Kornimate/medical-research-clean huggingface dataset:
tumor dna and mri/ct scan findings in patients with grade iii or grade iv malignant glioma

Conditions: High Grade Glioma

Summary: rationale: studying levels of tumor dna in the samples of blood from patients with cancer may help doctors find out whether the cancer has grown and how much. purpose: this laboratory study is comparing levels of tumor dna with mri and ct scan findings to measure cancer growth in patients with grade iii or grade iv malignant glioma.

objectives: * correlate changes in the level of serum tumor-specific dna over time with changes in brain tumor size as measured by serial mri or ct scans in patients with grade iii-iv malignant gliomas. outline: this is a multicenter study. blood samples are collected from patients at baseline and every 2 months thereafter. tumor and nontumor plasma is extracted. plasma samples are analyzed by polymerase chain reaction (pcr) to assess the p16_ink4a, p73, and o \^6-mgmt gene promoter methylation profile. quantitative realtime pcr is performed on samples with tumor-specific dna to determine the plasma concentrations of each methylated tumor-specific gene and the total plasma tumor-specific dna concentration. patients also undergo mri or ct scans every 2 months. projected accrual: a total of 60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed malignant brain tumor * one of the following grade iii or iv supratentorial gliomas: * anaplastic astrocytoma * anaplastic oligodendroglioma * glioblastoma multiforme * newly diagnosed or recurrent disease * planning to undergo anticancer therapy on a new approaches to brain tumor therapy (nabtt) consortium clinical trial patient characteristics: * karnofsky performance status 60-100% prior concurrent therapy: * see disease characteristics

Keywords: adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult giant cell glioblastoma recurrent adult brain tumor adult glioblastoma adult gliosarcoma
whole body vibration for hemiparetic cerebral palsy

Conditions: Physical Therapy

Summary: this study is to investigate the effect of whole body vibration in children with hemiparetic cerebral palsy on range of motion of shoulder, elbow and wrist and muscle strength of shoulder abductors and flexors, elbow flexors and extensors, wrist extensors and flexors.

studies show efficacy of whole body vibration in reducing spasticity, improving strength, balance, ankle dorsiflexion angle and gait parameters in post stroke and spinal cord injury patients improving posture and balance in patients with parkinson's disease and multiple sclerosis. although research suggests a positive influence of vibration on motor performance in individuals with neurological disorders, there are very limited numbers of studies in children with cerebral palsy. few studies have shown improvement in children with cerebral palsy: spasticity decrease as measured by isokinetic dynamometer. strength of muscles increase as measured by hand held dynamometer. motor function increase as measured by gross motor function measure and gross motor function classification scale. increase of the activation and the co- activation of biceps and triceps. vibrations increase bone mass and muscle strength in upper limbs. vibration therapy decreases spasticity and improve motor performance in children with cerebral palsy. reduce flexors spasticity and improve functions in the rehabilitation of upper limb spasticity. focal muscle vibration on triceps brachii muscle can reduce the spasticity for both elbow and wrist joint muscles. so in this study, the investigators are trying to implement an additional rehabilitation method for upper limbs in hemiparetic children to improve their upper limb range of motion and strength which will reflect an improvement in their upper limb functions and activities of daily living.

Eligibility criteria:
inclusion criteria: children will be included if they have the following: 1. children diagnosed as hemiparetic cerebral palsy. 2. children of both sexes in the age group ranging from 3 to 6 years. 3. spasticity will be grade 1 and 1+ according to modified ashworth scale. 4. they will be selected with level i and ii according to gross motor function classification (gmfcs). 5. children could understand and follow commands given by the therapist. exclusion criteria: children will be excluded if they have any of the following: 1. history of convulsions and epilepsy. 2. children with impaired cognitive function. 3. any surgical procedure for correction of deformity or soft tissue release in the past one year.
a mobile application for post-op analgesic consumption

Conditions: Tooth Extraction Status Nos; Post Operative Pain; Patient Satisfaction; Narcotic Use; Mobile App

Summary: surgical extraction of third molars is one of the most common outpatient procedures performed by oral surgeons. the prescription of postoperative narcotic and nsaid analgesics is the standard of care practice to relieve symptoms of pain, swelling, and trismus after these procedures. the majority of these patients do not return for follow up unless they experience a problem. there is limited data on whether the patients use the narcotics as directed and what is their practice of disposal of the remaining medications that were not consumed. in this research the effectiveness of postop analgesic consumption, analgesic disposal practice, pain control, and patient satisfaction will be compared between patients who are randomized to the intervention group who will use a developed mobile application and a control group who will not use the mobile app.

a pilot randomized clinical trial will be conducted to determine if use of a mobile application improves adherence to narcotic analgesic use and their disposal and patient satisfaction post-surgical extraction of third molars in an outpatient setting. eligible consented subjects will be randomized into either the mobile app group or the control group. both groups will receive standard of care which includes prescription of postoperative narcotic and nsaid analgesics and usual postoperative instructions.for the mobile group, the medable axon software developed by stanford university will be used to customize a mobile application that will be used one week post surgery to monitor postoperative analgesic consumption and disposal practices, pain control, and patient satisfaction, in the control group, case report forms will be used to gather data from the electronic medical records and a telephone survey will be done one week post surgery to obtain data on patient satisfaction. a total of 20 consecutive eligible patients will be enrolled in this pilot trial..

