Kornimate/medical-research-clean huggingface dataset:
descriptive observational study of the evolution of the lifestyle alteration in patients with breast cancer

Conditions: Breast Cancer

Summary: scientific context: with more than one million cases per year, breast cancer is the most common female cancer. all treatments such as surgery, chemotherapy, radiotherapy or hormone therapy lead to major changes patients' lifestyle. these treatments can lead to a decrease of physical activity due to fatigue and also changes in the diet. sometimes, chemotherapy induces nutritional aversions and can cause weight gain that is known to increase the risk of recurrence. cognitive complaints are also frequent, in particular in patients who received chemotherapy and can also lead to quality of life's alteration fatigue assessed with prevalence between 70 % and 100 % is usually a part of a series of symptoms including anxiety, depression, pain, sleep disturbance, decreased activity level, nutritional changes and pre-existent comorbidities. these symptoms can lead to an alteration of the quality of life. the chemotherapy involves disturbances at physiological, psychological and social levels and eating disorders leading to changes in eating habits which can lead to weight loss or weight gain. to limit these deleterious changes in lifestyle, increased physical activity, specialized counseling and nutritional monitoring may be recommended. according to current knowledge there is no prospective study that evaluated different lifestyle changes according to different types of patients and the appearance of the installation of these symptoms during the patient pathway. research hypothesis: the study hypothesis is that description of the evolution of the quality of life and, physical, nutritional and cognitive parameters in a population of patients with non-metastatic breast cancer will better characterize these patients in order to propose an appropriate and personalized rehabilitation intervention.the investigators propose this feasibility study consisting of 2 cohorts of patients according to the adjuvant therapy given (+/- chemotherapy) after the primary breast surgery.


Eligibility criteria:
inclusion criteria: * women between 18 and 65 years old * breast invasive or in situ cancer (all histology), unilocal or multilocal tumor * treatment by first surgery and adjuvant radiotherapy validated at the multidisciplinary consultation meeting with +/- adjuvant chemotherapy (all chemotherapy) * patient reading and understanding the french language * non-opposition of patient exclusion criteria: * patient with a history of treated breast cancer * presence of metastasis * other cancer or severe disease under evaluation or treatment at baseline (to avoid selection bias) * patient with psychiatric disorders * patient under protection status * pregnant or nursing women or absence of contraception in a patient of childbearing age withdrawal criteria : - other cancer or severe illness diagnosed during the study
induction and concurrent chemoradiotherapy with cetuximab for patients with locally advanced nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent cisplatin. addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma cells with high egfr protein expression, may enhance the effectiveness of radiation and result in better tumour control. this study investigates the addition of 2 cycles of cisplatin/5fu chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent with radiation, for treatment of locally advanced nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * signed written informed consent * inpatients or outpatients, 18-65 years of age * histologically confirmed, newly diagnosed locally advanced (uicc/ajcc stage iii to ivb) nasopharyngeal carcinoma requiring radiotherapy * evidence of unidimensional measurable disease as per recist criteria * no systemic metastatic disease (m0) * ecog performance status of 0 or 1 at study entry * effective contraception * white blood cell count ≥ 3,000/mm3 with neutrophils ≥1,500/mm3, platelet count ≥100,000/mm3, hemoglobin ≥ 5.6 mmol/l (9 g/dl) * total bilirubin ≤ 1.5x upper reference range * ast \& alt ≤ 1.5x upper reference range * glomerular filtration rate \> 60 ml/min * serum creatinine ≤ 1.25x upper reference range exclusion criteria: * previous radiotherapy, chemotherapy, surgery (excluding diagnostic biopsy) or any investigational drug for the npc * concurrent chronic systemic immune therapy, targeted therapy, anti-vegf therapy or egfr-pathway targeting therapy not indicated in this study protocol * known hypersensitivity reaction to any of the components of study treatments * pregnancy or lactation period * systemic metastatic disease * clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia * peripheral neuropathy \> grade 1 * previous malignancy except basal cell cancer of the skin or preinvasive cancer of the cervix * known alcohol or drug abuse * medical or psychological conditions that would not permit the patient to complete the study or sign informed consent * legal incapacity or limited legal capacity

