Kornimate/medical-research-clean huggingface dataset:
pk/efficacy bridging study of astx727 in chinese subjects with myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes

Summary: this is an open-label, crossover, pharmacokinetic and efficacy bridging study of oral astx727 versus iv decitabine in chinese subjects with myelodysplastic syndromes


Eligibility criteria:
inclusion criteria: 1. agree to participate in this trial and voluntarily sign the informed consent form. 2. men or women ≥ 18 years at the time of signing the informed consent form. 3. subjects with mds previously treated or untreated with de novo or secondary mds. 4. eastern cooperative oncology group (ecog) performance status of 0 to 1 at screening. exclusion criteria: 1. prior treatment with more than 1 cycle of azacitidine or decitabine. 2. cytotoxic chemotherapy or prior azacitidine or decitabine within 4 weeks of first dose of study treatment. 3. conditions as judged by the investigator to be inappropriate for participation in the clinical trial. 4. previous diagnosis of malignant tumor. 5. history of immune deficiency. 6. acute myeloid leukemia (aml) with bone marrow or peripheral blast count ≥ 20% or other malignant hematological diseases.
efficacy of antiviral medications in controlling vertigo attacks of patients with meniere's disease

Conditions: Meniere's Disease

Summary: meniere's disease is a chronic illness that affects a substantial number of patients every year worldwide. the disease is characterized by intermittent episodes of vertigo lasting from minutes to hours, with fluctuating sensorineural hearing loss, tinnitus, and aural pressure. it has recently been suggested that viral etiologies specially herpes virus might be the underlying reason. the investigators study is a randomized, double- blinded placebo-controlled clinical trial in amiralam hospital. in this study the primary objective is to assess efficacy of acyclovir in control of symptoms in patients with meniere's disease specially their vertigo attacks. inclusion criteria would be patient's willingness to participate in the study and follow ups, being 18 years old or older, having at least 2 vertigos per month each at least 20 min, interfering with function, and not on medication for meniere's disease for at least 3 months before the trial. they should not have any history of allergy to acyclovir, renal insufficiency or creatinine above 1.5 mg/dl, hepatic enzymes more than three times normal, serious uncontrolled illness, be pregnant or nursing or have previous surgeries on endolymphatic sac. participants will be randomly placed in 2 different arms getting either acyclovir 400 mg or placebo (inert ingredient). they will take the medication for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, 6 month intervals.


Eligibility criteria:
inclusion criteria: 1. patients' willingness to participate in the study 2. willingness to participate in follow ups 3. age of 18 or older 4. having at least 2 vertigos per month each lasting for at least 20 min, severely interfering with function 5. not on medication for at least 3 months before starting the trial exclusion criteria: 1. history of allergy to acyclovir or the drugs in the same category 2. renal insufficiency or having creatinine more than 1.5 mg/dl 3. hepatic enzymes more than 3 times normal 4. hematocrit less than 30% 5. thrombocytopenia 6. having a serious uncontrolled illness 7. pregnant or nursing ladies 8. using probenecid 9. previous surgeries on endolymphatic sac.
the efficacy and safety of medical expulsive therapy after extracorporeal shock wave lithotripsy (eswl) in pediatric urolithiasis

Conditions: Tamsulosin; Extracorporeal Shock Wave Lithotripsy; Stone, Kidney; Stone, Urinary; Pediatric Disorder

Summary: the aim of this study is to evaluate the clinical efficacy and safety of met after eswl in pediatric urolithiasis.


Eligibility criteria:
inclusion criteria: * radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone * normal kidney function. exclusion criteria: * bleeding diatheses * uncontrolled utis * severe skeletal malformations

Keywords: extracorporeal shock wave lithotripsy tamsulosin
phase i safety and tolerability study of staphylococcal protein a in adult patients with chronic itp

Conditions: Idiopathic Thrombocytopenic Purpura (ITP)

Summary: the primary purpose of this study is to evaluate the safety of multiple doses of staphylococcal protein a (prtx-100) in adult patients with idiopathic thrombocytopenia purpura (itp). the pharmacokinetics, immunogenicity and pharmacodynamics will also be studied. patients will be enrolled into 1 of 3 dose groups and receive 4 weekly iv doses of prtx-100. a safety monitoring committee will review safety data through day 28 for the first 5 patients in a dose group before escalation to the next higher dose level. patients will be followed for 8 weeks after dosing for safety, pk, immunogenicity and effect on platelet count(pharmacodynamics).


