Kornimate/medical-research-clean huggingface dataset:
an efficacy and safety study for epoetin alfa (procrit) in cancer patients not receiving chemotherapy or radiation

Conditions: Anemia; Neoplasms

Summary: the purpose of this study is to evaluate the effectiveness and safety of epoetin alfa (procritâ®) administered 80,000 units every three weeks in cancer patients that are not receiving chemotherapy or radiation therapy.

the current approved dosage for epoetin alfa is 40,000 units once per week with an escalation to 60,000 units once per week if the response is inadequate after four weeks of treatment at 40,000 units. this dosing scheme, while proven to be efficacious, is often inconvenient for both patients and medical personnel. this is an open-label, non-randomized, multi-center pilot study with the objective to investigate the efficacy of epoetin alfa (procrit®) with regard to hematopoietic response when administered at 80,000 units subcutaneously every three weeks in anemic patients with cancer not receiving chemotherapy or radiation therapy. patients will receive two epoetin alfa injections (40,000 units per injection) under the skin once every three weeks for a maximum of 13 weeks, totalling a maximum of four treatments. doses may be reduced depending on the patients' hemoglobin level.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of non-myeloid malignancy * baseline hemoglobin value of \<= 11 g/dl unrelated to transfusion * patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 13-week study period. however, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable * female patients with reproductive potential must have a negative serum pregnancy test at screening * patients must have signed an informed consent exclusion criteria: * uncontrolled hypertension * history (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder * transfusion within 28 days prior to first dose * planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry * no prior treatment with epoetin alfa or any other erythropoietic agent within the previous two months

Keywords: anemia neoplasms hemoglobin level
efficacy, immunogenicity, and safety of a single dose of v710 in adult patients scheduled for cardiothoracic surgery (v710-003 am2)

Conditions: Staphylococcus Aureus; Bacteremia; Mediastinitis

Summary: this study will assess the efficacy of a single dose of v710 vaccine to prevent serious staphylococcus aureus infections following elective cardiothoracic surgery. the study will also evaluate the immune response and general safety of the v710 vaccine.


Eligibility criteria:
inclusion criteria: * participant is scheduled to undergo cardiothoracic surgery involving a full median sternotomy (not including cardiac transplantation surgery) within 14 to 60 days after vaccination. * female participants of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination and must use an acceptable form of birth control. exclusion criteria: * participants had an invasive staphylococcus aureus infection within the past 3 months prior to study entry. * a realistic (\>50%) possibility that cardiothoracic surgery will be necessary sooner than 10 days after vaccination. * participant is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery. * participant has any type of ventricular-assist device in place at the time of study entry. * participant has a history of anaphylaxis to any of the vaccine components. * participant received v710 vaccine, any other investigational staphylococcus aureus vaccine, or investigational staphylococcus aureus antibodies. * participant has a temperature of ≥100.4ºf (≥38.0ºc), oral equivalent, within 48 hours prior to study vaccination. * participant has impairment of the immune system. * participant has a medical condition in which the expected survival is less than 90 days.
changes in different fat compartments and their effect on particular manifestations of metabolic syndrome after bariatric procedures.

Conditions: Morbid Obesity; Metabolic Syndrome; Visceral Obesity

Summary: the metabolic risks associated with obesity are closely correlated with central (abdominal), rather than a peripheral (gluteofemoral) fat pattern it has been shown that weight loss after bariatric surgery is followed by metabolic improvements. the amount of fat lost from each site may be independently regulated. very scant information is found in the literature regarding the relative changes in different fat body compartments, and their effect on the improvement of the metabolic profile. in this study we define the absolute and relative changes in the different adipose tissue compartment after weight loss surgery

the metabolic risks associated with obesity are closely correlated with central (abdominal), rather than a peripheral (gluteofemoral) fat pattern. the amount of fat lost from each site may be independently regulated. very scant information is found in the literature regarding the relative changes in different fat body compartments. rapid and preferential reduction of visceral fat mass could occur in morbid obese with visceral obesity. it has been previously shown, and it was also partially confirmed in this study, that a reduction in visceral fat was associated with metabolic improvements that included improved glucose tolerance and reduced plasma insulin and lipid levels. this again suggests a threshold of proportional visceral fat loss, above which there is an improvement in insulin sensitivity and other component of metabolic syndrom. we will quantify the different fat compartments changes after bariatric surgery by means of ct scan.

