Kornimate/medical-research-clean huggingface dataset:
a comparative study between two formulations of the ciprofloxacin hydrochloride + hydrocortisone otic suspension

Conditions: Otitis Externa

Summary: the objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/ml ciprofloxacin hydrochloride associated with 10 mg/ml of hydrocortisone with the reference product cipro hc®, in patients with acute otitis externa.

phase iii, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study. population: 224 patients with external otitis , men and women aged between 1 - 70 years. primary endpoint: the primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure). secondary endpoint: the endpoint will be the identification of the side effects of medication use.

Eligibility criteria:
inclusion criteria: * informed of the nature of the study and given written informed consent; * patients with acute otitis externa; * intact tympanic membrane. exclusion criteria: * known allergy or sensitivity to ciprofloxacin hydrochloride and hydrocortisone; * patient has the tympanic membrane not intact; * diabetes * bilateral acute otitis externa; * pregnant or lactating patients; * overt fungal acute otitis externa; * other diseases of the ear * current infection requiring systemic antimicrobial therapy. * current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
early ponv - a registry based study in sweden.

Conditions: Postoperative Nausea and Vomiting; Postoperative Complications

Summary: the study is an registry study based on data from the swedish perioperative registry (spor) during the years 2016-2022 with the aim to explore the risk for postoperative nausea and vomiting at the recovery unit (early ponv). the study will explore several cohorts (for example a specific procedure) on a national basis, report the risk for early ponv and identify associated factors.

the study is a registry study based on data from the swedish perioperative registry (spor) during the years 2016-2022 with the aim to explore the risk for postoperative nausea and vomiting at the recovery unit (early ponv). almost all hospitals in sweden report surgical procedures to spor and for the years 2016-2019 there are almost 1.7 million procedures in the registry for patients \>18years. data will be extracted from spor on a yearly basis and results will be reported on selected cohorts (time periods and/or type of surgical procedure) during the study period. there is an option for hospitals to register nausea and vomiting occurring at the recovery unit and submit the data to spor. if a hospital choose to use the variable in their dataset, all patients at their unit needs to be registered either with \[no_nausea or vomiting\], \[nausea\] or \[nausea or vomiting\]. in the year 2019, more than 50% of procedures under anesthesia in the registry had registration of ponv. the strength with this system is that if a unit uses the variable, all cases will be classified either as "noponv" or "ponv". the investigators aim to use the variable ponv at the recovery unit to describe the risk for early ponv and explore associated factors in several cohorts of surgical procedures in sweden. the first dataset (2016-2018) was sent to the investigators from the spor registry in may 2019 and during the period june 2019- may 2020, the dataset was used to build up a model for the analysis of data with a preliminary report of elective surgeries in sweden the year 2017. an updated dataset (all cases 2016-2019) was retrieved from spor on june 3 2020 and further analysis and reporting is based on the most updated dataset (yearly basis).

Eligibility criteria:
inclusion criteria: * procedure under general or regional anaesthesia * age \>=18 years at the day of the procedure. exclusion criteria: * no entry of the ponv-variable in the spor-registry
to evaluate the safety and efficacy of tqb2618 injection combined with penpulimab in the treatment of patients with relapsed and refractory lymphoma

Conditions: Relapsed/Refractory Lymphoma

Summary: this is a two-phase, open-label phase ib clinical trial to evaluate the safety and efficacy of tqb2618 injection combined with penpulimab in patients with relapsed and refractory lymphoma


Eligibility criteria:
inclusion criteria: * 1 subjects with pathologically proven with relapsed or refractory lymphoma and with disease progression during or after the last treatment or no objective response confirmed after adequate treatment. * 2 cohort 1: subjects with classical hodgkin lymphoma (chl) who had previously received at least twice systemic therapy and are resistant to pd-1 or pd-l1. * 3 cohort 2: subjects with b lymphocyte non-hodgkin lymphoma (b-nhl) who had previously received at least twice systemic therapy containing anti-cd20-targeted therapy. * 4 cohort 3：subjects with t lymphocyte non-hodgkin lymphoma (t-nhl) who had previously received at least one systemic therapy. * 5 subjects with measurable lesions as defined by lugano2014. * 6 aged 18-75 years ; eastern cooperative oncology group (ecog) score:0 \~ 1; expected survival ≥3 months. * 7 laboratory indicators meet the requirements. * 8 subjects voluntarily joined the study and signed the informed consent form. * 9 non-pregnant or non-breastfeeding women; negative pregnancy subjects. exclusion criteria: * 1 subjects who have developed or is currently suffering from other malignancies within 3 years, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ. * 2 subjects who have not recovered to ≤ common terminology criteria for adverse events (ctcae) grade 1 due to the adverse event of prior therapy. * 3 subjects with significant surgery or significant traumatic injury within 28 days before first injection (excluding needle biopsy or endoscopic biopsy). * 4 subjects with long-term unhealed wounds or fractures. * 5 subjects with the high risk of bleeding or bleeding history or subjects with bleeding event (≥common terminology criteria for adverse events grade 3) within 4 weeks before first injection. * 6 subjects with arterial/venous thrombosis within 6 months. * 7 subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders. * 8 subjects with any severe and/or uncontrolled disease. * 9 subjects with lymphoma originating from central nervous system, high-grade b-cell lymphoma or hemophagocytic syndrome during screening period. * 10 subjects with violating central nervous system (cns) . * 11 subjects with allogeneic hematopoietic stem cell transplantation. * 12 subjects with autologous hematopoietic stem cell transplantation or chimeric antigen receptor t-cell immunotherapy(car-t) within 3 months before first injection. * 13 subjects with other factors that might cause the study to be terminated halfway per the judgement of the investigator.
preoperative pain and pocd in elderly patients

