Kornimate/medical-research-clean huggingface dataset:
effect of vitamin d supplementation on the efficacy and adverse effects of neoadjuvant therapy in patients with breast cancer

Conditions: Vitamin D; Neoadjuvant Therapy; Breast Cancer; Adverse Reaction; Efficacy; Chemotherapy

Summary: this randomized controlled phase iii trial was designed to evaluate the impact of supplemental vitamin d (vd) on the efficacy and side effects of neoadjuvant therapy in patients with breast cancer.

this is a parallel-group, open-label randomized controlled trial designed to investigate the effects of supplemental vitamin d (vd) on the outcomes and side effects of neoadjuvant therapy in patients with breast cancer. both groups will receive standard neoadjuvant therapy on day 1 and for each subsequent cycle. additionally, vitamin d2 will be randomly administered to both groups.blood samples and imaging results will be collected and analyzed prior to the initiation of neoadjuvant therapy and after every two cycles. key outcomes to be recorded include the pathological complete response rate (pcr), objective response rate (orr), disease control rate (dcr), and grade iii or higher adverse effects related to neoadjuvant therapy. the primary and secondary study findings, along with adverse events, will be thoroughly evaluated.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years, with an eastern cooperative oncology group (ecog) performance status of 0-2. 2. primary diagnosis of breast cancer confirmed by preoperative pathological examination. 3. serum 25(oh)d levels less than 20 ng/ml (50 nmol/l). 4. patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of 5.neoadjuvant chemotherapy or combined targeted therapy. 6.life expectancy of at least 6 months. 7.no other uncontrolled benign diseases at the time of recruitment. 8.all patients must have complete clinical medical records. 9.willingness to voluntarily sign an informed consent form. exclusion criteria: 1. history of invasive breast cancer. 2. prior systemic treatment for the treatment or prevention of breast cancer. 3. known allergic reactions to vitamin d or calcium compounds. 4. comorbidities that may affect vitamin d or calcium balance or bone health. 5. vitamin d or calcium supplementation in the past 3 months. 6. presence of other tumors. 7. pregnant or lactating women. 8. individuals who do not wish to participate in the study.

Keywords: vitamin d breast cancer adverse reaction efficacy
effect of transparent, self-drying silicone gel on the treatment of hypertrophic abdominal scars

Conditions: Keloids; Hypertrophic Scars

Summary: keloids and hypertrophic scars are a common subject of dermatologic consultations. therapeutic management of such conditions remains challenging because of their high rate of recurrence and lack of curative treatment.

silicone gel sheeting (sgs) is one treatment modality that has proven effective for treatment of hypertrophic scar. one disadvantage of sgs is its application technique. to be effective, sgs must be applied on the scar for at least 12 hours daily. topical silicone gel is a novel therapy that has shown promising result on scar prevention. however, the efficacy and safety of topical silicone gel for treatment of hypertrophic scar has not been confirmed.

Eligibility criteria:
inclusion criteria: * subjects at least 18 years old * subjects with hypertrophic abdominal scar * have not received treatment on the scar at least 1 month prior to the enrollment. exclusion criteria: * subject who has previous history of silicone allergy * subject who smoke cigarette * subject who was treated with x-rays irradiation in the past

Keywords: hypertrophic scars topical silicone gel scar thickness scar color scar pliability scar appearance
evaluation of faisability, safety and effectiveness and of discogel in patients with aneurysmal and simple bone cysts

Conditions: Bone Cysts

Summary: there is no consensus in the scientific literature for the treatment of aneurysmal and simple bone cysts. some scientific articles with utilisation of sclerosis agents for the treatment of aneurysmal bone cysts: ethibloc no longer marketed, pure ethanol, aetoxisclerol.

the aim of this work is therefore the evaluation of discogel® in the treatment of discogel®, which appears to be a safe and efficacity of method.

Eligibility criteria:
inclusion criteria: * patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by discogel exclusion criteria: * refusal

Keywords: bone cysts aneurysmal bone cysts simple bone cysts discogel effectiveness safety
open-label posterior juxtascleral injections of anecortave acetate 15mg dose for long term use in patients with amd

Conditions: Macular Degeneration

Summary: the purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label anecortave acetate 15mg administered every 6 months.


Eligibility criteria:
inclusion criteria: * patients with subfoveal exudative age-related macular degeneration (amd) who were previously enrolled in long-term studies with anecortave acetate. * other protocol-defined inclusion criteria may apply. exclusion criteria: * other protocol-defined exclusion criteria may apply.

