Kornimate/medical-research-clean huggingface dataset:
pivotal study (pharmacokinetics, efficacy, safety) of bax 326 (rfix) in hemophilia b patients

Conditions: Hemophilia B

Summary: the purpose of this pivotal phase 1/3 study is to determine the pharmacokinetic (pk) parameters, the hemostatic efficacy, and the safety of bax 326, a recombinant factor ix, in previously treated patients (ptps) with severe and moderately severe hemophilia b.


Eligibility criteria:
main inclusion criteria: * participant is 12 to 65 years old at the time of screening * participant and/or legal representative has/have provided signed informed consent * participant has severe (factor ix (fix) level \< 1%) or moderately severe (fix level 1-2%) hemophilia b (based on the one stage activated partial thromboplastin time (aptt) assay), as tested at screening at the central laboratory * participant is previously treated with plasma-derived or recombinant fix concentrate(s) for a minimum of 150 exposure days (eds) (based on the participant's medical records); if a verifiable, documented history is unavailable, the participant can be enrolled if s/he has 100-150 eds to any fix product that are not fully documented and has participated in study 050901 for at least 50 eds to immunine prior to enrollment (not valid for us and japan). * participant has no evidence of a history of fix inhibitors * if the participant is to receive prophylactic treatment, the participant is willing to receive prophylactic treatment over a period of 6 months. * if the participant is to receive on-demand treatment, the participant has ≥12 documented bleeding episodes requiring treatment within 12 months prior to enrollment and is willing to receive on-demand treatment for the duration of this study. main exclusion criteria: * the participant has a history of fix inhibitors with a titer ≥0.6 bethesda units (bu) (as determined by the nijmegen modification of the bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening * the participant has a detectable fix inhibitor at screening, with a titer ≥0.6 bu as determined by the nijmegen modification of the bethesda assay in the central laboratory * the participant's weight is \ 120 kg * the participant has a history of allergic reaction, eg, anaphylaxis, following exposure to fix concentrate(s) * the participant has a known hypersensitivity to hamster proteins or recombinant furin (rfurin) * the participant has ongoing or recent evidence of a thrombotic disease, fibrinolysis or disseminated intravascular coagulation (dic)
development of ivr and web alcohol interventions

Conditions: Alcohol Consumption

Summary: the primary aim of the present study is to study the effect of a brief automated alcohol intervention in university students, and if there is a difference in effect between automated brief interventions delivered by internet (web) or interactive voice response (ivr), and to study if there is difference in effect between single and repeated interventions.


Eligibility criteria:
inclusion criteria: * females scoring 6 and above and males scoring 8 and above on audit. exclusion criteria: * females scoring 5 and below and males scoring 7 and below on audit

Keywords: alcohol consumption brief intervention automated techniques
clinical behavior of the asqelio™ trifocal diffractive intraocular lens

Conditions: Cataract

Summary: the main objective of this study was to evaluate distance, intermediate, and near vision in patients who have undergone cataract extraction with bilateral implantation of a new hydrophobic trifocal diffractive intraocular lens (iol) with a biospheric design, the asqelio trifocal iol (ast products, inc., billerica ma, usa), along with patient-reported outcomes (pro). for that purpose the clinical information of 50 eyes from 25 patients was retrospectively analyzed 3 months after implantation


Eligibility criteria:
inclusion criteria: * 50 years or older submitted to cataract surgery with binocular implantation of asqelio trifocal tflio130c iol * seeking spectacle independence after surgery * iol power between +5.0d y +34.0d * transparent ocular media, except for the cataract prior to surgery. * potential postoperatory visual acuity of 20/25 or better, as assessed prior to surgery exclusion criteria: * preoperatory corneal astigmatism greater than 1.0d * previous corneal surgery or trauma * irregular cornea (e.g. keratoconus) * choroidal hemorrhage * microftalmos * severe corneal dystrophy * uncontrolled or medically controlled glaucoma * clinically significant macular changes * severe concomitant ocular condition * cataract not age-related * severe optic nerve atrophy * diabetic retinopathy * ambyopia * extremely shallow anterior chamber * severe chronic uveitis * pregnancy or lactating * rubella * mature/dense cataract difficulting preoperatory eye fundus assessment * previous retinal detachment * concurrent participation in another investigation involving drugs or medical devices
effects of two doses of a common cold treatment on alertness

Conditions: Common Cold

Summary: this study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.


Eligibility criteria:
* participants with symptoms of cold \< 96 hours, rating of at least '2' on malaise at least 4 other symptoms of cold. * no history of clinically significant perennial rhinitis, no recent antibiotic, antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive medication in the 14 days prior to screening, no pregnancy, breastfeeding or participation in this trial, or another trial in the 30 days prior to screening.

