Kornimate/medical-research-clean huggingface dataset:
adjunctive clindamycin versus linezolid for β-lactam treated patients with invasive group a streptococcal infections

Conditions: Streptococcal Sepsis; Invasive Group A Beta-Haemolytic Streptococcal Disease; Necrotizing Soft Tissue Infection; Infection, Bloodstream; Infection, Bacterial; Streptococcal Toxic Shock Syndrome

Summary: this study aims to emulate a hypothetical target pragmatic multi-center, non-blinded trial of adult inpatients in the pinc aitm dataset with b-lactam treated culture confirmed monomicrobial invasive group a streptococcus (gas) between the years 2015-2021


Eligibility criteria:
inclusion criteria: * adult inpatients patients (=\> 18 y of age) * monomicrobial group a streptococcus invasive infection * primary therapy with a b-lactam agent (initiated before or on same day as adjunctive anti-toxin therapy) exclusion criteria: * patients with a polymicrobial gas culture (non-gas organisms identified on eligibility gas culture) * patients who received linezolid but have a documented linezolid resistant isolate * patients with gas infections of non-sterile non-invasive sites (i.e sites which do not meet above mentioned inclusion criteria) which include but not limited to the lower urinary tract, upper respiratory tract * patient with concomitant mssa/mrsa invasive infection (+/- seven days of index gas eligibility culture) * patients who receive both anti-toxin agents (violation of protocol) * patient who do not complete at least 3 days of b-lactam (violation of protocol)

Keywords: invasive gas necrotizing soft tissue infection streptococcal toxic shock syndrome linezolid clindamycin anti-toxin therapy
predictors for analgesic effect to standardized exercise therapy for osteoarthritic pain

Conditions: Osteoarthritis, Knee; Healthy Subjects

Summary: pain sensitization has been associated with pain severity in people with knee osteoarthritis (koa) and a neuropathic pain component has been identified in up to 30% of koa patients. in addition, exercise-induced hypoalgesia (eih), a measure of descending pain control, has previously been found dysfunctional in a subgroup of people with painful koa and has also been utilized as a predictive factor for pain progression following total knee replacement. measures of pain sensitization have been used prognostic to identify responders to treatment but eih as a prognostic tool for physiotherapy-guided evidence-based exercise therapy (peet) has not been investigated. the primary aim of this explorative study is to investigate if eih assessed pre-peet was associated with changes in pain, disability and paindetect (pdq) score post-peet. the secondary aim is to investigate if peet changes eih and pdq score in patients with painful koa. part 2: cross-sectional studies indicate, that daily level of activity influence the effectivity of the eih mechanims, while pain patients (e.g. koa patients) can have normal of dysfunctional eih. it has not been investigated if eih changes after prolonged exercise in healthy subjects. the aim of this secord part of the study, is to investigate if eih changes after 6-9 weeks of intensive military training in healthy subjects


Eligibility criteria:
inclusion criteria: * the american college of rheumatology for clinical knee osteoarthritis (excluding radiological oa assessment) exclusion criteria: * known factors to influence pain and pain sensitization. part 2: inclusion criteria * starting as recruits in defence command denmark exclusion criteria: * known factors to influence pain and pain sensitization.
effect of maolactin™ fmr on exercise recovery, inflammation and muscle comfort in an otherwise healthy population

Conditions: Chronic Inflammation; Mobility; Muscle Pain; Joint Pain

Summary: this is a double blind, randomised, placebo-controlled, parallel-group trial to evaluate the effect of maolactin fmr supplementation on chronic inflammation, mobility and muscle and joint pain in an otherwise healthy population of adults 45-65 years old over 14 weeks with 12 weeks supplementation. this is part b of the study.


Eligibility criteria:
inclusion criteria: * adults 45-65 years old * generally healthy * bmi 25.0 - 35.0 kg/m2 * c-reactive protein (crp) equal to or greater than 2.0 mg/l * feel pain or discomfort in joints/muscle for at least 3 months * able to provide informed consent * agree not to change current diet and/or exercise frequency or intensity during study period * agree to not participate in another clinical trial while enrolled in this trial exclusion criteria: * serious illness(1) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as ms, kidney disease, liver disease or heart conditions * unstable illness(2) e.g., diabetes and thyroid gland dysfunction * unstable intake of any medication or supplement(3) * acute injuries on reporting area * current malignancy (excluding basal cell carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years * currently taking coumadin (warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy including low dose aspirin * receiving medications known to affect inflammation such as steroids * active smokers, nicotine use or drug (prescription or illegal substances) abuse * chronic past and/or current alcohol use (\>21 alcoholic drinks per week) * pregnant or lactating women * allergic to any of the ingredients in active or placebo formula * participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month * any condition which in the opinion of the investigator makes the participant unsuitable for inclusion 1. a serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments. 2. an unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. 3. an unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks
efficacy of intermittent abdominal pressure ventilation in neuromuscular patients

