Kornimate/medical-research-clean huggingface dataset:
effects of caloric restriction in obesity and type 2 diabetes

Conditions: Type 2 Diabetes; Obesity

Summary: the study investigates whether a long-term 25% caloric restriction can prevent onset and/or progression of renal function deterioration, retinal involvement and cardiovascular complications in overweight/obese type 2 diabetic patients, trough the amelioration of concomitant metabolic abnormalities such as visceral obesity, insulin resistance, dyslipidemia, hypertension and inflammation. the main aim of the study is therefore to evaluate the role of calorie restriction (cr) on subjects at risk of nephropathy. secondary aims are to better understand the relationship between cr and the following aspects: renal disease and its associated metabolic abnormalities, retinopathy and cardiovascular complications, quality of life and treatment cost.


Eligibility criteria:
inclusion criteria * age \>40 years; * type 2 diabetes (ada criteria); * uae \<300 mg/24h; * body mass index (bmi)\>27kg/m2; * serum creatinine \< 1.2 mg/dl; * no major changes in calorie, protein and sodium intake in the last 6 mos; * no major changes in concomitant treatments with blood pressure, glucose or lipid lowering agents since 6 and 3 months respectively; * patients legally able to give written informed consent to the trial (signed and dated by the patient); * written informed consent. exclusion criteria * concomitant non-diabetic renal disease or ischemic kidney disease; * primary or immune-mediated renal disease; * urinary tract obstruction or infection; * treatment with steroids and/or non-steroid anti-inflammatory agents; * treatment with thiazide or loop diuretics that, on the basis of the investigator's judgment, might sustain hypovolemia and/or sodium depletion (with secondary kidney hypoperfusion/hypofiltration); * hearth failure and/or hemodynamically significant left ventricular systolic dysfunction, cirrhosis, uncontrolled hyperglycemia resulting in glycosuria, hyper/hyponatremia of any cause; * previous surgical procedures for weight loss; * previous episodes of depression, or suicide attempts; * chronic abuse of alcohol and drugs; * pregnancy, ineffective contraception or peri-menopausal age; * cancer or any chronic disease that might affect the completion of the study; * chronic obstructive pulmonary disease (copd) in treatment with positive airway pressure; * unwillingness or inability to adhere to cr intervention over the entire 24-months intervention period; * legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial; * evidence of an uncooperative attitude; * any evidence that patient will not be able to complete the trial follow-up; * inability to fully understand the potential risks and benefits of the study.

Keywords: calorie restriction type 2 diabetes obesity diabetic nephropathy prevention
home-administered trial of direct current stimulation

Conditions: Major Depression

Summary: transcranial direct current stimulation (tdcs) is a novel non-invasive brain stimulation treatment that is effective with no significant side effects. it can potentially be self-administered by patients in their own homes with remote monitoring, substantially reducing treatment costs and increasing accessibility, including to remote areas. this study will evaluate the feasibility and efficacy of home-administered tdcs treatment for depression.


Eligibility criteria:
inclusion criteria: * subject meets criteria for a dsm-iv major depressive episode, lasting more than 4 weeks * total madrs score ≥ 20 exclusion criteria: * diagnosis of any dsm-iv psychotic disorder * history of drug or alcohol abuse or dependence in the preceding 3 months * high suicide risk * clinically defined neurological disorder or insult * metal in the cranium or skull defects * skin lesions on the scalp (e.g. cuts, abrasions, rashes) at the proposed electrode sites * pregnancy
correlation between facial measurements and tooth size and pulp volume

Conditions: Cone-Beam Computed Tomography

Summary: the aim of this study was to investigate the correlation between the measurements of the specific points of the face (lower face height, midface height, the distance between zygomatic, pupillary distance,interalar distance, epicanthus distance, the distance between commissar) and the dimensions of the maxillary sixth molar tooth (mesiodistal distance, buccal palatal distance, root length, pulp volume).

radiographic images of patients who have been indicated for cone-beam computed tomography for the upper jaw for various reasons (such as impacted teeth, sinusitis, skeletal anomalies) will be reviewed retrospectively. facial measurements (lower face height, midface height, inter-zygomatic distance, inter-pupillary distance, interalar distance, epicanthus distance, the distance between commissures) of the patients who received cone beam computed tomography will be measured in the clinic. mesiodistal distance, buccal palatal distance, root length, pulp volume of maxillary sixth tooth will be measured using cone beam computed tomography. the data obtained will be compared.

