Kornimate/medical-research-clean huggingface dataset:
a comparison of the addiction liability of hydrocodone and sustained release morphine

Conditions: Chronic Pain

Summary: characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.

a placebo-controlled, double-blind, crossover trial will be conducted providing study subjects either hydrocodone/acetaminophen 30mg/975mg, sustained release morphine 45mg or placebo on separate gcrc visits. a long acting comparator (slow-release morphine sulfate 45 mg) will be chosen because of its putative equianalgesic effects to the dose of hydrocodone (30 mg) selected. subjects will participate in the three sessions at the uc davis/mather medical center general clinical research center (gcrc) at intervals of 7-10 days. sessions will be approximately 360 min in duration. subjects will receive either hydrocodone/acetaminophen or sustained release morphine around-the-clock for 7-10 days prior to the experimental session. at each experimental session, an assessment of abuse liability will be completed before the intake of medications, as well as at 0, 60, 120, 180, 240 minutes after the ingestion of the study medication.

Eligibility criteria:
inclusion criteria: * patients with chronic pain for periods greater than 6 months * patients taking greater than 80 mg morphine equivalents of a short acting opioid (\>8 vicodin or 4 oxycodone/day) * referral to pain or substance abuse clinic for self-escalation of opioids exclusion criteria: * inability to understand and comprehend spoken english * patients with munchausen's syndrome * patient has a history of peripheral vascular disease * patient has a history of raynaud's phenomenon * liver disease; child's classification greater than 1 (liver cirrhosis) will be excluded * renal disease (bun \>25 or cr \>1.5) * congestive heart failure; subjects with new york heart association (nyha)heart failure symptom classification system level of impairment ii, iii and iv will be excluded * coronary artery disease; recent mi within the past six months or recent history of angina not controlled with ntg within the past six months * hypertension; 1)previously normotensive subject; systolic bp \>140 mm hg and diastolic bp \> 90 mm hg 2) hx of active treatment with antihypertensive medications; systolic bp \>150 mm hg and diastolic bp \> 100 mm hg * cerebrovascular disease; recent history within the past year of a transient ischemic attack or recent history within the past year of a cerebrovascular event * malignancy requiring active treatment * patient is pregnant (as ascertained by a self-report and a mandatory commercial pregnancy test before any study medication is consumed)

Keywords: chronic pain opioids
evaluation of potential predictors of adherence by investigating a representative cohort of multiple sclerosis (ms) patients in germany treated with betaferon

Conditions: Multiple Sclerosis

Summary: this study aims to evaluate potential predictors of adherence by investigating a representative cohort of ms patients in germany treated with betaferon


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome * patients on treatment with betaferon or the decision to treat patients with betaferon has been made by the attending physician * patients using or willing to use the betaconnect autoinjector for betaferon application * written informed consent exclusion criteria: * patients receiving any other disease modifying drug * contraindications of betaferon described in the summary of product characteristics * patients participating in any other clinical or non-interventional study, evaluating ms therapy

Keywords: rrms, cis
efficacy and safety of fitpatch compared to standard opioid treatment in cancer pain (ft-015-in)

Conditions: Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.

Summary: primary objectives: * to determine non-inferiority of fitpatch with regard to efficacy compared to standard opioid treatment * to assess the safety of fitpatch compared to standard opioid treatment secondary objectives: * to assess the intake of oral morphine as rescue analgesic to fitpatch compared to standard opioid treatment * to assess quality of life reported with fitpatch compared to standard opioid treatment


Eligibility criteria:
inclusion criteria: subjects that have insufficiently treated, cancer-related chronic pain that requires long-term treatment with an opioid at step 3 on the who ladder, and with karnofsky performance status above 50. 1. subject informed consent given. 2. aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception. 3. no significant skin lesions on relevant surfaces on the body or diffuse skin diseases. 4. no impaired respiratory function nor neurological or psychiatric impairment. 5. no known abuse of drug, narcotic or alcohol. 6. not pregnant or nursing. 7. not hypersensitive/allergic to fentanyl or morphine. 8. no head injury, primary brain tumor, increased intracranial pressure or impaired consciousness. 9. not participating in other clinical trials. exclusion criteria: all exclusion criteria must be answered no for a patient to participate in the trial. 1. does the patient have significant skin lesions on the upper arms/flat surface of the upper torso or diffuse skin disease (psoriasis or eczema) that preclude application of fentanyl patches? 2. does the patient have a known abuse of drug, narcotic or alcohol? 3. is the patient pregnant or nursing? 4. has the patient neurological or mental impairment that may compromise data collection? 5. is the patient hypersensitive/allergic to fentanyl or morphine or any of the ingredients in the trial medication? 6. has the patient any major head injury, primary brain tumour, increased intracranial pressure or impaired consciousness? 7. does the patient participate in other clinical with other investigational drugs or investigation al medical devices or has been participating in such a trial for the past 30 days?
endoscopic full thickness resection without exposure to peritoneum

