Kornimate/medical-research-clean huggingface dataset:
a study of the safety, tolerability, pharmacokinetics, and immunogenicity of bcx17725

Conditions: Netherton Syndrome

Summary: this is a first-in-human, phase 1/1b, 3-part study that includes the evaluation of safety, tolerability, pharmacokinetics (pk), and immunogenicity of bcx17725 when administered via single and multiple doses in healthy adult participants (parts 1 and 2), and multiple doses in participants with netherton syndrome (part 3).

parts 1 and 2 are randomized, placebo-controlled, single-ascending-dose (sad) and multiple-ascending-dose (mad) study parts, respectively, in healthy participants. part 3 will evaluate multiple dose administrations in participants with netherton syndrome in an open-label design.

Eligibility criteria:
key inclusion criteria: * male or non-pregnant, non-lactating female aged 18 to 55 years, inclusive (parts 1 and 2) or aged 18 to 65 years, inclusive (part 3) * confirmed diagnosis of netherton syndrome (part 3 only) * bmi between 18 and 30 kg/m\^2, inclusive (parts 1 and 2 only) * estimated glomerular filtration rate (egfr) of ≥ 90 ml/min/1.73 m\^2 (parts 1 and 2) or ≥ 60 ml/min/1.73 m\^2 (part 3) * agree to follow the protocol contraception requirements from screening until 90 days after the last dose of study drug * in the opinion of the investigator, expected to adequately comply with all required study procedures and restrictions for the duration of the study

Keywords: first-in-human single ascending dose multiple ascending dose pharmacokinetics placebo control netherton syndrome
tight versus liberal blood glucose control in adult critically ill patients

Conditions: Critical Illness; Hyperglycemia

Summary: critically ill patients usually develop hyperglycemia, which is associated with an increased risk of morbidity and mortality. controversy exists on whether targeting normal blood glucose concentrations with insulin therapy, referred to as tight blood glucose control (tgc) improves outcome of these patients, as compared to tolerating hyperglycemia. it remains unknown whether tgc, when applied with optimal tools to avoid hypoglycemia, is beneficial in a context of withholding early parenteral nutrition. the tgc-fast study hypothesizes that tgc is beneficial in adult critically ill patients not receiving early parenteral nutrition, as compared to tolerating hyperglycemia.


Eligibility criteria:
inclusion criteria: - adult patient (18 years or older) admitted to a participating intensive care unit (icu) exclusion criteria: * patients with a do not resuscitate (dnr) order at the time of icu admission * patients expected to die within 12 hours after icu admission (= moribund patients) * patients able to receive oral feeding (not critically ill) * patients without arterial and without central venous line and without imminent need to place it as part of icu management (not critically ill) * patients previously included in the trial (when readmission is within 48 hours post icu discharge, the trial intervention will be resumed) * patients included in an imp-rct of which the pi indicates that co-inclusion is prohibited * patients transferred from a non-participating icu with a pre-admission icu stay \>7 days * patients planned to receive parenteral nutrition during the first week in icu * patients suffering from diabetic ketoacidotic or hyperosmolar coma on icu admission * patients with inborn metabolic diseases * patients with insulinoma * patients known to be pregnant or lactating * informed consent refusal
partnering for prevention: building healthy habits in underserved communities

Conditions: Parenting; Child Nutrition Disorders

Summary: this pilot study will estimate the unique and additive benefits of two parent-training programs (cooking matters for parents and promoting routines of exploration and play during mealtime) offered in undeserved communities.

the overall purpose of this research study is to estimate the nutritional benefits (in terms of intake and variety) of the mealtime prep intervention, as compared to, and in combination with nutrition education programming being offered in underserved neighborhoods of the greater pittsburgh area. this project will examine the effects of mealtime prep groups as compared with established nutrition education groups, cooking matters for parents. more importantly, this study will determine if offering these interventions in combination offers greater benefits than each in isolation. there are two specific aims of this pilot trial. 1. to examine the effects of a combined program (cooking matters + mealtime prep) in comparison to offering each of these programs (cooking matters vs. mealtime prep) in isolation on child nutrition over time. 2. to explore the effects of each of these programs (cooking matters vs. mealtime prep) and the combined program (cooking matters + mealtime prep) on parental stress and parent/child interaction over time. the investigators predict that children in all three arms (cooking matters, mealtime prep, and cooking matters + mealtime prep) will demonstrate improved nutrition. the investigators also predict that participants who receive the mealtime prep intervention will demonstrate better stability of gains over time.

