Kornimate/medical-research-clean huggingface dataset:
effects of long-term dry and humidified low-flow oxygen via nasal cannula

Conditions: Chronic Respiratory Failure

Summary: during normal breathing, the upper and lower airways performs the priming of inspired gas: humidification, heating and filtering from nose to the bronchios for adequate gas exchange occurs in the lungs. many patients with severe or advanced cardiopulmonary conditions (cystic fibrosis, chronic obstructive pulmonary disease, pulmonary hypertension, advanced heart failure among others) may develop chronic respiratory failure and require treatment with oxygen therapy. high fractions of inspired oxygen have been associated with deleterious effects on the nasal ciliary beating and nose mucociliary transport. at home assistance, the patient with chronic respiratory receives oxygen via nasal cannula to the patient has been applied with and without humidification, however, does not know the effects of these two types of dry and humidified administration on the mucosa of the nose, airways and lungs. the investigators will assess the subject in use of home oxygen therapy at baseline, 12 hours, 7 days 30 days, 12 months and 24 months.

after agreeing to the terms of informed consent, the individual will be admitted to the study. the objective of this study was to evaluate the effects of humidified oxygen and not humidified nasal catheter (12-24 hours/day) on the nasal epithelium of patients with chronic respiratory failure by non-invasive tests in 36 volunteers, of both sexes aged ≥ 18 years with a medical indication for the use of home oxygen via nasal cannula on: (1) nasal mucociliary transport through the saccharin test, (2) the physical properties of nasal mucus by simulated cough machine and contact angle, (3) cellularity via nasal and total count differential white blood cell nasal lavage, (4) ph nasal lavage and exhaled breath condensate (5) quantification of cytokines in nasal lavage and (6) quality of life questionnaire with rhinosinusitis (snot20). assessments will be performed at baseline, 12 hours, 7 days, 30 days, 12 months and 24 months of use. volunteers will be recruited from three basic health supervision of cathedral health, city health department, city of são paulo.

Eligibility criteria:
inclusion criteria: * subjects aged ≥ 18 years with a medical indication for the use of home low-flow oxygen via nasal cannula exclusion criteria: * inability to taste saccharin * nasal surgery * infection in the last 30 days (before the study)

Keywords: chronic respiratory failure oxygen therapy nasal catheter mucociliary clearance
an open-label maintenance study of the enzyme replacement therapy replagal in patients with fabry disease

Conditions: Fabry Disease

Summary: this study will continue to evaluate the safety of using intravenous doses of replagal for two patients with fabry disease. fabry disease is a genetic disorder inherited as an x-linked recessive trait. it causes a deficiency in the enzyme alpha galactosidase, which normally breaks down a lipid, or fatty substance called ceramidetrihexoside, a building block in all cells of the body. the deficiency in breaking down the lipid eventually causes that lipid to accumulate and injure cells. vascular, renal, and neurological problems are the results. it is not known exactly how lipid accumulation brings about such problems, studies of another lipid storage disorder. two patients 7 to 17 years of age who have fabry disease and have been receiving intravenous infusions of replagal at a dose of 0.2 mg/kg of body weight every 2 weeks may be eligible for this study. participants will undergo the following tests and procedures: * physical examination. * neurological examination. * medical and medication history. * vital signs. * assessment of height and weight. * blood tests to determine complete blood count and chemistries. * electrocardiogram. * doppler blood flow study. participants will go through a baseline evaluation, over a period of about 1 day. they will receive an intravenous infusion of replagal every other week, at the dose of 0.2 mg/kg of body weight. vital signs will be measured before the infusion and immediately and after and 1 hour afterward. there will be careful monitoring for allergic reactions and side effects. the infusion time takes approximately 40 minutes. this study will last at least 1 year, or until the sponsor doing the investigating or the drug manufacturer decides to withdraw support of the study.

objectives: this goal of this study is to continue treating two patients with fabry disease using enzyme replacement therapy (ert) using replagal (agalsidase alfa) at a dose of 0.2 mg/kg of body weight administered every 2 weeks. study population: two patients with fabry disease who are currently on clinical research protocols 00-n-0185/tkt011 or 02-n-0220/tkt015 and who are stable on ert. design: this is an open label study. outcome measures: mainly safety parameters will be obtained. study duration is estimated to be 2 years.

