Kornimate/medical-research-clean huggingface dataset:
respiratory strength training in persons with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: dysphagia (swallow impairment), dystussia (cough impairment) and respiratory impairment are hallmark features of amyotrophic lateral sclerosis (als). these symptoms are the cause of fatal aspiration, malnutrition and respiratory insufficiency that together account for 91.4% of als mortality. unfortunately, treatments to prolong and maintain these vital functions are currently lacking. although the use of exercise in als is controversial, recent evidence suggests that mild to moderate intensity exercise applied early in the disease slows disease progression, improves motor function, preserves motor neuron number, reduces muscle hypoplasia, atrophy astrogliosis, and prolongs survival in animal models of als and human clinical trials. this research study is designed to determine the impact of respiratory strength training on breathing, airway protection and swallowing in persons with amyotrophic lateral sclerosis (als).

this research study will measure the maximum inspiratory and expiratory pressure with secondary measures of respiration, swallow, cough, quality of life and global disease progression following twelve-weeks of treatment compared to the sham group. as a participant two evaluations at the university of florida swallowing systems core laboratory located at shands hospital, gainesville will take place. each will take approximately two-hours and these will be spaced exactly three-months apart. during each evaluation tests will be performed to look at breathing, swallowing, and ability to cough doing standard clinical exams. in addition, some surveys about eating, speaking and quality of life will be taken. breathing exercises: a home research therapist will train the participants how to use the hand-held respiratory trainer. training for both treatment groups will be very similar, except the powerlung trainer device will have an additional spring load valve inside it that will place a force on the respiratory muscles during training. the other breathing trainer will not have this spring so that no resistance will be placed on the respiratory muscles during training and this will represent an aerobic respiratory treatment. the breathing exercises will be completed five days a week for a total of three months (a total of 60 therapy sessions). during each session, a total of three sets of ten repetitions of breathing exercises will be performed. once a week the home research therapist will visit and guide participants through the breathing exercise.

Eligibility criteria:
inclusion criteria: * diagnosis of probable or definite amyotrophic lateral sclerosis (als), * amyotrophic lateral sclerosis rating scale revised score greater than 34, * forced vital capacity greater than 70%, * cognition within normal limits as determined by montreal assessment of cognition score \>25 exclusion criteria: * allergies to barium, * tracheotomy or mechanical ventilation, * diaphragmatic pacer, * concurrent respiratory disease (e.g. copd), * pregnant at the time of the study due to radiation exposure
impact of adding midzolam to bupavicaine 0.5% in regional spinal anaesthesia on maternal middle cerebral artery velocimetry in parturients with severer preeclampsia

Conditions: Midazolam in Preeclamptic Patients

Summary: trial to use gaba mimetic action of midazolam to ameliorate the severe preeclampsia induced neuronal excitotoxicity using middle cerebral artery transcranial doppler resisitive vasculer indices to evaluate . secondery goal is to study end organ injury


Eligibility criteria:
inclusion criteria: * all parturients with severe preeclampsia for urgent c.s exclusion criteria: * ladies refusal to participate. refusal to have spinal anesthsia
an observational study to evaluate the relationship of nasal mucus properties and symptoms

Conditions: Acute Rhinosinusitis; Allergic Rhinitis

Summary: this is a study to learn more about the common cold from studying the nasal secretions produced during a cold or episode of allergic rhinitis.

this study involves collecting and analyzing nasal mucus to see if there are changes in mucus properties during the course of a cold or episode of allergic rhinitis. outcome measures include snot20 questionnaire, nasal secretion collection, acoustic rhinometry on the fifth and fourteenth day of symptoms. the investigators will also collect snot20 questionnaires on the tenth and twenty-eighth day.

