Kornimate/medical-research-clean huggingface dataset:
phase 0/1 local application of the monoclonal antibody (mab) sb24m in patients with purulent pyoderma

Conditions: Pyoderma; Pyoderma Gangrenosum; Pyoderma Vegetans; Pyoderma Gangrenosum Surrounding Surgical Stoma

Summary: phase 0/1 local application of the monoclonal antibody (mab) sb24m in patients with purulent pyoderma (chronic ulcerative pyoderma) by injection into the affected areas. monoclonal antibody (mab) sb24 negatively regulates immune-inflammatory processes through cd47 / tnf-α axis promotes epithelialization of damaged tissue.

this is an open-label phase 0 trial that will enroll up to 10 participants with purulent pyoderma (chronic ulcerative pyoderma) by injecting 200 mg of the monoclonal antibody (mab) sb24m into the areas affected by pyoderma. monoclonal antibody (mab) sb24 negatively regulates immune-inflammatory processes through cd47 / tnf-α axis promotes epithelialization of damaged tissue. this study is a first-in-man since previously no clinical studies on the local application (injections) of monoclonal antibodies in pyoderma gangrenosum have been conducted.

Eligibility criteria:
inclusion criteria: * a confirmed severe form of any type of pyoderma with lesions of the skin and muscle tissue was diagnosed * male or female, age ≥ 21 years * previous treatment with tnf antagonists (infliximab, adalimumab, etanercept, certolizumab, golimumab) ended no earlier than 30 days before starting therapy * secondary treatment failure with up to one previous tnfα antagonist treatment (from the list above) * secondary failure of corticosteroid treatment * adequate hematologic, hepatic, and renal function * written informed consent. exclusion criteria: * history of primary resistance or intolerance to any tnfα antagonist. * history of congestive heart failure or current, controlled or uncontrolled * women who are pregnant or breastfeeding, or women of childbearing age if no effective method of contraception has been used during and for 3 months after the trial * men, if no effective contraceptive method was used during the study and for 3 months afterward * any prior exposure to hu5f9-g4 or other cd47 targeting agents * previous allogeneic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (gvhd), or need for graft-associated immunosuppression * refusal to sign the informed consent
left-colon wec may reduce insertion time compared with whole-colon wec.

Conditions: Polyp; Pain

Summary: in most of situation, left colon (especially sd junction) is considered the most difficult part of colonoscopy, where endoscopist may encounter difficulty for scope insertion and patients may feel pain or uncomfortable. it is suggested more than half of the whole time for scope insertion should be used in left colon. many methods, such as water immersion, abdominal palpation, have been used to facilitate insertion in left colon. colonoscopy with whole-colon water exchange method has been shown to be useful for reducing medication used, pain experienced during colonoscopy, increasing the success rate of cecum intubation and adenoma detection rate in sedated and unsedated patients undergoing screening colonoscopy. exchange of water during scope insertion minimizes loop formation and prevents lengthening and distension of the colon during colonoscopy. this will facilitate the colonoscopy in average or difficult colonoscopy. however, it is not known whether the benefits of water exchange method of colonoscopy was mainly due to its effect on the left colon. we hypothesized that left-colon water exchange colonoscopy (lwe) may have the similar effect regarding the maximal pain score and mean pain score in unsedated patients compared with whole-colon water exchange colonoscopy (wwe). at the mean time, lwe may reduce the insertion time compared with wwe. here we performed a prospective, randomized controlled study to investigate the efficacies of whole-colon water exchange, left-colon water exchange and air methods of colonoscopy on pain score and insertion time in unsedated outpatients.


Eligibility criteria:
inclusion criteria: * outpatients with unsedated colonoscopy exclusion criteria: * history of colon resection * severe colonic stricture or obstructing tumor * hemodynamic instability * current pregnancy * inability to provide informed consent

Keywords: colonoscopy
efficacy of animal-assisted therapy in patients with borderline personality disorder and addictions.

Conditions: Diagnosis, Dual (Psychiatry)

Summary: animal-assisted therapy (aat) is a complementary intervention of therapy that has shown positive results in the treatment of various pathologies. this study assesses the viability of the implementation and the effectiveness of an aat program in patients diagnosed with borderline personality disorder and substance abuse disorder. our hypotheses are that participation in the taa program will reduce negative symptoms, improve the quality of life of people with dual pathology, whose mental illness is schizophrenia, and increase adherence to treatment for people with dual pathology, whose mental disorder it's schizophrenia.

animal assisted therapy (aat) is a complementary intervention to therapy that presents positive results in the treatment of different pathologies. the study assesses the implementation and effectiveness of a taa program in patients diagnosed with borderline personality disorder and substance abuse disorder.

