Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of cadazolid versus vancomycin in subjects with clostridium difficile - associated diarrhea

Conditions: Clostridium Difficile Infection

Summary: this clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with clostridium difficile-associated diarrhea (cdad).

subjects selected to participate in the study are treated either with cadazolid or vancomycin for 10 days. at the end of treatment, clinical cure is assessed; subjects are then followed-up to assess any disease recurrence.

Eligibility criteria:
inclusion criteria: * signed informed consent. * male or female ≥ 18 years of age. females of childbearing potential must agree to use an adequate and reliable method of contraception. * subject with a diagnosis of mild-moderate or severe cdad (first occurrence or first recurrence within 3 months) with: diarrhea: a change in bowel habits with \> 3 liquid or unformed bowel movements (ubm) within 24 hours prior to randomization, and positive c. difficile toxin test on a stool sample produced within 72 hours prior to randomization. exclusion criteria: * more than one previous episode of cdad in the 3-month period prior to randomization. * evidence of life-threatening or fulminant cdad. * likelihood of death within 72 hours from any cause. * history of inflammatory colitides, chronic abdominal pain, or chronic diarrhea. * antimicrobial treatment active against cdad administered for \> 24 hours except for metronidazole treatment failures (mtf) * known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones. * unable or unwilling to comply with all protocol requirements. * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Keywords: post-antibiotic diarrhea clostridium difficile infection
a phase 2 dose-finding study of atacicept in subjects with rheumatoid arthritis (august i)

Conditions: Rheumatoid Arthritis

Summary: this was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (tnfa) antagonist due to lack of efficacy.


Eligibility criteria:
inclusion criteria: 1. rheumatoid arthritis (ra) satisfying american college of rheumatology (acr) diagnostic criteria with a disease history of at least one year 2. male or female greater than or equal to (\>=)18-years of age at time of informed consent 3. active ra as defined by: * \>=8 swollen joints (66-joint count), * \>=8 tender joints (68-joint count), and * c-reactive protein (crp) \>=10 milligram per liter (mg/l) (central laboratory) and/or erythrocyte sedimentation rate (esr) \>= to 28 millimeter per hour (mm/h) 4. failure of at least one tnfa antagonist therapy (previously or at the time of screening) as specified in the protocol 5. other protocol defined inclusion criteria could apply exclusion criteria: 1. any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the investigator constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation 2. treatment with biologics aiming at b cell modulation such as rituximab or belimumab within 2 years before study day 1 3. any previous treatment with anakinra (kineret), abatacept (orencia) or tocilizumab within 3 months before study day 1 4. use of etanercept (enbrel) within 28 days before study day 1, or of infliximab (remicade) or adalimumab (humira) within 60 days before study day 1 5. participation in any interventional clinical trial with an unapproved investigational therapy within the 3 months before the start of this study (or within 5 half-lives of the investigated compound before study day 1, whichever is longer) 6. other protocol defined exclusion criteria could apply

Keywords: atacicept arthritis
a phase iii, multi-centre, randomised, placebo-controlled study in combination with ca-based p binders in patients with hyperphosphatemia

Conditions: Chronic Kidney Disease; Dialysis; Hyperphosphatemia

Summary: this study consists of a 4 week run-in period with a ca based phosphate binder and 12 weeks treatment period by mci-196 or placebo, (both on ca based phosphate binder). during the treatment period, mci-196 or placebo will be titrated every 3 weeks.


Eligibility criteria:
inclusion criteria: 1. male or female, 18 to 80 years of age. 2. stable phosphate control using calcium-based phosphate-binding medication only. 3. the subject is undergoing regular dialysis treatment. 4. on a stabilised phosphorus diet. 5. if female and of child-bearing potential, has a negative serum pregnancy test. sexually active females must agree to take appropriate steps not to become pregnant. 6. male subjects must agree to use appropriate contraception. exclusion criteria: 1. current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study. 2. body mass index (bmi) \ 40.0 kg/m2. 3. current or a history of significant gastrointestinal motility problems 4. a positive test for hepatitis b surface antigen, hepatitis c antibody or hiv 1 and 2 antibodies. 5. a history of substance or alcohol abuse within the last year. 6. seizure disorders. 7. using phosphate binder medication other than calcium based phosphate binders 8. using colestyramine, colestipol or colesevelam 9. a history of drug or other allergy 10. participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days, prior to signing of the informed consent.

Keywords: chronic kidney disease dialysis hyperphosphatemia
evaluating the acute effects of electronic nicotine delivery devices marketed to smokers.