Conditions: Neuromuscular Diseases

Summary: non-invasive ventilation (niv) is an established treatment to manage respiratory muscles dysfunction in neuromuscular disease, preventing the progression of respiratory failure to intubation and/or a tracheotomy. niv is commonly needed at first during the night, but when the disease worsens, it is required during the day. it is provided via nasal or oronasal masks, causing discomfort and/or aesthetic issues that result in poor compliance. intermittent abdominal pressure ventilation (iapv) is a valid, though unconventional, alternative to daytime niv: it consists of a portable ventilator with an internal battery and a corset as interface. the iapv corset is lightweight, comfortable and, thanks to velcro fasteners, easier and better fitting than a face mask. cyclical inflation of a rubber bladder inside the corset moves the diaphragm upwards like a pneumobelt causing air to enter in the lungs via the upper airways as gravity draws the diaphragm back to its resting position. iapv is indicated in neuromuscular disease and has already been tested in few preliminary studies and case reports. this study wants to verify the hypothesis of its application in population of neuromuscular patients.


Eligibility criteria:
inclusion criteria: * diagnosis of neuromuscular disease (amyotrophic lateral sclerosis, duchenne muscular dystrophy, spinal muscular atrophy, pompe disease) * non invasive ventilation \> 16 hours/day * informed consent signed exclusion criteria: - diagnosis of kyphoscoliosis

Keywords: neuromuscular diseases; intermittent abdominal pressure ventilation; iapv;
trial of modifications to radical prostatectomy

Conditions: Prostate Cancer

Summary: this trial will evaluate whether the following aspect of surgical technique influence outcome: lymph node dissection. in some patients, scans taken before surgery show that a lymph node has cancer. surgeons make sure to remove those affect lymph nodes and all other lymph nodes in the area. however, it is not known whether removing lymph nodes helps prostate cancer patients whose scans do not show positive nodes. in this study, patients with clear scans will either receive a lymph node dissection or not."


Eligibility criteria:
inclusion criteria: * patients do not have to be eligible for both modifications to be included in the study. lymphadenectomy vs no lymphadenectomy: * patients 21 years or older scheduled for radical prostatectomy for treatment of prostate cancer with one of the consenting surgeons at mskcc hemostatic agent vs. no hemostatic agent * patients 21 years or older scheduled for minimally invasive radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at mskc exclusion criteria: lymphadenectomy vs no lymphadenectomy * presence of positive/suspicious pelvic nodes on mri, ct or psma scan (positive/suspicious defined as a pelvic node \>15mm in short axis on ct or mri, a psma avid node, or a node with abnormal morphology such as roundness or irregularity or loss of fatty hilum) * any prior pelvic radiation therapy used to treat prostate cancer hemostatic agent vs. no hemostatic agent * no additional exclusion criteria

Keywords: radical prostatectomy anastomotic suturing lymph node dissection 11-096
imaging multiparametric/multimodality for lungcancer

Conditions: Lungcancer

Summary: 1. to build an imaging biobank of 200 patients with lungcancer, including pathologic and molecular characteristics of the tumor (mutational status, circulating deoxyribonucleic acid (dna) from serum biobank...), staging of the cancer (according to the new 2016 tumor node metastasis (tnm) status, the table that classify non-small cell lungcancer) and follow-up informations (response to first-line treatment (response evaluation criteria in solid tumors (recist)), disease-free survival, 1-3 years survival). 2. to propose a simple severity scoring system based on tumor features such as size, doubling time (if available), location, amount of enhancement and necrosis. such approach has been proposed for glioma evaluation (visually accessible rembrandt images (vasari)) but is not available for the lung. the objective is to do better than the tumor node metastasis (tnm) staging. 3. to develop and evaluate an intravoxel incoherent motion (ivim) protocol for lungcancer evaluation.


Eligibility criteria:
inclusion criteria: * adults over 18 years * high suspicion of lungcancer confirmed * tumor \> 2 cm * incomplete cerebral staging or not yet realized in the initial consultation of screening exclusion criteria: * lungcancer medical history * during pregnancy * contraindications to mri * patient not able to understand the information of the protocol, taking into account the state of the brain * patient unable to keep lying in mri the necessary time
placebo-controlled study of mometasone furoate nasal spray (mfns) 200 mcg once daily (qd) in the treatment of seasonal allergic rhinitis (study p05067)(completed)

Conditions: Seasonal Allergic Rhinitis

Summary: this study is designed to assess the effectiveness of mometasone furoate nasal spay (mfns) once daily (qd) compared with placebo in subjects with seasonal allergic rhinitis (sar) in reducing the total nasal symptom score and the total ocular symptom score.