Eligibility criteria:
inclusion criteria: * meeting dsm-5 criteria for substance abuse disorder and the presence of borderline personality disorder. * voluntary participant in the study and having signed the informed consent exclusion criteria: * patients whose functioning could be altered by factors not specifically related to addictive pathology or mental disorder (severe cognitive impairment, intellectual deficiency or language barrier) * animal-specific phobia

Keywords: animal-assisted therapy borderline personality disorder substance abuse dual pathology residential treatment
a phase ii, repeat single oral dose study of iped2015 in healthy male subjects with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: this is a phase ii, randomised, double-blind, parallel-group, placebo-controlled study to investigate the effects of repeat single oral doses of iped2015 in otherwise healthy male subjects with ed. up to 120 subjects are planned to be enrolled into 3 groups. group 1 is planned to consist of 60 subjects, group 2 is planned to consist of 36 subjects and group 3 is planned to consist of 24 subjects. groups 1, 2 and 3 will be conducted in parallel. each subject will be dosed on four occasions. there will be three study treatments of dose 1 of iped2015, dose 2 of iped2015 or matched placebo. in each group, subjects will be randomised evenly to each of the three study treatments and will receive the same treatment on each visit.

the primary objective of this study is to investigate the effects of repeat single oral doses of iped2015 on male subjects with erectile dysfunction (ed) on ability to develop and maintain an erection.

Eligibility criteria:
inclusion criteria: otherwise healthy male subjects with ed as determined from an iief-5 score of \<16, with a body mass index of 18 to 35 kg/m2 (inclusive), of any ethnic origin. subject must have had at least one intent to have sexual intercourse during the last 3 months prior to screening. exclusion criteria: any significant cns, cardiac, pulmonary, metabolic, renal, hepatic (including gilbert's syndrome), gastrointestinal (gi) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion of drugs, or with the completion of treatment according to this protocol. clinically significant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during screening or day -7 as judged by the investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, gi, hepatic, or renal disorder). clinically significant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ecg and vital signs, or physical findings at screening. in case of uncertain or questionable results, tests performed during the screening visit may be repeated to confirm eligibility or judged to be clinically irrelevant for otherwise healthy subjects with ed.
study of fetal movements using multichannel ultrasound pulsed doppler in normal and pathologic pregnancy

Conditions: Pregnancy; Fetal Distress

Summary: to enable an investigation of fetal movements, the researchers have developed a multichannel ultrasound pulsed doppler called actifoetus. this new fetal monitor includes three transducers of four sensors which are placed on three different zones of the mother's abdomen. one of the transducers is aimed at the fetal heart, another at the lower limbs and one transducer at the thorax and the fetal upper limbs to detect heart and body movements. the signals are analysed and processed by software which computes a number of parameters describing the movements. ninety pregnant women from 28 weeks gestation will be monitored over a 40 minute period every month or every 2 weeks in case of pathological pregnancy. the final purpose will be to develop a system of home monitoring as an indicator of fetal well-being.

the main objective of the study is to detect quantitative and qualitative disorders of fetal movements from 28 weeks of amenorrhea on a fetus presenting in fetal distress. the fetal rhythm will be recorded during 24 hours and a correlation between maternal and fetal movements will be studied. specific measures: * the fetal heart rate * the number and extent of fetal movements

Eligibility criteria:
inclusion criteria: * 18 years of age or older * pregnancy with singleton * woman from 28 weeks of amenorrhea exclusion criteria: * fetal malformation

Keywords: maternal's movements recorded by a specific sensor parameters of fetal distress (umbilical and cerebral doppler) and new-born parameters.
sherlock 3cg™ diamond tip confirmation system

Conditions: Indication for Peripheral Intravenous Catheterization; Atrial Flutter; Premature Atrial Contraction; Premature Ventricular Contraction; Premature Junctional Contraction; Tachycardia; Atrioventricular Block; Bundle-Branch Block

Summary: this study is a single-arm, prospective, multi-center study to assess clinical performance of the sherlock 3cg™ diamond tip confirmation system (tcs) with modus ii software for confirming correct tip position of peripherally inserted central catheters (piccs) in adult subjects with altered cardiac rhythm.

this study is intended to confirm the accuracy of the sherlock 3cg™ diamond tcs with the addition of modus ii (slm2) software to eliminate the need for post-procedural chest x-ray (cxr) in adult subjects with cardiac abnormalities that alter presentation of the p-wave. atrial fibrillation will be the primary target while data on pacemaker driven rhythms and other arrhythmia types will also be collected to explore overall performance.

