Kornimate/medical-research-clean huggingface dataset:
transcranial magnetic stimulation treatment for alzheimer's disease

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Logopenic Progressive Aphasia; Amnestic Symptoms

Summary: in this research study we want to learn more about the effects of non-invasive brain stimulation on memory and brain-network function in cognitively unimpaired older adults and in patients with amnestic mild cognitive impairment (amci). this study will use a form of non-invasive brain stimulation called repetitive transcranial magnetic stimulation (rtms). rtms will slightly alter activity in an area of your brain that controls memory. changes resulting from this stimulation will be measured with behavioral tests of memory and general cognition, as well as by taking images of your brain with magnetic resonance imaging (mri). participants will come in for one baseline visit followed by 10 days of daily rtms study visits (monday through friday) and an evaluation visit. then, there will be a 2-week break. after this break, they will return for another baseline visit, an additional 10 days of rtms, and a final evaluation visit.


Eligibility criteria:
inclusion criteria: 1. between the ages of 40-99 2. native english speakers 3. willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points 4. patients with ppa will be asked to bring a study partner to all visits 5. patients with very mild or mild ppa, patients with amnestic mild cognitive impairment and cognitively unimpaired participants with preclinical ad will be included. exclusion criteria: 1. history of head trauma involving loss of consciousness or alteration in consciousness 2. another major neurologic or psychiatric condition 3. known presence of a structural brain lesion (e.g. tumor, cortical infarct) 4. any contraindication to mri, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body 5. longstanding premorbid history (i.e. longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed 6. any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol. 7. unwilling to return for follow-up, undergo neuropsychological testing, tms, and mr imaging 8. history of unprovoked seizures (i.e., seizures that occur in the absence of a clear provocation such as hyponatremia, hypoglycemia, etc.). 9. subjects who have a first degree relative (e.g., father, mother or sibling) with a seizure disorder. 10. subjects currently taking, or plan to take, medications which are highly epileptogenic. these include: clozapine, high doses of bupropion (i.e., greater than 400mg daily), diphenhydramine, cyclosporine, isoniazid, imipenem, chloroquine, tramadol and theophylline. 11. subjects actively on anti-amyloid treatments. this is because they are at risk for bleeding due to amyloid-related imaging abnormalities (aria) that could provoke seizures.

Keywords: transcranial magnetic stimulation
nasal fentanyl for patient controlled treatment of pain in cancer

Conditions: Chronic Pain; Cancer

Summary: traditionally cancer pain is treated with long acting opioids such as morphine around the clock. however, there is no evidence that all patients have a stable pain requiring around the clock medication. so far opioids for self-administration with a rapid onset of action have not been available. recently a nasal formulation of fentanyl (an opioid similar to morphine) was released in europe for treatment of breakthrough pain, i.e. an unpredictable pain with short duration that breaks through the otherwise stable pain controlled with the around the clock medication. the basic idea is that this formulation may open for patient controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of nasally delivered fentanyl. this means that the patient only takes medication when in pain. this single center feasibility / safety study is the first part of a study to investigate this alternative cancer pain treatment approach.


Eligibility criteria:
inclusion criteria: 1. cancer patients with metastatic disease 2. adult (older than 18 years) 3. life expectancy of \> 3 months 4. cancer-related pain \> 3 on an 11 point numerical rating scale (nrs) 5. in the need of opioids (step ii or iii) 6. able to use nasal drugs. 7. women of child bearing potential using adequate contraception 8. informed consent given according to applicable requirements before any trial-related activities. trial-related activities are any procedure that would not have been performed during the routine management of the patient exclusion criteria: 1. history of substance abuse 2. cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures 3. treated with mao inhibitor within the last 14 days 4. known hypersensitivity to study drug or specific contraindications to the study drug 5. nasopharyngeal device such as gastric tube 6. concomitant participation in any other trials dealing with pain with an investigational drug or device apart from cancer treatment within 14 days prior to inclusion in this trial 7. pathological conditions of the nasal cavity as contraindication to nasal fentanyl 8. sleep apnoea syndrome 9. pregnant or breastfeeding women 10. psychiatric disease

Keywords: pain adverse effects safety feasibility
luminor registry: registry of the results of angioplasty with drug-eluting balloon (paclitaxel) in the treatment of infrainguinal occlusive lesions and restenosis from prior endovascular procedures in this sector.