Eligibility criteria:
inclusion criteria: * must be 12 years of age or older, of either sex and of any race. * must have at least a 2-year documented history of sar which exacerbates during the study season. * must have a positive skin-prick test response to an appropriate seasonal allergen at screening (visit 1). immunoglobulin e (ige)-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes. * must be clinically symptomatic at the screening visit. * must be clinically symptomatic at the baseline visit. * must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ecg) results. clinical laboratory test (complete blood count \[cbc\], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor. * must be free of any clinically significant disease, other than sar, that would interfere with the study evaluations. exclusion criteria: * a history of anaphylaxis and/or other severe local reaction(s) to skin testing. * a subject with asthma who requires chronic use of inhaled or systemic corticosteroids. * current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. * a subject with rhinitis medicamentosa. * a history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays. * a subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the screening visit, or who has had a viral upper respiratory infection within 7 days before the screening visit. * a subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow. * a subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
study of pep02 as a second line therapy for metastatic pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: the purpose of this study is to see the effect of pep02 in the treatment of metastatic pancreatic cancer.

gemcitabine monotherapy or a gemcitabine-based combination regimen is the standard first line therapy for advanced pancreatic cancer. after disease progression, there is no standard treatment available. in animal studies and a previous phase i trial, pep02 has shown anti-tumor activity and preliminary efficacy in pancreatic cancer. in addition, a phase ii study of free-form irinotecan single agent has already shown encouraging activity as second-line treatment for patients with advanced pancreatic cancer refractory to gemcitabine. the liposome formulation of pep02 theoretically has therapeutic advantages over free-form irinotecan, such as site-specific delivery and extended release of drug. hence pep02 may be able to provide better efficacy than free-form irinotecan. the primary purpose of this phase ii study is to evaluate the activity of pep02 as a second-line therapy in patients with metastatic pancreatic cancer failed to gemcitabine treatment. the primary goal is to measure the 3-month survival rate. an optimal simon's 2-stage design will be used for this exploratory phase ii study.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of exocrine pancreas * metastatic disease * documented disease progression after treatment with 1 line of prior gemcitabine-based regimen * karnofsky performance status equal or more than 70 exclusion criteria: * with active cns metastases * with clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea \> grade 1) * major surgery or radiotherapy within 4 weeks * prior participation in any investigational drug study within 4 weeks * with prior irinotecan treatment

Keywords: phase ii study second line pancreatic cancer metastatic
hydroxychloroquine (hcq) for recurrent pregnancy loss

Conditions: Recurrent Pregnancy Loss

Summary: recurrent pregnancy loss (rpl) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to achieve parenthood. most cases of rpl are unexplained and have no effective treatment to improve the chance of a live birth. exciting indications for using hydroxychloroquine (hcq) include: malaria profylaxis and treatment, systemic and discoid lupus erythematosus (sle) and rheumatoid athritis (ra). hcq has been reported to have the following properties (anti-thrombotic, vascular-protective, immunomodulatory, improving glucose tolerance, lipid-lowering, and anti-infectious). there is no data concerning the benefit of hcq in rpl. administration for other indications provides extensive safety data during pregnancy. this study has the potential to establish support for a new treatment option for unexplained rpl.


Eligibility criteria:
inclusion criteria: 1. ≥ 4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained rpl 2. ≥ 3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained rpl with minimum one second trimester loss. exclusion criteria: 1. age below 18 years or above 39 at inclusion 2. abnomal uterine anatomi at hysterosalpingography/hysteroscopy or hydrosonography 3. chromosomal abnormalities within the couple 4. menstrual cycle below 23 days or above 35 days 5. lupusantikoagulans positivity or immunoglobulin (ig)g/igm anticardiolipinantibodies (≥10 gpl ku/l at rigshospitalets laboratorium) or plasma homocystein ≥25 mikrogr./l at repeated measurement with 12 weeks interval. 6. hiv or hepatitis b or c positive 7. psoriasis, retinopathy og serious imparied hearing (contraindications for hcq) 8. chronic disease that lead to intake of immunemodulatory drugs or potentially pregnancy toxic agents 9. hemoglobin ≤ 6.5 mmol/l, leukocytes \<3.5 e9/l, platelets \<145 e9/l at inclusion 10. previous treatment with hcq in pregnancy 11. \>1previous live birth 12. previous participation in this trial
us inhaled insulin therapeutic choice questionnaire study

Conditions: Diabetes Mellitus, Type 2

Summary: this is a questionnaire based study (no study drug is involved) that asks if more patients with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next treatment choice if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments. this study will also ask if patients with uncontrolled type 2 diabetes currently managed on diabetes pills + once daily insulin will choose as the next treatment choice to take insulin multiple times a day if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments.