Eligibility criteria:
inclusion criteria: * male or female, ≥ 21 years of age with altered cardiac rhythm (no recognizable p-wave on standard ecg) with diagnosis of specific arrhythmia type or identification of pacemaker driven rhythms as defined below: 1. atrial fibrillation with history of diagnosis per 12-lead ecg in medical record or diagnosed via bedside telemetry by study team rn at assessment, or 2. all other arrhythmias (including but not limited to atrial flutter, pac, pvc, pjc, tachycardia, av block, bb block) with history of diagnosis per 12-lead ecg in medical record or diagnosed via bedside telemetry by cardiac unit rn at assessment, or retrospectively by site cardiologist, or 3. pacemaker driven rhythm with temporary or permanent pacemaker device in place; * subject requires picc placement as part of standard of care; * subject or legally authorized representative (lar) has signed an informed consent form (icf). exclusion criteria: * subject has a contraindication to picc placement as listed in the instructions for use (ifu) to include: 1. the presence of bacteremia or septicemia (known or suspected), 2. the patient's body size is insufficient to accommodate the size of the implanted device, 3. the patient is known or is suspected to be allergic to materials contained in the device, 4. past irradiation of prospective insertion site, 5. previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site, 6. local tissue factors will prevent proper device stabilization and/or access; * subjects who previously had a picc in place and require a picc exchange; * subject has presence of active resting tremor (i.e. parkinson's, multiple sclerosis, etc.) deemed by investigator to have potential impact on procedure accuracy; * subjects who are pregnant or think they may be pregnant.
multisensory physical exercises in people with cognitive impairment

Conditions: Dementia

Summary: the main objective of the study is to evaluate the efficacy of a combined training program of physical exercise and multisensory stimulation (physiocognitive integration) in people with mild/moderate cognitive impairment.

alzheimer's disease and other dementias are the main cause of cognitive impairment, with a prevalence of 0.4% worldwide and 1.23 in europe. the who estimates that the growth of people with cognitive impairment to some degree will increase in the coming years, exceeding 75 million people in the world in 2030, and 135 million in 2050. the prevention of cognitive deterioration is mainly based on the implementation of non-pharmacological therapies. multisensory stimulation is a non-pharmacological therapy that has benefits in patients with cognitive impairment, producing an improvement in cognitive function. physical exercise is associated with a lower risk of onset of cognitive impairment and less cognitive impairment as well as a slower progression in people with mild cognitive impairment and in mild-stage dementias. in addition to the cognitive sphere, the positive effect of physical exercise in preventing falls has been widely studied. the main objective of the study is to evaluate the efficacy of a combined training program of physical exercise and multisensory stimulation (physiocognitive integration) in people with mild/moderate cognitive impairment. in order to do this, a experimental group will perform 20 sessions of multisensory training in addition to their current therapy and a second, control group, only their current therapy. before and after the time need to complete the 20 sessions, all subjects were perform a battery of motor and cognitive tasks.

Eligibility criteria:
inclusion criteria: * absence of treatment with psychotropic drugs or stable dose of the same (without drug or dose modifications in the last four weeks). in the case of subjects who are part of the intervention group, the following will also be inclusion criteria: * caregiver or family member who presents the appropriate skills for collaboration in the implementation of the exercises and in the management of the mobile application. * availability of the necessary time for the initial training in the handling of the devices, the development of the sessions and the communication with the researchers. exclusion criteria: * insufficient physical condition for participation. * sensory deficits that make participation difficult. * unstable clinical situation. * unstable mental disorder or not adequately controlled with medication (depression, agitation, etc.). * presence of associated pathology that involves treatment with drugs that alter cognitive abilities or interfere with the user's participation.

Keywords: exercise rehabilitation sensory stimulation
observational study to evaluate the efficacy and safety of suganon tab. or sugamet xr tab.

Conditions: Diabetes Mellitus, Type 2

Summary: multi-center, open, non-intervention and observational study to evaluate the efficacy and safety of suganon tab. or sugamet xr tab. in patients with type 2 diabetes


Eligibility criteria:
inclusion criteria: 1. the subject is aged ≥19 years 2. the subject has type 2 diabetes mellitus exclusion criteria: 1. the subject has a contraindication
comparison of aerosol delivery of infasurf to usual care in spontaneously breathing rds patients

Conditions: Respiratory Distress Syndrome

Summary: study to test the hypothesis that aerosolized infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

treatment will not be masked. the study objective is to document that aerosolized infasurf is superior to "usual care" and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop rds in the first hours of life and (b) patients who received instillation of surfactant for rds in the first hour of life, were extubated, and have continuing rds.