Eligibility criteria:
inclusion criteria: * upper dental arches which have maxillary first molars * at least one tooth which has no deep caries, filling or crown restoration must be * no resorption or pathology in the root of the tooth which disrupt integrity must be * healthy subjects exclusion criteria: * deep caries, filling or crown restoration * resorption or pathology in the root of the tooth

Keywords: facial measurements dental measurements cone beam computed tomography
quantifiably determine if the botanical formulation, llp-01, has a significant clinical effect on proteomic inflammatory biomarkers and epigenetic changes in healthy, older individuals.

Conditions: Aging; Inflammation

Summary: this is a prospective, interventional, double-blinded placebo-controlled study of up to 40 participants to evaluate the effect of a botanical formulation on inflammatory biomarkers and epigenetic age.

the objective of this study is to understand the impact of a multi-botanical formulation on measurements of protein markers, with a focus on inflammation over a 60-day period. the primary objective of this study is to assess the effect of the formulation, llp-01, on inflammatory proteomic biomarkers and epigenetic changes. adverse events will be self-monitored by participants and will be reported. changes in weight/calculated bmi and grip strength, as well as changes in well-being through a self-reported questionnaire will also be measured.

Eligibility criteria:
inclusion criteria: * age: 50-75 years of age * any sex / gender * all ethnicities * able to participate in a 2 month trial * able to provide informed consent * participant must be able to comply with treatment plan and laboratory tests * can swallow 00 size capsules exclusion criteria: * any clinically diagnosed medical disease or disorder that requires prescribed medication(s) * currently on any anticoagulant medicines, such as warfarin * planned surgical procedure during study period * consumption of any supplements within the last 30 days that include the following botanicals/ingredients: green tea extract, ashwagandha, fisetin, curcumin/turmeric extract, rosemary extract, cordyceps, ginseng * allergy or other sensitivity to any of the botanicals in the investigated product * currently or have been sick (bacterial or viral infection) in the last 14 days * alcoholism or drug addiction * participation in a clinical research trial within 30 days prior to enrollment in this trial * cognitive impairment, illiteracy, inability or unwillingness to give voluntary informed consent * unable or unwilling to provide required blood sample for testing and for use in a scientific publication (personal information undisclosed) * participants with any condition that may preclude venipuncture/ venous blood draw
feeding premature infants during non-invasive respiratory support

Conditions: Premature Infant; Non-invasive Respiratory Support

Summary: a randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support


Eligibility criteria:
inclusion criteria: * infants \<1500gr, on non-invasive respiratory support * feeding\>20 ml/kg/day exclusion criteria: * major congenital malformations * unstable infants because of sepsis, central nervous system, cardiac or other significant morbidities * gastrointestinal morbidity such as spontaneous intestinal perforation (sip) and necrotising enterocolitis (nec).
strength training in fibromyalgia on balance, neuromuscular performance and symptoms

Conditions: Fibromyalgia

Summary: the purpose of this study is verify the effects of a 8 weeks strength training, on balance, neuromuscular performance and symptomatology of fibromyalgia.

thirty participants will be recruited. volunteers will be randomly assigned to the control group or experimental group. before the training period, symptoms, balance and neuromuscular performance will be assessed. participants in the experimental group will perform strength training twice a week (50 min each) for eight weeks. then, four weeks of detraining will be completed.

Eligibility criteria:
inclusion criteria: * medical diagnosis of fibromyalgia according to the american college of rheumatology criteria * at least 18 years old exclusion criteria: * severe comorbidity or any other type of condition that negatively influences participation in the training program * cognitive disorders * heart problems * surgeries or fractures in the last 6 months * regular practice of physical exercises in the least 3 months before program.
study to assess inhibition of spore production in patients with c. difficile infections: fidaxomicin versus vancomycin

Conditions: Clostridium Difficile Infection

Summary: the purpose of this study is to compare number of vegetative cells and spores in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of c. difficile infection.

the purpose of this study is to: * compare quantitatively the number of vegetative cells in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of c. difficile infection * compare quantitatively the number of spores in the stool over time for patients presenting with their first episode of c. difficile infection having been treated with either fidaxomicin or vancomycin.

