Kornimate/medical-research-clean huggingface dataset:
reduced intensity conditioning (ric) regimen for patients with non-malignant disorders

Conditions: Non Malignant Diseases; Immunodeficiencies; Hemoglobinopathies

Summary: this is a phase ii pilot study to evaluate engraftment and toxicity of patients with non-malignant diseases using a reduced intensity conditioning regimen in the setting of allogeneic transplant for non malignant diseases. bone marrow or cord blood will be acceptable as a stem cell source. recently, reduced intensity conditioning (ric) regimens have been used for both adult patients with leukemias and pediatric patients with non-malignant diseases. these regimens are better tolerated, resulting in less transplant related morbidity and mortality. stable mixed chimerism, while insufficient for eradication of leukemias, may be sufficient to cure patients with non-malignant diseases.

there are two conditioning regimens in this protocol for children \>6 months. alemtuzumab (campath), fludarabine and melphalan are used. the regimens differ by the timing and dosing of alemtuzumab (campath). the two timings are distal and intermediate. * distal campath is initiated 22 days prior to the allogeneic transplant. * intermediate campath is initiated 14 days prior to allogeneic transplant. the conditioning regimen for children with immunodeficiencies \<6 months omits melphalan, and substitutes two days of busulfan. this regimen is successfully used in the united kingdom, and has been successful in a 3 month old infant at the children's hospital of philadelphia (chop) who engrafted with a haploidentical donor.

Eligibility criteria:
inclusion criteria: 1. age \>6 months- 25 years 2. diseases eligible for distal alemtuzumab: * immunodysregulation polyendocrinopathy enteropathy x-linked (ipex) syndrome * sickle cell disease * thalassemia major * bone marrow failure 3. diseases eligible for intermediate alemtuzumab * hemophagocytic lymphohistiocytosis other macrophage activation syndromes, severe langerhans histiocytosis * severe combined immune deficiency, adenosine deaminase deficiency, common variable immunodeficiency * wiskott-aldrich syndrome 4. organ criteria: * cardiac: echocardiogram shortening fraction \>27% * renal: serum creatinine less than 1.5 times the upper limit of normal for age * hepatic: liver function tests must be less than 5 times the upper limit of normal 5. no active infections exclusion criteria 1. uncontrolled bacterial, fungal or viral infections

Keywords: non-malignant diseases immune deficiencies hemoglobinopathies reduced intensity conditioning(ric)
study in healthy volunteers to investigate the effects of quinidine on the pharmacokinetics of nktr-118

Conditions: Drug Induced Constipation

Summary: study in healthy volunteers to investigate the effects of quinidine on the pharmacokinetics of nktr-118

a randomized, 2-part, crossover, single center study to evaluate effect of quinidine on the pharmacokinetics of nktr-118 and the concomitant effect of quinidine and nktr-118 on morphine-induced miosis

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study-specific procedures. * male and female (nonchildbearing potential, nonlactating) healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture. * female volunteers must be nonpregnant and nonlactating. women of childbearing potential must have negative pregnancy test (screening and admission) and be using a highly-effective form of birth control for 3 months before enrollment. * male volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the ip. the female partner should use contraception during this period. * volunteers must have a bmi between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg. exclusion criteria: * any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine) which, may put the volunteer at risk of participation in the study, or influence of the adme of drugs. * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of ip. * any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the investigator. * history (personal or family) of torsades de pointes, any other polymorphic ventricular tachycardia, long qt syndrome, sudden death or brugada syndrome, or personal history of sustained (greater than 30 s) monomorphic ventricular tachycardia. * abnormal vital signs, after 10 minutes supine rest as defined in protocol.

Keywords: phase 1 healthy male and female volunteers drug-drug interaction pharmacokinetics nktr-118
everolimus in combination with exemestane in the treatment of postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer who are refractory to letrozole or anastrozole

Conditions: Breast Cancer

Summary: there are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (nsai). in light of the need for new treatment options for postmenopausal women after failure of prior nsai therapy, the purpose of this phase iii study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to nsai.


