Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of high protein diet versus gfr based protein diet in heart failure patients with renal insufficiency

Conditions: Heart Failure With Reduced Ejection Fraction; Renal Insufficiency

Summary: effect of high calorie high protein diet versus high calorie,glomerular filtration rate (gfr) based protein intake in non-obese advanced hf patients will be assessed. in this regard, protein intake impact will be measured on muscle mass, physical performance and renal function as main outcome. rehospitalization, quality of life, depression an inflammatory status are second endpoints.

patient examinations: baseline data will be gathered on demographic and clinical characteristics, medical history, treatments and medications. before initiating intervention, individuals will be assessed for anemia and 25 (oh) d2 and electrolytes status. any insufficiency or imbalance will be corrected by drug therapy or supplementation. at baseline and at all visits, half or one month intervals, routine laboratory tests for heart failure patients (including complete blood count (cbc), electrolytes status, glucose, albumin, cholesterol, triglyceride, blood urea nitrogen (bun), c-reactive protein (crp),creatinine, uric acid, ferritin, 25 (oh) d, b-type natriuretic peptide (bnp), thyroid function, prealbumin, urine analysis), appetite status and anthropometric measurements (weight, hip and waist circumference) will be performed. at baseline and by the end of month 6, body composition, muscle mass, hand grip strength, short physical performance battery (sppb), plasma lactate and interleukin 6 (il-6), gfr, depression status and quality of life will be assessed. follow up duration will be one year for measuring readmission and mortality rate. if a study participant did not attend a visit, a staff of randomized clinical trial (rct) center will attempt to reach her/him, her/his designated friend or family member by phone call.

Eligibility criteria:
inclusion criteria: * advanced hf patients class iii in new york heart association (nyha) based on european society of cardiology (esc) definition * hand grip strength less than normal for age, * age \>18 years, * glomerular filtration rate (gfr) 30-90, * bmi \ 2 standard deviations (sds) below mean in individuals aged 18-39 y in the nhanes iii cohort. exclusion criteria: * respiratory failure, * ventilator dependence, * dialysis treatment, and sepsis, * open abdominal surgery within 6 weeks prior to enrolment, * diseases or conditions that might change the calorie and macronutrients requirement.
an analysis of adverse events and satisfaction outcomes of women who underwent primary and secondary breast augmentation using silimed® breast implants with smooth surface

Conditions: Breast Implant; Complications; Quality of Life; Satisfaction; Safety and Performance

Summary: the study investigates the safety and performance of silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. the safety of the smooth-surfaced silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk/adverse event rates through patient reports of adverse events after implantation. the performance of using silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.


Eligibility criteria:
inclusion criteria: * provide written informed consent * female at birth * be 18 years of age or older * have a complaint of hypomastia * have an indication for breast augmentation with silicone implants * ability to comply with the protocol throughout the follow-up period. exclusion criteria: * replacement of breast implants due to a complication * breast reconstruction in at least one breast * informed pregnancy or breastfeeding at the time of inclusion * sequelae of mastopexy * ptosis requiring mastopexy * breast changes or lumps rated bi-rads 3 or higher on preoperative ultrasound or mammograms * advanced fibrocystic disease at the time of implantation * neoplasia of any type not yet treated or undergoing treatment at the time of implantation, - active infection not yet treated or undergoing treatment at any site at the time of implantation * report or record of adverse reactions or intolerance to silicone prior to implantation * report or record of immune diseases affecting the active or undergoing treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation * signs of inflammation of the breast or implant site at the time of implantation * increased risk of post-implantation complications -immediate surgical complications caused by illicit drug use or medication use * having participated in another clinical trial within 6 months prior to implant placement * any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, make study participation unsafe, compromise protocol adherence, complicate the interpretation of study outcome data, or otherwise interfere with the achievement of study objectives

Keywords: breast implant satisfaction qualify of life smooth surface post-market safety efficacy
a study of adrx-0706 in select advanced solid tumors

Conditions: Solid Tumors; Triple Negative Breast Cancer (TNBC); Urothelial Cancer; Cervical Cancer

Summary: the primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of adrx-0706 in patients with select advanced solid tumors.

this is a 2 part study. the phase 1a will consist of a dose escalation of adrx-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in the phase 1b. the phase 1b will further evaluate the safety and tolerability, as well as preliminary efficacy, and identify the optimal dose of adrx-0706 in patients with urothelial cancer, triple negative breast cancer, and cervical cancer.

