Kornimate/medical-research-clean huggingface dataset:
pk/pd of ertapenem in patients with tb

Conditions: PK of Ertapenem in TB Patients

Summary: rationale: treatment of multidrug or extensively drug resistant tuberculosis (mdr/xdr-tb) is a real challenge as failure in response to treatment and serious side-effects are frequently encountered. new, more effective drugs with less side effects are therefore urgently needed to solve this problem. although several new drugs against tb are in the pipeline, physicians currently have limited treatment options for treatment of complicated mdr/xdr-tb cases. therefore, drugs developed and labeled for other infectious diseases are evaluated for tb. objective: the main objective of this prospective clinical trial is to evaluate pharmacokinetics of a standard dose (2000mg) of ertapenem in tb patients. this clinical trial will provide important information on pk of ertapenem in tb patients for future studies. data can be used for limited sampling strategies for ertapenem based on a pharmacokinetic population model constructed from the full pk curves of the patients. study design: a prospective pharmacokinetic study. study population: 12 tb patients. intervention: single dose of 2000mg in a 30 minutes intravenous infusion. main study parameters/endpoints: the pharmacokinetic parameters (vd, cl, auc, etc) of ertapenem are the primary endpoints of the study. the t\>mic and auc0-24h/minimal inhibitory concentration (mic) ratio are most likely the best predictive parameters for efficacy of ertapenem treatment and will be calculated for a range of m tuberculosis isolates.


Eligibility criteria:
inclusion criteria: * patients with tb, with mycobacterium tuberculosis (or m. africanum) by culture and / or molecular test * adults: from 18 years until 64 years of age exclusion criteria: -contra-indications for ertapenem: * there are few adverse effects of ertapenem. the only absolute contra- indication is a previous anaphylactic reaction to ertapenem or other β-lactam antibiotic. * renal insufficiency, defined by a egfr of 30ml/min * pregnancy * hiv * body weight \< 40 kg

Keywords: ertapenem tuberculosis pharmacokinetics
jsp191 antibody targeting conditioning in scid patients

Conditions: SCID

Summary: a phase 1/2 study to evaluate the safety, tolerability, and efficacy of an antibody conditioning regimen, known as jsp191, in patients with severe combined immune deficiency undergoing blood stem cell transplantation

a phase 1/2 study to evaluate the safety, tolerability, and efficacy of an antibody conditioning regimen, known as jsp191, in patients with scid undergoing blood stem cell transplantation. blood stem cell transplantation offers the only potentially curative therapy for scid. the biological conditioning regimen, jsp191, is an antibody that binds to cd117. cd117 is the receptor for stem cell factor on blood forming cells. cd117 binding to stem cell factor is critical for survival and maintenance of blood forming stem cells. the binding of jsp191 to cd117 blocks cd117 from binding to stem cell factor on blood forming stem cells. in the absence of cd117/stem cell factor binding, hematopoietic stem cells that are currently occupying the bone marrow niches in scid patients exit from the bone marrow.

Eligibility criteria:
key inclusion criteria: 1. typical scid as defined by primary immune deficiency treatment consortia including but not limited to the following subtypes: 1. t-, b+, nk-: il-2rcγ deficient, jak3-deficient (no longer enrolling) 2. t-, b-, nk+: rag1/2 deficient, artemis-deficient 3. t-, b+, nk+: il7rα deficient, cd3 subunit deficient, cd45 deficient (no longer enrolling) or variant scid with absent or low t cell function, omenn syndrome, leaky scid, reticular dysgenesis, adenosine deaminase deficiency, and purine nucleoside phosphorylase deficiency may be included after consultation with the medical monitor. 2. patients with human leukocyte antigen (hla) matched related or unrelated donors 3. adequate end organ function as defined in study protocol 4. age ≤ 12 years 5. prior donor of appropriate age (≥ 5 years old) available for re-collection of stem cells 6. previous allogeneic hematopoietic cell transplantation hct (≥ 6 months post initial transplant) with poor graft function key exclusion criteria: 1. patients with any acute or uncontrolled infections 2. patients receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy 3. patients with active malignancies 4. active gvhd within 6 months prior to enrollment, or on immunosuppressive therapy for gvhd

