Kornimate/medical-research-clean huggingface dataset:
the effect of hormonal add-back therapy in adolescents treated with a gnrh agonist for endometriosis: a randomized trial

Conditions: Endometriosis

Summary: the purpose of this study is to determine whether a regimen of norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens is superior in maintaining skeletal health and quality of life in adolescents treated with a gnrh agonist for endometriosis.

endometriosis has become increasingly recognized as a chronic illness which begins during adolescence. untreated endometriosis may lead to chronic pain and infertility. as recognition of the need for prompt therapy increases, so does the length of time patients will be exposed to treatments. as a result, there exists a pressing need to evaluate adjunctive measures that may limit the associated negative health consequences of treatment. a gonadotropin-releasing hormone (gnrh) agonist is one medication utilized for patients who have failed other treatments. while gnrh-agonists are effective in relieving symptoms, their long-term use is problematic. gnrh agonists induce a low-estrogen state, causing deleterious effects on bone mineralization. these negative consequences are especially important for our pediatric patients. adolescence is the critical period in a woman's life for bone acquisition and attainment of peak bone mass. anything that interferes with this process puts patients at risk for lifelong low bone density and future fracture. "add-back" therapy appears to be a promising adjunct to treatment for prevention of this bone loss. daily therapy with low-doses of hormones preserves bone density in adult patients, without altering the efficacy of the gnrh-agonist. however, no data exist on the effect of add-back therapy in adolescents. the aim of the current study is to evaluate the safety and efficacy of two add-back regimens, norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens, for the preservation of skeletal health and quality of life in adolescents with endometriosis treated with a gnrh-agonist.

Eligibility criteria:
inclusion criteria: * age 13-22 years, at least two years post-menarche * body mass index (bmi, kg/m2) between 18 -30 kg/m2 * surgical diagnosis of endometriosis * clinical decision to treat with a gnrh agonist, leuprolide depot (lupron depot®; tap pharmaceuticals, inc.) 11.25 mg intra-muscular every 3 months exclusion criteria: * concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, renal disease, or diabetes mellitus * markedly impaired liver function or liver failure * personal history of thromboembolic event (such as deep venous thrombosis) * medication use known to affect bone metabolism: * glucocorticoid therapy (including inhaled steroids) or anticonvulsants used in the last 6 months

Keywords: endometriosis adolescents bone density gnrh agonist add-back therapy
botulinum toxin a for the treatment of keratoconus

Conditions: Keratoconus

Summary: the purpose of this study is to associate the use of botulinum toxin type a for patients with keratoconus to demonstrate that tension eyelid has an important role in disease progression.

subcutaneous injection of botulinum toxin type a will be performed at two points in a nasal and temporal extent of the orbicularis muscle of a group of patients with keratoconus (botulinum toxin a group).the idea is to evaluate the change in palpebral fissure in patients from group botulinum toxin a over a period of 18 months.the measurements of the palpebral fissure will be performed by the image j (version 1.34s) program, developed by the national institutes of health (usa).the unit of measure is the millimetre.the patients of the botulinum toxin a group will be compared with a control group, without any intervention.

Eligibility criteria:
inclusion criteria: * patients with documented keratoconus * best-corrected visual acuity measurable at refraction test * age between 10-40 years * good health * understand the procedure and its limitations exclusion criteria: * only one functional eye * previous ocular surgery * concurrent corneal infection and other ocular diseases that modified the visual acuity * known allergy to botulinum toxin * pregnancy * poor collaboration for performing the examinations and the procedure

Keywords: keratoconus tetanus toxin
efficacy of a nutritive bar, in reduction of weight, body fat and control of appetite

Conditions: Overweight or Obesity

Summary: the main objective of the trial is to measure the efficacy of a nutritive bar, in the reduction of weight, body fat and the control of appetite, in patients with overweight and obesity. it will be a randomized single-blind design conducted in 40 subjects.

primary objective and outcome: difference in body fat percentage and summation of the absolute value of 7 body folds secondary objectives and outcomes: * characterize demographically and clinically the population participating in the research study. * determine the differences in body weight between the study groups. * determine the median of minutes of appetite onset in each of the groups. design: the proposed study is a randomized, single-blind, paralell, single center study. number of subjects: the number of subjects will be 40. at the start of the study, subjects will be randomly assigned to 2 different groups. all participants will have a evaluation with a nutritionist for an anthropometric assessment that includes the measurement of percentage of fat, sum of body folds, weight, height and body mass index. all participants will receive a nutritional intervention providing a caloric deficit of 500 calories, depending on their daily requirements,and they will be prescribed moderate physical activity from 60 to 90 minutes daily. participants will then be randomly assigned to gruop a: the nutritional bar group or group b: control. participants in group a will be instructed to consume the nutritional bar as an integral part of the previously established caloric regimen so as not to increase the number of prescribed calories and will be instructed to consume the product twice a day during the whole study, approximately 2 to 4 hours after breakfast and 2 to 4 hours after lunch, without additions of other foods or beverages, during consumption, may only be accompanied with water. participants in group b will be instructed to consume a nutritious snack corresponding to the amount of calories provided by the bar, 2 to 4 hours after breakfast and 2 to 4 hours after lunch. the nutritional intervention will be carried out for 8 weeks for both groups, during the forth week and during the eight week of the intervention, a new nutritional assessment will be carried out with the same protocol of the first evaluation, by a nutritionist to all participants.