Eligibility criteria:
* patients are under direct care of pi and have previously been treated with replagal under tkt, inc. sponsored study numbers 02-n-0220/tkt/010/015.

Keywords: lysosomal disease glycolipid stroke peripheral neuropathy storage disorder
fat emulsion in preventing hypersensitivity reactions in patients with cancer receiving carboplatin or oxaliplatin

Conditions: Advanced Malignant Neoplasm

Summary: this randomized pilot trial studies how well fat emulsion works in preventing hypersensitivity reactions in patients with cancer receiving carboplatin or oxaliplatin. giving lipids before chemotherapy may prevent some drug reactions from carboplatin or oxaliplatin.

primary objectives: i. to determine if the infusion of a lipid emulsion before each dose of chemotherapy appears to prevent carboplatin and oxaliplatin hypersensitivity reactions in high-risk patients. ii. to explore if lipid infusions modulate a well-established panel of mediators of hypersensitivity reactions and if these mediators appear to predict reactions. outline: patients are randomized to 1 of 2 groups. group i: patients receive fat emulsion intravenously (iv) immediately before each dose of either carboplatin or oxaliplatin. treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity. group ii: patients receive placebo iv immediately before each dose of either carboplatin or oxaliplatin. treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * advanced, incurable cancer * 7th or later cycle of intravenous carboplatin or oxaliplatin infusion planned or 4 months after the first cycle of agent (whichever is of longer duration) =\< 30 days after registration * anticipated 2 or more subsequent chemotherapy infusions of either carboplatin or oxaliplatin at the time of study registration; note: the dose of carboplatin or oxaliplatin, choice of other chemotherapy, and other ancillary treatment, such as antiemetics, will be left to the discretion of the treating healthcare provider * willing to provide mandatory blood and urine specimens for correlative research; note: can be waived with permission of study chair (documentation such as an email must be provided) * serum creatinine =\< 1.5 times the institutional upper limit of normal (uln); note: can be waived with permission of study chair (documentation such as an email must be provided) * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \< 3 x the upper limit of normal * triglycerides \< 500 mg/dl * alkaline phosphatase =\< 3 x the institutional upper limit of normal exclusion criteria: * concurrent liposomal doxorubicin or any other liposomal agent * prior carboplatin or oxaliplatin hypersensitivity reaction * taking aspirin, nonsteroidal anti-inflammatory agents, or zileuton =\< 7 days prior to registration; note: can be waived with permission of study chair (documentation such as an email must be provided) * allergy to egg or egg byproducts
the combination of endometrial injury and freeze all strategy in women with a history of rif

Conditions: Endometrial Injury; Hysteroscopy; Repeated Implantation Failures

Summary: the investigators checked the hypothesis whether endometrial injury performed during the cycle before a frozen embryo transfer in women with rif can improve pregnancy rates

after a freeze all cycle, participants were divided in two groups: an intervention group (n=30), who underwent endometrial injury before the transfer, and a control group (n=30), who underwent no other intervention. the primary outcome was clinical pregnancy rate, while secondary clinical and laboratory parameters. baseline and cycle characteristics were also compared between groups.

Eligibility criteria:
inclusion criteria: * women with rif under 42 years old * bmi 20-30 * normal endometrial cavity * fsh \<15 iu/l * absence of immunological or hematological disorder exclusion criteria: * women over 42 years old * fsh\>15 iu/l * women with chronic immunological or hematological disorder * stage iii or iv of endometriosis * women with pathology concerning the endometrial cavity * women with a medical history of adnexectomy or oophorectomy

Keywords: endometrial injury hysteroscopy rif ivf art
clinical study on the immune response characteristics of novel coronavirus and influenza virus infection

