Kornimate/medical-research-clean huggingface dataset:
transcranial direct and alternating stimulation of the prefrontal cortex for cognitive improvement in schizophrenia

Conditions: Schizophrenia; Cognitive Dysfunction

Summary: the purpose of this study is to investigate different stimulation intensities and frequencies of transcranial direct and alternating current stimulation over the dorsolateral prefrontal cortex for cognitive improvement in schizophrenia.

in this randomized, double-blind study, 50 patients diagnosed with schizophrenia are randomly assigned into two arms. the first group receives transcranial direct current stimulation (tdcs) at three intensities (2 ma, 3 ma, and sham) and the second group receives transcranial alternating current stimulation (tacs) at three different frequencies (8 hz, 40 hz, and sham) over the left dorsolateral prefrontal cortex for 20 min. there are at least 72 hours between stimulation sessions. the patients conduct three cognitive tasks from the cantab neuropsychological battery for schizophrenia during stimulation including a working memory task, a cognitive flexibility task, and an emotion recognition task. mood stability is also evaluated before and after each stimulation session with the positive and negative affect scale (panas).

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia based on dsm v, * being 18-50 years old (male and female) * if female, negative urine pregnancy test * feasibility for tdcs interventions according to safety guidelines * stable medication regime especially the classical neuroleptics and all cns-activating medications, if taken, 4-6 weeks before the experiment * fluency in the native language * right-handed * required written informed consent signed by patients' guardian exclusion criteria: * pregnancy * alcohol or substance dependence * history of seizure * history of neurological disorder * history of head injury * presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces).

Keywords: schizophrenia tdcs tacs cognition dorsolateral prefrontal cortex
study of three doses of aripiprazole in patients with acute schizophrenia

Conditions: Schizophrenia

Summary: a study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia


Eligibility criteria:
inclusion criteria: * men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months
investigation of analgesic and anti-hyperalgesic effect of opioids in experimental pain

Conditions: Pain

Summary: to compare the analgesic and anti-hyperalgesic effect of buprenorphine and fentanyl against experimental pain in skin, muscle and bone. the study will be performed with healthy volunteers.


Eligibility criteria:
inclusion criteria: * written informed consent * men \> 18 years exclusion criteria: * women * known allergy against the investigated drugs * ongoing participation in other experiments or participation in other experiments 14 days before screening * previously pain or psychiatric conditions * simultaneously use of pain killers * alcohol * previously drug-addict or member of family with drug-addicts * chronic constipation * ileus * inflammatory bowel syndrome * abdominal surgery within the last three months

Keywords: buprenorphine fentanyl analgesic effect anti-hyperalgesic effect experimental pain
omega-3 fatty acids plus vitamin e cosupplementation versus vitamin e in fibrocystic breast patient

Conditions: Mastalgia

Summary: to identify the effect of omega-3 plus vitamin e cosupplementation on mastalgia in patients with fcc and to compare its effect with that of vitamin e only.

120 patients will be enrolled in the study and divided into three groups each group consisted 40 patient then the severity of mastalgia in the three groups before, through and after intervention. radiological assessment was done before and after the intervention.

Eligibility criteria:
inclusion criteria: * all females with mastalgia aged 18 to 55 exclusion criteria: pregnant and lactating women, patient who had a recent breast abscess or breast drainage, patient used omega-3 and vitamin e supplementation before the trial and postmenopausal women. -
electric stimulation of the eye to improve vision after trauma

Conditions: Non-arteritic Anterior Ischemic Optic Neuropathy (NAION); Trauma; Multiple Sclerosis (MS)

Summary: transcorneal electrical stimulation (tes) using the "okustim®" device delivers electrical impulses to damaged and/or diseased photoreceptor cells. this electric stimulation of the retina may help to preserve visual acuity and/or the visual field.

the finely detailed, precise anatomy of the retina and optic nerve capture light impulses from the environment through a biochemical process and then transmit these images to the brain via electrical impulses conducted from the inner retina to the optic nerve and ultimately to the occipital cortex. in the human eye, three types of specialized ganglion cells transmit electrical impulses to the brain. among these three cell populations are rod and cone cells, which participate in the photo-transduction step of light perception, along with other light sensitive ganglion cells. it is a system whereby the photosensitive pigment rhodopsin (or one of its analogs) rearranges in response to light, and this change in chemical structure fires electrical impulses to the brain which in turn interprets the incoming impulses as a visual image. transcorneal electrical stimulation (tes) using the "okustim®" device delivers electrical impulses to damaged and/or diseased photoreceptor cells. this electric stimulation of the retina may help to preserve va and/or the visual field.

