Kornimate/medical-research-clean huggingface dataset:
a study of mk-2060 in participants with chronic and/or end-stage kidney disease (mk-2060-011)

Conditions: End-Stage Renal Disease; End-Stage Kidney Disease; Kidney Failure, Chronic

Summary: this is a three-part study of mk-2060 in participants with chronic and/or end-stage kidney disease. the purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of mk-2060 in stage 4 chronic kidney disease (ckd4) or stage 5 chronic kidney disease (ckd5) participants in part 1, of multiple subcutaneous doses in ckd4 or ckd5 participants in part 2, and of a single subcutaneous dose of mk-2060 in participants with end-stage kidney disease in part 3. the primary hypothesis is that, in part 1, the true geometric mean of the area under the concentration-time curve from 0 to infinity (auc0-inf) after a single-dose of mk-2060 in adult ckd4 or ckd5 participants is at least 11300 nm\*hr.


Eligibility criteria:
inclusion criteria: * at the time of screening, has stage 4 or 5 chronic kidney disease (parts 1 and 2) or end-state kidney disease on peritoneal dialysis (part 3). * has a body mass index (bmi) ≥ 18 and ≤ 45 kg/m\^2. exclusion criteria: * has a history of cancer, including adenocarcinoma, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignances which have been successfully treated ≥ 5 years prior to prestudy with appropriate follow-up. * has a history of deep vein thrombosis or pulmonary embolism, a history of vascular access thrombosis within 1 month prior to enrollment, or has a personal or family history of bleeding disorder. * has a history of gastrointestinal (gi) bleeding, duodenal polyps, or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in the last 3 months. * has a history of or current frequent epistaxis within the last 3 months or active gingivitis. * has ongoing anticoagulant therapy or antiplatelet therapy. aspirin is permitted. * has planned significant dental procedures at the time of screening or pre-dose or other planned surgical procedures within duration of participation of study. * is positive for hepatitis b surface antigen or human immunodeficiency virus (hiv). * has had major surgery and/or donated or lost 1 unit of blood (approximately 500 ml) within 4 weeks prior to the pre-study visit. * has a history (participant recall) of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (ivig) or rhogam within the last year. * has a history (participant recall) of receiving any biological therapy (including human blood products or monoclonal antibodies; excluding erythropoietin and insulin) within the last 3 months or vaccination within the last 1 month, except the seasonal flu and pneumococcal vaccine or covid-19 vaccine.
cerebral and renal oximetry study in preterm patients who require surfactant administration

Conditions: Respiratory Distress Syndrome of Prematurity

Summary: respiratory distress syndrome of prematurity (rdsp) is an acute respiratory condition that occurs in preterm infants due to pulmonary surfactant deficiency. exogenous surfactant administration is a crucial therapeutic measure in the management of rdsp, being the 'less invasive surfactant administration technique' (lisa) the gold standard, according to the latest reviews. oximetry based on near-infrared spectroscopy is a non-invasive monitoring modality that provides continuous information on the degree of regional hemoglobin saturation present in the underlying tissue, mainly in the venous compartment. it is thus, a reflection of the balance between oxygen supply and demand of oxygen to the tissues. we intend to perform a prospective analysis of newborns under 32 weeks of gestational age who require surfactant administration, as we wish to study cerebral and renal perfusion by oximetry in the group of patients who receive surfactant by lisa and in the group of patients who receive surfactant via endotracheal tube (patients intubated at birth for stabilization), since there are few data published in the literature. our main hypothesis is that the administration of surfactant by lisa technique does not negatively influence cerebral and renal oximetry. our secondary hypothesis is that patients requiring intubation at birth will present greater hemodynamic and respiratory instability in the first 72 hours of life, with a greater decrease in cerebral and renal oximetry with the administration of surfactant, compared to the group that does not require intubation at birth.


