Kornimate/medical-research-clean huggingface dataset:
perioperative vs postoperative chemotherapy + bevacizumab in colorectal cancer, liver mets

Conditions: Colorectal Cancer; Liver Metastasis

Summary: early-stage colorectal cancer(crc)is localized and resectable, but 20% of the patients have metastatic disease at the time of diagnosis and 50% of all patients eventually die of the disease. the most frequent site of colorectal metastases is the liver, which accounts for 30% to 60% of cases. in these patients, the extent of liver disease is the main determinant of survival. hepatectomy is the only potentially curative therapy for colorectal liver metastases (clm), but when traditional criteria for resectability were used, only 10% of patients were candidates for surgical resection. although adjuvant systemic therapy after resection of primary colorectal tumors is well established, there are relatively few data on the use of postoperative therapy vs. surgery alone in patients who have undergone resection of liver metastases. in this trial, the absolute increase in the 3-year pfs rate with the addition of folfox4 was a modest but significant 9% in patients who had resection (from 33% to 42%; p = .025). for improving survival in patients with clm, several studies with biologic agents have been tried. the use of bevacizumab, a monoclonal antibody against vascular endothelial growth factor (vegf), has resulted in increased response rates in patients with stage iv colorectal cancer and improved os and pfs. in an ongoing phase ii trial presented in asco 2008, in patients who were potentially curable through resection of liver metastases, perioperative treatment with capecitabine and oxaliplatin (xelox) plus bevacizumab yielded an overall response rate of 73% with stable disease in 21% and a mean pfs of 27 months. response to chemotherapy significantly correlated with a prolonged pfs (p \< .001). on the basis of these backgrounds, we designed a phase ii study to compare the effectiveness of combination chemotherapy with perioperative or postoperative bevacizumab treatment in patients with clm.


Eligibility criteria:
inclusion criteria: * histologically proven colorectal adenocarcinoma * with hepatic metastasis and no evidence of extrahepatic metastasis (the liver metastases must be determined by a hepatic surgeon to be resectable) * 20\~80 years * ecog performance status 0 - 1 * adequate laboratory findings exclusion criteria: * prior chemotherapy for metastatic disease * prior adjuvant chemotherapy, if administered within 6 months before study entry * previous hepatic-directed therapy including hepatic resection and/or ablation, hepatic arterial infusion therapy, or hepatic radiation therapy * uncontrolled medical illnesses including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months * chronic active hepatitis or cirrhosis

Keywords: colorectal cancer, liver metastasis, bevacizumab, perioperative/postoperative chemotherapy
efficacy study of relaxation to 12 weeks against placebo in the overall care chronic pain in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the main objective of this protocol is to measure the improvement of the overall situation of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment relaxation. secondarily,is to evaluate the evolution of physical variables, psychological and social improvement of the quality of life. to evaluate the evolution of drug consumption


Eligibility criteria:
inclusion criteria: * men or women over 18 years * established diagnosis of fibromyalgia as defined by the american college of rheumatology: widespread pain and eleven tender points at 18 sites listed (acr, 1990) * eva ≥ 4 (on a scale of 10 cm) * no change in treatment for 15 days, except for treatment "on demand" or "rescue" * patient has given its written consent * patient wishing to benefit from relaxation sessions * people who can meet the self-assessment and hetero-assessment * people with a social security number exclusion criteria: * any painful situation that cannot be distinguished from fibromyalgia pain by the patient * patients untreated or treated for less than a month * patient with psychosis or severe depression or severe anxiety or impulsivity characterized, at the discretion of the clinician. * patients receiving benzodiazepines at the request * patient with deafness * patient after a body treatment using a relaxation method, relaxation therapy or hypnosis

Keywords: fibromyalgia relaxation improving the quality of life
shear wave elastography for diagnosis of heart failure with preserved ejection fraction

Conditions: Shear Wave Elastography; Heart Failure With Preserved Ejection Fraction

Summary: the diagnosis of heart failure with preserved ejection fraction (hfpef) is often complex. echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of hfpef. however, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of hfpef. myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. it is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of hfpef. shear-wave elastography is a novel ultrasound-based elastography technology. based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with hfpef can be directly reflected. currently, no relevant studies have applied shear-wave elastography to the diagnosis of hfpef. this study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with hfpef based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of hfpef.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. clear epidemiological and population characteristics of hfpef 3. symptoms and/or signs of heart failure 4. echocardiographic examination of lvef≥50% 5. objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular diastolic dysfunction and/or elevated left ventricular filling pressure, including elevated levels of natriuretic peptides 6. hfpef score ≥6 or hfa-peff score ≥5 exclusion criteria: any one item per patient was excluded from the study: 1. arrhythmia. 2. ischemic heart disease. 3. valvular heart disease or congenital heart disease with severe hemodynamic changes. 4. history of pacemaker implantation or other cardiac surgery. 5. poor ultrasonic image quality cannot meet the parameter measurement and analysis.
drug interaction study with bi 201335 and methadone or buprenorphine/naloxone

Conditions: Hepatitis C

Summary: otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered bi 201335 daily to determine if a drug interaction occurs between bi 201335 and either methadone or buprenorphine/naloxone.


