Kornimate/medical-research-clean huggingface dataset:
a clinical study of klh-2109 in uterine fibroids patient with menorrhagia and pain

Conditions: Uterine Fibroids (MeSH Heading: Leiomyoma)

Summary: multi-center, randomized, double-blind, parallel-group study to confirm superiority of klh-2109 to placebo in uterine fibroids patient with menorrhagia and pain


Eligibility criteria:
inclusion criteria: * premenopausal japanese woman diagnosed with uterine fibroids * patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions: * larger than a certain standard * no calcification * not receiving surgical treatment * patients with a normal menstrual cycle * patients diagnosed with menorrhagia * patients with pain symptoms associated with uterine fibroids exclusion criteria: * patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia) * patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis * patients with undiagnosed abnormal genital bleeding
preventive treatment of latent tuberculosis infection in people with diabetes mellitus

Conditions: Diabetes Mellitus; Tuberculosis

Summary: diabetes mellitus (dm) increases susceptibility to tuberculosis (tb) and worsens tb patient outcomes. the number of patients with combined tb and dm now outnumbers that of combined tb and hiv and it has been estimated that 15-30% of tb disease may be attributable to diabetes globally. this may be expected to rise substantially as dm prevalence increases. treatment of latent tb infection (ltbi) in this population will likely have a significant clinical benefit. similar to hiv-infected individuals, those with dm might benefit from therapy to prevent the development of tb disease. current international guidelines do not recommend ltbi management in people with dm, but this is because no studies have examined the risk-benefit ratio of such an intervention. to date, no rcts have been conducted to investigate the efficacy and safety of preventive treatment of ltbi in dm patients. based on evidence on effectiveness, safety, and treatment completion rates, 3hp has been selected as the regimen of choice for this study of african people living with dm. people living with dm will be randomized to 3hp or placebo to determine the efficacy of 3hp in the prevention of tb disease in this population. protid's preventive treatment of ltbi among people with dm will generate the first solid evidence to support or refute the use of preventive treatment against tb in people with dm.


Eligibility criteria:
inclusion criteria: 1. enrolled in diabetes care with a history of dm and current use of anti-diabetic medication ('known dm'); or in the absence of anti-diabetic medication an hba1c of =6.5% (48 mmol/mol) or a fasting venous plasma glucose of =7.0 mmol (126 mg/dl). for those with no previously known dm a repeat test above the diagnostic cut-point is required to confirm the diagnosis ('new dm') 2. adult (18 years or older) 3. diagnosed with ltbi, defined as a positive igra test or tst reactivity =10 mm 4. voluntarily signed informed consent form 5. if sexually active, willing to use an effective contraceptive method for the duration of preventive therapy. exclusion criteria: 1. weight \<45 kg 2. previous tb disease, defined as either bacteriologically confirmed or clinically diagnosed and treated 3. treatment with a rifamycin medication or isoniazid in the previous 2 years. 4. diagnosis of probable or definite tb during screening 5. confirmed hiv-infection or receiving antiretroviral treatment 6. liver dysfunction, defined as serum aspartate aminotransferase (ast) level 5 times the upper limit of normal 7. pregnant or planning to become pregnant in the next 3 months, or lactating 8. known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation 9. other conditions inapplicable for participation in this study, such as likely to fail to adhere to study commitment or to complete the whole study, at the discretion of the site investigator

Keywords: tuberculosis drugs social science health systems epidemiology diabetes
use of ultrasound guidance to assist with labor epidural placement in patients with a bmi ≥40

Conditions: Labor Pain

Summary: placement of labor epidurals is a very common daily practice in obstetrical anesthesia. currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. this study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.


Eligibility criteria:
inclusion criteria: * current (pregnant) bmi ≥ 40 * age ≥ 18 * asa score of 3 or less * full term pregnancy (37 weeks gestational age or greater) exclusion criteria: * known scoliosis * known contraindications to neuraxial blockade * intrauterine fetal demise or non-viable fetus.
hemosonics-uva hemosonics-uva cardiac surgery clinical study protocol

Conditions: Coronary Artery Disease

Summary: this study compares the results of current standard coagulation measurement devices to the quantra system, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.

hemosonics is developing a novel poc diagnostic device, the quantra system, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. the quantra system employs a patented technology named sonorheometry, which was invented at the university of virginia. sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. the initial assay performed on the quantra system will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients. a clinical study will be conducted to evaluate the analytical performance as well as provide a preliminary evaluation of the performance comparability of the hemosonics' device as compared to existing coagulation monitoring technology in heart surgery. this study will be performed at hemosonics and the university of virginia health system and will involve patients undergoing cardiac surgery requiring bypass.