Eligibility criteria:
inclusion criteria: * male and female, age \> = 18 years and \<= 80 years with a diagnosis of type 2 diabetes made at least 6 months prior to study entry * currently treated with either: * 2 or more oral antidiabetic agents, or 1 or more oral antidiabetic agents and insulin glargine exclusion criteria: * type 1 diabetes * smoking within the past 6 months
role of oral lactoferrin in prevention of recurnt bacterial vaginosis in pregnancy

Conditions: Bacterial Vaginosis &#X7C; Vaginal &#X7C; Microbiology

Summary: lactoferrin is believed to modulate immunity and help in prevention of recurrent bacterial vaginosis.in this study, the role of lactoferrin is assessed during third trimester of pregnancy.

this study will be conducted at zagazig university hospitals, obestetrics and gynecology department, zagazig university ,outpatient clinic .assuming the cure rate was 70.8% vs 33.3% in intervention vs placebo group. at 80% power and 95 % ci, the estimated sample will be 66 cases, 33 cases in each group. among enrolled women those who have symptome of bacterial vaginosis will be treated with standard antibiotic therapy (metronidazole 500 mg twice daily for 7 days) and women who have history of recurrent bacterial vaginosis randomly assigned to one of two study arms: study grop receiving lactoferrin (2 capsules/day for 5 days followed by further 10 consecutive days at the dosage of 1 capsule/day) by oral intake.(pravotinr). and another group not reciving lactoferrin.(control group) during follow-up period, all women ingested 1 capsule of lactoferrin or placebo per day, for 10 consecutive days per month.(study group) . - all participating women attended 3 visits (from t0 to t2) at the gynaecologic centres at recruitment (t0), swap will be repeated after one month (t1) and two months (t2). in each clinical examination, 2 vaginal swabs (for vaginal culture and nugent score) will be collected. during the first visit (baseline), patient medical history was recorded, informed consent was signed and women were allocated into the two study arms. - the evaluation of efficacy is based on clinical cure rate of bv symptoms (defined as absence of vaginal discharge or itching), microbiological cure rate (defined as remission and vaginal microbiota improvement by restoration of healthy nugent score with range 0-3), and overall cure rate (absence of symptoms and nugent score \<7). in addition, recurrence rate was calculated for both groups as percentage of women presenting with symptoms and nugent score more than 3 during the follow-up period. safety is assessed by recording all side effects (i.e. adverse events, serious adverse events, and suspected unexpected serious adverse reactions). an adverse event is considered severe if it was fatal, life threatening, required hospitalisation, or led to permanent injury.

Eligibility criteria:
inclusion criteria: 1. pregnant women of age group 20-37 years. 2. primigravida. 3. 28-40 week gestation. 4. history of receurent bacterial vaginosis . exclusion criteria: 1. multiple gestations. 2. multiparity. 3. medical disorders as: * diabetes mellitus. * chronic hypertension. * endocrinal diseases. * autoimmune diseases. * renal diseases. * blood diseases. 4. allergy to lactoferrin .
immediate effects of bowen technique versus dynamic soft tissue mobilization on hamstrings tightness in chronic non-specific low back pain.

Conditions: Hamstring Tightness

Summary: low back pain (lbp) is leading cause of disability and its burden is growing worldwide with an increasing and ageing of population. poor flexibility or tightness of hamstring muscle has been associated with low back pain. it is a prominent cause of activity limitations and work absenteeism throughout world. hence this study was designed to find out superior form of effective technique on active knee extension and experience of pain and disability in chronic nonspecific low back pain.

low back pain (lbp) is leading cause of disability and it is most leading cause of work absenteeism throughout world. poor flexibility or tightness of hamstring muscle has been associated with low back pain. hence this study was designed to find out superior form of effective technique on hamstrings tightness and experience of pain and disability in chronic nonspecific low back pain. this study will also assist to set the foundation for further more studies designing magnificent protocols of treatment for affected population.

Eligibility criteria:
inclusion criteria: * the patients aged 18-45 years will be included in the study. * patients with chronic low back pain (more than 3 months) will be included. * both genders. * 20 to 40 degrees active knee extension loss with hip in 90 degree flexion * pain intensity (moderate to severe) nprs (4-6 intensity) exclusion criteria: * individuals who were receiving treatment for their pain with another(medical treatment) at the same time * patients who had undergone vertebral column surgery (less than three months before the time of this study). * patients with the infection, neoplasms, metastasis, rheumatoid arthritis, fractures or inflammatory processes were excluded. * dislocations of lower limb * hypermobility of lower limb joint * hamstrings injuries * nerve lesions of lower limb

Keywords: low back pain