Kornimate/medical-research-clean huggingface dataset:
immunomodulation with romiplostim in young adults with itp

Conditions: Immune Thrombocytopenia

Summary: the study aims to investigate immunomodulatory effects of thrombopoietin-receptor agonist (tpo-ra) in patients with primary itp, who failed first-line therapy or who became intolerant to it. it is hypothesized that the early phase of this autoimmune disease may exhibit a stronger immunomodulatory potential in response to a stimulus, such as romiplostim. such a process may subsequently be capable to induce regulatory mechanisms or tolerance. romiplostim (a thrombopoietin-receptor agonist, tpo-ra) will be administered subcutaneously once weekly over 22 weeks with a starting dose of 1mcg/kg body weight. the dose will be adjusted based on platelet counts as described in the summary of product characteristics (smpc).


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature (see informed consent form) * primary itp according to the definition of rodeghiero et al. (52) and a platelet count of \<30x109/l * age range: 18-45 years * previously treated patients, with failure or intolerance to first-line therapy, or relapse after first-line therapy, i.e. corticosteroids, intravenous immunoglobulin (ivig), or anti-d immunoglobulins exclusion criteria: * adults older than 45 and children younger than 18 years * platelet count higher than 30x109/l at time of screening * suspicion of secondary itp * positive family history for itp * presence or history of autoimmune disease as judged by the investigator * hepatosplenomegaly * presence or history of relevant hepatic disease as judged by the investigator * presence or history of thromboembolic disease as judged by the investigator * patients with splenectomy * women who are pregnant or breast feeding * intention to become pregnant during the course of the study * lack of safe double contraception (see 7.1) * any vaccination 2 weeks prior start of the study * drugs with a known impact on the immune system or on platelet function must be recorded and an exclusion of the study should be discussed with the study center * known or suspected non-compliance, drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the study subject * participation in another study with investigational drug within the 30 days preceding and during the present study * previous enrolment into the current study * previous treatment with romiplostim or eltrombopag * hypersensitivity to the active substance or to any of the excipients or to e. coli derived proteins * enrolment of the investigator, his/her family members, employees and other dependent persons

Keywords: immunomodulation
cpi-006 alone and in combination with ciforadenant and with pembrolizumab for patients with advanced cancers

Conditions: Non-Small Cell Lung Cancer; Renal Cell Cancer; Colorectal Cancer; Triple Negative Breast Cancer; Cervical Cancer; Ovarian Cancer; Pancreatic Cancer; Endometrial Cancer; Sarcoma; Squamous Cell Carcinoma of the Head and Neck; Bladder Cancer; Metastatic Castration Resistant Prostate Cancer; Non-hodgkin Lymphoma

Summary: this is a phase 1/1b open-label, dose escalation and dose expansion study of cpi-006, a humanized monoclonal antibody (mab) targeting the cd73 cell-surface ectonucleotidase in adult subjects with select advanced cancers. cpi-006 will be evaluated as a single agent, in combination with ciforadenant (an oral adenosine 2a receptor antagonist), in combination with pembrolizumab (an anti-pd1 antibody), and in combination with ciforadenant and pembrolizumab.


Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status 0-1. 2. documented incurable cancer with one of the following histologies: nonsmall cell lung cancer, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability(msi), bladder cancer, cervical cancer, uterine cancer, sarcoma, endometrial cancer, and metastatic castration resistant prostate cancer. 3. at least 1 measurable lesion per response evaluation criteria in solid tumors (recist 1.1). 4. for escalation: at least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease. for expansion: subject must have progressed on, be refractory to, or intolerant to 1-3 prior systemic therapies. 5. willingness to provide tumor biopsies. exclusion criteria 1. history of severe hypersensitivity reaction to monoclonal antibodies. 2. subjects who have received prior therapy with regimens containing cytotoxict-lymphocyte antigen-4 (ctla-4), programmed cell death ligand 1 (pdl1), or pd1 antagonists are not permitted to enroll unless all adverse events (aes) while receiving prior immunotherapy have resolved to grade 1 or baseline prior to screening. 3. history of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis. 4. the use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited. 5. symptomatic, untreated, or actively progressing central nervous system (cns) metastases.

Keywords: nsclc rcc tnbc mcrpc crc lung cancer kidney cancer rectal cancer breast cancer sarcoma endometrial pancreatic ovarian scchn nhl
safety and tolerability study of pf-06835375 in subjects with seropositive systemic lupus erythematosus or rheumatoid arthritis

Conditions: Systemic Lupus Erythematosus; Rheumatoid Arthritis

Summary: this is a phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of pf-06835375 in subjects with seropositive sle or ra. the design is double-blind, sponsor open and placebo controlled. this study will include two parts: part a and part b. part a will consist of single ascending dose cohorts, part b of multiple ascending dose cohorts. this study will enroll up to a total of approximately 112 subjects at approximately 10 sites.