Conditions: Smoking

Summary: the study's aim is to develop a clinical model that can be used to measure the nicotine delivery and tobacco/nicotine abstinence-suppressing capability of electronic devices that are marketed as a means to deliver nicotine to cigarette smokers. the study will compare the nicotine delivery, cardiovascular effects, and tobacco withdrawal suppressing effects of two devices currently marketed in the u.s.: crown seven and njoy. specifically, the effects of these devices will be compared with the effects of own brand cigarettes (positive control), and an abstinence condition (sham smoking; puffing from an unlit cigarette). the primary hypothesis is that the nicotine delivery, withdrawal suppression, and other effects of electronic devices marketed as a means to deliver nicotine to smokers can be measured during a period of acute exposure.

potential reduced exposure products (preps) are being developed and marketed by the tobacco industry in an attempt to reduce some of the risks involved in tobacco use (see breland et al., 2002b). evaluating the effects of these products is crucial to public health, as past industry-sponsored efforts at harm reduction (e.g., so-called "light" and "ultra-light" cigarettes) were not evaluated and failed to reduce carbon monoxide (co), nicotine, and carcinogen exposure in smokers; these efforts thus failed to reduce the harms of smoking (stratton et al., 2001). this study is part of an on-going, nih-funded program of research to develop a science-based model that uses outcome measures relevant to evaluating current tobacco industry-sponsored smoking harm reduction efforts systematically and efficiently.

Eligibility criteria:
inclusion criteria: participants must be healthy, between 18 and 55 years of age, and report a cigarette intake of \> 15 cig/day for at least 1 year. they must provide an afternoon screening co level of \> 15 ppm at intake. they must also provide a urine sample for cotinine analysis, and receive a result of at least 4 on the urine immunoassay test strip scale (possible range = 0-6) at intake. exclusion criteria: exclusion criteria include: history of chronic health problems or psychiatric conditions, breastfeeding, or pregnancy (assessed by urinalysis). individuals who report current attempts to quit smoking, previous experience with crown seven or njoy. individuals who report alcohol or marijuana use greater than 20 days within the last 30 days, or recent illicit drug use such as cocaine or heroin. women reporting active menopause will be excluded (menopause may cause tobacco/nicotine withdrawal-like symptoms, such as depression, parry et al., 2001).

Keywords: tobacco cigarette nicotine
biochemical role of long non-coding rna malat 1 and serum tumor necrosis factor alpha in bronchial asthma patients.

Conditions: Bronchial Asthma

Summary: bronchial asthma affects more than a quarter of a billion people worldwide. it is responsible for over 1000 deaths a day, of which the majority are preventable (levy, 2015). asthma is a common heterogeneous disease characterized by chronic airway inflammation. it is defined by the history of variable respiratory symptoms, such as shortness of breath, chest tightness, wheezes, and cough, together with variable expiratory airflow limitation. airflow limitation may later become persistent (gina, 2023). the diagnosis of asthma is based on the history of these characteristic symptoms and evidence of variable expiratory airflow limitation from bronchodilator reversibility testing or other tests (gina, 2023).


Eligibility criteria:
inclusion criteria: * all patients were admitted to sohag university hospital, chest department diagnosed as bronchial asthma exclusion criteria: * patients with malignancies, major trauma or surgery, and acute or chronic infectious diseases were excluded.
neoadjuvant carboplatin in triple negative breast cancer

Conditions: BRCA1 Hereditary Breast and Ovarian Cancer Syndrome

Summary: breast cancer is the most frequent neoplasm in women in brazil and in the world and up to 15% of all cases diagnosed correspond to the triple negative subtype. triple negative breast cancer affects young women with germline mutations in brca 1/2 genes. giving the lack of target therapies to date, there is no consensus regarding the most effective treatment for this subgroup of tumors. although evidence shows that triple negative breast cancer is highly sensitive to chemotherapy when compared to other breast tumors, there is no evidence to support the hypothesis that patients with triple negative breast cancer and mutation in brca1 / 2 genes have higher chemosensitivity to neoadjuvant therapy. the investigator proposes a prospective, randomized, open-label, phase ii study, evaluating the rate of complete pathologic response, disease-free survival, overall survival and prognostic evaluation of brca1 / 2 mutation status in women with triple negative breast cancer submitted to sequential neoadjuvant chemotherapy based on anthracycline and taxane, with or without carboplatin.


