Kornimate/medical-research-clean huggingface dataset:
rct versus placebo of rtmsqp over visual cortex for the prevention of chronic migraine

Conditions: Chronic Migraine

Summary: evaluation of inhibiting rtms qp over the visual cortex for the prevention of chronic migraine. the aim of the study is to confirm that inhibiting rtms qp is capable to decrease the frequency of migraine and if its effect is stronger than placebo effect.

the investigators have already inquired if inhibiting rtms qp over the visual cortex determines a reduction of frequency of migraine in a previous study. after 2 weekly sessions for a month, the investigators demonstrated a reduction of 47% in migraine frequency. in this study, the investigators aim to compare rtms qp effect with the placebo effect and to evaluate if rtms qp is capable to induce changes in vep, cheps and qst.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic migraine (ichd iii beta 1.3) with or without medication overuse. exclusion criteria: * other diseases or contraindication for the magnetic stimulation (epilepsy, pacemaker, metallic prothesis)
atrial pacing for termination and prevention of atrial fibrillation

Conditions: Bradycardia; Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common sustained arrhythmia and is associated with substantial morbidity and mortality. present treatment strategies are aimed at termination of af and prevention of af recurrence using antiarrhythmic drugs or heart rate control drugs. drugs are not always well tolerated, so atrial pacing as a strategy for prevention of atrial tachyarrhythmias is being explored. the at501 pacemaker has both "prevention" and "treatment" algorithms for atrial tachyarrhythmias. the investigators wish to determine whether these special features, over the long term, decrease the amount of time the person experiences af.

there are some clinical and experimental data to suggest that atrial overdrive pacing should prevent af. in our pacemaker population with tachy-brady syndrome, and in the pa3 study population, we observed that af frequently clusters and may recur early following an episode of af. we are conducting a randomized trial of both prevention algorithms and antitachycardia pacing (atp) therapies for the treatment of atrial tachyarrhythmias and thereby prevention of af over the longterm. patients with a history of paroxysmal af who received an at501 pacemaker for the treatment of bradycardia will be randomized to having both the prevention and therapy algorithms "on", both "off" or having only the therapy algorithms "on". they will be followed every 3 months for 1 year, then every 6 months for an 2 additional years. recurrence and frequency of af will be determined over time based on data retrieved from the device at each follow-up visit.

Eligibility criteria:
inclusion criteria: * reason for pacing: symptomatic bradycardia * paroxysmal af (\>5 min duration, \>3 episodes) post implant of at501 pacemaker * on stable antiarrhythmic drugs * life expectancy \>3 years exclusion criteria: * life expectancy \<3 years * unable to give informed consent * unable to come for followup * chronic af

Keywords: symptomatic bradycardia paroxysmal atrial fibrillation antitachycardia pacing therapies prevention algorithms
fluorescence surgery for sentinel node identification in melanoma

Conditions: Melanoma; Lymph Node Metastasis

Summary: sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis (i.e. groin/axilla) in very early stages. this study aims to add a new technology over the standard procedure - a fluorescent contrast (indocyanine green) using special light (near infra-red) - looking for more precise diagnosis of the presence of the lymph node metastasis.

the main objectives of this study is perform a new technique added to the usual procedure for sentinel lymph node biopsy for cutaneous melanoma. the fluorescence surgery consists in a injection of indocyanine green around the primary tumor, or, when already excised (excisional biopsy), the biopsy site at the beginning of the surgery. patient performs, in a standard fashion, the lymph scintigraphy prior the surgery and is injected at the same time a blue die similarly the indocyanine green. immediately after the indocyanine infusion, the injection site is massaged and a near infra red light (nir) is focused over it. an appropriated infra red camera is positioned over the lymphatic pathway, searching for the fluorescence and localizing the sentinel node at the basin. the skin is opened and the sentinel node is resected. the success or not in localizing the sentinel node is pointed and the standard techniques are applied - gamma probe and surgical location of a blue lymph node. all sentinel node characteristics are noted as number, which technic identified it, time, location. later information will be gathered as histological status, surgical complications, recurrence and survival.

