthesiologists physical status class iii or greater. * abnormal vital signs on the day of admission for surgery \[heart rate (hr, \>100 bpm or \ 180/100 mmhg or \<90/60 mmhg), room air transcutaneous oxyhemoglobin saturation (spo2) \<96%\] that are not correctable with his or her routine medication or commonly used pre-operative medication. * unable to open mouth (\<2.5 cm) or unable to breathe through their mouth or nose. * any person with an anticipated difficult airway. this will include subjects that require or may require either a fiberoptic intubation or intubation while awake. * gastric-esophageal reflex or a full stomach. * neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or transient ischemic attack (tia) within 2 weeks. * pregnant women and women less than one month post-partum. ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. if the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative. * emergency cases and subjects who have not adhered to the asa npo (nil per os - nothing by mouth) guidelines.

Keywords: general anesthesia positive-pressure ventilation masks
registry for esophageal and gastroesophageal junction cancer

Conditions: Gastroesophageal-junction Cancer; Esophageal Cancer

Summary: the purpose of this registry study is to create a database-a collection of information-for better understanding standard treatments for esophageal and gastroesophageal junction cancer/gej cancer. researchers will use the information from this database to learn more about the effectiveness of different treatment options.


Eligibility criteria:
inclusion criteria: * newly diagnosed stage iv adenocarcinoma of the esophagus or gej with omd at the time of diagnosis, defined as the following: * retroperitoneal lymph nodes (e.g., para-aortal, intra-aorto-caval, parapancreatic, or mesenterial lymph node) * liver * lung * extra-abdominal lymph nodes (e.g., supraclavicular or cervical lymph nodes) * adrenal gland * unilateral or bilateral ovarian metastases (in the absence of gross or microscopic peritoneal disease \[positive cytology\]) * bone * ≤2 sites of disease (excluding the primary tumor and regional lymph nodes) * ≤3 tumors within each organ system * ≤5 metastases * all nonregional lymph nodes (including cervical, supraclavicular, and retroperitoneal nodal disease) are considered 1 discrete lesion * satellite lesions in the primary esophageal malignancy, such as skipped esophageal primaries, are not considered metastatic sites * all sites of disease must be amenable to complete local therapy after systemic therapy, according to the treating physician. treatment modalities include: * surgery * definitive chemoradiation * stereotactic radiation * ablation or similar techniques (e.g., irreversible electroporation) * age ≥18 years exclusion criteria: * presence of metastases, at the time of diagnosis, to the following: * peritoneum, including positive peritoneal lavage (on the basis of baseline diagnostic laparoscopy to rule out gross disease and positive peritoneal lavage cytology; laparoscopy may be omitted for patients in whom all sites of disease are above the diaphragm) * malignant pleural effusion * brain metastases or leptomeningeal disease * other sites not specifically noted must be reviewed and approved by the pis * any site of disease that is not amenable to definitive local therapy * unfit for best systemic therapy * metachronous omd * secondary primary cancer, with the exclusion of basal cell carcinoma of the skin * pregnant, lactating, or intending to become pregnant * unwilling to provide informed consent

Keywords: quality-of-life assessments 24-206
use of a dietary supplement to support digestive health in children with chronic diarrhea

Conditions: Antibiotic-associated Diarrhea

Summary: micronutrients missing in the diet may assist in supporting digestive health in children with chronic gi issues. this study will monitor changes in symptoms associated with digestive problems in children provided with a dietary supplement that will be taken in conjunction with the standard of care.

children with gi symptoms have varying response to the standard of care treatments. a dietary supplement of polyphenols from green tea and pomegranate extracts provides micronutrients often missing from conventional american diets. the objective of this study is to monitor changes in gi symptoms when the supplement is provided alongside the standard of care for children with symptoms that have been present for more than two weeks.

Eligibility criteria:
inclusion criteria: * out-patients with diagnosis of unresolved gastrointestinal distress * parent or guardian willing to administer the dietary supplement orally once daily for up to 21 days * parent or guardian willing to record changes in gi symptoms on a questionnaire * parent or guardian willing to bring the child for a clinic visit to close-out participation in the study exclusion criteria: * requires care in an icu * has documented intestinal stricture, stenosis, obstruction, or abscess * has concomitant congenital diseases * are immunodeficient * has malformation of the gi tract * is unable to swallow fluids * parent or guardian is unable or unwilling to provide informed consent
spine pain intervention to enhance care quality and reduce expenditure

Conditions: Back Pain; Neck Pain

Summary: low back and neck pain are among the leading causes of medical visits, lost productivity and disability. there is an urgent need to identify effective and efficient ways of helping subjects with acute spine pain while guiding practitioners towards high-value care. this trial will be a block and cluster-randomized open-label multi-centered pragmatic randomized clinical trial comparing healthcare spending and clinical outcomes for subjects with spine pain of less than three months' duration, in whom there are no red flag signs or symptoms. subjects will be randomized to one of three treatment strategies: (1) usual primary care provider-led care; (2) usual pcp-led care with spine pain treatment directed by the identify, coordinate, and enhanced decision making (ice) care model, and (3) usual pcp-led care with spine pain treatment directed by the individualized postural therapy (ipt) care model. our outcomes of interest will be spine-related healthcare utilization at one year as well as pain and functionality of the study participants.