Conditions: Postoperative Cognitive Dysfunction

Summary: the purpose of this study is to investigate whether preoperative pain is the risk factor of pocd in elder patients.

postoperative cognitive dysfunction (pocd) occurs mainly in aged patients. the mechanism of pocd is not clear yet and no effective therapy method. in the present study, we conducted a single-center observational prospective cohort trial in elder patients who undergoing hip joint replacement surgery with general anesthesia to test our hypothesis that preoperative chronic pain is one of the risk factors of pocd after major joint replacement surgery.

Eligibility criteria:
inclusion criteria: 1. elder than 65 years old 2. speak chinese mandarin 3. those who will undergo major low limb surgery like hemiarthroplasty or total hip arthroplasty with general anesthesia. 4. signed the inform consent 5. american society of anesthesiologists classification i to ii exclusion criteria: 1. existing cerebral disease, or have a history of neurological and psychiatric disease including alzheimer disease, stroke, epilepsy and psychosis 2. existing cognitive impairment as evidenced by mini-mental state examination scores below 24 3. severe hearing or visual impairment 4. unwillingness to comply with the protocol or procedures 5. cannot communicate with chinese mandarin 6. serious pulmonary, heart , liver or renal insufficiency patients 7. had anesthesia or surgery within the past 30 days

Keywords: postoperative cognitive dysfunction elderly patients preoperative pain
vay736 in combination with ibrutinib in patients with cll on ibrutinib

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: patients enrolled to the study had chronic lymphocytic leukemia (cll) and received ibrutinib. patients had either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation to ibrutinib. this study had two parts, a dose escalation part and a dose expansion part.


Eligibility criteria:
inclusion criteria: * diagnosis of cll per the who classification * at least 18 years of age * lack of a complete response after receiving ibrutinib for \> 1 year or presence of known ibrutinib resistance mutation * actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm) exclusion criteria: * known history of hiv * active hepatitis b or c infection * receipt of attenuated vaccine within 2 weeks prior to starting study treatment.

Keywords: ibrutinib vay736 chronic lymphocytic leukemia cll bruton's tyrosine kinase btk mutation
study to learn more about the stomach and intestine complaints of children aged from 3 to 14 years

Conditions: Functional Gastrointestinal Disorders

Summary: in this observational study, researchers want to gain more information on children suffering from abnormal stomach and intestine function (based on the rome criteria) and treated iberogast. the rome criteria have been developed by experts to support doctors to diagnose stomach and intestine disorders. this study will focus on children aged from 3 to 14 years in age treated by their doctor with the herbal drug iberogast for their stomach and intestine complaints for one week. researcher want to learn more about the efficacy of iberogast by observing the changes of symptoms related to the stomach and intestine disorders. in addition information on the safety of the drug and how well the drug is tolerated by the patients will be collected.


Eligibility criteria:
the selection of the children to be documented was the sole responsibility of the physician whereby the information of the rome iii criteria on functional gastrointestinal diseases in children as well as the prescribing information on iberogast could be consulted as guideline. only the therapeutic necessity was determining for the use of all medicines. the treating physicians received standardised information regarding the ailment picture (rome iii criteria) before the beginning of the study and during the investigator meetings.
exercise as a buffer against stress-induced overeating

Conditions: Obesity

Summary: the purpose of this study is to examine the psychological benefits of chronic exercise as well as the effects of exercise training on eating behaviors and stress-induced overeating in overweight and obese women. participants will be randomized to an 12-week exercise condition or a delayed exercise condition. assessments will occur at baseline, 6 weeks, and 12 weeks and will include answering surveys in real-time using smartphones, several assessments of eating behaviors and dietary intake, and questionnaire measures of factors which could mediate the relationship between exercise and eating. participants will be compensated for completing assessments and for adherence to the exercise protocol.


