Kornimate/medical-research-clean huggingface dataset:
the effect of intravenous ketamine on non suicidal self injuries.

Conditions: Non Suicidal Self Injury

Summary: non-suicidal self-injuries (nssi) is a deliberate harm a person causes directly to their body, resulting in structural or functional damage, without suicidal ideation. this behavior is related to unbearable internal stress, thoughts, or mental pain, which nssi assists in dismantling. to date, there is no generally approved therapy that assists in lowering nssi. ketamine is a sedative drug, presently at the focus of psychopharmacologic research, which was found to improve depression, when taken orally, and lower suicidal ideation, when given intravenously. our aim is to assess the efficiency of intravenous ketamine in decreasing nssi symptomology in women with a history of childhood sexual abuse presenting with such behavior. participants will be recruited among hospitalized patients from the tel-aviv medical central psychiatric ward, who will present with either nssi urges or behavior. the study design is a randomized control, double blind trial. each patient will be assessed before, during, and after the trial by physical examination, blood tests and questionnaires. the patients will be randomized into research group (treated by ketamine and midazolam intravenously) or control group (treated intravenously via midazolam only). our hypothesis is that treatment by intravenous ketamine will lower nssi symptomology, and enable optimal treatment while being hospitalized.


Eligibility criteria:
inclusion criteria: * age 18-65 y.o. * women * hospitalized * willing to sign the informed consent * fluent in hebrew * reporting unbearable urge for self-injury and / or active nssi behaviour) upon admittance, or on the preceding week. * not pregnant, nor breast feeding * no history of drugs abuse * no previous treatment with ketamine * no psychotic disorder, nor severe physical condition (including unstable hypertension, arrhythmias or severe / active neurological condition) exclusion criteria: * age \ 65 years * men * inability to sign informed consent, non-fluent in hebrew. * no report of nssi, last nssi event took place further than preceding week * active pregnancy or breast feeding * history of drugs abuse * previous trial involving ketamine treatment during which no improvement was observed. * presence of psychotic disorder, and / or major physical condition (including unstable hypertension, arrhythmias or severe / active neurological condition).

Keywords: ketamine, midazolam, non-suicidal self-injury, intravenous
suctioning flexible ureteroscopy with intelligent control of renal pelvic pressure

Conditions: Renal Calculi

Summary: this study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(sf-urs) with automatic control of renal pelvic pressure for the treatment of upper urinary calculi using a prospective, randomized design. half of participants will receive suctioning flexible ureteroscopy with automatic control of renal pelvic pressure, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscopy.

retrograde intrarenal surgery using flexible ureteroscope has become the first-line treatment for renal calculi \< 3.0 cm and is recommended by the european association of urology due to its minimally-invasive nature and satisfactory result. however, high perfusion rate leads to renal pelvic pressure increase, resulting in absorption of liquid, bacteria, and endotoxin into blood, followed by short-term complications such as systemic inflammatory response syndrome(sirs , 8.1%), sepsis (0-4.5%), renal pelvic and ureteral tumor spread, and long-term complication of renal function impairment. currently the commonly used flexible ureteroscope sheath (ureteral access sheath, uas) reduces the renal pelvic pressure to a certain extent, but still can not control and monitor the renal pelvic pressure to reduce the incidence of complications, which, limit the clinical application of ureteroscopy. recently, the investigators present a novel technique of sf-urs with automatic control of renal pelvic pressure. in this study, transverse comparison is designed to evaluate the safety and efficacy of the suctioning flexible ureteroscopy with automatic control of renal pelvic pressure for the treatment of renal calculi.

Eligibility criteria:
inclusion criteria: * subject has provided informed consent and indicated a willingness to comply with study treatments * subject has a diagnosis of renal stones according to computer tomography (ct) results * subject is 18-75 yrs of age * subject has a single stone \< 3 cm in size, or multiple stones \< 3 cm in cumulative size * subject has a serum creatinine level within the normal range for the study center exclusion criteria: * the patient who do not agree with the intention of the clinical study. * subject needs bilateral procedures within one-stage ureteroscopy * subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.) and severe hematuria * subject has been diagnosed with a urethral stricture or bladder neck contracture * subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding * subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) * subject has other diseases and could not tolerate the endoscopic surgery * subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery * subject has been diagnosed with hydronephrosis larger than 3 cm according to the b-scan ultrasonography examination
interaction study of clopidogrel 600/150 mg given alone or concomitantly with omeprazole 80 mg in healthy subjects

