Kornimate/medical-research-clean huggingface dataset:
subclinical organ damage in overweight and obese patients: does presence of metabolic syndrome matter?

Conditions: Metabolic Syndrome; Subclinical Organ Damage; Overweight; Obese

Summary: microalbuminuria and homocysteine levels are shown to be markers for endothelial dysfunction and subclinical organ damage and predictors of cardiovascular risk in several epidemiologic and randomized clinical trials. carotis intima-media thickness is also found to be elevated in early stages of atherosclerosis. recent studies have shown correlations between homocysteine, microalbumin levels and carotis intima-media thickness in type 2 diabetics but no data exists for obese or overweight patients who also have metabolic syndrome, in terms of markers of subclinical organ damage. since obesity is a risk factor for cardiovascular disease and since it is known that patients with metabolic syndrome are at higher risk of cardiovascular events, the investigators wanted to examine whether there is an association between homocysteine, microalbumin levels and carotid intima-media thickness in patients with or without metabolic syndrome, who are either overweight or obese.


Eligibility criteria:
inclusion criteria: 1. 18-80 years 2. bmi \>= 25 3. ex or non-smokers (must have quit smoking at least 5 years ago) exclusion criteria: 1. niddm or idddm 2. nephropathy (gfr \< 60 ml/min), previous history of coronary artery disease or peripheral arterial disease 3. current smokers 4. active infection or other acute illness

Keywords: metabolic syndrome obesity endothelial damage homocysteine microalbumin carotis intima-media thickness
placebo effect about fatigue in obesity

Conditions: Obesity

Summary: fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. however, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. from a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. it results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. in this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. the after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the rp) levels.


Eligibility criteria:
inclusion criteria: • right-handed diagnosis of obesity (the level of body mass index - bmi - higher or equal to 30). exclusion criteria: • concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders

Keywords: placebo effect fatigue motivation physical abilities
the effectiveness of massage therapy in patients with shoulder pain

Conditions: Shoulder Pain

Summary: the goal of this clinical trial is to evaluate the effectiveness of massage in pain reduction and its influence on the range of motion of the shoulder complex in sp. the main questions it aims to answer are: 1. does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism reduce pain in the shoulder area? 2. does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism increase the range of motion of the shoulder complex? researchers will compare a dedicated massage protocol to a control group to see if the massage protocol works to treat shoulder pain. participants in the massage group will: take part in 6 massage sessions (twice a week for 3 weeks) in the participants in the control group will: take part in 2 massage sessions (after the first and second assessment)

the aim of the study was to evaluate the effectiveness of massage therapy based on tensegrity principle in pain reduction and its influence on the range of motion of the shoulder complex in shoulder pain. . eesearch questions: 1. does the normalization of the tension of the tissues involved in the intercostal nerve entrapment mechanism reduce pain in the shoulder area? 2. does the normalization of the tension of the tissues involved in the intercostal nerve entrapment mechanism increase the range of motion of the shoulder complex? 3. does the intercostal nerve entrapment affect the pressure sensitivity of the muscles including the shoulder complex?89 4. what potential mechanisms may be induced by tensegrity massage in diseases of the shoulder complex? patients with symptoms of shoulder pain will be recruited for the study by general practitioners. the following parameters related to the function of shoulder will be assessed: 1. the active range of flexion, abduction and extension-adduction-rotation (hand behind back) of the upper limb were assessed. 2. pain sensations by the visual analogue scale-vas 3. the functional status of the shoulder complex by the ucla scale (the university of california at los angeles shoulder score). 4. pain treshold by an algometer, the pressure the study will rely on the palpation assessment and the massage methodology described in the recommendations of the polish society of physiotherapy, polish society of family medicine and college of family physicians in poland.

Eligibility criteria:
inclusion criteria: * age over 40 years, * written consent to participate in the study, * pain in the shoulder girdle area lasting at least 3 months, * no medical contraindication of massage therapy; exclusion criteria: * injuries, congenital defects in the chest area, cancer, deep vein thrombosis, heart attack in the last 5 years, * presence of inflammatory conditions in the respiratory, digestive, and genitourinary systems
efficacy of compuflo® technology in thoracic epidural space identification

Conditions: Thoracic Epidural Space Identification

Summary: the aim of this non inferiority trial is to assess the efficacy of compuflo® technology to identify the thoracic epidural space in relation to the gold standard loss of resistance technique.

this non inferiority trial shouts to adress whether the compuflo® technology to identify the thoracic epidural space is less efficacious to the gold standard loss of resistance technique (lor). after informed signed consent patients that will be subjected to gynecological operations and meet the inclusion criteria will be eligible to participate. all operations will be performed under general anesthesia and thoracic epidural analgesia regardless of study arm. patients will be randomly allocated into two study groups. in the first study group (group lor) the thoracic epidural space will be identified by the lor technique and in the second study group (group c) by the compuflo® technology. the primary outcome is the percentage of thoracic epidural space identification success in either study group.