Conditions: COVID-19; Influenza

Summary: this is an open-label, prospective observational study in people 18 years of age and older designed to track changes in the dynamics of the respiratory and peripheral blood immune response in people infected with influenza virus and new coronaviruses, and to resolve the characteristics of the virus-induced natural immune response.

the clinical trial enrolls 130 subjects aged 18 years and older with ≥3 months between their last covid-19/influenza vaccination or respiratory virus infection. mucosal and peripheral blood samples will be collected from covid-19-infected and influenza-infected patients during the preinfection, infection, and recovery periods, and cytokines, immune cell typing, immune cell transcription, and specific antibody levels will be examined in these patients. levels of cytokines, immune cell typing, immune cell gene transcription, specific antibodies, etc.

Eligibility criteria:
inclusion criteria: 1. volunteers aged 18 years and above at the time of screening; 2. informed consent obtained from volunteers and volunteers/witnesses able to sign the informed consent form; 3. an interval of ≥3 months from the last covid-19 or influenza vaccination; 4. an interval of ≥ 3 months from the last respiratory viral infection such as covid-19 or influenza virus occurs; 5.1 cohort 1：novel coronavirus virus antigen-positive and within 48 hours of onset of symptoms of infection; 5.2 cohort 2：influenza virus antigen-positive and within 48 hours of onset of symptoms of infection; 5.3 cohort 3：novel coronavirus and influenza virus antigen-negative, no febrile symptoms, and no symptoms of viral or bacterial respiratory infections. exclusion criteria: 1. known or suspected concomitant more serious and medically unstable disease in the judgment of the investigator, including: respiratory disease, tuberculosis, acute infections or active chronic disease, hepatic or renal disease, cardiovascular disease (cardiorespiratory failure), hypertension (systolic blood pressure ≥160 mmhg, diastolic blood pressure ≥100 mmhg), malignant tumors, infectious or allergic skin diseases, and the presence of hiv infection; 2. absence of spleen or functional absence of spleen; 3. immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and superficial corticosteroid therapy for acute uncomplicated dermatitis) within the past 6 months; 4. received blood products within the past 3 months; 5. has received other vaccines or investigational drugs within the past 1 month; 6. is receiving anti-tuberculosis treatment; 7. in the judgment of the investigator, due to a variety of medical, psychological, social, or other conditions that are contrary to the trial protocol or that affect the signing of informed consent by the volunteer.

Keywords: covid-19 influenza immune response characteristics clinical study
impact of interscalenous block anesthesia on hearing

Conditions: Hearing Loss

Summary: interscalene brachial plexus block (isbpb) is used frequently in shoulder, clavicle and upper arm surgeries to obtain analgesia in the postoperative period. our primary aim in this study is to evaluate if interscalene block anesthesia has an effect on hearing levels of patients undergoing orthopedic shoulder surgeries.

interscalene brachial plexus block (isbpb) is used for both anesthesia and analgesia purposes in shoulder, clavicle and upper arm surgeries. it is also frequently used to obtain analgesia in the postoperative period especially in patients undergoing shoulder surgeries. thus, it provides decrease in opioid need and opioid related side effects in the perioperative period. the effect of ibpb on hearing is probably not caused by an effect on the vestibulocochlear nerve because of its central location. the innervation area of the greater auricular nerve, a derivative of the cervical plexus, is often involved in an ibpb. however, this nerve is not known to affect hearing. the nerves supplying the outer ear canal and the tympanic membrane (branches of the mandibular, facial and vagal nerves) are located far enough from the ibpb injection site to make their involvement unlikely. however, sound conduction through the middle ear to the inner ear, and functioning of the spiral organ of the cochlea may be indirectly affected by regional sympathetic block that is most likely seen after ibpb. sympathetic block may cause vasodilatation and swelling of the mucosal membranes of the middle ear and the eustachian tube with deterioration of hearing. the patient will be examined by ent physician on the morning of the operation, after a detailed anamnesis. otoscopic examination will be performed, pure tone audiometry, speech audiometry and tympanometric examination will be performed and recorded.the same tests will be performed at the next day after the surgery but before the discharge and also when he/she applies for the first week check-up. ultrasaoun guided interscalene block anesthesia will be applied to all patients. each patient will be treated with the same multimodal analgesia method at the postoperative period.