Keywords: locally advanced nasopharyngeal carcinoma neoadjuvant chemotherapy chemoradiation cetuximab
risk factors for neck phlegmon after percutaneous tracheostomy in icu

Conditions: Tracheostomy Complication; Quality of Life

Summary: primary purpose: to investigate the incidence and risk factors related to the appearance of tracheal phlegmon in patients undergoing percutaneous tracheostomy. participant population/primary condition: patients admitted to intensive care main questions aims to answer: 1. - what are the risk factors associated with the development of tracheal phlegmon percutaneous tracheostomy? 2. - how does the appearance of tracheal phlegmon impact intensive care stay, hospital stay, mortality, and health-related quality of life? participants will be followed up after undergoing tracheostomy for 7 days to identify eventual phlegmons. at the two-year follow-up, the health-related quality of life will be assessed


Eligibility criteria:
inclusion criteria: * age greater than 18 years * presence of indication for tracheostomy exclusion criteria: * failure of the percutaneous tracheostomy technique or recourse to surgical tracheostomy
women with polycystic ovary syndrome have increased plasma chitotriosidase activity

Conditions: Polycystic Ovary Syndrome

Summary: in the present study, serum chitotriosidase activity and its relationship with insulin resistance were determined in patients with polycystic ovary syndrome (pcos).

cht activity is increased in patients with pcos in concordance with insulin resistance. these findings may reflect the pronounced risk for metabolic syndrome and atherosclerotic diseases in this particular patient group.

Eligibility criteria:
inclusion criteria: * absence of significant abnormalities on physical examination except hirsutism * no lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy * normal thyroid function and prolactin level * absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease exclusion criteria: * pregnant * ovarian tumors * congenital adrenal hyperplasia or bmi greater than 30 kg/m2

Keywords: polycystic ovary syndrome chitotriosidase activity
qatar universal diabetes outcomes (qudos) study

Conditions: Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: qudos is a cross-sectional population study aiming to answer key questions about diabetes and its complications in qatar as well as identify factors associated with the development and progression of diabetes complications.

qudos aims to gain a better understanding of diabetes in primary and secondary care over a period of 24 months. a range of patients with diabetes will be sampled (including those with type 1 diabetes as this group is under-studied in qatar). this will be important in designing appropriate intervention plans that will improve diabetic patients' health conditions to prevent or delay the onset of complications and will provide a strong foundation for longitudinal study. the broad objectives of the study are: qudos 1: aims to recruit 1,700 diabetic patients (including 200 with type 1 diabetes mellitus (independent of healthcare setting)) attending the hospitals and primary care and to collect the following data: * demographics: age, sex, ethnicity, socio-economic background, smoking status; * anthropometrics: vital signs, height, weight, body fat percentage, fat mass, neck and waist circumference; * medical history: medications, complications, comorbidities, latest hba1c and lipid profiles and family medical history; * routine laboratory data; * lifestyle: diet, physical activity,; * sleep: quality and daytime sleepiness; * cognition and mental health: depression, anxiety, stress and memory; * diabetes microvascular complications: diabetic neuropathy, urine albumin/creatinine ratio; routine retinal screening data. * gut microbiome from a stool sample qudos 2: to further characterise 500 patients, from the total 1500 patients with t2dm recruited in qudos 1, who accept to continue with qudos 2 (a more detailed study and assessment). this phase aims to concentrate on the following aspects: * obstructive sleep apnoea; * sleep duration and quality; * diet; * objective physical activity; * stress; * quality of life; * depression and anxiety; * perceived control of health; * detailed neuropathy screening; * cardiovascular function; * cognitive function; * biological samples.