Keywords: amd age-related macular degeneration anecortave acetate wet form of age-related macular degeneration cnv anecortave acetate
the efficacy and safety of using tranexamic acid by different means to reduce blood loss during total knee replacement

Conditions: Blood Loss

Summary: we will investigate the efficacy and safety of using tranexamic acid by intravenous, intra-articular and combinational administration to reduce blood loss during total knee replacement. we hypothesize a combined intra-articular and single intravenous dose protocol of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and extra-articular bleeding site with little or no systemic absorption and subsequent systemic side effects.

a randomized, double-blind, single-center, controlled and parallel-assigned study comparing the efficacy and safety of intravenous, intra-articular and combinational administration of tranexamic acid to reduce blood loss during total knee replacement. subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 3 months postoperatively.

Eligibility criteria:
inclusion criteria: * adult patients who plan to undergo primary total knee arthroplasty on unilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis; * all patients who have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio; * the use of only balanced electrolyte solutions and/or albumin for plasma volume restitution exclusion criteria: * allergy to tranexamic acid; * receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant; * patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina); * patients with thromboembolic disorders, or those exhibiting a deteriorating general condition; * preoperative anemia (a hemoglobin value of \<11 g/dl in females and \<12 g/dl in males), refusal of blood products; * preoperative use of anticoagulant therapy within five days before surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy (as identified by a preoperative platelet count of \ 1.4, or a prolonged partial thromboplastin time \[\>1.4 times normal\]).

Keywords: tranexamic acid antifibrinolytic blood transfusion total knee arthroplasty
effect of exendin (9-39) on glucose requirements to maintain euglycemia

Conditions: Congenital Hyperinsulinism

Summary: the primary aim of this study is to evaluate the effect of exendin (9-39) on glucose requirements to maintain euglycemia in pediatric patients with congenital hyperinsulinism (chi) who have failed medical therapy. the secondary aims are to determine the therapeutic plasma levels, plasma half-life and pharmacokinetics of exendin (9-39) during a 9-hour intravenous infusion.

this study will enroll infants with congenital hyperinsulinism owing to katp channel mutations who are unresponsive to medical therapy and will require a pancreatectomy to control hypoglycemia from a single academic medical center in the united states. an open-label, two-period, two-treatment crossover study design with a dose-escalation component will be implemented. successive cohorts of patients (up to 5 participants/cohort) will each receive a fixed dose of exendin (9-39) infusion and normal saline vehicle on two separate days in random order. the protocol specifies 0.02 mg/kg/hr, via continuous intravenous infusion, administered over 9-hours for the first cohort. the volume of saline to be infused will be calculated to match the volume of exendin (9-39). successive cohorts will be given doses that are increased in up to 1/2 log increments. overall, the investigators hypothesize that antagonism of the glp-1 receptor by exendin (9-39) will increase fasting blood glucose levels, prevent protein-induced hypoglycemia and decrease glucose requirement to maintain euglycemia in infants with chi. aim 1. to examine the effect of exendin (9-39) on glucose requirements to maintain euglycemia in infants with congenital hyperinsulinism unresponsive to medical therapy. aim 2. to determine therapeutic plasma levels, plasma half-life and pharmacokinetics of exendin-(9-39) during an intravenous infusion.

Eligibility criteria:
inclusion criteria: 1. confirmed clinical diagnosis of congenital hyperinsulinism 2. infants less than 12 months of age at study enrollment 3. failure to respond to treatment with diazoxide exclusion criteria: 1. evidence of a medical condition that might alter results, including kidney failure, severe liver dysfunction, severe respiratory or cardiac failure 2. treatment with medications that may affect glucose metabolism at the time of initiation of study procedures, including: 1. treatment with glucagon 4 hours prior to infusion (t=0) 2. treatment with octreotide 24 hours prior to infusion (t=0) 3. treatment with diazoxide 72 hours prior to infusion (t=0) 3. suspected beckwith-wiedemann syndrome or other syndromic forms of congenital hyperinsulinism.

