Kornimate/medical-research-clean huggingface dataset:
natural history of cerebral palsy prospective study

Conditions: Cerebral Palsy

Summary: the study will describe the natural history of cerebral palsy (cp) as children develop over the first 2 years of life.

this study aims to describe the early natural history of cerebral palsy (cp) by mapping the development of infants with, or at-risk of cp, over the first two years of life. infants will be assessed at regular intervals up to 24 months of age, across a variety of childhood development to provide the first comprehensive developmental trajectories of this group. in doing so, it will contribute to the existing knowledge of cp development to assist clinicians and therapists with accurate information on prognosis and provide targeted interventions early and at the 'just-right' challenge. where indicated, individual participants' results from this study will be used to inform their therapy. this study is intended to form part of a larger multi-site international study.

Eligibility criteria:
inclusion criteria: * infants will be included if they have a diagnosis of cp or "at high risk of cp" and under the age of 12 months. * infants at high risk of cp as defined by any two (any combination) of the following: 1. neuroimaging predictive of a motor disability including the involvement of 1 or more of the following structures: sensori-motor cortex, basal ganglia, posterior limb of the internal capsule, pyramids. 2. trajectory of cramped synchronized general movements (gms) on general movement assessment (gma) or absent fidgety gms at fidgety age 3. hammersmith infant neurological exam (hine) scores \<57 @ 3months or \<60 @ 6months or \<63 @9 months infants will also be included if they meet both of the following criteria (even if infants have a hine score greater than the cut off scores stated above: i. unilateral brain injury on neuroimaging (magnetic resonance imaging (mri) or cranial ultrasound (cus)) predictive of cp ii. clinical signs of asymmetry exclusion criteria: * infants with progressive or neurodegenerative disorders or genetic disorders not associated with cp * infants with other disability diagnoses e.g. down syndrome
lean mass evaluation of cirrhotic patients with ascites with the use dxa

Conditions: Liver Cirrhosis

Summary: malnutrition due to liver disease is common, however, their detection is difficult. the parameters used for nutritional assessment in clinical practice have limited use in this patient population. from this perspective, this study proposes to develop predictive equations for body composition for electrical bioimpedance (bia) in cirrhotic patients. besides being a fast and risk free, the bia offers the additional advantage of low cost compared to other methods that assess body composition (bc). will be selected patients male with liver cirrhosis (n = 112) of the liver transplant clinic of the hospital of the clinicas, faculty of medicine, university of são paulo. this pioneering study is of great clinical importance because malnutrition is a relevant factor in the prognosis of liver disease and there is not efficient method in clinical practice to properly assess the body composition in this population.

malnutrition due to liver disease is common, however, their detection is difficult. the parameters used for nutritional assessment in clinical practice have limited use in this patient population. from this perspective, this study proposes to develop predictive equations for body composition for electrical bioimpedance (bia) in cirrhotic patients. besides being a fast and risk free, the bia offers the additional advantage of low cost compared to other methods that assess body composition (bc). will be selected patients male with liver cirrhosis (n = 112) of the liver transplant clinic of the hospital of the clinicas, faculty of medicine, university of são paulo. after signing an informed consent, bc will be estimated by bioelectrical impedance analysis and by reference method (dxa). the data obtained by both methods are statistically treated to obtain specific bia prediction equations for the evaluation of cirrhotic patients. this pioneering study is of great clinical importance because malnutrition is a relevant factor in the prognosis of liver disease and there is not efficient method in clinical practice to properly assess the body composition in this population. such knowledge, in turn, can serve as a new tool for nutritional assistance in treating this disease.

Eligibility criteria:
inclusion criteria: * adults (18-60 years) of both sexes; * signing the free and informed consent; * show interest, conditions and availability to participate in all procedures included in the study protocol; * liver cirrhosis carrier exclusion criteria: * refusal to participate; * patients who have made liver transplantation; * physical amputation; * swelling in the lower limb;

Keywords: body composition sarcopenia cirrhotic with ascites
pharmacokinetics and pharmacodynamics of biod-961 vs. marketed glucagons

Conditions: Hypoglycemia

Summary: biod-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. the purpose of this study is to evaluate how much biod-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.

subjects receive on separate days, in random order one of the following: 1 mg biod-961 intramuscularly (im), 1 mg lilly (im), 1 mg novo (im), 1 mg biod-961 subcutaneously (sc), 1 mg lilly (sc), and 1 mg novo (sc).

