Kornimate/medical-research-clean huggingface dataset:
copeptin serum level in liver transplant recipients

Conditions: Liver Cirrhosis; Copeptin; Liver Transplant

Summary: the study aim is to measure perioperative copeptin concentration in blood of liver transplant recipients and to assess whether there is a correlation between its level and hemodynamic derangement.


Eligibility criteria:
inclusion criteria: - patient undergoing liver transplantation exclusion criteria: * serum creatinine \> 1,5 mg/dl * retransplantation * patient refusal * crrt or dialysis preoperatively
photodynamic therapy (pdt) effect on large surface photodamaged skin

Conditions: Actinic Keratosis; Photoaging; Solar Elastosis

Summary: in this study, 26 patients were selected and included for full-face photodynamic therapy sessions. all patients presented signs of photoaging skin and multiple actinic keratosis. photographs and biopsies were taken before and after the procedure. clinical and histological aspects as well as immunohistochemical aspects regarding neocollagen induction and tumor expression were evaluated.

study design: patients and methods: 26 patients (16 females, 8 males) age 35-90 years, mean 59,4 y skin types i-iv, severely photodamaged facial skin multiples aks on the face ( total 268) minimum of 3 per patient approved by local ethical committee and informed consent given treatment procedure: prior curettage full-face mal application ( metvix ®, galderma france) 1,5 tube per treatment incubation time 3 hs - in the first treatment session; and 1,5 h - in the 2 nd and 3 rd sessions illumination led (aktilite® photocure, norway) 635 nm 37 j/cm2 3 treatments performed, one month apart pain monitoring: forced air cooling device evaluation: clinical - 5 point scale based on dover's and zane's studies dover js et al. topical ala combined with ipl in photoaging. arch dermatol 2005; 141: 1247-52 zane et al. clinical and echographical analysis of mal- pdt in photodamaged skin. laser surg med 2007; 39: 203-9 histological - hematoxilin- eosin staining immunohistochemical study- hp 53, metalloproteinases, procollagen i,

Eligibility criteria:
inclusion criteria: * patients with severe photodamage and at least 3 actinic keratosis on the face exclusion criteria: * pregnancy, laser, chemical peel, imiquimod or 5-fu treatment in the last year
colonization of the female urethra with mycoplasma hominis, ureaplasma urealyticum, chlamydia trachomatis, or neisseria gonorrhea in patients with lower urinary tract symptoms

Conditions: Overactive Bladder Syndrome

Summary: the purpose of this study is to assess the prevalence of mycoplasma hominis, ureaplasma urealyticum, neisseria gonorrhea, and chlamydia trachomatis in women with overactive bladder symptoms, and to correlate these findings with cystoscopic and urodynamic findings.


Eligibility criteria:
inclusion criteria: * women with urogynecologic and urodynamic examination at our institution between 1.1.2009 and 31.12.2011 exclusion criteria: * none
a study to determine safety and efficacy of (remd-477) in controlling hyperglycemia due to copanlisib

Conditions: Hyperglycemia Drug Induced

Summary: remd-477 (volagidemab) is a human anti-glucagon receptor antibody. its proposed mechanism of action in controlling hyperglycemia is by blocking glucagon receptor (gcgr) signaling. in this way, it increases hepatic glucose uptake, decreases hepatic glycogenolysis and gluconeogenesis, increases glycogen synthesis, and ultimately decreases blood glucose levels. this protocol will test the hypotheses that remd-477 is safe and tolerable in patients with severe hyperglycemia on copanlisib and that it decreases the risk of severe hyperglycemia in patients receiving copanlisib for relapsed refractory lymphoma


Eligibility criteria:
inclusion criteria: * age 18 or older * relapsed or refractory lymphoma (grade 1, 2, 3a) * received 2 or more prior lines of systemic therapy for lymphoma * experienced glucose \>250 mg/dl after copanlisib infusion for treatment of lymphoma exclusion criteria: * evidence of histologic transformation * follicular lymphoma grade 3b * active cns involvement by malignancy * elevated ast or alt \> 5x uln at screening * unmanageable sensitivity to mammalian-derived drug preparations, or to humanized or human antibodies; managed sensitivities to agents such as obinutuzumab or rituximab or similar agents are not exclusionary * history of drug or alcohol abuse within the last 6 months * history or family history of pancreatic neuroendocrine tumors or multiple endocrine neoplasia * history or family history of pheochromocytoma * other gastrointestinal, cardiac, renal and cns (i.e. hypoglycemia unawareness) conditions specific to diabetes that would pose additional risk to subject's safety or interfere with the study evaluation, procedures or completion in the opinion of the treating physician. * female subject is pregnant or breastfeeding.

