Kornimate/medical-research-clean huggingface dataset:
feasibility study for the determination of oxysterols in patients with breast cancer receiving hormonal therapy with tamoxifen or not

Conditions: Breast Cancer

Summary: this is a biomedical study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up. patients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be enrolled in this study. the main objective of this study is to evaluate the feasibility for the determination of oxysterols (ct, ce, ocdo) in this patient population, before and after the initiation of treatment (ie, at d0 before and d28 after beginning of treatment).


Eligibility criteria:
inclusion criteria: 1. women of more than 18 years old (menopause or not). 2. women with invasive breast cancer metastatic or non-metastatic, for which treatment with tamoxifen or anti-aromatase is retained. 3. cancer hormone-expressing estrogen receptor (er) and / or progesterone receptor (pr) (≥ 10% of tumor cells in technical hic). 4. any previous hormonal therapy, stopped for progression, should be discontinued for at least 21 days prior to study entry. 5. who ≤ 2. 6. women of childbearing age must use effective contraception for the duration of the study. 7. informed consent obtained and signed before any specific procedure in the study. 8. patient member in a national insurance scheme. exclusion criteria: 1. patient with breast cancer her2 positive (ihc and / or fish-cish) 2. patient already receiving hormonal therapy or patient who has not stopped hormonal therapy for at least 21 days. 3. patient that should receive a chemotherapy and / or another targeted therapy (other than hormonal therapy) for the treatment of the breast cancer. 4. any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator. 5. patient unable to follow procedures, visits, examinations described in the study. 6. pregnant women or nursing mothers can not participate in the study. 7. patients under legal guardianship.

Keywords: hormonal therapy breast cancer aebs oxysterols
fronto-parietal tdcs in severely brain injured patients with disorders of consciousness

Conditions: Vegetative State; Minimally Conscious State; Disorders of Consciousness

Summary: previous studies showed that anodal transcranial direct current stimulation (tdcs) transiently improves performance of memory and attention. in severely brain injured patients with disorders of consciousness (doc), a single stimulation over the left dorsolateral prefrontal cortex has shown to improve patients' sign of consciousness. nevertheless, other brain areas could be stimulated in order to increase the number of responders. in this study, investigators will assess the effects of bilateral fronto-parietal tdcs on coma recovery scale-revised (crs-r) scores in patients with doc in a double-blind sham-controlled experimental design.

following severe brain damage and coma, some patients may remain in a vegetative state (vs) or minimally conscious state (mcs). at present, there are no evidence-based guidelines regarding the treatment of patients with disorders of consciousness (doc). a previous study showed that a single stimulation (using transcranial direct current stimulation - tdcs) of the left prefrontal cortex induces an behavioral improvement in some patients in doc. nevertheless, only 43% of patients in mcs responded to the stimulation. therefore, it is needed to find new protocols to increase the number of responders and improve the effect of tdcs in patients with doc. in this study, investigators aim to assess the effect of single session anodal (i.e., excitatory) transcranial direct current stimulation (tdcs) over right and left fronto-temporal cortices (using 4 anodes and 4 cathodes), on the level of consciousness of patients with doc, in a double blind randomized sham controlled study. the anodes will be placed over f3, f3, cp5 and cp6. tdcs is a form of safe non-invasive cortical stimulation, modulating cortical excitability under the electrodes, via weak polarizing currents. it has been reported that anodal tdcs transiently improves working memory and attention by stimulating the left dlpf in healthy subjects and patients with stroke, parkinson's or alzheimer's disease. by increasing the surface of the stimulated area, it is expected to increase the number of responders as patients' brain lesion are very heterogeneous and widespread.

Eligibility criteria:
inclusion criteria: * post comatose patients * patients in minimally conscious state * patients with stable condition * patients free of sedative drugs and na+ or ca++ blockers (e.g., carbamazepine) or nmda receptor antagonist (e.g., dextromethorphan) exclusion criteria: * premorbid neurology antecedent * patients in coma * patients \< 28 days after the acute brain injury * patients with a metallic cerebral implant * cranioplasty * shunt

Keywords: vegetative state minimally conscious state disorder of consciousness transcranial current direct stimulation non invasive brain stimulation neuromodulation
image quality: ultra-low dose scanner versus standard dose conventional scanner for thoraco-abdominopelvic scans

Conditions: Imaging, Diagnostic; Lung Diseases; Abdomen Disease; Pelvis Disease; Bone Diseases