Conditions: Submucosal Tumor of Stomach

Summary: this study evaluates the feasibility of endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure eftr) in patients with gastric tumor.

current endoscopic full-thickness resection (eftr) methods are limited by their transmural communication and exposure of tumor to peritoneum. recently, endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure eftr) was developed. this new technique includes the steps of laparoscopic seromuscular suturing with a barbed suture thread (v-loc), which results in inversion of the stomach wall; eftr of the inverted stomach wall from inside the stomach; and finally, endoscopic mucosal suturing with endoloops and clips. this study evaluates the feasibility of simple non-exposure eftr technique in patients with gastric tumor. this study is single arm study and will be performed in single center.

Eligibility criteria:
inclusion criteria: * gastric subepithelial tumor * tumor invades of muscularis propria on endoscopic ultrasonography (eus) finding * tumor size more than 1.5cm or increasing size during observation exclusion criteria: * tumor size more than 5cm * refuse to be enrolled to study. * bleeding tendency, * inappropriate condition for surgery with general anesthesia
a comparison of symbicort® pmdi with formoterol turbuhaler® in subjects with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine if symbicort® delivered via a pressurized metered-dose inhaler, referred to as a pmdi, is effective in preventing copd exacerbations.


Eligibility criteria:
inclusion criteria: * a current clinical diagnosis of copd with copd symptoms for more than 2 years * current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year) * a history of at least 1 copd exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit exclusion criteria: * a history of asthma at or after 18 years of age * a history of allergic rhinitis at or after 18 years of age * subjects taking oral steroids * any significant disease or disorder that may jeopardize a subject's safety

Keywords: copd
ketones and muscle protein synthesis

Conditions: Ketosis; Regulation of Muscle Protein Synthesis

Summary: ketones are natural substances normally produced by the body during prolonged fasting and starvation, or in response to a "ketogenic" diet to be used as fuel by the brain and muscles. ketones are therefore similar to dietary proteins, carbohydrates and fats since they represent a source of energy for the body. in addition to serving as a source of energy, ketones have also been shown to stimulate increased rates of muscle protein synthesis in humans. the ingestion of dietary protein is well established to stimulate an increase in the rate of protein synthesis in skeletal muscle. the rate of muscle protein synthesis can be maximized following the intake of 20g of protein. as a result, smaller doses of protein (i.e. 10g) represent a sub-optimal dose of protein because there is still room for improvement concerning muscle protein synthesis. recently ketone-containing food products have become available that elevate ketone levels in the body without the need for ketogenic diets or prolonged fasting. therefore, the purpose of this study is to measure skeletal muscle protein synthesis rates after ingesting the following: 1. ketone monoester 2. ketone monoester supplemented with sub-optimal dose of whey protein 3. sub-optimal dose of whey protein it is hypothesized that muscle protein synthesis rates will increase following the ingestion of a ketone-containing beverage. further, muscle protein synthesis rates will be enhanced when the ketone-containing beverage and sub-optimal protein dose are taken together.


Eligibility criteria:
inclusion criteria: * male * aged between 18-35 years inclusive * healthy, moderately active * bmi \ 18.5 kg/m2 * having given informed consent exclusion criteria: * presence of any identified metabolic or intestinal disorders * use of tobacco products * allergies to milk proteins (whey or casein) * lactose intolerance * phenylketonuria (pku) * a history of neuromuscular problems * previous participation in amino acid tracer studies * adherence to a strict vegetarian or vegan diet * current use of ketone supplements or adherence to a ketogenic diet * use of medications known to affect protein metabolism * diagnosis of diabetes * engagement in sports or physical exercise 5 or more days per week

Keywords: ketone protein metabolism muscle
local consolidative radiation therapy plus tki versus tki alone in driver mutated om-nsclc

