Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics/pharmacodynamics of albiglutide

Conditions: Diabetes Mellitus, Type 2

Summary: the first part of the study includes a single dose treatment period to evaluate the pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug substance compared with process 3 drug substance. the second part of the treatment period will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study.

this is a randomized, double-blind, multicenter, 2 parallel group study. the first part of the treatment period will evaluate the pharmacokinetic bioequivalence of a single dose of a subcutaneous injection of 30mg of albiglutide from process 2 drug substance compared with process 3 drug substance. the second part of the treatment period will evaluate additional pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, effects on glycosylated hemoglobin and fasting plasma glucose, and safety and tolerability of repeat doses of subcutaneous injections of 30mg of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study.

Eligibility criteria:
inclusion criteria: * subjects with a historical diagnosis of type 2 diabetes mellitus who are experiencing inadequate glycemic control on their current regimen of diet and exercise or on a stable dose of metformin * body mass index ≥20 kg/m2 and ≤45 kg/m2 * fasting c-peptide ≥0.8 ng/ml (≥0.26 nmol/l) * thyroid-stimulating hormone level is normal or clinically euthyroid * female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception. exclusion criteria: * current ongoing symptomatic biliary disease or history of pancreatitis * history of significant gi surgery * recent clinically significant cardiovascular and/or cerebrovascular disease * history of human immunodeficiency virus infection * history of, or current hepatic disease * history of alcohol or substance abuse * female subject is pregnant, lactating, or \<6 weeks postpartum * history of type 1 diabetes * receipt of any investigational drug within the 30 days, or 5 half-lives whichever is longer, before screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of any glp-1 agents including albiglutide * history of, or family history of thyroid disease

Keywords: pharmacokinetics pharmacodynamics gsk716155 albiglutide
inhaled budesonide/formoterol in bronchiolitis obliterans following stem cell transplantation

Conditions: Bronchiolitis Obliterans; Allogeneic Stem Cell Transplantation

Summary: the purpose of this study is to determine whether inhaled budesonide/formoterol is effective in the treatment of bronchiolitis obliterans after allogeneic stem cell transplantation.

bronchiolitis obliterans (bo) is a life-threatening pulmonary late-onset complication following allogenic stem cell transplantation (sct), commonly attributed to graft versus host disease (gvhd), and carries a poor prognosis. although immunosuppressive treatments (is) represents the main therapeutic approach in this disorder, these medications are rarely efficient and alternative approaches are strongly needed. because, the combination of inhaled steroids and long-acting bronchodilator are known to decrease respiratory symptoms, prevent exacerbations and improve lung function in chronic obstructive pulmonary diseases with bronchiolar component, they may have beneficial effects in bo. thus, the investigators conducted a pilot open-labeled trial to evaluate the therapeutic effects of inhaled budesonide/formoterol combination (400/12 µg twice a day) without modifying systemic is received by the patients.

Eligibility criteria:
inclusion criteria: * adult allogeneic stem cell transplant recipients with clinical respiratory signs assumed to be secondary to bo, without extra-thoracic extensive graft versus host disease exclusion criteria: * extensive extra thoracic gvh necessitating increasing immunosuppressive treatments

Keywords: bone marrow transplantation obstructive lung disease bronchodilators inhaled steroids late-onset pulmonary complication
feasibility and acceptability of a physical activity behavior change intervention for parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to assess the feasibility, in regards to acceptability and implementation, of the pre-active pd intervention for increased high intensity goal-directed aerobic exercise engagement in people with early-stage parkinson's disease (hoehn and yahr stage i \& ii). in addition, the study aims to explore the effect estimates of the pre-active pd intervention on self-efficacy, motivation, stage of behavior change, and physical activity levels in people with early stage parkinson's disease.

the investigators will recruit 14 individuals with early stage parkinson's disease (hoehn and yahr stage i \& ii). the investigators will conduct a single arm cohort. (pre and post intervention) pilot feasibility study over 4 months with embedded process analyses of preactive-hd, a physical activity coaching intervention program. previous studies conducted by the investigators will be utilized to adapt the engage-hd physical activity coaching program to people with early stage pd. the intervention will include a participant/coach interaction and disease-specific workbook grounded within the framework of self-determination theory. the coaching sessions will be conducted by an occupational therapist and will entail six coaching sessions (either face-to-face or remote video sessions via secure webex connection via computer or smart phone, or phone call if internet/smart phone is not available to participant). the first session (approximately 45 min) will lay the groundwork for the program, and the remaining sessions will serve to provide directed support in relation to regular physical activity and exercise. participants will develop physical activity goals and will be supported with individual physical activity progression. participants will be given fitbit devices as a motivational tool and to track activity progression.