Eligibility criteria:
inclusion criteria: * patients between the age of 18-40 years * patients who require two mandibular third molars extracted * patients with a smartphone exclusion criteria: * patients taking any recreational drugs and medications for chronic pain

Keywords: oral surgery medication adherence
preoperative chemoradiation versus short term radiation alone with delayed surgery for stage ii and iii resectable rectal cancer

Conditions: Primary Rectal Cancer

Summary: trial compares two preoperative stage ii and iii rectal cancer treatment strategies: short term radiotherapy 5x5 gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 gy + 5fu/lv and surgery also after 6 weeks.


Eligibility criteria:
inclusion criteria: * histologically confirmed stage ii and iii rectal cancer less than 15 cm from anal verge * less than 80 years old * no other cancer during 5 years period * compensate cardiovascular, pulmonary, hepatic and renal functions. exclusion criteria: * stage i or iv rectal cancer * other cancer in 5 years period * radiotherapy or chemotherapy in anamnesis * not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc. * pregnancy or baby feeding

Keywords: rectal cancer radiotherapy radiochemotherapy
pharmacokinetic study of oral alxn1840 in japanese and non-japanese adult healthy participants

Conditions: Wilson Disease

Summary: the main purpose of the study is to confirm how long alxn1840 stays in the body of japanese and non-japanese healthy participants (that is, pharmacokinetic \[pk\] profile).


Eligibility criteria:
key inclusion criteria: - body weight ≤80 kilograms (kg) and body mass index (bmi) within the range 18-25 kg/m\^2, inclusive, at screening. - negative serum pregnancy test. - female participants of childbearing potential and male participants with a female spouse or partner of childbearing potential must be willing to follow protocol-specified contraception guidance starting at least one menstrual cycle before first study drug administration and continuing for up to 3 months after the end of systemic exposure of the study drug (that is, 3 months after end of study visit). key exclusion criteria: - current or recurrent/chronic disease (for example, cardiovascular, hematological, neurological, endocrine, immunological, rheumatological, renal, hepatic, or gastrointestinal (gi) or other conditions) that or could affect clinical assessments or clinical laboratory evaluations. - current or relevant history of physical or psychiatric illness that are not stable or may require a change in treatment, use of prohibited therapies during the study or make the participant unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the study drug or study procedures. - any other significant disease or disorder which, in the opinion of the investigator, may put the participant at risk. - history of significant allergic reaction (for example, anaphylaxis or angioedema) to any product (for example, food, pharmaceutical). - use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on day 1, except with prior approval of alexion. - use of non-prescription/ over-the-counter medications including vitamins and dietary or herbal supplements, within 7 days prior to dosing on day 1. - donated or lost 400 milliliters (ml) blood or more within the last 16 weeks preceding the first day of dosing.
a study of donanemab (ly3002813) in participants with early alzheimer's disease (trailblazer-alz 2)

Conditions: Alzheimer Disease

Summary: the reason for this study is to see how safe and effective the study drug donanemab is in participants with early alzheimer's disease. additional participants will be enrolled to an addendum safety cohort. the participants will be administered open-label donanemab.

trailblazer-alz 2 is a phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of n3pg antibody (donanemab) in participants with early symptomatic ad (prodromal ad and mild dementia due to ad) with the presence of brain amyloid and tau pathology. following the double-blind 76-week main study period, a double-blind 78-week long-term extension period is added to further evaluate donanemab efficacy and safety over time. participants from the addendum safety cohort are not eligible for the extension period.

