Kornimate/medical-research-clean huggingface dataset:
evaluation of neuromuscular electrostimulation in addition to a physical activity program

Conditions: Prostate Cancer

Summary: the purpose of the study is to measure the muscle strength of the quadriceps 6 months from the start of the intervention, either the maximum load resistance that can be lifted in a single repetition under standardized conditions with the thigh press.

this is a prospective, longitudinal, open, comparative (two arms), randomized, monocentric study, focusing on a therapeutic strategy (muscle strengthening program with or without neuromuscular electrostimulation). patients will be cared for according to a nutritional and sports support program offered routinely in the investigating center, which corresponds to the recommendations for the care of patients with prostate cancer under androgen deprivation therapy.

Eligibility criteria:
inclusion criteria: * patient treated with pharmacological androgen deprivation therapy for prostate cancer for more than 26 weeks; * performance index (who): 0 or 1; * patient able to understand the information related to the study, to read the information leaflet and having consented to participate in the study; * patient benefiting from a social security scheme; exclusion criteria: * weight ≥ 130 kg; * vegetarian food; * other associated neoplasia; * patient having undergone a bilateral orchiectomy; * painful bone metastases, or at risk of fracture; * anemia (hemoglobin \< 10 g/dl); * thrombocytopenia (platelets \< 50 g/l); * renal impairment (creatinine clearance \ 30); * patient planning to travel more than 4 weeks continuously in the next 52 weeks; * absolute contraindication to physical training (e.g. musculoskeletal, cardiovascular or neurological disorders), according to the doctor specializing in the associated medical condition; * contraindication to the use of the neuromuscular electrostimulation device or the impedance meter, in particular infectious disease in the acute phase, fungal infection, dermatitis, unbalanced arrhythmia, epilepsy, wearing an active implantable device (pacemaker, heart artificial, prosthesis incorporating an electromagnetic system), open wound; * sports activity already supervised by a third party or at an equal or higher level than the bodybuilding/muscle strengthening work recommended in the study; * protected adult patient (under guardianship or curatorship, or under a regime of deprivation of liberty); * patient participating in another research, or in a period of exclusion from another research.
pseudoexfoliation and chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: background: pseudoexfoliation (pex) is characterised by the deposition of fibrillar material in an eye structures and many other parts of the body including kidneys and blood vessels. as both pex and chronic kidney disease (ckd) are associated with oxidative stress and endothelial dysfunction we studied if the risk of pex was increased in patients with ckd. methods: patients over age 40 with the diagnosis of ckd were included in the study. chronic kidney disease was diagnosed as decreased glomerular filtration rate (gfr) of less than 60 ml/min/1.73 m². study groups were arranged as group 1 consisting of hd receiving patients, group 2 consisting of stage 1-4 ckd patients and group 3 consisting of patients with normal kidney functions (control group). demographic properties and the rate of pex were evaluated and compaired between the groups.


Eligibility criteria:
inclusion criteria: * all patients with chronic kidney disease stage 1-5 exclusion criteria: * history of eye trauma or surgery

Keywords: pseudoexfoliation, chronic kidney disease
a study of prolonged electrocardiographic monitoring in patients with heart failure in sinus rhythm or atrial fibrillation

Conditions: Heart Failure; Atrial Fibrillation

Summary: it is an observational study in patients with heart failure investigating the incidence of arrhythmias using a wearable device which can monitor heart rhythm for up to 14 days. in addition to gathering routine clinical information, research assessments include a symptoms questionnaire and a corridor walk test. patients will be followed for clinical events (interventions for arrhythmias, hospitalisation, death) for 1 year.

due to the slow recruitment, on the one hand, and the fact that the preliminary analysis gave the valuable results, on the other hand, the number of patients was reduced from 400 to 100 and the follow-up from five years to one year

Eligibility criteria:
inclusion criteria: 1. heart failure 2. treated with loop diuretics for at least six weeks 3. willing and legally able to sign informed consent 4. at least 18 years of age 5. new york heart association (nyha) class ii - iv exclusion criteria: 1. myocardial infarction in the previous six weeks, 2. implanted pacemaker, including cardiac resynchronisation device, or defibrillator 3. already participating in an interventional randomized controlled trial assessing effects on morbidity and mortality (this study does not preclude participation in future clinical trials).