Eligibility criteria:
inclusion criteria: * 18 years of age and above * first diagnosis of c. difficile infection * treatment for c. difficile infection less than 24 hours * female subjects must be nonpregnant, nonlactating, and either postmenopausal for at least 1 year, surgically sterile (i.e., documented tubal ligation or hysterectomy) for at least 90 days, abstinent, or agree to use 1 of the following forms of contraception from the time of signing the informed consent form (icf) until 30 days after leaving the study site: a nonhormonal intrauterine device (iud) with spermicide, female condom with spermicide, contraceptive sponge with spermicide, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, or a sterile sexual partner. exclusion criteria: * history of hypersensitivity to fidaxomicin or vancomycin * pregnant or breast-feeding * active treatment with other therapies with activity against c. difficile * receiving any peristaltic agents * medical history including ulcerative colitis or chron's disease * ordered to be nothing by mouth or cannot swallow the study medication * participation in another clinical research study utilizing pharmacological treatment within 1 month or five half-lives of the medication whichever is longer * any other reason felt by the investigator to potentially affect the outcomes of the study
study to explore the effect of mefloquine in participants with progressive multifocal leukoencephalopathy (pml)

Conditions: Progressive Multifocal Leukoencephalopathy

Summary: the primary objective of the study was to explore whether mefloquine can delay or stop progression of progressive multifocal leukoencephalopathy (pml) as measured by jc virus (human polyomavirus or jcv) deoxyribonucleic acid (dna) levels in cerebrospinal fluid (csf). the secondary objective of the study was to explore whether mefloquine can delay or stop progression of pml based on neurological deterioration, magnetic resonance imaging (mri) measures of brain lesion evolution or the formation of new lesions, and mortality.


Eligibility criteria:
key inclusion criteria: * diagnosis of pml confirmed by detection of jcv dna in csf. * onset of pml symptoms within 6 months prior to study. key exclusion criteria: * other opportunistic infection of the central nervous system. * current severe illness or any other conditions that, in the opinion of the investigator, would make the subject unsuitable for enrollment. * active severe mental illness (e.g., depression, anxiety, psychosis, and schizophrenia). * hypersensitivity to mefloquine, quinine, or quinidine, or to any component of these drugs. * current treatment with quinine, quinidine, chloroquine, or halofantrine. note: other protocol-defined criteria may also apply.

Keywords: pml human polyomavirus jc hiv central nervous system disease mefloquine jc virus
prophylactic antibiotic coated nail to prevent infection: a clinical trial

Conditions: Osteomyelitis Tibia; Tibial Fractures; Open Tibia Fracture

Summary: this prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (im) nailing.

despite significant treatment advances and protocols to prevent infection, severe open fractures of the lower extremity still have very high rates of deep infection. infection in an active duty military population increases disability and decreases the likelihood of returning to duty. in addition, infection is one of the main factors associated with rehospitalization. further, deep infections have not only resulted in increased disability after injury, infection is implicated as one of the main factors in late amputation. among service members, only 20-25% with a severe open tibia fracture are able to return to active duty. novel techniques for reducing infection are needed. the proposed study addresses the focus area of fracture-related infections, specifically the prevention of infection. this prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (im) nailing. this prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (im) nailing. the target population for the proposed study is patients with severe open tibia fractures (type ii or type iii) who require definitive fixation with intramedullary nail recruited from one of the participating sites during the index hospitalization. one group will be treated prophylactically using an antibiotic coated intramedullary nail at time of definitive fixation (1cn), while the second group will be treated with traditional standard of care intramedullary nail without antibiotic-coating (sn). participant will be followed for 12 months (data capture including patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).

Eligibility criteria:
inclusion criteria: * patients 18 years or older * gustilo type ii or iii open tibia fracture requiring definitive fixation with intramedullary nail exclusion criteria: * less than 18 years of age * allergy to vancomycin or gentamicin * unable to speak english or spanish * pregnant and lactating women * prisoner * unable to follow up for 12 months

Keywords: antibiotic-coated nail
evaluation of the safety and effectiveness of the dexcom glucose monitoring (cgm) system

Conditions: Diabetes Mellitus

Summary: evaluation of the safety and effectiveness of the dexcom glucose monitoring (cgm) system

the objective of the study is to establish performance of the dexcom cgm system (system) in comparison to a blood glucose comparator method.

Eligibility criteria:
inclusion criteria: * ages 2 or older * diagnosis of type 1 diabetes or type 2 diabetes * willing to wear the required number of systems for the total duration of study wear * willing to participate in clinic session(s) during study wear exclusion criteria: * presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin * known allergy to medical-grade adhesives * pregnancy * hematocrit outside specification * ≥ 18 years of age: * male: 36.0%; * female: 33.0%; * 13-17 years of age: 35.0%; * 7 years - 12 years of age: 32.0%; * end stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period * required or scheduled to have a magnetic resonance imaging (mri) scan, computed tomography (ct) scan, or diathermy during the study wear period
computed tomography for evaluating supination-external rotation type ankle fractures

Conditions: Supination-external Rotation Ankle Fractures

Summary: to compare measures of ankle stability from an investigational cone beam computed tomography scanner to gravity stress x-ray in patients who have unstable supination-external rotation ankle fractures.