Keywords: hyperglycemia lymphoma anti-glucagon receptor antibody glucagon receptor volagidemab
an investigation of light therapy for cancer-related fatigue (the lite study)

Conditions: Cancer

Summary: cancer-related fatigue is one of the most common and distressing symptoms associated with a cancer diagnosis.fatigue related to cancer often appears before a diagnosis, worsens during treatment, and lasts for years after treatment in up to 35% of patients. despite the long-term effects of cancer-related fatigue, the treatment options available are not always appropriate or helpful for all patients.light therapy is an effective treatment for other disorders related to fatigue. the purpose of the study is to investigate the role of light therapy on quality of life, sleep patterns, and physical measures of immune function and stress hormones in individuals with post-treatment cancer-related fatigue.


Eligibility criteria:
inclusion criteria: * english speaking * non metastatic cancer * at least 3 months post chemotherapy/radiation treatment (hormone treatment ok) * meets criteria for cancer-related fatigue exclusion criteria: * under 18 years of age * presence of a sleep disorder other than insomnia or hypersomnia * shift work * presence of an axis-i psychiatric condition * presence of a medical condition that may impact levels of fatigue * presence of conditions contraindicated to the use of light therapy or photosensitizing medications * randomization refusal

Keywords: fatigue sleep quality of life light cancer
oto smartphone app in treating tinnitus amongst adult patients compared with standard talking therapies

Conditions: Tinnitus

Summary: a study that looks at treating tinnitus and its associated burden, insomnia and quality of life effects with a smartphone app when compared with the talking therapies already offered on the national health service. three separate questionnaires will be used to collect this data from patients at regular time intervals.

single-site randomised controlled study looking at tinnitus burden, insomnia severity and quality of life in adults with chronic primary subjective tinnitus when using oto smartphone app compared with national institute for health and care excellence (nice) approved tinnitus retraining therapy. this will be assessed objectively through questionnaires at the baseline meeting, one month, three months and six months.

Eligibility criteria:
inclusion criteria: * adult patients (male or female) aged over 18 years of age presenting to nhs ent and hearing services with primary non-pulsatile tinnitus irrespective of hearing. * patients must be suffering from tinnitus for a minimum of 3 months * patients that have a willingness to use as well as have access to a smartphone device capable of running oto. * willing and able to provide written informed consent. * those that would be offered tinnitus retraining therapy (trt) as management for their primary tinnitus exclusion criteria: * patients with secondary tinnitus as confirmed by magnetic resonance imaging (mri). * patients undergoing any other tinnitus therapies concurrently (including hearing aids / implants). previous tinnitus therapies including cbt in the past are accepted. * patients who are not willing to use the app due to not having a suitable phone to download the application or due to own limitations in working oto.

Keywords: tinnitus therapeutics telemedicine outcomes otology otolaryngology
effects of a health belief model-based community educational program to increase the awareness of atrial fibrillation among older adults: a randomized controlled trial

Conditions: Atrial Fibrillation (AF)

Summary: the goal of this study is to evaluate the effects of a theory-based community educational program among older adults in the community on atrial fibrillation (af) knowledge. it will also learn about their competency to detect irregular pulses and compliance to regular pulse check. the main questions it aims to answer are: do older adults in the community who received the health belief model-based educational program have higher af awareness? researchers will compare the educational program with the control, who receive an information leaflet about af to see the effect on improving af awareness. participants will: receive a 5-week health belief model-based educational program or receive an information leaflet about af. be reassessed immediately post-intervention and 3 month afterwards. keep a logbook on their compliance to the advice of regular pulse palpation to detect af pulse .


Eligibility criteria:
inclusion criteria: * adults aged 65 or older * without a confirmed diagnosis of af exclusion criteria: * cannot read chinese * with cognitive impairment (abbreviated mental test ≤ 6) * physical limitations in performing pulse palpation
optical coherence tomography in multiple sclerosis patients

Conditions: Multiple Sclerosis; Optic Neuritis

Summary: to evaluate the ability of different spectral domain optical coherence tomography (oct) devices, as well as different acquisition and analysis packages, to detect disease progression in patients with multiple sclerosis with and without a history of optic neuritis

optical coherence tomography imaging of the retina has been shown to be an effective non invasive method to study retinal changes associated with multiple sclerosis induced optic neuritis. the retina is a unique structure in that it is an unmyelinated part of the central nervous system (cns). however, it is uncertain which layer of the retina provides the best correlation with ms disease. the investigators propose a prospective, case-control study to compare oct measurements from different parts of the retina of ms patients with optic neuritis, those without optic neuritis, and healthy controls. the investigators will then correlate the oct measurements to clinical measures of disease. this will allow future studies to use oct technology as a primary outcome in studying ms axonal and cell body injury of the cns, as well as evaluating strategies in treating ms.