Eligibility criteria:
inclusion criteria: * patients eligible for sentinel node biopsy in standard care exclusion criteria: * previous neoplasia * previous surgery or scar in the lymph node basin or primary tumor, except primary tumor biopsy * local recurrence * hypersensibility or allergy history to indocyanine or iodine-based contrast media

Keywords: sentinel node biopsy near infra red light indocyanine green micrometastasis
rubinstein-taybi syndrome: functional imaging and therapeutic trial

Conditions: Rubinstein-Taybi Syndrome

Summary: an exploratory phase 2 therapeutic trial in children from 6 to 21, rts carriers, randomized to be treated either with sodium valproate with the usual pediatric dosage (30 mg/kg/j), or by placebo for one year. the investigator would like to include children because they could best profit from it due to their neuronal plasticity as cbp and ep300 take effect through neuronal and synaptic plasticity. the therapeutic effect of sodium valproate in rts patients will be assessed thanks to a clinical approach (learning and memory neuropsychological evaluation, fine motor skills assessment by pointing), to a biological approach (histone acetylation functional tests), and to imaging (morphological and functional mri).

such a multidisciplinary approach has never been presented for this syndrome; it should enable us identifying specific cognitive and motor deficits and their association thanks to imaging markers. assessing the various aspects of motor skills, i.e. primary (movements, standing at ease position, immobility) and complex motor skills (actions and behaviours, motor aspects of feelings and language expressions) is an integral part of the clinical examination in psychiatrics. the main interest of a functional capacity analysis is to be used as an index allowing the assessment of the nervous system's global capacities and the study of the connections between cognitive functions and motor skills main objective: evaluate long term memory with subtest "point location" - cms and "image recognition" rbmt a patient is said to be responder if after one year his or her test result increase for one point at least one of the two tests : a increase of one point to "point location" or "image recognition". double-blind phase 2 clinical trial, designed as a one-step fleming design but with a control group. rubival is a two-parallel group randomized trial: * a placebo group of 20 patients * a group of 40 patients taking sodium valproate (hdac inhibitor) with an oral dosage of 30 mg/kg/jour

Eligibility criteria:
inclusion criteria: * children over 6 and under 21 * rts confirmed by a genetic study with a cbp gene or ep300 gene mutation * sufficient cognitive capacities for neuropsychological evaluation * free and informed consent of the parents or guardians * children affiliated to or benefiting of the french social welfare system exclusion criteria: * contraindication to sodium valproate * women of reproductive age without effective contraception means * case history of sodium valproate treatment * monotherapy treatment for epilepsy with lamictal with a dosage superior to 5 mg/kg/j * family history of severe hepatitis including drug * acute or chronic hepatitis * pregnancy

Keywords: rts rubinstein taybi explorative phase 2 clinical approach biological approach motor skills
the effect of low-frequency rtms on motor function in pd patients with freezing of gait

Conditions: Parkinson's Disease

Summary: this study is a double blind comparative study examining the effectiveness of the rtms treatment on freezing of gait (fog) phenomenon in patients with parkinson's disease. we hypothesize that treatment using rtms stimulation on frontal lobe areas will improve gait quality and decrease the frequency of fog in patients with parkinson's disease.

a course of low-frequency repetitive transcranial magnetic stimulation (rtms) delivered over the supplementary motor area (sma) improves motor symptoms in patients with parkinson's disease (pd). the present study is a comparative study that examines the effectiveness of rtms treatment technique freezing of gait (fog) phenomenon in parkinson's disease patients. we hypothesize that treatment using rtms stimulation on frontal areas will decreasing frequency of fogs in patients with parkinson's disease and improve gait quality and quality of life.

