Kornimate/medical-research-clean huggingface dataset:
real-world clinical benefit evaluation in breast cancer patients with pharmaceutical interventions for cancer-related fatigue

Conditions: Cancer-related Fatigue

Summary: this retrospective study is to collect and analyze the data from medical records within the period that breast cancer patient is receiving nhi-covered crf treatment. this study will evaluate the clinical use, fatigue improvement, and treatment satisfaction of breast cancer patients with crf treatment.

this is a single arm, multicenter, and retrospective study. about 200 breast cancer patients' data from medical records are expected to collect and analyze in this retrospective study. the data collection from medical records of breast cancer patients who approved to use nhi to pay for crf treatment drug will include the demographic information, disease characteristics and cancer treatment information, fatigue score by visual analog fatigue scale, fatigue clinical global impression, crf pharmacological treatment record, hematological lab data, ecog, cancer drug compliance record, overall clinical evaluation after crf treatment by physicians and patient's expectation to continue crf treatment etc. data of three return visits (i.e. at the time of before crf treatment, after 4 times of crf treatment and crf treatment completed) per patient will be collected from medical records to analysis within the period that patient is receiving nhi-covered crf treatment.

Eligibility criteria:
inclusion criteria: * breast cancer patients who approved to use nhi to pay for cancer-related fatigue treatment drug exclusion criteria: * n/a

Keywords: cancer-related fatigue breast cancer
investigation of the effectiveness of resistance exercise program given with diet in obese individuals.

Conditions: Obesity

Summary: the aim of this study is to examine the effects of diet and combined resistance exercise training on physical activity and sleep patterns compared to diet program alone.

the study was planned as a randomized controlled trial. the groups will be divided into two as control group and exercise group by simple randomization method.while the normal diet program will be applied to the obese individuals in the control group, the individuals in the exercise group will be given resistance exercise training together with the diet program.before and after the treatment, fatigue severity scale pittsburgh sleep quality scale international physical activity index questionnaires will be applied to the participants.in addition, sociodemographic characteristics and waist circumference measurement will be recorded. after the 12-week diet program, the data of the participants will be compared by making statistical analysis.

Eligibility criteria:
inclusion criteria: * be 18 years or older. * having a body mass index of 30 or higher. * to have accepted the voluntary consent form that requires participation in the study. exclusion criteria: * any neurological or psychological problems. * do not accept the voluntary consent form.

Keywords: resistant exercise diet
estrogen receptors and peripheral artery disease

Conditions: Estrogen Deficiency; Peripheral Artery Disease

Summary: it is estimated that \>200 million people have peripheral artery disease (pad) worldwide. pad is related to increased morbidity or mortality in affected patients. more severe forms of pad are surgically managed. estrogen receptors (ers) are strictly linked with vascular disease, and may be involved also in pad onset and progression. this study will explore the expression of ers, (er-alpha, er-beta,and a g protein-coupled of estrogen receptor -gper-) in vessel wall of arteries of operated pad patients, through the entire clinical spectrum of pad.

pad is the atherosclerotic obstruction of the arteries of the lower extremities and it is widespread especially in highly developed countries. the most common complication of pad is critical limb ischemia with rest pain and leg ulcers. to date the pathophysiology of pad is linked to atherosclerosis but other pathways are also under evaluation. a recent study (serra et al) investigated the presence of er-alfa, er-beta, and gper in the wall of normal and varicose veins. the aim of this observational study is to evaluate the expression and the role of estrogen receptors in patients with pad, and undergoing surgical treatment with reconstructive arterial surgery. therefore, we will collect tissue samples from diseased arteries that will be further analyzed for er expression. we will then correlate the results with the clinical spectrum of the patients.