Eligibility criteria:
inclusion criteria: * phase 1a dose escalation: subjects with histologically confirmed select advanced solid tumors, including urothelial carcinoma (uc), head and neck squamous cell carcinoma (hnscc), breast cancer, cervical cancer, ovarian cancer, non-small cell lung cancer (nsclc), and pancreatic cancer. subjects must have received at least one prior systemic regimen and have no other therapy available known to provide meaningful clinical benefit in the opinion of the investigator. * phase 1b dose expansion: subjects with urothelial cancer, triple negative breast cancer or cervical cancer with disease progression after at least one prior systemic regimen and no standard treatment options available and considered appropriate in the opinion of the investigator, unless subject refuses standard therapy. * measurable disease according to recist version 1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematologic, liver, and renal function exclusion criteria: * active and uncontrolled central nervous system metastases * significant cardiovascular disease * history of another malignancy other than the one for which the subject is being treated on this study within 3 years * receipt of any anticancer or investigational therapy within 5 elimination half-lives or 14 days (whichever is less) * any p-gp inducers/inhibitors or strong cyp3a inhibitors received within 14 days prior to the first dose of study drug * receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted

Keywords: urothelial cancer triple negative breast cancer cervical cancer adc
a phase i/ii study of cediranib (azd2171) in japanese metastatic colorectal cancer patients in combination with folfox

Conditions: Metastatic Colorectal Cancer

Summary: this study is in two parts, the first part is to make sure that combining a potential new treatment, cediranib (azd2171), with a standard treatment (folfox) for metastatic colorectal cancer is safe. once this part is complete and it is decided that it is safe to continue the study will the go on to look at the efficacy of the two drugs together. this will be done by studying two treatment options. one will be the standard treatment alone (folfox) + dummy cediranib (azd2171) tablets and the other will be the standard treatment (folfox) + real cediranib (azd2171) tablets. using dummy tablets means the study is 'blinded' and that non-one can tell the difference between the two treatment groups. this kind of study design is done to try to avoid the chance that the results might be biased in some way. the overall aim of the second part of the study is to see if adding cediranib (azd2171) to a standard treatment for metastatic colorectal cancer (mcrc), in this case folfox, gives better results. that is, it's better than giving standard treatment alone in helping to prevent progression of mcrc.


Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer * who performance status 0-1 * life expectancy is 12 weeks or longer exclusion criteria: * patient with uncontrolled brain metastases * patient with inappropriate laboratory tests values * patient with poorly controlled hypertension

Keywords: colorectal cancer recentin metastatic cancer folfox
dna double-strand breaks after spect

Conditions: Coronary Artery Disease

Summary: ionizing radiation has a number of harmful effects in humans. the most important among these is the induction of cancer. it is assumed that damage to dna in the nucleus of a single cell can induce cancer. among the different types of lesions inducted, dna double-strand breaks (dsbs) are considered to be the most relevant effects that can initiate carcinogenesis. the investigators are already conducting several other studies to prospectively compare the inducted dsbs by coronary ct-angiography and conventional coronary angiography. extending these examinations to investigate the induced dsbs by myocardial scintigraphy allows a comparison of all three relevant imaging methods of the heart that incorporate ionizing radiation. to evaluate this, the investigators are planning to examine patients who are scheduled for a clinically indicated myocardial scintigraphy. these examinations are routinely done by the department of nuclear medicine in either a 1-day or a 2-day protocol according to the diagnostic reference values of the federal department for radiological protection. blood samples will be taken from these patients at predefined time steps before and after the examination and dna double-strand breaks will be determined from these blood samples specifically considering the applied activity of the tracer and the exposition kinetics.


Eligibility criteria:
inclusion criteria: * myocardial spect clinically indicated exclusion criteria: * acute leukaemia or lymphoma * radiation or chemotherapy in the last 6 months * x-ray or scintigraphy within the last 3 days * age below 18 years * egfr of below 60 ml/min

Keywords: clinical indication for myocardial spect suspected or known coronary artery disease
the effect of anti-inflammatory analgesics on pain following hallux valgus surgery

Conditions: Postoperative Pain

Summary: the effects of none-steroidal anti-inflammatory drugs (nsaids) and selective cyclooxygenase inhibitors (coxibs) on the formation of bone and fracture healing have been a matter of debate since long. there is, however, limited data in humans and further prospective randomised studies are warranted. ekman et al studied in a prospective randomised double blind study the effects of celecoxib, a selective cox-ii-inhibitor, on pain and bone healing following spine surgery. they found significant effects on reduction of pain and need for opioid analgesics postoperatively but could see no negative effects the numbers of "none-unions" at a 1-year follow up 3. in a similar prospective randomised double-blind study design significant effects in reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative effects could bee seen on six month follow-up of the strength of the reconstructed ligament. the aim of the present study is to further study the effects of the perioperative use of etoricoxib, a selective cox-ii-inhibitor (coxibs), in a prospective randomised double-blind study on bone healing, pain and need for rescue analgesia in patients undergoing elective hallux valgus surgery with a standardised surgical technique including an osteotomy of metatarsale i and excision of exostosis. study population 100 american society of anesthesiology (asa) physiological status1-2 patients scheduled for elective hallux valgus (hv) surgery the patients are going to be randomised into 2 groups, 50 patients in each; 1. etoricoxib 90 mg once daily x 5 2. tramadol 100 mg twice daily x 5 first line rescue medication t. paracetamol 1 gr up to 4 gram daily second line rescue t. oxycodone 10 mg primary study variables: * x-ray evaluation (computer tomography (ct)-investigation) of bone healing assessed a ct-scan modelling of the osteotomy at twelve weeks after surgery * number of patients requiring rescue medication * patient assessment using "brief pain inventory" 24 hours and 2 weeks after surgery secondary study variables are; * visual analogue scale (vas) grading day 1-7 * compliance to base medication * need for rescue analgesia day 1-7 * adverse effects * experience of any emetic symptoms * experience of any gastrointestinal symptoms * satisfaction with pain medication day 20 * wound dressing day 20 * clinical evaluation 17 weeks, final assessment