Eligibility criteria:
inclusion criteria: * diagnosis of chronic itp \> 4 months * mean platelet count \ =50 x 10\^9/l for patients receiving stable dose of corticosteroids exclusion criteria: * splenectomy within 45 days of screening * rituximab within 6 months prior to screening * cyclophosphamide, vincristine, or any other non-monoclonal antibody treatment for itp within 3 months prior to screening * ivig, winrho or other anti-rhd within 30 days prior to screening

Keywords: autoimmune diseases bleeding disorders blood and blood disorders
energy homeostasis in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the purpose of this study is to investigate the potential biological predispositions that contribute to the difficulty patients with anorexia nervosa have in maintaining normal weight.

anorexia nervosa (an) is a psychiatric illness that is characterized by extreme weight loss and severe body image distortions. in this study, we are examining changes in body composition, metabolic rate, and reproductive function before and after treatment for an. more specifically, we are testing the hypotheses that 1)weight-restored patients with an have elevated resting energy expenditure (ree) compared to controls, 2) weight-restored patients with an have a central disposition of body fat compared to controls, 3) weight-restored patients with an who gain the most fat centrally will have the least improvement on psychological measures, 4) weight-restored patients with an will have leptin levels out of proportion to body fat mass. it will also investigate the relationship between ree and leptin with respect to the return of menses.

Eligibility criteria:
patients: inclusion criteria: * dsm-iv diagnosis of anorexia nervosa * bmi ≤ 17.5kg/m2 (equivalent to 80% of ideal body weight) * medically stable * participation in in-patient treatment sufficient to restore patient to a bmi of at least 19kg/m2 exclusion criteria: * on medication\* * current substance abuse or dependence * history of suicide attempt or other self-injurious behavior within the previous 6 months * non-removable metal on/in their body (e.g. metal pacemaker, surgical clips, metallic-ink tattoos) controls: inclusion criteria: * no current psychiatric disorder (including eating disorder, depression, bipolar disorder, schizophrenia, substance abuse/dependence) * no history of an eating disorder * bmi greater than 19kg/m2 and less than 21kg/m2 * weight stable (+/- 2kg) for the previous 6 months * no history of excessive or repeated dieting * no history of excessive exercise (defined as greater than 6 hours/week) * regular menstrual cycles exclusion criteria: * on medication\* * pregnant or lactating * significant medical problem * non-removable metal on/in their body (e.g. metal pacemaker, surgical clips, metallic-ink tattoos) * at the time of testing, subjects will be free of fluoxetine for 6 weeks, and free of all other medications for a minimum of 2 weeks

Keywords: anorexia nervosa body composition metabolic rate
enterprise 2 vascular reconstruction device

Conditions: Aneurysm

Summary: the primary objective of this study is to collect data regarding the effectiveness of using the enterprise 2 reconstruction device in successfully embolizing intracranial aneurysms with wide neck configuration.

the codman enterprise 2 vascular reconstruction device is a self-expanding nitinol, compliant, closed-cell, recapturable design that can be deployed by a single operator. the codman enterprise 2 vascular reconstruction device is packaged sterile as a single unit with an introducer sheath and a detachable push wire. this device was designed to assist in the stent-assisted coil embolization of intracranial aneurysms, specifically those that have a wide neck that would not otherwise maintain the coil embolization material within the aneurysm because of the wide opening at the base of the aneurysm. the codman enterprise 2 vascular reconstruction device is approved by the fda as a humanitarian use device (hud) in cases of wide-necked saccular cerebral aneurysms. the primary objective of this study is to collect data regarding the effectiveness of using the enterprise 2 reconstruction device in successfully embolizing intracranial aneurysms with wide neck configuration. secondly, to determine any safety or delivery problems that may occur, or any adverse patient events that may have previously been undocumented.

Eligibility criteria:
inclusion criteria: * adult patients (18 years old or older) with intracranial aneurysms with a wide neck (defined as \> or = to 4mm, or with a dome to neck ratio of 2:1 or greater). exclusion criteria: * small-necked aneurysms, inappropriate for stenting. * inability to tolerate anti-platelet medication.
adjunct targeted temperature management in acute severe carbon monoxide poisoning

Conditions: Carbon Monoxide Poisoning; Neurologic Sequelae; Hypothermia

Summary: this randomized trial will investigate important neurocognitive clinical outcomes of patients with acute severe carbon monoxide poisoning (ascop) randomized to receive either therapeutic hypothermia or normothermia combined with hyperbaric oxygen therapy (hbo).

co-poisoned patients are identified by medical history and carboxyhemoglobin (co-hb) value \>5% (\>10% in smokers). patients presenting with acute co poisoning will receive one hbo. ascop is defined as mental status showing response to painful stimulus or unresponsiveness requiring intubation for airway protection and ventilation support at the emerency department, and persistence of depressed mental status despite the hbo. after hbo treatment, eligible patients who provide consent will be randomly allocated to receive hypothermia, or normothermia treatment administered in a open label fashion except for blinding of outcome assessor. outcome measures will be administered at 1 month and 6 months after co exposure. in addition, we will examine the differences in serum markers and mortality between the hypothermia and normothermia groups.

