Kornimate/medical-research-clean huggingface dataset:
dwi in assessing treatment response in patients with breast cancer receiving neoadjuvant chemotherapy

Conditions: Breast Cancer

Summary: rationale: imaging procedures, such as diffusion-weighted magnetic resonance imaging (dwi) and dynamic contrast-enhanced magnetic resonance imaging (dce-mri), may help in evaluating how well patients with breast cancer respond to treatment. purpose: this research trial studies dwi and dce-mri in assessing treatment response in patients with breast cancer undergoing neoadjuvant chemotherapy.

objectives: primary * to determine if the change in tumor apparent diffusion coefficient (adc) value measured from each treatment timepoint to baseline is predictive of pathologic complete response (pcr). secondary * to determine if the combined measurement of change in tumor adc value, change in tumor volume, and change in peak signal-enhancement ratio (ser) is predictive of pcr. * to investigate the relative effectiveness of the individual measurements, change in tumor adc value, change in tumor volume, and change in peak ser for predicting pcr in experimental treatment arms. * to assess the test-retest reproducibility of adc metrics applied to breast tumors. outline: this is a multicenter study. patients undergo diffusion-weighted magnetic resonance imaging (dwi) at baseline, after week 3 of neoadjuvant paclitaxel regimen, and prior to and after completion of 4 courses of neoadjuvant chemotherapy. patients then undergo surgery. patients undergo dwi prior to contrast administration for dynamic contrast-enhanced magnetic resonance imaging (dce-mri). after completion of treatment procedure, patients are followed up for 5 years on the i-spy 2 trial.

Eligibility criteria:
disease characteristics: * meets i-spy 2 trial inclusion criteria * high-risk for recurrent disease patient characteristics: * able to tolerate imaging required by protocol prior concurrent therapy: * not specified

Keywords: stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer her2-negative breast cancer her2-positive breast cancer
ect schizophrenia serotonin study

Conditions: Schizophrenia

Summary: we suggest to investigate serotonin uptake in schizophrenia patients receiving ect

we suggest to investigate serotonin uptake in schizophrenia patients receiving ect

Eligibility criteria:
inclusion criteria: participants must meet dsm-iv criteria for schizophrenia, as assessed by the structured clinical interview - patient version (scid) (first et al., 1995). ages 18 -55 men and/or women - exclusion criteria: 1. history of neurological disorders, active substance abuse in the previous 3 months. 2. estimated iq less then 70. 3. ssris treatment 4 weeks prior to the study. 4. any subject suffering from inflammatory fever disease will be excluded from the study. -
antipsychotic response in schizophrenia

Conditions: Schizophrenia

Summary: motor slowing is a hallmark, clinical sign in mental illness. slowness can be related to a specific disease process, as in negative schizophrenia or depression or it can be the result of medications used to treat forms of mental illness. prior research has lead to a novel instrumental approach for distinguishing subtypes of motor slowing - one type related to cognitive processes and another related to parkinsonism. the purpose of this study is to test whether new medications used to treat schizophrenia improve the cognitive or parkinsonian components of motor slowing. patients will be studied in the laboratory before and 8-weeks after starting a new antipsychotic. the n of this study = 60 patients. the results of this study will improve our understanding of the complex interactions between cognitive processing and motor behavior in patients with psychotic illnesses and how drugs work to treat these problems.


Eligibility criteria:
schizophrenia diagnosis currently treated with conventional antipsychotic willing to be switched to an atypical antipsychotic.

Keywords: antipsychotics schizophrenia motor retardation bradykinesia
evaluation of safety and efficacy of specific immunotherapy with recombinant major allergens of timothy grass pollen adsorbed onto aluminium-hydroxide in patients with ige-mediated allergic rhinoconjunctivitis +/- controlled asthma

Conditions: Rhinoconjunctivitis

Summary: efficacy and safety from a high-dosed subcutaneous recombinant preparation


Eligibility criteria:
inclusion criteria: * allergic rhinoconjunctivitis attributable to grass pollen * positive spt * positive east * positive provocation test exclusion criteria: * serious disease * other perennial allergies

Keywords: grass pollen allergy specific immunotherapy
comparison of the effectiveness of spinal manipulation and yoga in chronic low back pain

Conditions: Low Back Pain; Spinal Manipulation; Yoga

Summary: the aim of our study was to compare the effectiveness of chiropractic manipulation and yoga-based exercise techniques on pain, functionality, depression and anxiety in patients with long-term low back pain.

