Kornimate/medical-research-clean huggingface dataset:
controlled high risk avonex® multiple sclerosis prevention study in ongoing neurological surveillance

Conditions: Multiple Sclerosis

Summary: phase iv, multi-center, non-treatment, observational, registry study to determine long term effects of avonex® therapy on edss, mri, qol, and cognition.

the primary objective of this study is to determine the impact of long term avonex® treatment on physical status, measured by expanded disability scale score (edss), of patients with multiple sclerosis (ms) after their first clinical event (clinically isolated syndrome) and magnetic resonance imaging (mri) consistent with ms. secondary objectives are to determine the impact of long term therapy with avonex® on the following: a) mri parameters- new or enlarging t2 lesions, t2 lesion volume, t1 lesion volume, brain parenchymal fraction (bpf) b) quality of life (qol): heath status questionnaire (sf-36) c) symbol digit modality test (sdmt) 2. to determine the long term impact of therapy on the following in patients treated at the onset of clinically isolated event (cis) 1. edss 2. mri parameters 3. sf-36 4. sdmt 3. to determine early clinical and mri predictors of disease progression. approximately 383 patients participated in champs, the original avonex® placebo trial, will be approached for study participation. the patient population will be divided into two cohorts. cohort 1: patients that participated in champs and champions 10 will be approached for study participation at approximately twenty-four champions continuation investigative sites. cohort 2: patients that participated in champs will be located and approached for study participation. patient that participated in champions 10 will not be excluded from cohort 2. efforts will be made to potentially locate patients through either the original champs investigative sites, through the biogen idec patient services database, and/or a third party (i.e., patient location service vendor) or some combination of the three. . for both cohorts, public databases may be utilized for patient reported death.

Eligibility criteria:
inclusion criteria: * patients are eligible to be screened for this study if all of the following criteria are met: 1. all patients must have been originally enrolled in champs, regardless of randomization arm. only cohort 1 patients must have been enrolled in champions 10. 2. willing and able to provide informed consent (cohort 1), waiver of informed consent (cohort 2), or reported patient death through public database search. 3. ability to read and write english (patient reported assessment tools are in english only). exclusion criteria: * candidates will be excluded from study screening if any of the following exclusion criteria exist: 1. patients not participating in the original champs study. 2. alternative diagnosis to ms discovered. 3. patient unwilling or unable to provide informed consent (cohort 1) or waiver of informed consent (cohort 2), as applicable. 4. any other reasons that, in the opinion of the investigator (cohort 1) or patient coordination center (cohort 2), the patient is determined to be unsuitable for enrollment into this study.
impact of a mobile phone and educational intervention

Conditions: Pulmonary Disease, Chronic Obstructive; Asthma COPD

Summary: the purpose of this pilot study was to: 1. partner with african american churches to increase awareness of copd. 2. use a community-based approach to facilitate early detection of copd in the church setting. the pre-screening with a paper-based tool and spirometry testing were provided at community health fairs at the churches. 3. determine the impact of a combined intervention (education and mobile phone/text messages) on health related-related quality of life and health behaviors of african americans with asthma and copd. the study used a randomized controlled trial (rct) design to assess the effect of the intervention (education and mobile text-messaging) on health-related quality of life and health behaviors recommended for improved copd self-management. all participants received the educational component then were randomized to a control group and intervention group, in which participants received mobile phone-based text messages on improving health behaviors associated with better self-management of asthma and copd.

this pilot study evaluated the feasibility and impact of a combined intervention on hrqol and three health behaviors (nutrition, physical activity, avoiding triggers) in african americans with asthma or copd. this was a community-based intervention that recruited participants from six predominantly african american churches. african americans over 18 years with asthma or copd were randomized to control or intervention. intervention received education (asthma copd (acopd) program) and a one-month text-messaging program, while control received the acopd program alone. measures were made at three- and 9-month follow-up. independent and paired t-tests were used to examine hrqol between groups and over time.

Eligibility criteria:
inclusion criteria: * eligible participants for the study were african american adults of 18 years and above. participants had to have reported physician diagnosed (on the survey distributed at the church) or spirometry diagnosed (at the community health fair) asthma or copd, access to a text-messaging enabled mobile phone, and provision of signed informed consent. exclusion criteria: * individuals unwilling to participate in the study and patients with other chronic lung diseases, terminal, or comorbid illnesses more severe in nature than asthma or copd (i.e., heart disease and cancer) were excluded from the study.
the role of ctdna and pbmc in treatment of biliary tract cancer

Conditions: Biliary Tract Neoplasms

Summary: our study aims to evaluate the role of ct-dna and pbmc as biomarkers in the treatment of biliary tract cancer.

