Kornimate/medical-research-clean huggingface dataset:
development of an evaluation method of elderly condition in patient receiving chemotherapy treatment

Conditions: Lymphoma; Digestive System Diseases; Ovarian Diseases; Pulmonary Disease; Prostatic Disease; Bladder Disease

Summary: incidence of cancer in 75+ years old is 16,500 new cases per year, more than fifty percent of people with cancerthey are very few therapeutic trials dedicated. oncologists hesitate to treat them because they are either afraid of inducing toxicity or of breaking down quality of life. consequently, we decided to launch a protocol with both oncologists and geriatricians which principal aim is to find out if geriatric assessment data can help to better predict for chemotherapy toxicity, loss of autonomy and survival. we plan to accrue 360 patients diagnosed for cancer, including digestive, pulmonary, prostate, lymphoma, bladder, ovary cancer for whom first-line chemotherapy is planned. patients are initially classified according to usual methods of medical oncology practice into three groups: patients who can receive standard treatment, reduced standard treatment or treatment adapted to the frail condition. around aquitaine, , we organised seven teams composed of one geriatrician and one nurse. two kind of teams were activated: one which cover ten treatment sites in bordeaux area and six sedentary teams which worked half a day a week in designated hospitals . geriatric evaluation included test of cognitive functions (mms), nutritional status (mna), co-morbidity (cirs-g), mobility (get up and go), activities (adl;iadl), quality of life (qlq-c30), depression (gds-15) and lachs-balducci screening. patients have four geriatric evaluations : before treatment, day 1 cycle 2, day 1 cycle 4, day 1 cycle 7 and/or end of chemotherapy. since september 2002, 177 patients have been included, 112 have finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3% stopped because they were in progression and changed their treatment, 11.6% met administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and 3.6% finished their treatment before. the following results have been obtained: before treatment, 73% of these patients were at risk of undernutrition (mna\ 20seconds, 27% adl\>1, 34% ps\ 6), 25% thought they had poor quality of life (qlq-c30\<4). protocol will be closed in september 2005.


Eligibility criteria:
inclusion criteria: * age ≥ 70 years * first line of chemotherapy * cancer previously mentioned

Keywords: cancer elderly geriatric evaluation safety chemotherapy
study to predict the benefits of first-line humidification use and comparison of the effect of thermosmart™ and no humidification on adherence

Conditions: Obstructive Sleep Apnea

Summary: this study aims to investigate the benefits of using first line heated humidification. the primary objective of this research is to determine the effect of high levels of humidification delivered by thermosmart™ on cpap adherence. in addition, to determine if it is possible to predict which patients benefit the most (i.e. be more adherent with therapy) from high levels of humidification delivered by thermosmart.


Eligibility criteria:
inclusion criteria: * older than 18 years of age * diagnosed with osa and eligible for cpap treatment under local requirements (ahi\>30 or if ahi is lower than 30, at least 10 micro arousals identified during diagnosis psg). * naïve to cpap therapy, i.e have not been prescribed, or used cpap in the last 5 years * patients receiving social security coverage (excluding meas) * fluent spoken and written french exclusion criteria: * severe heart disease * co-existing lung disease * co-existing sleep disorder * pregnant * refused participation
long-term efficacy and safety of fingolimod (fty720) in patients with relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (fty720) in patients with multiple sclerosis. the extension study was an extension to the 24-month core study (cfty720d2301/nct00289978).


Eligibility criteria:
inclusion criteria: * patients should complete the 24 month core study exclusion criteria: * patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc. * pregnant or nursing women other protocol-defined inclusion/exclusion criteria may apply.

Keywords: multiple sclerosis. relapse-remitting fingolimod
telmisartan versus ramipril after acute coronary syndrome

Conditions: Acute Coronary Syndrome; Myocardial Infarction; Coronary Disease

Summary: the purpose of this study is to compare the antinflammatory and endothelial progenitor cell (epc) mobilizing effect of ramipril and telmisartan in patients presenting with acute coronary syndrome


Eligibility criteria:
inclusion criteria: * biochemical evidence of myocardial infarction as indicated by elevation of ctnt, * presence of ecg ischemic changes, * angiographic evidence of a primary coronary event, such as plaque erosion and/or rupture, fissuring, or dissection at coronary angiography, * successful coronary revascularization of at least one culprit coronary vessel. exclusion criteria: * age\>80 years, current ace inhibitor or arb treatment, * ejection fraction \<35%, infarction secondary to ischemia due to an imbalance of o2 supply and demand, * ecg abnormalities that could affect the recognition of st segment shift, * recent or chronic infective or inflammatory diseases, * malignancy, and myocardial infarction, * surgery or trauma in the previous month.
a web-based multimedia intervention for head and neck cancer patients

Conditions: Cancer of the Head and Neck

Summary: the overall goal is to develop and examine the acceptability of a web-based (internet) intervention program for patients with head and neck cancer who have recently completed radiation therapy.

the overall goal is to develop and examine the acceptability of a theory-guided, web-based multimedia intervention program for head and neck cancer patients who have recently completed radiation therapy. the effects of this intervention on patients' quality of life (qol) will also be evaluated.