Eligibility criteria:
inclusion criteria: * patients with rheumatoid arthritis: confirmed diagnosis according to 2010 acr/eular criteria with symptom duration at least 6 months and positive with rheumatoid factor and/or anti citrullinated peptide antibody * patients with systemic lupus erythematosus: confirmed diagnosis according to the slicc classification criteria with symptom duration at least 6 months and at least one of the following: positive antinuclear antibody titer, positive anti-dsdna, anti-smith antibodies exclusion criteria: * active central nervous system manifestations, systemic vasculitis or pleuro/pericarditis * active lupus nephritis * treatment with b cell depleting agents within 52 weeks prior to screening
access ii - trial of warfarin to prevent malfunction of haemodialysis catheters

Conditions: End Stage Renal Disease; Thrombosis; Bleeding

Summary: this study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding.

patients with end-stage renal disease receiving or about to initiate hemodialysis are randomized to receive either adjusted dose warfarin to achieve an inr of 1.5-1.9 or adjusted dose placebo within 72 hours of hemodialysis catheter placement. the primary outcome is mechanical failure of the catheter, as outlined below.

Eligibility criteria:
inclusion criteria: * newly placed double-lumen hemodialysis catheter exclusion criteria: * major bleed within last 3 months * platelet count less than 50 x 10 9/l or current coagulopathy (most recent inr \> 1.5, not due to warfarin) * active peptic ulcer disease * anticipated need for invasive intervention within next 2 weeks * taking warfarin for an indication other than access prophylaxis * allergic to, or intolerant of, warfarin * pregnant * woman of child-bearing age who has not agreed to use an adequate method of birth control for the duration of the study * catheter likely needed for 2 weeks or less * patient previously took part in the study * patient has known aortic aneurysm of 6cm or greater * patients nephrologist has refused consent * patient has refused consent

Keywords: end stage renal disease thrombosis bleeding
safety and immunogenicity of an aluminium hydroxide/lhd153r adjuvanted meningococcal c-crm197 conjugate vaccine

Conditions: Infections, Meningococcal

Summary: dosage-escalation study to evaluate the safety and immunogenicity of an aluminium hydroxide/lhd153r adjuvanted meningococcal c-crm197 conjugate vaccine in healthy adults (18-45 years of age).


Eligibility criteria:
inclusion criteria: 1. male or female individuals of 18 through 45 years of age on the day of informed consent 2. healthy volunteers with good physical and mental health status, determined on the basis of the medical history, a physical examination and the results of the screening tests as judged by the investigator 3. individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry 4. individuals who can comply with study procedures including follow-up 5. individuals that are able to understand, read and write german language 6. females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination. exclusion criteria: 1. progressive, unstable or uncontrolled clinical conditions 2. hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study 3. clinical conditions representing a contraindication to intramuscular vaccination and blood draws 4. abnormal function of the immune system 5. received immunoglobulins or any blood products within 180 days prior to informed consent 6. received an investigational or non-registered medicinal product within 30 days prior to informed consent or intend to participate in another clinical study at any time during the conduct of this study 7. vulnerable subjects (e.g. persons kept in detention), study personnel or an immediate family or household member of study personnel, subjects with legal incapacity or limited legal capacity 8. any relevant deviation from the laboratory parameters at screening as judged by the investigator 9. previously received any vaccine that included a menc antigen 10. previously suspected or confirmed disease caused by n. meningitides 11. had household contact with and/or intimate exposure to an individual with culture proven menc 12. a positive serum or urine pregnancy test prior to the study vaccine administration or are currently lactating. 13. a positive drugs-of-abuse test prior to the study vaccine administration; 14. received any other vaccines within 30 days prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the administration of study vaccines 15. any other condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
nutrigenomics investigation of the body's metabolic response to 2 different meal challenges

Conditions: Healthy Subjects

Summary: the purpose of this study is to investigate the biological response to a metabolic stress, given in the form of a high carbohydrate or fat meal in normal weight, overweight and obese individuals and to further explore these responses using novel metabolomic, proteomic, transcriptomic and genotyping techniques.

the most recent statistics from the department of health in ireland (2005) indicate that the leading causes of death are those in which nutrition can play a key preventative role. the proposed study will provide information on the metabolic stress from varying body weight overlaid by the additional metabolic stress of a test-meal challenge, in this case being delivered in the form of an oral glucose tolerance test (ogtt) and oral lipid tolerance test (oltt), standard metabolic challenges in post-prandial research. previous studies assessing metabolic risk factors associated with a disease have typically focused on information collected from individuals in a fasting state only. however, it is equally important to assess how the body responds when stressed. employing an acute high fat or carbohydrate intake is sufficient to induce a mild stress in which time an individual's unique post-prandial response can be monitored. this study will combine traditional markers (dietary, anthropometric, lifestyle, clinical and physical activity) with nutrigenomics, a tool that attempts to describe the genome-wide influences of nutrition by examining the impact of diet on genes (genomics), mrna (transcriptomics), proteins (proteomics) and metabolites (metabolomics).

