Kornimate/medical-research-clean huggingface dataset:
effect of the consumption of a fermented milk enriched with plant sterols (italy)

Conditions: Mildly Hypercholesterolemic Subjects

Summary: the purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins


Eligibility criteria:
inclusion criteria: * male and female aged 20-75 years; bmi between 19 and 30 kg/m2 , ldl-cholesterol plasma level between 130 mg/dl to 190 mg/dl (bounds included) with or without any statin monotherapy, with stabilized hypercholesterolemia (since more than 3 months), accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (ncep-atp iii guidelines), used to consume dairy products, agreeing to a written informed consent, for female: effective contraceptive methods used exclusion criteria: * subject with plasma triglycerides (tg) levels \> or = 350 mg/dl, with any cardiovascular event in the last 6 months, subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy, diabetic (type i and type ii), smoking strictly more than 20 cigarettes/day, presenting known allergy or hypersensitivity to milk proteins, and soy, receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with renal failure or any other metabolic disorder which could interfere with the evaluation of efficiency or safety of the product , pregnant and breast feeding women

Keywords: plant sterol - hypercholesterolemia - diet - dairy
the use of fibrin sealant to reduce bleeding after total knee replacement

Conditions: Total Knee Replacement; Primary Knee Arthroplasty; Osteoarthritis of the Knee

Summary: a randomized controlled study is performed to address the question of whether the topical application of a novel fibrin sealant, evicel (johnson \& johnson wound management, ethicon, somerville, nj) in patient undergoing total knee replacement (tkr) reduce the perioperative blood loss and the need for allogenic blood transfusion compared to a control group. we hypothesize that fibrin sealant decrease the drop in post-operative hemoglobin level after total knee replacement.

total knee replacement is an invasive surgical procedure that can expose patients to massive perioperative bleeding. this hematic loss results in a high rate of blood transfusion after total knee replacement (tkr) with an incidence from 10% to 58%.methods to prevent the need for allogenic blood transfusion after tkr include hemodilution, perioperative blood salvage and reinfusion, hypotensive anesthesia, preoperative autologous blood donation and intravenous administration of tranexamic acid. in the last decade, the topical use of fibrin sealant has become a logical surgical stratagem for reducing blood loss in total knee arthroplasty.fibrin sealants mimic the final step of the coagulation cascade reducing blood loss and transfusion requirements. a novel hemostatic agent derived from banked allogenic human plasma (evicel, johnson \& johnson wound management, ethicon, somerville, nj) is recently available on the market for a variety of surgical specialty. a randomized controlled study is conducted to test if the post-operative reduction in hemoglobin level would be lower in the fibrin sealant group compared to a control group.

Eligibility criteria:
inclusion criteria: * patient scheduled for tkr * written informed consent * diagnosis of osteoarthritis exclusion criteria: * previous intervention on the same knee (except for meniscectomy) * hb pre-operative level lower than 12g/dl for man and 11g/dl for woman * anticoagulation therapy or any anti-aggregate treatment not suspended at least 4 days before surgery

Keywords: tkr blood loss fibrin sealant
a study to evaluate the use of extended release alprazolam in the treatment of adolescents with panic disorder

Conditions: Panic Disorder

Summary: the purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics of alprazolam extended release (xr) for the treatment of adolescents with panic disorder

due to recruitment difficulties in this adolescent population, the clinical program for alprazolam xr was cancelled and this study was terminated on 1 september 2004. there were no safety concerns that led to this decision.

Eligibility criteria:
inclusion criteria: * a primary dsm-iv-tr diagnosis of panic disorder with or without agoraphobia based on the mini international neuropsychiatric interview for children and adolescents * at least an average of one 4-symptom panic attack per week over the last 4 weeks prior to screening * at least an average of one 4-symptom panic attack per week over the last 4 weeks prior to baseline * at least one 4-symptom panic attack in the 7 days prior to baseline exclusion criteria: * current (in the past 6 months) dsm-iv-tr diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence * primary dsm-iv-tr diagnosis of social anxiety disorder, post-traumatic stress disorder, simple phobia, separation anxiety disorder, generalized anxiety disorder, conduct disorder, oppositional defiant disorder, or attention deficit hyperactivity disorder * any current or past history of schizophrenia or psychosis; bipolar disorder or cyclothymia; dementia, delirium or other organic brain disease; an axis i eating disorder; mental retardation, asperger's disorder, or any other serious developmental disorder * a cdrs-r score \>35
patterns of care and outcomes in patients with metastatic bone tumors (metabone)