Eligibility criteria:
inclusion criteria: 1. neurologist confirmed clinical dx for parkinson's disease hoehn \& yahr stage i or ii 2. ambulatory for indoor and outdoor mobility without assistance or assistive device 3. successful completion of physical activity readiness questionnaire (par-q) (thomas et al., 1992), or medical clearance from gp exclusion criteria: 1. musculoskeletal injury that would prevent participation in an exercise program 2. other neurological disease or disorder such as stroke 3. already engaging in aerobic exercise for at least 30 minutes for 5 or more days per week.
home rehabilitation after acute pulmonary embolism

Conditions: Pulmonary Embolism

Summary: the purpose of this study is to evaluate whether a home rehabilitation program after hospitalization for acute pulmonary embolism (pe) improves clinical outcomes at 3 months compared to usual care. daily physical activity tasks that incorporate heart rate monitoring will be sent through email or text. this information could help improve the management of acute pe.


Eligibility criteria:
inclusion criteria: * english speaking (\>18 years old). daily messages will be sent in english. * acute pe with right ventricular enlargement or dysfunction defined by echocardiogram report, ct angiogram report, or elevated cardiac biomarker (nt-pro bnp or troponin). * baseline testing started within 7 days of hospital discharge. exclusion criteria: * pregnancy. * cardiac effort \>2.5 beats/m during 6mwt. this is for safety. * cardiac effort \<1.2 beats/m during 6mwt. they are unlikely to benefit. * resting tachycardia \>120 beats/m during screening or at hospital discharge. * suspicion for chronic thromboembolic pulmonary hypertension. * systolic blood pressure \>180 mmhg during screening or at hospital discharge. * inability to walk. * estimated prognosis \<12 months at the time of discharge due to underlying co-morbidities. * advanced neurologic disease. * lack of access to email or text messaging. * inability to follow daily instructions. * participation in a structured exercise routine at least three days per week in the prior four weeks. * principal investigator discretion
evaluating the relative effectiveness of two feeding interventions for the treatment of moderate acute malnutrition

Conditions: Child Nutrition Disorders

Summary: supplementary feeding programs for children with moderate acute malnutrition have been implemented in developing countries using treatment foods with minimal or no evidence of their effectiveness. fortified peanut paste is a popular new treatment food for children with severe and moderate malnutrition. objectives: to investigate the relative effectiveness of two non-identical therapeutic foods in children with moderate malnutrition by comparing differences in performance indicators (i.e. recovery rates), recovery times, and change in weight-for-height z-scores in each group. this proposed research project will evaluate the relative effectiveness of two non-identical treatment foods for the treatment of moderate acute malnutrition in children

this research protocol will be embedded as a component of the un world food programme (wfp) -supported supplementary feeding programmes in ethiopia. the proposed study is a prospective cluster-randomized equivalence trial that will compare the relative effectiveness of two feeding interventions in four woredas (districts). research will be implemented in two comparable woredas (one with csb and one with rusf), in two different areas in sidama zone that represent different livelihood zones, main source of crop income, and level of food insecurity

Eligibility criteria:
inclusion criteria: * all children 6 to 60 months of age who are identified as malnourished based on muac measurements with wfh ≥70 to \<80%. exclusion criteria: * children with wfh \< 70% or presenting with bilateral pitting oedema (they will be referred to therapeutic feeding programme). * children with any illness or clinical condition that prevents them from safely ingesting either supplementary foods. a child is medically assessed upon admission for any complicated clinical condition (oedema, malaria, vomiting, chronic diarrhea, infections, appetite, etc) that would require medical care and those children will be referred to the therapeutic feeding programme. * all children transferred from the therapeutic feeding programme directly into the supplementary feeding programme - however they will not be included in the research study. * children with wfh \> 80% but muac 110 to 120 mm- they will be admitted to sfp however will not be included in the research study.

Keywords: united nations world food programme blended food (csb) ready-to-use supplementary foods (rusf) plumpy®
maximal rate of force development of ankle muscles and functional ability in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis; Knee Arthritis

Summary: this study is a detailed assessment of the maximal rate of force development of ankle muscles and its association with functional ability in patients with knee osteoarthritis (oa).

this research is designed to study the link between force development in ankle muscles and functional abilities in knee oa patients. it aims to understand the influence of ankle muscle strength, specifically plantar flexors, on the stability, pain, and functionality of patients with knee oa. the study will analyze the rate of force development, its importance in explosive strength improvement, and impact on preventing knee injuries. furthermore, it will investigate the compensatory mechanism of the plantar flexors developed by patients in advanced stages to balance other muscle failures.