Eligibility criteria:
inclusion criteria: 1. idiopathic parkinson's disease (pd), as diagnosed by a neurologist. 2. the mini-mental state examination questionnaire score above 24 points. 3. suffer from a disabling phenomenon called freezing of gait (fog) (freezing of gait questionnaire score\> = 10) 4. negative responses to the preliminary safety magnetic stimulation treatment questionnaire. exclusion criteria: 1. other neurological or psychiatric disorders. 2. severe personality disorder. 3. high blood pressure. 4. history of epilepsy, seizures or convulsions. 5. history of epilepsy or convulsions in first-degree relatives. 6. history of head injury or stroke. 7. metal remains of the skull or inside the brain (outside the oral cavity). 8. surgeries including metallic implants or known history of metal particles in the eye, pacemakers, hearing devices transplantation, or medical pumps. 9. current history of migraines for the last six months. 10. a history of drug or alcohol abuse 11. other medical research in the time to experiment or three months ahead. -

Keywords: parkinson's disease, rtms, freezing of gait
postnatal prevalence of bacteriuria in women with catheter versus no catheter in labour: a prospective cohort study

Conditions: Urinary Tract Infection in Pregnancy; Urinary Tract Infection Following Delivery; Catheter Infection

Summary: catheterisation is an accepted tool in intrapartum bladder care and indwelling catheters are used routinely before elective caesarean sections. however, urinary catheters are associated with an increased rate of urinary tract infections which can lead to complications including increased maternal morbidity and prolonged hospital stay. a cochrane review (2014) concluded that there is insufficient evidence to assess the routine use of indwelling bladder catheters in women undergoing caesarean section. the incidence and causation of catheter-associated infection in this population is unknown. we propose to provide this data, by comparing urine samples from pregnant women before and after their delivery and analysing this against observational catheter use during the delivery. this will be vital in conducting future research into potential change in policy on routine catheterisation. it will also be beneficial to patients as it could reduce the burden of catheterisation by reducing their chance of developing a uti and by reducing the associated morbidity.

research question is the intrapartum use of a catheter - either intermittent or indwelling - associated with an increased incidence of postnatal bacteriuria when compared with women who are not catheterised? method pregnant women will be recruited at gloucestershire royal hospital maternity department from 37 weeks gestation. once eligibility is met, they will be asked to provide a mid-stream urine sample which will be tested for microscopy, culture and sensitivity (mc\&s). they will be analysed according to their mode of delivery. their notes will be scrutinised to assess whether or not a catheter was sited during their labour. postnatally, they will be asked to provide an msu on day 3 and day 28, which will both be sent for mc\&s. a comparative analysis between each msu will be performed and correlated to whether intrapartum catheterisation was undertaken. data collection \& analysis the data collection phase will take approximately three months, with data analysis and write-up estimated to take a further one-two months.

Eligibility criteria:
inclusion criteria: * • participant is willing and able to give informed consent for participation in the study * intact membranes * at least 37 weeks pregnant exclusion criteria: * • history of microbiologically-confirmed bacteriuria in preceding 28 days * patients who are in active labour * women who have had either urine-specific or broad-spectrum antibiotics within the last 28 days

Keywords: catether pregnancy postnatal infection
examination of psychological and physiological pathways linking gratitude and pain

Conditions: Acute Pain; Positive Thinking; Emotions

Summary: the goal of this clinical trial is to compare the effects of a brief gratitude intervention on individuals' psychological and physiological responses to acute pain. furthermore, these associations will be examined in the context of genetic variations associated with both pain and psychological processes.

after being informed about the study and potential risks, all patients giving written informed consent will be randomized to a behavioral writing intervention and a cold pressor task. participants will be randomized to a gratitude or neutral writing condition.