Eligibility criteria:
inclusion criteria (ms with acute optic neuritis group): * history of unilateral optic neuritis as a manifestation of multiple sclerosis. * age between 18 and 65, inclusive. * ability to perform adequate oct exam. * able to provide informed consent to participate in study. exclusion criteria (ms with acute optic neuritis group): - refractive error greater than ±6 diopters. inclusion criteria (ms without acute optic neuritis group): * history of multiple sclerosis without optic neuritis * age between 18 and 65, inclusive. * ability to perform adequate oct exam. * able to provide informed consent to participate in study. exclusion criteria (ms without acute optic neuritis group): - refractive error greater than ±6 diopters. inclusion criteria (healthy controls): * age between 18 and 65, inclusive. * ability to perform adequate oct exam. * able to provide informed consent to participate in the study. exclusion criteria (healthy controls): * prior history of neurological disease. * first degree relative with ms. * refractive error greater than ±6 diopters.
dose response effect of probiotics for the prevention of antibiotic-associated diarrhea in chinese adults

Conditions: Antibiotic-associated Diarrhea

Summary: the purpose of this study is to determine the dose response effect of probiotic capsules for the prevention of antibiotic-associated diarrhea (aad).


Eligibility criteria:
inclusion criteria: * age 30-70 years * initiating antibiotic therapy * informed consent exclusion criteria: * current diarrhea * life threatening illness * habitual probiotic use

Keywords: antibiotic diarrhea probiotic
a study of azd2936 anti-tigit/anti-pd-1 bispecific antibody in participants with advanced or metastatic nsclc

Conditions: Non-Small-Cell Lung Carcinoma

Summary: this is a phase i/ii study designed to evaluate if experimental anti-tigit/anti-pd-1 bispecific antibody rilvegostomig (azd2936) is safe, tolerable and efficacious in participants with advanced or metastatic non-small cell lung cancer.

this is a first-time-in-human (ftih), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (pk), pharmacodynamics, and efficacy of rilvegostomig (azd2936) in adult participants with stage iii unresectable or stage iv nsclc. the study includes 4 parts: part a (dose escalation) and parts b-e (dose expansion).

Eligibility criteria:
inclusion criteria: * written informed consent * aged 18 or above * part a and part b: unresectable stage iii or stage iv squamous or non-squamous nsclc not amenable to curative surgery or radiation. part c and part d: stage iv squamous or non-squamous nsclc not amenable to curative surgery or radiation. part e: stage iv squamous nsclc not amenable to curative surgery or radiation. * documented pd-l1 expression by pd-l1 ihc per local report. * part a and part b: confirmed progression during treatment with a cpi-including regimen. * part c and part d: no prior i/o treatment for metastatic nsclc. * part e: no prior treatment for metastatic nsclc. * ecog performance status of 0 or 1 at enrolment. * life expectancy of ≥ 12 weeks at enrolment. * have at least 1 measurable lesion per recist v1.1. * adequate bone marrow, liver and kidney function exclusion criteria: * sensitizing epidermal growth factor receptor (egfr) mutations or anaplastic lymphoma kinase (alk) fusion * documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ros1, ntrk fusions, braf, v600e mutation) * previous treatment with an anti-tigit therapy * any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment. * part a and part b: primary or secondary resistance after treatment with 2 or more regiments including a cpi. * part c and part d: any prior systemic treatment with an immune oncology agent (prior administration of immune-oncology agent for curative intent to treat other invasive malignancy is permitted). treatment with one previous systemic chemotherapy will be allowed. * part e: any prior systemic treatment for metastatic nsclc, including but not limited to chemotherapy, anti-pd-1, anti-pd-l1, anti-ctla-4. * symptomatic central nervous system (cns) metastasis. * thromboembolic event within 3 months prior to enrolment. * other invasive malignancy within 2 years prior to screening.

Keywords: tigit, anti-tigit pd-1, anti-pd-1 nsclc, non-small cell lung cancer advanced, metastatic, solid tumor, solid tumour stage 3 nsclc, stage iii nsclc stage 4 nsclc, stage iv nsclc pd l1+ tumors
effect of cancer nurse navigators on patient outcomes

Conditions: Lung Cancer; Breast Cancer; Colorectal Cancer; Prostate Cancer

Summary: there is widespread anecdotal evidence that cancer nurse navigators (cnns) are highly valued by cancer patients, but no studies have evaluated the effects of cnns on important patient-reported outcomes or indicators of quality of care. this study has two aims: 1. to assess the feasibility of studying the impact of aurora cnn program. 2. to pilot test the effects of cnn services on patient-reported outcomes and indicators of quality of care.