Eligibility criteria:
inclusion criteria: * male and female subjects 12 years of age and older with acute nasal discharge fewer than 7 days or a history suggesting nasal allergic symptoms for at least 1 year. internet access required during the course of the study. patients must be symptomatic at screening. exclusion criteria: * symptoms suggesting bacterial rhinosinusitis such as fever ≥ 101ºf/38.3ºc, facial swelling, and serve tooth pain. history of crs or sinus/nasal surgery for this condition within 6 months before screening. history of respiratory signs and symptoms due to allergic rhinitis. therapy with bronchodilators, nasal steroids, oral corticosteroids in the past 30 days. therapy with antihistamines, nasal (neti) washings, or decongestants in the past 24 hours. use of any otc cold or allergy medication 24 hours before study visits requires a 24 hour washout phase

Keywords: cold acute rhinosinusitis allergic rhinitis
retinol-induced dermatitis in aged skin

Conditions: Aged Skin; Photoaged Skin

Summary: topical therapy with retinoids is the only proven medical therapy for aged/photoaged human skin. however, topical therapy with retinoids often result in unwanted cutaneous dermatitis, including erythema and scaling. the reseachers intend to investigate the dose, frequency of use, and time dependence of topical retinol-induced dermatitis. the researchers intend to evaluate retinoid-induced dermatitis biochemically, including retinol regulation of retinoid responsive genes that control retinoid metabolism and serve as markers for retinoid bioactivity. the researchers will also investigate the role of egf receptor pathway in retinoid-induced dermatitis.


Eligibility criteria:
inclusion criteria: * male or female * subject is at least 21 years of age * good general health * no disease states, physical conditions or medications that would impair evaluation of the test sites * willingness and ability to follow protocol * signed written and witnessed informed consent form * no use of oral retnoids in the past year * no use of topical steroids to the treatment area in the past 2 weeks exclusion criteria: * has received an experimental drug or used and experimental device in the 14 days prior to admission to the study * history of keloids * history of hypersensitivity to lidocaine or epinephrine * pregnant or nursing women * disease states or physical condition that would impair evaluation of the test sites or compliance with the protocol * history of chemical peels or laser treatments to the sites evaluated

Keywords: aged skin photoaged skin retinol topical retinoids
the efficacy of acupuncture in treating chemotherapy side effects in breast cancer patients

Conditions: Breast Cancer Stages I Through III

Summary: the goal of this study is to determine if acupuncture improves multiple symptoms associated with chemotherapy on the md anderson symptom inventory (mdasi): nausea, vomiting, fatigue, anxiety, anorexia, pain, disturbed sleep, shortness of breath, dry mouth, depression, and peripheral neuropathy (see statistical section). the investigators hypothesis is that acupuncture will result in lower mdasi scores over the course of chemotherapy for the acupuncture group vs. control group.


Eligibility criteria:
inclusion criteria: * 18 years or older * english speaking/reading/writing * breast cancer stages i through iii * any performance status suitable for chemotherapy as determined by the physician * primary or secondary chemotherapy, but enrolling patients prior to a chemotherapy regimen regardless of previous radiation therapy exposure and/or previous mastectomy. * scheduled to receive either of the following two regimens: * adriamycin (60 mg/m2), cytoxan (600 mg/m2), taxol (175 mg/m2) * adriamycin (60 mg/m2), cytoxan (600 mg/m2), taxol (80 g/m2) * taxotere (75mg/m2), cytoxan (600 mg/m2) * taxotere (75 mg/m2), carboplatin (auc 6), perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) exclusion criteria: * history of narcolepsy * sleep apnea requiring continuous positive airway pressure (cpap) * other acupuncture treatment within one month of enrollment * acupuncture treatment for chemotherapy in the past * current participation in any other research studies

Keywords: breast cancer acupuncture taxol cytoxan adriamycin taxotere carboplatin perjeta chemotherapy chemotherapy-induced nausea, vomiting chemotherapy-induced peripheral neuropathy adriamycin (60 mg/m2), cytoxan (600 mg/m2), taxol (175 mg/m2) adriamycin (60 mg/m2), cytoxan (600 mg/m2), taxol (80 g/m2) taxotere (75mg/m2), cytoxan (600 mg/m2) taxotere (75 mg/m2), carboplatin (auc 6), perjeta (840 mg loading fixed dose)
efficacy and safety of ultra small dose decitabine for the lower risk mds patients with transfusion dependent