Conditions: Oligometastatic Disease; Non-small Cell Lung Cancer; Driver Mutation

Summary: a phase ii randomized controlled trial of tki alone versus tki and local consolidative radiation therapy in oncogene driver mutated oligo metastatic non-small cell lung cancer patients.

randomization arms: eligible patients will be randomized in 1:1 ratio to tki alone or tki + lcrt. this will be an intention to treat randomized study. arm 1: continuation of tki therapy alone arm 2: continuation of tki therapy + local consolidative radiation therapy to loc0-regional disease and 1-5 oligometastatic sites

Eligibility criteria:
inclusion criteria: 1. patients with pathologically proven diagnosis of nsclc 2. patients with positive oncogene driver mutation (egfr or alk/ros) 3. patients who have received at least 2-4 months of tki therapy without progression 4. patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible) 5. patients suitable for local consolidative therapy 6. adequate end-organ function cbc/differential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows: * absolute neutrophil count (anc) ≥ 500 cells/mm3; * platelets ≥ 50,000 cells/mm3; * hemoglobin ≥ 8.0 g/dl (use of transfusion or other intervention to achieve hgb ≥ 8.0 g/dl is acceptable); 7. patients with ecog performance status of 0-2 8. age \> 18 years 9. for females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration exclusion criteria: 1. patients with progressive disease after 2-3 months of initial tki therapy 2. patients with negative oncogene driver mutations (egfr/alk/ros) 3. patients not suitable for local consolidative radiation therapy 4. patients who are not suitable for further continuation of tki therapy due to toxicity 5. severe, active co-morbidity defined as follows: * unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; * transmural myocardial infarction within the last 6 months; * chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; 6. patients with prior history of radiation therapy to thorax 7. patients with second malignancy (synchronous or metachronous) 8. pregnancy

Keywords: oligometastatic nsclc driver mutation tki local consolidative therapy sabr oligometastases
combining wearable technology to crate internet+digital hospital-remote home type 2 diabetes follow-up management mode

Conditions: Diabetes Mellitus, Type 2

Summary: this study intends to combining wearable technology to crate internet+digital hospital-remote home type 2 diabetes follow-up management mode.to preliminarily explore compared with the traditional medical treatment mode, whether the new management mode of dm can improve the management objectives and patient satisfaction of t2dm and reduce medical costs. the study provides a powerful reference for establishing corresponding platforms and promoting such models at the government management level in the future.

background:the prevalence of t2dm in chinese adults has exceeded 10%, and the prevalence of abnormal glucose metabolism has exceeded 40% in people older than 18 years. this will lead to a significant increase in the prevalence of dm complications in the next decade, and the disability and death caused by complications will also seriously affect the quality of life of patients and bring a huge social and economic burden.this randomized controlled trial intends to combining wearable technology to crate internet+digital hospital-remote home t2dm follow-up management mode.to preliminarily explore compared with the traditional medical treatment mode, whether the new management mode of dm can improve the management objectives and patient satisfaction of t2dm and reduce medical costs. the study provides a powerful reference for establishing corresponding platforms and promoting such models at the government management level in the future. methods:the study was a parallel-group, randomised, controlled trial. the number of cases planned to be included in 200 cases. participants were randomly assigned to the intervention or control group.the intervention group receives internet + digital hospital-remote home management mode,including remote monitoring devices+internet management platform, dietary recommendations, exercise supervision, web education, information pushing, doctor-patient interaction, etc.the control group receives the traditional management mode, including routine dietary and exercise recommendations, education as well as monitor in the clinic.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes according to the world health organization criteria; * aged between 18 and 70 years; * glycosylated haemoglobin (hba1c%) between 7% and 9%. exclusion criteria: * type 1 diabetes; * gestational diabetes; * other special types of diabetes; * moderate-severe insufficiency of heart , liver, kidney and lung; * complicated with acute disease or stress status.
preoperative chemoradiotherapy with cetuximab in rectal cancer

Conditions: Rectal Neoplasms; Neoadjuvant Treatment

Summary: this study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and capecitabine concurrent with radiotherapy given preoperatively in patients with resectable rectal cancer.

