Kornimate/medical-research-clean huggingface dataset:
testing of adi-peg in hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: amino acid deprivation therapy is an effective means for the treatment of some forms of cancer. recently it has been found that human hepatocellular carcinomas (hcc) cell lines appear to require arginine for growth. arginine is not an essential amino acid for human adults or infants as it can be synthesized from citrulline (for review see rogers 1994). therefore, selective elimination of arginine from the circulation may be a means of treating patients with metastatic melanoma or non resectable hcc. the enzyme arginine deiminase (adi) metabolizes arginine into citrulline (cunin 1986). however, adi is only found in microbes and not in humans. adi is therefore, highly immunogenic and has a short serum half-life following injection. these potential drawbacks (microbial source and thus viewed as foreign by the human immune system, and a short serum half-life) can be overcome by covalent attachment of polyethylene glycol (peg) to argininedeiminase and termed this drug adi-peg 20. adi-peg 20 appears to be an effective anti-cancer treatment for human hcc. pharmacokinetic and pharmacodynamic data indicates a once a week injection of 160 iu/m2 of adi-peg 20 eliminates all detectable arginine from the circulation for at least 7 days. this treatment appears to be well tolerated. the purpose of this study is to determine the efficacy of this treatment in patients with hcc. efficacy is a primary end point of this study. no patients will recieve placebo.


Eligibility criteria:
* histologically confirmed diagnosis of hepatocellular carcinoma. * non-resectable disease. * progressive disease after chemotherapy, radiotherapy, surgery or immuno-therapy, and be no longer responding to such therapy, or have refused such therapy. * been off previous treatment for at least 4 weeks. * been fully recovered from all prior surgery. * age of \> 18 years. * karnofsky performance status of \> 70. * expected survival of \> 12 weeks. * total bilirubin \< 3.0 mg/dl. * serum albumin \> 3.0 g/dl. * serum sgot \< 5 x upper limit of normal. * serum alkaline phosphatase \< 5 x upper limit of normal. * serum ammonia \< 55 mg/dl. * serum glucose \> 60 mg/dl. * serum amylase \< 1.5 x upper limit of normal. * anc \> 1,500 / ml. * platelets \> 100,000 / ml. * female subjects of childbearing age and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study. females must not be pregnant at the start of the study, and a serum hcg pregnancy test must be negative before entry into the study. * informed consent. * not be enrolled in other ind studies. * disease must be measurable or evaluable.
trial to evaluate the effectiveness of angular stable locking system (asls) in patients with distal tibial fractures

Conditions: Tibial Fractures

Summary: in many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. the play between screw and nail can result in loss of reduction and the instability due to the interfragmentary movement can result in malunions or nonunions. therefore, an angular stable locking system for intramedullary nails (asls) was developed to enhance axial and angular fracture stability. asls provides angular-stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes. preliminary results of a pre-study show a trend towards reduced time to pain-free full weight bearing in patients being treated with asls. this hypothesis will be tested in the present randomized controlled study.

the primary aim of the present study is to evaluate the effectiveness of the angular stable locking system (asls) in patients with distal tibial fractures treated with expert tibial nails (etn). in many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. the play between screw and nail can result in loss of reduction and the instability due to the interfragmentary movement can result in malunions or nonunions. therefore, an angular stable locking system for intramedullary nails (asls) was developed to enhance axial and angular fracture stability. asls provides angular-stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes. preliminary results of a pre-study show a trend towards reduced time to pain-free full weight bearing in patients being treated with asls. this hypothesis will be tested in the present randomized controlled study.

Eligibility criteria:
inclusion criteria: * the patient is ≥ 18 years old * the patient suffers from an acute distal third tibial fracture classified as: ao 42 a1-a3, ao 42 b1-b3, ao 42 c1-c3, ao 43 a1-a3 * the fracture is fixed with an expert tibia nail (etn) * the patient was able to walk without walking aid prior to the accident * the patient is able to understand and read local language at elementary level * the patient is willing and able to give written informed consent to participate in the study according to the cip exclusion criteria: * the patient is legally incompetent * preexistent malunion or nonunion of the fracture under investigation * osteotomies * the patient suffers from additional fractures of the lower extremities (exception: ipsilateral fibular fracture) * the patient suffers from a pathologic fracture * the patient suffers from active malignancy * the patient is pregnant, breast feeding or planning to get pregnant during the study period * the patient suffers from a life-threatening condition * the patient is affected by drug or alcohol abuse * the patient has participated in any device related clinical trial affecting the lower extremities within the previous month * the patient has participated in any drug related clinical trial affecting bone healing within the previous month
comparative study of anaconda system use versus conventional sedation in covid-19 patients.