the study will include 60 individuals between 18 and 65 who meet the inclusion criteria. demographic and anthropological information will be recorded before starting the study. after these measurements, the participants will be randomly divided into three groups. these groups will be formed as chiropractic manipulation group (n=20), yoga-based exercise group (n=20) and conventional exercise group (control group) (n=20). in the chiropractic manipulation group, chiropractic manipulation (hvla maneuver) will be applied to the facet joints of the lumbar vertebrae and the sacroiliac joint 2 times a week for eight weeks. the yoga-based exercise group will exercise with an exercise program that includes balance, coordination and stretching exercises. yoga exercises will be done in groups of 3-4 people, including breathing exercises and various relaxation techniques, and will be done in 60-minute sessions 2 days a week for 8 weeks. this will include yoga techniques such as suyanamaskar and asana. the control group will perform stabilization exercises for the lumbar region. these exercises will be given in 3 phases following the protocol given to the chiropractic manipulation group. the exercises will be explained to the participants via video. individuals will perform this exercise program 2 days a week for 8 weeks. participants will then be assessed using the numeric pain scale, roland morris disability questionnaire for functional status, hospital anxiety and depression scale for quality of life and range of motion of the hip and lumbar region.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * experiencing low back pain for at least 3 months * pain above 3 on the numeric pain scale * the patient diagnosed with chronic low back pain by a specialist doctor does not have any contraindications to chiropractic applications * no contraindications to exercise (systemic diseases, neurological diseases, etc.) * patients without joint-related listhesis, spinal stenosis and active discopathy * signing the voluntary consent form exclusion criteria: * having a fracture or dislocation of the spine, * presence of malignancy and infectious disease * presence of joint-related listhesis, spinal stenosis and active discopathy * presence of osteoporosis * those with a history of trauma within at least 3 months * pregnancy and suspected pregnancy * individuals with inflammatory low back pain * those who have undergone surgery and have neurological loss. * those with psychiatric problems

Keywords: yoga chronic low back pain chiropractic manipulation exercise
immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions.

Conditions: Allergy, Insect Venom; Allergy Insect Stinging; Insect Sting Allergy

Summary: observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. it includes the evaluation of controlled and spontaneous stings. this study will be conducted in spain (multicentric), multicentric and data will be collected prospectively.

observational, multicentric (spain), prospective study and data will be collected properly. the total number of participants is expected to be 80. the patients aged equal or more than 14 years old, sentitized to himenoptera venom, not gender differentiation.

Eligibility criteria:
inclusion criteria: * the study population consisted of allergic participants indicated for treatment with hymenoptera venom immunotherapy (apis mellifera or vespula spp.) according to standard clinical practice. * participants of both sexes aged 14 years or more. * participants who have not received immunotherapy with hymenoptera venom in the previous 5 years. * participants who have agreed to take part in the study and sign the informed consent form. in the case of minors, the patient's parent or guardian must also sign. exclusion criteria: * pregnant or breastfeeding women. * having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study. * participants who do not agree to participate and/or do not sign the informed consent form. * participants who do not comply with medical indications or do not cooperate with immunotherapy treatment.

Keywords: allergy immunotherapy apis mellifera vespula sp controlled sting
low versus high pressure suction drainage after total knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: principal hypothesis: a low suction drainage (-50 mmhg) reduce a 25% the blood loss with respect a standard closed drainage (-700 mmhg) following total knee arthroplasty.

secondary's hypothesis: * it don't expect differences in: 1. incidence of hematomas 2. incidence in surgery wound infection 3. time of immobilization 4. duration of hospitalization * the low suction drainage (-50 mmhg) will be more cost-effective than the standard closed drainage (-700 mmhg)

Eligibility criteria:
inclusion criteria: * adult knee replacement patients who agreed to participate in the study exclusion criteria: * people that not accomplished the inclusion criteria

Keywords: blood loss total knee arthroplasty adults drain drainage system
efficacy of wireless capsule endoscopy and ct enterography in obscure gastrointestinal bleeding

Conditions: Gastrointestinal Bleeding

Summary: the purpose of this study is to compare the efficacy between video capsule endoscopy and ct enterography in diagnosis of obscure gastrointestinal bleeding.

all adult patients with obscure gastrointestinal bleeding will undergo both video capsule endoscopy and ct enterography. the interval between two tests will be less than 1 month. the capsule reading gastroenterologist and the ct reading radiologist are blinded to each others' results.