Conditions: Metastatic Bone Tumor

Summary: bone tumors make up about 3-5% of childhood cancers and less than 1% of cancers in adults. of these, osteosarcoma (oss) is the most commonly diagnosed primary malignant bone tumor. oss is a primary mesenchymal malignant tumor of bone characterized by the production of osteoid or immature bone by the malignant cells. despite its rarity, oss is the most common primary malignancy of bone in children and adolescents, and the fifth most common malignancy among adolescents and young adults aged 15 to 19 years. ewing sarcoma (es) is the second most frequent bone tumors in children and may arise also in soft tissues. this disease encompasses tumors formerly known as askin's tumor, peripheral neuroectodermal tumor (pnet) and the ewing sarcoma family of tumors (esft). chondrosarcoma are rare sarcoma reputed chemorefractory in the non-operable setting and for which little is known in terms of palliative management with systemic treatments. despite adequate loco-regional treatment, up to 40% of patients with sarcoma, soft tissue or bone, will develop metastatic disease. when metastases are detected, the standard of care is based on palliative chemotherapy with a median survival in this setting of only 18 months. a slight improvement has been obtained over years thank to registration of a couple of drugs such as trabectedin and pazopanib, the first antiangiogenic registered for soft tissue sarcoma patients. pazopanib is routinely prescribed worldwide after failure of first line chemotherapy in soft tissue sarcoma. however, bone tumors have not benefited from these small advances yet and treatment still rely on chemotherapy combining doxorubicine cisplatinum and ifosfamide. there is no standard in relapse and palliative settings, and after failure of these agents the survival is very poor. bone sarcomas are therefore tumors with very little available data and low level of evidence on palliative systemic treatments in clinical trials and in the real life setting. the primary objective of the metabone study is to conduct a retrospective descriptive analysis of clinic-biological profiles, patterns of care and modalities of treatment for a set of patients with malignant bone tumors in a real-life national setting.


Eligibility criteria:
inclusion criteria: * patients of all ages * informed consent obtained for inclusion in the databases * histology of ewing's sarcoma type, osteosarcoma, chondrosarcoma * diagnostic between 2007 and 2016
gallium ga 68-dotatate pet/ct in predicting tumor growth in patients with meningiomas

Conditions: Meningioma

Summary: this phase i trial studies how well gallium ga 68-dotatate positron emission tomography (pet)/computed tomography (ct) works in predicting tumor growth in patients with meningiomas. giving gallium ga 68-dotatate before pet/ct scan may work better in predicting tumor growth in patients with meningiomas.

primary objectives: i. to assess the ability of imaging with gallium ga 68-dotatate (68ga-dotatate) positron emission tomography/computed tomography (pet/ct). ii. to assess a metabolic response to radiation therapy in meningiomas as measured by a reduction in the tumor to background ratio of the maximum standardized uptake values (suv) of the tumor compared to background brain parenchyma. outline: patients receive gallium ga 68-dotatate intravenously (iv) over a few minutes and, after 60 minutes, undergo a pet/ct scan over 5-10 minutes 14 days before starting scheduled radiation therapy and 6 weeks after completion of radiation treatment.

Eligibility criteria:
inclusion criteria: * any meningioma with at least 10 mm measurable residual disease. * age 18 years or older. * planned radiation therapy for meningioma. * ability to understand and the willingness to sign a irb approved written informed consent document in accordance with regulatory and institutional guidelines before study entry. * no restriction based on language that would prohibit enrollment of the participant. irb approved vtps form will be utilized when non-english speaking patient is enrolled exclusion criteria: * neurofibromatosis type 1 or 2. * children. * pregnant. * contraindication to mr imaging. * body weight greater than 400 lbs (181.4kg).
multicomponent therapy with telerehabilitation

Conditions: Fibromyalgia

Summary: in this prospective, randomized study, our aim was to evaluate the comprehensive multicomponent treatment of fibromyalgia women with telerehabilitation, including "patient education, special psychotherapy/psychosocial intervention, and exercise including relaxation exercises". does it differ in terms of reduction and functionality?

patients who meet the inclusion criteria will be randomized into two groups by computer program after being numbered according to the order of application. 33 patients in the multicomponent treatment group selected to group 1 (g1) will be treated with telerehabilitation for a total of 6 sessions of two hours once a week for 3 weeks. after 1 month, one more session will be applied for a two-hour follow-up and sustainability. as a control group, 33 patients selected to group 2 (g2) will be given exercise and training with telerehabilitation. patients to whom a multicomponent treatment program will be applied will be included in the program in groups of 10. the presentations will be prepared as power-point presentations and will be presented to the patients online with telerehabilitation. interventions to be applied in the multicomponent treatment protocol: 1. patient education 2. exercise training 3. private psychotherapy 4. relaxation