Keywords: alertness
glucocorticoid injection in patients with lumbar radicular pain

Conditions: Radiculopathy Lumbar

Summary: the purpose of this study is to demonstrate the efficacy of intramuscular betamethasone injection on pain and other clinical parameters in patients with radicular pain due to lumbar disc herniation. the investigators also aimed to determine the effects on electrophysiological findings.

low back pain is an important health problem that causes difficulties in daily living activities, loss of work performance and disability. some patients with low back pain have radicular symptoms due to intervertebral disc herniation. lumbar radiculopathy is characterized by radiating buttock and leg pain in a lumbar nerve root distribution. the pathophysiology of radiculopathy is related to compression of the nerve, as well as the local release of inflammatory cytokines. systemic corticosteroids have been used for treatment of lumbar radicular pain for a long time. the effects of corticosteroids are related to their anti-inflammatory effects, which may help reduce swelling and related compression on the affected nerve. corticosteroids can be used systemically (i.e. oral, intravenous, or intramuscular routes) or administered directly into spinal structures through injections. in the current study, the investigators aimed to demonstrate the efficacy of intramuscular betamethasone injection on pain, disability and health related quality of life in patients with lumbar radicular pain due to disc herniation. the investigators also aimed to determine the effects on electrophysiological findings.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 65 years old with acute (less than 6 weeks) lumbar radicular pain due to intervertebral disc herniation. * neurological findings such as sensory, motor and reflex abnormality matching the l4, l5 or s1 nerve distribution. * patients who confirmed to have root compression (radiculopathy) by electrophysiological investigations. exclusion criteria: * contraindication for steroid usage (acute infection, uncontrolled diabetes and hypertension, severe cardiac failure), hypersensitivity to steroids * acute trauma * inflammatory low back pain * indications for neurosurgery (pronounced motor weakness or cauda equina syndrome) * lumbar spinal stenosis * history of back surgery, history of steroid injection in the last 3 months * pregnancy, lactation * malignancy

Keywords: glucocorticoid radicular pain lumbar radiculopathy
safety and efficacy of telapristone acetate (proellex®) administered vaginally for the treatment of uterine fibroids

Conditions: Uterine Fibroids

Summary: the primary objective of this study is to determine the safety and efficacy of two vaginal doses of proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an off-drug interval (odi), to premenopausal women with symptomatic uterine fibroids.


Eligibility criteria:
inclusion criteria: * adult females between 18 and 47 years. * have a history of at least 3 regular menstrual cycles in which menorrhagia is due to uterine fibroids. * must have uterine fibroids. * agreement not to attempt to become pregnant during the trial. * agreement to use only sanitary pads provided throughout the course of the study, tampon use is prohibited . * ability to complete a daily participant diary and study procedures in compliance with the protocol. * have a negative pregnancy test at the screening and baseline visits, and subsequent study visits. * a body mass index (bmi) between 18 and 45 inclusive. * menstrual blood loss \> 80 milliliters (ml) by alkaline hematin assay. exclusion criteria: * post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy. * pregnant or lactating or is attempting or expecting to become pregnant during the entire study period. * received an investigational drug in the 30 days prior to the screening for this study. * history of polycystic ovarian syndrome (pcos). * concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, dihydroepiandrosterone (dhea) or hormonal products for at least 2 weeks prior to screening and during the study. * use of oral contraceptives in the preceding 30 days. use of depo-provera® in the preceding 10 months. * use of gonadotropin releasing hormone (gnrhas) (e.g. lupron depot) within 3 months of the first dose of study drug (lupron depot must have a wash-out period of 3 months). * has an intra uterine device (iud) in place. * known or suspected carcinoma of the breast or reproductive organs. * recent history (within past 6 months) of alcoholism or drug abuse. * clinically significant abnormal findings on screening examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study.

Keywords: uterine fibroids leiomyoma fibroid tumor fibroma
pilot evaluation of the everybody project

Conditions: Body Image; Eating Disorder Symptom

Summary: a pilot randomized-controlled trial explored the feasibility, acceptability, and efficacy of an inclusive dissonance-based body image intervention called the everybody project. the professionally delivered everybody project was evaluated in a universal college student population compared to a waitlist control group through one-month follow-up.

an existing dissonance-based body image program (the body project; stice, shaw, burton, \& wade, 2006) was adapted to directly discuss diversity within cultural appearance ideals (including race, gender identity, sexuality, ability, and age) and the individual and collective impact of pursuing exclusive appearance norms. the feasibility, acceptability, and efficacy of the everybody project was assessed in an initial randomized-controlled trial. college students within a university in the pacific northwest united states were invited to participate in programming (universal intervention target). professional delivery of the two-session everybody project was compared to a waitlist control condition. intervention groups were facilitated by one "expert" (faculty or staff with body image expertise) and two college student co-facilitators. mixed methods assessment included a comparison of changes in quantitative eating disorder risk factor outcomes across randomization conditions and among students with marginalized identities at pre-intervention, post-intervention, and one-month follow-up. qualitative interviews assessed the impact of the program on participants with marginalized identities. feasibility and acceptability of the program was assessed to evaluate the appropriateness of the everybody project within universal college student audiences.