Conditions: Healthy

Summary: primary objective: * assess the effects of clopidogrel (600 mg loading dose followed by 4 days 150 mg/day) on adenosine diphosphate (adp)-induced platelet aggregation when given concomitantly with omeprazole 80 mg/day compared to given alone in healthy male and female subjects secondary objective: * compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole

the total study duration per subjects is 8 - 9 weeks broken down as follows: * screening: 2 to 21 days before the first dosing (clopidogrel or omeprazole) * period clopidogrel/placebo: 7 days including 5 days treatment * period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment * washout between periods: at least 14 days after last dosing with respect to clopidogrel treatment * end of study: 7 to 10 days after the last dosing

Eligibility criteria:
inclusion criteria: healthy subject: * as determined by medical history, physical examination including vital signs and clinical laboratory tests: * with a body weight between 50 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a body mass index (bmi) between 18 and 30 kg/m² exclusion criteria: * evidence of inherited disorder of coagulation/hemostasis functions * smoking more than 5 cigarettes or equivalent per day * abnormal hemostasis screen * unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration \>any contraindication to clopidogrel and/or omeprazole the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a clinical trial to assess the efficacy and safety of subjects with dry eye disease

Conditions: Dry Eye Disease

Summary: a randomized, double-masked, vehicle-controlled parallel group clinical trial to assess efficacy and safety of 0.25% reproxalap ophthalmic solution compared to vehicle in subjects with dry eye disease

dry eye chamber challenge trial.

Eligibility criteria:
inclusion criteria: * eighteen to 70 years of age at the time of screening (either gender and any race) * ability to provide written informed consent * reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to visit 1 * reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to visit 1 exclusion criteria: * clinically significant slit lamp findings, intraocular pressure, and visual acuity findings at visit 2 that may include active blepharitis, severe meibomian gland dysfunction, lid margin inflammation, glaucoma, ocular allergy, infection or any other disorder that, in the opinion of the investigator, may interfere with trial conduct or assessments * diagnosis at visit 1 of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease that, in the opinion of the investigator, could interfere with trial conduct or assessments * contact lens use within 7 days of visit 1 or anticipated use of contact lenses during the trial * laser-assisted in situ keratomileusis (lasik) surgery within 12 months of visit 1 and/or planned ocular and/or lid surgeries during the trial or any other ocular surgery within 6 months of visit 1 * systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of visit 1, or any planned immunomodulatory therapy during the trial * eye drop use within 2 weeks of visit 1 and/or an unwillingness to discontinue any topical ophthalmic prescription or over-the-counter solutions, artificial tears, gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)

Keywords: dry eye reproxalap
efficacy and safety of add-on therapy with dlbs3233 in patients with type-2 diabetes mellitus

Conditions: Type-2 Diabetes Mellitus

Summary: this is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of an add-on therapy with dlbs3233 in improving blood glucose control, lipid profile, and adiponectin in subjects with type-2 diabetes mellitus.

there will only be one group in this study who will receive study treatment as follows: anti-diabetic agents currently used by respective subjects for at least 3 months prior to screening, treatment intensification (lifestyle modification), and dlbs3233 at a dose of 100 mg once daily for 12 weeks. clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at interval of 6 weeks over the 12-week course of therapy.

Eligibility criteria:
inclusion criteria: * male subjects with age of 40 - 70 years; or female subjects with age of 55 - 70 years (post-menopause) at screening * diagnosed with type-2 diabetes mellitus * have been being treated with a combination of two oha for at least 3 months prior to screening * a1c level of \>= 7.0 % * hemoglobin level of \>= 10 g/dl * body mass index (bmi) \> 18.5 kg/m2 * refuse insulin therapy * able to take oral medicine exclusion criteria: * subjects with symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia * uncontrolled hypertension defined as systolic blood pressure \> 160 mmhg and/or diastolic blood pressure \> 100 mmhg * history of or current chronic treatment with insulin * history of renal and/or liver disease * impaired liver function: serum alt \> 2.5 times upper limit of normal and positive result of chronic or acute hepatitis b or c test * impaired renal function: serum creatinine \>= 1.5 times upper limit of normal * current treatment with systemic corticosteroids or herbal (alternative) medicines * any other disease state or uncontrolled illness, which judged by the investigator, could interfere with trial participation or trial evaluation * participation in any other clinical studies within 30 days prior to screening

Keywords: type-2 diabetes mellitus add-on therapy
effect of kw-3902iv in combination with iv furosemide on renal function in subjects with chf and renal impairment

Conditions: Heart Failure, Congestive; Renal Insufficiency

Summary: the purpose of this study is to characterize the safety and tolerability of kw-3902iv and measure its effect on renal function.