see brief summary

Eligibility criteria:
inclusion criteria: * health asa 1-2 patients 18-65 years of age exclusion criteria: * asa/nsaid allergy * renal disease * lithium therapy * complicated cardiovascular disease

Keywords: day surgery hallux valgus pain analgesics
erector spinae block versus thoracic paravertebral block for acute thoracic herpes zoster

Conditions: Acute Thoracic Herpes Zoster; Erector Spinae Plane Block; Thoracic Paravertebral Block; Pain Relief

Summary: the aim of this research is to study and compare the efficacy and safety of single injection erector spinae plane block and thoracic paravertebral block in prevention of post herpetic neuralgia in patients with acute thoracic herpes zoster.


Eligibility criteria:
inclusion criteria: * over 50 years of age * chest wall herpetic eruption of less than one week * moderate or severe pain exclusion criteria: * patient refusal * eruption more than one week duration * patients who will not receive appropriate anti-viral therapy * patients with mild pain * infection at the site of injection * patients with a history of renal, hepatic diseases, coagulopathy, steroid therapy, malignancies. * patient taking chemotherapy and/or radiotherapy.
caffeine for hypoxic-ischemic encephalopathy

Conditions: Hypoxic-Ischemic Encephalopathy

Summary: hypoxic-ischemic encephalopathy (hie) due to perinatal asphyxia is common and often fatal. therapeutic hypothermia reduces mortality and morbidity in infants with hie. even with the widespread use of therapeutic hypothermia, \~60% of infants with hie die or have neurodevelopmental impairment. as a result, there is an urgent, unmet public health need to develop adjuvant therapies to improve survival and neurodevelopmental outcomes in this population. caffeine may offer neuroprotection for infants with hie by blocking adenosine receptors in the brain and reducing neuronal cell death. in animal models of hie, caffeine reduces white matter brain injury. drugs in the same class as caffeine (i.e., methylxanthines) have been shown to be protective against acute kidney injury in the setting of hie. however, their safety and efficacy have not been studied in the setting of therapeutic hypothermia and their effect on neurological outcomes is not known. since these drugs reduce injury to the kidney in infants with hie, they may also reduce injury to the brain. this phase i study will evaluate the pharmacokinetics, safety, and preliminary effectiveness of caffeine as an adjuvant therapy to improve neurodevelopmental outcomes in infants with hie.


Eligibility criteria:
inclusion criteria: * documented informed consent from parent or guardian * ≥ 36 weeks gestational age at birth * receiving therapeutic hypothermia for a diagnosis of hie * intravenous (iv) access * postnatal age \< 24 hours exclusion criteria: * receiving \> 1 anti-epileptic drug for seizures * sustained (\>4 hours) heart rate \> 180 beats per minute * known major congenital anomaly * any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
study to assess the efficacy and safety of spoton specs™ for the treatment of chronic dizziness

Conditions: Chronic Dizziness

Summary: the diagnosis and management of acute vertigo and dizziness is most of the time an easy task for the general practitioner. however, following an acute vestibular disorder and very often with no any overt cause, a considerable number of patients complain on chronic dizziness and subjective disturbance of balance despite normal clinical and laboratory tests. patients describe that perceptual visual stimulus provoke or aggravate their symptoms that are frequently accompanied by anxiety. these cases have been described in the medical literature as phobic postural vertigo, visual vertigo, chronic subjective dizziness and motion and space discomfort (2,3,4,5). treatment of these conditions includes physical therapy (similar to vestibular rehabilitation exercises) and anti-anxiety or anti-depressant agents such as benzodiazepines and ssri, however, the effectiveness of these approaches is debatable. because visual stimuli play a crucial role in space orientation and motion perception, it is reasonable to hypothesize that certain visual stabilizing signals applied on the peripheral visual field (that is involved mainly in the perception of motion) could be of help in patients suffering from dizziness. this is the rationale of a new technology (smb- senso mental balance technology) developed to alleviate the feelings of dizziness. trial is conducted in meir medical center, israel. recruitment only in israel!