Eligibility criteria:
inclusion criteria: 1. stable dose of either methadone or buprenorphine/naloxone for 30 days for opioid maintenance therapy. 2. male and female volunteers with a body mass index (bmi) = 18.5 and \< 32 with a minimum weight of 50kg. exclusion criteria: 1. any other significant medical illness of clinical significance. 2. history of rash or photosensitivity 3. chronic or acute infections including hiv, hepatitis b and hepatitis c. 4. history of allergy considered significant for this study 5. intake of any other medications except for methadone or buprenorphine/naloxone. 6. qtc on electrocardiogram (ecg) \> 470. 7. use of any other investigational drug within 30 days of the study. 8. drug or alcohol abuse (other than the defined opioid maintenance therapy with either methadone or buprenorphine/naloxone) 9. blood donation of more than 100ml within four weeks of the trial. 10. excessive physical activities one week prior to and during the trial. 11. any clinically relevant laboratory value. 12. concomitant use of any food product known to alter p450 or p-gp activity such as grapefruit juice, seville oranges and st. john's wort. 13. inadequate venous access for women of childbearing potential: 14. pregnancy or planning to become pregnant within 3 months of the trial 15. positive pregnancy test at screening visit 16. no proof of sterilization or unwilling or unable to use a double barrier method of birth control during the study and up to 3 months after the study. 17. lactation with active breastfeeding from screening up to 30 days after last study visit.
controlled clinical study to determine novel health benefits of cheese consumption

Conditions: Metabolic Syndrome X

Summary: to determine the effects of high cheese diets varying in carbohydrate content on markers of disease risk.

summary of proposed research: this project will involve four controlled 4 wk feeding periods in individuals with metabolic syndrome (currently 1/3 of us adults). after a 2 wk run-in period, 20 subjects will be fed one of three diets in a randomized and balanced order: a typical american high-carb diet high in cheese (6 oz/day), a high-carb diet low in cheese (0 oz/day), or a moderate-carb, high-cheese diet (6 oz/day), low-carb, high cheese where cheese displaces an isocaloric amount of carbohydrate. there will be a 2 wk washout period separating trials during which subjects consume their normal diet. specific menus will be designed for each feeding phase and all food will be prepared for subjects. testing will occur at baseline and after each feeding period. measures of cholesterol beyond standard ldl- and hdl-cholesterol will be done by examining lipoprotein particle size, apolipoproteins, and fatty acid composition \[i.e., accumulation of saturated fat in blood and tissues, palmitoleic acid (highly linked to cardiovascular disease), and detection of phytanic acid (a uniquely bioactive fatty acid in dairy fat)\]. changes in whole body and regional fat, including measures of visceral fat and liver fat, will be examined non-invasively by dual-energy x-ray absorptiometry (dxa) and magnetic resonance imaging (mri).

Eligibility criteria:
inclusion criteria: * waist circumference (≥101.6 cm men, ≥88.9 cm women) * blood pressure (≥130/85 mm hg) or current use of antihypertensive medication * fasting plasma glucose (≥100 mg/dl) * triglycerides (≥150 mg/dl) * hdl-c (\<40 mg/dl men, \<50 mg/dl women) exclusion criteria: * hypercholesterolemia * diabetes * liver, kidney or other metabolic or endocrine dysfunction, gastrointestinal disorders * regular smokers * lactose-intolerant * consume excessive amounts of alcohol (\>3 drinks/d) * have used cholesterol, diabetic, antibiotic or antifungal medications in the past 3 months * women who are pregnant or lactating * participants taking any probiotics or supplements known to affect serum lipid levels, inflammation, antioxidant status or the gut microbiota will be asked to discontinue use to allow for washout of any metabolic effects.

Keywords: diet intervention metabolic syndrome feeding study prediabetes
monotherapy brexpiprazole (opc-34712) trial in the treatment of adults with early-episode schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to investigate the effects of flexibly dosed brexpiprazole monotherapy in the improvement of early-episode schizophrenia through the assessment of social functioning, efficacy, and tolerability. early-episode schizophrenia is defined as episodes occurring ≤ 5 years after the onset of the first episode.


