Kornimate/medical-research-clean huggingface dataset:
a trial of erbitux for recurrent and metastatic mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces

Conditions: Mucinous Gastrointestinal Adenocarcinoma

Summary: this is a phase ii open-label trial evaluating the efficacy, and safety of erbitux in patients with mucinous gastrointestinal adenocarcinoma involving the peritoneal surface.


Eligibility criteria:
inclusion criteria: * able to take care of self. out of bed less than 50% of the day * absolute neutrophil count \>=1,500 * platelet count \>=100,000 * total bilirubin count \<=1.5 times the upper limit of normal exclusion criteria: * prior epidermal growth factor receptor antibody * prior treatment with erbitux * other cancers
safety study of ge-145 320 mg i/ml injection vs. iopamidol 370 mg i/ml in elderly subjects undergoing coronary procedure

Conditions: Chronic Renal Insufficiency; Diabete Mellitus; Congestive Heart Failure

Summary: to evaluate cardio-renal and overall safety profile of ge 145 320 mg i/ml injection when compared to iopamidol 370 mg i/ml. the study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (dm) requiring drug therapy, or congestive heart failure (chf) nyha class iii or greater, who are referred for a coronary catheterization procedure with or without pci.


Eligibility criteria:
inclusion criteria: * males and females 65 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without pci. * the subject has at least one of the following comorbidities: * 1) chronic renal insufficiency, (egfr \<60 but 15 ml/min/1.73 m2 according to the mdrd equation) as measured within 2 weeks or at the screening visit; * 2) dm diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy; * 3) chf (nyha) class iii or greater measured within 2 weeks of enrollment or at the screening visit. exclusion criteria: * the subject has known allergies to either iodine or any icm. * the subject has severe renal insufficiency (egfr \<15 ml/min/1.73 m2 according to the mdrd equation) or is on dialysis. * the subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention. * the subject is not willing or unable to discontinue metformin (e.g., glucophage) at the time of the study procedure.

Keywords: cath catheterization ci-aki contrast-induced acute kidney injury dm diabetes mellitus egfr estimated glomerular filtration rate mdrd modification of diet in renal disease nyha new york heart association pci percutaneous coronary intervention scr serum creatinine
grid therapy as palliative radiation for patients with advanced and symptomatic tumors

Conditions: Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation

Summary: palliative radiation therapy represents 40% of the on-going radiation at the jewish general hospital. in a traditional palliative radiation treatment to bulky or radioresistant tumors, radiotherapy schema varies from 24 to 30 gys given in 3 to 10 fractions, depending on the tumor size, tumor location and tumor pathology. however, for many patients this treatment involves considerable toxicity, travel and time spent at the hospital. spatially fractionated radiation (sfr) is an alternative technique that consists in delivering one single treatment, given through a grid containing holes. the present study is proposing to validate sfr as a safe and effective mean to palliate patients with symptomatic bulky tumors (more than 8 cm) or with tumors known to be resistant to radiation.


Eligibility criteria:
inclusion criteria: * patient with histologically or cytologically confirmed malignancy. all malignant histologies/cytologies are eligible. * patient with bulky tumor (larger than 8cm), or with a tumor known to be resistant to radiation (eg. melanoma, hypernephroma, sarcoma), or with a tumor previously irradiated with a palliative intent requiring more than 1 fraction of radiation * patient planned to undergo palliative radiation therapy treatments to one of the following 5 sites: extremities, neck, chest, abdomen and pelvis * who performance status of 0-2 * aged 18 years or older * ability to sign and understand an informed consent form exclusion criteria: * potentially curable patient * previous palliative radiation with hypofractionation * tumor located near the spinal cord or in the brain * pregnant or nursing woman
evaluating the sublocade treatment exit strategy

Conditions: Opioid Use Disorder

Summary: the purpose of this study is to observe and assess the successful taper and opioid withdrawal experience after participants stop receiving sublocade because their healthcare provider determines their disease symptoms have been controlled for at least 9 months and they, together with their healthcare provider, plan to discontinue moud.

this is a phase iv, observational, multicentre, open-label, study in participants with a history of oud, who have been on sublocade treatment for at least 12 injections, have had disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and both healthcare provider and participant plan to discontinue moud treatment.