Eligibility criteria:
inclusion criteria: 1. women 2. symptom persistence for more than 3 months 3. pervasive network scale score \>7 and symptom severity score \>5 according to 2016 acr criteria 4. symptom severity score of \>9 and diffuse pain scale score between 4-6 according to 2016 acr criteria 5. getting a high (11 and above) score on the hospital anxiety and depression scale 6. having the opportunity to participate in the applications online 7. no change in the medical treatment he received for fibromyalgia syndrome during the study period 8. those between the ages of 18-55 exclusion criteria: 1. patients with endocrine, neuromuscular, infectious and inflammatory rheumatological diseases 2. patients with liver or kidney disease 3. patients with malignancy 4. patients with a history of severe trauma 5. patients with severe psychiatric illness 6. patients with serious physical comorbidities 7. the illiterate 8. known central nervous system or peripheral nervous system disease, progressive neurological deficit 9. peripheral venous insufficiency, coagulopathies and anticoagulant drug use 10. serious cardiovascular pathologies 11. loss of sensation, loss of position sense, unhealed fracture or open surgical wound 12. pregnancy

Keywords: telerehabilitation multicomponent therapy psychotherapy pain fibromyalgia
clonidine with morphine in patient controlled analgesia pump in vaso-occlusive crisis in sickle cell disease patient

Conditions: Sickle Cell Disease; Vaso-occlusive Pain Episode in Sickle Cell Disease

Summary: vaso-occlusive crisis are highly painful in sickle-cell patients. morphine is the treatment of choice for this pain. various adjuncts have been studied for the treatment of vaso-occlusive crisis. the investigators aimed to study the effect of clonidine associated with morphine in pcia (patient controlled intravenous analgesia pumps) regimen. the investigators will compare it to the morphine alone in pcia for the treatment of vaso-occlusive pain. the investigators will measure the morphine consumption of all patient, the impact on the apparition of the morphine secondary effect and on inflammation biomarkers and the biopsychosocial respond. each patient will be hospitalized and follow by haematologist from the hospital, pain doctors and nurses. it will be a double blind randomised, prospective study. the randomisation will be done by the pharmacy.


Eligibility criteria:
inclusion criteria: * vaso-occlusive crisis in sickle cell disease patients exclusion criteria: * minor * patient's refusal * pregnancy * contr-indication clonidine therapy

Keywords: clonidine morphine acute pain management patient controlled analgesia
effect of covid-19 on platelet aggregation

Conditions: COVID-19; SARS-CoV-2

Summary: this is a mechanistic, observational, prospective, case and control study, to compare platelet aggregation, analyzed by multiplate-adp, in hospitalized patients diagnosed with covid-19 versus healthy controls. thus will be included 60 patients who present with respiratory symptoms within 72 hours of hospitalization and confirmation of the diagnosis of covid-19 by laboratory method (rt -pcr and / or positive serology for sars-cov-2 - covid group); this group will be compared to 60 healthy individuals (asymptomatic and with negative sars-cov-2 serology), matched by sex and age to the previous group.

there is strong evidence that sars-cov-2 infection is associated with atherothrombotic phenomena. however, platelet activity in covid-19 has not yet been studied. thus, the main objective of this project is to evaluate platelet aggregation by the multiplate-adp method in hospitalized patients diagnosed with covid-19, in comparison with the platelet aggregation evaluated by the same method in healthy controls. secondary objectives include the assessment of parameters related to coagulation, inflammation, and clinical outcome variables. this is a mechanistic, observational, prospective, case and control study, which will include 60 patients who present with respiratory symptoms within 72 hours of hospitalization and confirmation of the diagnosis of covid-19 by laboratory method (rt -pcr and / or positive serology for sars-cov-2 - covid group); this group will be compared to 60 healthy individuals (asymptomatic and with negative sars-cov-2 serology), matched by sex and age to the previous group.

Eligibility criteria:
inclusion criteria: * agreement to sign the free and informed consent form (icf). * case group: patients with up to 72 hours of hospitalization for respiratory symptoms. * control group: healthy volunteers, defined as having no history (confirmed or suspected) of covid-19 or chronic diseases (except hypertension, obesity, dyslipidemia) exclusion criteria: * known platelet dysfunction or platelet count \ 450,000 / µl; * terminal illness; * known liver disease or clotting disorder; * hematocrit less than 34% or greater than 55%; * previous use of antiplatelet agents and / or anticoagulants (except acetylsalicylic acid and prophylactic heparin); * patients on invasive mechanical ventilation or receiving high oxygen flow.