Conditions: Peripheral Vascular Disease

Summary: the purpose of the study is to obtain data regarding safety and efficacy of drug-eluting balloon luminor 14 \& luminor 35 in the treatment of infrainguinal occlusive lesions (superficial femoral artery (sfa), popliteal artery (pa) and tibial arteries (ats)) and restenosis from prior endovascular procedures in this sector.


Eligibility criteria:
inclusion criteria: * patients of both sexes aged at least 18 * primary injuries and restenosis of the infrainguinal sector of afs, ap and ats, and intrastent restenosis or post-atp prior in that sector. * stenosis \>50% and occlusions. (image test) * length: 20 to 200 mm * artery diameter: 2-7 mm. * symptomatic patients (grades 2-5 rutherford-baker both included; fontaine ii-iv), affected in their quality of life and that accept treatment (moderate / severe claudication patients, critical ischemia without gangrene or injuries severe enough to foresee limb amputation). exclusion criteria: * patients with acute or subacute ischemia will be excluded. * existence of flow-limiting lesions in arteries of the "in flow" or the "out flow" of the sector or artery under treatment (\> 50 % of the arterial diameter). * aneurysmal dilatation in the ipsilateral arterial axis. * intolerance / allergy to heparin, thienopyridine derivatives (clopidogrel , ticlopidine) and aspirin. * hemorrhagic diathesis during the 3 months prior to inclusion. * patients with a life expectancy of less than 12 months. * serious allergy to contrasts or ptx. * inability to cross the lesion with the guide (these cases will be recorded for the analysis as "intention to treat). * those participating simultaneously in another clinical trial. * pregnancy or lactation (pregnancy tests on fertiles).
chronic postsurgical pediatric pain. evaluation risk factors to develop chronic postsurgical pain in children and adolescents undergoing surgery in a first level hospital

Conditions: Chronic Postoperative Pain; Pediatric ALL

Summary: chronic postsurgical pain had number of prevalence on 20%. its derivates from risk factors, but recent research provide new potential risk factors to develop chronic postsurgical pediatric pain. to increase the body of knowledge, an observational study is proposed in pediatric patients undergoing surgical intervention.

a cohort of pediatric patients undergoing surgery will be followed at the maternal and child hospital october 12, madrid. the group of patients that develops post-surgical chronic pain and the group that does not develop it will be observed, and risk factors will be studied. before the surgical intervention, the risk factors described in the literature will be analyzed. children will be followed up to 6 months after surgery.

Eligibility criteria:
inclusion criteria: * children with age from 4 years to 18 years. undergoing surgery for any surgical specialty. asa status (american society of anesthesiologist) from i to iii. exclusion criteria: * children who do not understand and speak spanish correctly. children with verbal communication problems.

Keywords: chronic postsurgical pediatric pain
metformin and dietary restriction to prevent age-related morbid events in people with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: phase iii randomized controlled trial on men and women with metabolic syndrome (mets) to test the hypothesis that comprehensive life-style changes and/or metformin treatment prevent age-related chronic non-communicable diseases (arcd). the aim of the present study is to evaluate the effect of a comprehensive life-style intervention (including moderate physical activity and mediterranean/macrobiotic diet with moderate calorie and protein restriction), and of treatment with metformin (a calorie restriction mimetic drug) for the prevention of arcd.

phase iii randomized controlled trial on men and women with mets to test the hypothesis that comprehensive life-style changes and/or metformin treatment prevent arcd. design: 2x2 factorial: 2,000 volunteers will be randomized in four equal groups of 500 each, and allocated to the following treatments: metformin (1700mg/day) + active lifestyle intervention placebo + active lifestyle intervention metformin (1700 mg/day) alone placebo alone the metformin /placebo component of the study will be double blind.