Eligibility criteria:
inclusion criteria: * patients who present with passing melena or hematochezia or have iron deficiency anemia * no lesion found on both esophagogastroduodenoscopy and colonoscopy * age at least 18 years exclusion criteria: * allergy to iodinated intravenous contrast * chronic kidney disease stage at least 3 patients who do not on regular dialysis * suspected small bowel obstruction

Keywords: obscure gastrointestinal bleeding, ct enterography
evaluating the use of patient-reported outcome measures for improving the inter-rater reliability of common terminology criteria for adverse event ratings

Conditions: Cancer

Summary: this open randomized trial investigates, if clinicians complete ctcae ratings differently when receiving patients' patient-reported outcome (pro) data prior to their ctcae completion. the primary objective is to demonstrate superior inter-rater reliability of ctcae ratings from physicians relying on eortc pro data as additional data source over traditional ctcae ratings not including pro information.

in oncology, detection and tracking of adverse events (aes) are a top priority in both clinical trials and routine care. the classification of aes mostly relies on the common toxicity terminology for adverse events (ctcae) developed by the us-american national institutes of health and the national cancer institute. it is known, however, that the assessment of aes can greatly vary depending on whether they are assessed by patients or by clinicians. procedure: the patients (any oncological diagnosis, day clinic or inpatient for treatment with chemotherapy or immunotherapy; open 1:1 randomized) fill out an eortc quality of life questionnaire electronically (c30 + further questions). these pro data are immediately available for the clinicians. independently of each other, two different clinicians conduct a medical consultation with the patient and electronically a ctcae rating. for the intervention group, clinicians see the pro values directly next to the input options for the ctcae rating. for the control group, clinicians see the input options for the ctcae rating. the similarity of the assessments is checked using intra-class correlation. the combined use of pros and ctcae data makes particular sense for aes/aspects that are directly experienced by the patient (fatigue, pain, cognitive problems, emotional functioning, ...) and can only be adequately recorded by the clinician through communication with the patient.

Eligibility criteria:
inclusion criteria: * any cancer diagnosis * current treatment with chemotherapy or immunotherapy * symptom burden equal or greater score 3 of the screening question "on a scale of 0 to 10, to what degree did you experience physical or emotional symptoms/problems during the last week?" * ability to understand the questions linguistically and cognitively * written informed consent exclusion criterion: * psychiatric diagnosis or mental health problems

Keywords: patient-reported outcomes (pro) common terminology criteria for adverse events (ctcae) quality of life electronic data assessment
study to estimate the relative bioavailability of ertugliflozin (pf-04971729, mk-8835) in healthy adult participants (mk-8835-039)

Conditions: Healthy

Summary: the purpose of this study is to examine the rate and extent of absorption of three oral formulations of ertugliflozin (pf 04971729, mk-8835) administered in lean to obese healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 65 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests). women must be of non childbearing potential * body mass index (bmi) of 18.5 to 35.4 kg/m2; and a total body weight \>50 kg (110 lbs). * an informed consent document signed and dated by the subject. * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening). * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen at screening or prior to dosing in period 1. * history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening.

Keywords: relative bioavailability pharmacokinetics pharmacodynamics
cognitive effects and potential mechanisms of tbs in subjects with mci

Conditions: Mild Cognitive Impairment

Summary: this study aims to examine the effects and potential mechanisms of theta-burst stimulation (tbs) on cognitive function in individuals with mild cognitive impairment (mci).

the investigators apply the nia-aa criteria to subtype different endophenotypes of biomarker-defined mci individuals. this is a prospective, open-label clinical trial, and combined functional neuroimaging study of 18f-fdg-pet to further explore the potential mechanisms. a total of 80 mci patients will be consecutively recruited and be subjected to itbs for 5 daily interventions per week for two consecutive weeks. cognitive evaluation will be performed before and immediately after tbs intervention, and 8 weeks after tbs. data on functional neuroimaging will be also collected before and after tbs protocol.

Eligibility criteria:
inclusion criteria: 1. subjects aged 50-90 year 2. subjects meet petersen's criteria for mild cognitive impairment (petersen, smith et al. 1999) 3. the cdr of mci patients can be 0-0.5 4. amyloid pet should ever be performed exclusion criteria: 1. any subject has a definite diagnosis of epilepsy or history of seizure attack. 2. current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor. 3. any subject has clinically significant or unstable medical diseases including metabolic, renal,liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders. 4. any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia,bipolar disorder, and previously prolonged substances abuse. 5. any females who is pregnant or lactating. 6. general mri, tms and/or pet exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not mr compatible in the body. withdrawal criteria 1. complications onset after intervention that affect efficacy and safety judgments. 2. new onset or progression of disease that may affect outcomes. 3. use of other therapies or drugs during the intervention period to change cognitive functions. 4. any subjects who are recognized as high risk of adverse effects by principle investigator.