Keywords: heart failure atrial fibrillation ambulatory ecg monitor
study on the efficacy and safety of jinlida granules in patients with inadequately controlled type-2 diabetes and dyslipidemia under life style intervention (enjoy life study)

Conditions: Type 2 Diabetes; Dyslipidemia

Summary: the aim of the present study is to evaluate the efficacy and safety of jinlida granules in patients with inadequately controlled type-2 diabetes and dyslipidemia under life style intervention.


Eligibility criteria:
inclusion criteria: 1. age of 20-70 years; 2. diagnosed with type 2 diabetes inadequately controlled under life style intervention with 3 months before screening; 3. hba1c ≥6.5% and ≤10.0%, and fasting plasma glucose ≥7 and ≤13.3mmol/l at baseline; 4. diagnosed with dislipidemia with triglycerides\>150mg/dl (1.70mmol/l), and/or total cholesterol \>200mg/dl (5.16mmol/l), and/or ldl-c\>100mg/dl (2.58mmol/l) 5. body mass index (bmi): 20\<bmi\<40 kg/m2; exclusion criteria: 1. moderate or severe liver dysfunction, abnormal renal function; 2. severe dysfunction of the heart; 3. histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months; 4. psychiatric disease or severe infection; 5. pregnancy or planned pregnancy; 6. use of any drug (including insulin) for treatment of diabetes or dyslipidemia within 3 months; 7. use of chronic (\>7 days) systemic glucocorticoid therapy within 8 weeks or receive growth hormone therapy within 6 months; 8. diagnosed with type 1 diabetes, or gestational diabetes, or other specific types of diabetes; 9. history of malignant tumor within 5 years.
cost-effectiveness of endwarts® freeze - an alternative home cryotherapy device for wart treatment

Conditions: Cryotherapy Effect; Warts

Summary: this study aimed to study cost-effectiveness of endwarts® freeze for wart treatment, compared to conventional liquid nitrogen cryotherapy

cutaneous warts, caused by human papilloma virus (hpv), are common skin disease. the prevalence reported in primary school children are 2-20%, and even higher in adults. non-intact skin are prone to the infection, with all parts of the body can be affected. even warts are not malignant, they can cause lack of confidence or affected patients' quality of life. nowadays there are many treatment methods for warts, such as topical application with salicylic acid and electrical cauterization. cryotherapy with liquid nitrogen has been the therapy of choice due to its clinical effectiveness, which reported for 6-65%. treatment mechanism in cryotherapy relies on in-depth freezing of infected keratocyte. endwarts® freeze is alternative home treatment cryotherapy device containing nitrous oxide. recent clinical study found that it delivers significant result with good tolerability, and is user friendly. as for our knowledge, no study has been reported about cost-effectiveness of this device, so this study was designed to demonstrate the efficacy of this product in cutaneous warts.

Eligibility criteria:
inclusion criteria: * diagnosis of plantar or common wart at department of dermatology, siriraj hospital exclusion criteria: * patient with more than 5 warts or wart more than 1 cm in diameter * wart at face, genitalia, scalp, joint * pregnancy or breastfeeding patient * wart with wound/irritation or local infection * diabetes mellitus patients or patients with coagulopathies or cryoglobulinemia * immunocompromised host or on immunosuppressive drug * received any treatment in previous 3 months before inclusion

Keywords: cryotherapy effect warts treatment endwarts freeze
effect of passive leg raising for fluid responsiveness

Conditions: Body Fluid Retention; Impedance; Cardiac Output, Low

Summary: changes in volumetric hemodynamic parameters and fluid overload (cardiac index,stroke volume, thoracic fluid content, systemic vascular resistance) were measured using a impedance cardiography (icg) (cardioscreen 1000 - haemodynamic measurement system, medis. gmbh ilmenau) while lifting the leg at different angles. the measurement lasted 12 minutes.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * no clinical cardiovascular disease during the 6 months proceeding entry exclusion criteria: * not meet above criteria * episode of illness (for example: infection) * pregnancy
a phase 1/2 study of aeb1102 in patients with arginase i deficiency