Eligibility criteria:
inclusion criteria: * willing \& able to provide written informed consent * at least 18 years-old * have medial clear space measuring less than 5 mm with clinical suspicion of instability and would normally require a gravity stress x-ray exclusion criteria: * pregnant (females) * prisoners * open fracture * clinical signs of foot deformity * previous foot trauma or surgery on the affected foot * significant osteoarthritis or pre-existing ligamentous instability or pain in the affected foot * unable to stand in the weight bearing position during the ct scan
docetaxel and carboplatin with or without trastuzumab before surgery in treating women with locally advanced breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. it is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer. purpose: this randomized phase ii trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.


Eligibility criteria:
inclusion criteria: * confirmed infiltrating adenocarcinoma of the breast * primary breast cancer \> 5cm, or skin/chest wall involvement, any n, without evidence of metastasis. * no prior radiation to the involved breast * ecog (electrocochleography) performance status 0-2 * age 18 years to 80 years * absolute neutrophil count \> 1500 cell/μl, platelet count \> 100000 cells/μl and hemoglobin \> 9 g/dl * all liver function tests \< upper limit of normal * serum creatinine \< 2.0 mg/dl * normal left ventricular ejection fraction (lvef) as determined by muga (multiple gated acquisition) scan or echocardiogram * her-2/neu status is determined by a fish (fluorescence in situ hybridization) test. \[fish (+) is her-2/neu (+)\] * if female of childbearing potential, pregnancy test is negative * if premenopausal and not surgically sterilized, the patient agrees to use effective birth control method for the duration of the study * informed consent has been obtained exclusion criteria: * non-confirmed infiltrating adenocarcinoma breast cancer * evidence of metastasis * previous chemotherapy using the drugs proposed in this study, specifically herceptin®, taxotere®, and/or carboplatin * prior radiation to the involved breast * recent breast cancer drug therapy within last 5 years of any form * history of allergy to polysorbate or castor oil * ongoing active infection * concurrent life-limiting disease with a life expectancy of less than one year * past or current history of other malignancy within the past 5 years which could affect the diagnosis or assessment of breast cancer, except for curatively treated non-melanoma skin cancer and/or in situ carcinoma of the cervix * pregnancy, nursing, fertile women who do not use birth control device * inability to give informed consent * patients with pre-existing peripheral neuropathy \> grade 2

Keywords: stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage ii breast cancer
nicotine and tobacco message framing among lgbt young adults

Conditions: Tobacco-Related Carcinoma

Summary: this trial refines and evaluates how cultural targeting influences the effectiveness of anti-tobacco messages among lesbian, gay, bisexual, and transgender (lgbt) young adults at risk for the use of more than one tobacco product (polytobacco use). polytobacco use is associated with nicotine dependence and tobacco use into adulthood, and is disproportionately high among lgbt young adults. this trial seeks to determine how cultural targeting can be applied to communicate polytobacco use risk to at-risk lgbt young adults.

the goal of this study is to identify if culturally targeted (ct) or non-targeted (nt) anti-polytobacco messages are most effective for engaging lgbt consumers. using the most effective nt messages from aim 1, investigators will create a set of ct messages. message framing will remain consistent between ct and nt messages; however, ct messages will include language and graphics representing lgbt values formative research and the existing peer-reviewed literature. participants will be randomized to view ct or nt messages in a virtual lab where investigators will assess eye-tracking, self-reported perceived effectiveness, risk perceptions, and behavioral intentions. participants will also complete a 1-week follow-up. the study aims to determine the effects of cultural targeting on attention to anti-polytobacco messages and perceived effectiveness among lgbt young adults susceptible to polytobacco use.

Eligibility criteria:
inclusion criteria: * speaks english fluently * self-identifies as lesbian, gay, bisexual, transgender, queer, or another non- heterosexual orientation or non-binary gender identity * ever used e-cigarettes and combustible cigarettes * currently uses e-cigarettes, combustible cigarettes, or both e-cigarettes and combustible cigarettes * resides in the united states * access to a laptop or desktop computer with a camera for virtual eye-tracking exclusion criteria: * glaucoma * cataracts

Keywords: health communication lgbt