Kornimate/medical-research-clean huggingface dataset:
a placebo-controlled safety and tolerability study of intravenous (iv) and subcutaneous (sc) azd1163 in healthy volunteers

Conditions: Healthy Volunteers

Summary: a study to demonstrate the safety and tolerability of azd1163 when administered intravenously and subcutaneously in healthy participants.

this is a first time in human (ftih), placebo-controlled, sequential study in healthy participants. this study consists of two parts: part 1 single ascending dose (sad) and part 2 multiple ascending dose (mad). part 1 will contain 9 cohorts, 8 intravenously (iv) administered dose levels and 1 subcutaneously (sc) administered dose level of azd1163. part 2 will contain 2 sc dose levels of azd1163. a sentinel dosing approach will be taken. each participant will be involved in the study for approximately 70 weeks. the study will comprise of: * a screening period of maximum 28 days for both part 1 and part 2. * part 1: a single dose of azd1163 with an in-clinic period of 7 to 8 days. * part 2: two doses of azd1163, given 2 weeks apart both with an in-clinic period of 7 to 8 days. * an outpatient follow-up period of approximately 15 months.

Eligibility criteria:
inclusion criteria: * healthy male and female participants with suitable veins for cannulation or repeated venipuncture * all females must have a negative pregnancy test * females of childbearing potential must not be lactating and, if heterosexually active, agree to taking approved method/s of contraception * bmi between 18 and 32 kg/m\^2 and weigh at least 45 kg exclusion criteria: * has received another new chemical entity * history of any disease or disorder which may put participant at risk in the study * current or recurrent disease of clinical significance * medical history of malignancies except for cervical carcinoma and non-melanoma skin cancer (nmsc) * any clinically important illness, medical/procedure, or trauma * any clinically important abnormalities in clinical chemistry, hematology, or urinalysis result at screening * any positive result on screening for serum hepatitis b surface antigen (hbsag), hepatitis b core antibody (hbcab), hepatitis c virus (hcv) antibody, or human immunodeficiency virus (hiv) * history of latent or active tuberculosis (tb) or exposure to endemic areas * evidence of active tb or untreated/inadequately/inappropriately treated for latent tb * positive testing for covid-19 prior to dosing, case of covid-19 within 4 weeks, or long-term covid-19-related sequelae * active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever * any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ecg), and any clinically important abnormalities in the 12-lead ecg * known or suspected history of alcohol or drug abuse or excessive intake of alcohol * history of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity

Keywords: rheumatoid arthritis pharmocokinetics healthy volunteers
randomized clinical trial of intravenous infusion umbilical cord mesenchymal stem cells on cardiopathy

Conditions: Dilated Cardiomyopathy

Summary: the purpose of this study is to determine the safety and clinical effectiveness of umbilical cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure.

phase i-ii clinical trial - safety and efficacy of umbilical cord derived mesenchymal stem cells (ucmsc) in patients with heart failure randomized, double blind, controlled prospective study in patients with compensated heart failure in dilated phase. thirty patients will be selected, who will undergo a strict 3-month followup of ventricular function before being sequentially randomized into two groups: the first group of 15 patients will receive a sole injection of ucmsc and the remaining 15 patients will comprise the control group. every patient will maintain their standard treatment of heart failure, with maximum tolerated dosage without side effects. the day of infusion will be considered day zero. from that moment, followup will be divided into 0-3, 3-6, and 6-12 months. clinical results will be analyzed after completion of 12 months of followup.

Eligibility criteria:
inclusion criteria: * symptomatic heart failure patients in dilated stages * etiologies: dilated cardiomyopathy, chronic hypertensive cardiopathy in dilated stage, chronic coronary cardiopathy in dilated stage * ejection fraction ≤ 40%. * patients who are stable under optimal medical treatment for a period of at least 3 months prior to randomization exclusion criteria: * severe or persistent heart failure * recurrent myocardial ischemia * uncontrolled ventricular tachycardia * malignant disease (life expectancy of less than one year) * manifest ventricular asynchrony * hematologic disease * recent cerebrovascular disease * recent acute coronary syndrome * serum creatinine \>2.26 mg/dl (200 umol/l) * atrial fibrillation without heart rate control in the last 3 months

Keywords: heart failure coronary heart disease adult stem cells umbilical progenitor cells umbilical cord stem cells allogenic left ventricular function intravenous injection
assessment of colonic permeability by confocal laser endomicroscopy

Conditions: Inflammatory Bowel Disease; Ulcerative Colitis; Irritable Bowel Syndrome

Summary: the purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in assessment of colonic permeability against conventional sugar absorption test.

increased intestinal permeability has been shown significant in many gastrointestinal diseases, including inflammatory bowel disease and recently irritable bowel syndrome. the conventional test methods of permeability is sugar absorption test which is neither reliable and practical. confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa. in our preliminary study we found that the commonly used contrast agent, fluorescein sodium shew differences of leakage into colonic crypt lumen among different patients. the fluorescein leakage might be due to abnormal colonic permeability, so we planed to compare the fluorescein leakage under confocal laser endomicroscopy with conventional sucralose absorption test.