Eligibility criteria:
inclusion criteria: * age 55-74, waist circumference equal or greater than 85 cm for women and 100 cm for men, plus at least two other factors among those defining the mets exclusion criteria: * diagnosed diabetes (or baseline fasting glycemia above 7mmol/l at baseline examination) * cancer (except skin carcinoma) diagnosed in the last 5 years, or under treatment * excessive frailty: in absence of agreed-upon measurements parameters and cutoff points, the investigator will exclude subjects under the lower 5th percentile of the muscular mass distribution estimated by impedance in previous studies * conditions that contraindicate the use of met because might favour lactic acidosis: * renal, cardiac, hepatic, or respiratory insufficiency * serum creatinine \<124μmol/l, or proteinuria at baseline examination * current treatment with k-sparing diuretics, or with proton pump inhibitors * excessive alcohol consumption * distressing side effects of met treatment. nausea and diarrhoea typically occur in about one third of patients receiving met for the first time at full dose. to avoid dropouts for gastrointestinal discomfort we will treat all volunteers with half the planned dose for one month in order to exclude intolerant subjects before randomization. participants randomized in the intervention group will continue to take half a dose for one month and then shift to the full dose.
slc2a1 variants and diabetic nephropathy

Conditions: Diabetic Nephropathy.

Summary: cells damaged by hyperglycemia are unable to downregulate glucose entrance in presence of high extracellular glucose resulting in intracellular activation of deleterious biochemical pathways. expression of glut-1, the major glucose transporter in mesangial cells, is increased and participates in the induction of diabetic nephropathy. variants in the gene encoding glut-1 (slc2a1) have been associated to this diabetic complication. the aim of this study was to test whether polymorphisms in slc2a1 confer susceptibility to diabetic nephropathy in brazilian type 1 diabetes patients.

in this study, 449 patients, included between october 2004 and october 2012, were sorted into three groups according to diabetic nephropathy stages: without (persistent normoalbuminuria, n=248), incipient (microalbuminuria, n=82) and overt diabetic nephropathy (macroalbuminuria or proteinuria or renal replacement therapy, n=119). measurements of urinary albumin-to-creatinine ratio (acr) or urinary albumin excretion rate (uaer) were used to define dn: patients with persistent normoalbuminuria (\ 300 mg/g creatinine or \>200 µg/min), proteinuria (\>500 mg/24 h) or renal replacement therapy were classified as having overt dn (n=119). genotyping of polymorphisms was performed by real time pcr using fluorescent -labelled probes.

Eligibility criteria:
inclusion criteria: * overt 10 years of diabetes mellitus exclusion criteria: * patients presenting autoimmune diseases, hiv or hcv infections * patients with glomerular filtration rate \< 60 ml min-1 1.73 m2 without diabetic retinopathy
relationship between some vitamins and antioxidants with in vitro fertilization outcomes

Conditions: In Vitro Fertilization; Infertility

Summary: observation of females condition will getting pregnant by undergoing assisted reproductive technologies, the most important of which is the in vitro fertilization (ivf), where blood and follicular fluid samples are collected from them at the same stage of in vitro fertilization, and then monitor the ivf outcomes until pregnancy occurs or not, based on blood tests. the levels of interested markers in blood and follicular fluid samples of the study individuals are assayed in order to compare these levels with the egg criteria such as egg number and maturation rate and finally compare the results with occurrence or absence of pregnancy.

