Kornimate/medical-research-clean huggingface dataset:
the lymphocytic infiltrate of lung tumors.

Conditions: Lung Cancer; Immune System

Summary: the study is configured as a monocentric observational transversal biological study. the main objective of the study is the reconstruction of the molecular organization of tumors of the thoracic cavity, in particular non-small cell lung cancer (nsclc). the study involves the collection of clinical data and biological material (blood and tumor tissue) from 70 subjects diagnosed with thoracic tumors.

inclusion criteria: the study population will include all patients with the following characteristics: * ability to provide informed consent * men and women over the age of 18 years old * patients candidates for surgical treatment diagnosed with thoracic tumors the procedures to which the patient will undergo during the study follow the standard of clinical practice for the treatment of pathology. exclusion criteria: * previous chemotherapy for any cancer within the last 6 months * pregnant and/or breastfeeding women * immunosuppressive state (states of immunosuppression or ongoing immunosuppressive/immunomodulatory treatments) the time of observation of the patient for the purposes of the study is limited to the time of hospitalization and the surgical procedure, the patient will therefore perform a single visit to the hospital and there is no provision for the collection of further data following discharge. the study involves a single timepoint of data collection and samples. the study will have a total duration of 3 years.

Eligibility criteria:
inclusion criteria: * ability to provide informed consent; * men and women over the age of 18; * patients candidates for surgical treatment diagnosed with thoracic tumors exclusion criteria: * previous chemotherapy for any cancer within the last 6 months; * pregnant and/or breastfeeding women; * immunosuppressive state (states of immunosuppression or ongoing immunosuppressive/immunomodulatory treatments)

Keywords: thoracic tumors immune checkpoints lymphocytes
protein needs study

Conditions: Colorectal Cancer; Breast Cancer

Summary: severe muscle loss in patients with cancer has been associated with increased physical disability, extended hospitalization, infectious and noninfectious complications, increased risk of severe toxicity during cancer treatment, poor quality of life and shortened survival. adequate protein is key to sustain muscle mass and overall health. however, current nutritional recommendations are not specific or evidence-based. the aim of this project is to determine the protein needs of patients with colorectal or breast cancer. protein needs will be determined using a novel, non-invasive approach. our results will inform nutritional recommendations and guidelines with the ultimate goal of improving outcomes for people with cancer.


Eligibility criteria:
inclusion criteria: * outpatients age 45-80 years; * patients attending the new patient clinic at the cross cancer institute with a diagnosis of colorectal cancer or breast cancer (stages ii to iii); * able to complete baseline visits within approximately 4 weeks of starting chemotherapy or after a minimum of 4 weeks post-surgery if not undergoing chemotherapy; * ambulatory. exclusion criteria: * premenopausal women due to impact on protein requirements; * received anti-cancer hormone treatment or immunotherapy in the 4 weeks before first baseline visit; * renal impairment based on a creatinine clearance for estimated glomerular filtration rate (egfr) of \<60 ml/min * abnormal glucose metabolism based on a fasting glucose level \>6mmol/l and an hba1c \>5.7% or as reviewed by study team; * comorbidities or medications that would interfere with the participants ability to follow the study protocol or the quality of the data(e.g. diabetes, class iii obesity, hormone therapy, another active cancer diagnosis); * unable/unwilling to provide urine, breath and blood samples (e.g. oxygen tank, catheter, etc.); * unable to eat the meals provided (i.e. receiving parenteral or enteral nutrition, severe allergies); * substance dependent (e.g. alcohol, cigarettes, illicit drugs) and unable to follow study protocols.
guided relaxation training for the reduction of self-reported stress in individuals with newly diagnosed breast cancer

Conditions: Breast Cancer

Summary: the primary objectives of this study are to determine if the use of guided relaxation training (grt) during cancer treatment in individuals with newly diagnosed breast cancer increases their ability to cope as measured by the coping self-efficacy scale (cses) and reduces their perceived stress as measured by the perceived stress scale (pss).

this is a study of self-reported stress in individuals with newly diagnosed breast cancer. subjects will be randomized to either the standard of care (soc) arm or the intervention arm. the principle investigators will be blinded to the arm assignment. the intervention utilized will be six weekly on-site grt sessions. in addition, subjects will be provided with a cd utilizing a standardized grt script and music for home use twice daily during the study period. during the intervention period, they will also be provided with a diary and required to keep a record of date and time of cd utilization at home. the subjects will also be required to record their stress level before and after each of the two home sessions. the sessions must be at least 4 hours apart. the soc arm will consist of an education session with the nurse or nurse practitioner and supportive care / symptom management as needed. this group will also be required to keep a daily diary in which they record their stress levels twice daily, at intervals separated by at least 4 hours.

