Kornimate/medical-research-clean huggingface dataset:
an evaluation of safety and efficacy of anecortave acetate versus placebo in patients with subfoveal cnv due to exudative amd

Conditions: Macular Degeneration; Maculopathy, Age-Related

Summary: the purpose of this study is to demonstrate that anecortave acetate is superior to placebo in maintenance of visual acuity at the 12- and 24-month visits.


Eligibility criteria:
patients at least 50 years of age, of any race, and either sex with a clinical diagnosis of exudative amd and a primary or recurrent subfoveal cnv lesion in the study eye.

Keywords: amd anecortave acetate wet amd age-related macular degeneration macular degeneration maculopathy, age-related age-related maculopathies age-related maculopathy maculopathies, age-related
wear-time trial for self-fitting hearing aid

Conditions: Hearing Loss, Sensorineural

Summary: this document describes a clinical validation study for a double-blind repeated-measures comparative study of the great nordic (gn) self-fitting method to a validated audiology-best-practices method when fitting the gn self-fitting hearing aid, a device intended for persons aged 18-75 years old who have mild-to-moderate hearing loss. a crossover wear-time field trial will be conducted. the focus of the study is on the validity of the self-fitting process used to select appropriate frequency-gain characteristics for the gn self-fitting hearing aid, and the safety and effectiveness of the device.


Eligibility criteria:
inclusion criteria: * mild-to-moderate bilateral sensorineural hearing loss (thresholds from 250 - 8000 hz less than 60 decibels hearing level (db hl) and from 2000 - 8000 hz, at least one threshold greater than 20 db hl) * mix of male and female subjects (aiming for a representative balance) * mix of prior hearing-aid use (aiming for 70-80% persons with no prior hearing aid use) * 18-75 years old (aiming for primarily 50-70 years old, with avg. age \~65 years) * apple iphone (ios 14 compatible or greater, as required for the self-fit app) * able to read and comprehend english * patient willing to provide informed consent exclusion criteria: * hearing outside of limits noted above * self-reported ear-related pathology (including chronic severe dizziness or chronic severe tinnitus)
self-efficacy in weight loss treatment

Conditions: Overweight; Obesity

Summary: this randomized clinical trial of weight loss treatment will examine if adding personalized, one-on-one treatment session to standard behavioral group treatment will result in greater weight loss, less weight regain after weight loss, and better adherence to the treatment protocol. everyone who enrolls in the study will receive information on healthy eating, how to increase their physical activity and develop healthy exercise habits and ways to change their eating so that they will lose weight. this information will be provided at evening group sessions. there will be a total of 20 group meetings over an 18-month period that will be held: * every week during the first month of the study, * every other week for the second month * once a month for months 3-12 * every 6 weeks for months 13-18 participants in the self-efficacy group will also be asked to participate in one-on-one lifestyle counseling sessions with a study interventionist throughout the study. everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the phone, and have blood tests done every six months (at the beginning of the study, at 6, 12, and 18 months) a total of 4 times for the study.


Eligibility criteria:
inclusion criteria: * age 18 years or older * bmi \> 27 and \< 43 * willing to be randomized to one of the two treatment conditions * successful completion of screening requiring 5-day recording of food intake in a paper diary * have at least two risk factors for coronary heart disease, e.g., overweight or obese, hypertension, dyslipidemia, positive family history (first degree relative) note: although residing in western pennsylvania is not an explicit eligibility criterion, participants are asked to travel to the university of pittsburgh frequently (weekly for the first month) exclusion criteria: * presence of a current serious illness or unstable condition requiring physician-supervised diet and exercise (e.g., diabetes, recent acute myocardial infarction) for which physician supervision of diet and physical activity prescription is needed * physical limitations precluding ability to engage in physical activity at moderate intensity * pregnancy or intention to become pregnant in the next 18 months * current treatment for a psychological disorder * reported alcohol intake \> 4 drinks/day * previous participation in a formal weight loss program within the past 5 years, e.g., weight watchers or a research program, or current use of weight loss medication * planned extended vacations, absences, or relocation within the next 18 months