Eligibility criteria:
inclusion criteria: 1. type 1 and type 2 diabetes mellitus; 2. male or female; 3. resident in qatar; 4. mena birthplace and family origin; 5. 18-70 years old; 6. capable to give informed consent and complete the study. exclusion criteria: 1. known pregnancy or planning pregnancy during the duration of study; 2. congenital disorders; 3. terminal illness; 4. enrolled in a clinical trial involving medication; 5. uncontrolled mental illness preventing participation; 6. those who have already experienced a definitive microvascular complication: i. end-stage renal disease; ii. major amputation; iii. blindness.

Keywords: diet middle east and north africa country health complication cardiovascular disease obesity stress obstructive sleep apnoea (osa)
efficacy of nasal spray hypertonic puressentiel on symptoms of allergic rhinitis

Conditions: Allergic Rhinitis

Summary: prospective multicentric study. 60 subjects with allergic rhinitis will be enrolled to test the efficacy of nasal hypertonic spray puressentiel on symptoms of allergic rhinitis and nasal peak flow. subjects with allergic rhinitis and nasal obstruction will use during 30 days the nasal spray (2 nebulisations /day in each nostril) during 30 days. rhinitis symptoms questionnaire and nasal inspiratory peak flow will be evaluated before and after 30 days of exposure.

objective: evaluate the efficiency of a nasal hypertonic spray puressentiel in subjects with allergic rhinitis and nasal obstruction. inclusion criteria: subjects with allergic obstructive rhinitis without treatment or remaining symptomatic despite treatment. duration of exposure: 2 nasal sprays per day (morning and evening) during 30 months. primary criteria of efficacy: rhinitis questionnaire. secondary criteria: inspiratory nasal peak flow

Eligibility criteria:
inclusion criteria: * allergic rhinitis with nasal obstruction exclusion criteria: * pregnant patients * patients with severe asthma
investıgatıon of the effıciency of pulsed electromagnetıc field therapy and stretching exercises

Conditions: Muscle Injury; Pulsed Electromagnetic Therapy; Muscle Stretching Exercise

Summary: in this study, a total of 69 wistar albino rats were used, five of which were in the preliminary study. the preliminary study was planned to determine the ideal pemf treatment time. in the study, animals were divided into 5 groups (control, inj, inj+exercise, inj+pemf, inj+exercise+pemf). experimental animals were sacrificed on the 7th and 14th days to see the effects of the treatments. at the end of the experiment, genetic, histopathological, and immunohistochemical evaluations were made in the muscle tissue.

purpose: the aim of this study was to evaluate the efficacy of stretching exercise and the pulsed electromagnetic field (pemf) method in the treatment of muscle injury (inj). methods: in this study, a total of 69 wistar albino rats were used, five of which were in the preliminary study. the preliminary study was planned to determine the ideal pemf treatment time. in the study, animals were divided into 5 groups (control, inj, inj+exercise, inj+pemf, inj+exercise+pemf). experimental animals were sacrificed on the 7th and 14th days to see the effects of the treatments. at the end of the experiment, genetic, histopathological, and immunohistochemical evaluations were made in the muscle tissue.

Eligibility criteria:
inclusion criteria: * healthy young wistar albino rats exclusion criteria: * not having any injury

Keywords: muscle injury tgf-beta 1 fibrosis
perceptual distortions in acute neck pain

Conditions: Neck Pain, Posterior; Pain, Acute

Summary: research has shown that chronic pain is related to variety of perceptual distortions. little is known on how acute pain experience influences perception, especially precision of touch. this project is aiming to test the hypothesis of pain as a process of biological value leading to improvement in tactile acuity.

this project has following goals: 1. to test the hypothesis of pain as a process of biological value leading to improvement in tactile acuity 2. to investigate intra-rater reliability of tests measuring perceptual distortions in pain 3. to investigate validity of novel tests measuring perceptual distortions in pain 4. to explore the influence of acute neck pain on left/right recognition task 5. to explore the effect of acute neck pain on body perception

Eligibility criteria:
inclusion criteria: * only participants without tactile dysfunction will be included. * participants reporting availability during the days in which the research will be performed. exclusion criteria: * current pain experience * episodes of neck * thoracic or lumbar pain lasting more than 24 hours within previous month * history of chronic pain, i.e. pain lasting more than three-month period * comorbidities affecting nervous system * cardio-vascular diseases * psychiatric illnesses * any disease requiring systematic drug consumption * diagnosed scoliosis.