Eligibility criteria:
inclusion criteria: * able to speak and understand english * at or between the ages of 18 and 75 * newly diagnosed with breast cancer (within 12 weeks of study entry) * expected to receive chemotherapy and/or radiation * willingness to complete cses, pss-14 and facit-f scales * minimum score of 4 on the 0-10 visual analog scale for stress * willingness to participate for the 18 week duration of study and follow-up * ability to travel to cancer center weekly specifically for on-site guided relaxation training sessions * access to a cd player exclusion criteria: * cognitive or mental status affecting ability to follow directions * previous or current use of complementary therapies for their cancer diagnosis, except herbal supplements * brain metastasis * treatment for any other diagnosis of cancer within the previous 5 years * any condition that, in the opinion of the investigator might interfere with the subject's participation in the study, pose an added risk for the subject or confound the assessment of the subject

Keywords: complementary medicine alternative medicine breast cancer
the change of the detrusor thickness after hypospadias repair - comparison with the normal control group

Conditions: Hypospadias

Summary: even successfully managed hypospadias without any complication, voiding problem could be developed due to the increased urethral resistance. the investigators are trying to analyze the effect of hypospadias operation on voiding function by checking the detrusor thickness and urinary nerve growth factor.


Eligibility criteria:
inclusion criteria: \ 1. 6mo-2yr old penile hypospadias patients before operation \ 2. 6mo-2yr old male patients without hypospadias \ 3. penile hypospadias patients under the age of 5 yr who got tubularized incised plate operation at out institution at the age between 6mo and 2yr old and more than 1 yr have passed \ 4. 2yr-5yr old male patients without hypospadias1. 0-3 year old children without any abnormality of urinary tract exclusion criteria: \ 1. patients with history of urethral operation, febrile urinary tract infection, neurogenic abnormality om operation \ 1. patients with history of urethral operation other than hypospadias repair, febrile urinary tract infection, neurogenic abnormality 2. patients with development urethra-cutaneous fistula

Keywords: hypospadias, bladder outlet obstruction, ultrasonography
early intravenous administration of nutritional support

Conditions: Cancer of Stomach; GastroEsophageal Cancer

Summary: the present trial will be conducted to verify if early supplemental parenteral nutrition in combination with nutritional counseling improves survival and the feasibility of chemotherapy, in addition to nutritional status, body composition, functional status and quality of life in treatment-naïve patients with metastatic gastric cancer at nutritional risk undergoing first-line chemotherapy.

although it is known that nutritional support can improve clinical outcomes, the literature shows that only around 50% of cancer patients are able to satisfy estimated protein-calorie requirements. it is also emerging a strong correlation between nutritional status, particularly body composition, and adherence to active treatment. international guidelines suggest that parenteral nutrition (pn) is recommended in malnourished, hypophagic cancer patients suffering from gastrointestinal complications or with expected prolonged inadequate food intake, when enteral nutrition is not feasible. although recent trials suggest that supplemental pn (spn) could help to improve the nutritional status of malnourished cancer patients, there are no studies on the clinical effects of early spn in cancer patients at nutritional risk receiving first-line chemotherapy.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of metastatic gastric and gastroesophageal cancer; * no previous chemotherapy for metastatic disease; * indication for a first-line chemotherapy with a combination of 2 drugs including platinum derivatives (plus trastuzumab if her2+) to be used by investigator's choice within the framework of good clinical practice and in agreement with current italian association of medical oncology guidelines; * measurable disease based on response evaluation criteria in solid tumors (recist); * presence of nutritional risk (nutritional risk screening 2002 score ≥3); * availability of permanent venous access (port, groshong, picc); * eastern cooperative oncology group (ecog) performance status ≤2; * availability of a home parenteral nutrition service to continue nutritional plan as scheduled; * signed informed consent. exclusion criteria: * age \<18 years * ecog performance status \>2 * indication to complete artificial nutrition support (totally compromised spontaneous food-intake) * contraindication to parenteral nutrition (abnormal glucose and electrolytes control, hyper-triglyceridemia, impaired hemodynamic control and fluid retention) * availability of jejunostomy for nutritional purposes * ongoing home artificial nutrition * unfeasible home parenteral nutrition for social/familial reasons * absence of caregivers * patients refusal