biliary cancer ranked fifth in all gastrointestinal malignant cancer. epidemiological surveys showed a significant increasing trend in recent years. how can make an early diagnosis of bile duct cancer as well as prognostic evaluation and efficacy monitoring, has become the hotspot. "liquid biopsy", which is meant to detect cancers by sequencing the dna in a few drops of a person's blood. it may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation. cf-dna in cancer patients often bears similar genetic and epigenetic features to the related tumor dna. there is evidence that some of the cf-dna originates from tumoral tissue. this, and the fact that cf-dna can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer. and we call the cf-dna of tumor as ct-dna. peripheral blood mononuclear cells (pbmc) is any peripheral blood cell having a round nucleus. these cells can be extracted from whole blood using ficoll, a hydrophilic polysaccharide. pbmc contains genetic material of tumor and may be applied as a biomarker. this study aims to evaluate the role of ct-dna and pbmc as biomarkers in the treatment of biliary tract cancer.

Eligibility criteria:
inclusion criteria: * patients with suspected biliary tract cancer * age from 18 - 70 years * no serious organic and mental illness; exclusion criteria: * pregnancy * no pathologic result * suffering other malignancies at the same time.

Keywords: biomarkers, neoplasms
serum fetuin level in polycystic ovary syndrome

Conditions: Polycystic Ovary

Summary: polycystic ovary syndrome is a common gynecological problem

understanding the pathophysiology and the cause is of much importance for proper management of this problem

Eligibility criteria:
inclusion criteria: * women who have pcos in group 1 and who donnot have pcos in group 2 with age between 20 -42 years exclusion criteria: * women above 42 years old
cardiac arrhythmias at extreme altitude

Conditions: Arrhythmias, Cardiac; Tachycardia, Ventricular; Tachycardia, Supraventricular; Bradycardia

Summary: background: exposure to high altitudes has been associated with an increased risk of cardiac arrhythmias in healthy subjects and an increased risk of sudden cardiac death. aim: the aim of the present study is to evaluate the risk and the incidence of cardiac arrhythmias at extreme altitude. methods: this is a prospective cohort study of healthy volunteers determined to climb mount everest. subjects will be evaluated for eligibility by electrocardiography and echocardiography. all study participants will undergo ambulatory rhythm monitoring in their home environment within 12 weeks of the climb. subsequently, ambulatory rhythm monitoring will be repeated during the ascent from basecamp to the summit of mount everest. the primary endpoint will be the composite of supraventricular and ventricular tachyarrhythmias, and bradyarrhythmias.

background: several physiological changes at high altitude give rise to a pro-arrhythmic milieu. a fall in atmospheric pressure at high altitude decreases the partial pressure of oxygen (pao2) and causes arterial hypoxemia. respiratory alkalosis secondary to hyperventilation causes hypokalemia and hypocalcemia. both factors facilitate the occurrence of rhythm disturbances, and may be further exacerbated in an adrenergic state with increased epinephrin levels. objectives: the primary objective is to investigate the incidence of supraventricular and ventricular tachyarrhythmias, and the incidence of bradyarrhythmias in climbers during the ascent of mount everest. the secondary objective is to investigate clinical, electrocardiographic and echocardiographic predictors of cardiac arrhythmias at extreme altitude. methods: this is a prospective cohort study of healthy volunteers climbing mount everest. subjects will be evaluated for eligibility by electrocardiography and echocardiography. all participants will undergo a stress test in order to rule out pre-existing rhythm disturbances during exercise. study participants will undergo ambulatory rhythm monitoring in their home environment within 12 weeks of the climb. subsequently, subjects will repeat ambulatory rhythm monitoring during the ascent from basecamp to the summit of mount everest. the subjects will act as their own controls.

Eligibility criteria:
inclusion criteria: * age ≥18 years * normal electrocardiogram * normal echocardiography * written informed consent exclusion criteria: * known cardiac arrhythmia * evidence of av-block, left bundle branch block, or repolarization disorders on electrocardiogram * evidence of structural heart disease (valve disease more than mild) or compromised left ventricular ejection fraction as assessed by echocardiography * symptoms or history of skin cancer, rash, skin disease, keloid or injury * cardiac pacemakers, cardiac defibrillators, implantable electrical devices * pregnancy, breastfeeding
effect of rtms of the cerebellum on parkinson's disease

Conditions: Parkinson Disease; Transcranial Magnetic Stimulation

Summary: the goal of this clinical trial is to learn about the efficacy of low-frequency rtms of the cerebellum in parkinson's disease.

the main question it aims to answer is: how to improve parkinson's disease by rtms. participants will be treated with active low-frequency rtms/sham rtms over the cerebellum and receive: 1) resting state functional magnetic resonance imaging (fmri), 2) blood sampling, and 3) unified parkinson disease rating scale (updrs) before and after the treatment course. researchers will compare the data collected from fmri scan, blood sample analysis, and updrs rating between the active rtms group and sham controls before and after the treatment to see if there are meliorating effects of rtms on parkinson's disease.

