Kornimate/medical-research-clean huggingface dataset:
plasma copeptin in response to oral urea in healthy adults and patients with polyuria-polydipsia syndrome

Conditions: Arginine Vasopressin Deficiency; Primary Polydipsia

Summary: the aim of this study is to investigate whether oral urea stimulates copeptin release and, if so, whether it may provide a novel diagnostic test in the differentiation between avp-d (arginine vasopressin deficiency) and pp (primary polydipsia).

this study consists of two parts, including healthy adults (study part 1 - proof of concept) and adults with an established diagnosis of pp or avp-d (study part 2 - pilot study). if the results of study part 1 suggest that oral urea is a potent stimulator of copeptin in healthy adults, study part 2 will be conducted, meaning that adults with an established diagnosis of pp or avp-d will be included. if study part 1 demonstrates no relevant copeptin increase in response to oral urea, the study will be terminated thereafter and study part 2 will not be conducted.

Eligibility criteria:
healthy volunteers inclusion criteria: * age ≥18 years * healthy with no medication except hormonal contraception exclusion criteria: * participation in a trial with investigational drugs within 30 days * evidence of disordered drinking habits and diuresis defined as polyuria \>50ml/kg body weight/24h and polydipsia \>3l /24h * known allergy towards components of the study drink * pregnancy and breastfeeding * intention to become pregnant during the study * evidence of acute illness patients inclusion criteria: * age ≥ 18 years * documented pp or avp-d based on accepted diagnostic criteria, i.e., water deprivation test, hypertonic saline infusion test or arginine infusion test. accordingly, patients must have evidence of disordered drinking habits and diuresis defined as polyuria \>50ml/kg body weight/24h and polydipsia \>3l /24h or must be on regular daily desmopressin medication exclusion criteria: * participation in a trial with investigational drugs within 30 days * known allergy towards components of the study drink * pregnancy and breastfeeding * evidence of acute illness

Keywords: diabetes insipidus copeptin oral urea
center for the study of vascular disease in hispanic and native americans

Conditions: Vascular Disease

Summary: this is a working registry of a longitudinal cohort of hispanics, native americans, and non-hispanic whites (as controls) for tracking of vascular disease endpoints. blood samples collected for ongoing pilot projects as well as specimen banking. pilot studies are observational and involve risk measures for stroke, atherosclerosis, and vascular inflammatory responses. questionnaires on demographics, risk factors, and vascular disease history are performed. no interventions proposed as yet.


Eligibility criteria:
hispanics and native americans are oversampled, but non-hispanic whites will be included for comparison purposes. no other exclusion criteria.

Keywords: vascular diseases
early treatment based neuroscience education in knee

Conditions: Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Injuries

Summary: determine the effecttiveness of a cross-education strength training protocol in a group of subjects with an anterior cruciate ligament surgery.

the cross-education (ce) phenomenon has been studied in recent years as a form of gain muscle strength not only in healthy subjects but also in acute injuries such as musculoskeletal disorders and immovilitations. unilateral training of the not injured limb has been suggested as an option to produce cross-edutation in terms of strength and skills. in addition, functional magnetic resonance imaging have been postulated as a promising tool to study the mechanisms of transfer. in the context of our study, arthrogenic muscle inhibition (ami) of knee extensors is a common consequence after acl repair in which a ce strength training can lead to reduce quadriceps atrophy and its implications in long terms achievements. thus, an unilateral strength protocol of the uninjuried limb, according to the last delphi consensus, will be run for 8 weeks to check the possible benefits of the transfer in a sample of acl repair.

Eligibility criteria:
inclusion criteria: * people between 18 and 40 years whith mri diagnosis of acl rupture. * autograft, allograft or artificail graft of any source. * with/without any meniscal resection/repair. exclusion criteria: * diagnosis of systematic disease, no injury or symptomatic in contralateral lower limb, pregnancy, current or prior neurologic condiction.

Keywords: cross-education physiotherapy unilateral strength training fmri anterior cruciate ligament
telerehabilitation using mirror therapy in patients with phantom limb pain following lower limb amputation.