Eligibility criteria:
inclusion criteria: * aged 18 to 60 years * not taking medication (other than contraceptive pill/hrt) * irish resident and living in dublin area exclusion criteria: * known chronic/infectious disease * pregnancy/lactation * desire to conceive or lose weight during study * athlete

Keywords: post-prandial nutrigenomic test meal oral glucose tolerance test oral lipid tolerance test
a phase 1 feasbility study of volume intracardiac echo in assessment of patients with structural and valvular heart disease undergoing percutaneous transcatheter therapy

Conditions: Structural and Valvular Heart Disease

Summary: this study will compare 3 dimensional intracardiac echo (ice) with 2 dimensional ice or transesophageal echo in patients with structural and valvular heart disease who are already scheduled to undergo a percutaneous intervention. specifically those patients would be those scheduled for a pfo or asd repair, mitral balloon valvuloplasty, diagnostic cardiac catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve replacement.


Eligibility criteria:
inclusion criteria: * patients in the study population referred to the cardiac catheterization laboratory for a percutaneous procedure to treat structural or valvular heart disease exclusion criteria: * class iv chf, inadequate femoral access, coagulation abnormalities, intracariac thrombus or dvt
prospective cohort of respiratory insufficiency outcome

Conditions: COPD; Non Invasive Ventilation

Summary: the respiratory insufficiency outcome (rio) project consists in a french multicenter prospective cohort of patients with chronic obstructive pulmonary disease (copd) undergoing domiciliary noninvasive positive pressure ventilation.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd * domiciliary noninvasive ventilation exclusion criteria: * noninvasive ventilation set up for a neuromuscular disease
closing the loop for 36 hours in adolescents with type 1 diabetes: evaluation of reduced meal bolusing

Conditions: Type 1 Diabetes

Summary: the main focus of our research is the development of a closed-loop system for glucose control in people with type 1 diabetes. after having demonstrated the safety and efficacy of overnight closed-loop insulin delivery, we are extending the evaluation of closed-loop to the daytime. meal-related insulin dosing can be challenging and prandial insulin overdosing can be associated with the occurrence of postprandial hypoglycaemia, thus representing a confounding factor of hypoglycaemia free glucose control during the day. a further investigation is needed to evaluate alternative strategies for prandial insulin dosing. we will study eight adolescents with type 1 diabetes during closed-loop insulin delivery combined with either standard or reduced insulin doses with the meals, in a randomised crossover design. stable glucose isotopes will be administered to collect data for modelling of glucose turnover around the meals, during daily activities and overnight. the information provided by the use of glucose isotopes would be very helpful to increase our understanding of the physiology of glucose turnover and to facilitate the development of an improved control algorithm. ultimately this study will help with the development of a closed-loop system to match insulin infusions to change in glucose levels in real life conditions.


Eligibility criteria:
inclusion criteria: * the subject is between 12 and 18 years of age (inclusive). * the subject has had type 1 diabetes, as defined by who for at least 1 year or is confirmed c-peptide negative. * the subject will have been on insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment. * hba1c ≤ 12 % based on analysis from central laboratory exclusion criteria: * non-type 1 diabetes mellitus including those secondary to chronic disease * any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results * current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and mao inhibitors * known or suspected allergy against insulin * subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the clinician * total daily insulin dose \>= 2 iu/kg * post-menarchal girls who are pregnant or intending to become pregnant or are breastfeeding * any coexisting cardiac and respiratory condition

Keywords: closed-loop insulin delivery post-prandial hypoglycaemia meal insulin dosing
double blind study of thymopentin effects on patients with hiv-1 infection

Conditions: HIV Infections

Summary: examine the ability of thymopentin (timunox) to: reduce the amount and/or frequency of virus isolation. stimulate the immune system and alter the clinical findings in patients infected with hiv who do not yet have aids.


