Kornimate/medical-research-clean huggingface dataset:
a study of omalizumab in the prevention of allergen induced airway obstruction in adults with mild allergic asthma

Conditions: Allergic Asthma

Summary: this was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma.


Eligibility criteria:
inclusion criteria: * signed informed consent form * meet criteria for the diagnosis of allergic asthma * be between the ages of 18 to 65 years * have a normal chest x-ray within 2 years of screening exclusion criteria: * need daily controller medication for asthma * history of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin) * have a documented medical history of anaphylaxis * have lung disease other than mild allergic asthma * have taken other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer * are unable or unwilling to comply with study procedures and visits * are pregnant or lactating * have significant medical illness other than asthma, including malignancies, parasitic infections, immune system disorders, and thrombocytopenia * have been treated with omalizumab within 12 months prior to screening * currently smoke or have a history of smoking more than 10 pack-years * have a history of drug or alcohol abuse, which, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study

Keywords: aqua anti-cd11 cd11a asthma allergy
effect of tegaserod on orocecal transit in elderly chronic constipation patients

Conditions: Chronic Constipation

Summary: this study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.


Eligibility criteria:
inclusion criteria: * male \& females aged 65 and older * patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks * patients must have had a colonoscopy within the past 5 years * patients must pass a balloon expulsion test at screening * patients must be able to comply and understand the use of a diary exclusion criteria: * patients with a clinically significant medical condition that would interfere with the patient completing the trial * patients with loose stools at least once per week * patients with ibs * known allergies to the same class of drug and/or allergies to eggs * patients who require the use of manual maneuvers to have a bowel movement other protocol-defined inclusion/exclusion criteria may apply.

Keywords: constipation, tegaserod, orocecal transit, colonic transit, gastric emptying
identifying biomarkers for chronic pain after breast cancer treatment.

Conditions: Neoplasm, Breast; Carcinoma Breast; Chronic Pain

Summary: up to 40% of women experience chronic pain after treatment for breast cancer, and this pain is often very disabling. however, chronic pain after breast cancer remains under-recognised and undertreated. an effective and patient-tailored approach of (chronic) pain after breast cancer indeed requires a thorough knowledge and evaluation of the pain. in daily clinical practice, however, guidelines for a comprehensive diagnosis of pain in cancer patients and survivors are lacking. further research in this topic is crucial for an efficient, preventive as well as curative, approach of pain after breast cancer. besides the high prevalence and the important impact of pain in this population, the breast cancer population is also an ideal population to study chronic pain and its natural time course in different stages, since most patients start pain-free, but almost half of them end up with chronic pain. therefore, this study aims to map biomarkers (both predictive, prognostic and diagnostic) for chronic pain after breast cancer treatment. we will study possible biopsychosocial biomarkers in relation to (chronic) pain and monitor their temporal changes from the moment of diagnosis until 1 year after surgery. the potential biomarkers are situated within the medical imaging of the brain, measurements of pain sensitivity and psychological variables.


Eligibility criteria:
inclusion criteria: * unilateral breast cancer * pain at enrollment \<3/10 on average during the past week * first cancer diagnosis exclusion criteria: * pre-existing pain conditions * major pre-existing neurological disorders * no recurrent cancer or metastasis * no previous surgery in area
cardionomic stop-adhf study

Conditions: Acute Decompensated Heart Failure

Summary: stop-adhf study: an evaluation of the safety and performance of the cardionomic cardiac pulmonary nerve stimulation (cpns) system in patients with acute decompensated heart failure.

the stop-adhf is a prospective, two-arm, multi-center study to evaluate the safety and performance of the cpns system in patients with acute decompensated heart failure (adhf). the cpns system is a neuromodulation system, intended to provide acute (≤5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery. the system consists of a temporary neuromodulation stimulator catheter and a stimulator. approximately 90 patients will be enrolled in the study and will be followed up through 6-months post-discharge from the hospital. patients enrolled in the treatment group will receive cpns therapy and followed closely in an intensive care unit setting. patients enrolled in the control arm in will receive standard treatment for their heart failure.