Keywords: overweight obesity self-efficacy treatment adherence
effect of ketanserin after lsd administration

Conditions: Healthy

Summary: lsd (lysergic acid diethylamide) is a serotonergic (5-ht) hallucinogen widely used for recreational and/or ethnomedical purposes. lsd is thought to induce its prototypical psychedelic effects primarily via stimulation of the 5-ht2a receptor. this study investigates whether an lsd experience can be attenuated and shortened using 5-ht2a receptor antagonist ketanserin administration after lsd once the psychedelic effects have established.

lsd is a so-called "classic" or serotonergic hallucinogen or psychedelic.the effects of lsd have been frequently investigated in the past in both healthy participants and patients. in these studies, lsd produced acute transient alterations in waking consciousness including visual perceptual alterations, audio-visual synesthesia, derealization and depersonalization. moreover, several of these studies described robust and sustained effects of lsd in patients suffering from addiction, anxiety and depression. its psychedelic effects are mainly attributed to its potent partial 5-ht2a receptor agonism. consistently, administration the 5-ht2a receptor antagonist ketanserin (40 mg) prior to the administration of lsd (100 μg) almost completely prevented the acute effects of lsd in another study of our research group (nct03321136). the present study hypothesis is that ketanserin (40 mg) administered 1h after lsd shortens and reduces the acute subjective effects of lsd (100 μg) compared to lsd alone (100 μg) followed by placebo in healthy humans. such a finding would confirm a primarily competitive antagonism of ketanserin and lsd at the 5-ht2a receptor in vivo and indicate that lsd produces its psychedelic effects only when present at the receptor.

Eligibility criteria:
inclusion criteria: 1. age between 25 and 65 years old 2. sufficient understanding of the german language 3. understanding of procedures and risks associated with the study 4. willing to adhere to the protocol and signing of the consent form 5. willing to refrain from the consumption of illicit psychoactive substances during the study 6. abstaining from xanthine-based liquids and foods from the evenings prior to the study sessions to the end of the study days 7. willing not to operate heavy machinery within 48 hours after substance administration 8. willing to use double-barrier birth control throughout study participation 9. body mass index between 18-29 kg/m2 exclusion criteria: 1. chronic or acute medical condition 2. current or previous major psychiatric disorder 3. psychotic disorder or bipolar disorder in first-degree relatives 4. hypertension (\>140/90 mmhg) or hypotension (sbp\<85 mmhg) 5. hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months 6. pregnancy or current breastfeeding 7. participation in another clinical trial (currently or within the last 30 days) 8. use of medication that may interfere with the effects of the study medication 9. tobacco smoking (\>10 cigarettes/day) 10. consumption of alcoholic beverages (\>20 drinks/week)
effect of mtx discontinuation on shingrix response in ra

Conditions: Rheumatoid Arthritis

Summary: the goal of this clinical trial is to learn if methotrexate discontinuation affect on immunogeneity of shingrix in ra patients. the main questions it aims to answer are: discontinuation of methotrexate after shingrix immunization increase efficacy of the vaccine in patients with ra ? researchers will compare humoral and cell-mediated immunity against herpes zoster in ra patients who are vaccinated by shingrix, and compare these immunity between ra patients with mtx discontinuation and mtx continuation groups. participants will: vaccinated with shingrix twice. mtx continuation group will keep taking mtx after shingrix vaccination, whereas mtx discontinuation group will stop mtx for 2 weeks after shingrix vaccination. visit the clinic at baseline (first shingrix vaccination), 2 months later for 2nd shingrix vaccination, then 3 \& 6 months later from baseline to achieve blood sample.


