Kornimate/medical-research-clean huggingface dataset:
evaluating the efficacy of a novel oral supplement in tackling malnutrition in the elderly

Conditions: Malnutrition; Muscle Health

Summary: promo aims to investigate the effectiveness of a newly developed ons in increasing body weight, muscle mass and function in malnourished elderly compared to standard care.


Eligibility criteria:
inclusion criteria: * age 65+ * at risk of malnutrition/ malnourished exclusion criteria: * • mental status that is incompatible with the proper conduct of the study * illness of such severity that life expectancy is considered to be less than 12 months * use of diabetes medication (e.g. insulin, methformin) * use of an oral nutritional supplement in the previous three months * participating in any regular exercise training program (≥2h/w) * renal insufficiency (egfr \<30 ml/min/1.73 m2) * unstable organ failure or organ failure necessitating a special diet * chronic corticosteroids use * recent (previous 2 months) use of antibiotics * recent (previous 3 months) change in habitual medication use (e.g statins and thyroxin) * recent blood donation (\<1 month prior to day 01 of the study) * not willing or afraid to give blood during the study * allergic or sensitive for milk proteins * reported vegan or macrobiotic life-style * drug and/or alcohol abuse (current consumption of more than 21 alcoholic drinks per week) * individual unable to give informed consent * current participation in other research from the division of human nutrition * not having a general practitioner * personnel of wageningen university, department of human nutrition, their partner and their first and second degree relatives
use of arthroscopy in treatment of acute pediatric septic hip infection

Conditions: Acute Pediatric Septic Hip Infection

Summary: acute septic hip infection in pediatric population is a true orthopedic surgical emergency that require early diagnosis and prompt management. open surgical debridement and drainage of the hip through lateral approach is the gold standard method of treatment. usage of hip arthroscopy in the treatment of such condition has been in clinical practice for more than 30 years. however, literature is still lacking in actual prospective comparison about the outcome of both methods.

the study will divide the children presented with acute septic hip infection into two groups; the control group in which the child will undergo traditional open surgical debridement and drainage of the hip via lateral approach, and the intervention group in which arthroscopic drainage and debridement of the hip will be done. the outcomes of both methods will be recorded and compared. the research hypothesis is that arthroscopic management of acute pediatric septic hip infection is as effective as open surgery; with fewer complications and faster recovery.

Eligibility criteria:
inclusion criteria: * age 10 months - 14 years _unilateral or bilateral acute septic hip arthritis exclusion criteria: * children with pre-existing other pathology of the affected hip, whether he / she has surgery for management of this pathology or not. * patients whose parents refuse to participate in the study
sex steroids and the serotonin transporter

Conditions: Transsexualism

Summary: the aim of this study is to prove the influence of the sex steroid hormones estrogen, progesterone and testosterone on the serotonin transporter (5-htt) binding using positron emission tomography (pet) and the selective radioligand \[11c\]dasb. specifically, the 5-htt binding will be quantified before and after hormone therapy underwent by 10 male-to-female (mtf) and 10 female-to-male (ftm) transsexuals urging for hormone treatment. the high-level, long-term administration of opsite sex steroid hormones in transsexuals provide the unique opportunity to investigate the influence of sex steroid hormones on the serotonergic system. since the serotonin transporter serves as a primary target molecule for antidepressant treatment, the results of the study will be of benefit for the assessment of the clinical relevance of estrogen and testosterone as modulatory and neuroactive agents.


Eligibility criteria:
inclusion criteria: * somatic health * no previous sex hormone medication * willingness to sign the written informed consent exclusion criteria: * severe diseases * steroid hormone treatment within 6 months prior inclusion * treatment with psychotropic agents such as selective serotonin reuptake inhibitors (ssris) * any implant or stainless steel graft * positive urine pregnancy test in women at the screening visit at each pet day

Keywords: serotonin transporter hormone therapy gender dysphoria transsexualism
the effect of cold vapor application on postoperative sore throat

Conditions: Sore Throat

Summary: to determine the effect of cold vapor given in the post-extubation period on sore throat.

general anesthesia increases the comfort of the patient by ensuring that the patient does not feel the surgical interventions and pain during the operation. the necessity of intubation is known in patients who have undergone surgery under general anesthesia. intubation provides benefits such as keeping the airway open, controlling the airway and breathing, reducing respiratory effort and dead space volume, preventing aspiration, and facilitating resuscitation in case of any problem. although surgical interventions are an important treatment option for health problems, postoperative complications such as sore throat, dry throat, hoarseness and dysphagia due to laryngeal and pharyngeal traumas caused by intubation are frequently observed especially in patients receiving general anesthesia. although it is seen in the literature that pharmacological, non-pharmacological and herbal methods are applied to reduce postoperative sore throat, there are not enough studies examining the effect of cold steam application on sore throat. with this research, it is expected that the cold steam given in the postoperative period will contribute to the relief of sore throat.