Conditions: Myelodysplastic Syndromes

Summary: myelodysplastic syndrome (mds) is widely recognized as a clonal hematopoietic stem cell disorder. decitabine has been approved for the treatment of all subtypes of myelodysplastic syndrome (mds). however, the use of decitabine is often limited by its severe toxicity represented by myelosuppression even at relatively low doses. in lower-risk patients (including ipss low and int-1 risk groups), treatment mainly aims at improving cytopenias, especially anemia. however, although several drugs may improve anemia, sometimes durably, most of lower risk mds eventually require red blood cell (rbc) transfusions during their disease course. long term rbc transfusions lead to iron overload mainly due to an increase in reticulo-endothelial iron recycling.cardiac, liver and endocrine (diabetes mellitus) dysfunction due to iron overload and often leading to fatal outcome has been reported in heavily transfused lower risk mds patients. to date, the optimal regimen for decitabine treatment is not well established. in this study, we perform a prospective analysis to explore the decitabine schedule for the treatment of lower risk myelodysplastic syndrome patients with transfusion dependent.

the investigators are undertaking a single-center, single-arm study of 50 lower risk myelodysplastic syndrome patients with transfusion dependent from shandong university qilu hospital . all the participants are selected to receive ultra small dose decitabine treatment (given intravenously at a dose of 3.5mg/m2, qd x 5d, every four weeks for one cycle). a routine blood examination is performed twice every week. bone marrow (bm) is examined with routine aspirate smear and g-banding analysis every 1-2 treatment courses to evaluate responses.adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: * diagnosis of mds * the ipss \[17\] score ≤ 1 * patients with transfusion dependent * adequate hepatic and renal function (aspartate aminotransferase \[ast\] ≤ 2.5 x upper normal limit, alanine aminotransferase \[alt\] ≤ 2.5 x upper normal limit, bilirubin ≤ 1.5 x upper normal limit and creatinine \ 60ml/min ). exclusion criteria: * decitabine and arsenic trioxide allergy * pregnancy and lactation * cardiovascular disease * ecog score \> 2 * hcv, hiv, hbsag seropositive status

Keywords: decitabine myelodysplastic syndrome
registration study sarcoma

Conditions: Sarcoma

Summary: the prospective and retrospective data collection on bone and soft tissue sarcoma is an observational cohort study aimed to collect clinical data and patient reported outcomes of all patients who have been diagnosed with bone or soft tissue sarcoma in the netherlands. all patients diagnosed with bone or soft tissue sarcoma who are treated, planned for treatment or currently being treated, will be asked to participate in this project.

the main objectives of this project are: * to improve the knowledge and therefore the treatment care, in patients with bone or soft tissue sarcoma in the netherlands * to start an observational cohort study of bone and soft tissue sarcoma patients from their primary diagnosis until death * to prospectively and retrospectively collect data on medical history, co-morbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, functional outcome, cosmetic outcome, hospital stays and interventions. * to collect data on health related quality of life and work ability, to collect data on patient reported outcomes measures. * to create a continuous basis for a large variety of research purposes including: * prognostic and predictive research * health care policies and cost-effectiveness studies

Eligibility criteria:
inclusion criteria: * histologically proven bone or soft tissue sarcoma, excluding gastrointestinal stromal tumours exclusion criteria: * altered mental status that would prohibit the understanding of and giving of informed consent
tolerability of grazax in patients with hayfever in real life settings

Conditions: Allergic Rhinoconjunctivitis

Summary: the purpose of this study is to assess the safety profile of specific immunotherapy with grazax for three consecutive grass pollen seasons.