Keywords: congenital hyperinsulinism hyperinsulinism hypoglycemia katp channel metabolic diseases pancreatic disease glucose metabolism disorders infant, newborn, diseases
comparison of epidural analgesia with intra-articular infiltration analgesia

Conditions: Epidural; Analgesia; Local Infiltration

Summary: the results of combining infiltrative analgesia applied by orthopedists with epidural analgesia applied by anesthesiologists after knee replacement surgery will be compared. it aims to compare epidural analgesia with the maximum reduction of postoperative pain in patients, as well as in terms of both analgesic and complications. the study will include patients who have undergone knee replacement surgery for six months. in the study, we will compare the results of painkillers applied to the patient from the waist or knee after the waist numbing anesthesia, which includes some of the routinely applied protocols of your knee replacement surgery. it is a condition that will be monitored after surgery. the study aims to reduce maximum pain with two painkiller methods applied in small amounts or together. no interventional application will be made to the patient who will undergo surgery other than routine application. after the surgery, you will be asked verbally about your pain level and side effects at certain hours after the surgery and the amount of painkillers used and the amount of painkillers will be determined according to the follow-up hours (1st, 2nd, 6th, 12th, 24th and 48th hours after the surgery). in addition to these, complications will also be monitored. the results of patients who can be fully followed up at the end of 6 months will be presented as a scientific study.


Eligibility criteria:
inclusion criteria: 1. age range 18-75 2. those who underwent surgery with combined spinal anesthesia 3. drugs administered with combined spinal anesthesia and intra-articular infiltration analgesia exclusion criteria: 1. those who do not want to participate in the study 2. those who underwent surgery under general anesthesia 3. patients outside the specified age range 4. patients with inadequate follow-up results (patient, drug and device related)

Keywords: ranawat epidural analgesia knee replacement surgery
esophagus imaging for radiofrequency ablation of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: as the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left atrium may damage the esophagus and create esophageal perforations and esophageal left atrial fistula. the aim of the present study is to compare different methods for visualization of the esophagus to prevent this complication.

percutaneous catheter ablation with circumferential pulmonary vein isolation using radiofrequency energy has become an important therapeutic option to treat atrial fibrillation over the last years. importing images from pre-acquired 3-d ct or mri scans into the 3-d mapping system with superimposition of the electro-anatomical map is increasingly used. despite these advances, the interventional electrophysiologist must be aware of potential complications that are associated with this procedure. as the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left atrium may damage the esophagus and create esophageal perforations and esophageal left atrial fistula. to prevent this lethal complication integration of an esophagus tag into the electroanatomic left atrium map visualizing the anatomic relationship has been studied und reported. another possibility of visualization of the esophagus is to perform the ct after placing a conventional radio-opaque gastric tube, which provides information about the course of the esophagus in relation to the la and may be scanned by ct . it has been shown that under normal conditions, if no barium is administered, there is little change in the anatomical relationship between the posterior left atrium and the esophagus during the entire cardiac cycle. however it is not clear whether the position of the esophagus in relation to the left atrium is changing over days. the aim of the present study is to evaluate whether visualization of the esophagus by placing a conventional gastric tube before performing the ct scan and visualization and integration of the esophagus into the 3-d electro-anatomical map the day before ablation is accurate compared with integration of an esophagus tag into the electroanatomic left atrium map visualizing the anatomic relationship during the radiofrequency ablation.

Eligibility criteria:
inclusion criteria: * patients with atrial fibrillation undergoing radiofrequency ablation

Keywords: radiofrequency ablation
resolute international registry: evaluation of the resolute zotarolimus-eluting stent system in a 'real-world' patient population

Conditions: Coronary Artery Disease; Cardiovascular Diseases

Summary: the primary objective of the resolute international registry is to document the safety and overall clinical performance of the resolute zotarolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.

as part of the broader clinical program of the resolute stent, the resolute international registry will expand the experience and understanding of the device performance in a 'real-world' setting. the registry intends to enroll patients from a large number of centers under commercial usage conditions, with the aim to reflect 'real-world' usage as much as possible.

Eligibility criteria:
inclusion criteria: * minimum legal age (18) * acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines * patient has consented to participate and authorized in writing the collection and release of medical information * elective use of the endeavor resolute stent exclusion criteria: * pregnancy * high probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * currently participating in another trial preventing routine hospital treatment * previous enrollment in the resolute international registry

Keywords: drug eluting stent interventional cardiology percutaneous coronary intervention
a measurement study of tis-modnv and accugait force platform in people with ms

Conditions: Multiple Sclerosis

Summary: the current project will fill a knowledge gap in the follow-up of people with multiple sclerosis (ms) with mild and moderate disability levels, with the purpose to assess the adequacy of measurement tools for trunk control and balance, functions that are pre-requisites for optimal performance in everyday physical activities.

