Kornimate/medical-research-clean huggingface dataset:
chlorhexidine vs lactobacillus plantarum for oral care in intubated icu patients

Conditions: Pathogenic Bacteria in the Oropharynx; Ventilator-associated Pneumonia

Summary: critically ill patients often need ventilatory support through a plastic tube connected to a ventilator. those patients have a altered microbiological flora in the mouth, oropharynx as well as throughout the intestine. bacteria that can cause illness are often found in the oropharynx in such patients and measures are taken in order to reduce the risk of secondary infections by those bacteria. in all intensive care patients oral care is provided by the nursing staff aiming at a reduction of the pathogenic species. this is done by a variety measures. chlorhexidine (chx) is an antisepticum with a capability to reduce bacterial counts in the mouth and oropharynx and has been shown to be of value also for intubated patients. it is used frequently throughout the world. ventilator-associated pneumonia (vap) is a costly rather frequent complication to intensive care and mechanical ventilation and is usually caused by aspiration of infected secretions from the oropharynx. chx has in some studies been shown to reduce the frequency of vap. the probiotic bacterium lactobacillus plantarum 299 has the ability to adhere to the mucosa throughout the gastro-intestinal tract including the mouth and in our pilot study we found that l plantarum had better ability to reduce colonisation with enteric bacteria in the oropharynx than chx had. figures not statistical significant so this present study is aiming to get a larger amount of data. the procedure was found to be safe hypothesis: lactobacillus plantarum is better than chx for the reduction of pathogenic bacteria in the oropharynx in intubated mechanically ventilated patients and consequently has a better potential to reduce the frequency of vap

this study is an expansion of a pilot study performed at the icu lund university hospital, sweden where 50 patients were included (isrctn00472141). results have been published in critical care 2008, 12:r136 the protocol is the same and in this second phase we intend to include 100 patients and results will be summed up. three centres are engaged. the results from the pilot study is encouraging and we are aiming at getting statistical significance in the differences in pathogenic findings in the cultures from oropharynx and also better a better basis for the calculation of the number of patients needed to get sufficient power to study difference in vap frequency.

Eligibility criteria:
inclusion criteria: * 18 years or older * critically ill patients anticipated to require mechanical ventilation for at least 24 hours exclusion criteria: * pneumonia as admission diagnosis, * fractures on the facial skeleton or the skull base; * known ulcers in the oral cavity, the oropharynx, or the esophagus * known immune difficency * carrier of hiv or hepatitis * patient being moribund

Keywords: probiotics lactobacillus plantarum 299 ventilator-associated pneumonia vap chlorhexidine tracheal secretions oropharyngeal secretions
house dust mite allergy trial in children

Conditions: Allergic Rhinitis Due to Dermatophagoides Farinae; Allergic Rhinitis Due to Dermatophagoides Pteronyssinus; Allergic Rhinitis Due to House Dust Mite

Summary: a research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (matic)

the trial aims to demonstrate efficacy of the house dust mite slit-tablet compared to placebo in children (5-11 years of age) with house dust mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment. in addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (qol). the trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase iii trial conducted in europe and north america. the treatment period will be approximately 1 year.

Eligibility criteria:
inclusion criteria: * male or female subjects aged 5-11 years * a clinical history of hdm ar/c (allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening * have a certain level of ar (allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period * use symptomatic medication for treatment of hdm allergic rhinitis during at least 8 of the last 14 days of the baseline period * positive skin prick test (spt) and ige (immunoglobulin e) to d. pteronyssinus or d. farinae at screening * lung function ≥ 70% of predicted value exclusion criteria: * sensitised and regularly exposed to perennial allergens * any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation * asthma requiring treatment with high dose of inhaled corticosteroid * a relevant history of systemic allergic reaction

Keywords: allergic rhinitis hdm pediatric
a multicentre, randomlsed, controlled, umbrella trial for minimally invasive neurosurgery with al-assisted robotic guidance for moderate basal ganglia hemorrhage

Conditions: Basal Ganglia Hemorrhage

Summary: a nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (ai) robot guiding system on the perioperative and long-term recovery of patients with moderate-volume basal ganglion hemorrhage.

basal ganglion hemorrhage is one of the most common subtypes of cerebral hemorrhage, characterized by high morbidity, mortality, and disability rates. minimally invasive surgery for cerebral hemorrhage, particularly utilizing a fiber tract-based ai robot guiding system, has shown potential advantages for patient prognosis. however, there is currently no standardized practice or robust evidence confirming the effectiveness and safety of this technology for small-volume basal ganglion hemorrhage. therefore, we are conducting a nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (ai) robot guiding system on the perioperative and long-term recovery of patients with moderate-volume basal ganglion hemorrhage.