Eligibility criteria:
inclusion criteria: * stable congestive heart failure * impaired renal function * taking oral loop diuretic exclusion criteria: * acutely decompensated (unstable) and end stage heart failure * diuretics other than loop diuretics * pregnant or nursing * inability to follow instructions * participation in another clinical trial within past 30 days

Keywords: renal insufficiency diuretic heart failure, congestive
long-term hemodialysis catheter removal and delayed replacement, versus exchange over a guidewire to treat catheter related blood stream infection

Conditions: Catheter Related Blood Stream Infection

Summary: prospective, randomized study of tunneled cuffed hemodialysis catheter removal and delayed replacement, versus exchange over a guidewire to treat catheter related blood stream infection

the aim of this study was to compare the clinical outcomes of catheter-related (crbsi) managed with two different strategies: guidewire exchange of the infected catheter with a new one over a guidewire versus catheter removal with delayed replacement.

Eligibility criteria:
inclusion criteria: * all patients end stage renal disease on hemodialysis from tunneled cuffed dialysis catheters with suspected catheter-related bloodstream infection with no identifiable infection source except the catheter were included. exclusion criteria: * metastatic infection,
parp inhibitor with cdk4/ 6 inhibitor and endocrine therapy in hr+/ her2-advanced breast cancer

Conditions: Breast Cancer Metastatic

Summary: this study is a prospective, open-label, phase iii clinical study for patients with hr+/her2- advanced breast cancer.

patients with snf3 subtype of hr+/her2- advanced breast cancer confirmed by the department of pathology and key laboratory of breast cancer of fudan university affiliated cancer hospital are planned to be enrolled. the main purpose is to evaluate the efficacy of parp inhibitor in snf3 subtype of hr+/her2- advanced breast cancer in randomized controlled phase iii clinical studies with larger sample size.

Eligibility criteria:
inclusion criteria: * females ≥18 years and ≤ 75 years old; * histologically confirmed hr + / her2- invasive breast cancer (specific definition: immunohistochemical detection of er \> 10% tumor cell positive is defined as er positive, pr \> 10% tumor cell positive is defined as pr positive, er and / or pr positive is defined as hr positive; her2 0-1 + or her2 is ++ but negative followed by fish detection, no amplification, defined as her2 negative); * subtype of similarity network fusion-3 (snf-3) confirmed by the department of pathology and key laboratory of breast cancer of fudan university affiliated cancer hospital • locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer; * measurable disease according to response evaluation criteria in solid tumors v1.1 (recist v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions; * has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /l; platelet count \> 75x10ˆ9 /l, hemoglobin \> 9g/dl; * patients had received no previous chemotherapy or targeted therapy for metastatic disease * has adequate liver function and kidney function: serum creatinine * ecog score ≤ 2 and life expectancy ≥ 3 months; * participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. exclusion criteria: * treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease * symptomatic, untreated, or actively progressing cns metastases(glucocorticoids or mannitol needed to control symptoms); * significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months); * is pregnant or breast feeding; * malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
a study in healthy men to test whether bi 474121 can reverse the memory problems caused by ketamine

Conditions: Healthy

Summary: to investigate the effect of bi 474121 compared to placebo on ketamine-induced cognitive deficits to predict efficacy in patients with cognitive disorders.