Conditions: Phantom Limb Pain

Summary: the overall aim of this randomized controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor exercises without a mirror in patients following lower limb amputation.

up to 75% of patients after amputation of an arm or leg suffer from chronic phantom limb pain that still is perceived in the missing limb, leading to limitations in daily activities and quality of life. the treatment of phantom limb pain is still challenging. despite many different pharmacological interventions, the outcomes on the longer-term are in many cases not satisfying. alternative, non-pharmacological interventions, such as mirror therapy, are gaining increased recognition in the treatment of phantom limb pain. in this context, telerehabilitation plays an important role to support long-term self-management and autonomy of these patients. in the developmental phase of the project, a user-centred design is applied. patients as well as physical and occupational therapists are interviewed concerning their preferences and needs with respect to the design and content of the telerehabilitation. additionally, two focus groups with each five participants will be conducted. subsequently, a prototype of the telerehabilitation will be developed based on user preferences, available evidence, expert opinion and already existing systems. this prototype will be tested on its usability and technical performance in phase three using the thinking-aloud-method and data logging. accordingly, a multicenter, randomized controlled trial will be conducted to evaluate the cost-effectiveness of the telerehabilitation.

Eligibility criteria:
inclusion criteria: 1. lower limb amputation 2. at least since one week constant or intermittent phantom limb pain (plp) with an average intensity of at least score 3 on the 11-point nrs and a minimum frequency of one episode of plp per week. 3. sufficient cognitive, communicative and motor functions to be able to use the telerehabilitation service, to concentrate for at least 15 minutes on the mirror image and to follow instructions and questionnaires; this is based on clinical judgment of recruiting physicians or therapists. exclusion criteria: 4. duration of inpatient rehabilitation not long enough to ensure the 4-week clinical intervention phase. 5. bilateral amputation, severe co-morbidity (e.g. stroke) or pain affecting the intact limb; this prevents engagement in the prescribed exercise programs of the study. 6. severe psychiatric disorders that preclude patients from participating in the trial. 7. intensive course of mirror therapy in the past (\> 6 treatments during the last three months).

Keywords: telerehabilitation, mirror therapy, phantom limb pain
photon/proton radiation therapy for carcinoma of the nasopharynx

Conditions: Nasopharynx Cancer

Summary: the purpose of this study is to collect outcomes information to see what effects photon/proton beam radiation has on nasopharynx cancer.

data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Eligibility criteria:
inclusion criteria: \* nasopharynx cancer. exclusion criteria: * evidence of distant metastasis. * previous radiation for head and neck cancer.

Keywords: nasopharynx cancer, proton radiation, outcomes
us post-marketing safety study of moxetumomab pasudotox-tdfk (lumoxiti)

Conditions: Hairy Cell Leukemia

Summary: this study is being conducted to satisfy a post-marketing requirement (pmr) to provide evidence characterizing 1) the safety of moxetumomab pasudotox-tdfk in patients who are 65 years of age and older and/or 2) the safety of moxetumomab pasudotox-tdfk in patients who have moderate renal impairment defined as an estimated gfr of 30-59 ml/min

the pivotal phase 3 study (study 1053) supported full approval of moxetumomab pasudotox-tdfk from the us food and drug administration (fda) for the treatment of adult patients with relapsed or refractory hairy cell leukemia (hcl) who received at least two prior systemic therapies, including treatment with a pna, on 13 september 2018. since hcl is a rare disease, clinical research has limited information concerning the safety of moxetumomab pasudotox-tdfk in elderly patient populations and patients with moderate renal impairment.this study is being conducted to satisfy a post-marketing requirement (pmr) to provide evidence characterizing the safety of moxetumomab in these patients.

Eligibility criteria:
inclusion criteria: * provision of written informed consent, if required * patient received at least 1 dose of moxetumomab pasudotox-tdfk and has completed or discontinued the treatment * patient has a medical record available from the start of first dose of moxetumomab pasudotox tdfk and at least 1 of the following: * patient is ≥65 years old at the time of starting initial treatment with moxetumomab pasudotox-tdfk or * adult (≥18 years old) patient has moderate renal impairment, at the time of starting initial treatment with moxetumomab pasudotox-tdfk

Keywords: capillary leak syndrome hemolytic uremic syndrome renal toxicity infusion-related reaction electrolyte abnormalities hcl and all relevant indications where lumoxiti will be prescribed
randomized pilot trial of the impact of bedside delivery of discharge medications to pediatric patients with asthma

Conditions: Asthma

Summary: this randomized pilot study proposes to field-test key logistical aspects of studying an intervention already available to patients on the pediatric ward, namely a discharge medication delivery service, called "meds-in-hand," which has been refined via a quality improvement process, but not rigorously studied nor fully implemented.