Eligibility criteria:
inclusion criteria: * overweight or obesity (bmi range between 25.0 and 35 kg per m2 and * percentage of fat ≥28 for women and ≥20 for men exclusion criteria: * pregnant * people with gastrointestinal, thyroid, renal, hepatic or cardiovascular diseases. * diabetics or hypertensive. * people with eating disorders. * use of anti-obesity drugs in the last 4 weeks. * use of nutritional or medicinal anti-obesity supplements in the last 4 weeks. * celiac disease. * allergies to peanuts, nines, eggs, milk or products derived from milk. * vegans. * physical or mental disability.

Keywords: protein weight control appetite overweight and obesity
reduction of low-density lipoprotein cholesterol (ldl-c) with pcsk9 inhibition in heterozygous familial hypercholesterolemia disorder study

Conditions: Hypercholesterolemia, Familial

Summary: the primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (amg 145), compared with placebo, on percent change from baseline in ldl-c in adults with heterozygous familial hypercholesterolemia (hefh).


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 to ≤ 75 years of age * diagnosis of heterozygous familial hypercholesterolemia by having met the diagnostic criteria outlined by the simon broome register group (scientific steering committee 1991) * on an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks * fasting low-density lipoprotein cholesterol (ldl-c) ≥ 100 mg/dl * fasting triglycerides ≤ 400 mg/dl exclusion criteria: * homozygous familial hypercholesterolemia * low-density lipoprotein (ldl) or plasma apheresis within 12 months prior to randomization * new york heart association (nyha) iii or iv heart failure, or known left ventricular ejection fraction \< 30% * uncontrolled cardiac arrhythmia * myocardial infarction, unstable angina, percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or stroke within 3 months prior to randomization * type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (hba1c \> 8.5%) * uncontrolled hypertension

Keywords: heterozygous familial hypercholesterolemia proprotein convertase subtilisin/kexin type 9 (pcsk9)
mean systemic filling pressure continuous diuretics critical care patients

Conditions: Sepsis; Heart Failure; Heart Diseases; Septic Shock; Surgery; Critically Ill

Summary: within clinical settings observation of hemodynamic changes (e.g. mean systemic filling pressure, cardiac output) in critically ill patients with a clinical indication for deresuscitation with intravenous diuretic therapy.

rationale: the assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (map) and cardiac output (co) supply insufficient information about the circulating volume and cardiac performance. there is a clinical need for adequate determination of intravascular volume status. however, in determining the intravascular fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. the importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce co many times more than a similar increase in arterial resistance. mean systemic filling pressure (pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. positive fluid balance and /or substantial weight gain in critically ill patients is a common problem in the intensive care unit (icu), potentially associated with a poor outcome. this problem, in association with hemodynamic instability and increase of creatinin, ureum and sodium, may lead to peripheral edema. furosemide, a loop diuretic, is frequently administered to critically ill patients to increase urine output and to relieve edema. objective: observing changes in pms during continuous furosemide administration. study design: prospective, observational study study population: patients with a picco® system with a positive fluid balance and / or substantial weight gain and therefore with a clinical indication for diuretic therapy. intervention: continuous furosemide administration. main study parameters/endpoints: pms measured at baseline, changes in pms during continuous furosemide administration. adverse events: no risks involved.

Eligibility criteria:
inclusion criteria: * patients must be at least 18 years * picco in situ (cardiac output device applied in light of clinical treatment) * cvl in situ * clinical indication for continuous furosemide administration exclusion criteria: * patients younger then 18 years * patients without picco * pregnant women