vitamin d, vitamin e, zinc and glutathione peroxidase will be measured in blood and follicular fluid samples of study subjects for women undergoing in vitro fertilization after monitoring their health for two to three months before beginning the first stage of in vitro fertilization. once start the ovulation induction protocol, which is the first stage of in vitro fertilization, we will monitor all the results from the number of eggs and follicles, their diameter, the thickness of the endometrium, the number of mature eggs, the egg maturation rate and fertilization rate to the occurrence of biochemical pregnancy or not later, based on the blood human chorionic gonadotropin (hcg) levels two weeks after the embryos transfer to the uterus. the patient is monitored until clinical pregnancy is complete or not. on the other hand, we will later compare the levels of studied parameters with the aforementioned egg quality criteria and with the clinical pregnancy rate of the study group in order to understand the relationship between these studied parameters and the occurrence of pregnancy.

Eligibility criteria:
inclusion criteria: * cases of healthy women (in terms of reproductive function). * aged between 20-40 years and were close in terms of education, nutrition, and social status. * explicit male factor such as oligospermia, azoospermia, asthenozoospermia, or tesa (testicular sperm aspiration), ensuring that there is no fertility-interfering female factor. * undergoing long gonadotropin-releasing hormone (gnrh) agonist down-regulation protocol. exclusion criteria: * cases classified by the specialist clinician as a female factor such as pcos (polycystic ovary syndrome), uterine fibroids, uterine infections, uterine adhesions, and endometriosis. * compound cases. * sex selection cases. * undergoing short gnrh agonist or antagonist protocol. * women aged under 20 or above 40. * women who took nutritional supplements, for at least two to three months before the egg retrieval procedure. * smokers. * cases with the following medical conditions: tumors, diabetes, multiple sclerosis, autoimmune diseases, liver or kidney disorders, cushing's syndrome, and women who take chronic medications

Keywords: vitamin d vitamin e zinc glutathione peroxidase
local application of ozone gas for infected ulcers

Conditions: Ulcer; Wound Infection

Summary: this study evaluates the efficacy of local application of ozone gas in healing of infected ulcers. half the participants received conventional treatment with placebo generator and the other half received conventional treatment with ozone generator.

ozone gas has been used since world war i and is known for its wound healing properties by way of being a powerful oxidant that stimulates the antioxidant system, immunomodulation, microbicidal and perhaps other unknown mechanisms. it has largely been regarded as a complementary therapy form but with elucidation of it's biological actions and availability of reliable ozone generators it may form a novel treatment option for a range of medical conditions with ample literature available on wound healing. in this study it was used as an adjunct to conventional treatment i.e surgical procedures, antibiotics and wound care. it was locally applied as a gas though there are various other routes of administration such as major and minor autohematotherapy, intramuscular and intraarticular injections, rectal and vaginal insufflation.

Eligibility criteria:
inclusion criteria: * infected ulcer size of atleast 10 cm. * patient willing to participate in the study and for follow up. exclusion criteria: * patient unwilling for participation and follow up. * chronic kidney disease, * peripheral occlusive vascular disease, * venous ulcers, * pressure sores, * use of immuno suppressant drugs, * immunosuppressed state

Keywords: ozone gas ulcer infected ulcer
impact of non-intentional leaks on noninvasive ventilation

Conditions: Intermittent Positive-pressure Ventilation; Respiratory Physiological Phenomena

Summary: the investigators hypothesized that increasing non intentional leaks could increase work of breathing and could lead to patient/non-invasive ventilation (niv) asynchrony. the main objective is to compare ventilatory pattern (work of breathing, flow, pressure) under niv with and without non-intentional leaks in 10 awakened healthy subjects and 10 awakened and asleep obese hypoventilation syndrome (ohs) patients. methods: while the subjects will be under niv, several levels of leaks will be simulated in a random order with an automatically opening valve. breathing pattern (work of breathing,flow, pressure, thorax and abdominal movements) will be recorded by polygraphy. healthy subjects will be recorded only during awakened state. ohs patients will be recorded both during awake and sleep sates. analysis: a repeated measures analysis of variance (anova) will compare work of breathing according to the different levels of leaks.