Eligibility criteria:
inclusion criteria: 1. adult (18 years of age or older) 2. treated at aurora st. luke's or west allis medical center 3. new or recurrent dx of lung, prostate, colorectal or breast cancer - exclusion criteria: 1. previously received cnn services at an aurora treatment facility 2. unable to read/write in english 3. living in a nursing home/long term care facility 4. not capable of completing study questionnaires -

Keywords: nurse navigator satisfaction with care quality of life symptom distress
international registry for primary hyperoxaluria

Conditions: Primary Hyperoxaluria; Nephrocalcinosis; Kidney Stones

Summary: the purpose of this study is to collect medical information from a large number of patients in many areas of the world with primary hyperoxaluria. this medical information will be entered into a registry to help the investigators compare similarities and differences in patients and their symptoms. the more patients that the investigators are able to enter into the registry, the more the investigators will be able to understand primary hyperoxaluria and learn better ways of treating patients with this disease. it is the investigators hope that by entering as many patients with ph as possible, the information that the investigators collect may help physicians diagnose patients sooner and determine what treatments may work best on patients with similar medical or genetic backgrounds.

this study involves the collection of medical information to create a computer database (registry) for patients with ph. the information will be entered into the registry by your physician, healthcare provider or a staff member of the mayo clinic hyperoxaluria center. the computer web site for the registry is secure and protected by a required password. some information which will be entered may include your age at first symptoms of ph,kidney stone history, lab values, kidney function, and your health over time. information for a patient can only be viewed by the appropriate physician and staff. once the information is entered into the registry, you will only be identified by a code number.

Eligibility criteria:
inclusion criteria: * liver biopsy or genetic analysis that confirms a diagnosis of hyperoxaluria * in the absence of a liver biopsy: * urine oxalate excretion of \>0.8 mmol/1.73 m² /day without other causes such as enteric hyperoxaluria * family history of ph in a sibling will be supportive * a history or current finding of kidney stones or nephrocalcinosis will be supportive * an increase in urine glycolate may suggest phi or an increase in urine l-glycerate may suggest phii, though not required for diagnosis. * patients presenting in renal failure with an elevate pre-dialysis plasma oxalate of 60 umol/l and a kidney biopsy that confirms extensive oxalate deposition, or evidence of systemic oxalosis exclusion criteria: * patients without any of the above or a confirmed diagnosis of ph

Keywords: ph primary hyperoxaluria type i type ii noni-nonii kidney stones oxalate oxalosis
seretide vs flixotide in mild persistent asthma (ginaii)

Conditions: Asthma

Summary: an 18 months randomised double-blind study with two parallel arms with start dose of inhaled seretide 50/100mcg bd or flixotide 100mcg bd, phase i is 6 months where the patient will be up-titrated until well controlled is achieved, after 6 months the treatment continues without changes during 9 months = phaseii. the aim is to investigate and evaluate the assumption that the combination therapy with seretide controls mild persistent asthma better than inhaled corticosteroids(flixotide) alone.


Eligibility criteria:
inclusion criteria: * willing to give informed consent. * males or females aged 18-70. * able to understand and complete dairy cards. * mild persistent asthma according to gina. in addition, at randomisation subjects were required to have: 1. day time symptoms more than once a week but not every day. 2. night-time symptoms not more than once a week. 3. fev1 \>80% predicted 4. pc20 \<8mg/ml exclusion criteria: * change to regular asthma medication in 4-weeks prior to visit 1. * use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1. * lower respiratory tract within 4 weeks of visit 1 * received investigational study drug within 4 weeks of visit * smoking history of \>10 pack years of more. * serious uncontrolled disease. * medical conditions or medications known to affect the assessments or endpoints. * evidence of alcohol or drug abuse. * known pregnancy or planned pregnancy. * known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose. * previous enrollment in the study

Keywords: asthma exacerbation persistent bronchial hyperresponsiveness mild ginaii
prospective study to validate the clinical accuracy of the norbert device to measure pulse rate

Conditions: Healthy; Arrhythmia

Summary: the study will evaluate the mean average error (mae) of measuring pulse rate using the norbert device (nd) as compared to a reference heart rate measured using an electrocardiogram (ecg).

the study design is to validate the pulse and heart rate accuracy as required per iso 80601-2-61, clause 201.12.1.104. the study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the nd's pulse rate measurement compared to a reference heart rate manually measured by observing r-peaks in a standard concurrently recorded ecg from an fda 510(k)-cleared reference clinical ecg (rcecg). the sponsor will ensure that the study staff enrolls a range of types of arrhythmias including tachycardia, bradycardia, atrial fibrillation, bigeminy, trigeminy, and others.

Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 or over * ability to provide signed informed consent exclusion criteria: * pregnant * otherwise deemed unsuitable to participate in the study based on judgment of the study investigator

Keywords: medical device validation arrhythmia ecg pulse rate norbert device norbert health