Keywords: immunodeficiency pediatric scid bone marrow transplantation gvhd stem cells chimerism transplant bmt
extracorporal cytokin removal in septic shock: a prospective, randomized, multicenter clinical trial

Conditions: Septic Shock

Summary: sepsis and septic shock have mortality rates between 20-50%. when standard therapeutic measures fail to improve patients' condition, additional therapeutic alternatives are applied to reduce morbidity and mortality. one of the most recent alternatives is extracorporeal cytokine hemoadsorption. one of the most tested devices is cytosorb, however, there are a lot of open questions, such timing, dosing and of course its overall efficacy. this study aims to compare the efficacy of standard medical therapy (group a, smt) and continuous extracorporeal cytokine removal with cytosorb therapy in patients with early refractory septic shock. furthermore, we compare the dosing of cytosorb adsorber device - as the cartridge will be changed in every (12 group b) or 24 hours (group c).


Eligibility criteria:
inclusion criteria: * septic shock as defined by the sepsis-3 criteria * septic shock both medical or surgical ethiology (except for re-operation) * apache \> 25 * mechanical ventilation * norepinephrine requirement ≥0.4 µg/kg/min for at least 30 minutes, when hypovolemia is highly unlikely as indicated by invasive hemodynamic measurements assessed by the attending physician * invasive hemodynamic monitoring to determine cardiac output and derived variables * procalcitonin level ≥ 10 ng/ml * inclusion within 6 - 24 hours after the onset of vasopressor need and after all standard therapeutic measures have been implemented without clinical improvement (i.e.: the shock is considered refractory) exclusion criteria: * patients under 18 years and over 80 * lack of health insurance * pregnancy * standard guideline-based medical treatment not exhausted (detailed below at 3.6) standard medical therapy) * end stage organ failure * new york heart association class iv. * chronic renal failure with egfr \< 15 ml/min/1,73 m2 * end-stage liver disease (meld score \>30, child-pugh score class c * unlikely survival for 24 hours according to the attending physician * acute onset of hemato-oncological illness * post cardiopulmonary resuscitation care * re-operation in context with the septic insult * immunosuppression * systemic steroid therapy (\>10 mg prednisolon/day) * immunosuppressive agents (i.e.: methotrexate, azathioprine, cyclosporin, tacrolimus, cyclophosphamide) * human immunodeficiency virus infection (active aids): hiv-vl \> 50 copies/ml * patients with transplanted vital organs * thrombocytopenia (\<20.000/ml) * more than 10%-of body surface area with a third-degree burn * acute coronary syndrome

Keywords: sepsis, septic shock, cytosorb, cytokine removal
reno- and vascular protective effect of a vitamin-d-analogue in moderate to severe chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: recently it has been documented that vitamin d has important functions in the human body that are unrelated to its primary effects in calcium homeostasis and bone mineralization. in clinical studies, paricalcitol - a low-calcemic vitamin d analogue - has been shown to decrease proteinuria, a marker of disease progression and cardiovascular risk in patients with chronic kidney disease (ckd). the purpose of this study is to investigate the effect of a paricalcitol on renal and cardiovascular variables in patients with moderate to severe ckd.


Eligibility criteria:
inclusion criteria: * kidney disease corresponding to egfr: 15-59 ml/min * albuminuria \> 30 mg/l exclusion criteria: * total parathyroidectomy * diabetes mellitus * cancer * illicit drug or alcohol abuse * pregnancy og nursing * ongoing nsaid or corticosteroid treatment * b-hemoglobin \< 6 mmol/l * p-albumin \< 25 mmol/l * clinically significant hypercalcemia * office blood pressure \> 170/105 mmhg that despite antihypertensive treatment still is \> 170/105 mmhg when using home blood pressure measurements or 24-hour ambulatory blood pressure measurement.