daily fractions of radiotherapy at 1.8 gy to total of 45 gy to tumor and draining lymph nodes and followed by a coned-down boost of 5.4 gy to the tumor are delivered concurrently with chemotherapy. cetuximab 400 mg/m2 is given intravenously on d-6 (1 week before radiation), followed by 250 mg/m2 once a week (d 1, 8, 15, 22 \& 29). administration of irinotecan and capecitabine starts on day 1 of radiotherapy. capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (monday to friday) during radiotherapy. irinotecan 40 mg/m2 is given intravenously once a week (d 1, 8, 15, 22 \& 29). four to eight weeks after completion of chemoradiotherapy, curative surgery is performed. safety evaluation of the study will be performed after the first 6 patients treated. if more than 1 out of 6 patients received less than 70-80% of planned dose of capecitabine or irinotecan, the dosage of chemotherapy in the further study patients will be adjusted by a protocol amendment.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the rectum * distal margin of tumor located from 0 to 8 cm from anal verge * stage t3/t4 ± n+ by mri ± endorectal ultrasonography * ecog performance status 0-2 * no prior chemotherapy, radiotherapy to pelvis, immunotherapy, and egfr pathway targeting therapy * adequate organ functions * patients must sign the informed consent exclusion criteria: * malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease * any defined hereditary colorectal cancer * any unresected synchronous colon cancer * r0 resection of tumor is not clinically possible * any distant metastasis * intestinal obstruction or impending obstruction, but decompressing colostomy is permitted * any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix * any other morbidity or situation with contraindication for chemoradiotherapy * patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine * history of severe pulmonary disease * pregnant or lactating women or patients of childbearing potential not predicting adequate contraception

Keywords: rectal neoplasms neoadjuvant treatment cetuximab irinotecan capecitabine radiotherapy combination chemotherapy
deep rtms and varenicline for smoking cessation

Conditions: Tobacco Use Disorder; Smoking Cessation

Summary: the purpose of this study is to investigate the effect of deep repetitive transcranial magnetic stimulation (rtms) using the insula h-coil on smoking outcomes in smokers receiving varenicline. it is hypothesized that active deep rtms will improve abstinence rates, attenuate craving and reduce cigarette consumption and dependence severity.

this study will be a randomized, double-blind, sham-controlled clinical trial. nicotine dependent participants will be recruited and randomized tor receive either active or sham rtms intervention for 4 weeks (5 sessions/week). all participants will receive an open-label treatment of varenicline for 12 weeks and weekly counselling sessions. the aims of the study are: 1. to examine the efficacy of bilateral deep rtms to the insula on point prevalence smoking abstinence in smokers receiving varenicline treatment. 2. to examine the efficacy of bilateral deep rtms to the insula on other smoking outcomes such as craving, cigarette smoking and dependence severity. 3. to examine the effect of bilateral deep rtms to the insula on abstinence at the end of rtms treatment and at 6-month follow up. abstinence will be measured by point prevalence at week 4 and 12 and prolonged continuous abstinence at week 26. this will be confirmed using plasma cotinine levels. all other measures will be done using various questionnaires such as fagerstrom test of nicotine dependence (ftnd), timeline follow-back (tlfb), minnesota nicotine withdrawal scale (mnws), and tiffany questionnaire of smoking urges (t-qsu).

Eligibility criteria:
inclusion criteria: * age 18-65; * nicotine dependent as assessed by diagnostic and statistical manual of mental disorders (dsm-v); * reported daily cigarette consumption ≥ 10 and expired carbon monoxide (co) measurement of ≥ 10 ppm; * fagerstrom test of nicotine dependence (ftnd) ≥ 4; * reported motivation to quit within 30 days as assessed using the contemplation ladder score of ≥ 7. exclusion criteria: * reported smoking abstinence in the 3 months preceding screening visit; * current use of other smoking cessation aids; * allergy and/or contraindication to varenicline or rtms; * pregnancy, trying to become pregnant or breastfeeding; * current or recent history of cardiovascular or cerebrovascular disease and/or current hypertension; * current or historical evidence of suicidal behavior; * serious current or personal history of medical condition/disease (neurological disorders, brain lesions, multiple sclerosis, head trauma, loss of consciousness, hearing loss, etc.); * current, personal history or family history of seizures; * cognitive impairment as defined as a mini mental state examination (mmse) score \<24; * concomitant use of medication that lowers seizure threshold

Keywords: smoking cessation varenicline deep rtms insula addiction tobacco use disorder