at this time, meds-in-hand is not currently utilized for approximately 40% of patients admitted to the pediatric ward at boston medical center. currently patients do not receive their discharge medications via the delivery service for a variety of reasons, however they continue to receive the usual care standard employed by most hospitals, where prescriptions are sent to their home pharmacy for pickup after discharge. this study does not change the actual medications patients receive, but how and when they get them. rigorous study of the relationship between meds-in-hand and patient satisfaction and clinical outcomes has not been performed to date, so there is equipoise about the value of the intervention, however observational data in the population in question, namely children admitted for an asthma exacerbation, suggest that patients who receive meds-in-hand prior to discharge have a reduced likelihood of a return visit to the emergency department in 30 days. the study will focus on parent-patient dyads admitted with an asthma exacerbation where the child is aged 2-17 years, however parents will be the exclusive study subjects. parents of the patients will be asked a baseline, in-hospital survey as well as participate in phone follow-up interviews to report on the patient experience and parent-reported child health outcomes at approximately 3 and 30 days after leaving the hospital. 60 total parents will be enrolled, 30 in each arm of the study. this pilot study will also obtain empiric estimates of key study parameters to inform future study design and begin to examine trends between the groups of patients who are randomized to the meds-in-hand intervention and those randomized to usual care.

Eligibility criteria:
inclusion criteria: * admission includes treatment for asthma exacerbation * discharge medications will require a new prescription * primary care taker speaks english or spanish exclusion criteria: * patients being discharge outside of the operating hours of the delivery service
study of reslizumab in participants with uncontrolled asthma and elevated blood eosinophils

Conditions: Asthma

Summary: the primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.


Eligibility criteria:
inclusion criteria: * written informed consent is obtained. * the participant is male or female, 12 years of age and older, with a diagnosis of asthma. * the participant has forced expiratory volume in 1 second (fev1) reversibility according to standard american thoracic society (ats) or european respiratory society (ers) protocol. * the participant has required an inhaled corticosteroid. * the participant has required an additional asthma controller medication besides inhaled corticosteroids. * the participant has a history of asthma exacerbation. * the participant must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol. * additional criteria may apply, please contact the investigator for more information exclusion criteria: * the participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety. * the participant has another confounding underlying lung disorder * the participant has a known hypereosinophilic syndrome. * the participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers. * the participant is a pregnant or lactating woman, or intends to become pregnant during the study. any woman becoming pregnant during the study will be withdrawn from the study. * the participant is a current smoker or has a smoking history. * the participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer. * the participant was previously exposed to reslizumab. * the participant has a history of an immunodeficiency disorder including human immunodeficiency virus (hiv). * the participant has current or suspected drug and alcohol abuse. * the participant has an active helminthic parasitic infection or was treated for one within 6 months of screening. * the participant has a history of allergic reaction or hypersensitivity to any component of the study drug. * additional criteria may apply, please contact the investigator for more information
trial to evaluate the efficacy and safety of tp-03, libra study

Conditions: Blepharitis

Summary: the phase iii main study is a randomized, controlled, multicenter, double blind, trial to evaluate the efficacy and safety of tp-03 (lotilaner ophthalmic solution, 0.25%), for the treatment of demodex blepharitis in chinese patients. the pk sub-study is a single-arm, open-label trial to evaluate systemic tp-03 in whole blood following topical ocular administration

the main study is designed to demonstrate the superiority of tp-03 compared to vehicle for the treatment of demodex blepharitis in chinese patients. the vehicle of tp-03 was selected as the control since there are no approved pharmaceutical treatments for demodex blepharitis. the vehicle as the control will provide evidence that the active ingredient is responsible for the response, not the vehicle alone. a pharmacokinetics (pk) sub-study is included in the overall study design to evaluate systemic pk parameters of tp-03 in chinese participants with demodex blepharitis. the pk sub-study sites are separate from those of the phase iii study as described above.

Eligibility criteria:
inclusion criteria: 1. male or female, aged ≥ 18 years of age. 2. be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol. 3. has blepharitis 4. stated willingness to comply with all study procedures and availability for the duration of the study. exclusion criteria: 1. have used lid hygiene products (e.g., lid scrubs) within 14 days of screening or unwilling to forego the use of lid hygiene products during the study. 2. have initiated treatment with an ocular topical prostaglandin analogue within 30 days of screening or have any plans to change or discontinue treatment during the study 3. pregnancy or lactation. 4. any intraocular surgery (including ocular surface surgery, cataract surgery and intravitreal injection) or periocular surgery within 60 days prior to randomization, or any planned ocular surgical procedure during the study period 5. have any unstable or uncontrolled, cardiac, pulmonary, renal, oncological, neurological, metabolic or other systemic condition that, in the opinion of the investigator, would possibly require the participant to seek emergent medical treatment during the course of this study. this includes, but is not limited to, unstable or uncontrolled cardiac arrhythmias, hypertension, coagulopathies, renal failure or advanced diabetes mellitus.