Eligibility criteria:
inclusion criteria: american society of anesthesiologists (asa) physical status classification system i-iii body mass index: 18 -35 kg/m2 gynecological laparotomy with midline incision under general anesthesia and thoracic epidural analgesia exclusion criteria: patients' denial to participate in the study asa physical status classification system \>iv contraindications to epidural analgesia patients with sepsis patients with pre-existing neurologic deficits pre-existing operations in the thoracic spinal cord emergency operations patients with end-stage cancer

Keywords: thoracic epidural space loss of resistance technique compuflo® technology
a clinical study to compare long-term efficacy and safety of an aliskiren based regimen to a hydrochlorothiazidebased treatment regimen with optional addition of amlodipine

Conditions: Hypertension

Summary: this study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an hctz based treatment regimen with optional addition of amlodipine in patients with essential hypertension.


Eligibility criteria:
inclusion criteria: -patients with essential hypertension exclusion criteria: * severe hypertension * history or evidence of a secondary form of hypertension * history of myocardial infarction. other protocol-defined inclusion exclusion criteria also apply
a study evaluating the safety and efficacy of ave5530 (4 weeks) in patients with mild to moderate hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the primary objective of this study is to assess the effect of ave5530 on ldl-c levels over a period of 4 weeks. the secondary objectives are to assess the effects of ave5530 on other lipid plasma levels and the safety and tolerability of ave5530.


Eligibility criteria:
inclusion criteria: * patients with mild to moderate primary hypercholesterolemia with stabilized ldl-c baseline ≥130 mg/dl and ≤ 250 mg/dl (≥ 3.36 mmol/l and ≤ 6.46 mmol/l) * male aged ≥ 18 years or postmenopausal women at screening exclusion criteria: * presence of any clinically significant endocrine disease known to influence serum lipids or lipoproteins * patients with type 1 diabetes * presence or history of cancer within the past five years * triglycerides ≥ 300 mg/dl (3.39 mmol/l) * fasting plasma glucose \> 160 mg/dl (8.9 mmol/l) * impaired kidney function and active liver disease * within one month prior to screening visit and/or at the time or after the screening visit, administration of any lipid lowering treatment * creatine kinase \> 2xupper limit of normal range the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
lactate and complications in cytoreduction surgery for peritoneal carcinomatosis

Conditions: Lactacidemia and Complications

Summary: serum lactate is a risk factor for postoperative complications in patients undergoing cytoreduction surgery in peritoneal carcinomatosis

background. cytoreduction surgery has been developed as a treatment of peritoneal carcinomatosis. however, this surgery is associated with important complications. the present study attempts to assess the relationship between lactacidemia levels and the rate of associated complications in patients undergoing cytoreduction surgery during the immediate postoperative period in a critical unit. methods. retrospective observational study. 57 patients underwent cytoreduction surgery during the years 2014 and 2015 at the general university hospital of castellón. all patients were admitted to the critical unit immediately after surgery. lactacidemia levels at the time of admission and discharge from the critical unit were collected. post-surgical complications that appeared during the stay in the critical unit were recorded and classified according to the clavien-dindo classification. lactacidemia levels were still significantly higher in this group at the time of discharge.

Eligibility criteria:
inclusion criteria: * patients diagnosed with peritoneal carcinomatosis who underwent cytoreduction surgery in the multidisciplinary unit of abdomino-pelvic oncology surgery (muapos) of the university general hospital of castellón. exclusion criteria: * patients without lactic acid levels in the register.

Keywords: lactic acid cytoreductive surgery postoperative complications
a phase ii study of mk0457 in patients with t315i mutant cml and ph+all (0457-008)

Conditions: Leukemia

Summary: this study will evaluate mk0457 in patients with chronic myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia. efficacy and safety will be evaluated.