Eligibility criteria:
inclusion criteria: 1. age \> 18 2. diagnosed with hypertensive basal ganglia hemorrhage (ct, cta, etc.) 3. hematoma volume 15 - 30ml 4. with functional impairments (e.g., motor or sensory aphasia, muscle strength ≤ 3 in hemiparetic limbs, or nihss ≥ 15) 5. ct shows stable hematoma (a ct scan at least 6 hours after the diagnostic ct, with hematoma volume increase \< 5 ml) 6. randomized intervention can be initiated within 72 hours 7. prior mrs ≤1 8. patients who have consent exclusion criteria: 1. hematoma involving the thalamus, midbrain, or other areas 2. radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage 3. brain herniation 4. any irreversible coagulation disorders or known coagulation system diseases 5. patients with severe concomitant diseases that may interfere with outcome assessment 6. pregnancy or possible pregnancy 7. difficulty in follow-up or potential poor adherence due to various factors
comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus nephritis

Conditions: Lupus Nephritis

Summary: the purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.

patients with biopsy proven active lupus nephritis will be randomized to receive tacrolimus or mycophenolate mofetil, on top of corticosteroids, for initial treatment. efficacy and adverse effects will be compared.

Eligibility criteria:
inclusion criteria: 1. patients who fulfill at least 4 of the acr criteria for sle 2. age \>= 18 years 3. biopsy proven active lupus glomerulonephritis (isn/rps class iii/iv/v) 4. serum creatinine \< 200 umol/l at the time of randomization exclusion criteria: 1. patients who refuse to be randomized for treatment 2. patients who prefer treatment with conventional agents such as oral or intravenous cyc for various reasons 3. serum creatinine \>= 200 umol/l at the time of randomization 4. patients without renal biopsy or those who have lupus nephritis isn/rps class i,ii,vi 5. patients who are pregnant or plan for pregnancy within 12 months after randomization

Keywords: lupus nephritis tacrolimus mycophenolate mofetil
a study evaluating the efficacy and safety of botox® or solifenacin in patients with overactive bladder and urinary incontinence

Conditions: Overactive Bladder; Urinary Incontinence

Summary: a study to evaluate the efficacy and safety of botox® or solifenacin in patients with overactive bladder (oab) and urinary incontinence.


Eligibility criteria:
inclusion criteria: * symptoms of overactive bladder (oab) (frequency/urgency) with urinary incontinence for at least 6 months * inadequate response or limiting side effects with anticholinergics for the treatment of oab exclusion criteria: * overactive bladder caused by neurological condition * patient has predominance of stress incontinence * use of anticholinergics or other medications to treat oab symptoms in the 7 days prior to screening * previous use of solifenacin * history or evidence of pelvic or urological abnormality * previous use of any botulinum toxin of any serotype for any urological condition * previous use of any botulinum toxin of any serotype for any non-urological condition within 12 weeks of randomization * diagnosis of myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis
stem cell transplant for juvenile myelomonocytic leukemia (jmml)

Conditions: Juvenile Myelomonocytic Leukemia

Summary: the investigators hypothesize that long-term disease-free survival (dfs) in patients with jmml can be achieved with a treatment of busulfan (bu), cyclophosphamide (cy) and melphalan (l-pam) followed by hematopoietic cell transplantation (hct).

prior to transplantation, subjects will receive busulfan via the central venous line, six times a day for four days, cyclophosphamide via the central venous line once a day for two days, and melphalan via the central venous line for one day. busulfan, cyclophosphamide, and melphalan are given to destroy the subject's leukemia. as well, these drugs will destroy the subject's own immune system to help ensure the new bone marrow takes and grows after transplantation. on the day of transplantation, bone marrow or umbilical cord blood from the donor will arrive to the bone marrow transplant unit and be transfused via venous line. these new cells will replace the subject's bone marrow.

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of jmml and fulfill these minimal criteria (international diagnostic criteria for jmml): * leukocytosis (\> 13,000) with absolute monocytosis (\> 1,000) * the presence of immature myeloid cells in the peripheral blood * less than 30% marrow blasts * absence of t(9:22) or bcr-abl transcript * adequate major organ function including: * cardiac: ejection fraction \> 45% * hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites) * karnofsky performance status \> 70% or lansky score \> 50% * creatinine must be \< 2 x normal for age * written informed consent. exclusion criteria: * active uncontrolled infection within one week of hct.

Keywords: stem cell transplant long term survival retinoic acid
an efficacy and tolerability study for topiramate in obese patients with binge eating disorder.