Eligibility criteria:
inclusion criteria: * those who accept the research * elective laparoscopic cholecystectomy surgery planned * patients in asa i and ii class * 18 years and over * mallampati classification i and ii * operation time more than 30 minutes * literate * no hearing problem * patients without understanding difficulties exclusion criteria: * overweight patients (body mass index ≥ 40) * patients with sore throat and lower respiratory tract infection * patients with chronic obstructive pulmonary disease (copd) * patients with a history of allergies * patients with hearing problems * illiterate patients * asa classification iii and above * mallampati classification iii and iv patients * patients with an operation time of less than 30 minutes

Keywords: extubation sore throat cold vapor nursing
phase 3 safety and efficacy study of i.v. iclaprim v linezolid in csssi (assist-1)

Conditions: Complicated Skin and Skin Structure Infection

Summary: this is a multi-center, investigator-blind, comparative phase 3 study. patients will receive either iclaprim or linezolid for 10 to 14 days. patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at end of therapy, the test of cure visit (7 to 14 days post treatment), and a late follow-up (f/u) visit (7 to 14 days after the toc visit).

primary objective: the primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure (toc) visit (7 to 14 days after the end of treatment). secondary objectives: the secondary objectives of this study are to compare iclaprim with linezolid regarding: * clinical efficacy at the end of study medication treatment; * time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection (csssi); * clinical outcome in the microbiologically evaluable (me) population; * bacteriologic outcome in the me population; * bacteriologic eradication rates of baseline (bl) pathogens; * clinical outcome in the modified intent-to-treat (mitt) population; * bacteriologic outcome in the mitt population; * baseline in vitro susceptibility of isolated pathogens in the me population; and * safety and tolerability of iclaprim treatment.

Eligibility criteria:
inclusion criteria -diagnosis of an infection consistent with complicated skin and skin structure infection due to a gram positive pathogen. exclusion criteria: - known or suspected hypersensitivity to any study medication or other related anti-infective medication - any known or suspected condition or concurrent treatment contraindicated by the prescribing information - previous enrollment in this study - treatment with any investigational drug within 30 days before enrollment

Keywords: skin infection complicated skin infection skin structure infection
validation of a german version of the patient rated tennis elbow evaluation

Conditions: Elbow Tendinitis; Elbow, Tennis

Summary: the german version of the patient rated tennis elbow evaluation (prtee) questionnaire is tested for reliability, validity and responsiveness.

in this prospective study, patients with lateral epicondylitis will complete the prtee before acp injection, 6 weeks after treatment and 2-11 days later. the statistics will include analyses about reliability, validity and responsiveness.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * diagnosed lateral epicondylitis * receive a first acp treatment at the schulthess klinik * signed informed consent form exclusion criteria: * lack of german language skills, which make it impossible to complete the questionnaire * diseases or conditions that would prevent accurate evaluation (e.g. central neurological, psychiatric or metabolic diseases) * legal incompetence * recent operations on the elbow or hand (less than three months ago)

Keywords: questionnaire prtee
the impact of an adaptive patient-centered web application on medication optimization in hfref patients

Conditions: Heart Failure

Summary: the smarthf study is a 12-week prospective randomized controlled multicenter clinical trial. this study will investigate the efficacy of an adaptive web application to facilitate guideline-directed medical therapy (gdmt) optimization in hfref patients. eligible participants will be randomized to the web application intervention or control in a 1:1 manner, stratified by site. the intervention is an adaptive medication optimization web application that extracts and analyzes the ehr data with a computable medication optimization algorithm. the algorithm provides a medication quality score and outputs medication optimization recommendations written in a patient -friendly manner.

the investigators have developed an adaptive medication optimization web application, named smarthf, that provides patients with tailored information about potential hfref gdmt optimization. smarthf guides patients to share the gdmt optimization recommendations with their provider during a clinic visit. participants will be randomized to receive the web application intervention or control up to 30 days before a clinic visit in a 1:1 manner and followed for 12 weeks after the clinic visit. this trial will determine the efficacy of smarthf in prescribing gdmt in hfref patients compared to controls.