Eligibility criteria:
inclusion criteria: * subject is scheduled for cardiac surgery involving bypass circuit * subject is older than 18 years * subject is willing to participate and he/she has signed a consent form exclusion criteria: * subject is unable to provide written informed consent * subject is incarcerated at the time of the study * subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks * patients with renal disease (defined as serum creatinine greater than 1.5 mg/dl) * patients with history of active liver disease * patients on emergency cases * patients on heparin anticoagulation before the beginning of the study
a novel fnirs neurofeedback intervention for enhancement of working memory in attention deficit hyperactivity disorder (adhd)

Conditions: ADHD

Summary: the proposed study is to test and validate a novel intervention that integrates computerized cognitive training with real-time neuromonitoring and neurofeedback to enhance working memory by probing the individualized neural systems underlying working memory. we will test the proposed intervention on children with adhd with working memory deficits. the r61 proof-of-concept phase will assess the target engagement, effective dose and feasibility.


Eligibility criteria:
inclusion criteria include: * age from 7 to 11 years * diagnosis and/or current symptoms of adhd * full-scale intelligence quotient (iq) ≥80 * behavior rating inventory of executive functions (brief), working memory scale t-score \> 65 * allowed comorbidities include oppositional defiant disorder, learning disabilities excluding dyslexia, and mild anxiety and/or depression. exclusion criteria: * presence of severe neurological or psychiatric disease other than those allowed under inclusion * sensory deficits that would preclude participation in assessments or imaging * history of significant head trauma with loss of consciousness * contraindications to mri (e.g. metal implants or claustrophobia) * enrollment in other intervention studies

Keywords: adhd working memory functional near infrared spectroscopy (fnirs) magnetic resonance imaging (mri) neurofeedback cognitive training neuromonitoring
study of the molecular mechanisms underlying the cross-neutralizing capacity of as04-adjuvanted hpv vaccine (cervarix®) in comparison with the aluminiumhydroxyphosphate sulphate adjuvanted hpv vaccine (gardasil®)

Conditions: Infection With Human Papillomavirus

Summary: six identical female twins aged 9-13 years will participate. one sib of each twin pair will be given cervarix according to the 0, 1, 6 month vaccination scheme, while the other sib will be given gardasil according to the 0, 2, 6 month vaccination scheme. three blood samples will be taken (the first prior to vaccine administration, the second and third 7 days after dose 2 and 3, respectively). the blood samples will be used to determine: 1) the magnitude the anti-hpv 16 and anti-hpv-18 antibody responses, 2) as well as the cross-reactive pattern of these responses towards related, non-vaccine hpv strains (hpv-31 and -33, and hpv-45). 3) plasmablast isolated from blood taken 7 days after the 3rd dose in the first place (and eventually after the 2nd dose also) will be examined for for the usage of vdj and vj segments in the immunoglobulin heavy (vh) and light (vl) heavy and light chains. gene useg in b cells induced by cervarix and gardasil will be compared. finally the cross-reactive potential of monoclonal antibodies obtained by eukaryotic expression of a series of heavy (vh) and light (vl) chains from single asc isolated after the 3rd dose of a three-dose schedule of either cervarix or gardasil will be examined. the duration of the study is approximately 187 days. five study visits will take place, over a time period of 6.5 months, followed by a telephone call after 12 months. the purpose of the study is to learn more about the molecular mechanisms underlying the cross-neutralizing capacity of as04-adjuvanted hpv vaccine (cervarix®) in comparison with the aluminiumhydroxyphosphate sulphate adjuvanted hpv vaccine (gardasil®).