trunk control and balance, necessary for daily activities, are frequently impaired in people with ms. adequate measurement tools for clinical- and research purposes are thus warranted. in this study two measurement tools will be explored: 1. the trunk impairment scale - modified norwegian version (tis-modnv), which has demonstrated high validity and reliability in individuals with stoke (gjelsvik et al., 2012), however its properties has not yet been assessed in people with ms. concurrent validity with a balance scale, the mini-balance evaluation systems test (mini-bestest), will be assessed as well as its inter- and intra-rater reliability. 2. the amti accugait optimized™ multi-axis force platform (amti, inc., newton, ma) will be examined as there is a lack of studies measuring its properties within the ms population. a validity assessment of this tool will be included in this measurement study. this study is two-parted, each with a separate aim: aim part 1: to determine the validity and reliability of the tis-modnv across mild and moderate disability levels in the ms population. aim part 2: to determine the concurrent validity of the amti accugait optimizedtm force plate system compared to the mini-bestest across mild and moderate disability levels in the ms population.

Eligibility criteria:
inclusion criteria: * ms diagnosis (mcdonalds criteria) * edss= 0-6.5 * ability to walk minimum 6 meters exclusion criteria: * people will be excluded if not being able to follow test instructions

Keywords: multiple sclerosis trunk control balance outcome measure
subserosal laparoscopic cholecystectomy

Conditions: Cholecystitis

Summary: the aim is to study the safety and efficacy of subserosal laparoscopic cholecystectomy .


Eligibility criteria:
inclusion criteria: * adult with age of or above 18 years. * diagnosis of chronic cholecystitis , symptomatic cholelithiasis exclusion criteria: * previous operation or adhesion * severe acute calculus pancreatitis * gall bladder cancer * severe co-morbid conditions (uncontrolled diabetes, hypertension, severe direct hyper bilirubinemia) * recurrent cases
bioequivalence study of isotretinoin capsules 40 mg under fed condition

Conditions: Healthy

Summary: the purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fed conditions

an open label, randomized, two-treatment, single dose, oral bioequivalence study of isotretinoin capsules 40 mg of dr. reddy's laboratories limited,under fed conditions

Eligibility criteria:
inclusion criteria: 1. healthy males between 18 and 45 years of age inclusive. 2. informed of the nature of the study and given written informed consent. 3. have a body weight within 15% of the appropriate range as defined in the 1983 metropolitan life company tables and weighing at least 125 lbs. (appendix i). exclusion criteria 1. hypersensitivity to isotretinoin or related compounds. 2. any history of a clinical condition which might affect drug absorption, metabolism or excretion. 3. recent history of mental illness, drug addiction, drug abuse or alcoholism. 4. donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood. 5. received an investigational drug within the 4 weeks prior to study dosing. 6. currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. this prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician. 7. regular tobacco use in the 3 months prior to study dosing.
decitabine plus r-chop in diffuse large b-cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: this is a phase i/ii trial of decitabine + r-chop in diffuse large b-cell lymphoma


Eligibility criteria:
inclusion criteria: * histologically confirmed dlbcl, cd20 positive. * must have at least one site of measurable disease, 1.5 cm in diameter or greater. * has not had any previous treatment. * international prognostic index \>1. * able to adhere to the study visit schedule and other protocol requirements. * must have laboratory test results within these ranges: absolute neutrophil count ≥1500/mm3 platelet count≥75,000/mm3 serum creatinine≤1.5×upper limit of normal (uln) total bilirubin≤1.5×uln. higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis. ast (sgot) and alt (sgpt) ≤2×uln * disease free of prior malignancies with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. * women of childbearing potential must have a negative serum pregnancy test prior to decitabine treatment. * women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with decitabine. the effects of decitabine on the developing human fetus at the recommended therapeutic dose are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * age 15 to 75 years. * ability to understand and the willingness to sign a written informed consent document. * ecog performance status of 0-2 exclusion criteria: * patients must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * use of any other experimental drug or therapy within 28 days of baseline. * concurrent use of other anti-cancer agents or treatments. * known positive for hiv. if hbsag positive, should check hbv dna, dna positive patients cannot be enrolled. if hbsag negative but hbcab positive (whatever hbsab status), should check hbv dna, dna positive patients cannot be enrolled. * known central nervous system involvement by lymphoma. * known or suspected hypersensitivity to decitabine or mannitol. * pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.