Eligibility criteria:
inclusion criteria: * admitted to hospital with a principal diagnosis of adhf * bmi adjusted bnp ≥ 500 pg/ml or nt-probnp ≥ 2000 pg/ml * lvef ≤ 50% * at least one sign or symptom of fluid overload despite the administration of iv furosemide (or equivalent) (at least 40 mg or equivalent) exclusion criteria: * received a high dose inotrope or levosimendan during current hospitalization or treatment with a low dose inotriope within 24 hours before enrollment * requires mechanical support * cardiogenic shock or impending cardiogenic shock * systolic blood pressure \ 140mmhg * symptomatic hypotension * egfr \< 25 ml/min/1.732

Keywords: neurostimulation contractility right pulmonary artery
a study of retrograde reperfusion of renal graft to reduce ischemic-reperfusion injury

Conditions: Kidney Transplantation; Ischemic Reperfusion Injury; Reperfusion

Summary: to evaluate whether retrograde venous reperfusion of a renal graft before antegrade arterial reperfusion can reduce ischemic-reperfusion injury. all registered eligible candidates for kidney transplant will be randomized to receive either: * retrograde venous, then arterial reperfusion or * antegrade arterial reperfusion.

according to our hypothesis, retrograde venous reperfusion prevents and reduces the immediate and long-term effects of renal allograft ischemic-reperfusion injury. for the study chi-square method of sample size estimation with a=0,05, b=0,20 required a 14 subject per group. the study will include 30 potential kidney recipients for both group aged 18-60 years who will receive kidney transplants. only adult patients undergoing primary living donor kidney transplantation with standard three-component immunosuppression will be enrolled to the study.the main study group will consist of 15 patients with retrograde graft reperfusion, and control group - will include 15 kidney recipients with only conventional antegrade arterial reperfusion (without retrograde reperfusion). patients of the study group with standard kidney implantation surgery will undergo retrograde reperfusion through the renal vein after venous anastomosis. after the venous anastomosis of the graft, an arterial anastomosis is applied with the renal artery without tightening the suture to leave a lumen sufficient for the outflow of retrograde blood. then the retrograde blood flow through the renal vein is started, venous blood fills the graft and flows through the renal artery through the lumen of the anastomosis in a volume of 80-100 ml. retrograde blood collected for gas and lactate analysis at the beginning of reperfusion, at the first minute and at the fifth minute. further, the sutures of the arterial anastomosis are tightened, and after tying, a typical antegrade reperfusion of the graft through the renal artery is performed. patients in the control group will undergo standard kidney implantation surgery with typical antegrade arterial reperfusion. t-test and mann-whitney test will be used to compare the median of urea, creatinine levels in serum and glomerular filtration rate (gfr) on the 1st, 7th, 14th, 30th, 60th postoperative day.

Eligibility criteria:
inclusion criteria: * patients with end-stage kidney disease who are ready for kidney transplantation; * panel reactive antibodies (pra) less than 20%. * informed consent to participate in the study. exclusion criteria: * recipients preparing for combined organ transplantation; * recipients with previously performed transplantation of another organ; * recipients preparing for transplantation with a different immunosuppressive regimen; * upcoming blood group incompatibility (ab0-i) transplant; * pra antibodies more than 20%;
effects of oral citrulline on protein metabolism in patients with intestinal failure (citrugrêle 2)

Conditions: Intestinal Failure

Summary: the specific aim of this study is to determine whether oral citrulline administration enhances whole body protein synthesis in patients with intestinal failure. protein metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine. the investigators hypothesize that citrulline supplementation will decrease leucine oxidation without altering proteolysis, and consequently stimulate protein synthesis.


Eligibility criteria:
inclusion criteria: * adult between 18 and 75 years * patient with short bowel syndrome * patient with an incompetent small intestine after intestinal resection * patient fed orally and beyond more than 6 weeks after surgery * absence of any earlier supplementation with citrulline, glutamine, ornithine a-ketoglutarate, or stimol® * no current artificial feeding (parenteral) * no low-sodium diet- no renal, cardiac, respiratory or hepatic insufficiency * no chronic inflammatory disease (intestinal or other) * no current corticosteroid treatment * fasting blood glucose below 6mmol/l * patient able to understand benefits and risks of protocol * women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 15 days following the end of the study * signed informed consent exclusion criteria: * subject not fulfilling inclusion criteria * subject mentioned in articles l1121-5 to l1121-8 of "code de la santé publique" * pregnancy

Keywords: nutrition, protein metabolism, stable isotopes, mass spectrometry, intestinal failure
mother - daughter initiative (mdi) in cervical cancer prevention

Conditions: Cervical Cancer

Summary: the mother-daughter initiative (mdi) will test the feasibility and acceptability of a strategy to deliver comprehensive cervical cancer prevention services in thailand and the philippines by integrating the hpv vaccine for girls ages 9-13 into already successful screening and treatment programs for mothers.


