Kornimate/medical-research-clean huggingface dataset:
non-interventional study: real-life use of atypical antipsychotics in acute inpatient management of schizophrenia

Conditions: Acute Psychotic Episode; Schizophrenia

Summary: this is an observational study describing the real-life antipsychotic treatment during the hospitalisation of the patients due to acute psychotic episode. in this nis subject's data will be collected at one visit at the moment of discharge from the hospital. the results of the study would help to characterise the discrepancy between current clinical practice and treatment guidelines, indicating that atypical antipsychotics are preferable and should be used in monotherapy during acute psychotic episodes in subjects with schizophrenia. available evidence have revealed a frequent use of first-generation antipsychotics, polypharmacy, intramuscular route of administration and use of atypical antipsychotics in doses lower than recommended in registered summary of product characteristics.

reconnect-s gamma : a non-interventional study to observe real-life usage of atypical antipsychotics in the acute inpatient management of schizophrenia.

Eligibility criteria:
inclusion criteria: * written informed consent has been obtained from the subject and/or his/her legal representative (as per local regulatory requirements). * meet the diagnostic criteria for schizophrenia stated in the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria * subject is hospitalised due to an acute psychotic episode exclusion criteria: * current participation in any clinical trial. * previous enrolment in the present nis (in case of recurrence occurred during the enrolment period)

Keywords: schizophrenia antipsychotics real life treatment non-interventional
impact of hormonal therapy on prostate cancer recurrence after radical prostatectomy

Conditions: Prostate Cancer

Summary: prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease. measures to prevent recurrence are an important research priority for prostate cancer patients and their families. hormonal therapy (androgen deprivation therapy; adt) is routinely used to treat patients with metastases, but few clinical trials have examined if adjuvant adt after surgery will prevent cancer recurrence. we aim to address this research oversight and test the hypothesis that for men at high risk of cancer recurrence, 1 year of adt immediately after surgery will be safe and will significantly improve cancer outcomes.


Eligibility criteria:
inclusion criteria: 1. undetectable psa (\<0.02 ng/ml) within 16 weeks post-operative; 2. ≥25% predicted risk of psa recurrence within 5 years of surgery (based on the kattan nomogram) exclusion criteria: 1. unwilling to receive adt; 2. previously received adt; 3. lymph node metastases 4. allergy to any form of adt
a study evaluating the safety and tolerability of artesunate in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension (PAH)

Summary: this is a 20-week, phase 1, single-center, open-label, dose-escalation study evaluating the safety and tolerability of daily oral artesunate in patients with pah.


Eligibility criteria:
inclusion criteria * each participant must meet the following criteria to be enrolled in this study: * adults aged 18 to 75 years. * who functional class i, ii/iii despite treatment with maximally tolerated doses of 2 or more treatment modalities including pde5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids when appropriate. exclusion criteria * participants who meet any of the following criteria will be excluded from the study. * participants with serious concomitant morbidity per investigator assessment.

Keywords: pulmonary arterial hypertension artesunate pah
the use of magnetic brain stimulation to treat obsessive compulsive disorder, a pilot study

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this study is two-fold: first, to observe the effect of one session of repetitive transcranial magnetic stimulation (rtms) on the error-prediction abilities of patients with obsessive compulsive disorder (ocd) as well as healthy individuals; and second, to observe the clinical effect of 10 sessions of rtms in patients with ocd.

a battery of cognitive tasks designed to selectively measure several aspects of anterior cingulate cortex (acc) function, will be administered before and after one session of rtms in all participants. the first neurocognitive session will be administered in a separate day from the rtms session. the second neurocognitive session will be performed immediately after rtms and in the same day. participants will perform five tasks designed to test: error processing, error likelihood assessment, meta-memory, response inhibition, and affect recognition. the rtms paradigm will consist of four short trains of magnetic pulses which include 5 minutes of stimulation with 1hz frequency (overall 1200 pulses in one session) with an intensity of 110% of each participant's motor threshold, and 2 minute intervals between the stimulation trains. stimulation will be applied over the dorsal acc (dacc) using a double-cone rtms coil. dacc will be precisely targeted using neuronavigation software loaded a high resolution mri of each subjects' brain. ocd patients will go on to receive two weeks (10 sessions) of daily rtms treatments using the same protocol described above.