Eligibility criteria:
inclusion criteria: * fulfill 2010 acr/eular classification criteria for rheumatoid arthritis * age over 19 years * methotrexate user * agree for vaccination with shingrix exclusion criteria: * have other form of inflammatory arthritis or autoimmune-mediated disease * malignancy, current infection, pregnancy

Keywords: herpes zoster shingrix methotrexate
volatilomic approaches for the study of cftr modulators (volatil-cf)

Conditions: Cystic Fibrosis

Summary: this study relies on the hypotheses that (1) exhaled breath is intimately correlated to the patient's lung condition and that (2)the composition of exhaled breath , i.e. the vocs profile, will be significantly modified from the first days of treatment by cftr modulators in a or pauci/symptomatic patients such as young children under 12 years old. the non-invasive and longitudinal collection and analysis of exhaled breath may reveal modifications in signaling pathways impacted by these treatments on the very short term. this study is a single-center pilot study.

this is a single-center prospective cohort study that plans to include 20 children with cystic fibrosis aged 6 to 12 years old who will initiate kaftrio® in early 2023. the children will be monitored for one month; three visits are planned as part of routine care (before initiation of treatment, in the course of the first week and after one month of treatment) during which exhaled breath collection and analysis will also be performed. access to clinical data collected throughout routine follow-up of these children (analysis of induced sputum, urine and blood, sweat test, respiratory function tests) will be granted upon patient/parent authorization.

Eligibility criteria:
inclusion criteria: * patients with cystic fibrosis initiating kaftrio® treatment. * patients and holders of parental authority not opposing participation in this research. * patients affiliated to a health insurance system or beneficiaries. exclusion criteria * patients deprived of liberty or under guardianship. * pregnant or breastfeeding patients. * lung transplanted patients.

Keywords: cystic fibrosis volatile organic compounds (voc) exhaled breath cftr modulators
a patient-directed mobile tool to streamline the qol assessment and monitoring in urothelial carcinoma

Conditions: Urothelial Carcinoma (UC)

Summary: the goal of this observational study is to select contents and tools for the future development of a web app aiming to support patients' navigation for empowering decision-making through a higher awareness of urothelial carcinoma and its treatments, improving also educational aspects. the main question it aims to answer is: what are the contents that patients diagnosed with urothelial carcinoma find useful to include in a web app to streamline their quality of life assessment and monitoring? participants candidate for systemic treatments, or already under treatment, will answer questionnaires about the tools to include in a web app designed for urothelial carcinoma.


Eligibility criteria:
inclusion criteria: * histological diagnosis of urothelial carcinoma; * ≥ 18 years old, * candidate for systemic treatment with chemotherapy, immune-checkpoint inhibitors, antibody-drug conjugates, or target therapy (patients can be enrolled also if the treatment has started), * possession of a mobile device (e.g., smartphone or personal computer) with the physical and psychological ability to use mobile devices, * understanding and speaking the italian language, * ability to sign an informed consent. exclusion criteria: * not possession of a mobile device, * unwillingness to give informed consent.

Keywords: quality of life self-education educational urothelial carcinoma web-app mobile tool design-thinking
the reach intervention for caregivers of veterans and service members with tbi

Conditions: Traumatic Brain Injury; Caregiver

Summary: this randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called resources for enhancing all caregivers' health - traumatic brain injury (reach tbi) to decrease caregiver strain (primary outcome) and improve caregiver self-efficacy, anxiety, depression, and health care frustrations (secondary outcomes). this study will modify and adapt an award-winning caregiver intervention, resources for enhancing all caregivers health in the department of veterans affairs (reach va), to support the needs of caregivers of veterans and service members with tbi.