Eligibility criteria:
inclusion criteria: * participants are undergoing a shoulder surgery. * asa i and ii patients without uncontrolled diabetes and hypertension * participants have normal or near-normal hearing thresholds in the un-operated ear exclusion criteria: * participants have hearing loss (pta \> 35 db hl) in pure tone audiometry testing before surgery in any side * participants have medical conditions after the surgery which prevents having hearing tests * participants have abnormal tympanometric results * participants with chronic otitis media or a history of ear surgery

Keywords: hearing level interscalene block anesthesia
effect of the aquaretic tolvaptan on nitric oxide system

Conditions: Autosomal Dominant Polycystic Kidney Disease

Summary: tolvaptan is a selective vasopressin receptor antagonist (v2r) that increases free water and sodium excretion. inhibition of v2r increases vasopressin concentration in plasma, which stimulates v1-receptors in the vascular bed and may change both central and brachial hemodynamics and plasma concentration of vasoactive hormones. the purpose of the study is to measure the effects of tolvaptan on renal handling of water and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide (no)-inhibition with l-ng-monomethyl-arginine (l-nmma) in patients with autosomal dominant polycystic kidney disease.


Eligibility criteria:
inclusion criteria: 1. caucasian men and women 2. age between 18-65 years 3. adpkd, diagnosed by genetic testing of pkd1 (\>85%) or pkd2 mutations, or by ultrasonography: 1. patients with negative family history for adkpd and more than 10 cysts in each kidney and no extrarenal or renal findings that suggest causes to cyst formation. 2. patients with positive family history for adpkd: * 15-39 yr of age and at least 3 or more unilateral or bilateral. * 40-59 yr of age and 2 or more cysts in each kidney. * 60 yr of age and at least 4 cysts in each kidney. 4. kidney function corresponding to ckd stages 1-3(egfr\> 30 ml/min/1,73 m2), 5. bmi between 18.5 and 35.5 kg/m2. exclusion criteria: 1. clinical signs of diseases in the heart, lungs, endocrine organs, brain or neoplastic disease, 2. clinically significant abnormalities in blood or urine sample at the inclusion 3. previous cerebrovascular insults, 4. previous clinical evidence for aneurysm 5. alcohol or drug abuse, 6. smoking, 7. pregnancy or breastfeeding, 8. clinically significant changes in the electrocardiogram, 9. medication except antihypertensive agents and oral contraceptives, 10. blood pressure\>170/105 mmhg despite treatment with metoprolol and/or amlodipine.

Keywords: tolvaptan l-nmma adpkd
self fitting hearing aid clinical investigation

Conditions: Hearing Loss, Sensorineural

Summary: pre-market clinical investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids

the purpose of this study is to evaluate the outcomes of hearing aids with patient-driven fitting (pd) and clinician-driven fitting (cd). the participants will be 40 adults with mild to moderate symmetrical hearing loss. for each hearing aid fitting strategy, the participant will wear the hearing aids for 10 days. lab and field outcomes will be measured. this study will determine if perceived hearing benefit and speech recognition performance with the pd fitting method is non-inferior to that with the cd fitting method.

Eligibility criteria:
inclusion criteria: 1. native english speakers 2. ability to complete questionnaires and laboratory assessments 3. symmetric, mild to moderate sensorineural hearing loss 4. informed consent completed with signature 5. healthy outer ear/middle ear status 6. limited hearing aid use (non-owners of hearing aids) exclusion criteria: 1. inability to visit the starkey headquarters building for testing 2. central or middle ear hearing pathology 3. medical contraindications to wearing hearing aids 4. learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the pi or designee 5. hearing loss outside of the specified criteria (mild to moderate sensorineural hearing loss)

Keywords: self fitting
an extended follow up of a rts,s/as01e malaria vaccine trial