Eligibility criteria:
inclusion criteria: * gradual and progressive change in memory function reported by participants or informants for ≥ 6 months * mmse score of 20 to 28 (inclusive) at baseline * meet 18f flortaucipir pet scan (central read) criteria - does not apply to safety cohort * meet 18f florbetapir pet scan (central read) criteria * have a study partner who will provide written informed consent to participate exclusion criteria: * contraindication to mri or pet scans * current treatment with immunoglobulin g (igg) therapy

Keywords: alzheimer's dementia cognitive impairment amyloid plaque
withdrawal of immunosuppression in recipients of face and extremity transplants

Conditions: Vascularized Composite Allotransplantation

Summary: many patients suffer from devastating injuries to vascularized composite tissues. vascularized composite tissues are blocs of functional tissue that can contain multiple tissue types such as bone, muscle, nerves, blood vessels, tendons, ligaments, and others. examples of patients with severe vascularized composite tissue defects include limb amputees, patients with third-degree burns to the face or extremities, soldiers with improvised-explosive-device blast injuries to the face, and others. these patients cannot be helped satisfactorily with conventional reconstructive surgery; however, recently vascularized composite allotransplantation (vca) such as transplantation of faces and limbs became available to this patients. unfortunately, at this juncture, patients who receive vca must submit to life-long regime of immunosuppressant drugs with serious side effects such as infection, renal toxicity and cancer. immune tolerance is the absence of a destructive immune response from the recipient's body to the transplant, while otherwise maintaining sufficient immune function to fight infections and other threats. transplant recipients with immune tolerance do not need to take immunosuppression drugs. the investigators believe that they can achieve immune tolerance in recipients of face and limb transplants.


Eligibility criteria:
inclusion criteria: * adults who have received vca transplants at brigham and women's hospital * no less than 3 months elapsed since vca transplant, * on steroid-free immune dual immunosuppression with tacrolimus (6-8 ng/ml trough levels) and mycophenolate mofetil, * no current concerns of rejection exclusion criteria: * recent (\<3 months) episodes of rejection, * active bacterial or viral infection, * malignancy, * non-healing wounds * pregnancy
validation of questionnaires hal and hep

Conditions: Haemophilia

Summary: spanish validation of hal and hep questionnaire by double translation (english-spanish-english), with a pilotage pediatric patients with hemophilia and adults and parents of children with hemophilia. the final validity will be obtained with a sample of 60-100 patients with hemophilia

validation of the spanish hemophilia specific questionnaires: hal and hep (adult version version version children and parents). to do this, there will be a double inverse translation, a pilotage of validity and clarity with a small sample of subjects and analysis of reliability and validity with more than 100 patients and parents of children with hemophilia to complete the validation.

Eligibility criteria:
inclusion criteria: * patients with hemophilia a and b * parents of children with hemophilia a and b, under 18 * patients who have previously signed the informed consent document exclusion criteria: * patients with other congenital coaghulopatías (eg, von willebrand's disease) * patients with cognitive impairment, or oral or written understanding

Keywords: hemophilia validation questionnaires activities sport patients
resistance exercise and protein during weight loss

Conditions: Weight Loss; Starvation

Summary: the purpose of this study is to determine if post-exercise protein supplementation can rescue the anabolic response of muscle and bone to resistance exercise during caloric restriction.

1. preliminary testing prior to the study start, participants will be weighed and body composition will be determined using bioimpedance analysis. then participants will undergo a 5rm barbell back squat exercise testing procedure. 2. randomization participants will proceed through each of the following conditions lasting 3 days: con: participants will be in energy balance and consume 1.2 g protein/kg bw/day. participants will be provided 30 g maltodextrin post-exercise. cr+c: participants will be restricted to 15 kcal/kg ffm/day and consume 1.2 g protein/kg bw/day. participants will be provided 30 g maltodextrin post-exercise. cr+p: participants will be restricted to 15 kcal/kg ffm/day and consume 1.2 g protein/kg bw/day. participants will be provided 30 g whey protein post-exercise. 3. diet prescription dietary energy intake will be controlled using clinical products, maltodextrin and whey protein isolate to meet target energy intakes. participants will receive calcium and vitamin d supplementation throughout the study. 4. exercise prescription participants will perform one bout of 5 sets of 5 repetitions of barbell back squat exercise on the morning of day 3 each condition. additional exercise and intense physical activity will be prohibited. 5. assessments body weight and composition (dxa + bia), fasting blood draws for assessment of metabolic and anabolic hormones and questionnaires will be conducted before and after each condition. a 24-hour serial blood draw procedure will be conducted following each workout session on each day 3. 6. washout once a participant completes a study condition, participants will continue to take daily body weights at home for up to one week. then participants will be required to wait one more week before completing their next condition during which they will resume regular diet and physical activity.

