Kornimate/medical-research-clean huggingface dataset:
oedematous lower limb subcutaneous drainage in palliative care

Conditions: Edema

Summary: * background : edema of lower extremities is a concern ranging from 19 % to 60% of palliative cancer patients. lymphedema decreases mobility, induces pain, impacts daily activities, esthetic and behavior. usual treatment is based on diuretics and physiotherapy but is often unsuccessful. in case of conventional treatment failure, in palliative care, subcutaneous drainage can be discussed with the patients. the technique is simple, easy to use but remains off the record. since 2004, 23 cases were reported with various methods. all the cases reported were undertaken with various technical approaches and efficacy criteria. * purpose : investigator hypothesize that the subcutaneous drainage of edema (sdo) is effective in case of refractory lymphedema of the lower limbs in palliative care and leads to an improvement in qol in terms of behavioral and autonomy.

• abstract : in palliative care, lymphedema results from various associations of cancer, hypoalbuminemia, electrolytic disturbances or organ failure. the lymphatic circulation cannot be summarized by the starling's equation and obstruction cannot explain everything. an interstitial hypothesis underlines the role of the lymphatic pump and edema volume can be a crucial point. the sdo, via the direct liquid removal, can restore the lymphatic pump function. this volumetric effect can explain the long time effect of the sdo and the large range of liquid amount reported in effective sdo. the superficial lymphatic system, in the superficial layer of derma, drains 80 % of lymph flow. in edema, the increased volume leads to the creation of subcutaneous interconnected lacunas. the subcutaneous site for drainage is justified. after topic anesthesia, three subcutaneous channels are created on the ankle's medial face of the edematous limbs and liquids are absorbed by pads. an additional drainage can be done on the external face of the thigh with liquid collecting bags in bedridden patients. the study includes clinical examination, total and segmental bioelectrical impedance measured at j0, j4 and on exit or at j7 at the latest and daily weight, umbilic abdominal perimeters and segmental circumferences and qol evaluation before and after sdo. bioelectrical impedance is collected from hand-foot, thigh root-foot and under patella calf - foot electrodes. segmental circumferences are collected at thigh, calf and ankle points identified from bone relief distance.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * palliative care patients * karnofsky scale \< 50% * uni or bilateral lower limb oedema even if associated with lumbar or pelvi-scrotal oedema or ascitis whatever etiology involved (cancer, organ failure, hypoalbuminemia...) * effective social security regimen affiliation * signed informed consent exclusion criteria: * refusal to take part in the study * local anesthesic contraindication * infected skin lesions.

Keywords: lower limb edema subcutaneous drainage bioelectrical impedance quality of life
study of the safety and effectiveness of rilonacept (il-1 trap) administered subcutaneously in subjects with non dialysis-dependent chronic kidney disease (ndd-ckd) and anemia

Conditions: Chronic Kidney Disease; Anemia

Summary: anemia of inflammation is a common complication in patients with chronic kidney disease (ckd). patients with ckd and anemia of inflammation also exhibit decreased response to erythropoietic agents, even in the presence of adequate iron stores. this decreased responsiveness is associated with increased levels of proinflammatory cytokines. rilonacept is being developed for the treatment of inflammatory disorders. this is a clinical research study to determine the safety and effectiveness of rilonacept for the treatment of anemia in inflamed patients with ckd who are not yet on dialysis.


Eligibility criteria:
inclusion criteria: * male or female greater than 18 years of age * chronic kidney disease (ckd) not yet requiring renal replacement therapy (pre-dialysis patients) * not expected to require dialysis during duration of the study * adequate laboratory values * if on rhuepo therapy, the dose must be stable exclusion criteria: * persistent chronic or active infections * intravenous (iv) iron administration within 12 weeks prior to the screening visit * known history of severe uncontrolled hyperparathyroidism * prior recipient or scheduled to receive a kidney transplant during the study * abnormal laboratory values * unstable angina or myocardial infarction within the past 6 months prior to the screening visit * uncontrolled hypertension * coronary disease diagnosed in the 3 months prior to the screening visit * severe congestive heart failure * history of hiv * hepatitis b and/or hepatitis c * abnormal chest radiograph * a positive intradermal skin tuberculin test * history or presence of cancer within 5 years of the screening visit * history of alcohol abuse or current intake of 21 or more alcohol-containing drinks per week * history of drug abuse within the 5 years prior to the screening visit * lactating females or pregnant females

Keywords: non dialysis-dependent chronic kidney disease and anemia
study evaluating heated lidocaine/tetracaine topical patch in treatment of patients with shoulder impingement syndrome

Conditions: Shoulder Impingement Syndrome

Summary: the purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome

the purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome. a number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.