Eligibility criteria:
inclusion criteria: * patients with history of ulcerative colitis * bowel habits alterations meeting ibs diagnosis criteria and indications for colonoscopy investigation * asymptomatic individuals for health surveillance or patients for follow up after polypectomy * patients complained of hemafecia but colonoscopy revealed only haemorrhoid exclusion criteria: * known cancers or abdominal surgery * scheduled for endoscopic treatment * alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass * under conditions such as: * ascites * jaundice * liver cirrhosis * impaired renal function * coagulopathy * fever * pregnancy * breastfeeding * inability to provide informed consent * known allergy to fluorescein sodium

Keywords: permeability inflammatory bowel disease confocal laser endomicroscopy irritable bowel syndrome
suicide plus immune gene therapy for advanced melanoma

Conditions: Melanoma

Summary: safety evaluation of combined immunogene therapy in patients with advanced melanoma.

this phase i clinical protocol is proposed to evaluate the safety of combined immunotherapy genetics in humans. this treatment combines the high local cytotoxicity of the suicide gene system (hsv thymidine kinase: hsvt k) / prodrug (ganciclovir: gcv) with the immunostimulation of interleukin2 (hil2) and immunoamplification of granulocyte and macrophage colony stimulating factor (hgmcsf) in the presence of tumor antigens. the proposed scheme consists in the periodic intra / peritumoral application of plasmid dna complexes: cationic lipid (lipoplexes) containing the hsvtk gene, co-administered with the prodrug gcv, and subcutaneous injections of a vaccine (lgvax) produced with formolized extracts of allogeneic melanoma combined with lipoplexes carrying the hil2 and hgmcsf genes.

Eligibility criteria:
inclusion criteria: * patients with histologically and / or cytologically confirmed melanoma. * patients progressed or are intolerant to conventional systemic treatments. * patients that are not candidates for surgery under oncologic criteria (complete resection). * performance status (ecog) 0 or 1. * patients with life expectancy greater than 6 months. * patients with at least one accessible target lesion for gene inoculation (superficial localizations of the primary tumor, satelitosis, subcutaneous or accessible lymph node metastasis). * patients with measurable disease (according to recist 1.1 criteria, irrespective of the target lesion chosen for suicide gene inoculation) * patients with signed informed consent. exclusion criteria: * patients with uncontrolled cardiovascular disease * patients with uncontrolled respiratory disease. * patients with uncontrolled immune disease. * patients with glucocorticoids or immunosuppressive drugs or agents with immunomodulatory activity (except non-steroidal anti-inflammatory agents) up to 2 weeks before treatment. * patients performing other experimental therapies. * patients who are pregnant or breastfeeding. * patients undergoing concurrent chemotherapy or radiation therapy. * uncontrolled diabetes. * patients with active diagnosis of other malignant neoplasms. * hiv-positive patients. * uncontrolled thyroid abnormality. * patients with significant medical morbidity. * patients with a history of allergic reactions to chemicals or similar to those used in this study. * metastasis in the central nervous system. * laboratory eligibility criteria excluded: * hemoglobin: \ 2.0 mg / dl, got or gpt: 2.5 times\> than normal upper institutional limit (uln), alkaline phosphatase: 2 times\> uln, creatinine\> 2.0 mg / dl, creatinine clearence : \<60 ml / min / 1.73 m2.

Keywords: melanoma lipoplexes plasmid herpes simplex thymidine kinase interleukin-2 granulocyte-macrophage colony-stimulating factor tumor vaccine suicide gene
effect of active release technique and abdominal drawing-maneuver on pain and quality of life in patients with chronic low back pain

Conditions: Low Back Pain

Summary: to determine the effect of active release technique and abdominal drawing in maneuver on pain and quality of life in patients of chronic low back pain.


Eligibility criteria:
inclusion criteria: * patient with hamstring tightness\[9\] * subjects with pain between 4 and 7cm on visual analogue scale\[18\]. * subjects having 20-40 age group are included in this study\[11\] * patients having pain for more than 3 month of mild-moderate intensity\[9\] exclusion criteria: * patients with any spine injury\[11\] * lumber intervertebral disc fracture\[11\] * patients having any surgical history of spine\[11\] * spinal stenosis\[11\]
study of the safety and efficacy of opc-34712 as adjunctive therapy in the treatment of adults with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this is a double-blind study wherein patients with major depressive disorder (mdd) will receive either from 1 to 3 mg a day of study medication (opc-34712)or placebo (an inactive substance) in addition to an fda approved antidepressant in order to determine if the study medication is effective as an add on treatment of mdd.