Eligibility criteria:
inclusion criteria concurrent treatment: allowed: * aerosolized pentamidine. prior medication: allowed: * aerosolized pentamidine. exclusion criteria co-existing condition: patients with the following are excluded: * aids as defined by the cdc (except for those with hiv "wasting syndrome"). * significant hepatic disease. * thrombocytopenia (\< 75000 platelets/mm3). * abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to entry. * hemophilia a or b or other hematologic disorders requiring current or previous administration of blood products. * known hypersensitivity to thymopentin. prior medication: excluded within 30 days of study entry: * immunomodulatory or experimental therapy. * excluded within 90 days of study entry: * zidovudine (azt). patients must not have: * aids as defined by the cdc (except for those with hiv "wasting syndrome"). * significant hepatic disease. * thrombocytopenia (\< 75000 platelets/mm3). patients with the following conditions are included: * seropositive for hiv-1 (elisa assay) confirmed by western blot. * hiv-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (pbmc) on two separate occasions. * hiv "wasting syndrome". * must voluntarily sign consent. history of intravenous drug abuse.

Keywords: thymopentin acquired immunodeficiency syndrome
clinical deployment and validation of rho

Conditions: Low Bone Density

Summary: osteoporosis is a widespread disease characterized by the loss of bone mineral density (bmd). 16 bit has developed software, called rhotm, that analyzes various x-rays, performed in patient age 50 and above for any clinical indication, to identify patients with low bmd. rhotm is intended to function as a pre-screening device for low bmd. this study seeks to assess the clinical performance and impact of implementing rhotm in real-world settings by analyzing its performance and impact on dxa referrals.

osteoporosis is a widespread disease characterized by the loss of bone mineral density (bmd). 16 bit has developed an opportunistic screening tool for low bmd, called rhotm, that analyzes lumbar spine, thoracic spine, chest, pelvis, knee, and hand radiographs, performed in patient age 50 and above for any clinical indication to estimate lumbar and femoral neck bmd. the estimated bmd t-score is used to classify patients as having normal or low bmd. a finding of low bmd can be included in a radiologist's report, and is intended to support a discussion between healthcare provider and patient regarding the need for osteoporosis diagnosis by dual-energy x-ray absorptiometry (dxa). in this way, rhotm is intended to function as an opportunistic pre-screening device for low bmd. this study seeks to assess the clinical performance and impact of implementing rhotm in real-world settings by analyzing the diagnostic performance and impact on dxa referrals.

Eligibility criteria:
inclusion criteria: * age 50+ years * outpatient undergoing x-ray examinations of: * chest * thoracic spine * lumbar spine * pelvis * knee * hand/wrist exclusion criteria: * age \< 50 years * inpatient

Keywords: osteoporosis opportunistic radiography dxa
analgesic additives to epidural bupivacaine in normal labor

Conditions: Labor Pain

Summary: the aim of the study will be to compare the role of dexmedetomidine, nalbuphine and fentanyl as additives to epidural bupivacaine in painless vaginal delivery as regard of effectiveness analgesia and maternal safety.

labor pain often causes a strong stress response. several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased . recently, it was concerned by most mothers and doctors that how to alleviate the pain during delivery. the ideal labor analgesia should be based on maternal and child safety and should have a fast acting good analgesic effect and less adverse reaction . epidural anesthesia is convenient and has a less adverse reaction and obvious effect in the commonly used analgesic methods, which are widely used in the current way of analgesia . studies have confirmed the efficacy of dexmedetomidine in prolonging the duration of perineural nerve blocks. specifically, perineural dexmedetomidine enhances sensory, motor, and analgesic block characteristics. dexmedetomidine is a selective α₂ receptor agonist and has a sympatholytic, sedative, and opioid sparing effect. it does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings . it has also been proved that dexmedetomidine would not increase the risk of side effects, such as nausea, headache, vomiting, shivering, and hypotension . nalbuphine is a synthetic agonist-antagonist opioid that has the characteristics of mu-antagonist and kappa-agonist activities. nalbuphine has gained parenteral analgesia for intraoperative, postoperative, and obstetrical uses . the analgesic potency of nalbuphine has been found to be equal to morphine, but unlike morphine, it shows a ceiling effect on respiratory depression. it has the potential to provide effective postoperative analgesia with no risk of respiratory depression .

Eligibility criteria:
inclusion criteria: * \>/= 18 years of age * american society of anesthesiologists (asa) physical status 2 or 3 * full term pregnancy (\>37 gestational weeks) * planning vaginal delivery * planning epidural labor analgesia * vertex presentation exclusion criteria: * patient refusal to epidural analgesia, * contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity) * allergy to study agents (hypersensitivity to bupivacaine, nalbuphine, fentanyl or dexmedetomidine) * hemodynamic instability, severe aortic or mitral stenosis) * severe pre-eclampsia, * breech presentations * antepartum hemorrhage * cephalopelvic disproportion * body mass index ≥40 kg/m2. * uncontrolled systemic comorbidities \[i.e., diabetes, hepatic, renal or cardiac\] * known or suspected fetal abnormalities * inability to communicate or participate in study procedures

Keywords: epidural anathesia normal labor