Eligibility criteria:
inclusion criteria: * pain associated with shoulder impingement syndrome in a single shoulder * have tenderness at the attachment site of the rotator cuff tendons in the affected shoulder * have positive hawkins and neers signs exclusion criteria: * have used any topically applied pain medication on the target treatment area within 3 days preceding the screening/baseline visit * have used any injected pain medication within 14 days preceding the screening/baseline visit * are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.) * have a history of and/or past diagnosis of severe hepatic disease other protocol-defined inclusion/exclusion criteria may apply
exploring the efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis (expand)

Conditions: Secondary Progressive Multiple Sclerosis

Summary: evaluate the safety and efficacy of siponimod (baf312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (core part) followed by extended treatment with open-label baf312 to obtain data on long-term safety, tolerability and efficacy (extension part).

this study had two parts, a core part and an extension part. the core part of the study was a randomized, multicenter, double-blind, placebo-controlled parallel-group study in patients with secondary progressive multiple sclerosis (spms). eligible patients were randomized (2:1) to receive either siponimod or placebo. the duration of the core part of the study was variable for each patient, given that this was an event-driven study and terminated when a pre-defined number of confirmed disability progression (cdp) events had occurred irrespective of duration of individual patient participation. patients who had 6-month cdp during the treatment epoch of the core part were provided with options that included starting treatment with open label siponimod as rescue medication. patients who were eligible to enter the extension part received open label siponimod.

Eligibility criteria:
inclusion criteria: * prior history of relapsing remitting ms * spms defined as progressive increase of disability over at least 6 months * edss score of 3.0 to 6.5 * no relapse of corticosteroid treatment within 3 months exclusion criteria: * women of child bearing potential must use reliable forms of contraception. * diagnosis of macular edema during screening period * any medically unstable condition determined by investigator. * unable to undergo mri scans * hypersensitivity to any study drugs or drugs of similar class

Keywords: secondary progressive multiple sclerosis
safety and performance of invicta ventricular df4 leads with active fixation-(apollo)

Conditions: Ventricular Arrythmia; Lead; ICD; Heart Failure

Summary: the primary objective of this study is to assess the safety and key electrical performance of the invicta leads equipped with df4 connector: active fixation type models (single and dual coil: invicta 1cr, invicta 2cr)

apollo study is a pre-market approval (invicta leads - devices under investigation - are not ce marked), interventional, prospective, longitudinal, international (european), multicenter, single arm study. the devices under investigation, the invicta defibrillation leads, are new quadripolar leads, to be used with implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators (icd/crt-d). this clinical study intends to demonstrate safety and electrical performances of the invicta leads among the different models: active fixation either single coil (model 1cr) or dual coil (model 2cr)leads models. the clinical data will be used to support the application to ce marking of invicta leads. the primary endpoints will be evaluated at 3 months post-implantation; secondary endpoints will be evaluated up to 2 years post-implantation. a total number of 445 patients will be enrolled in the study, in up to 60 centers in europe. the follow-up visits are scheduled at hospital discharge, at 1 month, at 3 months, at 6 months, at 12 months, at 18 months and at 24 months, post-implant

Eligibility criteria:
inclusion criteria: 1. any patient presenting an icd or crt-d indication as detailed in the latest esc guidelines 2. scheduled for a de-novo implant of an icd (vr, dr) or crt-d, manufactured by microport crm and equipped with a df4 connector 3. signed and dated informed consent exclusion criteria: 1. tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue) 2. transient tachyarrhythmias due to reversible causes (such as drug intoxication, electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or electric shock) 3. contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate (dsp) 4. active myocarditis 5. previous implant of pacemaker, icd or crt-d device and leads 6. currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study 7. incapacitated subject or under guardianship, inability to understand the purpose of the study, or to meet follow-up visits at the implanting centre as defined in the investigational plan 8. minor subjects 9. pre-menopausal women 10. drug addiction or abuse 11. life expectancy less than 1 year
robyn study - robotic assisted surgery in gynecological indications compared to conventional laparoscopy

Conditions: GYN Disorders

Summary: robotic assisted surgery (da vinci system) in gynecological indications compared to conventional laparoscopy

a prospective, non-interventional, multinational, post-market clinical investigation

Eligibility criteria:
key inclusion criteria: * patient is willing to participate and to comply with the study procedures * patient present with gynecological disease that may be treated with surgical intervention key exclusion criteria: * life expectancy for less than 1 year
leipzig childhood obesity study

Conditions: Childhood Obesity

Summary: the aim of this study is to identify polymorphisms that make children and adolescents more prone to obesity and metabolic dysfunction, as well as to identify biomarkers that are linked to causes and consequences of obesity.

in order to identify single nucleotide polymorphisms blood and serum samples during oral glucose tolerance testing are routinely obtained from pediatric patients visiting the adiposity outpatient clinic.