Eligibility criteria:
inclusion criteria: * must be pain-free * must be at least 18 years old exclusion criteria: * cardiovascular disease * raynaud's disease * epilepsy * being pregnant * having a current injury to or open cut or sore on one's non-dominant hand * history of fainting or seizures * history of frostbite in non-dominant hand * chronic pain conditions (e.g., fibromyalgia, neuropathy, arthritis) * diabetes * malignant tumor * chronic lung disease * liver disease * kidney disease * gastrointestinal diseases * currently taking opioids
a pilot study of prostate cancer-specific anxiety in active surveillance

Conditions: Prostate Cancer

Summary: this study is a clinical trial to determine whether a 12-week group therapy intervention for patients undergoing active surveillance for prostate cancer can relieve disease-related anxiety and improve quality of life and delay elective treatment of prostate cancer. the goal of the study is to further our understanding of anxiety in men who have been diagnosed with prostate cancer and are undergoing active surveillance. men who have elected active surveillance for their management of prostate cancer are eligible to participate in this study. after signing informed consent, all participants will complete two brief questionnaires (the memorial anxiety scale for prostate cancer \[max-pc\] and the general anxiety and depression scale 7 \[gad-7\] to measure their anxiety levels. if the participant scores above a certain number, they will be asked to participate in the study. patients will be randomly assigned to either a control group, who will receive no treatment, but continue to follow up with their urologist to manage their prostate cancer as usual, or the treatment group. the treatment group will receive 12 one-hour group therapy sessions that will take place once a week for 12 weeks with a licensed psychologist free of charge. they will be instructed to follow up with their urologist as previously determined for their prostate cancer management. patients in both groups will be monitored for anxiety completing three questionnaires, the max-pc and gad-7 which they previously completed, and the functional assessment of cancer therapy - prostate (fact-p) during the 4th and 12th weeks of therapy. if patients require further therapy beyond the group treatment sessions, the investigators may refer them to a psychologist or psychiatrist for further treatment.


Eligibility criteria:
inclusion criteria: * age of 40 * primary diagnosis of prostate cancer * initial max-pc score of ≥16. * sign a consent form allowing related information to be included in this research. exclusion criteria: * prostate cancer is not their primary diagnosis. * have pre-existing diagnosed psychiatric conditions, are currently taking psychotropic medications (e.g., antidepressants, anxiolytics, mood stabilizers.) * have been diagnosed with cancer other than prostate cancer (and non-melanoma skin cancer) * evidence of active substance abuse. * participants in the treatment group who are absent from more than 3 therapy sessions will be excluded.

Keywords: prostate cancer, anxiety
epidemiological study of a prospective cohort of patients aged 60 and over managed for acute myeloid leukemia (aml) and receiving intensive induction therapy

Conditions: AML, Adult

Summary: this observational epidemiological study targets patients aged 60 and over with de novo or secondary acute myeloblastic leukemia suitable for intensive receive intensive induction therapy as defined by the group. the main aim of the study is to determine the epidemiological characteristics of aml patients, both clinically and biologically, and to correlate these to their outcome. the incidence of aml increases with age, exponentially after the age of 50, giving a median age at diagnosis of close to 70 years, with over half of patients half of patients are over 60 at diagnosis. the principle of treatment as in younger patients, is based on trying to achieve complete remission (cr). remission (cr). observed complete remission rates range from 38 to 70%. long-term survival of elderly subjects remains limited, at around 10 to 15%, despite the various types of consolidation tried out in recent years. years. however, intensive chemotherapy remains the preferred option for initial treatment of these hematological diseases when general condition and comorbidities allow. as shown by swedish registry studies, it is associated with improved life expectancy. the proportion of patients who can receive intensive initial treatment is not well known in france, probably varies widely from one region to another, and certainly decreases with increasing age. only the registry studies currently underway will enable us to assess this precisely.