Keywords: blepharitis
healthier you: optimizing screening, brief interventions, and referral to treatment (sbirt) in the emergency department

Conditions: Drug Abuse

Summary: screening, brief interventions, and referral to treatment (sbirt) for drug use/abuse offers opportunities for early detection, brief intervention/treatment, and substance use treatment referrals for patients in medical settings. although sbirt components, particularly screening and brief interventions, have been shown to be effective strategies for addressing alcohol misuse in primary care, data are limited on using all of the components of sbirt for drug-using patients, particularly in the emergency department (ed). further, because of the often chaotic environment of eds, many logistical and practical impediments exist for the adoption of the entire sbirt model in this setting.

the proposed study will use computerized screening using touch screen computer tablets with audio (\~4,900 patients) and will test intervention strategies in a two-factorial design (3x2). specifically, 900 patients aged 18-60 in an inner-city ed who screen positive for drug use in the past 3 months will be randomized to the combinations of three ed-based conditions (computer brief intervention-cbi; intervener brief intervention-ibi; enhanced usual care-euc), and two follow-up conditions (adapted motivational enhancement therapy-amet; enhanced usual care-euc) that will take place 3 months post-ed. all individuals who meet criteria for a drug use disorder will additionally receive the "referral to treatment" or "rt" component of sbirt. stratified random assignment \[by gender and diagnosis of a drug use disorder (yes/no)\] will take place at baseline for all ed based and follow-up conditions. all participants will receive written information including substance abuse and other community resources, and hiv prevention materials. recognizing that brief interventions are important, but not necessarily sufficient, for change in all patients who use drugs, the primary specific aims of the proposed study will determine the independent effectiveness of immediate "on-the-spot" ed-based brief intervention conditions, 3-month followup brief treatment conditions, and combinations of conditions, for decreasing drug use and improving health-related outcomes (including physical and mental health, and hiv risk behavior) at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * patients age 18-60 years presenting to the hmc for medical care (except exclusions as noted below) * ability to provide informed consent. additional inclusion criteria for intervention: past 3-month use of illicit drugs or misuse of psychoactive prescription drugs exclusion criteria: * patients who do not understand english (less than 1% in our prior work) - * prisoners * patients classified by medical staff as "level 1 trauma" (e.g., unconscious, intubated on respirators, in need of immediate lifesaving procedures such as surgery) * patients deemed unable to provide informed consent as stated above (e.g., intoxication, mental incompetence) * patients treated in the ed for suicide attempts or sexual assault
quantification of cannabinoids and comparison to post-surgical pain medication requirements and surgical outcomes

Conditions: Post-Surgical Pain; Post-Surgical Complication; Cancer; Cannabis Use

Summary: to determine how daily cannabis use affects surgical outcomes.

to determine if patients who are daily cannabis users that are undergoing inpatient abdominal surgery for the treatment of cancer are different from non-cannabis users regarding phytocannabinoid and endocannabinoid levels, pain scores, pain medication requirements, and surgical complications.

Eligibility criteria:
inclusion criteria: * patients \> 18 years old * undergoing abdominal surgery for the treatment of cancer * report no cannabis use in the last year or chronic cannabis use (defined as at least weekly use for 3 months or more) exclusion criteria: * patients with chronic pain, chronic pain syndrome on opioids * female patients who are pregnant or lactating * patients who report use of illicit substances

Keywords: cannabis post-surgical complications post-surgical pain abdominal surgery
a randomized, double blind, placebo-controlled study to evaluate the efficacy of lavandula angustifolia containing nasal spray medical device in preventing deterioration of covid-19 in symptomatic patients

Conditions: COVID-19 Infection

Summary: a nasal spray device containing dead sea minerals and plant extracts, used to shorten duration and mitigate effects of covid-19 infection in mild to moderate adult patients

a nasal spray device containing dead sea minerals and plant extracts, designed to incur a ppar-alpha agonistic effect, used to shorten duration and mitigate effects of covid-19 infection in mild to moderate adult patients

Eligibility criteria:
inclusion criteria: having tested positive to covid-19 on pcr test - exclusion criteria: pregnancy low blood pressure on immune system suppressing medications -