Eligibility criteria:
inclusion criteria: * all pediatric patients seen in the adiposity outpatient clinic * informed patient consent exclusion criteria: * none

Keywords: single nucleotide polymorphisms obesity insulin resistance metabolic syndrome oral glucose tolerance test
a post marketing survey study to evaluate the safety and effectiveness of intelence

Conditions: Acquired Immune Deficiency Syndrome

Summary: the purpose of this study is to assess the safety data of etravirine in a natural clinical practice.

this is a non-interventional (a scientific study to make a clear and easy understanding of the cause and effect relationship), prospective (in which the participants are first identified and then followed forward as time passes), consecutive survey for collecting safety and efficacy data of etravirine in treatment of acquired immune deficiency syndrome (aids) in a natural clinical practice.

Eligibility criteria:
inclusion criteria: * patients who are prescribed with etravirine for treatment of acquired immune deficiency syndrome (aids) exclusion criteria: * known hypersensitivity to intelence * intelence coadministered with medicinal products that are highly dependent on cyp3a and cyp2c9 for clearance * patients with galactose intoralance, lapp lactase deficiency, and glucose-galactose malabsorption

Keywords: acquired immune deficiency syndrome tmc125 etravirine intelence aids
bhb & car-t for lymphomas

Conditions: Large B-cell Lymphoma

Summary: the aim of this study is to assess the feasibility of β-hydroxybutyrate (bhb) supplementation in individuals who are receiving therapy for lymphoma with standard-of-care anti-cd19 car t-cells (car-t) to determine whether bhb supplementation is safe and tolerable in this patient population. additionally, this study will determine whether bhb supplementation leads to changes the gut microbiome and peripheral blood mononuclear cells (pbmcs). bhb supplementation will be performed through oral administration of hvmn ketone-iq, a commercially available bhb supplement, with an active ingredient of r- 1,3-butanediol, which is converted to bhb.


Eligibility criteria:
inclusion criteria: * age of 18 years or older * history of pathologically-confirmed large b-cell lymphoma (lbcl) * planned treatment with a commercially available anti-cd19 car-t product (yescarta or kymriah) * eligible for and with adequate organ function (investigator discretion) and performance status (ecog ps 2 or less) for standard of care, anti-cd19 car-t * not enrolled on a clinical trial of bridging therapy prior to car-t * patients must have a pet/ct scan (preferred), diagnostic ct scan, or mri with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesions or ≥ 1cm for extra- nodal lesions in largest dimension by low-dose computerized tomography \[ct\] scan with fdg-uptake ≥ liver) documented prior to leukapheresis for car-t manufacturing * resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator * can provide informed consent * willing to comply with all study procedures and available for the duration of the study exclusion criteria: * subject is pregnant or breast feeding * history of allergy to energy drinks * history of inflammatory bowel disease * history of type 1 diabetes mellitus or requirement for insulin * history of chronic kidney disease with an egfr \< 30 ml/min/1.73m2 * additional second primary malignancy for which the subject is receiving active therapy or that will impede the ability of the investigator to assess lymphoma response
acalabrutinib (acp-196) alone and in combination with pembrolizumab in ovarian cancer (keynote191)

Conditions: Ovarian Cancer

Summary: to characterize the safety and efficacy of acalabrutinib (acp-196) monotherapy and acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian cancer


Eligibility criteria:
inclusion criteria: * women ≥ 18 years of age. * histologically confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma. * progression of disease after the most recent anticancer treatment. at least 1 prior chemotherapy regimen must have included a taxane. * platinum-sensitive ovarian cancer defined by recurrence or progression of disease \> 6 and \< 24 months after completion of the most recent platinum-based therapy. * measurable disease as defined by recist 1.1. * ecog performance status of 0 or 1. * completion of all therapy for the treatment of cancer 2 weeks before the start of study therapy and recovered. exclusion criteria: * evidence of platinum-refractory ovarian cancer defined as recurrence or progression during the first 6 cycles of or \< 6 months after the beginning of first-line platinum based chemotherapy. * evidence of platinum-resistant ovarian cancer defined as recurrence or progression within 6 months after completing the most recent platinum-based therapy. * more than 3 prior lines of cytotoxic chemotherapy for ovarian cancer. * prior malignancy (other than ovarian cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years. * breastfeeding and pregnant. * known central nervous system metastases and/or carcinomatous meningitis. * subjects with active cardiovascular disease not medically controlled or those who have had myocardial infarction in the past 6 months.. * malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction.
electroacupuncture intervention in catheter ablation of atrial fibrillation

Conditions: Atrial Fibrillation; Catheter Ablation

Summary: this is a randomized control trial to determine whether electroacupuncture(ea) intervention with morphine can reduce the intraoperative pain and early post-operative complications in patients undergoing catheter ablation of atrial fibrillation.