Eligibility criteria:
inclusion criteria: * ≥ 19 years. * patients who received hbo within 24 hours for acute co poisoning. * patients who meet the definition of ascop (patients incapable verbal obey after hbo). * signed informed consent prior to study entry. exclusion criteria: * cardiac arrest before hbo * previous neurocognitive disorders * life-threatening underlying disease (ex: advanced cancer) * evidence of co-ingestion of sedative or hypnotics confirmed by intravenous flumazenil administration or history taking at the emergency department * absolute contraindication for th (active severe bleeding and profound shock not controlled by vasoactive drugs) * no admission * the significant co-ingested drug levels, which are alter the consciousness, is confirmed from the drug analysis lab * pregnancy * burns * more than moderate burn or inhalation burn * burns complicated by other trauma * electrical burn * burns in high risk patients (patients with chronic underlying diseases (i.e dm, esrd, liver cirrhosis, etc) which may cause delays or aggravate the wound healing)
clinical performance of injectable composite resins in class i cavities

Conditions: Caries,Dental

Summary: purpose of research: evaluation and comparison of 24-month clinical performance of injectable and conventional resin composites in class i cavities.

the mechanical properties of conventional resin composites have been tried to be improved. in addition to the developed mechanical properties, the need for easy and fast application led to the development of flowable composites. flowable composites have lower filler ratio than conventional hybrid composites so they are less rigid and have lower modulus of elasticity. for these reasons, the use of flowable composites in areas that may be exposed to high forces, especially occlusal cavities, is not recommended. today, it is aimed to increase the wear resistance by increasing the amount of filler in flowable composites and producing injectable composites. a new product recently introduced to the market, a high-strength nano-filled injectable composite material, gc's g-ænial universal injectable(tokyo,japan), was also included in the study. this is a low-viscosity composite in which modifications have been made to provide a product with high wear resistance and depth of cure to make it suitable for posterior restorations. one lesion in each patient will be randomly assigned to be restored using either the g-aenial universal injectable or filtek z250 resin composites. the adhesive, g2-bond universal will be used for adhesive procedures. the clinical procedure for the restorations will be performed by a single operator. the restorations will be evaluated by two calibrated examiners at baseline and at 6, 12, 18, 24 months in accordance with the modified usphs criteria. data will be statistically analyzed using the chi-square and cochran q tests (p \< 0.05).

Eligibility criteria:
inclusion criteria: * healthy individuals who do not have any systemic disease that prevents restorative treatment * individuals between the ages of 18-35 * brushing your teeth twice a day * having at least 20 teeth in occlusion and at least 2 occlusal lesions with antagonist teeth in the opposite arch * volunteer individuals who agree to participate in the research and sign the informed consent form and who have undergone initial periodontal treatment will be included in the study. exclusion criteria: * pregnant or breastfeeding women * individuals with advanced periodontal disease * individuals using removable partial dentures * individuals with bruxism * individuals with malocclusion * patients with known allergies to resin-based restorative materials and bonding agents * patients with a history of allergy to local anesthesia * endodontic treatment, teeth that need pulp capping or endodontic treatment is available

Keywords: conventional resin composite injectable resin composite class i restoration
comparing a home vision self-assessment test to office-based snellen visual acuity in myopic children

Conditions: Home Vision; Office-Based Snellen Visual Acuity; Myopic Children

Summary: this study aims to compare a home vision self-assessment test to office-based snellen visual acuity in myopic children.

visual impairment is an important public health issue worldwide, with a heavy socioeconomic burden. more than 400 million people globally have mild to severe visual impairment. visual acuity (va) screening is the most basic part of ophthalmic examination. home vision screening tests have become an important way to obtain a measure of an individual's va without an office-based clinic visit. knowing a patient's va can help ophthalmologists remotely triage acute calls, monitor visual recovery after medical or surgical interventions, and ensure visual stability in follow-up telemedicine visits. home vision screening tests have become an important way to obtain a measure of an individual's va without an office-based clinic visit. numerous electronic home vision assessment tools exist, but many of these are used through applications on mobile or tablet devices.

Eligibility criteria:
inclusion criteria: * age ≤ 18 years. * both sexes. * patients who completed the home visual acuity test and have a subsequent office-based visual acuity test. exclusion criteria: * last in-office visual acuity of 20/125 or worse in both eyes (to allow for a buffer of at least 2 lines of vision from the upper limit of 20/200 on the home vision assessment). * lack of access to mychart. * history of keratopathy, cataract, glaucoma, retinal detachment, neuro-ophthalmic disease, or other eye diseases. * history of ophthalmic surgery or trauma. * history of systemic diseases. * severe psychological or psychiatric diseases.
vitamin c for the prevention of uti in women who undergo elective gyn surgeries

Conditions: Catheter-Associated Urinary Tract Infection, Ascorbic Acid

Summary: this open-label randomized trial aims at assessing the role of vitamin c pills in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.