Eligibility criteria:
inclusion criteria: * patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx * are receiving or have completed radiation therapy within in the past 12 months exclusion criteria: * inability to read and/or communicate in english * head and neck cancers of non-squamous histology (e.g., adenoid cystic carcinoma, adenocarcinoma, sarcoma) * blindness or severity of visual impairment that precludes one's ability to view images/text * inability to provide informed consent
service development: assessing non-attendance rates in outpatient clinics

Conditions: Asthma; Sleep Apnea Syndromes; Tuberculosis; COPD

Summary: many studies have shown a high non-attendance rate in hospital outpatient clinics. the investigators have found a non-attendance rate of 25% in their asthma clinics and would like to investigate whether a reminder phone call will improve attendance rates. patients will be randomised into two groups; one group will receive a reminder phone call one week prior to their hospital consultation and the other group will be managed in the standard manner (i.e. no reminder of any sort). the phone calls will be carried out on a friday afternoon by a respiratory nurse specialist and a research officer for two asthma clinics based on a wednesday morning and a thursday afternoon.

many studies have shown a high non-attendance rate in hospital outpatient clinics. the investigators have found a non-attendance rate of 25% in their asthma clinics and would like to investigate whether a reminder phone call will improve attendance rates. patients will be randomised into two groups; one group will receive a reminder phone call one week prior to their hospital consultation and the other group will be managed in the standard manner (i.e. no reminder of any sort). the phone calls will be carried out on a friday afternoon by a respiratory nurse specialist and a research officer for two asthma clinics based on a wednesday morning and a thursday afternoon. to have an 80% chance of detecting a 10% reduction in non-attendance rates (at 5%) 500 patients are required for this study. the rate of non-attendance will be monitored for all the patients in both groups and some demographic information will be recorded for each patient(age, sex, diagnosis and home postcode).

Eligibility criteria:
inclusion criteria: * patients with appointments booked for 2 respiratory outpatient clinics exclusion criteria patients likely to only need one appointment

Keywords: telephone reminder
a nurse-led program for stroke patients

Conditions: Stroke; Psychosocial Problems

Summary: the aim of this study is to examine the effectiveness of nurse- led program on psychosocial problems and quality of life in stroke patients. this randomized controlled trial will be conducted in stroke center in istinye university liv hospital-bahcesehir. eligible participants will be randomly allocated to either the control group (receiving usual care/ routine follow-up group) or the intervention group (receiving nurse-led psychosocial program). a nurse- led program will be implemented for the management of psychosocial problems following a comprehensive evaluation. then, the effect of this program on psychosocial problems and quality of life will be evaluated in the 1st and 3rd months after discharge.

the aim of this study is to examine the effectiveness of nurse- led program on psychosocial problems and quality of life in stroke patients. this randomized controlled trial will be conducted in stroke center in istinye university liv hospital- bahcesehir. patients who meet the criteria will be randomized into the intervention group or control group. all patients will be assessed at discharge by use of following tools: national institutes of health stroke scale (nihss), modified rankin scale, functional independence measure (fim), montreal cognitive assessment (moca), hospital anxiety and depression scale (hads), pittsburgh sleep quality index (psqi). a nurse coordinated multidisciplinary program aiming to improve psychosocial problems has been developed and will be applied to the patients in the experimental group. this nurse-led program will start at discharge and continue for three months. the control group will be applied usual care. two groups will be compared at baseline and at the 3rd month after discharge in terms of psychosocial variables and quality of life.

Eligibility criteria:
inclusion criteria: * be literate * have a clinical diagnosis of ischemic stroke * history of any preceding cerebral vascular event * capable of giving informed consent exclusion criteria: * age ≤ 18 years * have a mental disorder that will prevent cognitive evaluation * have an impaired consciousness (confusion, delirium, etc.) * history of any type of cognitive decline * have severe neurologicial deficit * severe aphasia * living in a nursing home * known malignant disease or other chronic disease with poor prognosis and a low life expectancy

Keywords: stroke psychosocial problem nurse-led program quality of life
reinforcement of upper airway muscles in patients with osas

Conditions: Obstructive Sleep Apnea Syndrome

Summary: this study will investigate the effectiveness of a simple and quick myofunctional reeducation protocol of the tongue in reducing the obstructive sleep apnea syndrome (osas) severity.

this is a randomized controlled study. participants with moderate osas severity will be either allocated to receive a myofunctional reeducation protocol (study group) or a sham protocol (control group). apnea-hypopnea index (ahi) will be measured before and at the end (6 weeks) of the protocol. participants from the study group will follow an upper airway reinforcement regimen using the iopi (iowa oral performance instrument) device over 6 weeks while participants from the control group will perform a sham reeducation protocol using an "emt threshold" at minimal resistance.