Eligibility criteria:
inclusion criteria participants must meet all of the following criteria: * the participant, together with their healthcare provider (the investigator), have previously determined that it is appropriate to stop moud treatment, and the participant meets the following criteria: * has been treated with at least 12 injections of sublocade. * in the opinion of the investigator, has had their oud symptoms (ie, overdose, illicit/nonmedical use, withdrawal) controlled for at least 9 months. * in the opinion of the investigator, has had any other substance use disorder (excluding alcohol, nicotine, or cannabis) symptoms controlled for at least 9 months. * is willing to complete the baseline visit 4 to 8 weeks after the last dose of sublocade. * has signed the icf and is 18 years of age or older. * is not currently using opioids to treat a diagnosis other than oud.

Keywords: medicine for opioid use disorder (moud)
impact on the time to diagnosis of serious postoperative complications by a controlled connected medical device

Conditions: Medical Device

Summary: post-operative mortality in case of scheduled surgery is 3% in france (lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies. complications due to the medical practice are the third cause of morbidity (bmj, 2016). more than half are preventable and are mainly observed in surgical patients. in conventional hospitalization, excluding intensive care, monitoring is done discontinuously for most of the patients, which does not allow early diagnosis of a vital cardiovascular or respiratory failure. diagnosis and late treatment do not allow good recovery. the early identification of a vital failure by the continuous monitoring of three simple physiological parameters (spo2, heart rate and respiratory rate) would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality.

the challenge of this research is to transpose in an ordinary hospitalization unit the continuous monitoring of vital functions carried out in intensive care by the continuous measurement of simple parameters using the "smart angel intra-hospital" system's (connected medical devices and alerts).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients receiving a scheduled non-ambulatory surgical or interventional procedure * affiliation to a social security scheme, beneficiary or entitled person (excluding ame) * patient's written consent or of the trusted person in case of physical incapacity exclusion criteria: * inclusion in emergency situations * asa1 patient (without associated pathology) * patient with a multi-drug resistant germ in isolation * known linguistic inability of the patient to understand the study * known pregnancy or breastfeeding woman * patients with implantable pacemakers, implantable defibrillators or neurostimulators. * person under legal protection or unable to give consent * person deprived of liberty by judicial or administrative decision

Keywords: connected medical device time to diagnosis post-operative mortality "smart angel intra-hospital" system
the level of sst2 in pediatric heart failure

Conditions: Congenital Heart Disease; Congestive Heart Failure

Summary: introduction: suppression of tumorigenicity 2 (st2) is a receptor member belongs to the interleukin-1 (il-1) family. the ligand and soluble versions are its two isoforms. the interleukin-33-st2 ligand complexs development provides protection against heart fibrosis and hypertrophy. investigations on heart failure in adults has demonstrated that it does not change by age, body mass index (bmi), creatinine, hemoglobin, and albumin levels, in contrast to nt pro brain natriuretric peptit. in adult heart failure patients, it has been demonstrated to be an independent predictor of mortality and cardiovascular events. the most recent guideline recommends using it as class 2b in the diagnosis of adult heart failure. studies on st2 in children are rare. the purpose of this study is to assess the prognostic value of st2 for cardiovascular events in young individuals suffering from heart failure. method: the study included pediatric patients (0-18 years old) with congenital heart disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment. height, weight, gender, saturation, heart failure classification (ross or new york heart assosiation), medications taken, the electrocardiogram, echocardiography, pro bnp, and sst2 values of the patients, as well as any hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery during follow-up data on arrhythmia and death were gathered during a 1-year follow-up. the spss software application was used to carry out the statistical analysis.


Eligibility criteria:
inclusion criteria: * the patients were those with congenital cardiac disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment. exclusion criteria: * . excluded from the trial were individuals who had undergone cardiac surgery within past one month, had chronic renal failure, septic shock, myocardial dysfunction related to cardiopulmonary resuscitation, or for whom consent could not be received.

Keywords: suppression of tumorigenicity 2 (st2) congenital heart disease congestive heart failure
comparative study of turmeric extract in patients with arthrosis.

Conditions: Arthralgia; Stiffness of Unspecified Joint, Not Elsewhere Classified; Disturbance of Activity and Attention; Quality of Life

Summary: the aim of this study is to test if an extract of turmeric can alleviate symptoms of osteoarthritis in volunteers with osteoarthritis of the hip and or knee.

the included volunteers, who are devided into two groups either placebo or turmeric extract, will be tested using womac questionnaires focussing on pain, stiffness and daily activity. in addition different aspects of quality of life will be evaluated and the consumption of rescue medication will be recorded in patients personal diary. the treatment period is 3 month with the posibility to continue for an additional 3 month.

Eligibility criteria:
inclusion criteria: * healthy volunteers * 40 years of age or more * osteoarthritis of the hip and or the knee * suffering from pain in the hip and or knee - exclusion criteria: * if volunteers are on a waiting list for hip or knee surgery * if the volunteers are involved in an other clinical trial * if the volunteers are taking other herbal remedies, which canhav influende on # osteoarthritis. * abusers of alcohol and drugs * volunteers not easy to cope with

Keywords: arthralgia, stiffness of joints, quality of life
decrease implantation site infection (disinfection i): a randomized controlled trial

Conditions: Infection

Summary: cardiovascular implantable electronic device (cied) infections have been increasing out of proportion to the number of devices implanted we investigated recent trends and possible causes of the increasing numbers of cardiovascular implantable electronic device infections.

there are many studies on the preventive use of antibiotics or povidone iodine to cardiovascular implantable electronic device (cied) infections. but, studies of prophylactic use of hydrogen peroxide is still limited. we had planned research on effects of preventive using hydrogen peroxide before cardiac devices insertion.

Eligibility criteria:
inclusion criteria: * scheduled for cardiac devices implantation exclusion criteria: * under the age of 18 * hydrogen peroxide allergy * take an antibiotic * history of infection within 30 days

Keywords: cardiac devices prevention infection
ventilator hyperinflation with increase of inspiratory time

Conditions: Lung Infection; Mechanical Ventilation

Summary: the investigators hypothesis is that the adjustment of the inspiratory time may optimize the distribution of ventilation and increase tidal volume, producing potential therapeutic effects on the displacement of secretions and respiratory mechanics. the objective of this study was to evaluate the effects of hyperinflation with the ventilator associated with increased inspiratory time on respiratory mechanics.

a randomized crossover clinical trial was conducted with 38 mechanically ventilated patients with pulmonary infection. the order of hyperinflation or control (without changes in parameters) was randomized. hyperinflation was performed for 5 minutes in the controlled pressure ventilation mode, with progressive increases of 5cmh2o until reaching a maximum pressure of 35cmh2o, maintaining peep. after reaching 35cmh2o, the inspiratory time and respiratory rate were adjusted so that the inspiratory and expiratory flows reached the baseline, respectively. static compliance (cest, sr), total resistance (rsr) and airway resistance (rva), slow pressure drop (δp2) and peak expiratory flow (pef) were assessed before (pré), immediately after the maneuver (possimed) and after aspiration (pospasp). two-way anova was used for repeated measurements with tukey post-test, considering a significant p \<0.05.

Eligibility criteria:
inclusion criteria: * patients under mechanical ventilation for more than 48h * mucus hypersecretion (defined as the need for suctioning \< 2-h intervals) exclusion criteria: * severe bronchospasm, * positive end expiratory pressure \> 10cmh2o, * pao2-fio2 relationship \< 150, * mean arterial pressure \< 60mmhg, * pleural effusion or pneumothorax undrained, * bronchopleural or tracheoesophageal fistula, * decompensated congestive heart failure.

Keywords: physical therapy modalities, respiration artificial, respiratory care units, respiratory mechanics, positive-pressure respiration
telephone counseling: men with prostate cancer & partners

Conditions: Prostate Cancer

Summary: the purpose of this project is to test a telephone delivered educational support program versus an education only program for improving symptom management and quality of life in men with prostate cancer and their partners.

eligibility criteria for men: receiving treatment for prostate cancer,over 21 years of age, english speaking, have access to and ability to talk on the phone and have a partner willing to participate in the study. participants can live anywhere in the united states because the intervention is telephone delivered. partners can be anyone the man selects (friend or relative) who is over 21 years of age, english speaking and has access to or ability to speak on the phone. men and their partners will be assigned to one of two groups. each survivor will receive 8 telephone calls over an 8-week period for about 30 minutes each. each partner will receive 4 telephone calls every other week for about 30 minutes each. we will ask everyone to complete a baseline assessment over the telephone, after the 8 weeks, and then again about 8 weeks after the second assessment.

Eligibility criteria:
inclusion criteria: * receiving treatment for prostate cancer * over 21 years * access to and ability to talk on the phone * speaks english and has a partner to participate with him. * partners are anyone who the man chooses (friend or relative) who is over 21 years, english speaking and has access and ability to talk on the phone. exclusion criteria: * under 21 years * does not speak english

Keywords: psychosocial intervention men with prostate cancer & partners
lipoic acid and prevention of heart disease

Conditions: Atherosclerosis

Summary: the purpose of this study is to see if a dietary supplement, r-alpha lipoic acid, is able to reduce risk factors such as body weight and high blood cholesterol levels in overweight or obese participants.

the purpose of this study is to see if a dietary supplement, r-alpha lipoic acid, is able to reduce risk factors such as body weight and high blood cholesterol levels in overweight or obese participants. recruitment will be in the portland, oregon area.