Eligibility criteria:
inclusion criteria: * group 1 (knee oa group) 1. patients diagnosed with knee osteoarthritis according to performance of the 2018 classification criteria for early stage knee oa was tested using data from the osteoarthritis initiative (oai (leung et al.,2020). 2. grade 2-3 koa cases according to kelgren-lawrance classification 3. having knee pain for at least 6 months. 4. the visual analog scale (vas) score being at least 3 or more. * group 2 (healthy control group) 1. individuals with no signs or symptoms of knee oa or other neurological or musculoskeletal conditions. exclusion criteria: 1. patellar subluxation 2. surgery in any joint of the lower limb 3. meniscal injury 4. ligament instability 5. patients who received intra-articular injection in the knee in the last 6 months 6. patients with problems in the hip and ankle 7. patients who participated in in another physical therapy program in the last 3 months were not included in the study.
strengthening evidence on optimal multidrug-resistant tuberculosis treatment regimens

Conditions: Tuberculosis, Multidrug-Resistant; HIV

Summary: this is a multisite prospective cohort study of patients with multidrug- or rifampin-resistant tuberculosis who are treated with an all-oral shortened regimen under routine program conditions in one of three countries (peru, lesotho, kazakhstan).


Eligibility criteria:
inclusion criteria: * all patients with pulmonary tuberculosis that is resistant to rifampin (rif) or to both rif and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions, per local country guidance, will be included. exclusion criteria: * exclusions are based on local guidance in each country. currently, individuals with fluoroquinolone resistant tuberculosis are excluded from all-oral shortened treatment.
study and modulation of immune responses in primary and metastatic colon cancers

Conditions: Colon Cancer; Peritoneal Carcinoma

Summary: colorectal cancer (crc) is the 3rd most common cancer in france. treatment of crc relies primarily on surgical removal of the primary tumor and chemotherapy is the current standard of care for synchronous metastatic disease. overall survival remains strongly correlated with the tumor stage at the time of surgery, from 90% at five years for localized disease (stages 1 and 2), to around 20% for metastatic forms of the disease (stage 4). recent research in cancer highlights the role of the immune system in the development, evolution and fate of tumors. understanding the nature of interactions between different immune cells infiltrating the tumor is important for the development of innovative therapies. recently, the consensus molecular classification of crc confirmed the importance of the immune response in crc by showing that a "high immune response" is a good prognostic indicator for patients with this pathology. however, immunotherapies are effective for only a minority of patients with metastatic crc. indeed, anti programmed cell death 1 (anti-pd-1), -pd-l1 immune checkpoint blocking antibodies have only shown effectiveness in patients with microsatellite instability (msi), which only represents 5% of metastatic crcs. thus, the aim of this study is to better understand the role of the immune system on the development of crc and its possible modulation to treat or prevent metastatic recurrences.


Eligibility criteria:
inclusion criteria: * male or female 18 years of age or older * diagnosis of colorectal adenocarcinoma * scheduled resection of tumor and/or metastasis(es) exclusion criteria: * patient's opposition to research * patients under guardianship * the following situations 1. persons unable to understand and/or read the information leaflet 2. patient with one of the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or, having any involvement in the study 3. non-cooperative or potentially non-compliant person for the study and its procedures with foreseeable difficulties in regular follow-up over 5 years. 4. non-affiliation with a social security scheme, couverture médicale universelle or any equivalent scheme. * pregnant or breast-feeding women. * hiv-positive patients.

Keywords: organoids t-cells metastasis immunotherapies
levetiracetam or pregabalin in treating seizures in patients undergoing chemotherapy and/or radiation therapy for primary brain tumors

Conditions: Brain and Central Nervous System Tumors; Seizure

Summary: rationale: levetiracetam and pregabalin are drugs that treat seizures. it is not yet known which drug is more effective in treating seizures caused by primary brain tumors. purpose: this randomized phase ii trial is studying the side effects and how well levetiracetam or pregabalin work in treating seizures in patients undergoing chemotherapy and/or radiation therapy for primary brain tumors.

objectives: * to determine the safety and efficacy of antiepileptic drug monotherapy comprising levetiracetam or pregabalin in treating seizures in patients undergoing chemotherapy and/or radiotherapy for primary brain tumors. outline: this is a multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive levetiracetam. * arm ii: patients receive pregabalin. patients are followed at 2 weeks, 2 months, 6 months, and then at 1 year.