Eligibility criteria:
inclusion criteria: * current college student enrolled at institution where research was taking place exclusion criteria: * none
the impact of covid-19 on pulmonary procedures

Conditions: COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this study investigates the changes in practice by pulmonary procedural programs across the united states as they faced the coronavirus pandemic. information gathered from this study may help guide pulmonary programs on a wider scale and improve their practice. the study may also help researchers understand where they should focus research efforts to better respond to a pandemic in the future.

primary objective: i. to assess how pulmonary medicine programs adapted their procedural practices and techniques, ambulatory operations, and provider staffing in response to the coronavirus-2019 (covid-19) epidemic. outline: participants complete survey over 5-10 minutes.

Eligibility criteria:
inclusion criteria: * pulmonologists that are members of the american association of bronchology and interventional pulmonology (aabip) and/or the american college of chest physicians (accp) * these organizations were chosen because their member databases are composed of pulmonologists in the united states (u.s.) that perform the pulmonary procedures described in this survey. letters of approval will be obtained from these organizations and provided to the md anderson institutional review board (irb). once the md anderson irb approves this survey study, the survey will be sent to the relevant subcommittees of these organizations for their electronic dissemination to their membership exclusion criteria: none
contrast-enhanced ultrasound and shear wave elastography for the treatment of lymphedema

Conditions: Lymphedema Arm

Summary: the purpose of this research is to determine the preferred microbubble agent (lumason®, optison®, and definity®) for lymphatic channel visualization by ultrasound. this research will also evaluate the utility of preoperative high-frequency b-mode ultrasound with contrast-enhanced ultrasound for presurgical planning, and ultrasound shear wave elastography for assessing treatment response at 6-month follow up.

part 1 - evaluate the uptake of microbubble agent (lumason®, optison®, and definity®) for lymphatic visualization by ultrasound. part 2 - combine preoperative high-frequency b-mode ultrasound with contrast-enhanced ultrasound to identify patent lymphatic channels for lymphaticovenous anastomosis presurgical planning. evaluate the utility of ultrasound shear wave elastography for assessing treatment response at 6-month follow up.

Eligibility criteria:
inclusion criteria: * unilateral lymphedema in the upper extremity (isl stage 2 or 3) secondary to breast cancer or breast cancer treatment. * patient qualifies for lva surgery as determined by the plastic surgeons performing the surgery (dr. bill tran or dr. vahe fahradyan), and the patient consents to surgery. * patient must be able to come to the 6-month clinical follow-up appointment (part 2 only). * patients must be able to understand the study procedures and comply with them for the entire length of the study. * no contraception is necessary or required. exclusion criteria: * pregnant or nursing women. * known or suspected hypersensitivity to microbubble contrast agent, perflutren, blood products, albumin, polyethylene glycol (peg), or egg.31. * known or suspected cardiac shunts. * prior lymphedema surgery in the upper extremity. * tattoo or scar on either upper extremity. * current drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. * inability or unwillingness of individual or legal guardian/representative to give written informed consent.. * current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.

Keywords: lymphaticovenous anastomosis surgery
placebo-controlled, randomized trial of a simplified biofeedback technique for the treatment of rumination

Conditions: Rumination Disorders

Summary: rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsión or re-chewing and swallowing. in a previous study we showed that rumination is produced by an unperceived, somatic response to food ingestión. after having identified the key mechanisms of rumination, we developed an original emg guided biofeedback technique with specific targets for correction, based on emg-guided control of abdomino-thoracic muscular activity, and in a pilot study we showed the potential effectivity of this treatment. in a subsequent study this technique was validated by a formal placebo-controlled, randomized trial. the current aim is to test the efficacy of a simplified biofeedback technique not requiring emg-guided control.

abdomino-thoracic muscle activity after a challenge meal will be recorded by emg: in the biofeedback group, patients will be instructed to control muscle activity, whereas in the placebo group patients will not. in each patient 3 sessions will be performed over a 10-day period. physiological (muscular activity by emg) and clinical outcomes (number of rumination events by questionnaries administered daily for 10 days) will be measured before and after treatment.

