Kornimate/medical-research-clean huggingface dataset:
neoadjuvant herceptin in patients with breast cancer

Conditions: BREAST CANCER

Summary: the purposes of this study are to better understand how herceptin causes tumors to become smaller and to find out how effective herceptin, together with chemotherapy, is in treating advanced breast cancer.

we want to determine the effects of herceptin and to determine its efficacy in women with her-2 overexpressing advanced breast cancer. the end-points will include the comparison of an array of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving herceptin. the other aim of this study would be to determine clinical response to therapy with herceptin and taxotere.

Eligibility criteria:
inclusion criteria: * all patients must be female. * informed consent must be signed. * women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. locally advanced cancers must be of clinical and/or radiologic size \> 4 cm, and/or are deemed surgically inoperable. * her2/neu overexpressing tumors defined as herceptest score of 3+, or \>/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (fish) positive. * negative serum pregnancy test (bhcg) within 7 days of starting study, if of child-bearing potential. * kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal. * performance status (world health organization \[who\] scale) \ 6 months. * age \> 18. * no metastatic disease without concomitant primary breast cancer. * no previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. exclusion criteria: * pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential. * severe underlying chronic illness or disease. * cardiomyopathy or baseline left ventricular ejection fraction (lvef) \< 50%. * patients on other investigational drugs while on study. * severe or uncontrolled hypertension defined as blood pressure (bp) \> 180/100 on three separate occasions. * history of congestive heart failure. * history of coronary arterial disease.

Keywords: breast cancer advanced breast cancer
immersive virtual reality in orthopedics

Conditions: Virtual Reality; Orthopedic

Summary: interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. in order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines. the prosthetic knee surgeries are painful and anxiety-provoking acts. at the hospital of montauban, to relieve patients' pain, we offer them a therapeutic regimen with regional anesthesia (spinal anesthesia). we also use accompaniment hypnotic virtual reality to the management of anxiety and pain patients.

interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. in order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines. the prosthetic knee surgeries are painful and anxiety-provoking acts. at the hospital of montauban, to relieve patients' pain, we offer them a therapeutic regimen with regional anesthesia (spinal anesthesia). we also use accompaniment hypnotic virtual reality to the management of anxiety and pain patients. despite a high level of approval of patients (according our satisfaction surveys) concerning hypnotic virtual reality, we want to evaluate our practice. thus, in the future, we can invest in this type of material and make it available to a larger number of patients, but only if complementary care proves its effectiveness. the purpose of this study is to evaluate the effectiveness of hypnotic virtual reality support on the patient's state of anxiety before and after prosthetic knee surgeries under spinal anesthesia.

Eligibility criteria:
inclusion criteria: * eligible patients for prosthetic knee surgery under spinal anesthesia * patient who has received appropriate information and has provided informed consent * patient with french social security system exclusion criteria: * patient under general anaesthesia * patients treated in conventional inpatient care or in the traditional ambulatory circuit * patient under guardianship or trusteeship * minor patient \< 18 years of age * patient who has not provided informed consent or who cannot submit to the study protocol * patient suffering from cognitive disorders (ex: alzheimer's disease) * patients who are deaf or hearing-impaired or epilepsy * infected patient or identified as carrier of an infectious agent

Keywords: anxiety immersive virtual reality orthopedics pain
safety and efficacy of propionate for reduction of ldl cholesterol

Conditions: Hypercholesterolemia

Summary: the objective of the trial is to evaluate a potential impact of food supplements with the short chain fatty acid propionate on blood ldl cholesterol level.

62 patients with low cardiovascular risk will be 1:1 randomized to receive either placebo (b.i.d.) or 500mg of propionate (b.i.d.). the primary endpoint is the change (delta) in blood ldl cholesterol levels after 8 weeks.

Eligibility criteria:
inclusion criteria: * patients with hypercholestrolemia and a ldl serum level of \> 115 mg/dl * age of patient between 20 and 70 years * participant is fully competent and has given his/her written informed consent to the scheduled trial conduct exclusion criteria: * patients with acute coronary syndrome in the last 4 weeks * patients with chronic symptomatic heart failure (nyha 2-4) * patients with chronic renal failure and a gfr \< 45 ml/min * patients with chronic liver disease * patients with hematological diseases * patients with severe diseases of other organ systems (tumors, infections) * pregnancy

Keywords: propionate
tai-chi / qi-gong in patients with patients with gynecological malignancies

Conditions: Ovarian Cancer; Primary Peritoneal Cancer; Other Gynecological Cancers