Eligibility criteria:
inclusion criteria: 1. age 18 years and older at screening 2. diagnosis of heart failure with a left ventricular ejection fraction (lvef) \</= 40% (hfref) 3. have a general medicine provider or general cardiology provider for hfref 4. have internet access and access to their health system's patient portal 5. fluent in spoken and written english 6. at least two of the following: systolic blood pressure ≥ 110mmg, potassium ≤ 5.5, serum creatinine ≤ 2.5, heart rate ≥ 70 7. at least two eligible heart failure therapies (guideline-recommended bb, rasi, mra, or sglt2i) not yet initiated or below 50% of the target dose exclusion criteria: 1. end-stage hf (hospice candidate) 2. actively treated cancer, except non-melanoma skin cancer 3. implanted ventricular assist device 4. current treatment with chronic inotropic therapy 5. patient's provider for hfref care is considered an advanced hf specialist 6. currently pregnant or intends to become pregnant during the study period 7. dialysis
prospective assay for sars-cov-2 (covid-19) antibody detection indirectly by immunofluorescence: sars-cov2 iif method

Conditions: Sars-CoV2

Summary: prospective assay for sars-cov-2 antibody detection indirectly by immunofluorescence: sars-cov2 iif method

sample preparation, serum separation by centrifugation * 100 µl of serum for standard sars-cov2 elisa is used according to the instructions for use. * 100 µl of serum indirect immunofluorescent (iif) method is used, the samples thus prepared analysis is performed under an automated microscope

Eligibility criteria:
inclusion criteria: * person over 18 years of age * signing a package leaflet and a informal consent * in the case of a positive group, confirmed by sars-cov2 qpcr patient with covid-19 or recovered individual. * in case of negative group by sars-cov2 qpcr test 2 negative in covid-19 suffering individual exclusion criteria: * refuses to sign the consent form
interventional clinical trial comparing kerecis omega3 wound versus soc in diabetic foot wounds

Conditions: Diabetes; Diabetic Foot Ulcer

Summary: the kerefish study is a randomized controlled study to study the efficacy of kerecis omega3 wound on deep diabetic ulcers. this study is probably the first in his field: in this one, the kerecis omega3 wound dies are used on the types of wounds for which they are ultimately intended. this study aims to document the cost benefits of earlier closure of severe diabetic wounds, or the change of the deep and chronic wound into a smaller and shallower ulcer, and to radically alter its prognosis. the study, carried out in france, uses the pre-existing home nursing system with the transmission of photographs to the reference centre. the study was largely designed to ensure transparency of the financial calculations involved.


Eligibility criteria:
inclusion criteria: * diabetic patients, regardless of the age of their diabetes, with a grade ut 2 or 3 lower limb sore; grade 2: wound penetrating to the tendon or capsule. ut grade 3: wound penetrating to the bone or joint or hospitalized/ambulatory patients for diabetic foot sores or amputations, which have not closed or are dehiscent. * patients who can tolerate aggressive surgical debridement * patients without severe ischemia ips - 0.6 or pressure of the big toe - 50mmhg * longness of the wound: 30 days (does not apply to amputation wounds; patients may be included when the wound is less than 30 days old) or if the amputation level is under the ankle * patients willing and able to give informed consent to participate in the clinical trial. * male or female over the age of 18 * patients living at a geographical distance compatible with referral nurse visits * negative pregnancy test for women of childbearing age who do not use contraception. * patients covered by social security * patients who are capable (in the investigator's opinion) and willing to comply with all clinical trial requirements exclusion criteria: * patients whose wound surface is not measurable * patients with unsealed osteomyelitis * patients with fever related to a foot infection (it may be reassessed at a later time when the infection is gone) * patients with a necrotic wound that will not tolerate aggressive surgical debridement * immunosuppressed patients * patients with systemic corticosteroids or other treatments that may delay wound healing * pregnant, breast-feeding or planning pregnancy during the clinical trial * any other significant disease or disorder that the investigator believes may pose a risk to participants because of their participation in the clinical trial or that may influence the outcome of the clinical trial or the participant's ability to participate in the clinical trial. * patients with rheumatoid arthritis * patients with systemic lupus * patients with a known skin allergy to fish * patients deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure

Keywords: complex diabetic foot wounds kerecis omega3wound extracellular matrix
a pharmacokinetic and pharmacodynamic study comparing hlx01 and rituximab in patients with cd20-positive, b-cell lymphoma

Conditions: B-cell Non Hodgkin's Lymphoma

Summary: randomised, double-blind, parallel group study to compare pk and pd profiles between hlx01 and rituximab (mabthera®) in patients with cd20+ b-cell lymphoma.