Eligibility criteria:
inclusion criteria: have a diagnosis of schizophrenia as defined by the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) and confirmed by both the mini international neuropsychiatric interview (m.i.n.i.) for schizophrenia and psychotic disorders studies and an adequate clinical psychiatric evaluation. * had the start of their first schizophrenia episode ≤ 5 years before the time of consent. * are 18 to 35 years old at the time of consent (inclusive, and outpatients only). * have a positive and negative syndrome scale (panss) total score of ≤ 80 at screening and baseline. * exhibit schizophrenia symptoms with a score ≥ 4 on the panss for ≥1 items related to active social avoidance, emotional withdrawal, passive/apathetic social withdrawal, and difficulty in abstract thinking. * have a diagnosis of schizophrenia made at least 6 months prior to screening as confirmed by subject, caregiver, or documented history. exclusion criteria: subjects presenting with a first episode of schizophrenia based on the clinical judgment of the investigator. * subjects who have been hospitalized for psychotic symptoms within the last 6 months. * subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history or who have a history of failure to respond to clozapine or response to clozapine treatment only. * subjects with a current dsm-iv-tr axis i diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, mdd, bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders. also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders. * subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that require treatment with an antidepressant. * subjects with clinically significant tardive dyskinesia at enrollment, as determined by a score of\>= 3 on item 8 of the aims at screening or baseline. * subjects with a score of 5 (severe akathisia) on the bars global clinical assessment of akathisia at screening or baseline. * subjects who have met dsm-iv-tr criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding nicotine.

Keywords: schizophrenia mental disorders psychotic disorders social avoidance emotional withdrawal passive/apathetic social withdrawal antipsychotic
prospective longitudinal observational research in atopic dermatitis

Conditions: Atopic Dermatitis; Asthma; Atopic Dermatitis and Related Conditions

Summary: atopic dermatitis (ad) is a frequent chronic relapsing inflammatory skin disorder, characterized by intensely itchy eczema. ad usually starts within the first 2 years of life. in 30 - 60% of children, inflammation spreads onto other body surfaces such as the gastrointestinal tract, the respiratory tract, and the conjunctives within a few years. this sequence is called atopic march. atopic dermatitis and associated atopic diseases are more frequent in families, suggesting a genetic predisposition. however, the underlying factors such as genetic phenotype, environmental factors, or life style which cause or worsen an existing allergic disease are not understood yet. affected people suffer from recurrent flares that result in significantly impaired quality. this study will collect clinical and laboratory data to elucidate immunotolerance and preventiv stategies with the aim to develop new and individual treatment options of atopic diseases.

primary objetive: in the planned project, the main objective is to identify endogenous (e.g. immunological and molecular factors) and exogenous factors (e.g. environmental, socioeconomic and microbial factors) that influence the course and remission of ad. more specifically to identify factors that are significantly different between patients that have or do not have remission from ad. secondary objective: (i) to identify endogenous and exogenous factors such as immunological, molecular and microbial factors to separate subgroups of patients (endotypes) with distinct local and systemic inflammatory responses. (ii) to identify potential biomarkers predicting the individual clinical course of ad and other atopic diseases including asthma, food allergy and allergic rhinitis.

Eligibility criteria:
inclusion criteria: * age 0 - 85 years * diagnosis of ad and/or another disease of the atopic group (i.e. allergic rhinitis, allergic asthma, food allergy) * the inclusion of patients in this study is independent from the current therapy. during the study all patients will be kept on a therapy that is medically indicated the inclusion criteria for healthy controls in this study are as follows: * age 0 - 85 years * no diagnosis or history of allergic disease * the inclusion of patients in this study is independent from the current therapy. during the study all patients will be kept on a therapy that is medically indicated written consent will be obtained after detailed information of the study was given to the participant. exclusion criteria - unable to give consent or refusal to participate in the study

Keywords: eczema dermatitis atopy
study evaluating food effect and qtc in patients with advanced malignancies

Conditions: Advanced Malignancies; Solid Tumor; Hematological Malignancy

Summary: phase 1 2-part study to evaluate the effect of food on pharmacokinetics of pelabresib (cpi-0610) and the effect of pelabresib on qtc in patients with advanced malignancies


Eligibility criteria:
inclusion criteria: * 18 years of age or older * confirmed diagnosis of an advanced malignancy for which no effective standard treatment options are available * eastern cooperative oncology group (ecog) performance status of ≤2 exclusion criteria: * chronic or active conditions and/or concomitant medication use that would prohibit treatment

Keywords: pelabresib cpi 0610
platelet-rich fibrin and connective tissue graft in recession treatment