Eligibility criteria:
inclusion criteria: * patients with peripheral artery disease (pad) eligible to receive arterial reconstructive open surgery. exclusion criteria: * malignancy * estrogen therapy

Keywords: peripheral artery disease estrogens receptors gper
a randomized controlled hd-tdcs trial: effects on tinnitus severity and cognition

Conditions: Tinnitus

Summary: this randomized, placebo-controlled study will compare the effects of hd-tdcs (a non-invasive neuromodulation technique) with a sham stimulation. in the sham situation, patients will undergo an identical treatment but no stimulation will be applied, allowing to control for placebo effects. this study will assess the effects of hd-tdcs on chronic, non-pulsatile tinnitus in a reliable way, as confounding factors such as anxiety, depression, hearing impairment, tinnitus gradation, age, and sex will be controlled for. ultimately, this study will result in final recommendations for a standardised protocol for the use of hd-tdcs in tinnitus patients. when accurate, individualised, and effective therapy is available for the patient, the total cost (both economical and personal) will decrease significantly. the investigation's findings will be relevant for all caretakers dealing with tinnitus patients (psychologists, psychiatrists, manual therapists, general practitioners, ent specialists, audiologists, etc.).


Eligibility criteria:
inclusion criteria: * duration of tinnitus: \> 6 months * 24 \< tfi score \< 90 * hads depression subscale \< 12 * hads anxiety subscale \< 12 * hyperacusis questionnaire \< 40 * dutch- or flemish-speaking exclusion criteria: * somatic tinnitus * pregnancy * active middle ear pathology * hearing implants * known tumors in the head/neck region * patients having already had any other tinnitus treatment within the last 2 months

Keywords: tinnitus tdcs neuromodulation rct
feasibility study of a home rehabilitative network to treat prolonged weaned patients

Conditions: Chronic Diseases

Summary: patients at high complexity with severe chronic diseases can require several admission in intensive care units (icu) to overcome acute exacerbations by the use of assisted ventilation. in the last 10 years, new technologies and beds in icu evidenced a new group of patients often needing weaning procedures due to a long-lasting period of mechanical ventilation. these patients are often under chronic conditions with recurrent symptoms, reduced effort tolerance and depression. weaning process is a frail step in the medical history of a patient who has survived an acute episode of respiratory failure and has spent a period of time under mechanical ventilation. patients are followed for the duration of in-hospital stay, an expected average period of 4 weeks. when discharged fron an intensive care unit (icu) or a weaning center, the patient is usually managed by gps and by the hospital where he has been admitted to following re-exacerbations. the conventional approach is for sure inadequate for this type of patient whose clinical complexity, disability and frailty need for a continuity of care through a higher complex approach of management. a structured program of home rehabilitation could be a possible solution to this problem. thus, the hypothesis of the study is to evaluate feasibility and sustainability and efficacy of a home rehabilitative network for prolonged weaned patients discharged from a weaning unit.

patients referred to the fondazione salvatore maugeri for prolonged weaning are enrolled and trained in an individualised program of home care in order to recover their own autonomies. home care compares 2 arms: usual care vs physiotherapist (pt)-assisted care. usual care consists in supporting drug and oxygen therapy, mechanical ventilation, gp's assistance, periodical in-hospital visit. the pt-assisted home care is supported by pt at least 2 times/month, autonomous 50 min physical activity/working day by the help of a dvd. the physical activity consists in cyclette, calisthenic exercises, and training of the respiratory muscles. few brief educational lessons by pt preceded the training activity. every two weeks, pt calls the patient by phone for an educational reinforcement.

Eligibility criteria:
* general inclusion criteria: 1. signature of the informed 2. good expectation of life * specific inclusion criteria : score of general dependences \< 19 according to the critical patients autonomy planning (cpap) scale exclusion criteria: * patient with neuromuscular, highly progressive neurological diseases (i.e. amyotrophic lateral sclerosis), patient requiring surgical interventions, sedation, and hemodialysis. * unstable patient conditions as daily variability of the blood arterial pressure \>20%, arrhythmias, pao2/fio2 \ 38°c, presence of neurological or orthopaedic side effects, and recent embolisms from tvp. refusal.