Conditions: Arginase I Deficiency; Hyperargininemia

Summary: a phase 1/2 open-label study in patients with arginase i deficiency to investigate the safety, pharmacokinetics, and pharmacodynamics of intravenous aeb1102. this study is designed to evaluate the safety and tolerability of iv administration of aeb1102 for the treatment of pediatric and adult patients with arginase i deficiency and hyperargininemia. this study will be conducted in 2 parts: part 1 (single ascending dose escalation) and part 2 (repeated dosing). each part will be preceded by a baseline assessment of arginine levels. all patients who participate in part 1 may continue aeb1102 dosing in part 2 if they qualify for continued dosing. a data safety monitoring board (dsmb) will provide independent review of study safety data and recommend whether the sponsor should continue the study as planned, modify the study protocol, or discontinue the study.


Eligibility criteria:
inclusion criteria: * documented diagnosis of arginase i deficiency * adequate organ function: hgb ≥ 10 g/dl, anc ≥ 1.5 x 109/l, plt count ≥ 100,000/µl; liver transaminase levels ≤ 2.5x uln, total bilirubin ≤ 2.0 mg/dl; serum creatinine \<1.5 x uln * if female and of child-bearing potential, has a negative serum pregnancy test within 7 days before enrollment * if a sexually active (male or female), must be surgically sterile, post-menopausal (female), or must agree to use a physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration * patient or legal guardian is able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures and continuation of prescribed diet without modification) prior to any screening procedures exclusion criteria: * transfusion of ≥ 2 u rbc within 60 days * active infection requiring systemic treatment * known infection with hiv, hep b or hep c * severe hyperammonemia requiring hospitalization within 14 days. had more than one episode of hyperammonemia requiring hospitalization within the 30 days prior to enrollment. * current uncontrolled hyperammonemia * has a history of hypersensitivity to peg or any other component of the aeb1102 (co-argi-peg) formulation * if female, is lactating or breast feeding part 2 inclusion criterion: 1. did not experience any safety or tolerability event in part 1 which would preclude continued participation and dosing of aeb1102
can intrauterine levonorgestrel releasing device be a treatment option for postmenstrual spotting in isthmocele

Conditions: Isthmocele; Post-menstrual Spotting Bleeding; Pelvic Pain

Summary: it was planned to investigate the treatment effect of levonorgestrel releasing intrauterine device in patient with isthmocele who were suffering from postmenstrual spotting bleeding and who had no desire for fertility.

isthmocele is an acquired diverticulum like defect of myometrium in the anterior isthmic part of uterus due to previous cesarean section incision. it can be defined as thinning of the incised site of uterus smaller than 50 % of its normal thickness. the real incidence is unknown. due to low ability of contractility of the postmenstrual spotting bleeding. accumulation of blood in the isthmocele induces inflammation within the endometrium and causes pain as well. furthermore, this inflammation can be an absolute reason for secondary infertility. as a result, accumulation of blood in the isthmocele seems to start up the cascade of morbidities. when understanding the mechanism, preventing blood accumulation seems to prevent symptoms other than infertility. levonorgestrel releasing intrauterine devices can be a way of thinning the endometrium hence, blood accumulation can be avoided. in the literature, surgical correction of the isthmocele has been studied and medical treatment that was mentioned in the literature was the oral contraceptives and only a preliminary report of very small sample size, discussed the effect of levonorgestrel releasing device . in the light of aforementioned clinical knowledge, we planned to investigate the treatment effect of levonorgestrel releasing intrauterine device in patients with postmenstrual bleeding due to isthmocele who were not willing to have baby. these patients will be called back at 6th, 12th and 18th months after applying levonorgestrel releasing device to the uterus. gynecological examinations will be done and complainants will be questioned.