Keywords: tactile acuity tactile dysfunction sensory dissociation two-point discrimination perception
the use of n-acetylcysteine attenuating cisplatin-induced toxicities by oxidative stress

Conditions: Head and Neck Neoplasms

Summary: head and neck cancer corresponds to tumors located in the upper aerodigestive tract, such as the oral cavity, pharynx and larynx. the most effective treatment consists of high dose of cisplatin chemotherapy and radiotherapy, however, their use is limited due to toxicities caused mainly by oxidative stress. the objective of this study will be evaluate the use of n-acetylcysteine attenuating cisplatin-induced toxicities by oxidative stress in head and neck cancer patients. this is a randomized double-blind placebo-controlled clinical trial with consecutive sampling that will be conducted at oncology department of clinic hospital / university of campinas (unicamp). head and neck cancer patients who will begin cisplatin antineoplastic treatment (80-100mg/m2 on days 1, 22 and 43) and concurrent radiotherapy will be included in this research. they will be studied in 2 groups (n-acetylcysteine and placebo). all patients will be evaluated in relation to cisplatin induced hematologic and gastrointestinal disorders, nephrotoxicity, ototoxicity, and hepatotoxicity; plasmatic and cellular oxidative stress; quality of life; and pharmacoeconomic evaluation. results will be statistically analysed using chi-square, fisher, mann-whitney, and anova for repeated measures tests (p\<0.05.)


Eligibility criteria:
inclusion criteria: * head and neck cancer * anticancer treatment - cisplatin (80 to 100 mg/m²) plus radiotherapy * patients without previous treatment of head and neck cancer (surgery, chemotherapy and radiotherapy) exclusion criteria: * severe psychiatric diseases * impossibility of verbal communication * without caregivers or companions
clinical study for treatment-naïve iopd babies to evaluate efficacy and safety of ert with avalglucosidase alfa

Conditions: Glycogen Storage Disease Type II

Summary: this is a single group, treatment, phase 3, open-label study to assess efficacy, safety, pharmacokinetic (pk), pharmacodynamics (pd) of avalglucosidase alfa in treatment-naïve male and female participants with iopd. study details include: * study duration: screening - up to 4 weeks; * primary analysis period (pap) - 52 weeks; * extended treatment period (etp) - 52 weeks; * extended long term treatment period (eltp) - 104 weeks; 4-week follow-up period for a total study duration - up to 4.08 years. * treatment duration: up to 4 years * visit frequency: every other week and potentially every week

study duration may be variable by country, including at least completion of the pap and etp, and up to 4.08 years.

Eligibility criteria:
inclusion criteria: * participants must have confirmed diagnosis of infantile-onset pompe disease defined as: the presence of 2 lysosomal acid α-glucosidase (gaa) pathogenic variants and a documented gaa deficiency from blood, skin, or muscle tissue; or the presence of 1 gaa pathogenic variant and a documented gaa deficiency from blood, skin and muscle tissue in 2 separate samples (from either 2 different tissues or from the same tissue but at 2 different sampling dates). * participants must have established cross-reactive immunological material (crim) status available prior to enrollment. * participants must have cardiomyopathy at the time of diagnosis: ie, left ventricular mass index (lvmi) equivalent to mean age specific lvmi * +1 standard deviation for participants diagnosed by newborn screening or sibling screening; * +2 standard deviation for participants diagnosed by clinical evaluation. * parents or legally authorized representative(s) must be capable of giving signed informed consent. exclusion criteria: * participants with symptoms of respiratory insufficiency, including any ventilation use (invasive or noninvasive) at the time of enrollment. * participants with major congenital abnormality. * participants with clinically significant organic disease (with the exception of symptoms relating to pompe disease). * participant received any pompe disease specific treatment, eg enzyme-replacement gene therapy (ert). * participant who has previously been treated in any clinical trial of avalglucosidase alfa. * participant not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
prevalence of liver fibrosis and progression of liver fibrosis