Keywords: weaning severe chronic diseases utir
pens t6 with ambulatory self-applied patch vs conventional procedure

Conditions: Weight Loss

Summary: a prospective randomized study, including moderately obese patients will be included. patients will be randomized in 3 groups: * pens of dermatome t6 with an ambulatory self-applied patch + 1200kcal/day diet * pens of dermatome t6 with conventional procedure + 1200kcal/day diet * only 1200kcal/day diet the effect on appetite and weight loss will be investigated.

a prospective randomized study, including moderately obese (bmi 30-39 kg/m2) patients will be included. patients will be randomized in 3 groups: * pens of dermatome t6 with an ambulatory self-applied patch + 1200kcal/day diet * pens of dermatome t6 with conventional procedure (weekly stimulation in the outpatient clinic) + 1200kcal/day diet * only 1200kcal/day diet the effect on appetite and weight loss will be investigated.

Eligibility criteria:
inclusion criteria: * moderately obese patients (bmi 30-39 kg/m2) exclusion criteria: * endocrinological diseases causing obesity * heart pacemaker * previous bariatric procedure
impact study of 2 therapeutic strategy for aggressive remitting multiple sclerosis

Conditions: Multiple Sclerosis

Summary: cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis


Eligibility criteria:
inclusion criteria: * patients with remitting multiple sclerosis according to mac donald criteria * aggressive remitting multiple sclerosis according to following criteria: * 2 or less disabling relapse during the 12 months before inclusion * 1 or more * edss between 2 and 5 * aged less or equal to 40 years old for the women * effective contraception exclusion criteria: * patients less than 18 years old

Keywords: reemitting aggressive multiple sclerosis
evaluation of glycemic variability (glaive)

Conditions: Critical Illness; Anesthesia

Summary: this study compared two methods of insulin infusion by syringe pumps to assess the impact of medical devices on the glycaemic variability in patients under iit in icu. the main objective of the study was to show the superiority of the infusion system which permitted to dedicate a line for the insulin administration on the "standard" installation in terms of control of glycaemic variability.


Eligibility criteria:
inclusion criteria: * patients under postoperative intensive care * treatment with insulin on bi-lumen central venous catheter over than 48 hours * eligibility for interstitial glucose monitoring * blood glucose control every 3 hours exclusion criteria: * pregnant or breastfeeding women * patient unwilling to participate in the study * patients participating in another study biomedical over the same period * patient can not understand the study and its objectives * patient under guardianship, curatorship * patient malnourished (bmi \<18 kg / m²) * patient with morbid obesity (bmi\> 40 kg / m²) * patient in shock (septic or hemodynamic) * patients refusing to sign the medtronic consent on the storage of personal data

Keywords: glycemic lability index continuous glucose monitoring system intensive care insulin
s9313a protein expression analysis of breast cancer tissue microarrays from clinical trial swog-9313

Conditions: Breast Cancer

Summary: rationale: studying the proteins expressed in tumor tissue samples in the laboratory from patients with cancer may help doctors learn more about biomarkers related to cancer. it may also help doctors predict how patients respond to treatment. purpose: this laboratory study is looking at protein expression in predicting response to treatment using tumor tissue samples from women with stage i, stage ii, or stage iiia breast cancer treated on clinical trial swog-9313.