Summary: oncologic patients often report increased fatigue during and after chemotherapy. evidence suggests tai-chi/qi-gong may improve quality of life (qol) in oncologic patients treated with chemotherapy. previous studies, mostly performed in a population of breast cancer patients, have demonstrated the benefits of tai-chi/qi-gong practice in improving quality of life (1), reducing bone resorption (2), preventing the decrease of blood counts (wbc and hb) (3), and reducing inflammation (4). the aim of this pilot study is to evaluate the effect of tai-chi/qi-gong on qol, sleep, and fatigue in patients with gynecological malignancies, particularly in patients with ovarian cancer.

tai-chi/qi-gong is a complementary medicine technique that synergizes the mind-body connection. the technique employs a series of positions and movements that are performed in a slow, flowing manner to help a person concentrate on breathing and motion. the effect of tai-chi/qi-gong on fatigue, quality of life, and quality of sleep will be assessed in gynecological cancer patients. this trial will recruit 60 patients with gynecological malignancies, who receive first or second line chemotherapy. the patients will be allocated according to their preference to either the study or the control group. the tai-chi/qi-gong classes will take place once a week, for 10 consecutive weeks, at the facilities of the gyneco-oncology department. all patients will fill out the questionnaires at the beginning of the study, after 5 weeks, and upon the completion of the study (10 weeks).

Eligibility criteria:
inclusion criteria: * women with gynecological malignancies undergoing primary or secondary chemotherapy exclusion criteria: * motor disability; * less than 1 month since the last abdominal surgery; * ascites

Keywords: ovarian cancer gynecological malignancies chemotherapy tai-chi qigong fatigue quality of life sleep disturbance
emotional awareness and expression therapy for prediabetes

Conditions: PreDiabetes

Summary: this feasibility study seeks to develop and pilot test emotional awareness and expression therapy as a possible treatment for people with prediabetes.

prediabetes is a clinical condition in which hemoglobin a1c is between 5.6 and 6.4, and is usually associated with being overweight, poor diet, limited exercise, and psychological stress. this condition develops in to type ii diabetes in many people, and interventions to prevent such progression are needed. because stress can directly negative impact blood glucose metabolism and can indirectly affect it through unhealthy behaviors (e.g., diet, exercise), it may be possible to reduce stress and improve clinical outcomes. although most stress management approaches help people to calm their physiology and reduce their negative emotions, another approach to stress treatment is to help people disclose emotionally difficult experiences, become aware of and express their emotions, and change interpersonal relationships by becoming more assertive as well as more open/connected. emotional awareness and expression therapy (eaet) is an approach to stress reduction that uses these principles and it has been shown to be effective for somatic symptom disorders like chronic pain. in this study, we will adapt eaet to the prediabetes context and test its feasibility, acceptability and initial efficacy.

Eligibility criteria:
inclusion criteria: * affiliated with wayne state university (faculty, staff, student, or family member/friend thereof) * hba1c value of 5.7% to 6.4% * overweight or obese (≥25 kg/m2) also, if over ≥ 18 and \< 45 years of age must have at least one of the following: a) physical inactivity, b) close family history of diabetes, c) history of hyperlipidemia, d) history of hypertension, e) history of gestational diabetes, and/or f) from high risk race groups (e.g., african american, latino, native american, and pacific islander). exclusion criteria: * confirmed history of type 2 diabetes * have prediabetes being treated pharmacologically * pregnant * taking medications that affect blood glucose (e.g., corticosteroids) * chronic depression or major psychotic disorder * any comorbidities that limit survival or ability to tolerate the intervention (cushing's, cancer treatment, asthma with inhaled corticosteroids, unstable cad or mi in last 6 months, chf, copd requiring oxygen, chronic kidney disease)

Keywords: stress reduction emotional awareness and expression therapy
ambulatory pediatric asthma care

Conditions: Asthma in Children

Summary: the alpaca study has a prospective randomized control interventional design, including a follow-up period to evaluate follow-up effects. the study is divided into two phases of 3 months using ehealth and observational monitoring.

the alpaca study has a prospective randomized control interventional design, including a follow-up period to evaluate follow-up effects. the study is divided into two phases of 3 months; in the first phase subjects are randomized to either ehealth care (use of a communication portal including the weekly entry of spo2, spirometry results and act) and explorative observational home-monitoring or only explorative observational home-monitoring during regular care. the second phase is to evaluate the effects of ehealth care compared to the control group after a follow-up period of 3 months, and the time to healthcare events during follow-up in both groups (survival analysis). the study makes use of an intention-to-treat analysis.