Eligibility criteria:
inclusion criteria: * preterm infants less than 32 weeks gestational age requiring surfactant administration exclusion criteria: * major congenital malformations * chromosomopathies
comparison of ro 31-8959 plus zidovudine (azt) versus azt plus zalcitabine (ddc) versus ro 31-8959 plus azt plus ddc

Conditions: HIV Infections

Summary: primary: to determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (ro 31-8959) plus zidovudine (azt) vs. azt plus zalcitabine (dideoxycytidine; ddc) vs. ro 31-8959 plus azt plus ddc. secondary: to investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.


Eligibility criteria:
inclusion criteria prior medication: required: * at least 4 months total of azt at some point in the past, alone or in combination with other antiretroviral therapy. patients must have: * hiv seropositivity. * diagnosis of aids, arc, pgl, or asymptomatic infection. * cd4 count \> 50 to \<= 300 cells/mm3. * life expectancy of at least 6 months. * prior azt therapy. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * acute serious opportunistic infections requiring immediate treatment, including (but not limited to) tuberculosis, cmv, cryptococcal meningitis, disseminated mac, cerebral toxoplasmosis, and pneumocystis carinii pneumonia. * known intolerance to ro 31-8959, azt, or ddc. * symptoms suggestive of pancreatitis. * moderate or severe peripheral neuropathy as evidenced by discomfort from numbness, tingling, burning or pain of the extremities or any related symptoms that are accompanied by an objective finding. * visceral kaposi's sarcoma. * lymphoma that will require therapy within the next 6 months. * transfusion dependence. concurrent medication: excluded: * investigational or antineoplastic agents. concurrent treatment: excluded: * radiotherapy (other than local skin radiotherapy). * transfusions. prior medication: excluded: * any antiretroviral agent (other than azt) or immunomodulatory therapy within 14 days prior to study entry. * prior treatment with an hiv proteinase inhibitor.

Keywords: zalcitabine drug therapy, combination acquired immunodeficiency syndrome aids-related complex zidovudine saquinavir hiv protease inhibitors
sakk - a trial to evaluate antitumor efficacy of faslodex® after aromatase inhibitor failure in advanced breast cancer

Conditions: Breast Neoplasms

Summary: the primary objective of the study is to assess the activity of fulvestrant in postmenopausal women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase inhibitors by estimating the clinical benefit rate


Eligibility criteria:
inclusion criteria: * histological/cytological confirmation of breast cancer * progression under treatment with an aromatase inhibitor * at least one measurable or non-measurable lesion exclusion criteria: * prior treatment for breast cancer with more than 2 different hormonal agents * more than 1 chemotherapy for advanced disease * presence of life-threatening metastatic visceral disease

Keywords: breast cancer fulvestrant faslodex hormonotherapy aromatase inhibitor failure advanced breast cancer
a study of gc1111 in hunter syndrom patients

Conditions: Hunter Syndrome

Summary: the objective of this study is to evaluate the efficacy of gc1111 in hunter syndrome patients


Eligibility criteria:
inclusion criteria: * patients diagnosed with hunter syndrome * male at the age of ≥ 5 * adequate abilities (including 6-mwt) to participate in this study in the opinion of the investigator. * voluntarily signed written informed consent to participation in this study * consent to contraception exclusion criteria: * prior treatment with iduronate-2-sulfatase ert * history of bronchotomy, bone marrow trasplanation, or cord blood transplanation. * known hypersensitivity reactions to any of the components of the invetigational product * prior or planned administration of other investigational products within 30 days before treatment with the investigational product in this study or duirng this study. * unable to perform 6-mwt. * female

Keywords: gc1111 mucopolysaccharidosis ii mps ii idursulfase-beta ids
efficacy of exparel in comparison to standard of care for the treatment of post operative dental implant pain

Conditions: Postoperative Pain

Summary: this study is researching managing postsurgical pain by injecting both short-acting local anesthetics and exparel® at the time of surgery and reviewing if it could reduce or eliminate the need for postsurgical opioids and improve clinical outcomes following the fast dental implant surgery procedure. this approach is being compared to the current standard of care.