Summary: the new image reconstruction algorithm (precise image, philips healthcare) has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (uld) chest and abdomen-pelvis scans. the hypothesis is that the images obtained with the precise image algorithm for uld acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions.

recently a new image reconstruction algorithm based on deep-learning has been developed (precise image, philips healthcare). initial studies on phantoms have shown that this algorithm improves image quality and reduces patient dose compared to the idose4 iterative reconstruction algorithm. feasibility studies have validated the image quality for low-dose levels (ld). however, this algorithm has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (uld) chest and abdomen-pelvis scans. the hypothesis is that the images obtained with the precise image algorithm for uld acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions. the purpose of this study is to evaluate the concordance of the global quality of thoraco-abdominopelvic images of a uld scan acquisition compared to a standard dose ct acquisition and measure the global agreement of the global quality of the images with a 4-point likert scale. the uld acquisition will allow a significant reduction in the x-ray dose delivered to patients compared to a standard dose conventional scanner. this reduction is estimated at 70%.

Eligibility criteria:
inclusion criteria: * patient having given free and informed consent. * patient who has signed the consent form. * patient affiliated to or beneficiary of a health insurance plan. * patient with a bmi \< 35 kg/m2 exclusion criteria: * patient participating in research involving human subjects defined as category 1. * patient in an exclusion period as determined by another study. * patient under court protection, guardianship or trusteeship. * patient unable to give consent. * patient for whom it is impossible to give informed information. * pregnant patient. * patient with a bmi ≥ 35 kg/m2
intervention study to enhance patients' pain management after cardiac surgery

Conditions: Pain; Pain, Postoperative; Other Functional Disturbances Following Cardiac Surgery

Summary: the main objective of this randomized controlled trial is to evaluate the effect of an intervention formed as a pain booklet provided to patients at discharge from hospital following cardiac surgery. the primary objectives are to: 1. develop and implement a pain booklet to improve pain management after cardiac surgery 2. evaluate the effect of the pain booklet compared to a group of patients given usual care


Eligibility criteria:
inclusion criteria: * undergoing their first elective cabg, valve surgery or a combination * receiving the standard preadmission information * able to take care of themselves after discharge * able to read and write norwegian and fill in the questionnaires * able to be contacted by telephone exclusion criteria: * more than 12 hours at the intensive care unit after surgery
comparative effect of protein prescription strategies on nitrogen balance and upshots in critically ill patients

Conditions: Critical Illness; Malnutrition; Protein

Summary: this is interventional clinical trail will be conducted in internationale hospital icu s patients with higher nutrition risk. two doses of protein 1 g/kg/day vs 2 g/ kg day will be given and its outcome will be checked on nitrogen balance , clinical outcome length of hospital stay, mortality ratio and re admission within 30 days.

study design this is the prospective interventional randomized controlled trial in which effect of protein prescription on uun and clinical outcome of critically ill patients enroll in the study will compare the nutric scores will be calculated manually, based on data from the medical records of critically ill patients.this trail will be conducted in three stages. in phase i all admitted patients in critical care unit will be screen by. apache ii nutric score phase ii: patients with nutrition risk will randomly divided into two group (1:1) interventional group none interventional group phase iii: follow the patient for 28 days after discharge from hospital. study locale the study will be conducted in the icus (sicus, micus, hdu) of hospital in islamabad, for this study organizational approval from formal ethical committee will be taken during the time period of six months. statistical methods: descriptive statistics will be use for demographic data and over all outcomes, further more analytical stat will be used to the type of variables and objective of the study. z test will be use for the comparison of quantitative variables and chi square test will be use for categorical data. a nova will be use where applicable .

Eligibility criteria:
inclusion criteria: critically ill patient with nutritional risk age \>18 years pt. icu stay\> 48hours exclusion criteria: patients on ventilator \> 72 hours \< 48 hours.' stay in icu withdrawal of life support within 7 days of randomization

Keywords: critical illness protein malnutrition
a study of mk-4827 in combination with standard chemotherapy in participants with advanced solid tumors (mk-4827-008 am1)

Conditions: Cancer: Solid Tumors

Summary: this study will find the dose limiting toxicities (dlts), maximum tolerated dose (mtd), and recommended phase 2 dose (rptd) of mk4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults.

the decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.