Eligibility criteria:
inclusion criteria: * you are 18 years or older. * you have sustained trauma (more than 3 months before this study) or been diagnosed with non-arteritic anterior ischemic optic neuropathy (naion) (more than 6 months before this study) or been diagnosed with multiple sclerosis (ms) and suffered visual loss (more than 3 months before this study). * you are willing and able to give written informed consent. * you are able to commit to enrolling in the study during the full time period of up to 6 months. exclusion criteria: * you have any other significant ophthalmologic disease or condition (such as glaucoma, retinal degeneration, proliferative diabetic retinopathy, +/- six diopters of myopia, retinal detachment, exudative age-related macular degeneration). * you have amblyopia (lazy eye) in affected eye, previously diagnosed. * you are participating in any other interventional clinical trial. * if you are pregnant or a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for study duration or woman unwilling to perform a pregnancy test at study entry/screening. * you are unable to give signed consent due to memory, medical, communication, language, or mental health problems. * you are less than 18 years old. * you are unable or unwilling to complete the evaluation or questionnaire. * visual acuity better than 20/40 * inability to detect phosphenes during threshold detection * you are on seizure medications, or have a history of epilepsy.

Keywords: naion decreased vision eye trauma tes electrical stimulation multiple sclerosis optic neuritis
canakinumab in the treatment of gouty arthritis flare(s) and prevention of new flares in patients with chronic kidney disease

Conditions: Acute Gouty Arthritis

Summary: the purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (ckd) subgroup of patients participating in phase iii studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe ckd (stage 3 - 4).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of gouty arthritis history of ≥ 3 gouty arthritis flares within the previous 12 months * confirmed diagnosis/ documented history of chronic kidney disease (ckd) stages 3or4 * onset of current acute gouty arthritis flare within 3 days prior to randomization exclusion criteria: * hemodialysis ckd stage 5 organ transplantation * rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis * live vaccinations within 3 months prior to randomization other protocol-defined inclusion/exclusion criteria may apply

Keywords: frequent flares frequent attacks gout gouty arthritis chronic kidney disease renal impairment anti-interleukin-1β monoclonal antibody anti-inflammatory therapy
bioavailability study of sparc1210 and reference1210 in subjects with metastatic breast cancer

Conditions: Breast Cancer

Summary: pharmacokinetic, bioequivalence study


Eligibility criteria:
inclusion criteria: * the subject has given written, informed consent and is available for the entire study. * histologically or cytologically confirmed diagnosis of breast cancer; * locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option; * age 18 years or more exclusion criteria: * known hypersensitivity to both the study drugs or its excipients (cholesteryl sulfate, caprylic acid, polyvinylpyrrolidone, ethanol or polyethylene glycol); * presence of clinically evident active cns metastases, including leptomeningial involvement, requiring steroid or radiation therapy; * pre-existing clinically significant peripheral neuropathy (grade 2 or higher according to ctcae, version 4.0); * any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study
securatm icd clinical evaluation study

Conditions: Tachyarrhythmias

Summary: the purpose of the secura clinical study is to evaluate the overall system safety and clinical performance of the secura dr implantable cardioverter defibrillator (icd)

the secura icd is an investigational dual chamber icd that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation, dual chamber rate-responsive bradycardia pacing and diagnostics. the study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 15 centers. to allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the secura device. data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, system modifications, technical observations, study deviations, study exit, upon notification of new or updated adverse events and in case of death.

Eligibility criteria:
inclusion criteria: * patients who have an icd indication. * patients who are geographically stable and available for follow-up at the study center for the duration of the study. * patients who have signed a medical ethics committee (mec) approved informed consent form. exclusion criteria: * patients with a life expectancy less than the duration of the study. * patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients. * patients with mechanical tricuspid heart valves.
illness expectations in pulmonary fibrosis

Conditions: Pulmonary Fibrosis

Summary: this study aims to delve into the constructs of illness beliefs and expectations among patients with pulmonary fibrosis, exploring how these beliefs and expectations may influence the treatment journey, including oxygen therapy, non-invasive ventilation therapy, and pharmacological treatments.