Eligibility criteria:
inclusion criteria: * this study will evaluate mk0457 in patients with cml (chronic myelogenous leukemia) and ph+all (philadelphia chromosome-positive acute lymphoblastic leukemia) * patients must have adequate organ function * patients must have documented t315i mutation exclusion criteria: * patients within 3 months of allogeneic bone marrow transplant or not fully recovered from previous anti-leukemia therapy * patients with uncontrolled congestive heart failure * patients with active or uncontrolled infection or active hepatitis b or c * patients with known hiv positivity or aids related illness * patients with currently active second malignancy, other than non-melanoma skin cancer.
a study of obp-301 with radiation therapy in patients with esophageal cancer

Conditions: Esophageal Cancer

Summary: this is a phase 1 study to evaluate safety and tolerability of telomelysin (obp-301) in combination with radiation therapy in patient with esophageal cancer who are not applicable to standard therapy.

after screening, patients will undergo a combination therapy of obp-301 with radiation therapy for 6 weeks. at day 1, day 18 and day 32, obp-301 is directly injected to the location of the lesion. from day 4, patients receive radiation therapy. patients will be automatically entered follow-up period for 12 weeks to be observed tolerance and safety. this study is designated as standard 3 + 3 dose escalation study. the first 3 patients will be evaluated with low-dose of obp-301 and then the study move onto the high-dose cohort of obp-301. when the dlt (dose limiting toxicity) is observed, 3 more patients will be enrolled in the dose level.

Eligibility criteria:
key inclusion criteria: 1. patients who have primary tumor or metastatic lesion of histologically or cytologically diagnosed with esophageal carcinoma. 2. patients are feasible for injection of obp-301 into target legion 3. patients aged in 20 to 89 years. 4. patients with ecog performance status score ≤ 2. 5. patient who have life expectancy longer than 12 weeks. 6. patients who are not applicable to standard therapy. 7. patients who have adequate organ function. key exclusion criteria: 1. patients who have an active, treatment-required concomitant malignancy. 2. patients who had been enrolled within 4 weeks to other clinical trials of unapproved drugs. 3. patients who have had chemotherapy within 4 weeks. 4. patients who have treatment history of cancer immunotherapy. 5. patients who had radiotherapy to treatment targeted lesion. 6. patients who have active infection which required systemic treatment. 7. patients who are scored iii or iv by nyha (new york heart association). 8. patients who are judged as inappropriate to this trial by investigator(s).

Keywords: esophageal cancer obp-301 radiation telomelysin radiotherapy oncolytic virotherapy loco regional
virtual reality exposure therapy for acrophobia

Conditions: Specific Phobia; Acrophobia; Fear of Heights; Anxiety Disorders

Summary: the aim of this study is to examine the efficacy of virtual reality exposure therapy (vret) as a treatment for specific phobia (acrophobia). the study will randomly assign 42 participants with acrophobia to one of two conditions: a) the experimental condition (consisting of 3 sessions of virtual reality exposure) or b) a control condition. both groups will receive short information session about general principles of exposure therapy before the start of the study. after the end of the study, the waitlist group will be invited to attend the short version (one or two-sessions) of the vret. both groups will receive a final follow-up questionnaires 2 months after the last session.


Eligibility criteria:
inclusion criteria: * individual meeting icd-10 criteria for diagnosis of specific phobia * fluent in czech exclusion criteria: * currently receiving psychological treatment for acrophobia * psychotropic medication (unless on stable dosage for the previous 1 month and stabilized for the duration of the study) * another severe mental disorder, such as bipolar disorder or psychotic disorder * contradictions to using a virtual reality (e.g., epilepsy, balance problems)

Keywords: virtual reality exposure therapy specific phobia acrophobia
safety, tolerability, pharmacodynamics, and pharmacokinetics of mk-8666 in participants with type 2 diabetes mellitus (mk-8666-003)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a study of the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of mk-8666 in participants with type 2 diabetes mellitus (t2dm). participants enrolled in this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic agents. mk-8666 is planned to be administered orally for up to 2 weeks. the primary hypothesis for this study is that after 14 days of once daily treatment with mk-8666, at a dose that is safe and well tolerated, the placebo-corrected fasting plasma glucose reduction from baseline is ≥34 mg/dl.