Eligibility criteria:
inclusion criteria: * diagnosed obsessive compulsive disorder * not currently receiving cognitive behavioural therapy * not currently on any medication or only taking one selective serotonin reuptake inhibitor (ssri) exclusion criteria: * history of psychotic episodes * history of neurological illness * previous head injury * active alcohol or substance abuse * history of seizure disorders * currently pregnant

Keywords: obsessive-compulsive disorder transcranial magnetic stimulation error processing
effects of pioglitazone on insulin sensitivity in healthy overweight and obese males (mk-0000-170)

Conditions: Healthy; Overweight; Obesity

Summary: the purpose of this study is to evaluate whether 30 mg of pioglitazone administered once daily for up to 28 days to healthy overweight and obese subjects will lead to a significant change in insulin sensitivity, measured in the setting of a hyperinsulinemic euglycemic clamp


Eligibility criteria:
inclusion criteria: * subject has a bmi of greater than 28 kg/m\^2 and less than or equal to 38 kg/m\^2 * subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months * subject is willing to avoid major dietary changes for the duration of the study exclusion criteria: * subject has history of diabetes (type 1, type 2 or steroid-induced) * subject has a history of hypersensitivity to pioglitazone or other thiazolidinediones * subject has a history of liver disease, other than non-alcoholic fatty liver disease or non-alcoholic steatohepatitis * subject has a history of congestive heart failure * subject has a active or past history of atherosclerotic heart disease, heart failure, osteoporosis, osteopenia, recurrent bone fractures, or anemia * subject has a history of stroke, chronic seizures, or major neurological disorder * subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological or renal abnormalities or diseases * subject has a history of neoplastic disease within the past 5 years

Keywords: healthy volunteers
prescription audit in opd of nabh & jci approved hospital in capital territory of india

Conditions: Quality of Life

Summary: aim of the study: the aim of the study is to evaluate the quality of the prescription provided to the outpatient. need of study: for the promotion of the good clinical practice to improve the efficiency of the multidisciplinary team in the healthcare to utilize resources to provide better patient care to improve quality standards and quality of care for implication of professional practices to identify and eliminate deficient practice objectives: 1. to study the quality of good prescription 2. in minimization of prescription errors and medication errors 3. also to comply with good clinical practice 4. enhancement of patient safety 5. in the maintenance of rational prescribing 6. to study the quality of care provided by the hospital to the patient plan of study: * to select the patient based on inclusion and exclusion criteria * to collect the information from op's prescription * to identify prescribing errors and medication error * to study the management of good prescription study sites: max super speciality hospital, saket, new delhi (india) study design: observational cohort study study duration: 1 month (november 2022)

source of the data: review of out-patient prescription sample size: 100 prescription possible outcomes: minimization of prescribing errors it improves the quality of care enhancement of patient safety compliance with good clinical practice in the maintenance of rational prescribing

Eligibility criteria:
inclusion criteria: * participants who are willing to participate. * participants who are attending in the out-patient department. * participants reported during the study period. * participants who have a prescription which is legible and complete. exclusion criteria: * participants who are unwilling to provide the required information. * participants who are not attending the out-patient department. * participants whose prescription is not legible and competent

Keywords: medical audit prescription audit gender difference
cryoanalgesia for irreversible pulpitis

Conditions: Pulpitis - Irreversible

Summary: the aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold mepivacaine (5ºc) compared to 3% mepivacaine at room temperature in teeth with irreversible pulpitis.

mepivacaine has some advantages over other anesthetics. the investigators wanted to compare whether changing temperature could improve its effectiveness in cases of irreversible pulpitis.

Eligibility criteria:
inclusion criteria: all patients within the age group of 18-100 years old, * patients diagnosed of irreversible pulpitis. exclusion criteria: * moderate to pulp necrosis, * previous initiated treatment. * pregnancy or lactation. * allergy or problems to any substances used in the study, * acute apical abscess. * chronic apical abscess. * unrestorable teeth. * unsuccessful anesthesia technique (no lip numbness for lower molars or positive response to cold test).