Eligibility criteria:
inclusion criteria: * rumination syndrome exclusion criteria: * relevant organic disease
study evaluating the efficacy of a novel ibuprofen formulation on fever in patients with an uncomplicated acute infection

Conditions: Infection

Summary: this single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared to placebo in patients with a fever due to an uncomplicated acute infection.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with a fever secondary to an uncomplicated acute viral or bacterial infection. * oral temperature measurement from 100 to 104 degrees fahrenheit. * onset of fever 3 days or less. * otherwise good health. exclusion criteria: * fever secondary to a chronic underlying medical condition or serious infection. * currently taking antibiotics or antivirals. * currently taking any medication which may interfere with the assessment of fever. * pregnancy or breast-feeding. * any serious medical or psychiatric disorder.

Keywords: fever antipyretic uncomplicated acute viral infection uncomplicated acute bacterial infections
the inotrope evaluation and research patient registry

Conditions: Heart Failure

Summary: the interpret inotrope evaluation and research patient registry is a longitudinal, observational study designed to look at the demographics and outcomes of heart failure patients on inotropic therapy administered in the home or infusion suite setting. the data gathered in this registry will provide information on how a patient's quality of life and symptoms change over time while on inotrope therapy, and help healthcare providers to have a better understanding of the benefits and risks associated with bridge-to-treatment and palliative care.

eligible patients will be consented by the site investigator or staff to participate in the registry at the time of referral for home care. clinical data, including dosing, symptom severity, lab values, and hospitalizations, along with data on quality-of-life and patient compliance with treatment, will be collected by the home care nurses and pharmacists. the registry's goal is to significantly contribute to the medical understandings of heart failure treatment and to improve the quality of care for heart failure patients in the united states through active publication of registry findings and disease management approaches.

Eligibility criteria:
inclusion criteria: * patient must be prescribed inotropic treatment (milrinone, dobutamine or dopamine) * patient must be referred to coram for this treatment in an alternate site of care, either home or infusion suite * patient must be willing to receive care and comply with the teaching and training necessary to administer treatment * patient is age 18 or over exclusion criteria: * patient is unable to start, or stops taking, inotropic medication * patient and/or patient insurance will not cover cost of home inotropic treatment with coram, or patient elects not to start treatment * patient is under the age of 18

Keywords: inotrope milrinone dopamine dobutamine
the effectiveness of muscle energy technique combined with strengthening of deep neck flexors with and without core stability exercise in upper cross syndrome patients.

Conditions: Upper Cross Syndrome; Forward Head Posture

Summary: upper cross syndrome (ucs) is a common muscles related postural disorder which is increasing every new day that is affecting the health related quality of life. it is most prevalent amongst the individuals who work at computers or laptops, or on desks. the ucs is caused by poor posture. weak core musculature leads to poor body posture causing chronic degenerative changes and disturbing body alignment and body equilibrium. core stability exercises (cse) are a good strategy to improve body posture. the purpose of this study is to determine the effects of muscle energy technique (met) combined with the strengthening of deep neck flexors with and without core stability exercise to manage upper cross syndrome (ucs) patients.

this randomized controlled trial will be conducted at the dow university of health sciences ojha campus in karachi, pakistan. those patients who fulfill the criteria will be enrolled in physiotherapy opd and general opd. then they will be randomized into two groups as per the random allocation sheet for treatment. pre- and post-intervention assessment for pain, functional disability, and range of motions will be done by visual analog scale (vas), neck disability index (ndi), and goniometer. analysis of pre- and post-intervention measure analysis will be performed using spss version 21.the sampling technique will be nonprobability purposive sampling with sample size of 70 participants (35 in each group). intervention: the participant will be divided into two groups as per the random allocation sheet for treatment. in group a, the control group will receive a moist heat pack for 20 minutes then muscle energy technique (met) of the upper trapezius, levator scapula, and pectoralis muscles (major and minor) and strengthening exercise of deep neck flexors. in group b, the experimental group will receive the same treatment session as the control group along with the core stability exercise. there will be 12 sessions for each patient, 6 sessions regularly in the 1st week and then 3 sessions per week for the next 2 weeks.

Eligibility criteria:
inclusion criteria: * participants who were diagnosed or referred with ucs * the participant with the age of 18 - 45 years old. * both male and female. * craniovertebral angle less than 48. * restricted cervical range of motion. exclusion criteria: * • participants who were diagnosed with: inflammatory/rheumatoid arthritis , neurological disorders, history of trauma or fracture with cervical spine, cervical spine surgery or trauma or any spinal congenital deformities.

Keywords: core stability muscle energy technique core stability exercise goniometer craniovertebral (cv) angle