Eligibility criteria:
inclusion criteria: * participant has a locally advanced or metastatic solid tumor for which carboplatin, carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin are the standard of care. * participant has a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) performance scale. exclusion criteria: * participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study. * participant has had more than two prior lines of chemotherapy. * participant has known central nervous system metastases or a primary central nervous system tumor. * participant is pregnant or breastfeeding or expecting to conceive during the timeframe of the study. * participant is known to be human immunodeficiency virus (hiv) positive. * participant has a history of hepatitis b or c. * participant has a symptomatic pleural effusion. * participant with a left ventricular ejection fraction (lvef) below the institutional norm, or with prior exposure to doxorubicin is not eligible for the mk4827 + carboplatin/liposomal doxorubicin study arm.

Keywords: cancer advanced solid tumors
pharmacokinetics, safety, and tolerability study of the autoinjector and pre-filled syringe of sb4 in healthy male subjects

Conditions: Healthy

Summary: the purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the autoinjector and pre-filled syringe of sb4 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * healthy male subjects aged 18-55 years * have a body weight between 60.0 - 85.5 kg (inclusive) and a body mass index between 20.0 - 28.0 kg/m2 (inclusive) exclusion criteria: * have a history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to etanercept or to any of the excipient * have either active or latent tb or who have a history of tb * have clinically significant active infection within 4 weeks before the first ip administration * have had a history of serious infection * have previously been exposed to etanercept, if known * have previously been exposed to a biological agent or immunosuppressive agent within 120 days prior to the first ip administration * have a history of invasive systemic fungal infections or other opportunistic infections judged as relevant by the investigator
td-1607 mad study in healthy subjects

Conditions: Infections; Bacterial Infections

Summary: td-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.


Eligibility criteria:
inclusion criteria: * subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at screening. * subject has a body mass index (bmi) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg. subject has no clinically significant abnormalities in the results of laboratory evaluations at screening and day -1. exclusion criteria: * subject has evidence or history of clinically significant, relevant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for untreated, asymptomatic seasonal allergies at time of dosing). * subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin) or beta-lactam (e.g., penicillin or cephalosporin) antibiotics. * subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to screening or is currently participating in another trial of an investigational drug (or medical device). * subject has previously participated in a trial for td-1607.

Keywords: gram-positive
social media use of acne vulgaris patients: multicenter, survey work

Conditions: Acne Vulgaris

Summary: acne vulgaris is a chronic skin disease. however, chronic and repetitive due to the quality of life and psychological status of patients can affect. for this reason, patients carry out various research on their diseases on social media and follow programs on these issues in other media such as television and radio. however, there is no study on how much patients are interested in these publications, how much they trust them, and how they reach and organize information via social media. the aim of the study will be to clarify how and how patients with acne vulgaris use social media to obtain information about the diagnosis and treatment of their disease, the interaction of patient groups with each other, and how often social media is used, especially in which group of patients.


Eligibility criteria:
inclusion criteria: * acne vulgaris patient exclusion criteria: * who does not want to answer the questions
long-term safety and efficacy of itopride hydrochloride (hcl) in patients suffering from functional dyspepsia

Conditions: Dyspepsia

Summary: itopride is a compound already marketed in japan and in some countries of eastern europe under the name of ganaton. it is used to treat symptoms of functional dyspepsia. patients suffering from this condition have difficulties digesting food. patients feel full after eating; they have bloating and have stomach pain. the goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.

all patients who have completed study itofd04-03 will be offered to continue to be treated with itopride for a period of up to one year in duration. a target of 300 patients will be followed up for 6 months. of these, a target of 100 patients will be kept on treatment for an additional 6 months. patients will need to come to the clinic for evaluations every 8 weeks during the trial. evaluations done at these visits will include: lab tests, evaluation of the heartburn condition, and a questionnaire needed to be completed by the patient to see if the drug is helpful in relieving their symptoms.