Eligibility criteria:
inclusion criteria: * female * 18-60 years of age * bmi 25 to \<40 kg/m2 * physically inactive (\<60 min/week of physical activity) * must own a smartphone * must be willing to receive and respond to text message prompts for 14 days at baseline, 6 and 12 weeks exclusion criteria: * shift workers * individuals who do not endorse stress-eating * recent weight loss or current enrollment in a weight loss program * women who are pregnant or plan on becoming pregnant in the next 6 months * any medical condition that would limit participation in physical activity * diabetes * inability to walk without an assisted device * inability to meet exercise recommendations * failure to adequately complete all baseline assessment measures
safety, tolerability, and exploratory efficacy study of intrathecally administered gene therapy amt-162 in adult participants with sod1 amyotrophic lateral sclerosis (sod1-als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is the study of amt-162 in participants with sod1-als and is designed to evaluate the safety, tolerability, and exploratory efficacy of intrathecally administered gene therapy amt-162. amt-162-001 is a phase 1/2, multi-center, single ascending dose study.

amt-162 is an investigational gene therapy that encodes an artificial microribonucleic acid (microrna or mirna) targeting the sod1 gene. this clinical study will test the safety of amt-162 and explore the hypothesis that it will silence expression of mutant cytosolic sod1 and thereby ameliorate the course of als caused by this mutant gene.

Eligibility criteria:
inclusion criteria: * confirmed clinical and genetic diagnosis of sod1-mediated als (sod1-als) experiencing signs and/or symptoms of lower motor neuron dysfunction (weakness, atrophy, cramps, fasciculations), with or without upper motor neuron symptoms (weakness, bring reflexes, spasticity). * alsfrs-r score ≥ 25 at screening. * slow vital capacity (svc) ≥50% of predicted normal value. * capable of providing informed consent and complying with trial procedures, including: medically able to undergo lumbar puncture and has a responsible caregiver able to attend all clinic visit with the participant. exclusion criteria: * sod1 pathogenic or likely pathogenic variants in amino acid regions 43-47. * pathogenic repeat expansion in the c9orf72 gene * any of the following prior or concomitant treatments: * any prior sod1 suppression therapy with viral microrna mediators * prior sod suppression therapy with antisense oligonucleotide (aso) mediators such as tofersen (qalsody™). exception: patients who previously received tofersen may be enrolled if the last dose of tofersen was received at least 20 weeks prior to the first screening assessment and if there were no previous tofersen-related saes or ongoing tofersen-related adverse events that would increase the risk of receiving amt-162, per investigator judgment. * other als medications riluzole (rilutek®, tiglutik®), edaravone (radicava®), and sodium phenylbutyrate and taururosdiol combination (relyvrio) or bioequivalents are allowed if dose is stable for 30 days prior to immunosuppression. * any prior administration of an aav gene therapy. * participants must be willing to forego new als treatments through at least 6 months after infusion of amt-162. after 6 months, investigators and participants may decide to add new als medications or change existing als medications.

Keywords: gene therapy aav (adeno-associated virus) als sod1
decision making and implementation of aging-in-place/long term care plans among older adults

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Summary: this study seeks to better understand how older adult aging-in-place/long term care decision making and implementation is impacted by age-related changes (e.g. cognition, health literacy, chronic conditions), social influences (e.g. caregivers/supporters), and environmental factors.

subjects who are part of the national institute on aging (nia)-funded litcog study will be given access to planyourlifespan.org, a web-based decision-making and planning tool. participants will be followed for up to 42 months to examine the mediating/moderating factors involved in decision-making, timing of decision implementation, and goal concordance. findings have the potential to inform healthcare providers, caregivers, health/long term care insurers, area agencies on aging, and older adults nationally in supporting aging-in-place decisions and services use.

Eligibility criteria:
inclusion criteria: * current participant in the litcog trial \[r01ag03611\] * english-speaking * community-dwelling * currently use a computer or tablet with internet exclusion criteria: * previous participation in the advanced planning for home services study \[ih-12-11-4259\]
a therapeutic experience program (tep) study for improvement of gait in people with multiple sclerosis (ms)

Conditions: Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS)

Summary: pons therapy is a rehabilitation program that uses the pons device in conjunction with individualized physical exercise. this is an outcome research open label observational interventional multi-center study investigating the relationship between subject's adherence to pons therapy and therapeutic outcomes.

study participants will undergo fourteen weeks of on-label pons therapy and, specifically, two weeks in-clinic pons therapy directly supervised by a physical therapist who has been trained on pons therapy by helius medical and certified as a clinic pons trainer (phase 1) followed by 12 weeks of at-home unsupervised pons therapy once weekly in-clinic pons therapy session (phase 2). subjects will be then asked to return to the clinic six month after the end of the study phase 2 to assess maintenance of pons therapy effects.