Eligibility criteria:
baseline inclusion criteria: * weigh at least 110 lbs * weight-stable (2.5 kg) within the past six months * height-stable (\< 0.25 inches) within the past year * 3 years of resistance training experience tested inclusion criteria: - \<20% body fat (men) or \<30% body fat (women) exclusion criteria: * lactose intolerant * pregnancy * taking interfering medications such as steroids, thyroid or growth hormones
ventricular tachycardia ablation in lvad patients

Conditions: Ventricular Tachycardia; End-stage Heart Failure; Ventricular Arrythmia; LVAD (Left Ventricular Assist Device)

Summary: the channeled-registry is a multicenter retrospective study to (1) systematically assess the mechanism and origin of ventricular tachycardia in patients with end-stage heart failure carrying an left ventricular assist device (lvad) and (2) to evaluate procedural parameters and outcome of ventricular tachycardia ablation in this special subset of patients.


Eligibility criteria:
inclusion criteria: * all patients with end-stage heart failure with an lvad implanted undergoing vt ablation exclusion criteria: * patients \<18 years, pregnant women, patients undergoing vt ablation without an lvad

Keywords: catheter ablation vt ablation in lvad patients
human umbilical cord mesenchymal stem cells treatment in sepsis

Conditions: Sepsis

Summary: the primary objective: to evaluate the efficacy of intravenous infusion of universal uc-mscs and cd83+mscs subpopulation injection in the treatment of sepsis by using the 28-day survival rate of the subjects as the primary efficacy criterion.the secondary objectives: 1. to systematically evaluate the safety of universal uc-mscs and cd83+mscs subpopulation in the treatment of sepsis; 2. to provide theoretical basis and clinical research data for establishing a safe, effective and feasible clinical treatment plan for sepsis using stem cells.


Eligibility criteria:
inclusion criteria: * age: 0-65 years old, diagnosed with sepsis * clinical diagnosis of sepsis (based on sepsis 3.0 international guidelines) * confirmed or suspected infection exclusion criteria: * violation of medical ethics * significant confounding factors likely to bias study outcomes * poor adherence to the study protocol * concurrent participation in other clinical trials * specific medical conditions: 1. history of chronic enteritis, neuropsychiatric disorders, or transplantation (bone marrow, lung, liver, pancreas, or small intestine) 2. severe primary diseases affecting survival (e.g., life-limiting hepatic, renal, or endocrine disorders) or psychiatric disorders 3. history of hypersensitivity or severe adverse reactions to biological products 4. imminent terminal status (e.g., septic shock, life expectancy \<7 days) 5. foreseeable risk of medical errors or disputes during hospitalization 6. active drug-resistant infections 7. history of malignancy at screening 8. pregnancy, lactation, or plans for pregnancy within the next year
using fludarabine and melphalan conditioning regimen for cll,lymphoma,multiple myeloma

Conditions: Chronic Lymphocytic Leukemia; Lymphoma; Multiple Myeloma

Summary: allogeneic non-myeloablative stem cell transplantation using fludarabine and melphalan conditioning regimen for chronic lymphocytic leukemia, lymphoma, and multiple myeloma

treatment plan * conditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2. * fludarabine and melphalan will be infused intravenously over 30 minutes in d5w 100 ml. * melphalan will be administered following the completion of fludarabine infusion at day -2. * in case of unrelated donor hct, thymoglobuline 3 mg/kg in n/s 500 ml (less than 0.5 mg/ml) or lymphoglobuline 15 mg/kg in n/s 500 ml (less than 2 mg/ml) iv qd on days -4, -3 and -2. infuse over 4 hrs. premedicate with avil 45.5 mg ivp and tylenol 600 mg po. methylprednisolone 2 mg/kg in d5w 100 ml will be given iv over 30 minutes before thymoglobulin (or lymphoglobuline) on days -4 to -2. * before the administration of melphalan, prehydration will be done intravenously with 0.9% ns 1l over 3 hours. * 30 minutes before melphalan infusion, premedication with dexamethasone 10 mg and ativan 1 mg i.v. push will be given. appropriate antiemetics such as ondansetron 8 mg i.v. push every 4-6 hours and ativan 1-2 mg i.v. push every 4-6 hours will be administered. * hydration with 0.9% ns at 80 ml/hour will be administered for at least 7 days. appropriate amount of kcl should be mixed. * gvhd prophylaxis will include cyclosporine a (csa) and methotrexate.

Eligibility criteria:
inclusion criteria: * patients must be 15 years of age or older and 65 years of age or younger * patients with cll, lymphoma, or multiple myeloma will be included in this study * no prior anti-cancer treatment should be done within 30 days. * informed consent should be given. * patients should have an hla-identical or single hla-locus mismatched donor. * karnofsky performance scale should be 50 or over (see appendix i). exclusion criteria: * patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the stem cell transplant treatment unlike, and making informed consent impossible. * patients with high serum creatinine level will be excluded. * patients should have uncontrolled infection. * no major anticipated illness or organ failure incompatible with survival from stem cell transplant. * serum bilirubin less than or equal to 4.0 mg/dl.