Eligibility criteria:
inclusion criteria: * healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests * age of 18 to 55 years (inclusive) * body mass index (bmi) of 18.5 to 32 kg/m2 (inclusive) * signed and dated written informed consent(s) prior to admission to the study, in accordance with international council for harmonisation-good clinical practice (ich-gcp) and local legislation prior to admission to the trial * if men who are able to father a child, are willing to participate, they have to use an adequate form of effective contraception for the duration of study participation and for at least 30 days after treatment has ended exclusion criteria: * any finding in the medical examination (including ecg) deviating from normal and assessed as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 50 to 90 bpm evaluated as clinically significant by investigators * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease assessed as clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * history of diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * history of relevant orthostatic hypotension, fainting spells, or blackouts further exclusion criteria apply.
auditive and renal long term outcomes - risk after aminoglycoside therapy in neonates (aurora)

Conditions: Hearing Loss; Gentamicin Adverse Reaction; Renal Tubular Disorder

Summary: gentamicin, in combination with a beta-lactam antibiotic, is commonly used for treatment of neonatal sepsis. neonates have a high volume of distribution. it is a paradox that most neonatal dosing schedules still recommend lower gentamicin doses (4-5 mg/kg) than in older children (≥ 7 mg/kg). in the neonatal unit in tromsø a simplified gentamicin high-dose (6 mg/kg) regimen has been in use since 2004. the investigators have previously shown that this regimen was associated with low number of elevated trough levels, low numbers of prescription errors and no evidence for ototoxicity in the immediate neonatal period. however, the long-term safety of gentamicin therapy in neonates is not well studied when it comes to ototoxicity and possible nephrotoxicity. the objective of the current study is therefore to perform a detailed hearing evaluation, including an extended high-frequency (ehf; 9-16 khz) audiometry, in a follow-up study of children (participants) aged 6-15 years who were exposed to a high-dose gentamicin regimen in the neonatal period. moreover, we will investigate blood pressure and urine biomarkers to assess renal tubular function. the aim is to include 250 children exposed to gentamicin in the neonatal period and a control group of 25 healthy children. ehf audiometry is a more sensitive method for detecting ototoxic damage and provides evidence of ototoxicity before any hearing loss is detected by conventional systems. this is the background for choice of method. the primary outcome is the difference in average hearing threshold in the ehf range between the control group and the exposed group. secondary outcomes are i) difference in average hearing threshold in the ehf range between the children with gentamicin trough levels \> 1.0 mg/l versus those who had lower trough levels, ii) markers of renal tubular function (kidney injury molecule 1) and iii) blood pressure.


Eligibility criteria:
inclusion criteria: * exposed to gentamicin therapy in the neonatal period and treated at neonatal unit at the university hospital of north norway exclusion criteria: * not able to cooperate during an audiometry
professional continuous glucose monitoring at the parkland diabetes clinic

Conditions: Diabete Mellitus

Summary: the purpose of this study is to assess whether the short-term use of professional continuous glucose monitoring (pro-cgm) at the parkland diabetes clinic in selected patients with poorly-controlled diabetes due to hyper- and/or hypoglycemia leads to improvements in patients' glycemic control within 3-6 months, subjective understanding of how food, activity, and medications affect blood sugar levels, and diabetes self-care practices. the study will be a prospective cohort study that assesses patients glycemic control and diabetes self-care practices before and 3-6 months after utilization of a pro-cgm for 10 days. glycemic control and diabetes self-care practices will be assessed based on hemoglobin a1c measurements and glucose data download from glucometer and pro-cgm. a short survey will be administered at the end of the 10 days pro-cgm use to assess whether the pro-cgm use had a positive impact on patients' understanding of how different activities affect their blood sugar and diabetes self-care practices. parkland diabetes clinic serves an ethnically diverse, low socioeconomic patient population, the majority of whom do not have access to diabetes technology like continuous glucose monitoring. cgm measures sugar levels every 5 to 15 minutes and have been shown in clinical studies to improve glycemic control. establishing a professional cgm program at the clinic will provide short-term access to this technology. one of the main reason for conducting this study is to determine if pro-cgm would be a useful intervention to integrate into the clinic's routine practice in the future.


Eligibility criteria:
inclusion criteria: patients of the parkland diabetes clinic who meets one or more of the following criteria: * patients with inaccurate hgba1c due to conditions that affect red blood cell turnover (examples include but not limited to: anemia, hemoglobinopathies, chronic kidney disease) * patients with suspected recurrent hypoglycemia and/or hypoglycemia unawareness * patients with persistently elevated hgba1c \>8% despite reported adherence to medications and lifestyle modifications and after assessment by a certified diabetes care and education specialist (cdces) * patients with inability to do frequent fingersticks for blood glucose checks due to physical limitations (examples include but not limited to: vision loss, dexterity problems) exclusion criteria: * patients who already have their own personal continuous glucose monitoring device

Keywords: continuous glucose monitoring