Conditions: Gingival Recession

Summary: the aim of the trial is to evaluate the effectiveness of coronally advanced flap (caf)+connective tissue graft(ctg)+platelet-rich fibrin(prf) combination in miller i and ii recession treatment by comparing with caf+ctg. 40 patients were surgically treated either with caf+ctg+prf (test group) or caf+ctg (control group). clinical parameters of plaque index (pi), gingival index (gi), vertical recession (vr), probing depth (pd), attachment level (al), keratinized tissue width (ktw), horizontal recession (hr), mgj localization (l-mgj), tissue thickness (tt) were recorded at baseline, 3 months (ps1) and 6 months (ps2) post-surgery. root coverage (rc), complete rc (crc), attachment gain (ag), and keratinized tissue change (ktc) were also calculated.

given the encouraging effects of platelet-rich fibrin (prf) in healing and regeneration, it has been hypothesized that prf might develop the outcomes obtained with coronally advanced flap (caf)+connective tissue graft(ctg). therefore, it was aimed to evaluate the effectiveness of caf + ctg + prf in miller class i and ii recession defect treatment by comparing the outcomes with caf + ctg in a preliminary, controlled, randomized clinical trial (rct) with a 6-month follow-up. the study was conducted with 40 patients randomly grouped in half shares into indicated study groups. after phase i therapy, clinical variables including plaque index (pi), gingival index (gi), vertical recession (vr), probing depth (pd), attachment level (al), keratinized tissue width (ktw), horizontal recession (hr), mgj localization (l-mgj), tissue thickness (tt) were recorded. the surgical sites were prepared by using sulcular and adjacent vertical incisions and ctgs were harvested from the palatal regions. different from caf+ctg group, prf was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in caf+ctg+prf patients. then the gel was placed over the exposed root surface in the same group. the caf was primarily closed and postoperative instructions were given. after suture removal at second postoperative week, the patients were followed-up by monthly recall visits. same periodontal clinical variables were recorded 3 and 6 months after surgery.

Eligibility criteria:
inclusion criteria: * systemically healthy * single miller type i or ii recession defect ≥ 3 mm localized to anterior/premolar area * no alveolar bone loss * identifiable cemento-enamel junction * probing depth ≤3mm exclusion criteria: * smoking * pregnancy * history of periodontal surgery in last two years * mobility * excessive occlusal contacts * caries * loss of vitality
sepsis trial of early physical therapy outside the icu

Conditions: Sepsis

Summary: the purpose of this study is to determine whether an additional physical therapy program can improve the mobility and functional outcomes of patients diagnosed with severe sepsis (an illness in which the body has a severe response to bacteria or other germs and develops worsened function of a major organ such as the kidneys, heart, or lungs).

patients who are admitted to the hospitalist service at the university of michigan hospital will be screened for the presence of severe sepsis. those who are deemed eligible and provide consent will be enrolled. study patients will receive additional physical therapy according to a protocol developed for this study in addition to the usual care recommended by their regular treating physician. additional treatments will be individualized based on enrolled patients' baseline physical function and progress and may include standing, stretching, transferring, and walking - either with assistance or independently. treating therapists have been trained in the use of the protocol and individualization to maintain the highest standard of patient safety. patients will be contacted 30 days after discharge to answer questions about their health and ability to perform routine tasks at home.

Eligibility criteria:
inclusion criteria: * any english-speaking patient over the age of 18 who is currently admitted to a general care floor under the care of the medicine faculty hospitalist service at the university of michigan health system and has severe sepsis is eligible to take part in this study. exclusion criteria: * subjects must be deemed by the study team to give informed consent by being able to state the basic purpose of the study. consent by a legally authorized representative (lar) will not be sought.
describing the effects of insoles in children with increased femoral anteversion and pes planovalgus

Conditions: Femoral Anteversion; Pes Planovalgus; Flat Foot

Summary: increased femoral anteversion is a transverse plan problem that affects lower body alignment, walking and standing characteristics and also pes planovalgus mostly accompanies with ifa. it is shown that children with ifa and ppv have back and leg pain, fatigue, muscle cramps and they are under the risk for chronic disorders such as osteoarthritis, scoliosis and muscle injuries. insoles, which reduce pronation of foot (flat foot), provide apparently a static correction by supporting proper alignment in children with ifa and ppv. however, the dynamic effects of insoles to lower extremity biomechanics while walking is not known. the aims of this study are to determine the effects of the insoles on walking biomechanics in children with ifa and ppv by comparing with their healthy peers.


Eligibility criteria:
inclusion criteria: * insole group between the ages 7-15, trochanteric prominens angle test \> 20⁰, hip internal rotation angle \> 60⁰, without insole foot posture index score \> 5, with insole foot posture index score \> 4, using their insoles' at least one month. * control group between the ages 7-15, trochanteric prominens angle test \< 20⁰, foot posture index score \< 5, without any neurologic or orthopedic disease exclusion criteria: neurological and / or musculoskeletal problems, orthopedic problems to prevent walking.

Keywords: femoral anteversion, flat foot, insole, gait