Eligibility criteria:
inclusion criteria: * parent to a child aged 1-5 years * speaks english * willing to participate in 6 or 12 weekly group sessions at local family support center exclusion criteria: * previously completed a cooking matters for parents cooking class

Keywords: prevention nutrition early childhood parent training underserved
a pilot study to test the safety and feasibility of a brillouin ocular analyzer

Conditions: Measurement of the Elasticity of the Anterior Eye Segment

Summary: a brillouin ocular analyzer uses a low-power near infrared laser light to probe the viscoelastic properties of the cornea and crystalline lens in the eye. the study hypothesis is that the instrument can measure the brillouin light scattering spectra from the eye safely and effectively from human subjects.


Eligibility criteria:
inclusion criteria: * healthy volunteers aged 20-60 * no refractional abnormalities * clear enough cornea and media to permit imaging exclusion criteria: * occludable narrow angles (without a patent peripheral iridotomy) * other ocular or systemic pathology, which precludes safe eye dilation * lasik eye surgery * allergies to the dilation medication * only one healthy eye * pregnant women or expected pregnancy within the timeframe of the study * do not or cannot understand the instructions for the imaging * restricted mobility

Keywords: lens cornea presbyopia
academic detailing about asthma

Conditions: Prescription Pattern

Summary: general practices in the capital region of denmark are offered a short educational visit and are randomized to either asthma (intervention) or another topic (control). the change in prescription pattern from before to after the visit is compared between the intervention and control group.

general practices in the capital region of denmark are offered a short educational visit. they are randomized by address to be offered a visit about either asthma (intervention) or another topic (control). the prescription pattern of each general practice (as seen by their regional registration number \[ydernummer\]) who receive a visit is investigated. the change in prescription pattern from before to after the visit is compared between the intervention and control group.

Eligibility criteria:
inclusion criteria: * general practices in the capital region of denmark, who owns a regional registration number \[ydernummer\] * want a visit * have time for a visit within the study period exclusion criteria: -
liquid biopsy of head and neck cancer patients in blood and saliva

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: prospective study for therapy monitoring of locally advanced and metastatic head and neck cancer patients by detection of circulating tumor nucleic acids in peripheral blood and saliva

clinical examination including imaging and - if necessary - tissue biopsy sampling - is the current clinical standard in therapy monitoring of metastatic head and neck tumors. this includes both the initial diagnosis, the assessment of the therapeutic response during ongoing chemotherapy / radiochemotherapy and follow-up care with the aim of detecting recurrences at an early stage. the detection of circulating nucleic acids as well as proteins in the peripheral blood and saliva could represent a minimally invasive and exact method for the assessment of the tumor burden, for the early detection of recurrences and for the individual assessment of the therapy response in patients with head and neck cancer. the present study aims to evaluate the value of tumor-specific nucleic acids and proteins in peripheral blood and saliva as possible biomarkers for minimally invasive therapy monitoring of head and neck tumors. for this purpose, next generation sequencing (ngs), elisa and quantitative polymerase chain reaction (pcr) methods are used as diagnostic methods. ngs initially enables the creation of a genetic profile of the primary tumor with targeted massive parallel sequencing of frequently mutated genes in head and neck tumors. the amount of nucleic acids in the peripheral blood and saliva is then quantified by means of digital pcr with the aid of specifically designed digital pcr assays. in addition, tumor-associated nucleic acids and proteins in the primary tumor, blood and saliva are examined. the aim is to examine if the amount of tumor specific circulating nucleic acids and the concentration of protein biomarkers found in the blood and saliva are associated with the response to treatment, early detection of recurrence, and the overall prognosis.

Eligibility criteria:
inclusion criteria: * head and neck squamous cell carcinoma (hnscc) * written informed consent exclusion criteria: * neoplasms other than hnscc

Keywords: liquid biopsy
motivational incentives for enhanced drug abuse recovery: drug free clinics - 1

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to test the utilization of incentive values (considerably lower than those typically used in research clinics) to motivate clients to attend treatment and initiate and sustain abstinence.

the purpose of the proposed research is to implement and systematically evaluate, in community treatment settings, motivational incentive procedures that have been well researched and have proven efficacious in a variety of treatment research clinics.

Eligibility criteria:
inclusion criterea: * new intake to a drug-free ctp * evidence of cocaine or methamphetamine use, any reported use in past 2 weeks or positive urine screen at study intake. for those exiting a controlled environment, any stimulant use within two weeks of entering the controlled environment exclusion criteria: * unable to give informed consent (fails simple consent quiz) * answers yes to question: are you in recovery from gambling? that is, have you stopped gambling because of previous problems with gambling?