Keywords: paricalcitol vitamin d kidney disease renin proteinuria
the influence of hormonal changes during pregnancy on corneal biomechanics in humans

Conditions: Pregnancy

Summary: the intraocular pressure in the human bulbus requires that the "wall" of the eye shows a certain (bio)mechanical strength. the human cornea represents the anterior portion of this wall. since several years, there is a growing interest in the ophthalmological community for identifying factors modulating the biomechanical stability of the human cornea. reasons are twofold: advances in keratoconus research and the increasing numbers of refractive laser surgery procedures with (correspondingly) increasing numbers of complications due to non-respecting the limits of corneal biomechanics. there is evidence that oestrogen, but also thyroïd hormone changes have a major impact on corneal biomechanics. a number of recent observational studies have reported on keratoconus and refractive laser surgery patients with decompensating biomechanics during pregnancy. both hormones also show physiological changes during pregnancy and little is known about the impact of these physiological changes on the human cornea. the aim of this study is to establish baseline values for physiological changes in the human cornea during pregnancy.


Eligibility criteria:
inclusion criteria: * older than 18 years * pregnancy confirmed by echography * before gestation week 14 exclusion criteria: * pre-existing corneal disease * previous eye surgery * inability to understand the nature of the study * patient with legal guardian

Keywords: cornea biomechanics pregnancy keratoconus refractive surgery
study of rivaroxaban for cerebral venous thrombosis

Conditions: Cerebral Venous Thrombosis

Summary: secret examines the safety of rivaroxaban versus standard-of-care for treatment of symptomatic cerebral venous thrombosis, initiated within 14 days of diagnosis.

secret is an open-label, randomized, controlled, phase ii study that will assess the safety of rivaroxaban, a non-vitamin k antagonist oral anticoagulant (noac), compared with standard-of-care (unfractionated or low-molecular weight heparin with transition to warfarin \[inr 2.0-3.0\], or continued low molecular-weight heparin) for cerebral venous thrombosis. recruitment will occur at 17 high-volume stroke research centres across canada over 3 years. during the pilot phase, 50 adult patients within 14 days of symptomatic cerebral venous thrombosis diagnosis will be randomized to receive rivaroxaban 20 mg daily versus standard of care (warfarin or low-molecular weight heparin). patients will be followed for 1 year. the feasibility of recruitment will be tested during the pilot phase and outcomes refined for a future phase iii trial.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 and above 2. new diagnosis of symptomatic cerebral venous thrombosis as confirmed on ct venogram or mr venogram 3. ability to randomize within 14 days of neuroimaging-confirmed diagnosis 4. the treating clinician is of the opinion that the patient is appropriate for oral anticoagulation as per standard of care 5. patient or legally authorized representative is able to give written informed consent exclusion criteria: 1. patient has known antiphospholipid antibody syndrome (apls; lupus anticoagulant, anti-beta 2-glycoprotein i antibodies, and anticardiolipin antibody) by sapporo-sydney criteria with a previous history of venous or arterial thrombosis 2. patient is anticipated to require invasive procedure (e.g. lumbar puncture, thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation\*\* 3. patient is unable to swallow due to depressed level of consciousness† 4. impaired renal function (i.e., crcl \< 30 ml/min using cockroft-gault equation) 5. pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hcg) test is positive 6. breastfeeding at the time of randomization 7. bleeding diathesis or other contraindication to anticoagulation 8. any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use 9. concomitant use of strong cyp3a4 inducers (e.g., ongoing use of dilantin, carbamazepine, hiv protease inhibitors) or cyp3a4 inhibitors (e.g., diltiazem, ketoconazole) 10. patient has a severe or fatal comorbid illness that will prevent improvement, or cannot complete follow-up due to the same, or cannot complete follow-up due to co-morbid non-fatal illness, non-residence in the city, or for any other known reason for which follow-up would be impossible.