Eligibility criteria:
inclusion criteria: * having isthmocele and complaining for postmestrual spotting bleeding * having cesarean section as a last delivery way. * not planning for fertility * complaining about dysmenorrhea and pelvic pain exclusion criteria: * having pelvic infection * having an any type of previous pelvic surgery * having leiomyoma, endometrial polyp or adnexal mass * having any type of malignancy * having thyroid dysfunction and prolactinemia

Keywords: isthmocele postmenstrual spotting bleeding pelvic pain
a study of pf-05280014 or trastuzumab plus taxotere® and carboplatin in her2 positive breast cancer in the neoadjuvant setting (reflections b327-04)

Conditions: Early Breast Cancer

Summary: the current study will compare pk, efficacy, safety, and immunogenicity of pf-05280014 (trastuzumab-pfizer) in combination with taxotere® and carboplatin (paraplatin) versus herceptin® (trastuzumab-eu) approved in the eu in combination with taxotere® and carboplatin (paraplatin) in patients with operable her2 positive, breast cancer in the neoadjuvant setting. the hypothesis to be tested in this study is the percentage of patients with steady state cycle 5 ctrough (cycle 6 pre-dose) \>20 µg/ml of trastuzumab-pfizer is similar to eu-approved trastuzumab, using a margin of -12.5%.


Eligibility criteria:
inclusion criteria: * histologically confirmed her2 overexpressing invasive breast cancer. * plan for definitive surgical resection of breast tumor (i.e., lumpectomy or mastectomy, and sentinel node (sn) biopsy or axillary lymph node dissection (alnd). * plan for neoadjuvant chemotherapy. * measurable disease in the breast after diagnostic biopsy, defined as longest diameter ≥ 2.0 cm. exclusion criteria: * bilateral breast cancer. * inflammatory breast cancer. * presence of known distant metastases. * received prior treatment, including chemotherapy, endocrine therapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer.

Keywords: biosimilars non-inferiority neoadjuvant setting early breast cancer pk phase 3 trastuzumab herceptin her2 positive
study of immune responses in patients with metastatic melanoma

Conditions: Metastatic Melanoma

Summary: in this study, anti-ox40 will be given to patients with melanoma to find out how the immune system responds to treatment with anti-ox40. it is hoped that this treatment will cause an immune response against melanoma resulting in tumor regression, but this is not known at this time. anti-ox40 is a large protein that can help immune cells that fight bacteria, viruses and cancer cells.


Eligibility criteria:
inclusion criteria: 1. patients with measurable or evaluable unresectable, stage iv metastatic melanoma. either histologic or cytologic diagnosis is acceptable. 2. eastern cooperative oncology group (ecog) performance status 0, or 1 (appendix a.) 3. age 18 years or above. 4. laboratory values (performed within 28 days prior to enrollment) as follows: * wbc ≥2000/microliter * absolute lymphocyte count \>300/mm3 * serum creatinine \<1.5 x upper limit of laboratory normal * hgb \>8g/dl (patients may be transfused to reach this level) * hct \> 24% * platelets \>100,000 cells/mm3 * total bilirubin \<1.5 x upper limit of laboratory normal, unless due to gilbert's disease * ast (sgot)/alt (sgpt) \<2.5 x upper limit of laboratory normal * alkaline phosphatase \<2.5 x upper limit of laboratory normal * hiv negative * hepatitis b surface antigen negative * hepatitis c antibody negative 5. women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. men must avoid fathering a child while on treatment. this exclusion is required due to the unknown toxicities that anti-ox40 may have on the forming fetus, spermatogenesis or the nursing child. also, because pregnancy may impair immune function it may limit the treatment efficacy. 6. ability to give informed consent and comply with the protocol. patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy. 7. no active bleeding. 8. no clinical coagulopathy (inr \<1.5, pt \<16 seconds, ptt \< 38 seconds). 9. anticipated lifespan greater than 12 weeks. 10. failed at least one prior medical therapy for metastatic melanoma. exclusion criteria: 1. active infection. 2. history of or active autoimmune disease. 3. prior mouse monoclonal antibody treatment. 4. pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus. 5. need for chronic maintenance oral steroids. 6. active brain metastatic disease. treated brain metastases with surgery, gamma-knife radiosurgery and/or whole brain radiation and stable for at least 4 weeks and off steroids are eligible. 7. any medical or psychiatric condition that in the opinion of the pi would preclude compliance with study procedures.