Eligibility criteria:
disease characteristics: * diagnosis of primary brain tumor * who grade ii-iv disease * undergoing chemotherapy and/or radiotherapy * no brain tumor without the potential need for chemotherapy (e.g., meningioma without anaplastic features) * has had at least one seizure provoked by the brain tumor, justifying introduction of antiepileptic drug (aed) treatment * no status epilepticus patient characteristics: * modified rankin score \< 4 at study enrollment * life expectancy ≥ 4 weeks * not pregnant * negative pregnancy test * fertile patients must use effective contraception * no known intolerance to the study drugs * no pre-existing psychosis and/or current suicidality prior concurrent therapy: * see disease characteristics * no concurrent iv aeds other than benzodiazepines * other concurrent aeds, except phenobarbital, allowed provided they are discontinued within 2 weeks after study enrollment

Keywords: seizure adult anaplastic astrocytoma adult diffuse astrocytoma adult pineal gland astrocytoma adult glioblastoma adult gliosarcoma adult giant cell glioblastoma adult brain stem glioma adult ependymoblastoma adult medulloblastoma adult supratentorial primitive neuroectodermal tumor (pnet) adult ependymoma adult anaplastic ependymoma adult anaplastic meningioma adult anaplastic oligodendroglioma adult oligodendroglioma adult pineoblastoma adult pineocytoma adult mixed glioma adult papillary meningioma recurrent adult brain tumor adult grade ii meningioma
increased focus on protein intake among geriatric patients

Conditions: Geriatric Diseases

Summary: up to approximately 38 (unknown drop-out rate) geriatric patients (at least 65 years old) are recruited from a geriatric ward at slagelse sygehus. after inclusion and baseline measurements, each individual will be randomized into either an intervention or control group arranged in blocks of 8 the intervention group (n≤19) will receive protein enriched snacks/dishes in the morning and late evening, before bedtime. moreover, upon discharge the intervention group will receive individual dietary counseling focusing on choosing protein-rich foods and on protein rich meals. the control group (n≤19) will receive normal hospital food without enrichment and no dietary counseling at discharge. in both groups the following data will be obtained: recorded protein intake, anthropometric measurements (weight, height, body composition estimated with bioimpedance), functional ability (de morton mobility index (demmi) and barthels adl-index), hand grip strength, sarkopenic status (sarc-f), quality of life (eq-5d-3l), length of stay (los) and readmissions (within 30 days after discharge). during hospitalization food intake will be registered, as well as 24 hour recall interviews and food frequency questionnaires will be done at follow-up visits. assessments will be performed at baseline, on the day of discharge and 4 weeks after discharge (follow up). the primary outcome is change in protein intake from baseline to 4 weeks after discharge. the hypothesis is that serving of individually selected protein enriched snack/dish in the morning and before bedtime during hospitalization results in higher protein intake during hospitalization and that this experience combined with dietary counseling at discharge, results in a higher protein intake at 28 days after discharge. further, we hypothesize that the increased protein intake will affect functional level, hand grip strength, sarcopenic status and quality of life in geriatric patients and will lead to shorter los and fewer readmission frequency.


Eligibility criteria:
inclusion criteria: * age: ≥65 år and admitted to the geriatric ward at slagelse hospital. * expected length-of-stay, los: more than 3 days * normal kidney function. (as long as the kidney values remain stable during the intervention it is deemed safe to take part, as the amount of protein given will not exceed the amount recommended by the danish authorities. exclusion criteria: * dysphagia * patients exclusively fed by tube/probe or parenteral nutrition. * gastrointestinal problems, that makes normal food intake impossible. * people suffering from dementia, deliriousness or severe memory loss * patients abusing alcohol * patients in isolation * terminal patients * patients that do not speak danish or english * patients suffering from food allergies/intolerances that makes it impossible to accommodate to the protein enriched foods.

Keywords: frailty geriatric hospitalized enrichment whey protein protein intake sarcopenia dietary counseling
automated sms-based appointment validation tool

Conditions: Diabetes Mellitus Type 2; Adult-onset Diabetes

Summary: medic mobile conceptualized and proposed the creation of an sms-based appointment validation tool to automate appointment confirmation and rescheduling. working in parallel with the san mateo medical center (smmc) electronic medical records (emr) system, the software tool will automate reminders that request text responses from patients to either confirm or request to reschedule their upcoming appointments. while simple in concept, this tool aims to free up scarce clinical resources which are currently allocated to daily patient phone call reminders. with funding from a bay area foundation, the investigators will develop and pilot this open-source software tool in a 12-month randomized-controlled trial, slated to begin in october 2012. the endpoints of the study will aim to demonstrate improvements in both appointment adherence and glycemic control.


Eligibility criteria:
inclusion criteria: * belong to willow clinic or fair oaks clinic under the san mateo medical center * have a diagnosis of type 2 diabetes as indicated by icd-9 code of 249.xx or 250.xx * have a most recent hemoglobin a1c (hba1c) level greater than 7% * are at least 18 years of age * have access to cell phone * are literate or live with a friend/family member who is literate and willing to handle associated text messages exclusion criteria: * have a terminal illness and prognosis of less than one year * are unable to demonstrate the ability to reply to an sms and lack an appropriate proxy * are pregnant or expect to be pregnant in the next 6-9 months