Eligibility criteria:
inclusion criteria: rds patients 1. nicu patient, ≥1hour of age and \<24 hours of age. 2. clinical diagnosis of rds, with or without chest x-ray data. 3. inspired oxygen ≥21% to maintain adequate oxygen saturation. 4. not intubated 5. requiring: 1. nasal continuous positive airway pressure (ncpap). exclusion criteria: 1. congenital anomaly limiting care options or requiring early surgery. 2. cardiopulmonary decompensation. 1. hypotension with metabolic acidosis (base excess \< -10 meq/l). 2. oxygen saturations \< 88% at start of aerosolization. 3. paco2 ≥ 60 mmhg at start of aerosolization. 3. grade 3 or grade 4 intraventricular hemorrhage by cranial ultrasound, if known. 4. acute hypoxic encephalopathy with or without seizures.

Keywords: aerosol surfactant calfactant infasurf respiratory distress syndrome rds premature neonates
primary care identification of patients with chronic neuropathic low back pain study

Conditions: Low Back Pain; Neuralgia

Summary: a0081256 is a prospective, open-label, multi-centre european study designed to raise awareness and enhance the diagnosis of patients with chronic low back pain with a neuropathic pain component in primary care who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain and evaluate the effectiveness and tolerability of pregabalin in this population. the impact of pregabalin on analgesia, patient satisfaction with treatment, patient anxiety and depression, sleep interference, physical functioning and work productivity will be assessed.


Eligibility criteria:
inclusion criteria: * patients must have low back pain with a neuropathic pain component between 3 months and 12 months duration prior to entering the study. * patients must have a score of at least 19 on the paindetect questionnaire and at least 4 on the standardized evaluation of pain (step) scale at screening. * patients must have a mean pain numerical rating scale (nrs) score of 4 or more during the one week screening period. * patients must have failed to respond to standard analgesic therapy (e.g. non-steroidal anti-inflammatory drugs \[nsaids\]) and/or one treatment for neuropathic pain (e.g. tricyclics, serotonin-norepinephrine re-uptake inhibitors \[snris\]) prior to entering the study). exclusion criteria: * a diagnosis of depression or a hospital anxiety and depression scale (hads) score of \> 15 on the depression sub-scale only. * patients with a history of renal impairment or who have reduced renal function at baseline (creatinine clearance \< 60 ml/min). * patients who have previously taken pregabalin or gabapentin within 6 months prior to entering the study. * patients who have undergone previous surgery for back pain. * patients who are using high doses of opioid medication (morphine \> 60 mg per day).

Keywords: identification chronic neuropathic low back pain primary care pregabalin
the effects of night call on intellectual performance

Conditions: Sleep Deprivation

Summary: the purpose of the current proposal will be to examine the clinical performance of both physicians in training as well as experienced faculty in pre and post call situations. groups will be matched for gender, age, experience and employment duration during regular hours versus immediate post call hour.

this is a prospective study evaluating the reaction time among attending anesthesiologists, and anesthesiology residents who take night shift call and are suffering from sleep deprivation. investigators plan to examine clinical performance by measuring reaction times using a 10 minute psychomotor vigilance test device on physicians in training as well as experienced physicians in pre and post call situations. all subjects will be informed of the scope and purpose of the study. 1. attending anesthesiologists: gender, age, years of experience, years of employment at the institution, hours of sleep and circadian rhythm will be taken into effect. 2. residents/fellows: gender, age, years of experience, years of employment at the institution and circadian rhythm will be taken into effect. all study subjects will be asked to fill a questionnaire regarding demographic data, coping strategy index. 1. baseline instruments; including demographics, and coping strategy indicator (csi), will be administrated. 2. reaction time, mood and simple cognitive test will be measured at approximately 7 am of a regular day, (when the subject is not on call). 3. reaction time, mood and simple cognitive test will be measured at approximately 7 am of after a call night. this proposal attempts to examine the impact of night shift on mood, cognitive and motor task performance in physicians as compared to regular hours.

Eligibility criteria:
inclusion criteria: * staff attending anesthesiologist who takes night shift call * anesthesiology residents who take night shift call exclusion criteria: * staff unwilling to participate