Eligibility criteria:
inclusion criteria: non pregnant women at least 18 years of age visiting the preadmission unit (pau) or the obgyn floor (7n), presenting for elective gyn surgery at the american university of beirut medical center (aubmc). exclusion criteria: * any women with the following: 1. nephrolithiasis 2. congenital anomaly or neurogenic bladder 3. allergy to ascorbic acid 4. who require therapeutic anticoagulant medicine during the 6 weeks after surgery 5. surgery did involve a fistula repair or a vaginal mesh removal 6. positive urinalysis in the pau 7. recurrent uti's 8. diabetes 9. g6pd 10. hemochromatosis 11. renal disorders patients already taking vitamin c supplementation will also be excluded from the study.

Keywords: vitamin c, cauti
a study to demonstrate improvement in symptoms of constipation in subjects that require around-the-clock opioid pain killer therapy

Conditions: Pain; Constipation

Summary: the primary research objective is to demonstrate that subjects taking oxn pr have improvement in symptoms of constipation as measured by the bowel function index (bfi) compared to subjects taking oxypr tablets alone with cancer and non-cancer related pain without reducing the effectiveness of pain relief as measured by the brief pain inventory (bpi).

the study oxn3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female subjects with non-malignant or malignant pain requiring opioids to assess analgesic efficacy and symptoms of constipation secondary to opioid treatment. subjects will be randomised to two treatment groups and will be treated with oxn pr or oxypr for up to 5 weeks. the study is composed of three phases, a pre-randomisation phase, a double-blind phase and an extension phase.

Eligibility criteria:
inclusion criteria * subjects who are receiving who step iii opioid analgesic medication for the treatment of non-malignant or malignant pain. * documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy exclusion criteria * females who are pregnant or lactating. * subjects with evidence or significant structural abnormalities of the gastrointestinal tract. * subjects with evidence of impaired liver/kidney function upon entry into the study.

Keywords: oxycodone naloxone combination severe chronic and non-malignant pain malignant and non-malignant pain that requires around-the clock opioid therapy opioid related constipation
function of circulating exosomes in sepsis-induced immunosuppression

Conditions: Sepsis; Septic Shock; Sepsis Syndrome; Sepsis Bacterial; Sepsis, Severe; Sepsis Bacteremia

Summary: this is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.


Eligibility criteria:
inclusion criteria: * ≥ 50 years with ≥ 2 chronic comorbidities * highly suspected bacterial infection based on clinical or radiologic evidence * ≥ 2 systemic inflammatory response syndrome (sirs) criteria * actual/anticipated admission to intensive care unit (icu) * anticipated length of hospital stay ≥ 5 days exclusion criteria: * pregnancy * underlying immunosuppression (solid organ transplant, hematopoietic stem cell transplant, neutropenia, hiv infection, long-term corticosteroid use (≥ 20 mg prednisone equivalents for ≥ 14 days), immunosuppressants, radiation, chemotherapy, immune-modifying biologics, viral hepatitis, or systemic autoimmune diseases) * current immunotherapy use * confirmed covid-19 infection
cognitive and neurophysiological effects of raloxifene in alzheimer's disease

Conditions: Alzheimer Disease

Summary: the aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication approved by the food and drug administration for the treatment of osteoporosis, in improving memory and the ability to live independently in postmenopausal women with alzheimer's disease.

the aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication (classified as selective estrogen receptor modulators (ser's)) approved by the food and drug administration for the treatment of osteoporosis, in improving memory and the ability to live independently in postmenopausal women with alzheimer's disease. patients who volunteer for this study will need to visit the clinic 7 times (participate) over a period of five months and will receive either raloxifene or a harmless, inactive pill called a placebo. neither the volunteers nor the study staff will know which type of pill a patient receives. patients must be generally healthy and have mild-to-moderate dementia. there must be a patient caregiver who can watch for side effects and ensure that the patient takes the study pills on schedule over a period of three months. patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. each visit will last approximately 3 hours. a total of 20 patients is being recruited to participate in this study at the university of wisconsin.

Eligibility criteria:
inclusion criteria: * postmenopausal women with alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic) * mini mental status exam score greater than 15/30 exclusion criteria: * history of deep vein thrombosis or blot clots * diabetes * active heart disease or stroke * liver problems including hepatitis * severe vision or hearing problems * tobacco use

Keywords: alzheimer disease postmenopausal women hormone therapy