postsurgical pain following the full arch surgical therapy (fast) dental implant surgery procedure is commonly managed with a variety of interventions, including local infiltration with short-acting local anesthetics during surgery and the use of postsurgical opioid and non-opioid analgesics. although this approach to managing postsurgical pain is considered the current standard of care, its reliance on opioid analgesics to provide analgesia beyond the duration of short-acting local anesthetics exposes patients to opioid-related adverse events (oraes) that may delay their recovery and have other deleterious clinical consequences. the primary objective of this study is to determine the efficacy and safety of local infiltration of exparel for the fast dental implant surgery procedure compared to standard of care.

Eligibility criteria:
inclusion criteria: * age 18 years or older; * ability to speak, read, and write in english; * ability to communicate via telephone; * scheduled to undergo fast dental implant surgery procedure at a study center within the next 30 days for both maxillary and mandibular repair with at least 4 upper and 4 lower teeth to be extracted; * willing to provide informed consent, participate in study, and comply with study protocol. exclusion criteria: * daily opioid consumption for more than 30 days prior to surgery; * any opioid consumption within 3 days prior to surgery. * prior treatment for alcohol, recreational drug, or opioid abuse. * hypersensitivity or allergy to local anesthetics, non steroidal anti-inflammatory drugs, or opioids; * breastfeeding, pregnant, or contemplating pregnancy prior to surgery.
associative peripheral stimulation for reduction of motor impairment during acute period of stroke recovery

Conditions: Stroke; Stroke, Acute; Stroke, Ischemic; Stroke, Hemorrhagic; Hemiparesis; Hemiparesis;Poststroke/CVA; Weakness of Extremities as Sequela of Stroke; Stroke Sequelae; Upper Extremity Paresis

Summary: associative peripheral stimulation (aps) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. this pilot study investigates whether aps applied during the acute phase of stroke recovery may reduce impairment and improve function in the affected upper extremity.


Eligibility criteria:
inclusion criteria: 1. confirmed ischemic or hemorrhagic stroke no earlier than 7 days prior to enrollment; 2. presentation of hemiparesis or paralysis of the upper extremity due to stroke; 3. ability to comprehend and follow study instructions; 4. ability to initiate finger extension (≥3°) at least three times per minute; 5. fugl-meyer assessment (upper extremity) score of \<47. exclusion criteria: 1. contraindications, intolerance, or high sensitivity to the experimental protocol; 2. history of upper-extremity disability prior to the index stroke; 3. neurological conditions (other than stroke) affecting motor function; 4. treatment of spasticity/increased tone in the affected upper extremity (e.g., with botox injection); 5. lack of access to a safe and suitable place of discharge for experimental sessions and follow-up visits.

Keywords: stroke rehabilitation associative peripheral stimulation
postoperative anxiety and depression among older chinese patients

Conditions: Depression; Anxiety; Elderly Patients; Non-cardiac Surgery

Summary: a multicenter, prospective observational study to describe the socioeconomic characteristics and the occurrence of postoperative anxiety and depression in the chinese old population.

as china's population ages, the proportion of elderly people undergoing surgery increases. perioperative anxiety and depression, particularly in elderly patients, is common and associated with multiple medical and social adversities. previous studies have found a 31 percent risk of anxiety and 29 percent risk of depression in older perioperative patients. however, nationally representative epidemiological data for postoperative anxiety and depression, in particular elderly patients undergoing non-cardiac surgery, are unavailable in china. therefore, providing nationwide epidemiological data on postoperative anxiety and depression in chinese elderly patients provides a valuable opportunity for policy makers and health care professionals to optimize the management of geriatric mental health in china.