Eligibility criteria:
inclusion criteria: * age: 18≤ years ≤85 * clinical diagnosis of chronic dizziness primary or secondary to vestibular disorder. * stable symptoms for more than one month and less than a year. * ability to perform all tests (including computerized test) and interviews. * gave informed consent for participation in the study. exclusion criteria: * dizziness disease with fluctuating symptoms such as in active meniere's disease or benign paroxysmal positional vertigo * cns disease or injuries * dizziness caused as a result of previous whiplash * any active or non-controlled disease that might cause dizziness (e.g. non-controlled diabetes, hypertension, anemia, respiratory, cardiovascular or endocrinological disorder etc.) * pregnant women * participation currently in another clinical study or enrolled in another clinical study within 30 days prior to this study.

Keywords: phobic postural vertigo visual vertigo chronic subjective dizziness motion and space discomfort spoton
real-life evaluation of high dose rosuvastatin in high risk patients after titration

Conditions: Hypercholesterolemia

Summary: to evaluate achievement ratio of treatment target goal in hypercholesterolemia patients with high risk after high dose rosuvastatin(20mg/day) titration


Eligibility criteria:
inclusion criteria: * high-risk hyperlipidemia patients who are prescribed with rosuvastatin 10mg, based on the physician's clinical decision and fulfill the following criteria 1. over 18 years of age 2. have history of chd or chd risk equivalents, such as peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease (tia or stroke of carotid origin or \>50% obstruction of carotid artery), dm, and 2+ risk factors with 10-year risk chd\>20% exclusion criteria: 1. patients already taking other hyperlipidemic agents 2. patients who do not fulfil the indication criteria for statin therapy 3. patients who do not have baseline and/or follow-up lipid data to verify the efficacy data

Keywords: hypercholesterolemia crestor ldl target goal high risk patients naturalistic observational
effect of n-acetylcysteine on oxidative stress in covid-19 patients

Conditions: Corona Virus Disease 19 (Covid19); Corona Virus Infection; Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)

Summary: the purpose of the study is to assess the potential therapeutic effect of n-acetylcysteine "nac" in covid 19 patients.

this is a phase 3 trial enrolling subjects with newly diagnosed corona virus disease 2019 ( covid-19) infection who are classified as moderate cases and require hospitalization. patients meeting eligibility criteria will be randomized either to receive oral n-acetylcysteine or not along with the institution treatment protocol . treatment efficacy will be assessed using certain endpoints as follows: 1. markers of inflammation and oxidative stress 2. length of hospital stay 3. need for ventilation 4. mortality rate

Eligibility criteria:
inclusion criteria: 1. adults aged more than 18 years 2. documented covid-19 infection (either performed on site or documented external report), only moderate cases will be included exclusion criteria: 1. known allergy or hypersensitivity to nac 2. pregnancy 3. critically ill or mechanically ventilated patients

Keywords: n-acetylcysteine
prevention of gvhd in patients treated with allogeneic sct: possible role of extracorporeal photophoresis

Conditions: Graft-Versus-Host Disease

Summary: the main aim is to test the preventive use of extracorporeal photophoresis (ecp) against development of graft-versus-host disease (gvhd) in patients undergoing allogeneic stem cell transplantation for hematological malignancy.

allogeneic stem cell transplantation represents the only available long-term control and possible cure of a number of hematological malignancies. a major obstacle to this treatment is the development of graft-versus-host disease (gvhd), affecting the majority of transplanted patients to some extent. today, combinations of various cytotoxic and immunosuppressive drugs are used to prevent and treat gvhd, but many of them are associated with severe side-effects. extracorporeal photophoresis (ecp) offers an alternative to chemo- and immunosuppressive therapy and confers apparently only mild side effects. the postulated rationale of ecp is to treat the patient's white blood cells ex vivo with ultraviolet irradiation after sensitization with 8-methoxypsoralen to dampen their immunoactivity. after engraftment the intervention group receives 2 consecutive ecp every week in 2 weeks then 1 ecp every week in 4 weeks ( a total of 8 ecp procedures).

Eligibility criteria:
inclusion criteria: * provide written consent to participate * understand norwegian or english * no previous history of malignant disease * no contraindication to ecp-treatment or undergone previous ecp treatment exclusion criteria: * (in addition to those regarding eligibility for transplantation itself): * unwilling to provide written consent to participate * unable to cooperate as judged by the responsible physician * ecog status \> 2 at time of inclusion * using anti-inflammatory or cytotoxic drugs other than those that are part of the treatment of the current hematological malignancy * known allergy to psoralens or citrate products * splenectomy * pregnancy/lactating