Keywords: cerebral venous thrombosis anticoagulation
rehabilitative therapy and pridinol in patients with lumbar spondylarthrosis and chronic low back pain

Conditions: Spondyloarthropathy

Summary: spondyloarthrosis is a degenerative disease involving the intervertebral disc, vertebral bodies, and adjacent soft tissues. treatment aims to slow disease progression and manage symptoms through an interdisciplinary approach.it can be conservative, pharmacological and interventional, rarely chirurgic. this study aimed to evaluate the effectiveness of a rehabilitation program combined with pridinol mesylate in the treatment of spondyloarthrosis in elderly patients in terms of pain resolution, improving disability, and quality of life versus single treatment. a randomized controlled trial was conducted in patients with spondyloarthritis. the patients recruited were divided into three groups: the combined group (cg), who received a rehabilitation program combined with pridinol mesylate; the rehabilitation group (rg), who received only the same rehabilitation program; and the drug group (dg), who received only the administration of the drug.


Eligibility criteria:
inclusion criteria: * age 65-75 years, * low back pain for at least 3 months, * nrs ≥ 4, * radiographic diagnosis of spondyloarthrosis, * written informed consent. exclusion criteria: * inflammatory diseases of the spine, * obesity (bmi 20-30), * positive radicular tests, * allergy or contraindications related to taking pridinol mesylate.

Keywords: spondylarthropathies pridinol mesilate low back pain rehabilitation therapy
internet-based behavioral intervention following acs

Conditions: Acute Coronary Syndrome; Online CBT Targeting Cardiac Anxiety

Summary: the aim of this study is to evaluate if an online cognitive behavioral therapy (cbt) protocol customized for patients following acute coronary syndrome (acs), reduce cardiac anxiety, enhance quality of life (qol), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention.

acs is a leading global cause of mortality and health-related losses. following acs, many individuals exhibit symptoms of anxiety and depression, recognized risk factors for recurrent cardiovascular events. specifically, anxiety related to cardiac symptoms and avoidance behavior, known as cardiac anxiety, has been shown to increase the long-term risk of adverse cardiac events. the purpose of the present interdisciplinary research project is to develop and evaluate an online cbt protocol tailored for acs patients. this project comprises a series of clinical studies aimed at accumulating knowledge about the most effective ways to treat acs patients with cbt over the internet. the aim of this study is to assess whether internet-based cbt, following acs, reduces cardiac anxiety and improves qol, while controlling for caregiver attention and expectancy of improvement using an active control group. method: a randomized controlled trial is conducted where participants are randomly assigned to either internet-based cbt (n=130) or internet-based cardiac lifestyle intervention (internet-cl) (n=130). the active control group receives internet-cl, focusing on lifestyle modification and health-promoting behaviors. weekly therapist support through online written communication is provided to participants in both groups. both treatment are conducted over 8-weeks and are comparable in terms of the number of treatment modules, intensity, and attention from the treating psychologist.

Eligibility criteria:
inclusion criteria: * acs ≥ 6 months before assessment (type 1 mi stemi/nstemi or unstable angina \[ua\]) * age 18 and older * clinically significant cardiac anxiety that leads to distress and/or interferes with daily life (cardiac anxiety questionnaire; caq: ≥18 * able to read and write in swedish exclusion criteria: * heart failure new york heart association class iv or ejection fraction ≤ 30% * significant valvular disease * planned coronary artery bypass surgery or percutaneous interventions * any medical restriction to physical exercise * severe medical illness or an acute health threatening disease (e.g., cancer) * grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic) * severe mental illness requiring urgent psychiatric hospitalization or intervention, or risk of suicide * alcohol or substance use disorder that would impede ability to complete study protocol * ongoing psychological treatment

Keywords: cardiac anxiety acute coronary syndrome acs internet-cbt cbt secondary prevention
the efficacy of a dentifrice in providing relief from the pain of dentinal hypersensitivity

Conditions: Dentine Hypersensitivity

Summary: a study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.