Keywords: mild cognitive impairment theta-burst stimulation repetitive transcranial magnetic stimulation (rtms)
effect of yoga in pregnancy on cardio-respiratory adaptation to challenge

Conditions: Yoga; Pregnancy; Autonomic Nervous System

Summary: yoga has received considerable attention for its potential therapeutic benefits over the past decades and it gradually became object of scientific scrutiny. there is currently extensive literature supporting its use as a non-pharmacological tool for managing a variety of medical problems. a few studies have also explored potential beneficial effects of practising yoga during pregnancy on maternal and neonatal outcomes. an association between prenatal yoga and decreased incidence of fetal growth restriction, preterm delivery, and labor abnormalities resulting in operative delivery have been reported. exact mechanisms by which yoga could improve perinatal outcomes have not been elucidated yet. one of such mechanisms could be the positive effect of yoga on autonomic nervous system (ans). maternal cardiovascular system undergoes profound changes during pregnancy and ans plays a central role in adaptation to pregnancy-related hemodynamic changes. increase in peripheral vascular resistance that characterises hypertensive disorders in pregnancy with fetal growth restriction is mediated by substantial increase in sympathetic vasoconstrictor activity. effects of yoga on ans outside of pregnancy have already been investigated in several studies. heart rate variability (hrv) indices, used as a one of proxy measures for ans activity, showed significant shifts towards parasympathetic dominance following yoga sessions. another objective means of assessing ans activity is measurement of phase synchronisation between cardiovascular and respiratory systems following acute challenge. the higher the cardiorespiratory synchronisation after acute challenge is, the higher is the ability of ans to flexibly adapt to challenge. the objectives of the study are: i. to examine whether there is a short-term shift in autonomic balance to the parasympathetic branch of the ans and ability of the cardiovascular and respiratory respiratory systems to flexibly adapt to acute psychological challenge following sessions in pregnancy. ii. to investigate potential long- term effects of yoga practice during pregnancy on hrv and cardio-respiratory synchronisation following acute psychological challenge.


Eligibility criteria:
inclusion criteria: * healthy pregnant women with singleton pregnancies. exclusion criteria: * multiple pregnancies * cardiovascular disease (including hypertension and arrhythmias) * taking medications that would affect heart rate or blood pressure * psychiatric disorders * epilepsy * kidney disease * liver disease * known fetal anomaly * autoimmune disorders * thyroid disease * diabetes mellitus * alcohol/drug abuse

Keywords: yoga pregnancy cardiorespiratory synchronisation hearth rate variability
zanamivir aqueous solution compassionate use program retrospective chart review study

Conditions: Infections, Respiratory Tract

Summary: gsk is conducting a global retrospective chart review of patients treated with zanamivir as part of the compassionate use program (cup), in an effort to collect as much information as possible on the use of this investigational drug. the retrospective chart review is intended to gain a better understanding of the safety profile of investigational zanamivir and of clinical outcomes in the large number of patients treated outside of a clinical trial setting.

this is an observational, retrospective, multi-centre, cohort data collection study. the cup retrospective review study has been designed to collect safety and clinical outcome data from pediatric and pregnant patients (collectively referred to as the "tier 1" cohort) treated globally within the cup during the 2009/2010 pandemic (from may 2009) through 31 january 2011. the study will also attempt to collect data from other adult patients (referred to as the "tier 2" cohort) who were treated at sites identified as having tier 1 patients. the treating physician at each site will receive a letter from the gsk medical director inviting him/her to participate in the retrospective chart review study. physicians (or their delegates) who agree to participate will receive study-related documentation \[including the protocol and case report form (crf)\] to orient the site to the study details and crf. for the purposes of this study, the term "site" generally refers to a hospital where in-patient treatment was provided. the retrospective chart review will be monitored via remote visits by telephone. the interviewer will be a kendle associate assigned to the study who will not have direct access to the patient's source documents or medical records during conduct of the study. the physician/delegate will review the patient's chart and record data on a paper crf. the crf will be in the english language. site personnel will mail completed crfs to kendle. kendle will review the crf for data quality, and conduct a remote monitoring visit via telephone to address any data queries, if required. no visits to participating sites are planned.

Eligibility criteria:
inclusion criteria: 1. pediatric or pregnant patients that received zanamivir aqueous solution as part of the compassionate use program from may 2009 through 31 january 2011 (tier 1 cohort). 2. adult patients (tier 2 cohort) that received zanamivir aqueous solution as part of the compassionate use program from may 2009 through 31 january 2011, treated at the same site as a tier 1 patient. exclusion criteria: 1. adult patients that received zanamivir aqueous solution at non-tier 1 sites. 2. pediatric or pregnant patients that received zanamivir aqueous solution as part of the compassionate use program after 31 january 2011.

Keywords: influenza