Eligibility criteria:
inclusion criteria: * patients with back or neck pain of ≤ 3 months' duration. all patients must have spine pain with or without radiation to the extremities or the head * age ≥ 18 years * willing and able to provide informed consent exclusion criteria: * patients with symptoms attributed to the spine but without actual pain in the spine (e.g. those with cervicogenic headache without neck pain) * currently pregnant * currently receiving disability benefits, worker's compensation, or involved in litigation for a workplace injury * currently enrolled in another intervention trial for the management of acute back or neck pain * cancer that is metastatic or being actively treated. (i.e chemotherapy, radiation, surgery) * history of receiving active therapy for back or neck pain in the past 3 months (7+ consecutive days of narcotic use, 6+ sessions of pt, chiropractic care, acupuncture, postural therapy, or other spine therapy delivered by a trained provider) * history of spine surgery or spine injections/ablation in the past 6 months * severe, active psychosis or major depression inhibiting ability to physically participate in intervention * red flag symptoms (fever, night sweats, unintentional weight loss, bowel or bladder dysfunction, neurologic weakness, history of intravenous drug use)
comparison of the two validated german versions of the "tinnitus functional index" for switzerland and for germany

Conditions: Tinnitus, Subjective

Summary: tinnitus is defined as a perception of sound without any external sound source. chronic tinnitus is a frequent condition that can affect the quality of life. the questionnaire "tinnitus functional index (tfi)" promises to be the new gold standard in tinnitus evaluation. due to the forward and backward translation of this questionnaire, there are two different german versions of tfi for switzerland and germany. both german versions were validated. the aim of this study is to compare the two german versions of the tfi with each other and to recommend the better one for the further use in tinnitus evaluation for the german speaking population.


Eligibility criteria:
inclusion criteria: * electronic given informed consent * older than 18 years * existing tinnitus * sufficient knowledge of the german language exclusion criteria: * insufficient knowledge of the german language * impossibility to fulfill an online questionnaire due to cognitive or physical limitation * no tinnitus * younger than 18 years
a study to compare the efficacy and safety of ct-p43 to stelara in patients with plaque psoriasis

Conditions: Psoriasis

Summary: this study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of ct-p43 to stelara in patients with moderate to severe plaque psoriasis.

ct-p43, containing the active ingredient ustekinumab, is a human igg1κ monoclonal antibody that is being developed as a biosimilar medicinal product to the reference product, stelara. the purpose of this study is to demonstrate similar efficacy and safety of ct-p43 and stelara in patients with moderate to severe plaque psoriasis.

Eligibility criteria:
inclusion criteria: - patient has had diagnosis of plaque-type psoriasis for at least 24 weeks. exclusion criteria: * patients diagnosed with forms of psoriasis other than plaque-type. * patients previously received ustekinumab or a biosimilar of ustekinumab. * patient who has allergies to the active substance or any of the excipients of ustekinumab or study drug, or patients with a hypersensitivity to immunoglobulin products or natural rubber and latex.
a prospective, observational study of pregnancy outcomes among women exposed to truvada for prep indication

Conditions: HIV Infection

Summary: this is a prospective, observational study to describe pregnancy outcomes among hiv-1 uninfected pregnant women who are taking emtricitabine (ftc)/tenofovir disoproxil fumarate (tdf) (truvada®) for a pre-exposure prophylaxis (prep) indication nested in the antiretroviral pregnancy registry (apr). information on subjects is provided to the apr prospectively (prior to the outcome of the pregnancy being known) through their healthcare provider, with follow-up obtained from the healthcare provider following determination of the pregnancy outcome.


Eligibility criteria:
key inclusion criteria: * pregnant women * part of the prospective arm of the apr target group inclusion criteria * hiv-1 negative * choosing to remain on ftc/tdf for prep during pregnancy or, * choosing to discontinue ftc/tdf for prep during pregnancy comparison group inclusion criteria * hiv-1 positive * on antiretroviral therapy key exclusion criteria: * this is an observational nested study and will monitor all reported exposures without intervention/exclusion. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: ftc/tdf truvada prep antiretroviral pregnancy registry
beta blocker de-prescription following coronary artery bypass graft surgery (beefburger trial).