Conditions: Binge Eating

Summary: the purpose of this study is to evaluate the effectiveness and tolerability of topiramate compared to placebo in patients with binge eating disorder receiving cognitive behavior therapy (cbt)

this was a 21-week multicenter, double-blind, parallel-group, randomized controlled trial comparing the efficacy and tolerability of an add-on treatment with 200mg of topiramate versus placebo in obese patients with bed receiving group cbt. the aim of this trial is to investigate the efficacy and tolerability of adjunctive topiramate to cbt in obese patients with bed through improvement in binge eating, related psychopathology, and weight loss. the study hypothesis is that the patients using topiramate + cbt will loose more weight than patients using placebo + cbt.tolerability will be investigated through reported adverse events and dropouts, with reasons for leaving the study being analyzed. the randomized patients will receive capsules of topiramate (25 mg, 50 mg) or placebo correspondent daily for 21 weeks

Eligibility criteria:
inclusion criteria: * have been meeting the diagnostic criteria for binge eating disorder (according to the diagnostic and statistical manual for mental disorders - iv edition criteria) with at least 2 days of binge eating per week and severity at least moderate defined by binge eating scale (score = 17) * bmi = \> 30 kg/m2 to \< 46 kg/m2 * women must be post menopausal for at least one year or surgically sterilized (hysterectomy, tubal ligation), or practice sexual abstinence or use an acceptable method of birth control (i.e. a hormonal contraceptive, spermicide plus barrier method, intrauterine device and/or vasectomized partner) exclusion criteria: * has a history or actual diagnostic of significant psychiatric disorder (schizophrenia, psychosis, major affective disorder, suicide risk, dementia, abuses alcohol or other drugs) * has a malignancy or a history of malignancy within the past 5 years (except basal cell carcinoma) * evidence of uncontrolled thyroid disorders * uncontrolled hypertension (defined as a diastolic blood pressure \>110 mm/hg and/or a systolic blood pressure \>180 mm/hg with or without medication). hypertensive patients on medications must have been on the same dose of the same antihypertensive medication for at least two months * history or significant renal failure or glaucoma.

Keywords: binge-eating disorder
motor_control_neck_ssed

Conditions: Neck Pain; Forward Head Posture

Summary: neck pain is a common problem in the western world. there is a group of people suffering from neck pain with a reduced ability to maintain an upright posture showing a forward head position and an altered muscle function. the aim of the study was to evaluate a motor control intervention for patients with persistent neck pain and a forward head posture. this pilot study used a single system experimental design (ssed) with an a-b-a-design and multiple baselines. the tailored motor control intervention addressed the faulty postural alignment and the deep muscles of the cervical spine.


Eligibility criteria:
inclusion criteria: * 20 - 50 years of age with pain originating from the neck for at least three months. * a visual forward head posture. * less than105 points on the örebro musculoskeletal pain screening questionnaire exclusion criteria: * neurological dysfunction. * former cervical surgery or compression fracture of the spine * no mental retardation * no physiotherapy treatment during the last 6 months.

Keywords: neck pain motor control intervention forward head posture
psma in gastrointestinal tumors (gipsma, focusing on neuroendocrine neoplasms)

Conditions: Gastrointestinal Cancer

Summary: the theranostic principle is based on the use of radiolabeled compounds which can be applied for diagnostic molecular imaging and targeted delivery of radiation to the tumor. gastrointestinal tumors (git), including gastroenteropancreatic neuroendocrine neoplasms (gep-nen) also express a phenotypic biomarker called prostate-specific membrane antigen (psma), thereby rendering it a potential diagnostic (through positron emission tomography (pet) scan imaging) and therapeutic target for radioligand therapy. aim is to evaluate whether psma-directed in-vivo imaging can be also applied to gep-nen patients to determine if i) biopsy-derived tissue of newly diagnosed patients exhibit a psma expression profile, ii) psma-pet shows upregulated psma expression in-vivo, iii) such a molecular imaging approach identifies more disease sites relative to conventional imaging, and iv) if the psma pet signal predicts further clinical course and outcome under guideline-compatible treatment.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed gep-nen prior to initiation of guideline-compatible, anti-tumor therapy * available tissue specimen to conduct psma expression profiling * male/female, above 18 years old * patients must provide written informed consent * patients must be willing to comply with study procedures and available for follow-up examinations exclusion criteria: * curative setting * not sufficient tumor tissue available * male patients: no prostate carcinoma * other malignant neoplasms in patient's history * pregnancy or breastfeeding * contraindications for pet/ct
immunotherapy using precision t cells specific to personalized neo-antigen for the treatment of advanced malignant tumor of biliary tract