to assess the safety profile with grazax according to the presence or not of polysensitization and/or asthma at enrollment

Eligibility criteria:
inclusion criteria: * history of grass pollen allergy * positive skin prick-test and/or positive specific ige to grass exclusion criteria: * severe, unstable or uncontrolled asthma (fev1\<70% of predicted value)

Keywords: allergic rhinoconjunctivitis immunotherapy
community study to reduce high blood pressure through text messaging (reach out)

Conditions: Hypertension; Stroke

Summary: one of the most powerful predictors of stroke is hypertension, with estimates of approximately 33% of adults in the united states experiencing this condition. hypertension is significantly more prevalent in african americans compared to european americans. importantly, hypertension is a modifiable stroke risk factor. this proposal will use a community-based participatory research approach to perform a randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure in an urban african american community in flint, michigan.

this is a randomized controlled trial of text messaging and blood pressure self-monitoring to reduce blood pressure.

Eligibility criteria:
inclusion criteria: * adult (\>18 y/o) participants with bp ≥140/90 who have mobile phones with text-messaging capability. exclusion criteria: * adult who is illiterate, non-english speaking, pregnant, incarcerated/ institutionalized resident, or has a pre-existing condition that makes follow-up for 6 months unlikely.

Keywords: hypertension treatment stroke prevention
reliability for the detection of sperm dna damage by a sperm chromatin dispersion test (halosperm)

Conditions: Infertile Men

Summary: it is proposed to measure sperm dna damage by sperm chromatin dispersion test. this measurement helps to better diagnose male infertility and seems easy to apply in routine. however, the reliability of this method needs to be evaluated before applying for clinical practice in andrology laboratory.

the aim of this study is to measure the inter and intra-observer reliability for the measurements of sperm dna damage by sperm chromatin dispersion test (halosperm). the gold standard to measure sperm dna damage is tunel (terminal desoxynucleotidyl end labelling) method. however, this method is not easy to apply in routine. therefore we investigate to analyse the inter-method reliability between sperm chromatin dispersion test and tunel.

Eligibility criteria:
inclusion criteria: * infertile men * \<50 years * with at least 5.106spermatozoa/ml in the ejacu exclusion criteria: * azoospermia
to evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: primary objective: to evaluate the immunogenicity of sarilumab administered as monotherapy. secondary objectives: * to evaluate the other safety aspects of sarilumab administered as monotherapy. * to assess the exposure of sarilumab administered as monotherapy.

total study duration was up to 34 weeks: up to 4-week screening period, 24-week open-label treatment phase, 6-week post-treatment observation. after completion of the treatment phase of this study, participants were eligible to enter a long term safety study (lts11210 - saril-ra-extend) for continuous treatment with sarilumab (sar153191 \[regn88\]).

Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis (ra) ≥ 3 months. * moderately to severely active rheumatoid arthritis. * participants who per investigator judgment were incomplete responders to at least 12 weeks of an adequate dose of continuous treatment with or who were intolerant of one or a combination of non-biologic disease modifying anti-rheumatic drugs (dmards). exclusion criteria: * participants \< 18 years of age. * past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than ra. * history of juvenile idiopathic arthritis or arthritis onset prior to age 16. * severe active systemic ra, including but not limited to vasculitis, pulmonary fibrosis, and/or felty's syndrome. * prior treatment with any biologic anti-interleukin 6 (il-6) or il-6 receptor (il-6r) antagonist therapies. * treatment with prednisone \> 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization. * new treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drug (nsaids) or cyclooxygenase-2 (cox-2) inhibitors within 4 weeks prior to randomization, except for the use of low-dose acetylsalicylic acid for cardiovascular diseases. * use of parenteral glucocorticoids or intra-articular glucocorticoids injection within 4 weeks prior to randomization. * prior treatment with a janus kinase (jak) inhibitor (tofacitinib). * new treatment or dose-adjustment to on-going medication for dyslipidemia, such as statin, within 6 weeks prior to randomization. * participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first dose of study drug administration, whichever is longer. * participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization visit. non-malignant lymphoproliferative disorders are also excluded. * participants with active tuberculosis or untreated latent tuberculosis infection. * pregnant or breast feeding women. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
troponin excretion in urine in patients with and without chronic kidney disease