Conditions: COVID-19; Respiratory Failure

Summary: at the beginning of 2020, a global alert emerged which saturated intensive care units due to covid-19 worldwide. this caused a need for mechanical ventilation due to atypical pneumonias that had a rapid evolution and respiratory failure; therefore the consumption of sedative agents in the intensive care units escalated. suboptimal sedation in the intensive care unit, increases the adverse effects, costs, and morbidity. for the time being, they focus on the use of intravenous agents such as propofol or dexmedetomidine, which are associated with tolerance, withdrawal, delirium, and hemodynamic effects. consequently, the need arises to maximize availability and effectiveness, which is why the intervention of the anaconda conservation device is carried out, which works with a heat and humidity exchange filter capable of administering isoflurane or sevoflurane with an efficiency of 90%.

analyze the difference in intravenous sedation requirements in patients with covid-19. patients who were assisted by a mechanical ventilator with sevoflurane versus conventional sedation.

Eligibility criteria:
inclusion criteria: * adult patients with confirmed covi-19 infection and assited with mechanical ventilation who entered critical care department. exclusion criteria: * tranfers to a different hospital. * death within the first 24 hours of hospital stay.

Keywords: sedatives acute kidney injury sars-cov-2 mechanical ventilation
comparison between effect of conventional, intensive and light emitting diodes (led) phototherapy on oxidative stress among neonates with unconjugated hyperbilirubinemia

Conditions: Oxidative Stress; Neonatal Hyperbilirubinemia; Phototherapy Complication

Summary: the aim of the present study is to test a hypothesis assuming that phototherapy might have an effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated hyperbilirubinemia.


Eligibility criteria:
inclusion criteria: * term and late-preterm neonates (≥35weeks) according to the guidelines of the american academy of pediatrics (2004) which stated that gestational ages of newborns were determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the ballard scoring system (ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present. * clinical significant indirect hyperbilirubinemia requiring phototherapy in the first week of life. * normal blood counts and peripheral blood smears * normal reticulocytic count. * breast fed newborn. exclusion criteria: * those in whom the total serum bilirubin (tsb) level rose by more than 5 mg/dl per day or was higher than 20 mg/dl within the first 24 hours after birth were excluded from the study. * infant of diabetic mothers. * maternal eclampsia-preeclampsia. * birth asphyxia * sepsis * congenital anomalies. * direct coombs'test positive * pathological causes of hyperbilirubinemia. * enclosed hemorrhage. * hemolytic type of hyperbilirubinemia due to blood group or rh incompatibility.
osteolysis of allograft prosthetic composite after shoulder resection for tumors

Conditions: Shoulder Disease

Summary: the gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. this is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...). the results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). in the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. the aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature).

quantify bone stock of the allograft by scanner measurement in post operative and in 6 month to 1 years after surgery. this is a retrospective study, and the scanner was performed routinely every 3 to 6 month, during 2 years, for oncological follow up.

Eligibility criteria:
inclusion criteria: * tumors of proximal humerus * malawer type i resection * primary reconstruction by allograft prosthetic composite exclusion criteria: * resection and reconstruction by prosthesis alone * resection and reconstruction by prosthesis and cement sleeve reconstruction * resection and reconstruction by hemiarthroplasty * revision protheses.
study of the safety and clinical effects of 2 doses of evp-6124 in subjects with alzheimer's disease who complete study evp-6124-024 or evp-6124-025

Conditions: Alzheimer's Disease; Dementia

Summary: this is a 26-week, randomized extension of the phase 3 double-blind placebo-controlled studies, evp-6124-024 and evp-6124-025. in this extension study, subjects who complete study evp-6124-024 or evp-6124-025 and fulfill all entry criteria will be randomized to receive evp-6124 for an additional 26 weeks.


Eligibility criteria:
inclusion criteria: * male or female subjects of any race, aged ≥55 and ≤85 years at time of entry into study evp-6124-024 or evp-6124-025 * informed consent form (icf) for this extension study signed by the subject or legally acceptable representative and an icf signed by the support person/caregiver before initiation of any study-specific procedures * successful completion (day 182) of study evp-6124-024 or evp-6124-025 * no clinically significant change in the judgment of the investigator in the subject's medical status during study evp-6124-024 or evp-6124-025 * in the judgment of the investigator, extension treatment is in the best interest of the subject * fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception \[including at least 1 barrier method\]) * reliable and capable support person/caregiver, who if not living in the same household, interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible exclusion criteria: * significant risk of suicidal or violent behavior in the judgment of the investigator * adverse events from the previous study (evp-6124-024 or evp-6124-025) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation * any condition that would make the subject in the judgment of the investigator unsuitable for the study * female subjects who are pregnant, nursing, or planning to become pregnant during the extension study

Keywords: alzheimer's disease cognition alpha-7 nachr
study comparing synthetic vascular grafts in patients with peripheral artery disease (pad) who require artery bypass.