Eligibility criteria:
inclusion criteria: * children with moderate-to-severe asthma. * children in the age group from 4 up to and included 11 years old. exclusion criteria: * children living in a house without wifi. * prior participation in ehealth care trial. * children/parents with an inability to understand or speak dutch. * children with divorced parents or other reasons that causes them to be less than 80% on the same living address. * children of whom family members have already participated in this trial. * children for whom it is not possible to perform at least one of the two discontinuous dyspnea assessment (lung function/pulse oximetry). * children using an inhaler that is not compatible with the findair smart inhaler cap, which cannot be replaced by a compatible alternative. * children with chronic diseases other than asthma (i.e. inflammatory bowel disease, behavioral disorders, mental retardation). * currently displaying covid-19-related symptoms, namely a fever, cough and/or difficulty breathing (during inclusion). * having been positively tested as infected with covid-19 in the past 14 days

Keywords: e-health
alpha-s1 casein hydrolysate on sleep

Conditions: Chronic Insomnia; Polysomnography

Summary: this study investigates the impact of aalpha-s1 casein hydrolysate (ach; lactium®) on sleep quality in individuals with chronic insomnia, employing both subjective sleep profiles and objective polysomnography (psg) recordings.

during the trial, the use of food or health products containing sedative or hypnotic ingredients or formulations is prohibited.

Eligibility criteria:
inclusion criteria: 1. age between 20 and 80 who meet the diagnostic criteria for chronic insomnia according to the international classification of sleep disorders (icsd) (third edition); 2. psqi score greater than 5; 3. participants must voluntarily agree to participate in the trial after explanation by a physician and complete the informed consent form. exclusion criteria: 1. currently using tranquilizers, hypnotics, or stimulant-related medications or substances (such as coffee or energy drinks); 2. patients with a history of significant head trauma; 3. individuals with alcohol abuse within the past year; 4. those with other severe medical conditions (e.g., hepatic or renal dysfunction); 5. pregnant women or breastfeeding mothers; 6. participants unable to comply with the trial schedule; 7. individuals on a vegetarian diet; 8. those with allergies to dairy products.

Keywords: alpha-s1 casein hydrolysate randomized controlled trial insomnia polysomnography
a nutrition-focused qip in outpatient clinics

Conditions: Malnutrition

Summary: a nutrition-focused qip will be implemented with a primary assessment of qip feasibility, patient health and economic outcomes as well as patient and provider experience data. a 2-phased qip study group will be prospectively enrolled from outpatient clinics affiliated with the usc health system and compared with historical and concurrent control groups.


Eligibility criteria:
qip group inclusion criteria: * poor nutritional status * 2 or more chronic conditions (other than those listed as exclusions) * estimated life expectancy of 90 days or greater * able to consume foods and beverages orally * literate and willing to sign informed consent form exclusion criteria: * pregnant * normal nutritional status * unable to consume foods and beverages orally * estimated life expectancy of less than 90 days * severe dementia or delirium and no dedicated caregiver to assure compliance with qip study requirements * uncontrolled eating disorder, significant neurological or psychiatric disorder (including substance abuse), or other conditions that may interfere with study product consumption or compliance * known allergy or intolerance to any ingredient found in ons products recommended in qip retrospective and concurrent groups eligibility are reflective of the qip eligibility criteria however, the timeframe differs.
efficacy of closed-loop ventilation to reduced sleep disorders

Conditions: Acute Mechanical Ventilatory Failure; Psychosis Associated With Intensive Care

Summary: sleep's deficiencies are very common in intensive care. mechanical ventilation is a known factor in this deterioration.the investigators hypothesize that close-loop ventilation mode (intellivent-asv) is able to minimize sleep deterioration, adjusting ventilation to the patient needs.

in intensive care, conventional mechanical ventilation (pressure support) generates apneas and asynchronies during sleep. intellivent-asv would be able to avoid apneas, providing controlled cycles when respiratory rate become too low. moreover, the constant adjustment of ventilatory parameters to the patient needs would avoid asynchronies between the ventilator and the patient ventilatory drive.

Eligibility criteria:
inclusion criteria: * patient under invasive mechanical ventilation since at least 6 hours and for expected at least 48 hours duration, including a continuous period of 24h, from 2 p.m. to 2 p.m. the next day. * age \> 18 years * body mass index \< 40 * informed consent signed by the family exclusion criteria: * patient requiring neuo-muscular blocking agent or deep sedation enough to abolish spontaneous ventilatory effort * patient with encephalopathy regardless of origin * patient with glasgow coma scale score \< 8 * patient abusing of drug or alcohol * patient with a contraindication for placement of a nasogastric tube such that sufferers of esophageal or gastric ulcer, tumors, diverticulitis or bleeding varices or patients with sinusitis epistaxis or having recently been operated on the nose or pharynx * patient with bleeding disorders * patient with unstable respiratory situation as defined by a arterial oxygen partial pressure and inspired oxygen fraction ratio (pao2/fio2) \ 12 cmh2o * patient with unstable hemodynamic situation as defined by systolic blood pressure (sbp) \< 75 mmhg despite a therapeutic optimization * inclusion in another research protocol submitted to consent

Keywords: sleep intensive care mechanical ventilation
effectiveness and safety study of filgrastine® in patientes with breast cancer treated with myelotoxic chemotherapy