Eligibility criteria:
inclusion criteria: 1. diagnosed with parkinson's disease according to the clinical diagnostic criteria for parkinson's disease (2015 edition) by the movement disorder society (mds) 2. citizens of the people's republic of china of either sex, aged between 40 and 80 years. 3. able to give informed consent and follow the research plan. 4. hoehn-yahr (h-y) stage ≤ 3 5. patients received a parkinson's stable medication before treatment (assessed via self report), which continued during treatment. exclusion criteria: 1. history or diagnosis of severe psychiatric disorders, such as depression, anxiety disorders, schizophrenia spectrum disorders, and bipolar disorders. 2. subjects with a clinically defined neurological disorder (assessed via self report) including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, history of stroke, transient ischemic attack within two years, cerebral aneurysm, dementia, multiple sclerosis. 3. significant cognitive disorders (mini-mental state exam (mmse)\<24 points) or unable to complete the questionnaire independently. 4. intracranial implants, such as cochlear implants, aneurysms clips, shunts, stimulators, electrodes, cardiac pacemakers and vagus nerve stimulation devices. 5. increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold (assess via self report). 6. showed significant discomfort after receiving the rtms treatment. 7. participated in other clinical trials. 8. inability to read or understand chinese.
evaluation of the role of prostaglandins in radiation-induced mucositis

Conditions: Cancer of the Head and Neck; Radiotherapy

Summary: this study will evaluate the role of cyclooxygenase pathways in radiation-induced and chemoradiation-induced mucositis.

oral mucositis is a significant toxicity of radiation therapy and chemoradiation therapy in head and neck cancer patients. however the mechanisms that induce such mucositis are not completely understood. previous work evaluating mucositis in bone marrow transplant patients has suggested that prostaglandin levels may be associated with the appearance of mucositis. the present study will measure the levels in saliva of the prostaglandins pge2 and pgi2 before, during, immediately after, and several weeks after radiotherapy for head and neck cancer. these salivary levels will be correlated with clinical observation of mucositis and patient reporting of pain levels. improved understanding of the mechanism of mucositis may lead to the development of more effective targeted agents to prevent this problem.

Eligibility criteria:
inclusion criteria: * histologically proven locoregional stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx * receiving radiation therapy or chemoradiation therapy to the oropharynx * older than 18 years old * ecog performance status of 0-2 * life expectancy greater than 2 months * signed informed consent exclusion criteria: * previous chemotherapy for this malignancy * previous radiotherapy to the head and neck * other cancer diagnosis within the last 5 years except for non-melanoma skin cancer or non-metastatic prostate cancer * patient taking nsaids

Keywords: cancer of the head and neck radiotherapy prostaglandins
cpap versus nppv in acpe

Conditions: Pulmonary Edema

Summary: to assess the intubation rate in patients affected by severe cardiogenic pulmonary edema treated with cpap or nppv.

background although non-invasive ventilation has shown to be an effective treatment for acute cardiogenic pulmonary oedema (acpo), literature still lacks of multi-centre randomised prospective studies that compares cpap with nppv. aim of the study was to assess efficacy and safety of cpap and nppv in patients with acpo. methods 80 patients with acpo were randomly assigned to receive cpap or nppv (40 for each group) through a face mask. inclusion criteria were: severe dyspnoea, respiratory rate \> 30, pao2/fio2 \< 200, muscle fatigue. main end-points were endotracheal intubation, length of ventilation, hospital length of stay and mortality.

Eligibility criteria:
inclusion criteria: * rapid onset of the symptoms * severe dyspnoea at rest * respiratory rate \> 30 breath per minute * use of accessory respiratory muscles * pao2/fio2 \< 200, radiological findings of acpe exclusion criteria: * st elevation myocardial infarction * hemodynamic instability (systolic arterial pressure \< 90 mmhg * need for immediate endotracheal intubation (respiratory arrest, bradypnea * inability to protect the airways, impaired sensorium (agitation or unconsciousness * inability to clear secretions, respiratory tract infections * chronic obstructive pulmonary disease (copd) exacerbation, chronic respiratory failure necessitating long-term oxygen therapy * pulmonary embolism, pneumonia, recent oesophageal-gastric surgery * gastrointestinal bleeding * facial deformities * haematological malignancy or cancer with eastern cooperative oncology group (ecog) performance status ≥ 2.
the use of near infrared spectroscopy in the diagnosis of acute compartment syndrome in injured soldiers

Conditions: Acute Compartment Syndrome

Summary: the purpose of this study is to define the reliability and accuracy of near infrared spectroscopy (nirs) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. the investigators hypothesize that this technology, combined with vital signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing acute compartment syndrome (acs), monitoring patients at risk for acs, and evaluating the adequacy of fasciotomy in patients treated for acs.