Conditions: Malaria

Summary: malaria is one of the leading causes of deaths in children below five years old. despite antimalarial drugs and insecticide treated bed nets, the established means of treatment and protection, malaria still continues to affect many children. a malaria vaccine would be a very effective way of reducing malaria infection in the community. rts,s/as01e is a leading malaria vaccine candidate which is being developed for children in africa. the investigators have done a study to find out if this vaccine is effective in reducing infection by malaria in children aged 5-17 months living in kenya and tanzania. the follow up of the original study was 14-18 months. the extended follow up is proposed to continue for another four years.

the rts,s/as01e candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas as part of the expanded program of immunization (epi). 30% efficacy against clinical malaria and 58% efficacy against severe malaria disease was seen with a related vaccine, rts,s/as02a, in children aged 1 to 4 years (malaria-026) in mozambique. the efficacy against clinical malaria and infection was sustained beyond 18 months. the rts,s/as01 vaccines have been developed in parallel with the rts,s/as02 vaccines, and differ in the adjuvant formulation which has been shown to be more immunogenic.the utility of a partially effective vaccination depends heavily on the overall effect of malaria incidence during a child"s acquisition of natural immunity. however, other cohorts vaccinated in phase ii studies have already discontinued follow up for episodes of malaria, and the planned phase iii studies will run for at most 30 months post vaccination. the proposed extended follow up is expected to run for four years and will inform the design of phase 4 studies and may prove critical in informing public health policy once the vaccine is licensed.

Eligibility criteria:
inclusion criteria: * enrollment and vaccination in the rts,s/as01e clinical trial (nct00380393) * written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child. exclusion criteria: * moving out of the study area, so that follow up is impractical.

Keywords: malaria vaccine rts,s,
evaluation of nephrogenic systemic fibrosis (nsf) in patients with chronic kidney disease following optimark injection

Conditions: Nephrogenic Systemic Fibrosis; Renal Insufficiency

Summary: the objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically nsf during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (egfr 30-59) and severe renal insufficiency or end-stage renal disease requiring dialysis (egfr \<30).


Eligibility criteria:
inclusion criteria: * referred for contrast-enhanced mri using gadoversetamide; * have a documented estimated glomerular filtration rate (egfr) of \<60 ml/min/1.73 m2 within the past 6 months or esrd requiring dialysis; and * willing and able to provide written consent (themselves or by a legally authorized representative) and agree to abide by study requirements, including being seen by a dermatologist and undergoing a skin biopsy if nsf is suspected. exclusion criteria: * have experienced a previous hypersensitivity reaction to a gbca; * have pre-existing nsf or nsf-like symptoms; or * have been exposed to a gbca within 12 months prior to the index procedure; or * has a medical condition or other personal situation that would prevent providing follow-up information, completing clinic visits or otherwise supplying meaningful data to meet study objectives.

Keywords: nephrogenic systemic fibrosis renal insufficiency gadoversetamide optimark magnetic resonance imaging
a study of nt 201 in the treatment of enlarged pores and excessive sebum production in the face

Conditions: Enlarged Pores; Sebum Production

Summary: the purpose of this study is to investigate the efficacy and safety of nt 201 injections in the treatment of enlarged pores and excessive sebum production in the face.

eligible subjects will be randomized to one of the two treatment groups: nt 201 group and placebo in order to receive one session of injections with either nt 201 or placebo in the upper face (forehead and cheek area) on day 1 and followed for about 90 days after treatment.

Eligibility criteria:
inclusion criteria: * cheek pore size assessed as "large" by the investigator * oily skin on the forehead exclusion criteria: * treatment with botulinum toxin (bont) of any serotype in the face within the last 12 months * facial cosmetic procedure (e.g., chemical peel, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, ultrasound treatment, tattooing of eyebrows) within the last 12 months * treatment with any dermal filler in the face within the last 12 months * any previous insertion of permanent material in the face, including permanent dermal fillers (e.g., silicone, polymethyl methacrylate) * any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype