Kornimate/medical-research-clean huggingface dataset:
a study of herceptin (trastuzumab) in combination with standard chemotherapy in patients with her positive metastatic gastric cancer

Conditions: Gastric Cancer

Summary: this open-label, multi-center study will evaluate the efficacy and safety of herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction. patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy * measurable disease, according to the response evaluation criteria in solid tumors (recist) * her2 positive tumor (primary tumor or metastasis * ecog performance status 0, 1 or 2 * life expectancy of at least 3 months exclusion criteria: * previous chemotherapy for advanced or metastatic disease less than 6 month before study start * lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study) * patients with active (significant or uncontrolled) gastrointestinal bleeding * residual relevant toxicity resulting from previous chemotherapy * other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)
effect of non-pharmacological anti-anxiety exercises on perceived stress and cortisol level before elective per cutaneous transluminal coronary angioplasty

Conditions: Percutaneous Transluminal Coronary Angioplasty

Summary: effect of non-pharmacological anti-anxiety exercises on perceived stress and cortisol level before elective percutaneous transluminal coronary angioplasty

patients will be selected from national heart institute their age from 30 -50 years old. patients will be assigned randomly into 4 groups 15 in each group, reflexology group, deep breathing group, combined group (reflexology and deep breathing) and control group. before procedure two tools will used to collect data (demographic characteristics format the beginning once and distress thermometer scale before and 30 minutes after application in all groups ) in addition blood samples (5 ml) will take from all the patients on an empty stomach between 08:30 and 10:00 in the morning and 30 minutes after the application to determine the cortisol level in all groups

Eligibility criteria:
inclusion criteria: * fully conscious patients, aged from 30 to 50 years. * will do percutaneous transluminal coronary angioplasty for the first time without any problem of communication. * accepting to give blood samples available between 08:30 and 10:00 in the morning (to avoid differences in cortisol levels), and agreeing to participate in the study exclusion criteria: * having myocardial infarction symptoms, * unconscious, having a surgery in the last 6 weeks, * previously diagnosed with a psychiatric disorder or still having a psychiatric disease, using anxiety medication (psychotropic), corticosteroid, using estrogen or amphetamine derivative drugs, * infection of the lower extremities, having varicose veins, having peripheral neuropathy and deep vein thrombosis or risk of development, high fever,
cirse registry for sir-spheres in france (cirt-fr)

Conditions: Liver Cancer

Summary: selective internal radiation therapy (sirt), also known as radioembolisation, is a minimal invasive, endovascular treatment for primary and secondary liver tumours. in france, sir-spheres are listed as reimbursable by the national health authorities (haute autorité de santé \[has\]). in order to evaluate the reimbursement after five years, all patients treated with sir-spheres will be entered into a registry that collects data on the real-life clinical application of sirt and reports to the national authorities.

selective internal radiation therapy (sirt), also called radioembolisation (re), with sir-spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. the microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. following administration, 94% of the radiation is delivered in 11 days. in france, sir-spheres are listed as reimbursable by the national health authorities (haute autorité de santé \[has\]). in order to evaluate the reimbursement after five years, all patients treated with sir-spheres will be entered into a registry that collects data on the real-life clinical application of sirt and reports to the national authorities. the goal of the research project is to gain a better understanding of the real-life clinical application of radioembolisation with sir-spheres and the impact of the treatment in clinical practice. secondary objectives will be to assess the observed treatment outcomes of sirt with sir-spheres y-90 resin microspheres in terms of safety, effectiveness, quality of life, technical considerations and diagnosis and treatment-related considerations. to better understand the palliative aspect of the treatment, acquisition of the change in quality of life is included by means of eortc's validated quality of life questionnaire qlq c30 with accompanying hcc module to measure quality of life in patients with hepatocellular carcinoma. besides data collection on the initial treatment, it will be advised to collect follow-up data and quality of life data every three months for a minimum of 24 months after treatment. cirt-fr is a post-market, prospective, non-randomized, observational study. patients are only asked to be enrolled when they are treated with sir-spheres microspheres as part of their treatment determined by the treating clinician. in no way will participation of the patient in the registry impact their treatment plan, or influence the quality of the treatment.

Eligibility criteria:
inclusion criteria: * 18 years or older * primary or secondary liver tumours * treatment of liver tumours with sir-spheres * signed informed consent form exclusion criteria: - consent denied
investigating changes in vital signs in neonates

Conditions: Infant; Newborn

Summary: 1 in 7 babies require neonatal care. during their time in hospital their vital signs (such as heart rate, breathing rate and oxygen saturation) are continuously monitored as part of standard care. many factors lead to changes in vital signs, for example, medical procedures such as blood tests can result in brief increases in heart rate. medication can also alter vital signs, either as an intended effect or as a side effect. however, different infants will respond in different ways to both procedures and medication. predicting how an individual infant may respond could lead to better individualised care for infants. for example, using an infant's baseline vital signs to predict whether they will experience cardiorespiratory side effects from a particular drug could mean that doctors could choose an alternative safer treatment plan. to develop these predictive models, it is essential to first better understand how infants' vital signs are affected by different procedures and drugs, and how these effects are impacted by other factors such as infection, other pathologies, interaction between drugs and age. despite their routine use in hospital neonatal units, detailed electronic records of vital signs are often not recorded. often, only major events or average values are stated on clinical records. subtle changes in vital signs are therefore missed, and more complex analysis that may reveal important predictive features within the data is not possible. in this study the investigators will electronically record infant vital signs across longer time periods and during a variety of clinically-necessary procedures and administration of drugs, to explore how these impact vital signs and are altered by factors such as age and pathology. these will be compared with control procedures, such as a nappy change, or when the infant is resting in their cot or receiving skin-to-skin care.


Eligibility criteria:
inclusion criteria: infants will be eligible to be included in the study if they are: * born to, or expected to be born to, a mother aged 16 or over * admitted to the newborn care unit, john radcliffe hospital, or anticipated delivery of a baby who will require admittance to the newborn care unit at birth * mother given informed written consent exclusion criteria: infants will be ineligible if the following exclusion criteria applies: • known chromosomal abnormality or life-threatening congenital abnormality

Keywords: preterm respiration oxygen saturation heart rate
ct-guided needle guidance using stereotaxic unit, navigation versus conventional biopsy technique for the percutaneous pulmonary nodule biopsy

Conditions: Percutaneous Pulmonary Nodule Biopsy

Summary: the purpose of this study was to compare the safety and efficacy of ct-guided needle guidance using stereotaxic unit, navigation versus conventional biopsy technique for the patients scheduled to undergo percutaneous pulmonary nodule biopsy.


Eligibility criteria:
inclusion criteria: * patient with localized lesions such as pulmonary nodules on chest x-ray, ct or pet ct * histopathologic examination is necessary if lung lesion is unknown * histologic findings affect the disease stage or treatment plan * if the investigator decides to perform a percutaneous lung biopsy because the biopsy or diagnosis through the bronchoscopy is not possible or has low risk-benefit * patient who have consented to contraception during the period of clinical trial participation (one month after the procedure) * patient who voluntarily agree to participate in this clinical trial and are willing to comply with the protocol exclusion criteria: * patient with pulmonary function insufficiency * patient who has difficulty in self-breathing (e.g, breathing through oxygen breathing apparatus) * patient with uncontrolled coagulation disorders (inr \> 1.3 or blood platelet count \< 50,000/µl) * patient with allergy to ct contrast agent * patient under 19 years old or over 80 years old * pregnant or lactating * patient with uncontrollable systemic disease (e.g, uncontrolled hypertension, uncontrolled cardiovascular disease, etc.) * patient who currently participating or has participated in other clinical trials within 30 days of the screening date * if it is judged inappropriate to participate in this clinical trial under the judgment of the investigator
non-invasive test-guided tailored therapy versus empiric treatment for helicobacter pylori infection.

Conditions: Helicobacter Pylori Infection; Antibiotic Resistant Infection; Antibiotic Resistant Strain

Summary: the aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher helicobacter eradication rates than an empiric antibiotic regimen. for this purpose, consecutive patients with dyspeptic symptoms, diagnosis of helicobacter pylori infection and naïve to eradicating treatments will be allocated to either of the two intervention arms.

study design: eligible subjects will be defined by the positivity to at least 2 out of 4 tests for helicobacter pylori infection diagnosis (i.e. histology, rapid urease test, urea breath test and serology). stool samples and gastric biopsy specimens of eligible patients will be analyzed at enrollment, using real time-polymerase chain reaction (rt-pcr) to detect bacterial dna mutations conferring resistance to amoxicillin, clarithromycin, tetracycline, metronidazole, and levofloxacin. participants allocated to the tailored intervention arm will receive an antibiotic combination therapy according to the result of stool sample molecular analysis. participants allocated to the empiric intervention arm will be treated by either a quadruple concomitant or bismuth-containing regimen, according to the 2017 european helicobacter pylori management guidelines. in all participants, infection eradication will be evaluated 30 days after treatment end, using urea breath test. we will also assess the diagnostic accuracy of the rt-pcr on fecal samples in detecting bacterial antibiotic resistances, using the rt-pcr on gastric biopsy specimens as the reference standard.

Eligibility criteria:
inclusion criteria: * presence of dyspeptic symptoms, according to rome iv criteria; * helicobacter pylori infection diagnosis by the positivity of at least 2 out of 4 diagnostic tests (i.e. histology, rapid urease test, urea breath test, and serology); * naive to helicobacter pylori treatment; * written informed consent. exclusion criteria: * previous helicobacter pylori treatment; * diagnosis of gastric cancer or other diseases requiring surgery; * contraindications to upper endoscopy; * chronic diarrhea; * known allergy to any drugs used in the intervention and control arm.
health-related quality of life in colon cancer

Conditions: Health Related Quality of Life

Summary: this study investigates health-related quality of life in colon cancer patients in västmanland, sweden, at diagnosis, at 6 months, 1, 2 and 3 years after diagnosis, measured by the well-validated eortc qlq-c30 questionnaire.

see above.

Eligibility criteria:
inclusion criteria: all patients diagnosed with colon cancer in region västmanland 2012-2016. exclusion criteria: language problems, declined inclusion,
study of adamts-13 activity, von willebrand factor and platelet-monocyte aggregation in coronary artery disease

Conditions: Coronary Artery Disease

Summary: the purpose of this research is to determine the relationship between proteins and enzymes in the blood and how they work with platelets to form blood clots in patients with coronary artery disease. the investigators hypothesize that the relationship between these factors could potentially be useful in identifying patients at higher risk for heart attacks.


Eligibility criteria:
inclusion criteria: * admission to hospital with suspected index event of non-st-elevation myocardial infarction (nstemi), unstable angina (ua) or stable angina (sa) * planned percutaneous coronary intervention during admission exclusion criteria: * recent history (\< 6 months) of an acute coronary syndrome (other than current admission) or stroke * recent history (\< 6 months) of major surgery, trauma or thromboembolic event * percutaneous coronary or peripheral intervention or any stent placement performed within the past 6 months * current evidence of infection
postdural punction headache after ceserian section

Conditions: Postdural Puncture Headache; Regional Anesthesia Morbidity; Pregnancy Related

Summary: the aim of this study is to compare the effect of spinal needle type on postdural puncture headache in patients who will undergo cesarean section. the main question\[s\] it aims to answer are: \[does spinal needle thickness affect postdural puncture headache?\] \[what is the response of patients who develop postdural puncture headache to treatment?\] in cases accepting cesarean section operation under spinal anesthesia, different tables were used with spinal needles, and it will be questioned whether headache will develop in the first 15 days postoperatively. postdural puncture headache after surgery will be described.

our study was designed as a prospective randomized study. patients aged 20-50 years who accepted cesarean section under elective spinal anesthesia were included in the study. randomized into 3 groups with 250 patients in each group: group 1: patients who underwent cesarean section under spinal anesthesia with 25 gauge spinal needle ( pencan® 0.42 × 88 mm- g27 × 3½, b. braun, melsungen, germany) group 2: patients who underwent cesarean section under spinal anesthesia with 26 gauge spinal needle ( atraucan® 0.42 × 88 mm- g27 × 3½, b. braun, melsungen, germany) group 3: patients who underwent cesarean section operation under spinal anesthesia with 27 gauge spinal needle ( pencan ® 0.42 × 88 mm- g27 × 3½, b. braun, melsungen, germany) postdural puncture headache (pdph) was evaluated by visiting patients who were discharged to the service after spinal anesthesia in the hospital for 24 hours, and by calling them within 15 days after discharge. conservative and medical treatment was recommended for patients who developed pdph, and the response of the patients to treatment was evaluated.

Eligibility criteria:
inclusion criteria: * pregnant women who accept spinal anesthesia and have no contraindications for spinal anesthesia ages of 20-50 years asa ii-iii exclusion criteria: * pregnant women who do not accept spinal anesthesia and who are contraindicated for spinal anesthesia morbid obesity(bmi\>40) coagulopaty asa 4 clinically known local anesthetic allergy

Keywords: cesarean section obstetric anesthesia spinal anaesthesia postdural punction headache
a six-month, open-label, crossover study of the maintenance of serum testosterone and psa suppression after switching between lupron 22.5 mg and eligard 22.5 mg or zoladex 10.8 mg and eligard 22.5 mg in patients with advanced prostate cancer

Conditions: Cancer of Prostate

Summary: comparing the effect of switching from lupron and zoladex to eligard. psa and testosterone levels are measured at set intervals to determine if eligard is equal or better then lupron or zoladex in advanced prostate cancer patients.


Eligibility criteria:
inclusion criteria: patient with advanced ca, on stable dose of lupron or zoladex - exclusion criteria: * previous exposure to eligard.
decision support for heart failure prescribing

Conditions: Decision Support Systems, Clinical; Heart Failure

Summary: clinical decision support (cds) tools can 'nudge' clinicians to make the best decisions easy. although required by "meaningful use" regulations, more than 40% of cds lead to no change and the remaining lead to improvements that are modest at best. this is because cds tools often ignore contextual factors and present irrelevant information. although many tools have undergone patient-specific optimization, 'traditional cds' are rarely clinician-specific. for example, a traditional cds tool for beta blockers and heart failure with reduced ejection fraction (hfref) addresses common prescribing misconceptions by stating asthma is not a contraindication and providing a safe threshold for blood pressure. for clinicians without these misconceptions, these statements are irrelevant and distract from key information. a 'personalized cds' would evaluate clinician past prescribing patterns to determine whether prescribing misconceptions might exist and then conditionally present information to address those misconceptions. the objective of this research is to create personalized clinician-specific cds that overcome shortcomings of traditional cds. the central hypothesis is a personalized cds that minimizes irrelevant information will lead to a higher rate of prescribing guideline-directed management and therapy (gdmt) for hfref compared to a traditional cds.


Eligibility criteria:
inclusion criteria: * the study subjects are potential users of the cds, specifically clinicians with prescribing privileges who practice at one of the health system's (uchealth) outpatient cardiology or primary care clinics. because we are observing their prescribing behaviors, we are also evaluating patient characteristics which could influence their prescribing decisions. exclusion criteria: * clinicians who do not practice in cardiology or primary care clinics or do not practice within uchealth system.
a bioequivalence study of daclatasvir tablets and bioavailability studies of daclatasvir and asunaprevir

Conditions: Hepatitis C Infection

Summary: grps 1, 2, 3 "this study will be testing the performance of asv and dcv pediatric chewable tablets. grp #4 the purpose of this group is to support the marketing authorization of a dcv 90-mg tablet


Eligibility criteria:
inclusion criteria: 1. signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's institutional review board (irb)/ institutional ethics committee (iec) 2. target population: healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations. 3. age and reproductive status : males and females, ages 18 to 49 years, inclusive. women of childbearing potential (wocbp) must have a negative serum pregnancy test within 24 hours prior to the start of study drug and must be using an acceptable method of contraception for 4 weeks prior to study drug administration. women must not be breastfeeding. males who are sexually active with wocbp must agree to follow instructions for method(s) of contraception for duration of treatment with study drug females must still undergo pregnancy testing as described in this section. exclusion criteria: 1. medical history and concurrent diseases : any significant acute or chronic medical illness. current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug. any major surgery within 4 weeks of study drug administration. any gastrointestinal surgery that could impact upon the absorption of study drug (appendectomies with no complications are allowed at the investigator's discretion). inability to tolerate oral medication, smokers or recent durg or alcohol abuse and any other sound medical, psychiatric, and/or social reason as determined by the investigator. 2. physical and laboratory test findings: evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg, or clinical laboratory determinations beyond what is consistent with the target population, positive urine screen for drugs, positive blood screen for hepatitis c antibody, hepatitis b surface antigen, or hiv-1, -2 antibodies. 3. allergies and adverse drug reaction : history of allergy to dcv, asv, hepatitis c virus (hcv) ns3 protease inhibitors, hcv ns5a replication cofactors, or related compounds.