Eligibility criteria:
inclusion criteria: * morbid obesity, * metabolic syndrome exclusion criteria: * previous abdominoplasty surgery, * previous major abdominal surgey

Keywords: morbid obesity metabolic syndrome visceral fat peripheral fat
twelve month safety and efficacy study of cvt-301 in parkinson's disease patients with off episodes

Conditions: Idiopathic Parkinson's Disease

Summary: this study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of cvt-301 for the treatment of up to 5 off episodes per day in pd patients experiencing motor fluctuations (off episodes). all patients will receive active treatment, but patients will be blinded to dose level. this will serve as an extension to the cvt-301-004 (nct02240030) study for those patients who participated in that study and remain eligible for this study. in addition, patients who previously completed the cvt-301-003 (nct01777555), cvt-301-009 (nct02807675) and cvt-301-005 (nct02352363) (observational arm completers), as well as cvt-301 naïve patients may be enrolled if they meet the cvt-301-004e eligibility criteria.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (pd) diagnosed between the ages of 30 and 80 years; * hoehn and yahr stage 1-3 in an "on" state; * require levodopa-containing medication regimen at least 3 times during the waking day; * experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness; * are on stable pd medication regimen; * total daily levodopa (ld) dose \<1600 mg/day; * able to perform a spirometry maneuver in the on and off states * normal cognition confirmed by mini mental state examination (mmse) score ≥25 ; exclusion criteria: * pregnant or lactating females; * previous surgery for pd or plan to have stereotactic surgery during the study period. patients who have had deep brain stimulation \[dbs\] will also be excluded unless the procedure was performed more than 6 months prior to study enrollment. * history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year; * known contraindication to the use of levodopa; * any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety; * any any contraindication to performing routine spirometry.

Keywords: parkinson's disease motor fluctuations levodopa inhaled drugs off episodes
an evaluation of the effect of the amniofix amniotic membrane allograft in patients undergoing posterior instrumentation removal

Conditions: Adhesions of Soft Tissue

Summary: the objective of this study is to evaluate the clinical effectiveness of amniofix™ in the reduction of the tenacity and frequency of soft tissue adhesions during the removal of segmental posterior lumbar instrumentation.


Eligibility criteria:
inclusion criteria: * adults (18 years or older) * diagnosed with lumbar pathology requiring elective lumbar interbody fusion * willingness to comply to follow-up examinations and diagnostic imaging procedures * ability to give full written informed consent exclusion criteria: * previous surgical procedure performed at same site * sign or symptoms of other disease which could result in allograft failure * require a corpectomy * participating in another drug or device clinical trial * pregnant or may become pregnant during the study * prisoner * involved in workmen's compensation or other litigation relative to a spine injury * past medical history of allograft implantation which resulted in graft failure * any condition requiring treatment above the normal standard of care * currently taking medications which could affect graft incorporation (supervising physicians discretion) * auto-immune disease * renal failure * failure to sign or understand informed consent information * history of drug and/or alcohol abuse * allergic to aminoglycosides

Keywords: lumbar pathology requiring elective lumbar interbody fusion
safety, tolerability, and efficacy of axa1125 in nash with fibrosis

Conditions: Non Alcoholic Steatohepatitis (NASH)

Summary: this study will compare the effects of axa1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (nash). as well as the safety and tolerability of axa1125. subjects will take one of two different doses of axa1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.


Eligibility criteria:
inclusion criteria: * willing to participate in the study and provide written informed consent. * male and female adults aged \> 18 years. * must have nash and fibrosis on a liver biopsy sample * if a historical liver biopsy is used for screening, obtained within 6 months prior to screening; * subjects may have a diagnosis of t2dm exclusion criteria: * history or presence of liver disease (other than nafld or nash) * history or presence of cirrhosis and/or history or presence of hepatic decompensation

Keywords: steatosis lobular inflammation ballooning liver biopsy liver fat liver stiffness nash aminio acids fibrosis
improving emergency department testing for deep vein thrombosis

Conditions: Deep Vein Thrombosis (DVT)

Summary: this observational study will use a new way to test for deep vein thrombosis (dvt) of the leg. a dvt is a blood clot in the leg and is a medical problem that can cause swelling, pain, and redness. if the blood clot is not treated, it can cause more serious, long-term effects, and occasionally lead to death. the main questions the study aims to answer are: 1. how safe is our new blood clot testing method? 2. how efficient is our new blood clot testing method? the study will be run in the emergency department and urgent care centre in kingston, ontario. patients who are tested for a dvt in the leg can be included in the study. researchers follow the patient through chart review to make sure the new system is safe and efficient.