Eligibility criteria:
inclusion criteria: * body mass index: 18.5-25.0 kg/m2 inclusive. * subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities. exclusion criteria: * type 1 or type 2 diabetes mellitus. * history of pheochromocytoma, insulinoma, glucagonoma, or glycogen storage disease. * history of regular alcohol consumption as defined by alcohol intake exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor. * significant cardiovascular (to include new york heart association (nyha) class iii or- iv functional capacity or uncontrolled hypertension), respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease. * any significant cardiovascular event history, including angina, myocardial infarction, therapeutic coronary procedure (e.g, percutaneous transluminal coronary angioplasty, coronary bypass surgery), stroke, or transient ischemic attack. * females who are breast feeding, pregnant, or intending to become pregnant during the study.
tethered capsule endoscope in screening patients with barrett esophagus

Conditions: Barrett Esophagus

Summary: this pilot clinical trial studies how well tethered capsule endoscope works in screening patients with barrett esophagus (be), a condition where the lining of the esophagus has changed or has been replaced with abnormal cells that may lead to cancer also called esophageal cancer. in an attempt to prevent the progression from be to esophageal cancer, patients undergo a standard procedure called esophagogastroduodenoscopy (egd) where patients are sedated and the doctor uses an endoscope to examine the tissue in the esophagus. tethered capsule endoscope is a tiny capsule with a laser scan inside and a very thin cord attached to it. patients swallow the capsule and the thin cord keeps the capsule in specific area in the esophagus. after pictures of the lining of esophagus are taken, the capsule is removed using the thin cord. tethered capsule endoscope may be able to identify tissue changes in patients with be without the need for sedation or anesthesia, thus eliminating the associated risks and costs associated with egd.

primary objectives: i. evaluate image quality and usability of the tethered capsule endoscope after repeated clinical use and reprocessing. ii. evaluate safety issues associated with the use of the device for this subject population - was there any noticeable difference from prior study of subjects at high risk of barrett's esophagus using the same device, but without reprocessing. secondary objectives; i. study other specified device characteristics or device application considerations. ii. obtain preliminary data for use in designing a subsequent pivotal study of the device. outline: patients swallow the tethered capsule endoscope (tce) and undergo endoscopic examination while they are seated on a standard endoscopy gurney. patients undergo standard of care egd on the same day.

Eligibility criteria:
inclusion criteria: * ability and willingness to provide written informed consent * scheduled for endoscopic screening and/or evaluation of barrett's esophagus exclusion criteria: * previous history of a swallowing disorder, such as scleroderma, achalasia, esophageal stricture or esophageal diverticulum * symptoms of dysphagia * suspicion or known history of gastrointestinal obstruction * history of prior surgery on the oropharynx, neck, esophagus, or stomach * current diagnosis of cancer, unstable cardiovascular disease, end-stage liver or kidney disease, or other major medical illness * currently taking anticoagulant medications or clopidogrel * major physical disability which would prevent subject from transferring from a chair to a bed and sitting in an upright position * inability to abstain from taking anything by mouth for at least 6 hours * currently pregnant * expected to undergo magnetic resonance imaging (mri) within two weeks following the study procedure
efficacy of granulocyte-colony stimulating factor (g-csf)

Conditions: Neutropenia

Summary: the purpose of this study was to analyze the clinical factors associated with the effect of granulocyte-colony stimulating factor (g-csf).

1. granulocyte-colony stimulating factor (g-csf) g-csf is known to be a synthetic cytokine that induces neutrophil differentiation and proliferation survival during leukocyte differentiation, and increases the activity in the periphery of mature neutrophils, which play an important role in human immunity. cytotoxic chemotherapy inhibits bone marrow hematopoiesis. inhibition of bone marrow hematopoiesis causes anemia, thrombocytopenia and leukopenia, and significant leukocytopenia causes opportunistic infection. g-csf is an indispensable drug for the treatment of leukopenia caused by cytotoxic chemotherapy in solid and blood cancer patients receiving chemotherapy. 2. chemotherapy with chemotherapy and g-csf the severity of neutropenia induced by chemotherapy was grade 1 (\<1500 / mm3), grade 2 (\<1500-1000 / mm3) and grade 3 (\<1000) based on the common terminology criteria for adverse events to 500 / mm3) and grade 4 (\<500 / mm3). cytotoxic anticancer drugs used in general chemotherapy cause neutropenia, and febrile neutropenia occurs in 10-20% of patients. in order to recover this, grade 4 neutropenia with an absolute neutrophil count (anc) of less than 500 and neutrophil to grade 2 or higher with g-csf in case of febrile grade 3 neutropenia. 3. g-csf dose and timing g-csf (renoglass team lenograstim 250 ug) was subcutaneously injected to a solid tumor (grade 3 or higher regardless of fever) with grade 3 or grade 4 neutropenia with fever until then, take medication daily. it is used regardless of gender, age, weight, body mass index, method of using anticancer, and injection time. however, the actual timing and extent of neutrophil recovery after g-csf administration varies from patient to patient. g-csf is a cytokine that is currently used in clinical trials. however, there are insufficient studies to investigate the clinical factors involved in the recovery of neutrophils in bone marrow after g-csf administration in domestic cancer patients. therefore, this study aims to analyze the clinical factors for the recovery of bone marrow hematopoietic function of g-csf administered in neutropenia following cytotoxic chemotherapy.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with solid cancer and blood cancer 2. patients who received chemotherapy with moderate risk (appendix 1, appendix 2) 3. ctcae version 4.0 showed grade 4 neutropenia, grade 3 neutropenia (blood cancer), decreased grade 3 neutrophils with fever (solid cancer) 4. those who understand and agree with the purpose of the research exclusion criteria: * 1) patients with hypersensitivity to g-csf 2) patients not diagnosed with hematologic tumor 3) grade 1, grade 2 or more neutropenia 4) patients who did not sign a consent agreement
fludarabine with or without cyclophosphamide in treating patients with advanced chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: rationale: drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. it is not yet known whether giving fludarabine together with cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic leukemia. purpose: this randomized phase iii trial is studying giving fludarabine together with cyclophosphamide to see how well it works compared to fludarabine alone in treating patients with advanced chronic lymphocytic leukemia.