Eligibility criteria:
inclusion criteria: * adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. * histological or cytological confirmation of estrogen-receptor positive (er+) breast cancer * postmenopausal women. * disease refractory to non steroidal aromatase inhibitors (nsai), * radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization. * patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above. exclusion criteria: * her2-overexpressing patients * patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.). * patients who received more than one chemotherapy line for advanced breast cancer. * previous treatment with exemestane or mtor inhibitors. * known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin). * radiotherapy within four weeks prior to randomization * currently receiving hormone replacement therapy, other protocol-defined inclusion/exclusion criteria may apply

Keywords: breast cancer estrogen receptor positive er+ exemestane mtor everolimus refractory nsai
hepatocellular carcinoma study comparing vaccinia virus based immunotherapy plus sorafenib vs sorafenib alone

Conditions: Hepatocellular Carcinoma (HCC)

Summary: this is a randomized phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (pexa-vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

this is a multi-center, randomized, open-label, phase 3 study comparing pexa vec followed by sorafenib versus sorafenib in patients with advanced hcc without prior systemic therapy. a total of 459 patients were randomly assigned to 2 treatment arms- 234 patients in the pexa-vec followed by sorafenib treatment group and 225 patients in the sorafenib only treatment group.

Eligibility criteria:
inclusion criteria: * histological/cytological diagnosis of primary hcc * advanced stage hcc (barcelona clinic liver cancer \[bclc\] stage c or b per american association for the study of liver disease \[aasld\] guidelines) * at least one measurable viable tumor in the liver, ≥1 cm longest diameter (ld), using a dynamic imaging technique (arterial phase of triphasic computerized tomography \[ct\] scan, or dynamic contrast-enhanced magnetic resonance imaging \[mri\]), and injectable under imaging-guidance (ct and/or ultrasound) * child-pugh class a * performance status 0 or 1 on the eastern cooperative oncology group (ecog) scale * adequate hematological, hepatic, and renal function: * additional inclusion criteria exist exclusion criteria: * histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma * symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months * current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation * history of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening * bulky disease patients - tumors encompassing \>50% of the liver volume and / or inferior vena cava invasion * known significant immunodeficiency due to underlying illness (e.g., hiv/aids) and/or immune-suppressive medication including high-dose corticosteroids * ongoing severe inflammatory skin condition (as determined by the investigator) requiring medical treatment * history of severe eczema (as determined by the investigator) requiring medical treatment * additional exclusion criteria exist

Keywords: hepatocellular carcinoma (hcc) pexastimogene devacirepvec (pexa-vec) sorafenib gm-csf therapy thymidine kinase-deactivated vaccinia virus oncology recombinant vaccinia virus oncolytic virus therapy oncolytic virotherapy
lenalidomide adherence in older adults

Conditions: Multiple Myeloma

Summary: to describe patterns of adherence and pilot baseline measures to investigate factors associated with lower adherence to lenalidomide in older adults with myeloma.


Eligibility criteria:
inclusion criteria: * age ≥65 * receiving lenalidomide for treatment of multiple myeloma. * anticipated to receive ongoing care at siteman cancer center and its satellite sites * able to read and understand english. * able to understand and willing to sign an irb-approved written informed consent document. exclusion criteria: * estimated life expectancy \<6 months. * anticipated duration of lenalidomide therapy \<3 months. * residing in a nursing facility where their medications are administered to them or patient reports they do not self-administer their own medications.
effect of mild sedation and analgesia on radial artery cannulation in novice residents

Conditions: Sedation and Analgesia

Summary: the aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the effect of mild midazolam combined with sufentanil on radial artery cannulation in novice operators.

outcome: patients discomfort，visual analogue scale，first-attempt success rate，the success rate of radial artery cannulation within 10 minutes, complication rate

Eligibility criteria:
inclusion criteria: * patients who required arterial cannulation for continuous blood pressure monitoring * aged \>20years * asa physical status of 1-3 * bmi 18-28kg/m2 * all patients agreed to participate in this study at the time of recruitment and signed an informed consent form. exclusion criteria: * a positive allen's test * infection at the puncture site * coagulation disorders; arterial diseases (such as raynaud's disease or thromboangiitis obliterans) * use of vasoactive drugs within 30 minutes before measurement during the study * patients with arterial abnormalities and bends; hemorrhagic shock * arterial atherosclerosis; radial artery puncture within the past 30 days * chronic use of opioid or benzodiazepine drugs * and known allergies or adverse reactions to benzodiazepines or opioids.