Eligibility criteria:
inclusion criteria: * ohs patients, in stable stade, teated with nocturnal non invasive ventilation for at least three months. * healthy subjects without known pathology exclusion criteria: * ohs patients: instable cardio-respiratory status and/or acute cardio-respiratory failure three month before the inclusion. latex allergy, oesophageal varices.

Keywords: non-invasive intermittent positive-pressure ventilation work of breathing pulse transit time
ombitasvir/paritaprevir/ritonavir and dasabuvir with and without ribavirin in protease-inhibitors ("pi") failures

Conditions: Hepatitis C

Summary: the purpose of this study is to evaluate the efficacy and safety of triple therapy of abbvie adults with chronic hepatitis c virus ("hcv"), who have not responded to prior treatment with protease inhibitors. the "triple therapy" of abbvie attacks various sites of the viral genome, thus increasing the potential efficacy of the treatment, especially for patients who have failed pi treatment.

patients with genotype 1 hcv, who underwent past triple therapy (telaprevir, boceprevir or simeprevir with pegylated interferon / ribavirin) and are non-responders, partial responders or in relapse - will be screened in all research centers up to 30 days before the first treatment. at the end of the initial assessment - the recruited participants will be allocated to different treatment groups in accordance with the hepatitis virus subtype 1a, 1b and presence of cirrhosis, as follows: * group a - genotype 1b without cirrhosis - 12 weeks of treatment \* * group b - genotype 1b with cirrhosis - 12 weeks of treatment * group c - genotype 1a without cirrhosis - 12 weeks of treatment * group d - genotype 1a with cirrhosis - 24 weeks of treatment (\* only this group will not get ribavirin) during the treatment period, participants will be asked to describe the treatment's tolerability (in terms of side effects) using self-administered questionnaires: sf-36, and wpai hep c v2.0. the follow up will also include physical assessments, side effects documentation, blood tests, abdominal ultrasound and fibroscan.

Eligibility criteria:
inclusion criteria: * diagnosis of hepatitis c, genotype 1a or 1b. * documentation of pi failure of treatment at least 12 months prior to study entry. * patients with cirrhosis - (only patients with cirrhosis child a with only 5 points). exclusion criteria: * inability to stay in the study for 36 weeks. * diagnosis of cross-contamination by hiv or hepatitis b virus. * renal disfunction (creatinine clearance \<30 ml / min). * evidence of hepatic carcinoma. * another serious disease, which may interfere with the study. * pregnant / breast-feeding women. * men with pregnant partners. * drug or alcohol abuse in the six months preceding the study. * chronic liver disease other than hepatitis c (such as primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis). * current other treatment for hcv. * past pi failure due to adverse events. * patients with cirrhosis child b. * patients with cirrhosis, who were at child b and improved to child a after treatment.

Keywords: "hepatitis c virus" "triple therapy" "pi failure" "genotype 1"
carbon dioxide versus air insufflation in oesophago-gastro-duodenoscopy (ogd)

Conditions: Pain

Summary: comparison on the effect on patient pain and discomfort by using co2 instead of air for insufflation during gastroscopy.

to achieve a satisfactory examination of the gi tract it needs to be distended during endoscopic procedures. after the examinations many patients complain of abdominal pain and discomfort. this pain has been substantially reduced by substituting room air with co2 in both colonoscopies and ercps. the use of co2 during colonoscopy has become routine practice at many endoscopy centers. in our study we will test the hypothesis that abdominal pain after gastroscopies also can be reduced by substituting room air with co2.

Eligibility criteria:
inclusion criteria: * patients scheduled for ogd at the outpatient clinic of telemark hospital exclusion criteria: * age \<18 * inability to give an informed concent * unsatisfactory norwegian language skills * patients not willing to participate * copd with dyspnoea nyha 3-4

Keywords: quality assessment pain reduction gastroscopy carbondioxide insufflation patient satisfaction