objectives: * assess in-situ protein expression of estrogen receptor (er), progesterone receptor (pr), her-2, and p53 by automated quantitative analysis (aqua™) and multiplexed analysis at 2 markers per slide using tumor tissue from women with stage i, stage ii, or stage iiia breast cancer treated on clinical trial swog-9313. * assess the main effects of er, pr, her-2, and p53, as well as interactions to generate classes formed by clustering of biomarkers, on a large breast cancer tissue microarray to predict disease-free and overall survival of patients who received high-dose cyclophosphamide and doxorubicin hydrochloride on clinical trial swog-9313. outline: this is a multicenter study. patients are stratified according to receptor status and menopausal status. tumor tissue samples are analyzed by quantitative protein expression analysis (aqua™, a fluorescent antibody technique) for estrogen receptor, progesterone receptor, p53 and her-2. aqua™ is used to assess markers individually and as ratios with the use of clustering algorithms to define reproducible classifications of tissue from patients treated on swog-9313 as a function of molecular classification. results of the aqua™ testing are compared to immunohistochemistry and fluorescent in situ hybridization (fish) results obtained on swog-9313.

Eligibility criteria:
disease characteristics: * diagnosis of primary invasive adenocarcinoma of the breast * stage i-iiia disease (t1-3, n0-1, m0) * enrolled on clinical trial swog-9313 * tumor tissue available for testing patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer
characterization of pulmonary langerhans cell histiocytosis

Conditions: Langerhans Cell Histiocytoses

Summary: very recent studies indicate that a high percentage of hcl, about 50%, have mutations in the b-raf oncogene. the development of ultrasensitive methodologies capable of identifying these mutations in bronchoalveolar lavage will represent a significant advance in the diagnosis and treatment of these patients. an undetermined percentage of hcl does not present mutations in b-raf. consequently, the deep genetic analysis, through the use of techniques of massive sequencing, can favor the identification of new alterations that contribute to the development of the disease. we hypothesized that patients with hcl may present a different inflammatory state to healthy subjects or smokers, allowing us to identify new biomarkers.

the main objective of this study is to expand the genetic and pathophysiological knowledge of this disease. for this, the following points will be developed: * identification of mutations in the b-raf oncogene in spanish patients with pulmonary lchf. * development of ultrasensitive genetic analysis methods capable of identifying mutations in b-raf in bronchoalveolar lavage (bal) samples. * to determine if patients with mutations in the b-raf oncogene present distinct clinical, radiological and / or functional characteristics compared to those with absence of the mutation. * characterization of the inflammatory profile of patients with hpcl.

Eligibility criteria:
inclusion criteria * men and women with no age limitation * established histiological diagnosis of histiocytosis of langerhans cells. * hclp-compatible clinical-radiological picture. * signed informed consent exclusion criteria * non-acceptance of informed consent. * absence in clinical history of clinical, radiological and functional variables essential for the diagnosis of hlcp. * psychiatric disorder or limitation for study compression (including language, socio-cultural problem, etc.). * radiological findings suggestive of another chronic lung disease. * active respiratory infection.
hope: home treatment and peer support for acute mental health crisis

Conditions: Severe Mental Health Condition With Indication of Hospital Admission

Summary: home treatment (ht) is an effective treatment modality for patients with severe mental illness (smi) in acute crisis that can often be considered equivalent to inpatient treatment in terms of treatment outcome. in peer support (ps) patients are supported by people with personal experiences in psychiatric crises. the current study investigates a combination of both approaches - a ht plus ps intervention - versus sole ht at different study sites throughout germany. it is hypothesized that a peer-supported home-delivered treatment (ht plus ps) is more effective than a professional-led home-delivered treatment (ht alone) with respect to the time until hospital readmission, self-efficacy, psychosocial health, recovery orientation, internalized stigma and service satisfaction. furthermore, it is hypothesized, that a peer-supported home delivered treatment (ht plus ps) is as effective as a professional-led home-delivered treatment (ht alone) with respect to disease severity and general functioning (secondary outcomes).