Eligibility criteria:
inclusion criteria: - emergency physician decides to test for dvt of the lower limb. exclusion criteria: * \<18 years of age; * tested for dvt without using the today algorithm at the index visit; * d-dimer level is known before today item assessment; * a new indication for anticoagulation at the emergency department assessment (other than dvt) in a patient not previously prescribed an anticoagulant; * a history of prior lower limb dvt, where there is no access to baseline ultrasound imaging; * suspected of having a pulmonary embolism; * has previously participated in this study; * has previously opted out of all research at hospital site; * left the emergency department or urgent care centre against medical advice; * d-dimer was ordered prior to initial physician assessment; * imaging for dvt or pulmonary embolism within the previous 30 days; * transferred from another hospital organization.

Keywords: deep vein thrombosis venous thromboembolism emergency medical services diagnosis
the painn study - a pilot cross sectional study

Conditions: Hospitalized Patient; Home Mechanical Ventilation; Pain; Pain Management

Summary: pain prevalence in hospitalized patients has been reported between 65% and 75%, indicating poor and/or insufficient management. in addition, pain prevalence has been estimated for separate groups of individuals with specific neurological/neurosurgical conditions (25% - 84%) and the overall prevalence was calculated as 36% (95% ci: 31% - 42%). however, investigations on prevalence of pain in danish neurologic inpatients is scarce, which may indicate an overlooked symptom in local neurologic settings. this project was a cross-sectional investigation to identify pain prevalence, intensity and interference in admitted patients needing home menicahal ventilation (hmv) and we conducted as an exploratory investigation to collect data from the patients by pain questionnaires/instruments, observation of patients' pain behavior and physiologic parameters. the main patients' diagnoses were spinal cord injury, amyotrophic lateral sclerosis, cerebral palsy, spinal muscular atrophy, and defects from birth such as tracheomalacia. the study included 40 participants, all recruited from respiratory center east, university of copenhagen, rigshospitalet


Eligibility criteria:
inclusion criteria: persons hospital admitted, minimum 18 years old, provided informed consent (provided by the patient or patient's relative). exclusion criteria: persons who did not understand written and spoken danish or denied participating in the study.

Keywords: pilot cross sectional study neurological patients home mechanical ventilation
adding magnesium sulfate to local anesthetic in combined pectoral nerve and stellate ganglion block for postoperative pain control after modified radical mastectomy

Conditions: Magnesium Sulfate; Local Anesthetic; Pectoral Nerve; Stellate Ganglion Block; Postoperative Pain; Modified Radical Mastectomy

Summary: we aim to study the effect of adding magnesium sulfate as an adjuvant to the local anesthetic used in the combined pectoralis nerve block ii (pecs ii) and stellate ganglion block for postoperative pain control in patients undergoing modified radical mastectomy.

post-operative pain from breast surgery can be controlled by regular pain medications such as paracetamol, non-steroidal anti-inflammatory (nsaids), and narcotics. nerve blocks are commonly used as multimodal approaches for acute post-operative pain relief. pectoral and stellate ganglion blocks are regional anesthesia techniques that target the thoracic nerves and sympathetic nerve ganglia to provide analgesia for the upper extremity and chest regions. when combined, these blocks have shown promising results in alleviating perioperative pain for patients undergoing modified radical mastectomy. magnesium sulfate, a well-known adjuvant, has been studied extensively for its analgesic properties and anti-inflammatory effects.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * female gender. * american society of anesthesiologists (asa) physical status ii or iii. * patients scheduled for elective modified radical mastectomy for breast cancer. * body mass index (bmi): \> 20 kg/m2 and \< 40 kg/m2. exclusion criteria: * bleeding tendency due to coagulopathy, * patients with opioid dependence or alcohol or drug abuse, * significant liver and renal sufficiency * patients with psychiatric illnesses that prevent them from proper perception and assessment of pain. * local infection at the site of the block. * known hypersensitivity or allergy to magnesium sulfate or local anesthetics. * patients with chronic pain syndromes or pre-existing neuropathic pain conditions. * pregnant or lactating individuals.
patient registry to evaluate the real-world safety of ruconest®