Keywords: mean systemic filling pressure diuretics pressure for venous return fluid balance de-escalation fluid therapy de-resuscitation guyton guytonian approach furosemide cardiac output cardiac index
pharmacogenetics in non small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: study the effect of genetic polymorphism in the membrane copper transporter 1 protein \[ctr1; encoded by the solute carrier family 31 member 1 gene (slc31a1 gene)\] and its genetic expression levels on the clinical outcome of cisplatin-based regimen used in the treatment of non-small cell lung cancer (nsclc) in terms of : * treatment response : partial response (pr) / complete response (cr) and progression-free survival (pfs) * treatment resistance : stationary disease (sd) or progressed disease * frequency and severity of regimen related toxicity

the cisplatin-based regimen is an effective treatment for advanced nsclc, showing significant beneficial outcomes such as prolong survival, improve clinical symptoms, and improve quality of life (qol) . although platinum-based therapy shows several benefits, but the five-year survival rate still less than 20%. pt resistance is an inevitable occurrence with rare exception. aside from germ cell tumors, metastatic solid tumors are generally thought to be incurable with cytotoxic chemotherapy due to the development of resistance and subsequent disease progression. despite the multifactorial nature of cisplatin resistance, intracellular accumulation of pt appears to be a major source of drug resistance . reduced intracellular drug accumulation is one of the most consistently identified features of cisplatin-resistant cells. many evidences indicated that alteration of copper transporter protein 1 (ctr1) which is the major plasma membrane transporter responsible for platinum uptake, was associated with platinum sensitivity and toxicity. genetic polymorphisms of ctr1 also have effects to platinum treatment response. therefore, ctr1 might be a potential prognostic factor for survival in cancer patients underwent chemotherapy and a treatment target for overcoming platinum resistance.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed with immunohistochemically and pathologically confirmed non- small cell lung cancer (nsclc). 2. ecog ps 0-2. 3. chemotherapy naïve. 4. age \>18 years. 5. adequate bone marrow reserve. exclusion criteria: 1. presence of central nervous system metastases. 2. inadequate liver function (bilirubin \> 1.5 times upper normal limit \[uln\] and alanine transaminase \[alt\] or aspartate transaminase \[ast\] \> 3.0 uln or up to 5.0 unl in the presence of hepatic metastases). 3. inadequate renal function (creatinine \> 1.25 times uln, creatinine clearance \< 50ml/min). 4. serious comorbid systemic disorder incompatible with the study. 5. second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, t1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence). 6. pregnancy

Keywords: pharmacogenetics lung cancer cisplatin
relationship between post-intubation tracheal stenosis and covid-19

Conditions: Tracheal Stenosis; COVID-19; Post-Intubation Subglottic Stenosis; Intensive Care Unit

Summary: tracheal stenosis (ts) is a serious complication that occurs in approximately 6-22% of patients due to prolonged endotracheal intubation. cuff hyperinflation of the endotracheal tube, use of large tubes, advanced age, female gender, smoking, obesity, and diabetes are risk factors for ts. the most common and serious complication in covid-19 patients is acute respiratory distress syndrome (ards), which requires oxygen and ventilation treatments. in the literature, it is reported that 9.8-15.2% of patients need invasive mechanical ventilation (imv). the concern of aerosol formation and prone position applications that emerged with the coronavirus pandemic caused delays in tracheostomy decisions and the use of uncontrolled high cuff pressures, paving the way for ts. the capillary perfusion pressure of the tracheal mucosa ranges from 20 to 30 mmhg. a cuff pressure of the endotracheal tube above 30 mmhg causes mucosal ischemia. cartilage inflammation due to ischemic injury may be partial or full thickness. depending on the degree of inflammation in the affected tracheal segments, stenosis and even perforation may develop. it is aimed to determine the etiological causes, to determine how much of the total ts cases covid-related ts constitutes, to examine the treatments and patient results in covid/non-covid ts. this study will contribute to the measures that can be taken during and after the care process in the intensive care unit.


Eligibility criteria:
inclusion criteria: * patients older than 18 years exclusion criteria: * patients undergoing surgical procedures for malignancy
diode laser pulpotomy of mature permanent molars with irreversible pulpitis

Conditions: Irreversible Pulpitis

Summary: thirty six patients are included in this study. for each patient, a pulpotomy procedure is performed.

for each patient, a pulpotomy procedure is done. group i (n=12) pulpotomy is performed and hemostasis is achieved by applying naocl, then the radicular pulp is covered with platelet rich fibrin (prf) and capped with biodentine, group ii (n=12) pulpotomy is done as in group i and hemostasis is achieved using diode laser and remaining pulp is capped with biodentine, group iii (n=12) pulpotomy is performed and hemostasis is achieved as in group ii then radicular pulp is covered with prf then capped with biodentine, the teeth are then restored with glass ionomer cement followed by composite restoration. pain is recorded every 24 hours for 7 days after intervention. clinical and radiographic follow-up are done at 1,3,6,9 and 12 months. cone beam computed tomography (cbct) is done immediate postoperative and will be used for the assessment of the outcome of the pulpotomy procedure at the end of the study period.