Eligibility criteria:
inclusion criteria: * patients aged 60 and over * patients with previously untreated de novo or secondary aml * patients suitable for standard intensive treatment * patients who have read the information document and agreed to the collection of data concerning them (signature of informed consent). exclusion criteria: * patients with aml 3 * patients with severe, uncontrolled infection at the time of inclusion * patients with psychiatric or social disorders that will prevent compliance with the protocol * patients without health insurance (affiliation to a social security scheme)
pilot study in patients with symptomatic steroid-naive asthma

Conditions: Asthma

Summary: the purpose of the study is to evaluate an investigational medication to treat chronic asthma. the research is being conducted at 20 clinical research sites in the us and is open to both men and women ages 18 to 70 years. participants in the study will have a number of visits to a research site over an 8-month period. all study-related care and medication is provided to qualified participants at no cost. this includes all visits, examinations and laboratory work.


Eligibility criteria:
inclusion criteria: * at least a 6-month history of asthma * no use of inhaled, oral or injectable steroids for at least 1 month prior to enrollment exclusion criteria: * patients with \> 10 pack years of smoking history or smoking within 12 months of study enrollment * no significant disease other than asthma

Keywords: asthma anti-il-4 monoclonal antibody pascolizumab
bleeding prediction in thrombocytopenia

Conditions: Thrombocytopenia

Summary: the purpose of the study is to investigate whether platelet indices from automated haematology equipment, whole blood impedance aggregometry and a standardized bleeding questionnaire predict bleeding in admitted patients with thrombocytopenia of various causes.

thrombocytopenia is a risk factor for bleeding, but studies concerning markers for stratification of bleeding risk among thrombocytopenic patients are lacking. this prospective observational cohort study investigates risk factor for bleeding in admitted patients with thrombocytopenia of various causes.

Eligibility criteria:
inclusion criteria: * admitted patients with thrombocytopenia * age ≥18 years * platelet count below 80 x109/l exclusion criteria: * platelet transfusion within the previous 14 days, * surgery or trauma within the previous 7 days * unable to give informed consent.

Keywords: bleeding platelet indices platelet aggregometry bleeding questionnaire
rifaximin, loperamide and the combination to treat travelers' diarrhea

Conditions: Travelers' Diarrhea

Summary: most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.the study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.

during short-term study, adult u.s. students in mexico (n = 310) with acute diarrhea (≥ 3 unformed stools with enteric symptoms) were enrolled in a double-blind, randomized trial wherein they were given rifaximin 200 mg three times a day for 3 days (r) (n = 102), loperamide 4 mg initially followed by 2 mg after each unformed stool not to exceed 8 mg/day for 2 days (l) (n = 104) or both drugs in the same dosage schedule (l/r) (n = 104). the major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (tlus).

Eligibility criteria:
inclusion criteria: * inclusion criteria include: irb approval; signing of a consent form;18 years of age or older, providing of an unformed pre-treatment stool; females must be non-pregnant and not nursing. exclusion criteria: * exclusion criteria include: diarrhea longer than 72 hours; moderate or severe dehydration, pregnancy or breast feeding, receipt of trimethoprim-sulfamethoxazole, azalide, doxycycline, or a fluoroquinolone in the past week; unstable medical condition; hypersensitivity to rifaximin or rifampin; fever (\>100.6o f) or bloody diarrhea.

Keywords: travelers' diarrhea rifaximin loperamide enterotoxigenic e. coli
nutrition and exercise intervention study

Conditions: Hypertension; Dyslipidemia; Diabetes; Low Back Pain

Summary: the purpose of the present study was to clarify the effects of increase in physical activity on incidence and surrogate marker of cardiovascular diseases. the working hypothesis of the present study was that the physical activity to satisfy the japanese guideline of ministry of health, labour and welfare is effective for the primary prevention of the lifestyle-related disease.


Eligibility criteria:
inclusion criteria: * males and females * ages 30-64 years old exclusion criteria: * during treatment of any diseases * two or more metabolic risk factors

Keywords: physical activity nutrition cardiovascular diseases musculo-skeletal problems