Eligibility criteria:
inclusion criteria: * triple negative breast cancer; * stage ii or iii; * performance status ecog \ 50%; * hematologic (minimal values): absolute neutrophil count \> 1,500/mm3 hemoglobin \> 10.0 g/dl platelet count \> 100,000/mm3 exclusion criteria: * stage i or iv; * other malignancies.
evaluation of efficacy and hypothalamus-pituitary-adrenal axis suppression due to corticosteroids intrabursal injection

Conditions: Tendinopathy; Adrenal Insufficiency

Summary: the purpose of this study is to compare the efficacy and effects on the hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder tendinopathy.

rotator cuff calcific tendonitis is a common disease, mainly affecting women aged 30 to 50 years old. it is associated to severe pain and impotence. us-guided percutaneous treatment is considered the gold standard treatment with the aim to destroy and wash out shoulder's calcification, responsible for inflammation, pain and functional limitation. corticosteroids are injected in the subacromial-subdeltoid bursa at the end of the procedure to facilitate the prompt pain relief and functional recovery. although corticosteroids represent the most powerful drugs to reduce inflammation and pain, their use is associated to important side effects, mainly the suppression of the hypothalamus-pituitary-axis (hpa). at the same time, no standardized protocols exist regarding the best type and dose of corticosteroid to be injected in association to the above mentioned treatment, nor data evaluating the exact duration of hpa suppression following a single intrabursal injection of corticosteroids. 40 patients affected by rotator cuff calcific tendonitis will be enrolled in the study and randomly assigned to two groups: one group (20 patients) will be treated with a single intrabursal injection of 40 mg of methylprednisolone; the other group (20 patients) will be treated with a single intrabursal injection of 40 mg of triamcinolone. all patients will be tested at time 0 (morning before treatment) and at 1, 7, 15, 30 and 45 days after the injection, using clinical, laboratory and us parameters in order to compare the efficacy and safety of the two drugs.

Eligibility criteria:
inclusion criteria: * painful rotator cuff calcific tendonitis demonstrated by ultrasounds exclusion criteria: * pregnancy * use of corticosteroids in the previous 2 months * systemic chronic inflammatory or allergic diseases * allergy to methylprednisolone or triamcinolone * diabetes * glaucoma * coagulopathies or current treatment with antiaggregants or anticoagulants * septic arthritis or infections * calcific enthesopathy

Keywords: rotatory cuff calcific tendonitis corticosteroids us guided percutaneous treatment methylprednisolone triamcinolone hypothalamus pituitary adrenal axis
de-escalated treatment approach for adult ph-negative acute lymphoblastic leukemia (all)

Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Summary: no high-dose methotrexate (mtx) and high-dose cytarabine (ara-c) consolidation blocks, l-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, t-all patients in complete remossion (cr) after the informed consent are randomized to: auto-hsct vs no auto-hsct, - with the similar further maintenance. stem cell harvest is performed after the 3rd consolidation by g-scf disregarding minimal residual disease (mrd) level. auto-hsct is planned after the 5th consolidation phase. all primary bone samples are collected and tested for cytogenetics and molecular markers, all included patients are monitored by flow cytometry by aberrant immunophenotype in a centralized lab.

* 7 days prednisolone prephase * 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses, 1. instead of 2 cph injections during induction, 2. instead of 4 ara-c blocks, distribution of of l-asp injections through all phases * after cr achievement t-cell all patients are being randomized to auto-hsct vs no auto-hsct * non-interruptive 5 consolidation phases with dose modification according to wbc and platelets count after cr achievement. rotation of consolidation is permitted * after the 3rd consolidation stem cells harvesting is carried out for t-cell all patients randomized to auto-hsct * auto-hsct after the 5th consolidation phase with non-myeloablative ceam conditioning * 2 years maintenance for all patients * 21 tit through the whole treatment with higher intensity during induction\|consolidation * centralized mrd monitoring at +70 d, + 133 d, + 190 days; before and after auto-hsct * allo-hsct is planned only for very high risk patients (11q23 all, mrd positivity at day +190)

Eligibility criteria:
inclusion criteria: * age 18-55 yy, newly diagnosed non-treated ph-negative all exclusion criteria: * age \> 55 yy, ph-positivity, relapsed\|refractory all, pretreated all
retrospective analysis of treatment outcomes in patients with bacterial overgrowth syndrome diagnosed by d-xylose breath testing

Conditions: Small Intestinal Bacterial Overgrowth Syndrome (SIBO); Small Bowel Bacterial Overgrowth Syndrome (SBBOS)

Summary: the objective of this study is to compare the efficacy of prokinetics versus antibiotics versus a combination of antibiotics plus prokinetics in the eradication of small-intestinal bacterial over-growth syndrome (sibo) in those with and without a positive d-xylose breath test. hypothesis: patients with sibo treated with a combination of prokinetics and in particular octreotide and antibiotics will have reduced recurrence rates of sibo than either therapy given alone.

we want to determine whether treatment with prokinetics such as octreotide, azithromycin, erythromycin or tegaserod alone, versus antibiotics alone, or combination of antibiotics plus prokinetics results in symptomatic improvement in patients with sibo (defined by a positive d xylose breath test).