objectives: primary * compare the progression-free survival, as well the overall survival and duration of remission in patients with previously untreated, advanced chronic lymphocytic leukemia treated with fludarabine with versus without cyclophosphamide. secondary * compare the incidence of side effects and quality of life of patients treated with these drugs. outline: this is a multicenter, randomized study. patients are randomized to 1 of 2 treatment arms * arm i: patients receive fludarabine iv on days 1-5. * arm ii: patients receive fludarabine iv and cyclophosphamide iv on days 1-3. in both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 375 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of previously untreated chronic lymphocytic leukemia (cll) * binet stage c and stage b are acceptable if there is rapid disease progression, symptoms of enlarged lymph nodes and organs, or severe b-symptoms * binet stage a is acceptable, if there are b-symptoms patient characteristics: * ecog performance status 0-2 * life expectancy \> 6 months * no severe organ dysfunction * no other previous or concurrent neoplasms, autoimmune hemolytic anemia, or thrombocytopenia prior concurrent therapy: * no prior or concurrent chemotherapy

Keywords: stage iii chronic lymphocytic leukemia stage iv chronic lymphocytic leukemia
the effect of lifestyle treatment in patients with morbid obesity

Conditions: Physical Capacity; Leg Strength; Eating Behavior; Life of Quality

Summary: the effect of lifestyle treatment on physical capacity, maximal strength, eating behavior and quality of life in patients with morbid obesity (lifetime)

in this study, the investigators will investigate whether more intensive day-based lifestyle treatment process have a better effect on weight loss and health-related quality of life than a previous treatment. investigators also want to investigate whether patients with good physical capacity (maximal oxygen uptake) and bone strength (maximum bone strength) before initiating treatment and / or after 3 and 6 months intensive training may have greater weight loss 1 and 2 years after treatment than patients with lower physical capacity and bone strength.

Eligibility criteria:
inclusion criteria: * treatment seeking morbidly obese patients (bmi ≥ 40 kg/m2 or bmi 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the vestfold hospital trust. exclusion criteria: * uncompensated heart failure * recent myocardial infarction or stroke (\<½ years) * severe arrhythmia or heart failure * unstable angina pectoris * renal failure * pregnancy * severe eating disorders * active substance abuse
study of ag-013736 in patients with refractory metastatic renal cell cancer

Conditions: Kidney Neoplasms; Carcinoma, Renal Cell

Summary: to determine the activity and response rate of ag-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).


Eligibility criteria:
inclusion criteria: * rcc with metastases and nephrectomy * failure of prior sorafenib-based therapy * at least 1 target lesion that has not been irradiated * adequate bone marrow, hepatic and renal function, \> or equal to 18 years of age. exclusion criteria: * gastrointestinal abnormalities * current use or inability to avoid chronic antacid therapy * current use or anticipated inability to avoid potent cyp3a4 inhibitors or cyp1a2 inducers * active seizure disorder or evidence of brain metastases.
a smoke-free home intervention in tribal communities

Conditions: Tobacco-Related Carcinoma

Summary: this clinical trial evaluates a smoke-free home intervention for reducing exposure to secondhand smoke from commercial tobacco in homes of participants who live in rural tribal communities. smoke-free homes are an innovative and relatively untapped strategy for cancer prevention in rural tribal communities. smoke-free policies, including those that target homes, can reduce exposure to secondhand smoke and support smoking cessation. rural and racial/ethnic inequities intersect to increase tobacco-related harms among indigenous populations. a smoke-free home program may improve the health of the household as well as impact smoking behavior among the family unit by reducing secondhand smoke exposure.