Eligibility criteria:
inclusion criteria: * moderate obstructive sleep apnea syndrome (ahi between 15 and 30 events per hour) * poor adherence to continuous positive airway pressure (\< 4h per night) exclusion criteria: * craniofacial malformation * use of hypnotic medication * had stroke in the past * present a concurrent neuromuscular or severe obstructive nasal disease
effect of oxycodone on anxiety state in painless abortion

Conditions: Abortion Complication

Summary: in this study, 300 patients who underwent painless abortion in ruijin hospital and sub-central hospitals were selected through a multi-center randomized controlled study, and 300 patients who underwent painless abortion in ruijin hospital and each sub-center hospital were divided into intravenous anesthesia with propofol with fentanyl (group f) and propofol with oxycodone (group o) by stratified group randomization method 1:1. the difference between the postoperative anxiety scores and depression scores of the two groups was observed, and the postoperative anxiety, depression and numerical pain scores were recorded. finally, the relevant data were statistically analyzed and conclusions were drawn.

this study is a multicenter, randomized controlled clinical study. a total of 300 patients who underwent elective painless abortion surgery in ruijin hospital and other sub-central hospitals were enrolled, and they were randomly divided into 1:1 patients who received intravenous anesthesia with propofol with fentanyl (group f) and propofol with oxycodone (group o). the scores of anxiety, depression and postoperative numerical rating scale (nrs) before and after surgery were observed, and the levels of serum stress response factors and inflammatory cytokines were monitored. the effects of oxycodone on anxiety, depression and postoperative acute pain in patients with painless abortion were investigated. 1. main observation indicators: the difference between the post-operative anxiety score and the preoperative anxiety score 2. secondary observational indicators: * post-operative anxiety score * the difference between the post-operative depression score and the preoperative depression score * post-operative depression score * pain assessment after surgical recovery (nrs) * laboratory tests * patient and family satisfaction with postoperative analgesic treatment

Eligibility criteria:
inclusion criteria: * age 18-45 years old * gestational age 6-12 weeks * american society of anesthesiologists （asa） grading i-ii * fluent communicator and able to complete self-rating scales on her own * voluntarily participate and sign the informed consent form exclusion criteria: * patients who are allergic to anesthetic drugs such as propofol, oxycodone, fentanyl, etc., or who have had other anesthetic adverse events * patients with anxiety or depression * presence of organic mental disorders, mental retardation * severe acute and chronic infection, severe heart, liver and kidney insufficiency * patients with complications or bleeding \> 50ml during surgery
application of perioperative remote ischemic conditioning in patients undergoing hepatectomy

Conditions: Hepatic Hemangioma; Liver Cancer; Hepatolithiasis; Hepatectomy

Summary: our primary aim is to investigate whether perioperative remote ischemic conditioning (pric) as an adjunctive treatment can improve postoperative recovery in patients undergoing hepatectomy as an adjunct to standard treatment.

remote ischemic conditioning (ric) can be applied as repeated short-lasting ischemia in a distant tissue that results in protection against subsequent long-lasting ischemic injury in the target organ. this protection can be applied prior to or during a prolonged ischemic event as remote ischemic pre-conditioning (riprec) and per-conditioning (riperc), respectively, or immediate after reperfusion as remote ischemic post-conditioning (ripostc). ric is a non-pharmacologic and non-invasive treatment without noticeable discomfort, commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion. however, whether perioperative remote ischemic conditioning (pric) can improve postoperative recovery in patients undergoing hepatectomy has never been investigated in a randomized controlled trial.

Eligibility criteria:
inclusion criteria: * patients undergoing hepatectomy under general anesthesia * american society of anesthesiology (asa) grade of ii \~ iii * male and female patients, age 25 to 75 years * new york heart association (nyha) grade of i \~ iii exclusion criteria: * patients with limb deformity or peripheral vascular disease affecting upper limb function * patients with a medical history of nervous system, immune system and mental illness * patients who have received hepatectomy in the past, have important organ diseases or have undergone surgical treatment recently * patients who have recently used anti-inflammatory analgesics, anticoagulants, hormone drugs, immunosuppressants, and atp-sensitive k-channel blockers (katp) * preoperative severe renal insufficiency (serum creatinine \> 442 umol/l, with or without serum potassium \> 6.5 mmol/l, or the clinician-recognized need for renal replacement therapy), liver insufficiency (child-pugh grade c) * patients and/or their family members refuse to participate in the program
motivational interviewing for weight loss