Eligibility criteria:
inclusion criteria: 1. aged from 18 to 65 years; 2. cd20-positive non-hodgkin's lymphoma (nhl); 3. having obtained cr (complete remission) or cru (uncertain complete remisson) after the prior therapy; 4. ecog performance status of \ = 3 months; 5. peripheral blood lymphocyte count \< 5×10\^9/l 6. signed an informed consent form which was approved by the institutional review board of the respective medical center . exclusion criteria: 1. other invasive malignancies within 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix; 2. chemotherapy within 1 month; 3. had received rituximab or other anti-cd20(+) monoclonal antibody treatment within 1 month before enrollment; 4. had received rituximab or other anti-cd20(+) monoclonal antibody treatment 1 month ago but with ada(+) before enrollment; 5. blood concentration of rituximab\> 24 μg/ml prior to study entry; 6. had received hematopoitic growth factor within 1 week prior to study entry; 7. receipt of a live/attenuated vaccine within 4 weeks prior to the screening visit; 8. recent major surgery (within 8 weeks prior to screening, excluding lymph node biopsy); 9. peripheral or central nervous system disease; 10. serious hematologic dysfunction (white blood cell count of \<3.0×109/l; absolute neutrophil count of \<1.5×109/l; platelet count of \< 100×109/l; hemoglobin level of \< 9.0 g/dl); 11. hepatic dysfunction (total bilirubin level of \> 1.5 × upper limit of normal (uln); aspartate amino transferase (ast) and alanine amino transferase (alt) levels of \> 2.0 × uln; alkaline phosphatase \> 3.0 × uln; renal dysfunction (serum creatinine level of \> 1.5×uln ); 12. abnormal thyroid function; 13. seropositive for hiv , hcv antibody; seropositive for hepatitis b virus surface antigen (hbsag). hbv dna\>1.0×103copies/ml; 14. serious underlying medical conditions, could impair the ability of the patient to participate in the trial (including but not limited to ongoing active infection, uncontrolled diabetes mellitus, significant cardiac disease, uncontrolled angina, gastric ulcers, active autoimmune disease); 15. pregnancy or breast feeding. for women of childbearing potential. 16. history of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial drug. 17. subjects had a history of alcoholism or drug abuse; 18. researchers think that do not fit into the group.
a study to compare chemotherapy alone versus chemotherapy plus nivolumab or nivolumab and bms-986205, followed by continued therapy after surgery with nivolumab or nivolumab and bms-986205 in participants with muscle invasive bladder cancer

Conditions: Urinary Bladder Neoplasms; Muscle-Invasive Bladder Cancer

Summary: the purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (gc) chemotherapy, followed by post-surgery continuation of immuno-oncology (io) therapy, with neoadjuvant gc chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (mibc).


Eligibility criteria:
inclusion criteria: * participant must be deemed eligible for radial cystectomy (rc) by his/her oncologist and/or urologist, and must agree to undergo radial cystectomy (rc) after completion of neoadjuvant therapy. * eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: * clinical evidence of positive lymph node(s) (ln) (≥ 10 mm in short axis) or metastatic bladder cancer * prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (turbt) or biopsies is also not permitted
the effect of pre-treatment biopsy for non-neoplastic renal disease vs no biopsy on estimated glomerular filtration rate in patients with small renal mass: a single-center, single-blinded, randomized, parallel group clinical trial

Conditions: Kidney Neoplasms

Summary: the purpose of this study is to determine if biopsy for non-neoplastic renal disease for patients with a small renal mass results in greater postoperative renal function than the current standard of care (no additional biopsy).


Eligibility criteria:
inclusion criteria: * age 18 or greater * scheduled for renal biopsy as part of clinical care * diagnosis of small renal mass (\< 4cm) based on imaging (ct, mri, ultrasound, or other) * patient must provide written, informed consent for study procedures before randomization * renal mass must be primarily solid (as opposed to cystic) in nature exclusion criteria: * patients less than 18 years of age * patients who are prisoners * women who are pregnant-self reported * patients with bosniak 3 or 4 cystic renal masses * patients with history of renal transplantation * patients with egfr less than 30-based on review of clinical labs * patients on dialysis * patients with bleeding disorders
chablis-sc2: a study of the efficacy and safety of subcutaneous blisibimod in subjects with systemic lupus erythematosus with or without nephritis

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active systemic lupus erythematosus (sle) as defined by selena sledai score ≥10.


Eligibility criteria:
inclusion criteria: * fulfill at least 4 diagnostic criteria for sle defined by american college of rheumatology * positive antinuclear antibodies (ana) and/or anti-double stranded dna (anti-dsdna) * active sle disease as defined by selena-sledai score ≥10 despite on-going stable corticosteroid therapy * subjects with stable nephritis may be enrolled * 18 years of age or older exclusion criteria: * severe active vasculitis, active central nervous system lupus, uncontrolled hypertension or poorly controlled diabetes * malignancy within past 5 years * known to be positive for hiv and/or positive at the screening visit for hepatitis b, or hepatitis c * liver disease * anemia, neutropenia, or thrombocytopenia * active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections * history of active tuberculosis or a history of tuberculosis infection * pregnant or nursing

Keywords: sle lupus lupus erythematosus, systemic autoimmune diseases a-623 blisibimod nephritis