Eligibility criteria:
inclusion criteria: * six homozygous twins in good health, without preceding sexual activity (virgin). subjects have a negative pregnancy test on the day of vaccination and have agreed to continue abstinence during the entire study period and for two months after completion of the vaccination series. exclusion criteria: * subjects are not participating in any other clinical trials and have not been vaccinated previously against hpv and have not had an administration of mpl or as04 in the past.
comparison of comparison of ropivacaine and liposomal bupivacaine for total knee arthroplasty

Conditions: Arthroplasty; Replacement; Knee

Summary: this is a randomized prospective outcomes study comparing two groups of patients. one group will receive liposomal bupivacaine for a periarticular injection. the other will receive ropivacaine for periarticular injection for pain relief after total knee arthroplasty. the primary objective of this study is to determine if liposomal bupivacaine provides superior pain control (decreased maximal pain scores within the first 72 hours post surgery) when compared to ropivacaine when injected in a periarticular injection.

the current standard of care at our institution for pain relief in total knee arthroplasty is ropivacaine injectate into the knee for acute postoperative pain relief. this provides pain relief for a duration of 6-18 hours after surgery. all patients in this study will also receive multimodal analgesia following surgery in both arms of the study. this will be the first study to prospectively analyze these two regimens. study group 1 (ropivacaine arm) consist of 100 ml (1 ml ketorolac, 2.5 ml morphine, 28.95 ml normal saline, 300 mcg of epinephrine, and 200 mg ropivacaine) study group 2 will consist of 100 ml (one syringe with 50 ml total: 40 ml 0.25% bupivacaine, 300 mcg epinephrine, 1 ml ketorolac, 2.5 ml morphine, 6.5 ml normal saline) (one syringe with 50 ml total: 20 ml liposomal bupivacaine 30 ml normal saline). the periarticular injection will occur at the end of the procedure. adequate analgesia will be defined as \< 3 vas at rest and if vas is greater that 3 adjustments in oral or intravenous pain medications. postoperatively the study team will evaluate for any signs of complications. pain scores and opioid usage will be recorded daily while the subject is in the hospital. a quality of recovery survey will be completed at 72 hours post injection. all subjects will be contacted by phone at day 14 to determine if there have been any adverse events and report their pain level.

Eligibility criteria:
inclusion criteria: * all patients undergoing primary total knee arthroplasty surgery 18-80. exclusion criteria: * patient on chronic anticoagulation * allergy to local anesthetics, nsaids, or opioids * patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post- operatively * daily use of opioid for more than three weeks * lack of patient cooperation
prevention of recurrent hepatitis b after liver transplantation

Conditions: Hepatitis B; Cirrhosis; Acute Liver Failure; Hepatocellular Carcinoma

Summary: hepatitis b accounts for approximately 5000 deaths per year in the united states. liver transplantation offers the only hope for patients who develop end-stage liver disease. early results of liver transplantation for hepatitis b were poor with recurrence rate of 80% and 1-year survival of only 50%. recent studies found that preventive therapy using hepatitis b immune globulin (hbig) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. however, hbig when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. some studies found that preventive therapy using both hbig and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of hbig needed when used in combination with lamivudine is not clear. adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis b but its role in liver transplantation is uncertain because of the risk of kidney damage. many studies showed that the risk of recurrent hepatitis b is related to the viral load before transplant. thus, it may be possible to tailor the preventive therapy according to the risk. the aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis b after liver transplantation.


Eligibility criteria:
inclusion criteria: adult patients listed for liver or liver-kidney transplant for hepatitis b. exclusion criteria: patients with contraindications to use of prophylactic antiviral therapy.
fluid responsiveness and arterial elastance in patients with septic shock or after aortic surgery

Conditions: Shock, Septic; Hyperlactatemia; Oliguria; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Ruptured; Aortic Stenosis

Summary: the mostcare system, thanks to the pressure recording analytical method (pram; vygon, padua, italy), provides new hemodynamic parameters of the cardiovascular system. the pram method is a noncalibrated pulse contour method which requires only an arterial line (radial or femoral). this method has been validated in various clinical conditions. among the collected parameters, some are well known and used daily care in intensive care unit (icu), i.e. cardiac output (co), arterial pressure, heart rate, stroke volume (sv). others such as arterial elastance (ea) or dicrotic pressure are more recent and merit further investigation to determine their interest in clinical practice. to date, it is rarely used to adapt therapies, mostly because of a lack of knowledge regarding the evolution of these parameters. the aim of this study is to analyze the relationship between the evolution of arterial elastance and fluid responsiveness after a 250 ml fluid challenge of crystalloids in 5 minutes in patients with either septic shock or in the postoperative course of a major vascular surgery. patients will be considered fluid responders if an increase \>10% of the stroke volume is observed .