Keywords: parenteral nutrition (pn) cancer
in-hospital outcomes of older patients with gastric cancer and their risk factors

Conditions: Gastric Cancer

Summary: the investigators plan to analyze the data of patients with gastric cancer (gc) consecutively hospitalized in ruijin hospital, a large tertiary center in china, comprehensively describe the characteristics of gc patients ≥65 years, and assesse their in-hospital outcomes regarding duration, fee, and death. factors associated with the in-hospital outcomes will be further comprehensively explored.


Eligibility criteria:
inclusion criteria: * older gastric cancer (gc) patients * with primary malignancies of the stomach (international classification of diseases for oncology, third edition \[icd-o-3\] topology code: c16) * ≥65 years exclusion criteria: * with benign, premalignant, or in situ tumors * with cancers originating from non-stomach sites
dual vaccine trial in myeloproliferative neoplasms

Conditions: Polycythemia Vera; Essential Thrombocythemia

Summary: a phase i-ii study in patients with mutated mpn by vaccinating with pd-l1 and aginase1 peptides with montanide isa-51 as adjuvant, to monitor the immunological response to vaccination and subsequently safety, toxicity and clinical effect.


Eligibility criteria:
inclusion criteria: * 1. diagnosis of essential thrombocythemia or polycythemia vera, according to the who criteria123,124 2. age ≥18 years 3. performance status ≤ 2 (ecog-scale) 4. expected survival \> 3 months 5. sufficient bone marrow function 6. creatinine \< 2.5 upper normal limit, i.e. \< 300 µmol/l 7. sufficient liver function, i.e. 1. alat \< 2.5 upper normal limit, i.e. alat \<112 u/l 2. bilirubin \< 30 u/l 8. for women: agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment. 9. for men: agreement to use contraceptive measures and agreement to refrain from donating sperm. exclusion criteria 1. other malignancies in the medical history excluding basal cell carcinoma. patients cured for another malignant disease with no sign of relapse five years after ended treatment is allowed to enter the protocol. 2. significant medical condition per investigators judgement e.g. severe asthma/copd, poorly regulated heart condition, insulin dependent diabetes mellitus. 3. acute or chronic viral or bacterial infection e.g. hiv, hepatitis or tuberculosis 4. serious known allergies or earlier anaphylactic reactions. 5. known sensibility to montanide isa-51 6. any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc. 7. pregnant and breastfeeding women. 8. fertile women not using secure contraception with a failure rate less than \< 1% 9. patients taking immune suppressive medications incl. systemic corticosteroids and methotrexate at the time of enrollment 10. psychiatric disorders that per investigator judgment could influence compliance. 11. treatment with other experimental drugs 12. treatment with other anti-cancer drugs - except ifn-a, hydroxyurea or anagrelide. 13. treatment with ruxolitinib. 14. treatment with chemotherapy or immune therapy (excluding ifn-a, hydroxyurea or anagrelide) within the last 28 days.
early detection of nocturnal hypoglycemia in type 2 diabetes using pulse rate variability measured by a smartwatch(educated-smartwatch)

Conditions: Hypodlycemia

Summary: in patients with type 2 diabetes, it is necessary to identify and manage nocturnal hypoglycemia as early as possible, so as to reduce the damage caused by nocturnal hypoglycemia.we explore whether smartwatches can provide early warning of nocturnal hypoglycemic events in patients with type 2 diabetes by detecting changes in pulse variability.