Eligibility criteria:
inclusion criteria: * age 9-13 at first hpv vaccine dose * mother/legal guardian and daughter are both interested and willing to have the girl receive the hpv vaccine * mother/legal guardian and daughter both indicate that they would be able to return to clinic for the three vaccine doses exclusion criteria: * girls with a known history of any allergies or severe reaction to any vaccines, food or medicine * pregnant adolescents will be excluded. if a girl becomes pregnant after the first dose is administered, she will not be provided with the second or third dose * girls with moderate or severe illnesses will be asked to postpone vaccination eg. pneumonia. * girls with a weakened immune system, cancer, leukemia, aids or other immune system problems * girls with a bleeding disorder or currently taking anticoagulants * girls that have received any other vaccinations in the past 4 weeks * girls currently on steroids, such as cortisone, prednisone, or anti-cancer drug.
a study to assess the clinical profile of patients in spain with moderate to severe psoriasis.

Conditions: Psoriasis

Summary: the purpose of this study is to assess the clinical profile of patients with moderate to severe psoriasis in spain. the primary objective is to analyze the clinical profile of patients with moderate to severe psoriasis, as defined by a set of conditions (obesity, hypertension, diabetes, abnormal amounts of lipids in the blood, cardiovascular disease, etc.) and its correlation to the patients' quality of life. the secondary objectives are to describe the demographic characteristics and habits of the patient, to evaluate the clinical characteristics of the disease, and to describe the diagnostic and therapeutic procedures being used in standard clinical practice and the patients' expectations for these therapies.

this is an epidemiological, non-interventional, multi-centre, cross-sectional, retrospective, observational study to assess the clinical profile of patients with moderate to severe psoriasis in spain. the data for each patient will be recorded only once, in one visit. during this visit the specialist will ask the patient a series of questions to describe the existence or absence of a number of conditions and their associated treatments, to record the characteristics of psoriasis experienced by the patient and the type of associated treatment. not applicable

Eligibility criteria:
inclusion criteria: * patient over 18 years of age * diagnosed with psoriasis at least 6 months before the visit * diagnosed with moderate to severe psoriasis * who have been treated or not for moderate to severe psoriasis * for whom the medical history dating back at least 6 months can be accessed * the patient's legal representative has signed informed consent, stating that the patient understands the study purpose and requirements and grants the patient consent to participate in the study exclusion criteria: * patient diagnosed with mild psoriasis according to the dermatologist or with a skin disease other than psoriasis * with any type of difficulty understanding the questions in the dlqi, sf-36 and pbi questionnaires * who and/or whose legal representative refuses to grant written, informed consent to participate in the study

Keywords: psoriasis comorbidities, associated treatment, quality of life
mechanochemical ablation vs thermal ablation

Conditions: Varicose Veins of Lower Limb

Summary: patients with gsv reflux were randomized to undergo either moca or thermal ablation with laser or radiofrequency. the main outcome measure was the occlusion rate of the gsv at one year.patients with gsv reflux were randomized to undergo either moca or thermal ablation with laser or radiofrequency. the main outcome measure was the occlusion rate of the gsv at one and three years.

during 2014-2015, all patients referred to our vascular surgery clinic by their general practitioners due to varicose veins were screened for gsv insufficiency. we invited all patients filling the inclusion criteria to participate in this study. included patients were randomized to receive either thermal ablation (laser ablation or radiofrequency ablation) or mechanochemical ablation with the clarivein device to treat the refluxing gsv. the patients filled the aberdeen varicose veins questionnaire (avvq) at the baseline. we recorded the preoperative diameter of the gsv, specifically the diameter at the most proximal 20 centimetres, and the mean overall diameter at the thigh. during the procedure, before discharge, and a week after, the patients reported pain scores using visual analogue scale (vas) on a scale of 0 to 10. at the one-month follow-up visit, we recorded wound healing, haematomas or bruising, nerve injuries, and pigmentation. the status of the gsv was examined with duplex doppler ultrasound. the patients were also asked to determine what would have been the optimal sick leave after the procedure. at the one-year follow-up, nerve injuries, pigmentation, and clinical status were recorded, as well as the status of the gsv with duplex doppler ultrasound. the patients also filled the avvq questionnaire.

Eligibility criteria:
inclusion criteria: * clinical classification of venous disease c2-c4 * ultrasound-verified reflux in the gsv * mean gsv diameter in the thigh between 5 and 12 millimetres * informed consent. exclusion criteria: * body mass index (bmi) of over 40 * peripheral arterial disease * lymphoedema * pregnancy * allergy to either the sclerosant or lidocaine * severe general illness * malignancy * previous deep venous thrombosis * previous varicose vein intervention in the same leg * coagulation disorders

Keywords: great saphenous vein thermal ablation mechanochemical ablation randomized controlled trial
visualization versus neuromonitoring of the external branch of the superior laryngeal nerve during thyroidectomy.