Conditions: HIV Infection and Chronic Alanine Aminotransferase Elevation

Summary: little is known about the clinical significance of chronic alanine aminotransferase (alt) elevation in hiv-infected patients without hepatitis b and c coinfection. study aim is first to evaluate the prevalence of liver fibrosis and cirrhosis in hiv-infected patients with chronic alt elevation and no chronic viral hepatitis using non-invasive diagnostic tests and second to find associated factors with significant fibrosis and cirrhosis. in a second longitudinal part we intend to assess fibrosis progression within 1 and 3 years.


Eligibility criteria:
inclusion criteria: case patients: * hiv-1 infection * no hepatitis b and c coinfection * chronic alanine aminotransferase (alt) elevation after 1.1.2007 * signed informed consent * no other common cause of liver disease control patients: * hiv-infection * no hepatitis b and c coinfection * no alt elevation after 1.1.2002, the date when alt values were regularly collected in the swiss hiv cohort study (shcs) * no known chronic liver disease exclusion criteria: please see inclusion criteria
phase ib study of olaparib plus weekly carboplatin and paclitaxel in relapsed ovarian cancer

Conditions: Stage III Ovarian Cancer; Stage IV Ovarian Cancer; Uterine Cancer

Summary: the purpose of this study is to determine the maximum tolerated dose (mtd) of the investigational agent, olaparib, to give in combination with carboplatin and paclitaxel in patients with relapsed ovarian cancer or uterine cancer. furthermore, the investigators intend to study the safety and tolerability of the study treatment, response to treatment, time to disease progression, and overall survival.


Eligibility criteria:
inclusion criteria: * advanced (stage iii or iv), histologically or cytologically documented ovarian cancer or serious uterine cancer patients who relapsed after primary therapy with a platinum and a taxane. this includes: * platinum sensitive: relapsed at least 6 months following platinum treatment * platinum refractory: the cancer grew while on platinum treatment * platinum resistant: recurrence within 6 months of platinum treatment * must have failed first line treatment * ecog performance status 0-2 * must be able to swallow and retain oral medication * life expectancy greater than 16 weeks * must have normal organ and bone marrow function defined as follows: * hemoglobin ≥ 9.0 g/dl * absolute neutrophil count (anc) ≥ 1.5 x 10\^9/l * white blood cells (wbc) \> 3 x 10\^9/l * platelet count ≥ 100 10\^9/l * total bilirubin ≤ 1.5 x institutional upper limit of normal * ast (sgot)/alt (sgpt) ≤ x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5 uln * serum creatinine ≤ 1.5 x institutional upper limit of normal (uln) exclusion criteria: * any previous treatment with a parp inhibitor, including olaparib * any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or longer period depending on the defined characteristics of the agents used) * currently receiving the following classes of inhibitors of cyp3a4: azole antifungals, macrolide antibiotics, and protease inhibitors * second primary cancer except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years * symptomatic uncontrolled brain metastases * major surgery within 2 weeks of starting study treatment * immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (hiv) * known active hepatic disease (i.e. hepatitis b or c) * uncontrolled seizures * history of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin or paclitaxel

Keywords: ovarian neoplasms cancer of the ovary ovarian cancer uterine neoplasms cancer of the uterus uterine cancer olaparib azd2281 carboplatin paclitaxel relapsed