Conditions: Breast Cancer

Summary: randomized study of the clinical efficacy and safety of filgrastine® in patients with breast cancer treated with myelotoxic chemotherapy. primary objective: to evaluate the activity and safety of filgrastine® in brazilian patients undergoing adjuvant treatment for breast cancer, with the frequency of grade 4 neutropenia in the first cycle of chemotherapy as the primary endpoint. secondary objectives: * frequency of febrile neutropenia during treatment; * frequency of neutropenia of any degree in the first cycle; * frequency of hospitalization during treatment; * duration of grade 4 neutropenia in the first treatment cycle; * toxicity during treatment; * immunogenicity throughout treatment. all endpoints will be descriptively analyzed in both groups of patients. study design randomized (2:1), open-label, multicenter study. chemotherapy will be given on the first day of each cycle of treatment, for a maximum of four to eight cycles, depending on the regimen, patients whose chemotherapy treatment is prolonged beyond this period being withdrawn from the study. patients will be evaluated through laboratory tests, including complete blood count, biochemistry and anti-filgrastim antibodies.


Eligibility criteria:
inclusion criteria: * provision of the free and informed consent form by written; * female sex; * age between 18 and 75 years old; * diagnosis of breast cancer confirmed by cytology or histopathology; * disease in stages ii or iii, according to the classification tumor-node-metastasis (tnm); * indication of chemotherapy with full dose of one of the regimens eligible; * performance status of 0 or 1; * appropriate body functions (absolute neutrophil count \[can\] ≥1,500/mm³; platelet count ≥150,000/mm³; serum creatinine ≤1.2 mg/dl; bilirubin and transaminases ≤1.5 times the upper limit of normal). exclusion criteria: * previous use of chemotherapy; * previous use of filgrastim; * prediction of prophylactic or therapeutic use of antibiotics, antifungals or antivirals in the first cycle of chemotherapy; * previous radiotherapy involving the pelvis or radiotherapy from any site within the last 6 weeks prior to randomization; * history of bone marrow transplantation (as a recipient); * presence of other neoplasms; * presence of severe co-morbidities; * recent (\<6 months) or planned participation in other studies clinical trials involving drugs of any nature or in studies of any form of intervention; * known intolerance or allergy to any of the components the filgrastim formulations evaluated in the study; * pregnancy or lactation (patients of childbearing potential must have a negative serological pregnancy test dated within 7 days prior to randomization).
safety study of thumb orthoses in osteoarthritis in the base of the thumb (btoa)

Conditions: Osteoarthritis

Summary: the prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted. interventions: thumb orthoses to be worn at night and usual care vs usual care. outcome measures: pain at 1 month assessed on visual analog scale is the main outcome measure. disability at 6 months (cochin hand function scale) and deformation at 1 year are the main secondary outcome measures.

the prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted. radiologically defined osteoarthritis of the hand has been estimated to represent 38% of women and 24.5% of men over 66 years of age but higher prevalence of 60-70% has also been reported. of patients with radiological signs, 20 to 40% become symptomatic. for patients over 55 years of age, the distal interphalangeal joints are the most prevalent site of osteoarthritis (20%) determined radiologically and clinically, followed by the base of the thumb (8%) and proximal interphalangeal joints (5%). this prevalence increases with age, and the incidence peaks in perimenopausal women. osteoarthritis in the base of the thumb (btoa) concerns the trapeziometacarpal joint, with a possible secondary location at the trapezotrapezoidial and scaphotrapezial joints. btoa induces a closure of the first web, which in turn causes an alteration of the thumb-index pinch and therefore a limitation in hand function. pain induced by the compression of the thumb column during pinching could also lead to functional disability. effect of a simple intervention such as wearing rest thumb orthoses on pain and disability is unknown.

Eligibility criteria:
inclusion criteria: * pain at the base of the thumb 30 mm on vas * patient aged 45 and \< 75 years old * at least 2 of the 5 items on the trapeziometacarpal joint radiograph osteophytes * joint space narrowing * subchondral bone sclerosis * subchondral cysts * at least 1 of the 2 clinical items trapeziometacarpal joint enlargement closure of the first web exclusion criteria: * post traumatic osteoarthritis * cristal arthropathy * inflammatory arthritis * neurologic disorder involving upper limb * psychiatric disorder needing treatment adaptation in the last 3 months * hand or wrist trauma within the last 2 months * previous hand surgery * unable to speak or write french * pregnancy * collagen diseases (dupuytren, marfan, ehlers danlos syndromes) * hand or wrist infiltration within 2 months * skin disease interfering with the wearing of the orthoses * having already worn a btoa orthoses * having bilateral btoa without predominant symptomatic side

Keywords: trapezotrapezoidial scaphotrapezial thumb pain orthoses osteoarthritis in the btoa concerns the trapezometacarpal joint