Keywords: substance use disorders
impact of total intravenous anesthesia following cancer surgery, tivacs study

Conditions: Pancreatic Adenocarcinoma

Summary: this phase ii trials studies the impact of total intravenous anesthesia (tiva) following cancer surgery. surgery and the anesthesia delivered causes physiologic stress and trauma resulting in immune suppression. tiva is an alternative method of general anesthesia that has several benefits over volatile inhalation agents such as reducing nausea, vomiting, and opioid consumption, and promotes earlier return of bowel function following surgery. in addition, tiva is less immunosuppressive than inhalational agents and has been shown to decrease cancer cell proliferation, migration, and metastasis formation. giving tiva during cancer-directed abdominal surgery may decrease the immunosuppressive state in the peri-surgical period.

primary objective: i. to evaluate the impact of anesthetic agent on inflammation and immunosuppression among patients undergoing abdominal cancer surgery. secondary objective: i. to determine the impact of anesthetic choice on short-term anesthetic and surgical outcomes. outline: patients are randomized to 1 of 2 arms. arm i: patients undergo surgical resection with tiva. arm ii: patients undergo surgical resection with inhaled volatile anesthetics. after completion of study treatment, patients are followed up for up to 2 years.

Eligibility criteria:
inclusion criteria: * adults: ≥18 years old on the day of consent * non-metastatic pancreatic adenocarcinoma * able to provide consent * ecog performance status of 0 or 1 * women of childbearing potential (wocbp) must have a negative urine or serum pregnancy test for the patient at the time of surgery. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * previous identified allergy or hypersensitivity to any component of the study treatment * allergies to eggs, egg products, soybeans, or soy products * personal or first degree relative with a history of malignant hyperthermia * has a known additional malignancy that is expected to require active treatment within two years, or is likely to be life-limiting in the opinion of the treating investigator. superficial bladder cancer, non-melanoma skin cancers, or low-grade prostate cancer not requiring therapy would not exclude participation in this trial. * uncontrolled intercurrent illness including, but not limited to: symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant or lactating females * major surgery within 2 months before enrollment. complete healing from major surgery must have occurred 1 month before enrollment. complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before enrollment. subjects with clinically relevant complications from prior surgery are not eligible. * patients who undergo reoperation during their initial hospitalization will be censored at the time of reoperation. * prisoner status
bone marrow stem cell infusion following a heart attack

Conditions: Acute Myocardial Infarction

Summary: the goal of this study is to determine the safety of giving a patient's own bone marrow-derived stem cells delivered with a catheter (tube) into the coronary arteries (blood vessels of the heart). stem cells are simple cells produced by the bone marrow that can develop into many types of cells. it is possible that these cells will decrease the size of damage caused to the heart from a heart attack and increase the pumping efficiency of the heart; which can be decreased due to a heart attack. the stem cells will be taken from bone marrow and then given back into the heart vessels.

this protocol will test the hypothesis that an intracoronary infusion of autologous, unfractionated, bone marrow mononuclear cells will attenuate infarct size and improve left-ventricular function in 60 patients following an acute anterior myocardial infarction who have undergone successful revascularization with ptca/stenting.

Eligibility criteria:
inclusion criteria: * patients age at least 21 years of age * patients with an acute anterior myocardial infarction limited to the proximal or mid-lad with an artery diameter of at least 2.5 mm. * ability to undergo cell therapy procedure within 2 to 7 days following acute mi and ptca/stenting. * ejection fraction following reperfusion with ptca/stenting is between 30% and 50% as assessed by left-ventriculography or echocardiography. * consent to protocol and agree to comply with all follow-up visits and studies. exclusion criteria: * history of sustained ventricular arrhythmias not related to their acute myocardial infarction who do not have an icd. * require coronary artery bypass surgery or percutaneous revascularization due to the presence of residual coronary stenosis \> 70% luminal obstruction in the non-infarct related vessel. * history of malignancy within the past 5 years excluding non-melanoma skin cancer or cervical cancer in-situ. * history of anemia (hb \< 9.0 mg/dl). * history of thrombocytosis. * pt or ptt greater than the upper limits of normal. * life expectancy less than one year. * patients on chronic dialysis. * history of untreated alcohol or drug abuse. * currently enrolled in another investigational drug or device trial. * history of stroke or tia within the past 6 months. * history of severe valvular heart disease (aortic valve area \ 3+ mitral regurgitation. * pregnancy * subjects who are hiv, hepatitis b or c positive. * patients with active inflammatory or autoimmune disease on chronic immunosuppressive therapy. * contraindications to cardiac mri