Keywords: cryoanalgesia irreversible pulpitis pain management
low- and moderate-intensity statin and clinical outcome of primary prevention in individuals aged >75 years: the scope-75 rct study

Conditions: Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease

Summary: one of the most effective drug in the primary prevention of cardiovascular disease is statins. the protective effects of statin on developement of cardiovascular disease has been demonstrated in elderly individuals aged over 75 years. since side effects of statin are more common in elderly individuals than in younger individuals, clinical guidelines recommend that use of low intensity statin is considered in elderly individuals. however, there are few randomized clinical trials evaluating the safety and efficacy of different intensity statins in elderly individuals. this is a multicenter, prospective, randomized clinical trial to compare efficacy and safety between low and high intensity statin for primary prevention of cardiovascular disease in elderly individuals.

healthy elderly individuals who are eligible to use of statin for primary prevention will be enrolled. they are randomly assigned to moderate intensity statin group and low intensity statin group by 1:1 manner. blood tests, physical examinations, and evaluation of statin associated muscle symptoms are conducted every 3 months after enrollment. general medical care for prevention of cardiovascular disease is continued after 6 months. the accrual period is 2 years and follow-up period is 4 years, so the total study period is 6 years.

Eligibility criteria:
inclusion criteria: (1 and, 2 or 3) 1. individuals aged 76-85 years old. 2. individuals who have serum ldl-cholesterol of 160-189 mg/dl. 3. individuals who have serum ldl-cholesterol of 80-159 mg/dl and ≥1 cardiovascular risk factor (male, diabetes, hypertension, smoking, serum hdl-cholesterol \<40 mg/dl, or family history of premature cardiovascular disease). exclusion criteria: (any) 1. individuals who have been diagnosed with cancer within the last 5 years. 2. individuals who have high level of serum aspartate aminotransferase (ast), alanine amino- transferse (alt) (\>2 upper normal limit). 3. past history of myopathy or rhabdomyolysis or creatine kinase (ck)\> 2-fold of upper normal limit 4. individuals who have serum creatinine ≥2 mg/dl. 5. individuals who have been diagnosed with cardiovascular disease (\>50% stenosis of coronary artery on imaging study, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, or myocardial infarction). 6. individuals who have been diagnosed with peripheral artery disease (\>50% stenosis of peripheral artery on imaging study, or ankle brachial index \<0.9 or ≥1.3). 7. individuals who have been diagnosed with hyperthyroidism or hypothyroidism. 8. individuals who are taking drug that can interact with statin. 9. individuals who have physical disability to live daily life. 10. genetic disorder such as galactose intolerance, etc
inflammatory mediators in erythema migrans

Conditions: Erythema Migrans

Summary: the main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity.


Eligibility criteria:
inclusion criteria: * erythema migrans in patients \> 18 years exclusion criteria: * pregnancy or immunocompromising conditions * taking antibiotic with antiborrelial activity within 10 days

Keywords: lyme borreliosis inflammation outcome
acupuncture in acute nonspecific low back pain

Conditions: Low Back Pain

Summary: acute low back pain is a common disorder in general practice. some general practitioners (gps) treat acute low back pain (lbp) with acupuncture, despite lacking evidence of its effectiveness for this condition. the aim of this study is to evaluate whether a single treatment-session with acupuncture can reduce time to recovery when applied in addition to standard lbp-treatment according to the norwegian national guidelines. analyses of prognostic factors for recovery and cost-effectiveness will also be carried out. the investigators hypotheses are: 1. acupuncture treatment contributes to faster pain-recovery in acute lbp compared to standard treatment in general practice provided in accordance with the norwegian national guidelines. 2. acupuncture treatment for acute lbp improves function, and reduces drug use and sick leave, compared to the standard treatment in general practice provided in accordance with national guidelines. 3. acupuncture treatment for acute lbp is a cost-effective treatment in general practice. the investigators intend to include a total of 270 patients, 135 in the intervention group and 135 in the control group. the investigators planned to do an interim analysis when reaching inclusion of 150 patients. however, this might lead to reduced overall significance level, and as a result of slow inclusion rate (by december 2015), the investigators plan to extend the inclusion time with one year and then complete the study in march 2017.