Eligibility criteria:
inclusion criteria: * male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by dsm-iv-tr criteria * the current depressive episode must be equal to or greater than 8 weeks in duration * subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three adequate antidepressant treatments. exclusion criteria: * females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug. * subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration. * subjects with a current axis i (dsm-iv-tr) diagnosis of: delirium, dementia,amnestic or other cognitive disorder schizophrenia, schizoaffective disorder, or other psychotic disorder bipolar i or ii disorder * subjects with a clinically significant current axis ii (dsm-iv-tr) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.

Keywords: opc-34712 major depressive disorder adjunctive treatment
dry powder inhalation of cyclosporine a in lung transplant patients with bronchiolitis obliterans syndrome

Conditions: Lung Transplantation; Bronchiolitis Obliterans

Summary: the purpose of this study is to investigate whether dry powder inhalation of cyclosporine a is beneficial in lung transplant patients with bronchiolitis obliterans syndrome. for patients suffering from this syndrome often no therapeutic options are available. furthermore, the side effects of the maintenance therapy leaves no room for dose increments. the hypothesis for this trial is that when cyclosporine a is administered locally (in the lungs) chronic rejection can be treated more effectively without extra systemic side effects.

because calcineurin inhibitors are not completely effective in a full prevention of acute rejection and the corresponding chronic disfunction of the transplanted organ (bronchiolitis obliterans syndrome, bos) a rejection risc remains. to effectively treat bos high doses of calcineurin inhibitors are necessary. on the other hand these high doses lead te serious side effects. the search for a balance between effectiveness and side effects leads to dose adjustments. ultimately, chronic rejection is unstoppable. in order to treat chronic rejection higher doses of calcineurin inhibitors are not a therapeutic option. the only option to reach a high dose in the target organ without extra systemic side effects would be inhalation. indeed, this has been extensively investigated at the university of pittsburgh (lead investigator iacono). the intervention in the pittsburgh trials existed of nebulization of cyclosporine in propylene glycol with pretreatment of nebulization of lidocaine/albuterol in order to make the inhalation tolerable. the investigational drug in this trial consists of dry powder inhalation of a sugar-glass based solid dispersion containing cyclosporine a. the effectiveness is measured by comparing the forced expiratory volume in 1 second (fev1) before and after the intervention.

Eligibility criteria:
inclusion criteria: * signed informed consent * primary lung transplant * tacrolimus as maintenance therapy * bronchiolitis obliterans syndrome stages 1 - 3: fev1\<80% of baseline * at least 3 months after last usual bos intervention * declining fev1 after last usual bos intervention exclusion criteria: * cyclosporine as maintenance therapy * bronchiolitis obliterans syndrome 0: fev1\>80% * renal failure: glomerular filtration rate \< 30 ml/min * chronic airway infections * clinical stability * pregnancy

Keywords: powder inhalation side effects nephrotoxicity calcineurin inhibitor bronchiolitis obliterans syndrome forced expiratory volume
data registry of intensive care unit (icu) siamitra and intensive care unit (icu) salad-samung

Conditions: Complication

Summary: as a general surgical intensive care units of the biggest tertiary referral university of thailand with more than 1,000 admissions/year, recently, more complicated perioperative care surgical patients were accepted with high complications, morbidities, mortality and resource utilization. good data registration was needed to provide information for quality improvement and resource allocation. this prospective observational (crosssectional) study was designed to register patient \> 18 years who will be admitted to these icus to explore the adequacy of these icus services, resource utilization (icu length of stay and ventilator day), icu complications, adverse outcome /icu readmission within 72 hours after discharging from icu. in addition, severe hemodynamic, respiratory, or neurological disturbance or complication intra and early postoperative (within 7 days after operation) that lead to icu admission eg, intraoperative hypotension, intraoperative cardiac arrest, perioperative pulmonary aspirtaion will also be studied.

this prospective obseverational study wae ans will be done in all surgical patient (age . 18 yeras) admitted to the general surgical icu (icu siammitra and icu salad-sumang) of the department of anesthesiology, siriraj hospital, faculty of medicine, mahidol university, bangkok, thailand. after approval by the irb of siriaj hospital, all information of the patients admiited to the icus were carefully recorded included patient demographic data, comorbidities, type of anesthesia, type of surgery, complication associated with anesthesia and surgery, type of icu admission and course in icu including outcome as iresouce utilization (cost in icu, ventilator day, icu and hosital length of stay. morbidity occcuring in icu, 28 and 90 days mortality also recorded.