Conditions: Coronary Artery Disease; Acute Myocardial Infarction; Coronary Artery Stenosis; ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction (NSTEMI)

Summary: beta-blockers have the greatest cardiovascular impact in patients with reduced heart function/heart failure and in reducing the peri-operative risk of atrial fibrillation. in patients without these high-risk features treated with coronary artery bypass graft (cabg) surgery, their continued long-term role is unclear.

this is an open-label, non-inferiority, randomized comparison of beta-blocker continuation versus de-prescription at the 6-8 week follow-up following isolated and uncomplicated cabg at royal university hospital, saskatoon. patients treated with isolated cabg (without valve repair/replacement) and discharged on a beta-blocker are eligible for recruitment if they have preserved systolic function (ef ≥45%) and no history of heart failure, atrial fibrillation/flutter, or an alternate compelling indication for beta-blocker therapy. after obtaining informed consent, eligible patients are randomly assigned at 6-8 weeks to one of the two treatment groups: continued beta-blocker therapy per their usual clinical care or beta-blocker de-prescription as per the study protocol. the primary objective of this study is to demonstrate recruitment feasibility for beta-blocker de-prescription 6-8 weeks following uncomplicated cabg. exploratory outcomes include the composite of all-cause mortality, myocardial infarction, stroke, arrhythmia, and cardiovascular-related hospitalization (congestive heart failure, recurrent ischemia, arrhythmia \[supraventricular including atrial fibrillation, and ventricular\], syncope or need for pacemaker) over a 3-year follow up duration. other exploratory outcomes will include a change in the patient reported quality of life using the short form (sf) 36 and euro qol (eq) 5d questionnaires and angina score using the seattle angina questionnaire (saq).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years treated with index isolated cabg * able to consent to study * on beta blocker therapy at the 6-8week visit * lv systolic function (≥45% assessed within 6months of cabg date) exclusion criteria: * prior heart failure with reduced ejection fraction (lvef \<45%) * pre- or peri-operative atrial fibrillation or flutter * peri-cabg stroke * unable to follow-up

Keywords: beta blocker drugs coronary artery bypass graft cabg de-prescription
sperm parameters and sexual quality of life

Conditions: Men Infertility

Summary: infertility has important repercussions for couples in their emotional and sexual lives; the same is true of assisted procreation, which has an impact on the daily life of couples and a cost to society. thus, fertility disorders are frequently associated with sexual dysfunction in both women and men (khademi et al., 2008). in couples with male infertility, men have higher sexual dysfunction scores than couples with infertility without male aetiology (smith et al., 2009). to study the evolution of the sexual quality of life of infertile men before and after knowing their spermatic parameters


Eligibility criteria:
inclusion criteria: * male patient presenting infertility status exclusion criteria: * none
a study to evaluate the effectiveness of cosopt® as first line therapy (mk-0507a-153)

Conditions: Glaucoma; Ocular Hypertension

Summary: evaluate the effectiveness of dorzolamide-timolol (cosopt®) as first line therapy in reducing intraocular pressure in patients with untreated open angle glaucoma (oag) or ocular hypertension (oh).


Eligibility criteria:
inclusion criteria: * patient has been recently diagnosed and is presently untreated for open-angle glaucoma or ocular hypertension with an iop of at least 27 mmhg in at least one eye (patient's worse eye) * patient already diagnosed with open-angle glaucoma or ocular hypertension and untreated for at least 30 days are eligible for the study if they have an iop of 27 mmhg or more in at least one eye exclusion criteria: * a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk by administering dorzolamide-timolol (cosopt®) or prostaglandins * the presence of any fundus pathology likely to change during the study or to influence iop (background of diabetic retinopathy is permitted) * any contraindication to the use of cosopt® including: - bronchospasm, including bronchial asthma or a history of bronchial asthma or chronic obstructive pulmonary disease. - sinus bradycardia, second or third degree av block, cardiac failure (grade iii and iv), cardiogenic shock * patient on oral carbonic anhydrase inhibitor, concomitant systemic or dermatological medication known to affect the iop, e.g. clonidine, corticosteroids, oral beta-blocking agents * pregnant woman or a woman of childbearing potential who is sexually active and not using an acceptable method of contraception (for ex: oral contraceptive, diaphragm, contraceptive sponge, intra-uterine device, long-acting contraceptive injections, double-barrier methods) beginning at least 7 days prior to treatment and continuing at least 14 days after the last visit or the discontinuation visit. (women who are postmenopausal or have received a hysterectomy or have undergone tubal ligature are considered as not having childbearing potential.) * severe renal impairment (serum creatinine \> 150 umol/l or creatinine clearance \< 30 ml/min)