Eligibility criteria:
inclusion criteria: * 1. ≥18 years old 2.continuous glucose monitoring in patients with type 2 diabetes 3.agreed to research into the group, and be able to sign the informed consent exclusion criteria: * 1.arrhythmia, such as sinus arrest, sick sinus syndrome, atrial fibrillation, atrial flutter 2.such as acute or chronic infectious diseases,hyperthyroidism and thyroid function did not return to normal pregnancy 3.nursing mothers
examination of balance, vestibular, and ocular functions and activity following concussion

Conditions: Brain Concussion

Summary: previous research and position statements have outlined the necessity of balance and gait testing in the post-concussion evaluation of athletes. however, many of the currently available balance testing techniques lack objectivity and sensitivity to the effects of concussion. such balance impairments may exist following concussion due to disruption of vestibular and/or ocular motor systems. however, no clinically feasible tools have been longitudinally examined to detect gait balance control deficits or to investigate how vestibular or motor dysfunction may lead to gait imbalance. additionally, participation in physical and cognitive activities post-concussion may affect recovery. while limited evidence exists to support this notion, further investigation is necessary to improve clinical management recommendations. the proposed study will allow for the examination of tools which add value to post-concussion clinical evaluations and study-related outcomes will enhance the understanding of dynamic balance control and vestibular/ocular motor recovery, and their potential for implementation into concussion management protocols.

to address study hypotheses, the investigators plan to recruit subjects who have been diagnosed with a concussion by participating sports medicine physicians at the boston children's hospital sports concussion clinic. if patients elect to participate, they will undergo their regularly scheduled clinical examination along with two testing components requiring less than 15 minutes of additional time to complete: an instrumented gait balance assessment, a vestibular-ocular motor screen, and a weekly activity survey. participants with concussion will be matched with control subjects who meet similar demographic characteristics and report to the clinic for other orthopedic injuries that do not affect brain function, gait, or either lower extremity. during the assessment, participants will complete a protocol which measures balance control while walking and simultaneously completing a cognitive task, a vestibular-ocular motor ability, and physical and cognitive activity levels. as a need exists to develop protocols which utilize inexpensive, objective, and sensitive measurements to track concussion recovery, this study seeks to incorporate innovative and clinically feasible methods into the clinical examination of concussion.

Eligibility criteria:
inclusion criteria: 1. age between 12 and 40 years 2. no history of concussion in the past year, and no lifetime history of more than 3 concussions 3. diagnosed with concussion within the past 21 days (concussion group only) exclusion criteria: 1. lower extremity deficiency or injury, which may affect normal balance or gait 2. history of permanent memory loss 3. diagnosis of attention deficit disorder (add), attention deficit hyperactivity disorder (adhd), learning disability, down syndrome, or developmental delay

Keywords: gait mild traumatic brain injury post-concussion syndrome recovery of function locomotion motor activity
glycerin suppositories for treatment of feeding intolerance in preterm infants

Conditions: Feeding Intolerance

Summary: feeding intolerance is a common problem in preterm infants.


Eligibility criteria:
inclusion criteria: * preterm infants with birth weight equal or less than 1500 g exclusion criteria: * significant congenital malformations * severity of illness such that death is likely in the first few days after birth
portable monitoring device for the diagnosis of sleep apnea in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Obstructive Sleep Apnea Syndrome

Summary: introduction: the prevalence of overlap between chronic obstructive pulmonary disease (copd) and obstructive sleep apnea syndrome (osas) is around 10%. this overlap syndrome is an important issue because is related to nocturnal desaturation and its complications. the use of portable monitoring devices (pm) for the diagnosis of osas was recently accepted as an alternative to full-night polysomnography (psg). however, there are not studies evaluating the pm recording in copd patients to detect or exclude osas. objective: to evaluate if a pm (stardust®, respironics, inc, usa) could accurately measure the apnea-hypopnea index (ahi) in copd patients with a suspicion of osas.