Eligibility criteria:
inclusion criteria: * 18-65 years old * male or female * active duty servicemen who have been evacuated from oif or oef through lrmc exclusion criteria: * patients not willing to provide consent * patients in whom application of nirs monitoring is viewed as an impediment to casualty care

Keywords: near infrared spectroscopy lower extremity injury
the role of granulocyte colony stimulating factor in embryo transfer outcomes

Conditions: Infertility; Infertility,Female; Infertility; Female, Nonimplantation; Infertility Unexplained; Infertility of Uterine Origin

Summary: the goal of this clinical trial is to test the effect of granulocyte colony-stimulating factor (g-csf, a.k.a. filgrastim) in infertility patients undergoing in vitro fertilization (ivf) treatment. the main question it aims to answer is: can in vitro fertilization-embryo transfer (ivf-et) outcomes be improved by supplementing the transfer media with granulocyte colony-stimulating factor (gcsf)? participants will undergo their embryo transfer as per the normal clinic protocol but will be randomized to either receive the standard embryo transfer media or the gcsg-supplemented transfer media. researchers will compare the gcsf and standard transfer media groups to see if clinical outcomes are improved (i.e., implantation rate, pregnancy, clinical pregnancy rate, live birth rate).

please see uploaded study protocol.

Eligibility criteria:
inclusion criteria: * recruited subjects will either be undergoing a fresh ivf-et cycle in which the embryo(s) generated from the initial treatment cycle are transferred during that same cycle (i.e., on day 5 or 6 post-egg retrieval) or an fet cycle in which the embryo(s) transferred were generated in a previous ivf cycle and were cryopreserved for subsequent warming and transfer. exclusion criteria: * patients with uterine factor or severe male factor infertility will be excluded. * patients who have had previous ivf failures will be excluded.

Keywords: infertility embryo transfer gcsf granulocyte colony-stimulating factor filgrastim neupogen implantation
a phase i study of adjuvant chemotherapy with gc in biliary tract cancer undergoing resection without major hepatectomy

Conditions: Biliary Tract Cancer

Summary: to decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus cisplatin combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy.

surgery currently remains the only potentially curative treatment for biliary tract cancer (btc), and most patients develop recurrence. therefore, effective adjuvant chemotherapy is required to increase the curability of surgery and to prolong the survival in these patients. however, to date, no standard adjuvant chemotherapy has been established, and a guideline for btc treatment recommends that trials of adjuvant chemotherapy be carried out. based on results from clinical studies in unresectable btc, gemcitabine, platinum agent, fluoropyrimidine are considered to have activity against btc. these agents are expected to be effective in the postoperative adjuvant therapy for btc, thus, randomized controlled trials with gemcitabine are ongoing, and the results are expected. recently, in the abc-02 study, the first prospective multicenter phase iii study in patients with unresectable btc, gemcitabine/cisplatin combination chemotherapy was compared with gemcitabine monotherapy and showed that the combination therapy significantly prolonged mst (from 8.1 to 11.7 months; p \< 0.001). gemcitabine/cisplatin combination therapy is now considered to be the standard regimen for unresectable btc, and we expect this regimen to be effective for postoperative adjuvant therapy. though hepatectomy is frequently performed in surgery for btc, it is unclear that the effect of anticancer agent is affected by hepatectomy. because gemcitabine is metabolized by cytidine deaminase primarily in the liver, it considered to have decreased the metabolic ability of gemcitabine after hepatectomy. some clinical studies demonstrated that patient with hepatectomy could not tolerate the standard dose and schedule of gemcitabine. in the adjuvant chemotherapy with gemcitabine, it is necessary to examine separately whether hepatectomy was undergone or not. in this study, we aimed to assess the safety and efficacy of gemcitabine/cisplatin combination chemotherapy in patients with biliary tract cancer undergoing curative resection without hepatectomy.

Eligibility criteria:
inclusion criteria: 1. biliary tract cancer (btc) with more than stage ib 2. btc undergoing r0 or r1 resection without major hepatectomy 3. older than 20 years old 4. ps0 or 1 5. no treatment other than surgery 6. no dysfunction of main organs 7. possible oral intake 8. treatment start; after 4 weeks and within 12 weeks after surgery 9. obtained written informed consent exclusion criteria: 1. patients with resection of major hepatectomy 2. patients with double cancers 3. patients having severe allergy 4. patients with severe organ dysfunction 5. patients with active infectious disease 6. pregnancy 7. patients with severe psychological disease 8. patients seem inadequate for this study by investigators