Eligibility criteria:
inclusion criteria: 1. elderly patients (age ≥ 65 years) 2. undergoing elective surgery with a planned overnight hospital stay following surgery 3. non-cardiac surgery, non-neurosurgical surgery exclusion criteria: 1. patients fully refused to participate in the study 2. patients with severe dementia, language disorder, severe hearing or visual impairment, coma, and end-stage status 3. patients whose surgeries were canceled 4. history of previous severe mental illness or long-term use of psychotropic medications 5. patients admitted to icu immediately after surgery 6. patients who died within 7 days after surgery 7. patients who did not complete the scale assessment
effect of extended infusion lines on pulse contour-based measurements

Conditions: Hemodynamic Instability

Summary: hemodynamic monitoring of the critically-ill patients is increasingly performed using an arterial pulse contour-based cardiac output device such as the proaqt system. the aim of this study is to evaluate the effect of extending the pressure lines on the arterial pressure wave and the calculated hemodynamic variables when using the proaqt system.

hemodynamic continuous monitoring of critically-ill patients is increasingly performed with minimally-invasive methods, such as the proaqt sensor (pulsion medical systems se, munich, germany). the proaqt sensor calculates hemodynamic variables such as the cardiac output, stroke volume (variation), pulse-pressure variation and systemic vascular resistance by pulse contour analysis of the arterial pressure waveform using an arterial radial or femoral catheter. this minimal invasive technique, also permits continuous beat-to-beat assessment. in patients in who an arterial catheter is placed for clinical reasons, the hemodynamic variables are continuously recorded. an extension line is coupled to a 3-way stopcock, connected to the proaqt sensor. in a neutral position of the 3-way stopcock, the pressure wave travels from the pressure sensor through the standard line. by turning the handle of the stopcock the standard line is bypassed and the pressure wave travels through the extended line. the hemodynamic registration will be as follows: * two minutes in the neutral position; * two minutes with one type of extension line * two minutes in the neutral position * two minutes with a second type of extension line * two minutes in neutral position the arterial pressure curve and all calculated hemodynamic variables are electronically registered. the influence of two types of extension lines on the accuracy of the calculated hemodynamic variables will be evaluated by comparing the variables measured in neutral position and variables measured with the extended pressure lines. the changes in the calculated variables will be correlated to possible arterial pressure waveform modifications and used to evaluate different algorithms, which might be used to reconstruct the primary pressure wave.

Eligibility criteria:
inclusion criteria: * asa 1-2 * arterial catheter necessary for clinical reasons exclusion criteria: * ≥asa 3

Keywords: cardiac output pulse contour analysis stroke volume hemodynamic monitoring
start treatment and recovery for opioid use disorder

Conditions: Opioid-use Disorder; Mental Disorder; Opioid Medication Assisted Treatment

Summary: the purpose of this study is 1) to evaluate whether emergency department-initiated medically assisted treatment with buprenorphine/naloxone in patients presenting with opioid use disorder will produce positive outcomes at 1 week, 3 months and 6 months after treatment initiation.

the emergency department is a critical missed opportunity to engage patients with opioid use disorder in medication-assisted treatment, the most effective current treatment for the disorder. patients presenting at the emergency department with opioid use disorder will be given the opportunity to immediately start medication assisted treatment with naloxone/buprenorphine then referred either to a specialized addiction bridge clinic or a local waivered provider for further treatment.

Eligibility criteria:
inclusion criteria: * patient at emergency department * diagnosis opioid use disorder according to criteria diagnostic and statistical manual (dsm) 5 exclusion criteria: * participating in alternate treatment program for opioid use disorder * prisoner * inability to communicate * psychosis * suicidality * history of buprenorphine injection * critical illness
safety and efficacy of lx102 gene therapy in patients with neovascular age-related macular degeneration (namd) (venus)

Conditions: Neovascular Age-Related Macular Degeneration

Summary: the goal of this study is to evaluate the overall safety and efficacy of lx102 gene therapy for namd.

in this phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of lx102 (n=20 for each dose level), or aflibercept (n=10). safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.