Eligibility criteria:
inclusion criteria: * age at least 18 years * septic shock (according to sepsis-3 definition) or patients who underwent elective or emergent abdominal aortic surgery * invasive blood pressure (radial or femoral) and mostcare monitoring * stroke volume between 20 and 50 ml/beat on the mostcare system * indication for a fluid challenge: hypotension (mean arterial pressure under 65mmhg) or oliguria (urine flow rate \ 2 mmol/l exclusion criteria: * age \<18 years * cardiac arrhythmia * arterial wave form distortion * inappropriate identification of the dicrotic notch for any reason * refuse to consent to the study

Keywords: mostcare vascular surgery arterial elastance dicrotic pressure fluid loading pressure recording analytical method hemodynamic monitoring pulse contour analysis
letrozole or laparoscopic ovarian diathermy for women with cc resistant polycystic ovary syndrome.

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to compare and determine the efficacy of letrozole administration to that of laparoscopic ovarian diathermy (lod) in infertile women with polycystic ovary syndrome(pcos)not responding to treatment with clomiphene alone.

in the letrozole group, withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation, then 2.5 mg of letrozole oral tablets (femara; novartis pharma services, switzerland) daily from day 3 of the menses for 5 days up to six cycles. all patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.

Eligibility criteria:
inclusion criteria: * cc resistant pcos exclusion criteria: * congenital adrenal hyperplasia * cushing syndrome * androgen secreting tumors

Keywords: polycystic ovary syndrome clomiphene resistance letrozole laparoscopic ovarian diathermy
combined ketamine and ecbt intervention for ptsd

Conditions: Post-Traumatic Stress Disorder

Summary: an open label rct assessing the efficacy of a combined treatment approach for ptsd, using ketamine infusions and online cognitive behavioural therapy.

objectives (i) to introduce a previously untreated patient population with ptsd to new therapeutic options. (ii) to provide new insights into the functional role of glutamate in affective disorders as well as in learning and memory. (iii) to explore the utility of pharmacologically-enhanced psychotherapy. outline the present study is an open label randomized control trial assessing the efficacy of a combined treatment of sub-anaesthetic iv ketamine in conjunction with online cbt (ecbt). in the study, 16 participants with refractory ptsd will be assigned either to an experimental group receiving a combination of ketamine and ecbt over 12 weeks, or they will be assigned to a 12-week control group. both groups will be assessed for symptoms of ptsd and comorbid disorders before treatment, at 2 midway points (4 and 8 weeks), and at the end of the 12 week experimental period. symptoms of ptsd and comorbid disorders for participants in the experimental group are expected to improve significantly more than participants in the control.

Eligibility criteria:
inclusion criteria: * diagnosis of ptsd by a psychiatrist on the team using the clinician administered ptsd scale (caps-5) with a score of at least 50 and a medium presentation. * patients will have received at least 2 different types of prior treatment, both of which produced less than a 50% reduction in the participant's symptoms. * participants with hypertension or cardiovascular disease must be receiving stable treatment to participate. * participants must speak and read english, and will have consistent and reliable access to the internet. * patients with suicidal ideation will be included. * patients with a history of substance abuse will be included (except for opioid use disorder). exclusion criteria: hypomanic/manic episodes, bipolar disorder, acute psychosis, opioid use disorder, treatment with naltrexone, pregnancy, postpartum, breastfeeding, untreated hypertension, cardiovascular disease, aspd, active homicidal ideation, and general noncompliance with the study protocol.

Keywords: ketamine cognitive behavioral therapy online cognitive behavioral therapy pharmacologically enhanced psychotherapy
dermaclose duke fasciotomy and wound study

Conditions: Wound of Skin

Summary: to evaluate the clinical performance of dermaclose and dermaclose xl continuous external tissue expander (cete) devices to reduce wound size and/or assist with closure in acute full thickness wounds of the skin and assess the need for skin grafting for patients undergoing a four-compartment leg fasciotomy.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age at the time of consent. * patient with a full thickness acute wound(s) of the skin: 1. on either the upper or lower extremity (including four-compartment leg fasciotomy), in whom dermaclose and/or dermaclose xl is applied during surgery, or 2. undergoing a four-compartment leg fasciotomy requiring conventional wound dressing. * patient has signed a written informed consent form (icf) per 21 code of federal regulations (cfr) part 50.55(e). exclusion criteria: * patient in whom the product was used off-label (except for patients who have the device on for longer than 14 days) * patient with wound(s) that exhibit any of the following: * ischemic tissue, * infected tissue, * acute burned tissue, * fragile tissue at the edges of the wound(s). * patient, who in surgeon's opinion, does not fit the criteria for this study.