Conditions: Advanced Biliary Tract Malignant Tumor

Summary: objectives: the purpose of this study is to evaluate the safety and prognosis of dendritic cell-precision t cell for neo-antigen in the treatment of advanced biliary tract malignant tumor. methods: this study designs a novel therapy using dendritic cell-precision multiple antigen t cells. 40 patients will be enrolled. they are randomly divided into gemcitabine group and dendritic cell-precision t cell for neo-antigen combined with gemcitabine group. gemcitabine treatments will be performed once a week with a total of six times. dendritic cell-precision t cell for neo-antigen combined with gemcitabine treatment: gemcitabine: once a week with a total of six times before 60 days prior to the start of drawing blood. dendritic cell-precision t cell for neo-antigen: once per 3 weeks with a total of three periods. the mail clinical indicators are progression-free-survival and overall survival.

a total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility criteria:
inclusion criteria: * 1. age 18\~65 years old, male or female;2. life expectancy \> 6 months;3. eastern cooperative oncology group (ecog) score: 0-2;4. laboratory examination: ① white blood cell ≥ 3 x 109/l. blood platelet count ≥ 60 x 109/l; hemoglobin ≥85g/l; ② total bilirubin ≤100 mol/l; aminopherase less than five times of the normal; ③ serum creatinine less than 1.5 times of the normal;5. signed informed consent;6. patients with fertility are willing to use contraceptive method. exclusion criteria: * 1. expected overall survival \ 2.5mg/dl; serum glutamic oxaloacetic transaminase (sgot) \> 5 times of the normal;total bilirubin \> 100μmol/l; 4.other drugs, biological, chemotherapy or radiation therapy were used within 1 months;5. without signed informed consent.

Keywords: advanced biliary tract malignant tumor dendritic cell precision t cell for neo-antigen
study of transitioning from alendronate to denosumab

Conditions: Postmenopausal Osteoporosis

Summary: the study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.


Eligibility criteria:
inclusion criteria: * postmenopausal females 55 yrs or older * received alendronate therapy for osteoporosis for at least 6 months prior to entry into study * lumbar spine or total hip bone mineral density (bmd) corresponding to t-score ≤ -2 and ≥ -4 exclusion criteria: * vitamin d deficiency * administration of intravenous bisphosphonate, or * fluoride (except for dental treatment) or * strontium ranelate * administration of parathyroid hormone (pth) or parathyroid hormone (pth) derivatives (eg; teriparatide) within the last year * administration of any bisphosphonate other than alendronate (aln) within 1 year of screening

Keywords: rankl rank denosumab amg 162 osteoporosis bone turnover bone mineral density clinical trial postmenopausal osteoporosis alendronate total hip bone mineral density
minimally invasive surgery: using natural orifice translumenal endoscopic surgery (notes)

Conditions: Appendicitis; Cholelithiasis

Summary: this is an observational study of pain and outcomes from patients undergoing transgastric notes removal of their appendix or gallbladder. subjects who elect to have a transgastric notes removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following: * subjects will complete a 7 day pain/temperature log after surgery * subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.


Eligibility criteria:
inclusion criteria for the group #1 transgastric appendectomy: 1. males and females between the ages of 18-75 2. clinical diagnosis of appendicitis emergency room evaluation within 36 hours of the onset of pain 3. asa classification i 4. mentally competent to give informed consent. 5. scheduled to undergo a transgastric notes appendectomy. exclusion criteria for group #1 transgastric appendectomy: 1. pregnant women 2. morbidly obese patients (body mass index \> 35) 3. patients who are taking immunosuppressive medications or are immunocompromised 4. patients who are on proton pump inhibitors (ppi) 5. patients with evidence of an abdominal abscess or mass on ct scan 6. patients who present with a clinical diagnosis of sepsis 7. patients who have a history of open abdominal surgery 8. patients with diffuse peritonitis 9. patients on blood thinners or aspirin inclusion criteria for group #2 transgastric cholecystectomy: 1. males and females between the ages of 18 -75 2. diagnosis of gallstone disease that require cholecystectomy 3. asa classification i 4. mentally competent to give informed consent. 5. scheduled to undergo a transgastric notes cholecystectomy. exclusion criteria for group #2 transgastric cholecystectomy: 1. pregnant women 2. patients with a body mass index \> 35 3. patients who are taking immunosuppressive medications or are immunocompromised 4. patients who are on proton pump inhibitors (ppi) 5. patients with suspicion of gallbladder cancer 6. patients with a history of open abdominal surgery 7. patients with known common bile duct stones (gallstones are not limited to the gallbladder) 8. patients on blood thinners or aspirin

Keywords: appendicitis cholelithiasis gallstones