Eligibility criteria:
inclusion criteria: 1. willing to sign the informed consent, and willing to attend follow-up visits. 2. age ≥ 50, and ≤ 89. 3. diagnosis of active cnv secondary to neovascular amd. 4. bcva etdrs letters between 19 and 73. 5. demonstrated a meaningful response to anti-vegf therapy. exclusion criteria: 1. cnv or macular edema in the study eye secondary to diseases other than namd. 2. retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement. 3. absence of rpe tear at screening. 4. acute coronary syndrome, myocardial infarction or coronary artery revascularization, cva, tia in the last 6 months. 5. uncontrolled hypertension defined as average sbp ≥160 mmhg or an average dbp ≥100 mmhg. 6. uncontrolled diabetes defined as hba1c \>8.0%.

Keywords: age-related macular degeneration amd neovascular amd neovascular age-related macular degeneration
efficacy and safety of floseal for hemostasis in total knee arthroplasty

Conditions: Knee Replacement Surgery; Osteoarthritis

Summary: the purpose of this study is to compare the efficacy and safety of floseal to standard of care for hemostasis in subjects undergoing total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * participant is 18 to 80 years of age inclusive at the time of screening * participant is planned for primary unilateral total knee arthroplasty * participant has signed the informed consent form * participant is in stable health (i.e., able to undergo surgery and participate in a follow-up program based on physical examination and medical history) * participant has a preoperative hgb level \> 10 g/dl * if female of childbearing potential, the participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study * participant is willing and able to comply with the requirements of the protocol exclusion criteria: * participant has had a previous total or partial knee arthroplasty or any surgery on the knee within the previous 6 months * participant has osteonecrosis or arthrotomy within the last year * participant has prior or current hardware in target knee * participant has had injections in the knee: 1. steroids within the 3 months prior to scheduled surgery, 2. synvisc, hyalin, etc. within the 6 months prior to scheduled surgery * participant has had general surgery within 3 months * participant has rheumatoid arthritis or any other inflammatory or traumatic bone injuries to the knee within the 12 months prior to scheduled surgery * participant has allergies to products of bovine origin * participant has a history of bleeding, platelet, or bone marrow disorders * participant has donated more than 1 unit of blood donation in the 3 weeks prior to surgery * participant has a history of a coagulation disorder * participant is currently taking dipyridamole/asa (aggrenox) and/or enoxaparin (lovenox) * participant has been treated with aspirin or warfarin (coumadin) or clopidogrel (plavix) within 7 days prior to surgery * participant is not permitted to remain without his/her anti-coagulant regimen (e.g. plavix) for 48 hours postoperatively * participant has taken nonsteroidal anti-inflammatory agents or herbal supplements within 7 days of surgery * participant has a history of substance abuse (alcohol, drugs) or is an active smoker * participant has liver cirrhosis * participant has erythropoietin agonist/stimulating agent within 90 days prior to surgery * participant has an active infection or previous history of infection in the affected joint within the previous 6 months * participant has participated in another clinical study involving an investigational product (ip) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an ip or device during the course of this study
the safety and efficacy of albis®: the prevention of aspirin-induced gastrointestinal ulcers in patients

Conditions: Patients Taking Low-dose Aspirin

Summary: the purpose of this study is to research the safety and efficacy of albis® for the prevention of aspirin-induced gastrointestinal ulcers in patients taking low-dose aspirin.

the safety and efficacy of albis®: the prevention of aspirin-induced gastrointestinal ulcers in patients taking low-dose aspirin, a pilot study double-blind, placebo-controlled, randomized, multicenter, parallel, prospective study

Eligibility criteria:
inclusion criteria: * male or female, aged 20 to 80 years * subjects identified with at least one of the following diagnosis (angina, myocardial infarction(old), cerebrovascular disease, peripheral vascular disease, diabetes, hypertension, hypercholeseterolemia, obesity) who are required to take a low dose of aspirin (100mg/day) for more than 12 weeks. exclusion criteria: * females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential * peptic ulcer or reflux oesophagitis * hemostatic disorder or coagulation disorder * known allergy or hypersensitivity to the study medication