Keywords: metastatic melanoma anti-ox40 immunostimulatory
translation and validation of bela-p-k for qol evaluation in pd patients

Conditions: Parkinson Disease

Summary: the bela-p-k was translated from dutch into italian. subsequently 102 patients with pd filled out the questionnaire

in order to provide an appropriate endpoint for the assessment of the effectiveness of rehabilitation treatments on qol of pd patients, in this study we translated and then validated the belastungsfragebogen parkinson kurzversion (bela-p-k). this tool allows evaluating separately two crucial aspects: i) the loss of personal autonomy in activities of daily life and ii) the psychological and psychosocial impact of the disease. the bela-p-k was translated from dutch into italian. subsequently 102 patients with pd filled out the questionnaire. pd patients were also evaluated by using the parkinson disease questionnaire -39 (pdq39), the unified parkinson's disease rating scale (updrs), the mini mental state examination (mmse) and the frontal assessment battery (fab) the internal consistency of the questionnaire was assessed by means of cronbach's alpha coefficient. the discriminant validity was assessed by testing for differences between mean values for patients grouped according to hoehn and yahr stages. this analysis was carried out by a one-way analysis of variance. finally, the construct validity was determined by assessing the relationship (spearman rank correlation coefficient) between bela-p-k and the pdq39

Eligibility criteria:
inclusion criteria: * parkinson's disease exclusion criteria: * any focal brain lesion detected in brain imaging studies (ct or mri) performed in the previous twelve months; * other chronic diseases with a known impact in qol. * mmse \< 24

Keywords: quality of life psychosocial and psychological problems
biomarkers for tuberous sclerosis complex (biotusccom)

Conditions: Hypomelanotic Macules; Facial Angiofibroma; Shagreen Patches; Ungual Fibromas; Cortical Dysplasia; Cardiac Rhabdomyoma; Lymphangioleiomyomatosis; Renal Angiomyolipoma; Subependymal Giant Cell Astrocytoma

Summary: international, multicenter, observational, longitudinal study to identify biomarker/s for tuberous sclerosis complex and to explore the clinical robustness, specificity, and long´-term variability of these biomarker/s

tuberous sclerosis complex (tsc) is an autosomal dominant genetic disorder characterized by the growth of numerous tumors in different body parts related to dysregulation of the mechanistic target of rapamycin (mtor) pathway. the overall incidence of tsc is estimated to be as high as 1 in 6000 to 10,000 live birth.the main aspects of tsc that influence the quality of life are associated with the brain: seizures, evelopmental delay, intellectual disability, and autism. however, the incidence and severity of the various aspects of tsc can vary widely. tsc is generally caused by pathogenic variants in the tumor suppressor genes: tsc1 and tsc2. confirmation of a clinical diagnosis of tuberous sclerosis is performed via tsc1 and tsc2 sequencing. there is no cure for tsc, therefore symptomatic therapy is the best possible choice, including mtor inhibitors, vigabatrin and other antiepileptic drugs for the seizures, and neurosurgery in cases of life-threatening neurological symptoms. the aim of the study is established tsc specific biomarker/s. such biomarkers aim to facilitate the diagnosis, treatment personalization and monitoring.

Eligibility criteria:
inclusion criteria * informed consent is obtained from the participant or from the parent / legal guardian * participant is aged between 2 and 50 years * diagnosis of tsc is genetically confirmed by centogene exclusion criteria * inability to provide informed consent * participant is younger than 2 or older than 50 years * diagnosis of tsc is not genetically confirmed by centogene

Keywords: tuberous sclerosis complex biomarker
study to compare overall survival in medicare patients with metastatic breast cancer treated with a medicine called palbociclib in combination with aromatase inhibitor and aromatase inhibitor by itself.

Conditions: Breast Cancer

Summary: a retrospective study of de-identified (to preserve patient privacy) patient information from the seer-medicare database to compare overall survival of first line palbociclib + aromatase inhibitor (ai) therapy versus ai therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor positive/human epidermal growth factor receptor 2 negative (hr+/her2-) metastatic breast cancer (mbc) in the united states


Eligibility criteria:
inclusion criteria: * de novo metastatic (stage iv) disease at initial breast cancer diagnosis during 2015-2019 * hr+/her2- molecular subtype at diagnosis * initiated 1l systemic therapy with palbociclib + ai or ai alone exclusion criteria: * patients will be excluded if their metastatic breast cancer diagnosis was first recorded in a death certificate or at the time of autopsy.

Keywords: breast neoplasm hormone receptor-positive human epidermal growth factor receptor 2 negative (hr+,her2-) palbociclib metastatic medicare seer-medicare