primary objective: i. to assess the effectiveness of a smoke-free homes intervention for tribal communities. outline: participants are randomized to 1 of 2 groups. group i: participants receive the smoke-free home program, consisting of mailed educational information about smoke-free homes at enrollment and in weeks 4 and 6, and attend one coaching call in week 2. group ii: participants receive usual care on study. participants may optionally receive the smoke-free home program following the 6 months follow-up. after completion of study intervention, participants are followed up at 3 and 6 months.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * self-report as being a smoker or living with a smoker * indicate that they do not reside in a smoke-free home * identify as living in an american indian household exclusion criteria: * children under the age of 18 will not be included
efficacy and safety of omalizumab in patients with severe persistent asthma

Conditions: Asthma

Summary: the purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma.


Eligibility criteria:
* with the diagnosis of allergic asthma \>1 year duration who, in addition to the standards of the american thoracic society (ats) meet the following criteria: * with a positive prick skin test (diameter of wheal \> 3 mm) to at least one perennial allergen (e.g. dust mite, animal dander, cockroaches), within the past 5 years or at visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study. a rast test may be performed for patients with a borderline skin prick test result. * with total serum ige level 30 to 700 iu/ml. * demonstrating 12% increase in fev1 over baseline value within 30 minutes of taking up to 4 puffs salbutamol (albuterol) or nebulized salbutamol up to 5mg (or equivalent of alternative b-2 agonist) documented within the past year, at screening, during the run-in period or at baseline prior to randomization. * with fev1 40-80% of predicted normal value for the patient (demonstrable at least 6 hours after short acting b-2 agonist use or 12 hours after long acting b-2 agonist use) at baseline. * who have either experienced at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year. or: * been admitted to hospital (including intensive care unit) or received emergency room (including urgent care centers) treatment in the past 12 months for an asthma exacerbation, which in accordance with the gina guidelines met all of the following criteria for a severe exacerbation: 1. pef or fev1\< 60% of predicted/personal best, or patient is too breathless to provide pef. 2. no improvement after initial treatment and therefore requiring repeated treatment with inhaled b-2 agonist (high dose, spacer or nebulized). 3. requiring treatment with systemic corticosteroids * receiving high dose inhaled corticosteroid (at least 1000ug beclomethasone dipropionate or equivalent) and a regular inhaled long acting b-2 agonist for at least 3 months prior to screening and prior to at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year or the severe asthma exacerbation requiring the hospitalization/er visit. * who are receiving an ics dosage \> 1000ug beclomethasone dipropionate or equivalent and a regular inhaled long acting b-2 agonist for the last 4 weeks of the run-in period and at randomization (to be maintained throughout the study). * whose asthma medication remains unchanged in the final 4 weeks of the run-in period (to be maintained throughout the study). * with evidence of poor asthma symptom control at screening (based on patient history) and during the 4 weeks immediately prior to baseline.
home hospital for lymphoma

Conditions: Lymphoma

Summary: the goal of this research is to evaluate an intervention, which the investigators call "home hospital for lymphoma," that involves remote patient monitoring and home-based supportive care for patients hospitalized with lymphoma at massachusetts general hospital.

this research study is a single arm pilot feasibility study, which is the first-time investigators are examining this hospital at home intervention for patients with lymphoma. the research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms and home monitored vital signs) and home-based supportive care (e.g. visits to patients' homes to address and manage any concerning issues identified), and interviews of participants, caregivers, and clinicians asking their perceptions of the home hospital for lymphoma program. participants will include 3 groups: enrolled participants receiving the hospital at home intervention, caregivers of participants, and clinicians. participants will be in the research study for about six months after consent. it is expected that up to 38 participants will take part in this research study.

Eligibility criteria:
inclusion criteria: * age 18 or older * receiving their lymphoma care with curative intent at mgh (treatment intent based upon chemotherapy order in the electronic medical record) * hemodynamically stable during the first 24 hours of hospital admission at mgh * residing within the designated geographic area for mgh home hospital service (an approximately 10-mile radius from mgh) * able to communicate and respond to questionnaires in english * lives with a family member or a friend who supports the patient at home * deemed eligible for supportive oncology care at home based on the mgh home hospital clinician evaluation exclusion criteria: * those admitted to the intensive care unit * have high oxygen requirement (fio2 \> 0.4) * experience active angina or cardiac arrythmias * have a planned inpatient surgical or interventional procedure * have uncontrolled psychiatric illness or impaired cognition that prohibits complying with the study procedures * have uncontrolled pain requiring intravenous pain medications * those deemed ineligible based on the home hospital service clinician evaluation

Keywords: lymphoma home care services, hospital-based cancer care