Eligibility criteria:
inclusion criteria: * adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days). exclusion criteria: * nerve root affection and/or radiating pain below the knee. * low back pain with suspected "red flags", i.e. infections, tumors and metastatic disease, rheumatic disease, fractures and significant deformities of the spine. * low back pain which starts in pregnancy. * physician reported sick leave of 14 days or more during the last month before the back pain, for any reason.

Keywords: low back pain acupuncture general practice
efficacy and safety of twhf and mtx in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. it has been confirmed that tripterygium wilfordii has effects of anti-inflammatory, immunosuppressive and cartilage protection. this is a multicenter ,double blind, randomized study to evaluated the efficacy and safety of tripterygium wilfordii in treating of patients with rheumatoid arthritis (ra) and establish a prediction model for tripterygium wilfordii response of rheumatoid arthritis (ra).

two arms were included in this study. active comparator: treatment of mtx patients were treated with methotrexate (mtx)and tripterygium wilfordii hook f（twhf）placebo.experimental: treatment of twhf patients were treated with methotrexate (mtx) and tripterygium wilfordii hook f（twhf).

Eligibility criteria:
inclusion criteria: * diagnosed with rheumatoid arthritis as determined by the 1987 or 2010 acr classification criteria; * no male or female fertility requirements, or around menopause women; * patients with mild-to-moderate activity, 2.6 \< das28≤5.1; * no serious system involved, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc; * within a month before the selected participants did not attend any drugs exclusion criteria: * patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath * active or chronic infection, including hiv, hepatitis c virus, hepatitis b virus, tuberculosis * previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (dmard) in 3 months. * previous treated with tripterygium wilfordii or mtx * patients with retinopathy.
level of middle cranial fossa dura in patients with cholesteatoma

Conditions: Cholesteatoma, Middle Ear

Summary: cholesteatoma is a destructive lesion that progressively expands in the middle ear, mastoid or petrous bone and leads to destruction of the nearby structures. erosion, which is caused by bone resorption of the ossicular chain and otic capsule, may cause hearing loss, vestibular dysfunction, facial paralysis and intracranial manifestations

cholesteatoma has three classical forms: (1) congenital, primary or genuine cholesteatoma: occurs behind an intact tympanic membrane. primary acquired cholesteatoma: looks like a limited diverticulum of the pars flaccida with little or no history of otorrhea. secondary acquired cholesteatoma: develops with posterosuperior perforations in eardrum and expansion of the disease process into the antrum, mastoid, attic and middle ear. granulation tissue, polyps and foul- smelling otorrhea are common findings in this type

Eligibility criteria:
inclusion criteria: * all adults above the age of 18 presented to the assiut university clinic with cholesteatoma will be included in the study. exclusion criteria: 1. patients with previous mastoid surgery 2. patients with craniofacial anomalies or cleft lip and palate 3. pediatric populations ≤ 18 years old 4. patients with congenital ear anomalies
comparison trial for chloraprep versus aqueous chlorhexidine (2%) for the prevention of catheter-related bacteremia

Conditions: Sepsis Affecting Skin; Central Venous Catheter Related Bacteremia

Summary: a multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (study group) with standard asepsis with aqueous chlorhexidine at 2% (group control). the incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated.

a multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (study group) with standard asepsis with aqueous chlorhexidine at 2% (group control). the incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated. the patients will assigned to the treatment group depending on where and when they are treated (site a or site b) and will continue the treatment until the end (continuous design): the patients of site a will receive the first treatment option and those of site b will receive the second treatment option during the first 6 months. after this, a rest period of 1 month will be established, during which patients will not be recruited and any of the two cutaneous aseptic methods will be used indiscriminately, in the opinion of the responsible nursing staff. after the resting period, the treatments will be reversed during the following 6 months.

Eligibility criteria:
inclusion criteria: * patients admitted to the icu. * patients with age greater than or equal to 18 years. * patients who require at least one central venous catheters during 48h or more. * obtaining informed consent. exclusion criteria: * intolerance or known allergy to chlorhexidine, isopropyl alcohol or orange yellow s (e110). * high probability of death within 48 hours after admission. * use of coated catheter. * previously included in the study.