Eligibility criteria:
inclusion criteria: to be eligible for the study, the participant must: * identify as a primary caregiver for a v/sm who sustained a tbi at least 6 months prior; * identify as a primary caregiver who has provided care for a v/sm with tbi for at least 6 months; * provide some level of daily supervision or assistance with either a physical, cognitive, or behavioral issue they think is likely related to tbi; * believe that at least half of their caregiving responsibilities are likely related to tbi rather than another health condition(s); and * endorse a score of at least high burden (a score of 8 or higher) on the zarit burden inventory-4. exclusion criteria: * no telephone; * current diagnosis of schizophrenia or other major mental illness; * auditory impairment that would make telephone use difficult; or * the caregiver believes that more than half of their caregiving for the v/sm is for issues related to another health condition(s) rather than tbi.
quintex® follow-up after one year minimum

Conditions: Degenerative Disc Disease; Spondylolisthesis; Trauma; Spinal Stenosis; Deformity of Spine; Pseudoarthrosis of Spine; Cervical Spondylosis; Instability; Back

Summary: prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the first thoracolumbar vbr (c2-t1), who received a quintex plate for stabilisation


Eligibility criteria:
inclusion criteria: - all patients who received a quintex® anterior cervical plate since 2014 until approx. end 2018 (minimum follow-up is one year) in the study center exclusion criteria: * patient informed consent not signed * patients living outside a radius of 80 km around the study center
lactoferrin effect on kidney and heart of rhabdomyolysis rats

Conditions: Rhabdomyolysis

Summary: this study focuses on detecting the possible beneficial effect of lactoferrin (lf) administration on the kidney and the heart of glycerol-induced rhabdomyolysis (rm) in rats and its relation to ferroptosis and ampk/nrf2/ ho-1 signalling pathway. the main questions it aims to answer are: 1. is lf administration 30 min. before or after rm induction in rats beneficial to kidneys and heart? 2. when administered to glycerol-induced rats, does lf act by upregulating the ampk/nrf2/ ho-1 signalling pathway and inhibiting ferroptosis?


Eligibility criteria:
inclusion criteria: * • twenty-four healthy male wistar albino rats weighing from 250 to 300 g exclusion criteria: * no exclusion criteria as this study is used to detect effects of drugs on experimental rats.
goal directed haemodynamic treatment for patients with proximal femoral fracture

Conditions: Femoral Fracture

Summary: the investigators aimed to compare the costs and consequences of 'routine perioperative fluid therapy' and 'gdht in terms of morbidity, mortality, length of hospital stay, activity of daily living, health related quality of life, cognitive functions and need of social services and up till 12 months following operations of proximal femoral fracture at elderly. the primary hypothesis is that 'gdht is a better strategy than 'routine fluid therapy' in terms of reduced frequency of postoperative complications.

the investigation is an open, randomized clinical study of individuals suffering from a proximal femoral fracture. the total study duration for each subject is approximately 12 months (+- 1 month); each patient will have 4'visits' (i.e. when pi extracts data to database) including regular praxis total: at registration; at discharge; 4 months and finally at 12 months after the surgery. for practical and logistic reasons, an interim-analysis will be conducted after approximately 100 patients whose data are completed.

Eligibility criteria:
inclusion criteria: * patients (men and women) age ≥ 70 years * patients´ scheduled for operation of proximal femoral fracture during office hours * patient who have a witnessed or written informed consent exclusion criteria: any of the following is regarded as a criterion for exclusion from the study: * concomitant medication with lithium * known allergy (or hypersensitivity) to lithium, or components of the medical device * weight ≤ 40 kg * other conditions or symptoms preventing the subject from entering the study, according to investigators judgment * life expectancy less than 6 months and/or pathological fractures * not possible to insert arterial line.

Keywords: proximal femoral fracture
acid-base compensation in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to evaluate changes in urine net acid excretion, blood pressure and body chemistry that occur when the dietary acid load is lowered by using a drug/dietary supplement similar to baking soda. this may be important for patients with kidney disease because they may have difficulty removing all of the dietary acid load from the body in the urine. participants with and without kidney disease will be recruited. each participant will be fed a controlled diet for one week with sodium bicarbonate and for one week without sodium bicarbonate to evaluate these changes. the investigators will also determine if the effect of dietary acid load reduction is different in patients with kidney disease compared to those without kidney disease.