Eligibility criteria:
inclusion criteria: 1. patients between 18 and 40 years of age. 2. deep caries in a permanent lower molar with mature roots. 3. clinical diagnosis of symptomatic irreversible pulpitis 4. no signs of pulpal necrosis including sinus tract or swelling. 5. vital bleeding pulp tissue should be present in all canals after complete pulpotomy. 6. the tooth is restorable. exclusion criteria: 1. patients with systemic disease. 2. negative response to cold testing. 3. presence of sinus tract or swelling. 4. no pulp exposure after caries excavation. 5. bleeding could not be controlled 6. absence of bleeding from any of the canals. 7. teeth with radiographic signs of internal resorption. 8. pulpal calcifications. 9. non-restorable teeth
efficacy and safety of alphanine versus benefix in patients with severe hereditary haemophilia b

Conditions: Hemophilia B

Summary: the goal of this non-randomized, multi-center study in subjects with severe hereditary haemophilia b was to determine and compare the pharmacokinetic and safety profiles of benefix in subjects having had 2 prior pharmacokinetic assessments with alphanine.

two pharmacokinetic assessments (studies) were carried out in the same subjects during a previous clinical trial. the first pharmacokinetic study (pk1) was performed after a single dose of alphanine. the second pharmacokinetic study (pk2) was performed following 26 weeks of alphanine treatment after pk1. to compare alphanine with benefix, a third pharmacokinetic study (pk3) (current study) was performed after a single dose of benefix administered following a 7- to 15-day wash-out period. the main objective of the pk3 study was to assess the pharmacokinetic profile of benefix and compare to the pharmacokinetic profile of alphanine from the pk2 study.

Eligibility criteria:
key inclusion criteria: * participated in the previous study "efficacy and safety of factor ix (fix) contained in alphananine in patients with severe hereditary haemophilia b": * congenital deficiency in factor ix (fix) * fix residual activity of ≤2% of normal * had required fix-containing products in the past and in clinical records that were collected data to assess a reliable estimation of at least 150 treatment exposure days to previous products * was able to receive treatment for more than 10 days for a 6-month period key exclusion criteria: * received a dose of fix in the 7 days prior to the infusion * fix inhibitor level of \>0.5 bethesda units (bu) or clinically relevant presence in the past (≥5 bu) * active bleeding at the moment of infusion * had a known allergic reaction to any benefix component * exhibited symptoms of any intercurrent infection (ie, fever, chills, nausea) at the time of the first infusion * had any disease that might affect the distribution or metabolism of fix and which could affect interpretation of the study (such as non-controlled diabetes mellitus) * had non-controlled arterial hypertension * had abnormal renal function (creatinine \>1.5 mg/dl) * had documented liver cirrhosis or any hepatic disorder with alanine aminotransferase (alt) levels 2.5x upper limit of normal (uln ) * prevision to be concomitantly treated with other fix-containing products * had conditions that might affect subject compliance (survival-limiting \[in 2 year time\] diseases, alcohol or other drug abuse, etc.) * unable to provide a storage plasma sample before the first dose of benefix

Keywords: factor ix (fix)
randomized global phase 3 study to evaluate the impact on nash with fibrosis of obeticholic acid treatment

Conditions: Non Alcoholic Steatohepatitis (NASH)

Summary: the primary objectives of this study are to evaluate the effect of obeticholic acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (nash) with liver fibrosis.


Eligibility criteria:
inclusion criteria: 1. histologic evidence of nash upon central read of a liver biopsy obtained no more than 6 months before day 1 defined by presence of all 3 key histological features of nash according to nash crn criteria. 2. histologic evidence of fibrosis stage 2 or stage 3 as defined by the nash crn scoring of fibrosis, or histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the following risk factors: * obesity (bmi ≥30 kg/m2) * type 2 diabetes diagnosed per 2013 american diabetes association criteria * alt \>1.5× upper limit of normal (uln). 3. for subjects with a historical biopsy, is either not taking or is on stable doses of tzds/glitazones or vitamin e for 6 months before day 1. 4. stable body weight. exclusion criteria: 1. model for end-stage liver disease (meld) score \>12 2. alt ≥10× uln 3. hba1c \>9.5% 4. total bilirubin \>1.5 mg/dl 5. evidence of other known forms of known chronic liver disease such as alcoholic liver disease, hepatitis b, hepatitis c, pbc, psc, autoimmune hepatitis, wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (hcc) 6. history of liver transplant, or current placement on a liver transplant list 7. current or history of significant alcohol consumption 8. prior or planned ileal resection, or prior or planned bariatric surgery 9. histological presence of cirrhosis 10. history of biliary diversion 11. known positivity for human immunodeficiency virus infection. 12. acute cholecystitis or acute biliary obstruction. 13. bmi \>45 kg/m2

Keywords: non alcoholic steatohepatitis, fatty liver disease, nash