Eligibility criteria:
inclusion criteria: 1. men and women ≥ 22 years of age with a diagnosis of ms. 2. edss scores \< 6.5 at screening; a demonstrated gait deficit. 3. can walk at least 10 meters with or without the use of walking aids. 4. participants must be stable without relapse for at least 60 days and agree to pons therapy regimen. exclusion criteria: 1. other neurological, visual, or orthopedic problems that significantly interfere with balance or gait. 2. dementia. 3. subjects who are currently attending physical rehabilitation and are unwilling to switch to pons-specific physical therapy regimen. 4. subjects who are already functional community ambulators (gait speed\>120cm/s43). 5. subjects will also be excluded as per the helius medical pons device indication for usage ("electrical stimulation should not be used: if there is an active or suspected malignant tumor; in areas of recent bleeding or open wounds; in areas that lack normal sensation; in women who are pregnant, or in people with sensitivity to nickel, gold or copper").

Keywords: gait, rehabilitation, pons, device, therapy, adherence, outcome
mental and physical well-being of frontline health care workers during coronavirus disease 2019 (covid-19)

Conditions: Healthy

Summary: study to support the mental and physical well-being of us health care workers during the covid-19 pandemic and ensure high-quality care for patients through stress first aid.

the goal of the project is to support the mental and physical well-being of u.s. health care workers (hcws) during the covid-19 pandemic to ensure high-quality care for patients, by establishing the effectiveness of a tailored stress first aid (sfa) intervention, compared to usual care (uc). the rand corporation will conduct a cluster randomized controlled trial (crct) with three cohorts containing matched pairs in approximately 40 diverse sites (hospitals and clinics) to evaluate whether sfa for hcws improves mental and physical well-being compared to uc. sequential roll-out of the intervention to three cohorts will allow investigators to quickly incorporate lessons learned and stakeholder feedback from each iteration into subsequent trainings, and share actionable findings given the urgency due to the pandemic. the end result will be an sfa toolkit tailored for hcws that can be implemented and scaleable across multiple settings. the proposed sfa intervention addresses an important and compelling clinical care delivery challenge during covid-19 by improving the mental well-being of hcws, who will benefit directly and be better equipped to provide higher quality, more sustained, and more patient-centered care to patients. the specific aims of the project are to: (1) test the comparative effectiveness of sfa versus uc on mental and physical well-being (quantitative); (2) understand and document any uc activities to support hcw well-being prior to implementing sfa across sites; and (3) assess the experiences of hcws and sites with sfa (acceptability, likelihood of uptake, lessons learned) and impact on hcw well-being (qualitative).

Eligibility criteria:
inclusion criteria: * health care workers and patient-facing support staff (e.g., front desk staff) exclusion criteria: * non-english speaking

Keywords: healthcare worker stress fatigue anxiety burnout covid-19 stress first aid
a study of taspoglutide in type 2 diabetic patients

Conditions: Diabetes Mellitus Type 2

Summary: this crossover study will assess the effect of 2 doses of taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. patients will receive a continuous subcutaneous infusion of a)the immediate release formulation (irf)of taspoglutide 300 micrograms/day for 2 days followed by taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. after a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving taspoglutide in period 1 will receive placebo in period 2, and vice versa. on days 2 and 4 of each period, insulin secretion patterns will be assessed. the anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age; * type 2 diabetes mellitus; * treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening. exclusion criteria: * type 1 diabetes mellitus; * type 2 diabetes duration of \<3 months; * treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months; * treatment with insulin for \>7 days within 6 months prior to screening.
optimizing antibiotic use in long term care

Conditions: Urinary Tract Infection, Antibiotic Use

Summary: the purpose of this study was to determine if a multi-faceted intervention to implement diagnostic and therapeutic algorithms for management of suspected urinary infection in nursing home residents could reduce antibiotic prescribing for urinary indications in this population.

antibiotic use is intense in nursing homes and frequently inappropriate when prescribed for urinary indications. evidence from randomized controlled trials suggests that treatment of asymptomatic bacteriuria, the presence of bacteria in the urine in the absence of urinary symptoms, is not beneficial. despite this, one in three prescriptions for urinary indications are for asymptomatic bacteriuria. to improve antibiotic prescribing in this setting we conducted a cluster randomized trial of a strategy to implement diagnostic and treatment algorithms for urinary infection. 24 nursing homes were randomized to either the intervention (implemented at the nursing home level using a multi-faceted approach: small group interactive sessions for nurses, one-on-one interviews for physicians, videotapes, written material, and outreach visits) or to usual care.

Eligibility criteria:
inclusion criteria: 1. individuals- all residents eligible 2. nursing homes * free standing long term care facilities with \>100 beds * no stated policy for diagnosis or treatment of urinary tract infections * the facility agrees to refrain from introducing new strategies for antibiotic utilization or clinical pathways during study exclusion criteria: -

Keywords: urinary tract infections, antibiotic use, long term care facilities