Eligibility criteria:
inclusion criteria: * age 18-60 * overweight (bmi, 25.0-29.9 kg/m2) or obese (bmi, \>30 kg/m2); * elevated plasma triglycerides (100-400 mg/dl); * weight stable for the last three months and at lifetime maximum; * exercise limited to 30 minutes 3 times a week or less; * hs-crp level at baseline of ≤ 10 mg/l; * consuming ≤ 2 alcoholic drinks per day; exclusion criteria: * pregnant, breastfeeding, or planning to become pregnant before the end of the study. * having had acute medical conditions, such as hospitalizations or surgeries, at least three months prior to entry into the study * diagnosed as having diabetes (fasting glucose \<125 mg/dl for entry), cardiovascular disease, congestive heart failure, angina, thyroid disorders, cancer, inflammatory disorders or renal, hepatic, or hematological abnormalities; * currently taking lipid-lowering drugs, anti-hypertensive drugs, insulin , or oral hypoglycemic agents, anti-inflammatory drugs, weight loss medications, or hormone replacement therapy; * on an extreme diet and not maintaining a prudent diet; * currently taking vitamin or antioxidant supplements, including r-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the daily value (dv) of the vitamins and minerals; * smoking within the last three months;

Keywords: atherosclerosis lipoic acid thioctic acid triglycerides overweight obesity oxidative stress inflammation
a phase ii, study to evaluate the efficacy and safety of ph-797804 in adults with moderate to severe chronic obstructive pulmonary disease (copd).

Conditions: Chronic Obstructive Pulmonary Disease

Summary: ph-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with copd. ph-797804 will be dosed to patients with copd to evaluate its potential safety and efficacy profile in copd.


Eligibility criteria:
inclusion criteria: * male or female subjects between, and including, the ages of 40 and 80 years. * subjects with a diagnosis, for at least 6 months, of moderate to severe copd (gold) and who meet the criteria for stage ii-iii disease, subjects must have had stable disease for at least 1 month prior to screening. * subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up \> 6 months ago. exclusion criteria: * more than 2 exacerbations of copd requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of copd within 3 months of screening or more than twice during the preceding year. * history or presence of significant cardiovascular disease. * ecg abnormalities. * significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study. * evidence of organ or blood disorders.
transcranial direct current stimulation in a smoking cessation trial

Conditions: Nicotine Dependence

Summary: the purpose of this study is to determine the effectiveness of transcranial direct current stimulation (tdcs) plus nicotine patch as a viable smoking cessation program for nicotine dependent smokers.

background: transcranial direct current stimulation (tdcs) is a form of non-invasive brain stimulation that involves the application of brief weak electric current to the scalp. tdcs may induce neuroplasticity, thereby engaging some of the same systems that figure prominently in the pathological neuroplasticity caused by addictive drugs. objective: to assess whether tdcs delivered along with nicotine patch reliably increases a) quit rates, b) duration of abstinence, and c) percentage of participants abstinent at follow-up. method: active (20min; 2ma) and sham (30sec; 2ma) stimulation will be applied to the dorsolateral prefrontal cortex (dlpfc) in both cerebral hemispheres. hypotheses: 1. active tdcs (20-min; 2 ma) will increase abstinence in a standard smoking cessation protocol relative to a sham procedure. 2. the benefits of active left anodal stimulation (anode-left/cathode-right) to the dlpfc will be greater than of active tdcs in the reverse configuration (cathode-left/anode-right).

Eligibility criteria:
inclusion criteria: * nicotine dependent * treatment-seeking * smoke minimum of 15 cigarettes per day * able to provide written informed consent * able and willing to attend weekly appointments, inter-treatment and follow-up assessment * able and willing to wear nicotine patch exclusion criteria: * currently taking gaba receptor agonists, nmda receptor antagonists, dopamine receptor agonists/antagonists, ssris, l-dopa, anticholinergics * pregnancy or lactation * any serious medical condition requiring treatment or medication including high blood pressure, heart problems, asthma, epilepsy * brain/neurological injury/disease/disorder * skin disease * current dsm-iv axis i psychiatric disorder * metal or medical device implants * current treatment for alcohol or drug use * current use of herbal/holistic preparations * current use of recreational drugs

Keywords: transcranial direct current stimulation nicotine dependence dorsolateral prefrontal cortex nicotine replacement therapy nicotine patch addiction smoking cessation neuroplasticity