Keywords: cell therapy
promoting physical activity behavior in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this research study is to evaluate whether tailored print material can promote physical activity and exercise, and subsequently improve quality of life and fitness levels among people with multiple sclerosis (ms). research suggests that routine physical activity is beneficial in people with mild to moderate ms. however, people with ms may face many barriers for engaging in regular physical activity. prescribing a home exercise program and receiving tailored motivational print material may help people engage in physical activity. thus, the investigators hope to figure out whether tailored print material can be used as strategy to promote physical activity and improve physical function in people with ms.

the objective of the proposed study is to further our understanding of methods to promote physical activity (pa) in people with multiple sclerosis (ms). the investigators will evaluate the efficacy of a print-based multifaceted intervention that consists of prescribing an exercise program and teaching self-management strategies.

Eligibility criteria:
inclusion criteria: * a physician-confirmed diagnosis of relapsing-remitting ms exclusion criteria: * exercise more than 150 minutes per week * pregnant * metabolic or cardiopulmonary disease that puts patient at high risk for engaging in a home exercise program (patients with controlled diabetes and high blood pressure will still be considered eligible) * four or more falls in the past 6 months * be able to walk 25 feet with or without a cane * severe cognitive deficits * unable to read at a 6th grade level * a condition besides ms that had lead to hospitalization in the past year

Keywords: multiple sclerosis exercise physical activity quality of life
a study of ravulizumab (alxn1210) in children and adolescents with paroxysmal nocturnal hemoglobinuria

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: the purpose of this study was to assess the pharmacokinetics (pk), pharmacodynamics (pd), safety, and efficacy of ravulizumab in pediatric participants with paroxysmal nocturnal hemoglobinuria (pnh).

the study consists of a 4-week screening period, a 26-week primary evaluation period, and an extension period of up to 4 years (with the exception of any country-specific mandates), whichever occurs first. efficacy and safety data are reported for the 26-week primary evaluation period only. analyses were conducted separately for complement inhibitor treatment-naïve participants and eculizumab-experienced participants.

Eligibility criteria:
inclusion criteria: 1. participants from birth up to \<18 years of age and weighing ≥ 5 kilograms at the time of consent. 2. pnh diagnosis confirmed by documented high-sensitivity flow cytometry. 3. presence of 1 or more of the following pnh-related signs or symptoms within 3 months of screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia, history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of packed red blood cell transfusion due to pnh. 4. lactate dehydrogenase (ldh) level ≥ 1.5 × upper limit of normal (uln) for participants not being treated with eculizumab at screening and ldh level ≤ 1.5 × uln for participants taking eculizumab. 5. documented meningococcal vaccination not more than 3 years prior to dosing, and vaccination against streptococcus pneumoniae and haemophilus influenzae. 6. female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab. exclusion criteria: 1. history of bone marrow transplantation. 2. history of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation. 3. unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to pnh). 4. females who are pregnant or breastfeeding or who have a positive pregnancy test at screening or day 1. 5. participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.

Keywords: ravulizumab alxn1210 ultomiris pharmacokinetics pharmacodynamics
a study to evaluate the efficacy and safety of the addition of canagliflozin in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and sitagliptin

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the effect of canagliflozin (jnj-28431754) compared to placebo in the treatment of participants with type 2 diabetes mellitus (t2dm), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

this is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a study drug, to test whether the study drug has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in participants with t2dm, who have inadequate glycemic (blood sugar) control on maximally or near-maximally effective doses of metformin \>=1500 mg/day and sitagliptin 100 mg/day. approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1 ratio for 26 weeks. during the study the participants will be also provided with diet and exercise counseling (standardized non-pharmacological therapy).

Eligibility criteria:
inclusion criteria: * must have a diagnosis of type 2 diabetes mellitus * must have a screening hba1c of \>=7.5% to \<=10.5% * must be on metformin \>=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening exclusion criteria: * history of diabetic ketoacidosis or t1dm, hereditary glucose-galactose malabsorption or primary renal glycosuria * a myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening * egfr \ =1.4 mg/dl for men and \>=1.3 mg/dl for women * known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis) * major surgery (ie, requiring general anesthesia) within 12 weeks before screening

Keywords: diabetes mellitus, type 2 canagliflozin hemoglobin a1c metformin sitagliptin t2dm jnj-28431754