Keywords: platelet aggreggation covid-19 sars-cov-2 multiplate
investigating best practices for children with cerebral palsy: a pilot study of two approaches

Conditions: Cerebral Palsy

Summary: this project (co-op ii) is the second in a series of three studies to validate a new treatment approach for children with cerebral palsy (cp). the initial study was comprised of a series of four single case studies with children with cp. it evaluated the potential of the cognitive orientation to occupational performance (co-op) approach to be used with children with cp and tested the procedures for co-op ii. the overall objective of the full series of studies is to determine whether better functional outcomes are achieved for children with cp with co-op intervention than with contemporary occupational therapy treatment. the primary objective of co-op ii is to establish the feasibility of conducting a full scale randomize control trial (rct) to discover if there are differences in functional outcomes (i.e., improvement in task performance, self efficacy) between a group of children with cp receiving co-op therapy and a group receiving a contemporary treatment approach (cta). in order to meet this objective, a pilot rct will be conducted to answer the specific research questions outlined below: 1. do children wiht cp acquire the skills they set as goals in each of the two treatment groups? 2. do the acquired skills generalize and transfer? 3. are the skills maintained at 4 months post intervention? 4. does the co-op approach produce a larger effect on skill acquisition and self efficacy than the cta? 5. does amount of parent involvement have any effect on skill acquisition or self efficacy? completion of this pilot rct will provide the necessary data to conduct a full study to test the following hypothesis: - children with cp who receive co-op treatment will be more successful than children receiving cta in improving their performance on child-chosen skills and they self efficacy.


Eligibility criteria:
inclusion criteria: * between 7 and 12 years of age * diagnosis of cerebral palsy with hemiplegia or spastic diplegia * level 1,2 or 3 on the gross motor function classification scale(gmfcs) * normal intelligence (iq\> 85 on at least one scale (verbal or performance) of the kaufman brief intelligence test (kbit-2) * child assent and agreement to participate * parental consent and agreement to participate * sufficient language ability to communicate with and be understood during treatment exclusion criteria: * previously received or presently receiving a cognitive treatment for motor-based performance problems * use of alternative communication system such as pecs or communication board * regular use of botox during intervention period
glycemic targets for pregnant women with gdm and t2dm

Conditions: Diabetes Mellitus in Pregnancy; Diabetes, Gestational; Diabetes Mellitus, Type 2

Summary: the purpose of this randomized clinical trial is to determine whether glycemic targets that are lower than those currently recommended by the american diabetes association (ada) and the american college of obstetricians and gynecologists (acog) would improve overall outcomes in pregnant patients with diabetes. eligible pregnant women with a diagnosis of gestational diabetes or type 2 diabetes will be randomized into either routine care with glycemic targets as currently recommended by ada and acog (control arm), or more aggressive care with lower glycemic targets that more closely resemble normoglycemia in pregnancy (intervention arm). the glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dl, pre-prandial ≤95 mg/dl, and 1-hour postprandial ≤140 mg/dl. the glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dl, pre-prandial ≤80 mg/dl, and 1-hour postprandial ≤110 mg/dl. the primary outcome will be a 250-gram difference in birth weight between the two study arms. secondary maternal and neonatal outcomes of interest will also be compared between the two study arms.


Eligibility criteria:
inclusion criteria: * pregnant women with a singleton gestation * 18 years or older * diagnosis of gestational diabetes (prior to 34 weeks gestational age) or type 2 diabetes exclusion criteria: * diagnosed with gestational diabetes at or beyond 34 weeks gestational age * type 1 diabetes * diabetic retinopathy * diabetic nephropathy * diabetic vasculopathy
1% metformin gel in the treatment of class ii furcation defects

Conditions: Chronic Periodontitis

Summary: metformin (mf), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. the present study aims to explore the efficacy of 1% mf gel as a local drug delivery system in adjunct to scaling and root planing (srp) for the treatment of class ii furcation defects in comparison with placebo gel.

background: metformin (mf), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. the present study aims to explore the efficacy of 1% mf gel as a local drug delivery system in adjunct to scaling and root planing (srp) for the treatment of class ii furcation defects in comparison with placebo gel. methods: sixty four patients with single mandibular buccal class ii furcation defects were categorized into two treatment groups: srp plus 1% mf (group 1) and srp plus placebo (group 2). clinical parameters were recorded at baseline, 3 months, 6 months, and 9 months, and radiographic parameters were recorded at baseline, 6 months, and 9 months. defect fill at baseline, 6 months, and 9 months was calculated on standardized radiographs using image analysis software.

Eligibility criteria:
inclusion criteria: 1. the presence of buccal class ii furcation defects in endodontically vital, asymptomatic mandibular first molars with a radiolucency in the furcation area on an intraoral periapical radiograph with pd≥ 5 mm and horizontal pd≥3 mm following phase i therapy (srp) exclusion criteria: * patients with known systemic disease; patients with known or suspected allergy to the mf; patients receiving systemic mf therapy; patients with aggressive periodontitis; patients using tobacco in any form; patients with alcoholism; patients who were immunocompromised; pregnant or lactating females.