Eligibility criteria:
inclusion criteria: * subjects who suffer from tooth sensitivity inclusion criteria: - none
exercise as a supportive measure for patients undergoing checkpoint-inhibitor treatment

Conditions: PD-1 Antibodies; Exercise; Melanoma

Summary: checkpoint inhibitors like the pd-1 antibodies pembrolizumab and nivolumab represent standard of care for patients with metastasized melanoma. numerous high quality studies demonstrate that endurance and resistance training in cancer patients is safe and elicits beneficial effects. however, there is no systematic experience with regard to exercise interventions in patients undergoing checkpoint inhibitor treatment. therefore, the sportivumab study aimed to investigate safety, feasibility and effectivity of a 12 week combined resistance and endurance exercise intervention program during checkpoint inhibitor treatment. it is planned to enroll 40 patients. participants will be randomized into an experimental and a wait-list control group (20 per group). the wait-list control group will receive the exercise intervention program after week 13 of enrollment.


Eligibility criteria:
inclusion criteria: * patients at age ≥ 18 years * diagnosed with melanoma stage (independent of stage) * assigned to receive an immunotherapeutic regimen (pd-1 antibody +/- ipilimumab) * sufficient german language skills * willing to train at the exercise facilities twice per week and to take part in the scheduled testing at the national center for tumor diseases * signed informed consent exclusion criteria: * any physical or mental conditions that would hamper the performance of the training programs or the completion of the study procedures * engaging in systematic intense exercise training (at least 1h twice per week)

Keywords: exercise cancer melanoma feasibility pd-1 antibodies checkpoint inhibitors immune system
initiation of androgen deprivation therapy for prostate cancer using degarelix followed by leuprolide

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine if patients initiating androgen deprivation therapy (adt) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate after an initial three-month period without a rise in serum testosterone. the investigators expect testosterone will quickly and reliably reach castrate levels after initiation of adt and will remain castrate during the transition, and there will be no "testosterone surge" after leuprolide injection.


Eligibility criteria:
inclusion criteria: * 18 years or older * histologically confirmed adenocarcinoma of the prostate * androgen deprivation therapy is indicated exclusion criteria: * baseline screening serum testosterone \<150ng/dl * eastern cooperative oncology group (ecog) score \> 2 * diagnosed spinal or brain metastases * hormonal manipulation within previous 6 months

Keywords: prostate cancer hormone therapy testosterone measures
translation, cross-cultural adaptation and validation of the mgqol-15-f

Conditions: Myasthenia Gravis

Summary: the purpose of this study is to translate and culturally adapt the mgqol-15 (health-related quality of life scale for myasthenia gravis) for use with french-speaking patients in france and to evaluate its psychometric properties to ensure reliability and validity.

it is a translation and validation of a quality of life scale. step 1: translation and cultural adaptation (forward and back translation, committee review, pre-testing with 10 patients for content and face validity). step 2 : psychometric testing : test-retest with a 2 day interval, correlation with clinical scores - the myasthenic muscle score and the (mg-adl) score and with a global quality of life score (whoqol-bref).

Eligibility criteria:
inclusion criteria: * auto-immune myasthenia gravis * age ≥ 18 years old * clinical classification (mgfa) i-iv * french speaking exclusion criteria: * cognitive or visual impairment which would limit the capacity to fill out the mgqol-15-f

Keywords: myasthenia gravis quality of life
long-acting g-csf for febrile neutropenia

Conditions: Epithelial Ovarian Cancer; Colony Stimulating Factors; Febrile Neutropenia; Myelosuppression Adult; Adverse Event; Cost-effectiveness

Summary: this study aims to analyze the effects of long-acting granulocyte colony stimulating factor (g-csf) on the prevention febrile neutropenia (fn) in epithelial ovarian cancer. patients are randomized into study group and control group. in study group, patients accept long-acting g-csf 48 hours from the chemotherapy. while the control group accept regular treatment rather than long-acting g-csf. the primary end is the incidence of fn in every course of chemotherapy. the secondary ends include: the incidences of myelosuppression, doses of g-csf and its expenses, visits to outpatient and emergency clinics, adverse events related to g-csf.


Eligibility criteria:
inclusion criteria: * willing to accepted debulking surgeries and adjuvant chemotherapy * good performance status * aged 18 years or older * signed an approved informed consents * no immunosuppressive disease exclusion criteria: * not meeting all of the inclusion criteria