Conditions: Peripheral Arterial Occlusive Disease

Summary: to demonstrate the patency and safety of vascular grafts: exxcel and fusion bioline.

the study is a prospective, randomized, single-blind, two-arm, parallel group, multi-center study to evaluate the safety and efficacy of fusion™ vascular graft with bioline (heparin) coating, compared with exxcel soft eptfe in a peripheral bypass setting, to support a claim of substantial equivalence.

Eligibility criteria:
inclusion criteria: * patient required either above-knee or below-knee femoral popliteal bypass; * patient had category 1, 2, 3 4 or 5 chronic limb ischemia as defined by the rutherford categories - chronic limb ischemia severity classification scale. * patient was at least 21 years of age; * patient had postoperative life expectancy of \>18 months; * patient was willing and able to have follow-up visits and examinations; * patient would not participate in other clinical trials that would conflict with this protocol * patient was willing and able to provide written, informed consent. exclusion criteria: * patient had a previous history of bypass in the diseased extremity (below the iliacs arteries); * patient had percutaneous transluminal angioplasty or stenting of the target femoral or popliteal artery at the anticipated site of the proximal or distal anastomosis within the previous 30 days; * patient had active infection in the region of graft placement; * patient had an acute arterial occlusion requiring an emergent intervention; * patient needed a cardiac surgical procedure or a different vascular surgical procedure within 30 days of planned lower extremity revascularization. planned endovascular procedures to address proximal stenotic lesions at the time of the index femoropopliteal bypass did not exclude a patient from the study; * patient required sequential extremity revascularizations or other procedures that require use of additional vascular grafts; * patient had known hypersensitivity or contraindication to aspirin; * patient had known coagulation disorders including hypercoagulability; * patient had previous instance of heparin-induced thrombocytopenia type 2 or has known hypersensitivity to heparin; patient was currently treated with coumadin (warfarin) that had not been stopped within 72 hours of the planned procedure * patient had severe chronic renal insufficiency (plasma/serum creatinine \> 2.5 mg/dl), is undergoing hemodialysis. * patient had prior renal transplant; * patient had a stroke or myocardial infarction within 6 weeks of the procedure or had evidence of prior massive stroke (modified rankin scale 3 or above); * patient had a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris; * patient had documented acute or suspected systemic infection; * patient was a woman of reproductive potential.
bioequivalency study of montelukast chewable 5 mg tablets under fed conditions

Conditions: Asthma

Summary: the objective of this study was to prove the bioequivalence of montelukast chewable tablet under fed conditions


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to montelukast or any comparable or similar product.
randomized trial of eus neurolysis in pancreas cancer

Conditions: Pancreatic Neoplasms

Summary: this is a clinical trial to determine more effective methods of controlling the pain in pancreatic cancer. although narcotic pain medication are effective, they have many side effects and are underutilized due to social stigma and fear of addiction. celiac plexus neurolysis is a nerve block procedure that has been shown to be effective in uncontrolled clinical trials. we hypothesized that celiac plexus neurolysis plus pain medication will be more effective and have fewer side effects than pain medication alone. we are evaluating the effectiveness of this standard pain medications with or without celiac plexus neurolysis in a randomized controlled trial. one half of the participants will receive pain medications only and the other half will receive pain medications plus neurolysis, delivered via an endoscopic ultrasound device placed in the stomach.

this is a phase iii randomized blinded sham controlled trial of endoscopic ultrasound guided celiac plexus neurolysis. patients with pancreatic cancer who are unresectable and who have significant pain (\> 3 on 0-10 scale) will be enrolled. at the time of a staging endoscopic ultrasound, patients will be randomized to celiac neurolysis or sham (injection of same medication into lumen of stomach). neurolysis will be performed using standard bupivicaine and ethanol. patients will be followed for at least 3 months for pain, quality of life and narcotic usage.