Conditions: Hereditary Angioedema

Summary: this is a prospective, real-world, observational patient registry for patients with hae who are receiving treatment with ruconest for hae.

see below.

Eligibility criteria:
inclusion criteria: 1. patient provides informed consent as documented on the institutional review board (irb) approved informed consent document (icf). for patients aged between 13 and 17 years old, the method of consent with or without assent will be determined by the irb. 2. patient is male or female and at least 13 years of age at the time of providing consent / assent. 3. patient has been prescribed ruconest for hae. exclusion criteria: 1. patient is receiving hae therapy as part of a clinical trial.

Keywords: hereditary angioedema hae ruconest rhc1inh registry pharming
flucelvax (tivc or qivc) pregnancy registry

Conditions: Influenza, Human; Pregnancy; Birth Defect

Summary: the study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with the tivc or qivc vaccine during pregnancy.


Eligibility criteria:
inclusion criteria - enrollment and data collection will be coordinated through a coordination center (cc). the minimum eligibility criteria required for enrollment are as follows: * sufficient information to confirm that the exposure of interest occurred during pregnancy and at which date. * sufficient information to determine whether it concerns a prospectively enrolled subject, since retrospective cases are ineligible for enrollment. * reporter (e.g. hcp) contact information to allow for follow-up exclusion criteria: * n/a
relationship between the sagittal lumbopelvic alignment and balance control in adolescents with mechanical low back pain

Conditions: Low Back Pain, Mechanical

Summary: to examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain.

to examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain.patients will be recruited from the secondary schools in benha city be general invitations, and the study will be conducted at outpatient clinic of faculty of physical therapy, benha university

Eligibility criteria:
inclusion criteria: * age between 15 and 18 years, either sex, and symptoms lasting longer than three months, which imply chronicity exclusion criteria: * spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for lbp
topic antiinflammatory therapy added to selective photocoagulation in macular edema

Conditions: Diabetic Retinopathy; Macular Edema

Summary: the purpose of this study is to determine the efficacy of ocular topic antiinflammatory therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness secondary to selective photocoagulation in diabetics with clinically significant macular edema.

selective photocoagulation is the standard treatment for clinically significant macular edema. this treatment decreased the incidence of moderate visual loss in the long term. nonetheless, in the first six weeks after treatment it is induced, probably because an exacerbation of macular edema secondary to treatment. an inflammatory response has been reported after selective photocoagulation. therefore, antiinflammatory therapy like ketorolac or nepafenac could be useful to manage center point thickness secondary to selective photocoagulation in diabetics with macular edema.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * regardless of diabetes duration and retinopathy severity level * one or both eyes with focal clinically significant macular edema * treated with selective or focal photocoagulation * visual capacity under subjective refraction before treatment * adequate quality 6mm fast macular map on the day of photocoagulation * signed of inform consent exclusion criteria: * ocular surgery in the last 4 months * previous selective photocoagulation * topic or systemic antiinflammatory therapy in the last week * allergic to antiinflammatory non-steroids therapy * lent contact used in tha last 2 days before photocoagulation * history of ocular trauma, ocular infection or lacrimal dysfunction in the last 3 months * history of uveitis or ocular inflammation in the last 12 months * any ocular external disease, infection or inflammatory process during evaluation * corneal abnormalities that could modify visual capacity per se * actual corneal disease * pregnancy * myopia over -6.00 diopters * any retinal disease different from diabetic retinopathy * adverse event of the drug * desert to pharmacology therapy after the second visit * no assistance after the second visit * inadequate quality 6mm fast macular map after the second visit

Keywords: diabetic retinopathy clinically significant macular edema selective photocoagulation topic ketorolac topic nepafenac efficacy treatment