Eligibility criteria:
inclusion criteria: * age \> 18 years * surgical patients exclusion criteria: * patient undergoing cardiothoracic surgery, traumatic surgery, neurosurgery

Keywords: general surgical icu icu siamitra icu salad-samung data registry icu refusal icu complications icu resource utilization adverse events icu readmission intraoperative hypotension intraoperative cardiac arrest
femoral versus adductor canal continuous peripheral nerve blocks for knee arthroplasty

Conditions: Postoperative Pain Following Knee Arthroplasty

Summary: patients typically experience moderate-to-severe pain following knee arthroplasty that is usually treated with a combination of oral and intravenous analgesics and enhanced by continuous peripheral nerve blocks. there are currently two locations to place a perineural catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an adductor canal catheter. both have been demonstrated to be effective following knee arthroplasty. however, it remains unknown if one location is superior to the other; or, more accurately, what the relative benefits are to each technique. while femoral cpnb has many benefits, one of the challenges of using this technique is that there is a decrease in quadriceps muscle strength which can be a limiting factor for rehabilitation. in contrast, the adductor canal catheter affects only the vastus medialis. this block may lessen block-induced quadriceps weakness following knee arthroplasty compared with a femoral infusion. the investigators hypothesize that compared with femoral perineural local anesthetic infusion, an adductor canal infusion is associated with a shorter time until four discharge criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3) ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.

of importance: the primary investigation involves 80 evaluable subjects (with primary endpoint data) having tri-compartment knee arthroplasty. in addition, the investigators will enroll up to 70 subjects having uni-compartment knee arthroplasty as a pilot study in preparation for a subsequent larger, definitive trial. these two groups will not be analyzed together--they represent two distinct studies: one a definitive rct for tri-compartment knee arthroplasty; and, one a pilot study for uni-compartment knee arthroplasty.

Eligibility criteria:
inclusion criteria: 1. primary, unilateral knee arthroplasty 2. age ≥ 18 years 3. postoperative analgesic plan includes perineural local anesthetic infusion of 48-72 hours exclusion criteria: 1. morbid obesity as defined by a body mass index \>40 (bmi=weight in kg/ \[height in meters\] 2. chronic, high-dose opioid use (greater than 20mg oxycodone-equivalent opioid use daily within the 2 weeks prior to surgery and duration of use \>4 weeks) 3. history of opioid abuse 4. allergy to study medications 5. known renal insufficiency (creatinine \> 1.5 mg/dl) 6. pregnancy 7. incarceration 8. any known neuro-muscular deficit of the ipsilateral femoral nerve, obturator nerve and/or quadriceps muscle (including diabetic peripheral neuropathy); and inability to ambulate 30 m preoperatively.
silent brain infarction after endovascular arch procedures

Conditions: Aortic Arch Aneurysm

Summary: this is the largest study to evaluate incidence and distribution of silent cerebral infarction (sbi) following endovascular repair for disease of the aortic arch. also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (co2) to prevent gaseous cerebral embolization.

introduction. poor data exist concerning the rate of silent cerebral ischemic events following endovascular treatment of the aortic arch. the objective of this work was to quantify these lesions using the step registry. methods. this multicentre retrospective cohort study included consecutive patients treated with an aortic endoprosthesis deployed in ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (dw-mri) within 7 days after the procedure. dw-mri was performed to identify the location and number of new silent brain infarctions (sbi), microbleeds ans general outcome of the patients.

Eligibility criteria:
inclusion criteria: * included patients underwent a proximal endograft deployment in ishimaru zone 0 to 3 exclusion criteria: * missing preoperative computed tomography angiography (cta) scan of the chest and any circumstances that precluded the dw-mri to be performed in the appropriate time window, such as a medical condition or an mri contraindication

Keywords: thoracic endovascular aortic repair silent cerebral infarction stroke magnetic resonance imaging dw-mri aortic arch disease
a novel approach to treating androgenetic alopecia in females with low level laser therapy

Conditions: Androgenetic Alopecia

Summary: this study will acquire data on hair growth of the head that is the result of treatment with a non-heat generating, laser product. this data will come from counting of terminal hairs before treatment begins and after treatment is completed. the treatment regime is every other day for 16 weeks.

the purpose of this study is to evaluate the efficacy of low level laser therapy product that is configured in the novel design of a baseball cap, for promoting hair growth in females diagnosed with genetic hair loss/female pattern hair loss.

Eligibility criteria:
inclusion criteria: diagnosis of androgenetic alopecia / female pattern hair loss fitzpatrick skin phototypes of i - iv ludwig-savin hair loss scale i - ii in overall good health as determined by the physician investigator active hair loss within the last 12 months willingness to refrain from using all other hair growth products or treatments - exclusion criteria: photosensitivity to the specific wavelength of light - 650 nanometers. malignancy in the target treatment area other forms of alopecia of the head past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously affects the scalp. in willingness to remove hair replacement products during the 16 weeks of therapy. using any medications deemed to inhibit hair growth as determined by the physician investigator. -