Eligibility criteria:
inclusion criteria: * if female, must be either postmenopausal or surgically sterile * a body mass index (bmi) ≥18 kg/m\^2 to ≤40 kg/m\^2, inclusive. * a diagnosis of t2dm * drug naïve or is being treated with no more than 2 oral antihyperglycemic agents (thiazolidenediones are excluded) * judged to be in good health except for t2dm * willing to follow a standard weight maintaining diet throughout the study * a nonsmoker or has not used nicotine or nicotine-containing products for at least 3 months exclusion criteria: * a history of clinically significant endocrine (except t2dm), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases * a history of myositis or complaints including diffuse myalgias, muscle tenderness, or weakness. * a history of cancer (malignancy) excepting adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix * has clinically unstable diabetic retinopathy, neuropathy, and/or clinical evidence of gastroparesis (frequent nausea, bloating or vomiting, severe gastroesophageal reflux, early satiety) * a history of type 1 diabetes mellitus and/or history of ketoacidosis * taking a medication for a co-morbid condition that is not permitted during the study * a history of significant multiple and/or severe allergies * positive for hepatitis b surface antigen, hepatitis c antibodies or human immunodeficiency virus * had major surgery, donated or lost 1 unit of blood within 4 weeks prior to study participation * participated in another investigational trial within 4 weeks prior to study participation * consumes excessive amounts of alcoholic or caffeine-containing beverages * a regular user of illicit drugs or a history of drug or alcohol abuse within the past year
study of brentuximab vedotin combined with bendamustine in patients with hodgkin lymphoma

Conditions: Hodgkin Disease

Summary: the purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory hodgkin lymphoma. it is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. the study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.


Eligibility criteria:
inclusion criteria: * histopathological diagnosis of classical hodgkin lymphoma * failed standard front-line therapy * measurable disease of at least 1.5 cm as documented by radiographic technique * eastern cooperative oncology group performance status less than or equal to 2 exclusion criteria: * received prior salvage therapy, including radiotherapy * chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug * concurrent use of other investigational agents

Keywords: antibody-drug conjugate antibodies, monoclonal hodgkin disease hematologic diseases drug therapy immunotherapy antigens, cd30 lymphoma monomethylauristatin e
bioburden reduction of diabetic foot ulcer

Conditions: Diabetic Foot Ulcer

Summary: study to see if a laser can get rid of bacateria called mrsa in your diabetic ulcer


Eligibility criteria:
inclusion criteria: * 18 and older * diabetic foot ulcer * mrsa positive exclusion criteria:osteomylelitis pregnancy allery to e mycin -
skeletal effects of type 1 diabetes on low-trauma fracture risk

Conditions: Type 1 Diabetes; Osteopenia; Bone Loss; Fractures, Bone

Summary: patients with type 1 diabetes mellitus (t1dm) have a higher risk of low-trauma (osteoporotic) fracture that is 7-12 times higher than non-diabetics. the bone density of people with type 1 diabetes is higher at the time of fracture than in non-diabetics. this suggests the presence of underlying bone tissue mechanical defects. the potential benefits to participants would be knowledge gained about their bone density and the results of laboratory tests. on a wider scale, there may be general benefits to society because the knowledge gained from this study may help better understand the effects of diabetes on bone health

the investigators will enroll 40 female, postmenopausal, patients with t1dm, fracturing or non-fracturing, who are age 50 and over, and have had diabetes for more than ten years. the investigators will perform 2 transiliac (hip bone) biopsies on each subject, one for mechanical testing, tissue analysis of ages, enzymatic crosslinks and bone tissue-bound water in cortical bone, and the other for histomorphometry and high-resolution 3d imaging in trabecular bone. a matched, non-diabetic, healthy control will be enrolled at the time each t1dm is enrolled.

Eligibility criteria:
inclusion criteria: criteria for enrollment of female diabetics 1. no chronic disease diagnoses that may affect bone, as confirmed by the pi. 2. normal clinical history, physical, and clinical laboratory exam (except for usual complications of a 10+-year diabetic, i.e., \~minimal neuropathy or retinopathy, known, but asymptomatic mild vascular disease, etc.) 3. glomelular filtration rate (gfr) \&gt;45 ml/min (renal association lower limit for "mild" kidney failure). 4. willingness to sign a consent form. 5. willingness to undergo a transilial bone biopsy incision that yields 2 bone specimens. 6. no abnormalities in clinical blood chemistry measurements (small, age-related decreases in gfr, will be permitted). 7. caucasian criteria for each non-diabetic subject, compared to their matched diabetic: 1. dual-energy x-ray absorptiometry (dxa) measures (bmd, gm/cm) must be within +/- 15% in total hip. 2. body mass index (bmi) must be within +/-10%. 3. age must be within +/- 5 years. 4. caucasian exclusion criteria: 1. women who have had type 1 diabetes for less than 10 years. 2. non-insulin dependent type 1 diabetic. 3. less than 50 years old. 4. less than 5 years post menopausal.

Keywords: bone cortical bone mechanical strength