Eligibility criteria:
inclusion criteria: * severe mental illness with indication of hospital admission (f2, f3, f6, f41, f42) exclusion criteria: * primary diagnosis of f0 or f1 (mental disorders due to known physiological conditions; mental and behavioral disorders due to psychoactive substance use) * acute suicidality * verbal or cognitive impairment severe enough to be unable to give informed consent
a prospective observational cohort to study the genetics of obstructive sleep apnea and associated co-morbidities

Conditions: Obstructive Sleep Apnea

Summary: the primary objective of this study is to build a well characterized cohort of patients that will be used to determine the genetic variants associated with obstructive sleep apnea (osa)and its co-morbidities.

the purpose of building the cohort is to allow the performance of genome-wide association studies with a large sample of patients that have been well-characterized using standardized procedures.

Eligibility criteria:
inclusion criteria: we will recruit subjects who are: * 18 years of age and older. * willing and able to give informed consent and any of the following: * psg (polysomnogram)requested by a physician based on clinical grounds * ahi (apnea-hypopnea index) ≥ 5 episodes per hour based on a prior psg. exclusion criteria: incapable of giving informed consent * under the age of 18
open-label,non-randomized trial of cisplatin chemotherapy in brca1-positive metastatic breast cancer patients

Conditions: BRCA1 Mutation; Metastatic Breast Cancer

Summary: among women with a brca1 mutation and breast cancer, choice of chemotherapy is a critical issue. there are emerging data which suggest that mutation carriers may respond differently than non-carriers to particular agents. brca1-associated cancers differ from non-hereditary cancers for a range of pathologic and molecular factors, including tumor grade and histologic appearance. several studies have shown that the response to treatment for women with a brca1-associated breast cancer reflects the underlying tumor biology, in particular, the impairment of the dna damage response and repair pathways, and that it is possible to exploit the sensitivity of brca1-associated cancers to dna damage. it is equally important that the investigators evaluate the benefit of cisplatin in women with disseminated breast cancer, including those who have previously been treated with one or more chemotherapy regimens. this study is undertaken to evaluate the efficacy of cisplatin chemotherapy in brca1 carriers with metastatic breast cancer. the primary objective is to determine the objective response rate of cisplatin in brca1 carriers with metastatic breast cancer. the secondary objectives are to determine 3-year survival and to evaluate the toxicities of cisplatin in brca1 carriers with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * female patients aged ≥ 18 years, with measurable (defined by response evaluation criteria in solid tumors (recist) criteria (14)) metastatic (stage iv) breast cancer, and who are known to carry a brca1 mutation, are eligible. * in addition, the following are required: * adequate hematologic * renal, and hepatic function * adequate recovery from recent surgery and/or radiation therapy * recovery from all prior treatment-related toxicities (to grade \< 2 according to national cancer institute common toxicity criteria, version3.0, except alopecia) * life expectancy of at least 12 weeks * eastern cooperative oncology group (ecog) performance status of 0 or 1. - * patients could have received up to four prior chemotherapies for metastatic disease. exclusion criteria: * patients with known brain metastases are not eligible. * patients previously treated with a platinum-based chemotherapy are not eligible.

Keywords: brca1 survival metastatic disease cisplatin
improving family engagement in acute cardiovascular care: the ngage trial

Conditions: Family Engagement

Summary: the objective of this study is to assess if the ngage real-time feedback tool improves family engagement in family members of people admitted to an acute cardiac care unit the investigators will randomize 88 family members of people hospitalized in the acute cardiac ward in a 1:1 manner to either the ngage intervention or usual care. family members will be eligible if the expected unit stay of their loved one is \>48 hours and if they can communicate in english or french. a family member is considered anyone with a biological, emotional, or legal relationship with the patient whom the patient wishes to be involved in their care. the primary outcome of the study will be the family engagement (fame) score at hospital discharge. secondary outcomes will be family mental health (by hads score) and family care satisfaction (by fs-icu score).


Eligibility criteria:
inclusion criteria: * family member of cv patient with expected stay \> 48 hours (as per treating team) * aged of at least 18 years old * ability to communicate in english or french * willing to fill out the questionnaires as per the study exclusion criteria: * expected stay of \< 48 hours * inability to communicate in english or french