Keywords: radial artery cannulation novice operators
endomicroscopy and crohn´s disease

Conditions: Crohn´s Disease

Summary: purpose: the main objective of this study is to determine endomicroscopic features of crohn´s disease. background: crohn´s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. diagnosis is based on several histologic features including transmural pattern of inflammation, crypt abscesses and granulomas. confocal laser endomicroscopy (cle) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure. scope: in patients with crohn´s disease.

methods: patients underwent colonoscopy for the evaluation of crohn´s disease. during the endoscopic procedure cle will be performed. procedure: the patient underwent colonoscopy. during the procedure the patient will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet, followed by in-vivo cle of the tissue. confocal images are digitally saved and analyzed afterwards.

Eligibility criteria:
inclusion criteria: * written informed consent * age 18-85 years * ability of subjects to understand character and individual consequences of clinical trial * subjects undergoing colonoscopy exclusion criteria: * inability to provide written informed consent * severe coagulopathy (prothrombin time \ 50 s) * impaired renal function (creatinine \> 1.2 mg/dl) * pregnancy or breast feeding * active gastrointestinal bleeding * known allergy to fluorescein, acriflavin or cresyl violet * residing in institutions (e.g. prison)
a safety, tolerability, pharmacokinetic and efficacy study of azithromycin plus piperaquine as presumptive treatment in pregnant png women

Conditions: Pregnancy; Infections, Plasmodia; Drug Kinetics; Clinical Efficacy

Summary: plasmodium falciparum parasitaemia in pregnancy is associated with maternal anaemia, low birth-weight and increased perinatal mortality. whilst continuous prophylaxis is difficult to implement, intermittent presumptive treatment in pregnancy (iptp) has proved to be practical and effective. in png, pregnant women currently receive iptp using sulfadoxine-pyrimethamine, however, this therapy has the potential to be compromised by parasite resistance. the aim of the present trial is to assess the safety, tolerability, pharmacokinetics and efficacy of azithromycin (azi) plus piperaquine (pq) given as iptp to pregnant papua new guinea women. the study will comprise of two sub-studies: (i) a safety, tolerability and pharmacokinetic study of azi-pq in pregnancy. (ii) a safety, tolerability and preliminary efficacy study of azi-pq in pregnancy.


Eligibility criteria:
inclusion criteria: * \>14 weeks and \<30 weeks gestation * no signs of severe malaria by world health organisation criteria * no significant concomitant disease (such as tb) * no prior history of an adverse reaction to azi or pqp * no prior treatment with these drugs in the past 4 weeks * can attend all follow-up visits * provide informed consent exclusion criteria: * have signs of severe malaria by who criteria * significant concomitant disease such as tb as assessed by the attending clinician * a history/family history of sudden death or of congenital prolongation of the qtc interval * any clinical condition known to prolong the qtc interval * a history of complicated pregnancies/deliveries * a prior history of an adverse reaction to azi or pqp * have taken these drugs in the past 4 weeks * cannot attend any of the follow-up visits * do not provide informed consent

Keywords: azithromycin piperaquine iptp pharmacokinetics efficacy
travoprost 3-month safety and efficacy study

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of travoprost 0.003% is equivalent to travatan® in adult patients with open-angle glaucoma or ocular hypertension.

this study consisted of six visits conducted during two sequential phases. the screening/eligibility phase included one screening visit and two eligibility visits. a washout period based on previous ocular medication preceded eligibility visit 1. subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. the treatment phase consisted of three on-therapy visits (week 2, week 6, and month 3).

Eligibility criteria:
inclusion criteria: * diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension. * qualifying intraocular pressure at both eligibility visits. * understand and sign an informed consent form. * other protocol-defined inclusion criteria may apply. exclusion criteria: * women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control. * severe central visual field loss in either eye. * chronic, recurrent or severe inflammatory eye disease. * best corrected visual acuity (bcva) score worse than 55 etdrs letters (equivalent to 20/80 snellen). * any abnormality preventing reliable applanation tonometry. * hypersensitivity to prostaglandin analogs or to any component of the study medications. * therapy with another investigational agent within 30 days prior to the screening visit. * other protocol-defined exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension
flexible laryngeal mask airway versus tracheal intubation in nasal bone fracture

Conditions: Laryngeal Mask Airway

Summary: in surgery under general anesthesia due to nasal bone fracture, laryngeal mask airway or tracheal intubation has been used. however, it has not been investigated that the difference of recovery profiles according to use of laryngeal mask airway or tracheal intubation in nasal bone fracture surgery. the aim of study is to evaluate the efficacy of the laryngeal mask airway regarding recovery profiles and airway complications, compared to tracheal intubation.