Eligibility criteria:
inclusion criteria: * patients must have completed the 8 week double-blind study itofd04-03 * female patients must not be pregnant (must have a negative serum pregnancy test) exclusion criteria: * patients with any newly occurring medical condition which was an exclusion criterion at itofd04-03 study entry

Keywords: abdominal symptom relief fullness bloating indigestion functional dyspepsia
pneumatic compression for preventing venous thromboembolism

Conditions: Deep Venous Thrombosis

Summary: patients admitted to the intensive care unit are at high risk of developing clots in the veins of the lower extremities. the objective of this study is to examine whether the use of a device that provides intermittent compression to the legs in addition to the use of low-dose blood thinners, provides an additional protection when compared to the use of blood thinners alone. patients who are admitted to the intensive care unit are receiving low-dose blood thinners to prevent clots are candidates for this study. patients who are enrolled will continue to receive blood thinners but some will additionally receive the leg compression. the additional use of leg compression may provide protection from clots. the main side effect is possible skin abrasions but this is usually mild. the study is sponsored by king abdullah international medical research center(kaimrc) and king abdulaziz city for science and technology(kacst) and will be conducted in several hospitals in saudi arabia, canada, australia, brazil and possibly other countries. the study started july 2014 and is to continue for 4 years.

there is no randomized controlled trial examining effect of the adjunct use of ipc with pharmacologic prophylaxis compared to pharmacologic prophylaxis (ufh, lmwh) alone in critically ill patients for vte prevention.

Eligibility criteria:
inclusion criteria a. medical-surgical icu patients \>14 years old at participating icu. icus that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years) b. weight \> 45kg c. expected icu los\> 72hrs d. eligible for pharmacologic thromboprophylaxis with ufh and lmwh. exclusion criteria a. patient treated with ipc for \> 24 hours in this current icu admission. b. patient in the icu\> 48 hours. c. patient treated with pharmacologic vte prophylaxis with medications other than ufh or lmwh. d. inability or contraindication to applying ipc to both legs i.burns in the lower extremities, lacerations, active skin infection, \& ischemic limb in the legs at the site of ipc placement ii. acute ischemia in the lower extremities iii. amputated foot or leg on one or two sides iv. compartment syndrome v. severe peripheral arterial disease vi. vein ligation, gangrene, recent vein grafts, and draining incisions vii. evidence of bone fracture in lower extremities e. therapeutic dose of anticoagulation with ufh or lmwh f. pregnancy g. limitation of life support, life expectancy \< 7 days or palliative care h. allergy to the sleeves material i. patients with inferior vena cava (ivc) filter

Keywords: deep vein thrombosis pulmonary embolism intermittent pneumatic compression pharmacologic dvt prophylaxis critically ill patients.
efficacy and cost effectiveness of malaria diagnosis procedures and the rational use of act in zanzibar

Conditions: Malaria

Summary: the purpose of this study is to assess performance and cost-effectiveness of rapid diagnostic test(rdt) aided malaria diagnosis versus symptom-based/clinical diagnosis in patients of all ages with reported fever last 48 hours alone in primary health care settings in zanzibar.


Eligibility criteria:
inclusion criteria: * any patient attending the study sites and reporting history of fever within past 48 hours or other symptoms compatible with malaria and giving their informed consent, will be eligible for the study. exclusion criteria: * patient's refusal to consent will disqualify participation in the study.
randomized controlled clinical study of biplanar ultrasound-guided puncture of lumbar interforamen

Conditions: Lumbar Disc Herniation; Percutaneous Endoscopic Lumbar Discectomy; Three-dimension Ultrasound; Learning Curves

Summary: the goal of this clinical trial is to compare xplane ultrasound with radiography for guidance of lumbar interforamen puncture in patients with lumbar disc herniation. the main question\[s\] it aims to answer are: * the feasibility that the xplane ultrasound assists surgeon in mastering lumbar interforamen puncture faster than radiography. * the clinical accuracy and safety of the xplane ultrasound-guidance lumbar interforamen puncture faster. participants will undergo lumbar interforamen puncture with guidance of xplane ultrasound or radiography. if there is a comparison group: researchers will compare the first success rate, number of punctures, number of radiographies, puncture time and operator confidence score.


Eligibility criteria:
inclusion criteria: 1. 16 to 80 years of age; 2. symptoms and confirmatory signs of lumbar radiculopathy that persisted for at least 6 weeks; 3. ldh at a corresponding level and side on imaging; 4. surgical candidates for epidural steroid injection (esi) or percutaneous endoscopic lumbar discectomy (peld). if the patient underwent esi and peld surgery on the same day, we only selected the data for the first one. exclusion criteria: 1. other diseases affecting the spine (tumor, infection, metabolic disease, immune system disease and fractures); 2. body mass index (bmi) greater than 32 kg/m2; 3. pregnancy; 4. refusal to participate; 5. severe mental illnesses in the trial.