Eligibility criteria:
inclusion criteria: * patients with pulmonary fibrosis * patients using oxygen therapy * patients using non-invasive ventilation * patients undergoing pharmacological treatment * patients who speak and understand the italian language exclusion criteria: * patients who do not provide their consent * patients without pulmonary fibrosis * patients with psychiatric disorders or cognitive impaiment * patients who don't speak or understand italian language

Keywords: pulmonary fibrosis clinical psychology rehabilitation psychology illness expectations illness perceptions adherence to treatment
the efficacy of adjuvant chemotherapy in locally advanced cervical cancer

Conditions: Cervical Cancer

Summary: the aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.

1. objective: to compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had ccrt alone to those who had adjuvant chemotherapy after ccrt. 2. patients: 1. cervical cancer stage iib to iva with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma 2. complete ccrt(radiation does: a point 85gy(+/-10%), b点50gy(+/-10%), concurrent platinum-containing chemotherapy（cisplatin or carboplatin） 3. mri is performed within 4 weeks after ccrt and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm). 3. methods: the patients who have residual lesions after ccrt are randomized to arm a by observation or arm b by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.

Eligibility criteria:
inclusion criteria: 1. cervical cancer stage iib to iva with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma 2. complete ccrt(radiation does: a point 85gy(+/-10%)，b点50gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin)) 3. mri is performed within 4 weeks after ccrt and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm). 4. ecog\<2 5. expected survival is longer than six months 6. hb≥70g/l、wbc≥3.5×109/ l 、anc≥1.5×109/l、plt≥80×109/l 7. alt and ast≤2×uln, serum creatinine≤1.5×uln 8. the serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial exclusion criteria: 1. activity or uncontrol severe infection 2. liver cirrhosis, decompensated liver disease 3. history of immune deficiency, including hiv positive or suffering from congenital immunodeficiency disease 4. patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure 5. have suffered or combined with other malignant tumor 6. myocardial infarction, severe arrhythmia and nyha (new york heart association)≥2 for congestive heart failure 7. a history targeted therapy or pelvic artery embolization 8. artery-enous thrombosis within 6 months 9. patients with autoimmune diseases 10. complications, need to be treatment with drugs which may lead to liver or kidney injury 11. patients with disease progression after chemoradiation

Keywords: locally adcanced ccrt adjuvant chemotherapy
transdiagnostic internet intervention to improve mental health among university students: pilot study

Conditions: Psychological Disorder

Summary: this study comprises the pilot phase of a randomized controlled trial (nct05085756) that will investigate the feasibility of a transdiagnostic cbt-based treatment for symptoms of depression and anxiety offered to swedish university students. it will offer treatment to participants who have previously responded to a universal online mental health screen conducted in university setting (who-wmh-ics survey). the pilot study initially has a prospective single-group design where 30 college students with elevated depressive and/or anxiety symptoms are enrolled in 8 weeks of therapist-guided cbt treatment via the internet. all participants included will receive treatment. mid-treatment, participants that are judged to be at risk of treatment failure will be randomized (1:1 ratio) to either continued treatment with no change, or to receive added therapist-support intended to enhance outcome. pilot study outcomes include various aspects of feasibility: participant uptake, self-reported credibility and expectancy, adherence to treatment protocol and assessments, treatment satisfaction, potential adverse events, causes for premature termination of treatment, and procedures for providing additional therapist support to a subsample of participants after mid-treatment. within-group effects for primary depression and anxiety measures will be quantified. a range of secondary measures are piloted for the subsequent randomized controlled trial. the assessment points for this study: baseline; 8 points during treatment; post-treatment; 6-month follow-up; 12-month follow-up; 24 month follow up. note. this study is retrospectively registered; this registration was completed prior to any outcome data-analyses.


Eligibility criteria:
inclusion criteria: * college/university student at institution of higher education in sweden * score 5-19 on the phq-9, and/or * score ≥5 on the gad-7 * completed baseline assessment exclusion criteria: * pharmacotherapy for mental health issue during the past 3 weeks) * concurrent psychological treatment during the past 3 weeks * mild levels of mental ill-health (under cut-off for primary outcome measures) * severe levels of mental ill-health * suicidal ideation or plans
a randomized controlled trial evaluating one drop | premium with afrezza vs. one drop | premium alone

Conditions: Diabetes Mellitus, Type 2

Summary: the a-one study is a prospective, randomized controlled trial evaluating the use of the one drop \| premium 'on track' in combination with afrezza treatment on the glycemic control, treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of people with type 2 diabetes (t2d) and a hemoglobin a1c (a1c) \> 7.0% already prescribed an injectable rapid-acting insulin.

eligible participants (n=400) with an a1c \> 7.0% already prescribed a rapid-acting insulin will be randomized to one of two groups: (1) one drop \| premium 'on track' (i.e., use the one drop \| mobile app with in-app diabetes education accredited by the american diabetes association with supplemental afrezza content and a live certified diabetes educator messaging in the app, the 'chrome' bluetooth-connected blood glucose meter that uploads blood glucose values in the app, and 150 test strips per month) in combination with afrezza treatment (n=200) or (2) one drop \| premium 'on track' plus their current rapid-acting insulin (n=200).