Eligibility criteria:
inclusion criteria: * patients who have had 14 c-d-xylose breath test performed in gi motility laboratory at the university of florida exclusion criteria: * those who cannot tolerate 14 c-d-xylose breath test for any reason

Keywords: small intestinal bacterial overgrowth syndrome (sibo) bacterial overgrowth syndrome small bowel bacterial overgrowth syndrome (sbbos) 14-co2 d-xylose breath testing antibiotics prokinteics prokinetic agents
effect of low-level red-light on ultra-high myopia

Conditions: Myopia

Summary: 100 eyes of ultra-high myopia were treated with daily low-level red-light. the age of children ranged from 3 to 16.3 years. the follow-up duration was one year. the objective was to explore the effect of daily low-level red-light on ultra-high myopia treatment


Eligibility criteria:
inclusion criteria: a. the age is over 3 years old and under 18 years old. b. the spherical equivalent error is ≤ -6 d diopter . d. be able to cooperate to complete various eye examinations. e. be able to attend follow-up according to the specified time. f the guardian can accompany the use of the instrument. exclusion criteria: a. complications associated with high myopia (such as choroidal neovascularization, macular split or hole, rhegmatogenous retinal detachment); b other macular diseases (central serous retinopathy) or other eye diseases (e.g.glaucoma, cataract, uveitis); c complicated with photosensitivity, psoriasis, albinism, hyperactivity disorder, nephrotic syndrome and systemic erythema immune system diseases such as lupus; d. other systemic diseases or pregnancy; e. other similar instruments have been used for treatment in the past six months. f. can't cooperate to complete various eye examinations. g. the guardian cannot accompany the use of this instrument.
efficacy of walking exercise with dog on tinnitus complaints in sleep apnea (obstructive sleep apnea)

Conditions: Tinnitus, Subjective; Obstructive Sleep Apnea

Summary: there is evidence that tinnitus (chronic subjective form) is highly prevalent among patients with obstructive sleep apnea. exercise is recommneded in chronic subjective form) and obstructive sleep apnea. walking with dog increase adherence to walking to maintain continuity of physical activity

the total participants will be forty in number.. those participants will complain form tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree).. the particiapnts will divided to groups.. the number of subjects in each group will be 20. the groups (both groups) will follow low calorie diet.. this diet will be applied for 12 weeks.. during this period the study group will receive free walking (30 min) with dog three timmes weekly. the control group will not receive free walking with dog

Eligibility criteria:
inclusion criteria: * obese persons * bilateral chronic subjective tinnitus * mild obstructive sleep apnea (mild apnea hypopnea index) * forty participants exclusion criteria: * body mass index more than 40 kg/m2. * cardiovascular problems * hepatorenal probelms * autoimmune problems * orthopedic probelms
an explorative rva of the motor development of children with dcd <2y

Conditions: Developmental Coordination Disorder; Autism Spectrum Disorder

Summary: this study compares motor development in three groups of infants (controls, dcd, dcd+asd) before the age of 2 years using retrospective video analysis of infants in home video contexts.


Eligibility criteria:
controls: inclusion criteria: * availability of video material of the child before the age of 2. * no indication of dcd (as measured by m-abc-2 pc\>16 and dcd-q) * no indication of asd (as measured by srs-2 t-score ≤60 ) exclusion criteria: * medical diagnosis possibly influencing motor development (dcd, asd, adhd, cp, ect) * severe ilnesses in the early developmental period (0-2y) which may have influenced the development (f.e. cva, cancer, severe traumas,...) * prolonged admission to the hospital (≥ 3 weeks) in the early developmental period (0-2y) dcd group: inclusion criteria: * availability of video material of the child before the age of 2. * formal diagnosis of dcd provided by multidisciplinary team in flanders * indication of dcd (as measured by m-abc-2 pc≤16 and dcd-q) exclusion criteria: * other medical diagnosis possibly influencing motor development (asd, adhd, cp, ect) * severe ilnesses in the early developmental period (0-2y) which may have influenced the development (f.e. cva, cancer, severe traumas,...) * prolonged admission to the hospital (≥ 3 weeks) in the early developmental period (0-2y) dcd+asd group: inclusion criteria: * availability of video material of the child before the age of 2. * formal diagnosis of dcd and asd provided by multidisciplinary team in flanders * indication of dcd (as measured by m-abc-2 pc≤16 and dcd-q) * indication of asd (as measured by srs-2 t-score \>60 ) exclusion criteria: * other medical diagnosis possibly influencing motor development (adhd, cp, ect.) * severe ilnesses in the early developmental period (0-2y) which may have influenced the development (f.e. cva, cancer, severe traumas,...) * prolonged admission to the hospital (≥ 3 weeks) in the early developmental period (0-2y)

Keywords: motor development baby infant motor milestones crawling independent walking