Conditions: Thyroid,; Goiter,

Summary: injury to the external branch of the superior laryngeal nerve (ebsln) during thyroidectomy results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. it remains unclear if use of intraoperative nerve monitoring (ionm) can improve clinical outcome of thyroidectomy in terms of preserved individual voice performance. this study was designed to test that hypothesis.

phonation changes following thyroidectomy have been reported in many investigations. they are considered to be multifactorial in origin and can be a consequence of laryngeal nerve injury or other events during thyroidectomy including arytenoids trauma after endotracheal intubation, cricothyroid dysfunction, strap muscle malfunction or lesion of the perithyroidal neural plexus, laryngotracheal fixation with impairment of vertical movement and psychological reaction to the operation. injury to the external branch of the superior laryngeal nerve (ebsln) can occur during the dissection and clamping of the superior thyroid vessels and the prevalence of this complication has been reported from 0.5% to 58%. this injury causes a complete paralysis of the cricothyroid muscle which results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. intraoperative nerve monitoring (ionm) has gained widespread acceptance as an adjunct to the gold standard of visual nerve identification and this technique can be used to identify both the recurrent laryngeal nerve (rln) and the ebsln. however, it remains unclear if there is any ionm added-value to the clinical outcome of thyroidectomy in terms of preserved individual voice performance. this study was designed to test that hypothesis.

Eligibility criteria:
inclusion criteria: * thyroid pathology qualified for first-time bilateral neck surgery in a female patient with small to moderate sized goiter (below 100 ml in volume). exclusion criteria: * male gender, * previous neck surgery, * unilateral thyroid pathology eligible for unilateral lobectomy, * goiter volume above 100 ml, * preoperatively diagnosed rln palsy, * abnormal preoperative voice assessment on grbas scale, * pregnancy or lactation, * age below 18 years, * high-risk patients asa 4 grade (american society of anesthesiology), * inability to comply with the scheduled follow-up protocol.

Keywords: external branch of the superior laryngeal nerve, recurrent laryngeal nerve, intraoperative neuromonitoring, thyroid surgery
beetroot juice as a potential ergogenic aid during exercise in hypoxia

Conditions: Hypoxia

Summary: the study will aim to describe and evaluate the effect of beetroot juice supplementation upon whole body running exercise at altitude. it is hypothesised that beetroot supplementation will decrease time to complete a 10 km time trial.


Eligibility criteria:
inclusion criteria: - trained athletes with personal best performances for a 10km run of sub 40 minutes exclusion criteria: - unable to give informed consent unstable medical condition.
fast-forward vs hai5

Conditions: Cancer, Breast

Summary: randomized comparison between the fast-forward schedule and the hai5 schedule for breast cancer radiotherapy in 5 fractions.

previously, radiotherapy treatments for breast cancer usually consisted of 20-25 sessions to treat the entire breast, followed by an additional dose ("boost") to the tumor bed of 4-8 sessions. today, 15-16 treatment sessions have become standard for whole breast irradiation, followed by a boost if indicated. the durability of further shortening the treatment to 5 sessions was proven in the fast and fast-forward studies. after 10 and 5 years, the outcome was comparable with 25 and 15 radiation sessions, both in terms of toxicity and locoregional control. there are currently 2 radiotherapy schedules in 5 sessions in use in belgium (the fast-forward schedule and the hai5 schedule), both of which have their advantages and disadvantages. in this project we want to investigate which schedule gives the fewest side effects and the best quality of life using questionnaires at different times (before, during and after radiation). patients participating in the study will be randomized 1:1 between the fast-forward schedule and the hai5 schedule. the first group is treated according to the fast-forward schedule, consisting of 5 radiation sessions on 5 consecutive working days (e.g. monday to friday). in the schedule 2 rest days are allowed, so that the treatment lasts a maximum of 7 days. the second group is treated according to the hai5 schedule, developed by the radiotherapy department of ghent university hospital. in this schedule, at least 1 day of rest is scheduled between each treatment session, so the treatment is administered over 10-14 days.

Eligibility criteria:
inclusion criteria: * histopathological diagnosis of breast cancer * age 18 years or older * male or female * treated with breast conserving surgery or mastectomy with curative intent * multidisciplinary decision of adjuvant radiotherapy after surgery exclusion criteria: * distant metastases * decision of preoperative radiotherapy * decision of partial breast irradiation * positive resection margins ('ink on tumour') * indication for boost on lymph node(s) * history of thoracic or ipsilateral axillary radiotherapy (including radiotherapy of the contralateral breast or chest wall) * need for bilateral irradiation * breast reconstruction or expander * patients unlikely to comply with the protocol (e.g. inability or unwillingness to complete the questionnaires at different time points).