Eligibility criteria:
inclusion criteria: * 18-75 years of age * self-reported diagnosis of t2d * diagnosed with diabetes for at least 12 months * prescribed a prandial rapid-acting insulin * willing to take afrezza rapid-acting insulin for 3 months instead of current rapid-acting insulin * willing to get a physician's prescription for afrezza * self-reported a1c \> 7.0% (later confirmed with a mail-in a1c laboratory test) * owns and uses an iphone or android phone with an operating system compatible with the one drop \| mobile app * has successfully downloaded and used a smart phone application previously exclusion criteria: * currently pregnant or planning to become pregnant during the trial period * cannot read or write in english * currently in a diabetes education or coaching program * had previously used one drop \| premium or one drop \| * experts coaching * had previously used or is currently using afrezza * currently smokes (cigaretts, e-cigs, pipes, cigars, marijuana) or has smoked anytime in the past 6 months * has chronic lung disease, e.g., copd and asthma

Keywords: diabetes mellitus, type 2 afrezza
study evaluating vancomycin-resistant enterococci in a hematology unit

Conditions: Gram-Positive Bacterial Infections

Summary: to determine the impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (vre) in a surgical intensive care unit (sicu)


Eligibility criteria:
inclusion criteria: * all patients admitted to or transferred to the sicu. * eligible patients will be patients of either sex, 18 years of age or older who are admitted or transferred to the sicu. * provide written informed consent exclusion criteria: * patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase inhibitors. * females who are pregnant and breast feeding * any underlying conditions or non-infectious diseases that will be ultimately fatal within 48 hours. * those who have already been participating other clinical study related with antibiotics.

Keywords: bacterial infections
inspiratory muscle training in hypercapnic copd

Conditions: COPD; Respiratory Failure

Summary: the trial intends to investigate, whether inspiratory muscle training in hypercapnic patients improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk within six minutes.

inspiratory muscle training is known to improve inspiratory muscle strength, inspiratory muscle endurance and walking distance within six minutes in patients with neuromuscular and thoraco-restrictive disease as well as in patients with copd. studies have only been conducted in patients without established respiratory failure. copd patients with respiratory failure though are characterized by higher work rates of the inspiratory muscles and higher esophageal pressure swings compared to non-hypercapnic patients indication a discrepancy between muscle load and muscle capabilities. therefore we hypothesize that for these patients training of their inspiratory muscles will be of benefit in terms of improvement of muscular and whole body endurance. during this investigation inspiratory muscle training will be applied in a randomized controlled fashion in 40 patients over a period of four weeks parallel to physical rehabilitation.

Eligibility criteria:
inclusion criteria: * copd with fev1/fvc \< 70 % * age \> 18 * stable disease * able to walk * carbon dioxide \>= 48 mmhg exclusion criteria: * ejection fraction of the heart \< 40 % * active psychiatric disease * bronchial hyperresponsiveness according to ats criteria * pregnancy * renal insufficiency with a creatinine \< 2 mg/dl

Keywords: copd respiratory failure inspiratory muscle training
outcomes of operative treatment of unstable ankle fracture - comparison between metallic and biodegradable implants

Conditions: Ankle Fracture

Summary: the purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. null hypothesis is that the clinical outcomes of biodegradable plate and screws for ankle fracture are not different from those of metallic implants.


Eligibility criteria:
inclusion criteria: * skeletally mature subjects (≥16 years old) with unilateral ankle fractures exclusion criteria: * subjects less than 16 years old, * subjects not followed up at this hospital, * multiple injuries, * bilateral ankle fractures, * open fractures, * pathologic fractures, * concomitant tibial shaft fractures, * previous history of immobilization due to significant injury or a fracture of either ankle, * significant peripheral neuropathy, * soft tissue infection in the region on either injured ankle, * or inability to complete the study protocol

Keywords: ankle metallic biodegradable freedom