Eligibility criteria:
inclusion criteria: 3.1 unresectable (t4 or m1 or non-regional lymph nodes) or inoperable (due to medical comorbidity) carcinoma of the pancreas as determined by ct or eus. patients with extensive portal vein or superior mesenteric vein involvement (t3 by 6th ed. ajcc staging manual) will be included only if the consulting surgeon feels the patients is unresectable based on the ct scan information. 3.2 presence of mid-abdominal pain ( 3 on vas scale) at least 2 days per week, lasting at least 1 hour per day. 3.3 no known coagulopathy as measured by prothrombin time (inr) 1.5. pre-eus inr is not required unless clinically indicated due to known warfarin use or suspected coagulopathy. 3.4 patient must not require more than 2 l/min oxygen supplementation to maintain saturation \>90%. 3.5 \> 6 months since previous myocardial infarction or angina. 3.6 ≥ 4 weeks since previous surgery. 3.7 no institution or change in chemotherapy or radiotherapy within 7 days prior (or 14 days post) esu-cpn. see section 7.0 and 7.1 for details of chemotherapy and radiotherapy allowances. 3.8 platelets ≥ 50,000. pre-eus cbc is not required unless clinically indicated due to known or suspected coagulopathy. 3.9 life expectancy \> 3 months 3.10 signed and dated informed consent. exclusion criteria: unable to sign informed consent

Keywords: pancreatic neoplasm
topical tranexamic acid versus topical vitamin c with microneedling in periorbital hyperpigmentation; comparative study

Conditions: Periorbital Hyperpigmentation

Summary: both vitamin c 20% and tranexamic acid 5mg/ml combined with microneedling were used for treatment of periorbital hyperpigmentation in a comparative pattern and both resulted in significant improvement of periorbital hyperpigmentation by dermoscopic and clinical evaluation with no statistically significant difference between them in addition to improvement of patients' visual analogue score (vas) and dermatology life quality index (dlqi).

sixty patients with periorbital hyperpigmentation were enrolled, patients were divided into 2 groups; 30 each. clinical grading according to sheth et al.,2014 , dermoscopic evaluation, visual analogue score (vas) and dlqi were done at week 0. group a one side was treated with vit.c 20% + microneedling, other side saline+ microneedling (placebo). group b one side was treated with tranexamic acid 5mg/ml + microneedling, other side saline+ microneedling (placebo). a total of 4 sessions were done 2 weeks apart and follow up was one month after the last session (week 10) at which patient was evaluated using above mentioned parameters in addition to evaluation by 2 blinded investigators. at week 10 there was significant improvement of clinical grading and as evaluated by blinded investigators, vas, dlqi, significant dermoscopic improvement in both vascular and pigmentary components of dark halos in sides treated with vit c and tranexamic acid compared to placebo but there was no statistically significant difference between both groups. the study concluded that tranexamic acid is a new safe effective modality in treatment of periorbital hyperpigmentation with results comparable to vitamin c.

Eligibility criteria:
inclusion criteria: * both genders. * age ≥ 18 years. * pigmentary, vascular and mixed types of dark halos exclusion criteria: * pregnancy and lactation * patients who received treatment in the past 3 months * patients with active dermatologic diseases or history of atopic dermatitis. * history of allergy to tranexamic acid or vitamin c * history of keloid or hypertrophic scars * pure structural type of dark halos, pigmentary demarcation lines

Keywords: periorbital hyperpigmentation vitamin c tranexamic acid microneedling
embolization procedures in the peripheral vasculature using the magellan™ robotic system

Conditions: Peripheral Vascular Disease

Summary: the purpose of this prospective study is to gather procedural use and safety data on the initial use of the magellan robotic system with the magellan robotic catheter 6 fr, vascular accessories 6 fr and microcatheter driver this study will focus on, but not be limited to, endovascular embolization procedures in the peripheral vascular, for example, embolization of the splenic and hepatic arteries, uterine arterial embolization (uae), prostatic arterial embolization (pae), and trans-arterial chemoembolization (tace). the data will be analyzed for medical education, societal presentation and/or publication by the investigator.

the primary objectives of this study are to evaluate the safety and clinical performance of the magellan robotic system with the 6 fr catheter, vascular accessories 6 fr and microcatheter driver in patients who are indicated for an embolization procedure or other endovascular procedure in the peripheral vasculature.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * able and willing to provide written informed consent * eligible for an embolization procedure or other endovascular procedure in the peripheral vasculature * not participating in an investigational study involving the peripheral vasculature exclusion criteria: * vasculature cannot accommodate the magellan robotic catheter or required accessories * the required delivery of therapeutic device(s) "through" the magellan robotic catheter in which the diameter for the therapeutic device(s) is/are incompatible with the magellan robotic catheter * an endovascular approach to the treatment of peripheral vasculature disease is contraindicated * sepsis * major coagulation abnormalities * presence of significant co-morbid illness that contraindicates surgery or an interventional radiological procedure * unmanageable contrast agent hypersensitivity * patients who are prisoners * patients who are mentally incapacitated, e.g., comatose, unresponsive, cannot provide informed consent, or are deemed unreliable or unstable by the investigator or with a cognitive impairment * pregnant or breastfeeding