patients will be recruited from the pneumology outpatient clinic of unifesp, patients had been diagnosed with copd in gold's stages ii and iii, were stable (no copd exacerbation in the last three months), were using bronchodilators without a dose change during that period, and had symptoms suggestive of osas (loud snoring, reported breathing pauses during sleep and excessive sleepiness). we excluded patients with other sleep-related disorders, a diagnosis and/or previous treatment for osas, severe cardiovascular disorders or neuromuscular disease and those using oxygen, psychotropic drugs, alcohol or other drugs of abuse. patients will undergo two assessments of sleep, randomly determined: 1) pm at home for one night, 2) pm in the sleep laboratory simultaneously to the psg. three apnea-hypopnea index (ahi) values will be obtained and analyzed: a) ahi from pm at home, b) ahi from pm in the laboratory, and c) ahi from the psg. analyses of all evaluations will be performed by two trained technicians, blinded to study details.

Eligibility criteria:
inclusion criteria: * presence of chronic obstructive pulmonary disease stage ii and iii of global initiative for chronic obstructive lung disease, stable for three months, and with symptoms suggestive of obstructive sleep apnea syndrome. exclusion criteria: * presence of chronic obstructive pulmonary disease stage ii and iii

Keywords: diagnostic test polysomnography obstructive sleep apnea syndrome chronic obstructive pulmonary disease
trial of tg4023 combined with flucytosine in liver tumors

Conditions: Hepatocellular Carcinoma

Summary: this trial is a phase i, open-label, dose-escalating study of the safety or percutaneous intra-tumoral injection of tg4023 (mva-fcu1) combined with systemic administration of 5-fluorocytosine in patients with primary or secondary hepatic tumors.


Eligibility criteria:
inclusion criteria: * patients with advanced disease without any other standard of care treatment options: * hepatic metastases of colorectal cancer (crc) or of other cancers * hepatocellular carcinoma (hcc) * at least one unresectable target tumor located in the liver, measuring 2-5 cm and accessible to it administration of tg4023 and amenable to radiological measurement using recist, * weight ≤ 100 kg, * patients with stable disease, who have to discontinue chemotherapy because of intolerance, * ecog performance status ≤ 2, * life expectancy ≥ 3 months, * hematology: * absolute neutrophil count \> 1,500/mm3, * hemoglobin \> 9g/dl, * platelet count \> 100,000/mm3, * prothrombin time international normalized ratio (inr) ≤ 2; partial thromboplastin time ≤ 1.66 times upper limit of normal (uln), * biochemistry: * total bilirubin ≤ 3 x uln, * aspartate amino-transferase (ast), alanine amino-transferase (alt), alkaline phosphatase * 5.0 x uln, * creatinin clearance ≥ 40 ml/min, * total albumin ≥ 30 g/l, * anti-vitamin k anticoagulants should have been switched for low-molecular weight heparin prior to tg4023 injection, * signed, written independent ethics committee (iec)-approved informed consent. exclusion criteria: * child-pugh stage c hepatic insufficiency, * impaired renal function (creatinin clearance \< 40 ml/min), * known deficiency in dihydropyrimidine dehydrogenase (dpd) or total dpd deficiency diagnosed at baseline in those patients not previously treated with 5-fu-related compounds, * ascites, * brain metastases, * significant impairment of gastro-intestinal (gi) tract absorption capacity, such as total gastrectomy, gastric mucosal atrophy, extensive intestinal resections or malabsorption disease will not be treated by oral 5-fc, * history of bleeding disorders, * pregnant or breast-feeding women, * human immunodeficiency virus (hiv) positive, * chronic use of immunodepressants within 4 weeks prior to tg4023 injection or immune-depressed patients, * hypersensitivity to 5-fc, * hypersensitivity to egg proteins, * concomitant or previous chemotherapy or targeted therapy within 4 weeks prior to tg4023 injection and last treatment with bevacizumab (avastin®) within 2 months prior to tg4023 injection, * concomitant treatment with anti-inflammatory drugs: systemic cortico-steroids and non-steroidal anti-inflammatory drugs (nsaids), * prior gene therapy, * prior participation in any other research protocol involving an imp within 2 months prior to tg4023 injection, * major surgery within 6 weeks of tg4023 injection,

Keywords: hepatic tumors metastatic colorectal cancer