Conditions: Chronic Kidney Diseases; Acute Myocardial Infarction

Summary: in this study, in order to better understand the mechanism of troponin clearance and the reason for elevated troponin levels in patients with ckd, we aim to evaluate quantitatively the excretion of troponin in the urine in patients with and without ckd, and with and without myocardial injury. we will compare urinary troponin levels with blood troponin levels in these patients. in addition, we will compare the levels of hs-ctnt and hs-ctni in the patients' sera and urine.

the study population will be screened at the internal wards, the nephrology ward and clinic, and the intensive cardiac care unit (iccu) of soroka medical center. it will include patients who suffer from ami, patients with ckd with and without any cardiac disease and patients with no known renal or cardiac disease. the following information and measurements will be collected: demographics - age, sex, weight, height. past medical history - specifically regarding renal and cardiac diseases and procedures. measured variables in blood serum - troponin t, troponin i, creatinine, total protein, albumin, myoglobin measured variables in urine - troponin t, troponin i, creatinine, total protein, albumin, microalbumin, β2-microglobulin calculations - gfr (according to mdrd equation), troponin correction to creatinine (gr troponin per gr creatinine), troponin excretion ( ), urine albumin/creatinine ratio, urine protein/creatinine ratio.

Eligibility criteria:
inclusion criteria: 1. patients who are able to give informed consent. 2. age ≥ 18 exclusion criteria: 1. pregnant women 2. patients after kidney transplantation. 3. patients after heart transplantation. 4. anuric patients.
incorporating mr imaging into prostate radiotherapy treatment planning

Conditions: Prostate Cancer; Adenocarcinoma of the Prostate Stage I; Adenocarcinoma of the Prostate Stage II; Adenocarcinoma of the Prostate Stage III

Summary: this research study is evaluating whether a standard prostate mri examination can improve radiation therapy planning for prostate cancer.

in this research study, the investigators want to determine if prostate radiotherapy treatment planning can be improved by using an mri scan to help doctors more accurately target the prostate with radiation and decrease radiation dose to the rectum, which is just behind the prostate. to do this, the investigators will create a treatment plan based on the mri scan and compare it to the standard treatment, which currently uses a ct scan rather than an mri. the results of this study will help inform doctors whether it is beneficial to routinely use an mri scan for prostate radiotherapy treatment planning.

Eligibility criteria:
inclusion criteria: * participants must have histologically confirmed prostate cancer. * psa level and prostate biopsy must be reviewed at brigham and women's hospital or the dana farber cancer institute and should support a diagnosis of stage i-iii prostate adenocarcinoma. * candidates with psa greater than 20, digital rectal exam consistent with disease outside the prostate (clinical t3/t4 disease), or gleason score 8 or greater, should have a bone scan and diagnostic pelvic ct or mri to exclude metastatic disease. * prostate biopsy, serum psa measurement, and any indicated diagnostic imaging studies must be performed within 60 days of the date of registration. * participants should not have had prior curative local treatment for prostate cancer, including no radiotherapy or prostatectomy. a maximum 90 days of systemic androgen deprivation therapy prior to registration is allowed. * participation is limited to adult patients, age 18 years or older. * ecog performance status ≥2 (karnofsky ≥60%) * life expectancy of greater than 10 years. * able to tolerate an mri examination. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * participants with known or suspected metastatic (stage iv) prostate cancer. * participants with an implanted device, prosthesis, or any other foreign body with ferromagnetic properties that would make them ineligible to undergo mri examination. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Keywords: prostate cancer stage i-iii prostate adenocarcinoma