Eligibility criteria:
inclusion criteria: 1. aged 18 to 80 years old; 2. atrial fibrillation 3. nonresponse or intolerance to ≥1 antiarrhythmic drug. exclusion criteria: 1. a history of allergy to acupuncture; 2. with uncontrolled congestive heart failure; 3. having significant valvular disease; 4. having moderate-to-severe pulmonary hypertension; 5. with myocardial infarction or stroke within 6 months of screening; 6. with significant congenital heart disease; 7. ejection fraction was \<40% measured by echocardiography; 8. allergic to contrast media; 9. contraindication to anticoagulation medications; 10. severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (copd); 11. left atrial thrombus; 12. having any contraindication to right or left sided heart catheterization
diabetes management intervention for south asians

Conditions: HbA1c; Diabetes

Summary: the goal of this study is to evaluate the effectiveness and implementation process of a multi-level, integrated intervention to decrease hba1c among south asians with uncontrolled diabetes, including four components: 1) an ehr-based registry function to increase identification of south asian patients with uncontrolled diabetes; 2) chw-led health coaching of registered patients to promote health behavior change; 3) hit-enabled and chw-facilitated identification and referral to culturally relevant community resources for patients; and 4) hit-enabled care coordination between the chw and other members of the healthcare team.


Eligibility criteria:
inclusion criteria: * south asian ethnicity (identified through a race and language code available in the ehr); * an appointment with a physician for routine non-emergent primary care in the last 12 months * diagnosis of diabetes * an hba1c reading of \>7 in the last 12 months exclusion criteria: * pregnant women and visits to obstetrician/gynecologist are excluded from the study
ambisome® preemptive treatment of multiple candida colonization in sepsis patients

Conditions: Sepsis; Candida

Summary: to assess the safety of ambisome 10 mg/kg/week in patients as a preemptive treatment in intensive care patients with a sepsis and rising candida colonisation. preemptive treatment (i.e., prophylactic treatment with two high doses of ambisome® administered with an interval of one week, in patiens with a high risk of developing a fungal infection) should decrease the incidence of actual systemic infections. the incidence of such actual fungal infections will be assessed directly and its impact on patients' survival and intensive care resourches assessed


Eligibility criteria:
inclusion criteria: * supportive mechanical ventilation for more than 48 h * lod \> 5 with with ailing body systems * candida colonisation of at least one site in addition to the digestive tract * suspected nosocomial infection with antibiotic treatment * informed consent exclusion criteria: * patients treated with oral or systemic antifungal agents within 15 days prior to inclusion * patients requiring treatment with an antifungal agent or with a documented (proven or probable) fungal infection according to the eortc criteria * patients with a saps score \> 65 * patients with neutropenia of that underwent a bone marrow tar organ transplant or with cancer chemotherapy * blood creatinine \> 220 µmol/l * hemodyalysis * pregnant women

Keywords: fungal infection sepsis intensive care ambisome preemptive treatment sepsis with candida colonisation
study of dasatinib (bms-354825) in patients with solid tumors

Conditions: Tumors

Summary: the primary objective of this study is to determine the maximum tolerated dose (mtd) or the maximum administered dose (mad) of dasatinib (bms-354825) in patients in japan.


Eligibility criteria:
inclusion criteria: * performance status (general conditions) specified by the eastern cooperative oncology group: 0-2 * histologic or cytologic diagnosis of a solid tumor which has progressed on or following standard therapies (including relapsed disease) or for which no standard therapy exists. * men and women, ages 20 and over * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized * adequate hepatic function exclusion criteria: * participants who are eligible and willing to undergo transplantation at pre- study. * women who are pregnant or breastfeeding with known brain metastasis or symptoms of brain metastasis * uncontrolled or significant bleeding disorder unrelated to a primary tumor * dementia or mental illness that would prohibit understanding or giving informed consent. * severe allergy to drugs required for appropriate supportive care of patients in this study. * history of gastrointestinal surgery or of any digestive disorder which has the potential to inhibit absorption of the study drug. * pleural effusion \> grade 1 * patient with dysphagia * does not agree to blood/blood products transfusion(s) * donated blood over 200 ml within 4 weeks prior to the start of study therapy * medication that known to have a risk of causing torsade de pointes * participants who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Keywords: solid tumors (including relapsed disease) that are refractory to standard therapies or for which no effective standard therapy exists