Conditions: Childhood Obesity

Summary: the investigators studied the effect of motivational interviewing (mi) on self-efficacy, health behaviors, and health outcomes in overweight children and adolescents (ages ranging from 10 to 18 years).

one empirically supported intervention with a large evidence base for improving adult outcomes in behavioral health-related disorders is motivational interviewing (mi). mi is strongly rooted in the client-centered therapy of rogers (1951). its relational stance emphasizes the importance of understanding the client's internal frame of reference and displaying unconditional positive regard for the client. motivational interviewing can thus be defined as a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence. mi manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting. adolescent participants exposed to motivational interviewing in conjunction with usual care (diet and exercise program) are expected to endorse greater self-efficacy, report increased engagement in healthy behaviors, demonstrate a decrease in body weight and report improved psychological outcomes. while motivational interviewing has been shown to increase adults' motivation to make healthy behavior changes, few adolescent studies have demonstrated this effect.

Eligibility criteria:
inclusion criteria: * obese youth (with body mass index (bmi) ≥ to 85th percentile for age and gender (as classified by the center for disease control)) * ages 10-18 years * attending a local obesity clinic ("healthy weights" clinic) time of entry into the weight-loss program was controlled for; however, both new and current participants had the option to participate in the study. exclusion criteria: * taking medication whose side effects may influence weight gain or weight loss * did not speak english * demonstrated a developmental delay * reported being pregnant and/or reported having an eating disorder

Keywords: motivational interviewing child and adolescent self-efficacy health behaviours
brief escalation of adalimumab treatment for prevention of clinical relapse in ibd

Conditions: Crohn Disease; Ulcerative Colitis

Summary: to examine whether a temporary three month increase in adalimumab dosing will prevent relapse in patients with inflammatory bowel disease in clinical remission who have elevated calprotectin.

patients using adalimumab for crohn's disease or ulcerative colitis who are in clinical remission will be followed with fecal calprotectin monitoring every 3 months. patients with a sustained rise in calprotectin who maintain clinical remission will be offered an opportunity to have an increase in adalimumab for three months. patients who use the three months of increased adalimumab dosing will be compared to patients who do not use increased dosing to determine if relapse rates differ between these two groups.

Eligibility criteria:
inclusion criteria: 1. adults ages 18 and older with crohn's disease and ulcerative colitis 2. patients are in clinical remission according to the last 'abbvie care' clinical symptom assessment (using partial mayo score \< 2 or harvey-bradshaw index \< 4) 3. patient using adalimumab at a dose of at least 40mg subcutaneously bi-weekly, and at a maximum dose of 40mg subcutaneously weekly (or 80mg subcutaneously bi-weekly). exclusion criteria: 1. pregnant women or plans for pregnancy within 3 months of study inclusion 2. abdominal abscess 3. inability or unwillingness to provide informed consent 4. any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study
venous thromboembolism in dm1

Conditions: Venous Thromboembolism; Pulmonary Embolism; Deep Vein Thrombosis; Myopathy; Myotonic Dystrophy 1

Summary: the risk for venous thromboembolism (vte) in dm1 and in other inherited myopathies, which can lead to chronic immobilization, are unknown. the purpose of this study is to evaluate incidence of vte in cohort of patients presenting with dm1 with a comparison to a group of other inheritable myopathies and to a community-based population.

a cohort of more that 2,800 adult patients admitted to our institutions between january 2000 and november 2014 with genetically proven myopathy will be retrospectively included. any information relative to their demographic and genetic characteristics, their muscular functional status and the occurrence of vte will be collected. statistical analysis will be performed to estimate the incidence of venous thromboembolism in this population, to identify predictors of vte, and to compare its incidence to a community-based population.

Eligibility criteria:
inclusion criteria: * age \> 18 years * genetically proven myopathy * admission in our institutions from january 2000 to november 2014 exclusion criteria: * patient refusal
safety and tolerability of gx-p1 in healthy male volunteers

Conditions: Autoimmune Diseases

Summary: this study is a single-center, double-blind, placebo-controlled, phase i study with healthy male volunteers receiving ascending single dose of gx-p1


Eligibility criteria:
inclusion criteria: 1. capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (icf) 2. healthy male volunteers aged 19-45 years within screening periods 3. body weight of 50-90 kg, and body mass index (bmi) of 18.0-30.0 kg/m2 4. healthy subjects as determined by medical history, physical examination vital signs, ecg and clinical laboratory testing exclusion criteria: 1. any clinical significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system disease or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation 2. history of or current disease evidence including malignant tumor 3. history of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug 4. have participated in another clinical trial with investigational drug within 180 days prior to screening period 5. positive for hcv antibody, hbsag, or hiv antibody at screening period 6. other clinically significant abnormalities which make subject unsuitable for inclusion this study judged by investigator