Eligibility criteria:
inclusion criteria: * patients with american society of anesthesiologists classification 1 or 2 who receive general anesthesia due to nasal bone fracture exclusion criteria: * patients with high risk of aspiration, patients who anticipated difficult airway

Keywords: laryngeal mask airway intubation nasal bone fracture recovery
the western galilee hospital in nahariya home monitoring registry

Conditions: Tachycardia

Summary: the purpose of this study is to study workload assessment of home monitoring based follow up for icd or crtd implanted patient.

ep unit device clinic is a very busy clinic. every 6 month the patients arrive for device follow up where the device parameters, patient condition and arrhythmic events are being reviewed, and reprogramming of the device (if needed) is done. average net time of patient's stay in the clinic is between 30-45 minutes. patients implanted with the lumax device family allows for a better automated follow up procedure via remote management (home monitoring). the purpose of the registry is to assess workload of a home monitoring based follow up for biotronik icd and crtd patients.

Eligibility criteria:
inclusion criteria: * approved indication for icd or crtd. * implanted with or replaced with a biotronik lumax device. * patient is willing and able to sign consent form. * willing and able to attend clinic visits and follow up schedule. * transmission of more than 80% at 3-month fu. * patient older than 18 years. exclusion criteria: * no indication for icd or crtd implant. * life expectancy shorter than 12 months. * pregnancy. * participation in other clinical studies

Keywords: home monitoring cardiomessenger icd
aqueous biomarker levels in diabetic retinopathy and diabetic macular edema

Conditions: Diabetic Retinopathy; Diabetic Macular Edema; Other Retinal Disorders

Summary: the dragons study is a non-interventional, prospective study that will 1. characterize disease state biomarker (including cytokines, kks metabolites, and cell adhesion molecules) levels from aqueous humor of subjects with various stages of diabetic retinopathy (dr) and diabetic macular edema (dme) as well as other retinal pathologies, and 2. correlate a broad array of aqueous humor disease state biomarkers with dr severity, dme anti-vascular endothelial growth factor (vegf) responsiveness, and other retinal pathologies.

the dragons study is a non-interventional study investigating aqueous humor biomarker levels in patients with various stages of dr, dme and other retinal pathologies. subjects will be included in the study if at least one eye meets any of the following criteria: group 1 - eyes with treatment naive dr with or without dme group 2 - eyes with dme that are incompletely responsive to anti-vegf therapy group 3 - eyes with various retinal conditions including eyes with dr and dme that are anti-vegf responsive as well as non-exudative retinal pathologies such as epiretinal membrane and macular hole the study will consist of a single visit and a retrospective chart review. the study visit will consist of: 1. screening for eligibility; 2. aqueous humor collection; 3. blood collection; 4. optical coherence tomography; 5. optical coherence tomography angiography; 6. fundus photography; and 7. fluorescein angiography. approximately 50 microliters (or more, up to 150 microliters) of aqueous fluid will be collected according to standard clinical procedures. plasma and serum will be collected according to standard clinical procedures, with citrated plasma being specifically collected in a plastic tube.

Eligibility criteria:
inclusion criteria: 1. subjects with at least one of the following retinal conditions in at least one eye: * treatment naive diabetic retinopathy (group 1 only); * diabetic retinopathy with dme that is incompletely responsive to anti-vegf therapy at principal investigators discretion with retinal thickening documented on oct (group 2 only); * various retinal disease including but not limited to diabetic retinopathy without dme which has previously been treated, dme which has responded to anti-vegf therapy, neovascular age-related macular degeneration, branch or central retinal vein occlusions, epiretinal membrane, or macular hole (group 3 only) exclusion criteria: 1. prior intraocular or subtenon steroid injection in the study eye within the prior 1 year of signing informed consent; 2. prior focal or grid laser photocoagulation in the study eye if within 90 days of signing informed consent; 3. prior panretinal photocoagulation in the study eye if within 90 days of signing informed consent; 4. intraocular or refractive surgery in the study eye within 90 days of signing informed consent; 5. systemic anti-vegf treatment within 90 days of signing informed consent