Eligibility criteria:
inclusion criteria: * estimated glomerular filtration rate ≥30 ml/min/1.73m2 * serum bicarbonate 20-28 meq/l exclusion criteria: * diabetes mellitus * uncontrolled hypertension or recent (\<3 weeks) titration of blood pressure medications * clinically significant volume overload on screening physical examination * selected medical conditions other than kidney disease and hypertension (active cancer, chronic liver failure, moderate to severe copd, new york heart association class 2 or greater congestive heart failure, obstructive sleep apnea requiring nightly continuous positive airway pressure, solid organ transplant) * use of alkali supplementation * body mass index \ 40 kg/m2 * ideal body weight \<45.5 kg * anemia at screening (hematocrit \<29% in participants with kidney disease or \<33% in healthy participants) * pregnancy or breastfeeding * allergies, intolerance or unwillingness to consume foods or supplement provided in feeding menu * serum calcium less than 8.6 mg/dl on screening laboratories

Keywords: kidney diseases renal insufficiency, chronic dietary nonvolatile acid load blood pressure urine net acid excretion
laparoscopic nissen versus toupet fundoplication: objective and subjective results of a prospective randomized trial

Conditions: Gastroesophageal Reflux Disease; Laparoscopic Antireflux Surgery

Summary: the aim of this study is to compare subjective and objective outcome and surgical "side effects" of nissen and toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of gastroesophageal reflux disease * long history of gerd symptoms * persistent or recurrent symptoms despite optimal medical treatment * persistent or recurrent complications of gerd * reduced quality of life owing to increasing esophageal exposure to gastric juice * pathological values in the preoperative evaluated functional parameters exclusion criteria: * previous esophageal or gastric surgery * poor physical status (american society of anesthesiologists (asa) scores iii and iv) * pregnancy
avj ablation followed by resynchronization therapy in patients with chf and af

Conditions: Atrial Fibrillation; Congestive Heart Failure

Summary: the purpose of the study is to determine if the combination of avj ablation followed by biv pacing significantly improves functional status and exercise capacity compared to pharmacologic rate control in patients with chronic af and depressed ejection fraction, regardless of rate or qrs duration.

* this is a prospective, randomized, double blinded, multicenter study * patients meeting all the enrollment criteria are screened at enrollment and randomized to group 1 (pharmacological therapy + single chamber icd) or group 2 (avj ablation + crt-d) * screened patients are implanted with a fda approved sjm icd/crt-d with compatible lead system * patients are followed at 1, 3, 6 and 12 months post implant * total # of centers - 20 centers * sample size - 180 patients

Eligibility criteria:
inclusion criteria: * symptomatic permanent af * class i or ii indication for icd * lvef ≤ 35% within 6 months * nyha class ii or iii with a history of chf * maximal tolerated drug therapy for chf and rate control with a stable regimen for ≥ 30 days * ability to independently comprehend and complete a qol questionnaire * ability to give informed consent for study participation and willingness and ability to comply with prescribed follow-up tests and scheduled evaluations exclusion criteria: * paroxysmal or persistent af * class i indication for pacing (including avj ablation for poor rate control) * ability to walk ≥ 450 meters in 6 minutes * musculoskeletal disorders that prohibit the completion of a 450 meters walk * nyha class i or iv at the time of enrollment * a contraindication to taking coumadin therapy * history of myocardial infarction, percutanous coronary intervention, or cabg in the past 30 days * history of mitral valve surgery * prior attempts for cardiac resynchronization therapy * the presence of an existing coronary sinus lead or epicardial lead * life expectancy \< 1year * age \< 18 yrs * current participation in other clinical studies except registry trials * use of calcium channel blockers * pregnancy * inability to give informed consent