Kornimate/medical-research-clean huggingface dataset:
pbmt for the prevention of cipn

Conditions: Breast Cancer

Summary: ne of the most common cancers in women worldwide is breast cancer. a common used therapy in early-stage and metastatic breast cancer involves chemotherapy. taxanes, microtubule-targeting agents (mtas), are one of the most used chemotherapeutic agents in breast cancer patients. unfortunately, this treatment comes with many unfortunate side effects. chemotherapy-induced peripheral neuropathy (cipn) is one of these common side effects. this condition involves paresthesia, numbness and/or burning pain in distal limbs. eventually, loss of temperature sensation, loss of tendon reflexes and pain sensation can occur. yet, no therapies have been developed to treat cipn. at the moment, only symptom management is possible. not only will this condition affect the patients' daily activities, but a chemotherapy dose reduction could also be necessary, influencing the outcome and overall survival rate of the patient. a new and emerging treatment for cipn is photobiomodulation therapy (pbmt) or low-level laser therapy. during pbmt, visible and/or (near)-infrared laser light is used at the affected area to improve tissue repair and thereby promote functional recovery of peripheral nerves. studies have shown positive results for patients with diabetic neuropathy. however, no studies have been undertaken specifically for taxane-induced neuropathy (tin). we hypothesize that pbmt is an effective treatment strategy to prevent sensory symptoms associated with tin. this can lead to an improved quality of life for the patient and no need for a chemotherapy dose reduction.


Eligibility criteria:
inclusion criteria: * diagnosed with non-invasive (stage 0) or invasive (stage 1, 2 and 3a) breast adenocarcinoma * age 18 years or above * are planned to undergo at least 3 cycles of taxane treatment (i.e. paclitaxel or docetaxel) * have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis). * signed informed consent exclusion criteria: * have a history of neuropathy before taxane treatment due to other medical conditions: diabetes, peripheral vascular disease, hiv infection, significant degenerative or familial neurologic disorder, nerve compression injuries (i.e., carpal tunnel syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root compression) * taking stable doses of medication on prescription or dietary supplements for peripheral neuropathy. related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; nsaids; glutamine, glutathione, vitamin e and vitamin b12; patients need to agree not to initiate a new therapy two weeks before and during the study period. * metastatic disease * have a diagnosis of ethanol addiction or dependence within the past 10 years. * concurrent chemotherapy with neurotoxic chemotherapeutic agents (i.e. platinum compounds or vinca alcaloids) * severe or unstable cardio- respiratory or musculoskeletal disease
arthrorisis of the subtalar joint with a polymeric endorthesis for flexible flatfoot treatment during the growth age prospective evaluation

Conditions: Subtalar Arthrorisis; Flat Feet; Growth Age

Summary: arthrorisis of the subastragalus joint represents one of the surgical treatments for addressing flexible flatfoot, a condition caused by joint deformity. the device is designed to restore the correct joint relationships between the astragalus and calcaneus, with the goal of maintaining the new and proper joint alignment over time, typically allowing for bone remodeling along natural growth lines, usually within a few years. several implants and various variations of the procedure have been developed.there are currently no prospective studies that assess radiographic and clinical data over time. therefore, the purpose of this study is to prospectively analyze the outcomes of surgical intervention using subastragalus arthrorisis with a polymeric endorthesis for the treatment of flexible flatfoot during the growth period in a consecutive series of 55 patients.


Eligibility criteria:
inclusion criteria: * idiopathic, flexible, symptomatic flatfoot * patients aged between 8 and 14 years exclusion criteria: * joint laxity * neuromuscular disorders * neurological conditions * traumatic sequelae * iatrogenic flatfoot * congenital flatfoot due to tarsal synostosis
autologous cord blood infusion for the prevention and treatment of prematurity complications in preterm neonates

Conditions: Anemia, Neonatal; Intracranial Hemorrhages; Necrotizing Enterocolitis; Respiratory Distress Syndrome, Newborn; Retinopathy of Prematurity; Bronchopulmonary Dysplasia

Summary: the purpose of this study is to test the safety and effectiveness of a whole own (autologous) umbilical cord blood transfusion in the first 5 days after birth if the baby is born premature \<34 weeks and developed anemia of prematurity.

the purpose of this pilot study is to conduct the investigation of the safety and efficacy of autologous cord blood infusion in premature neonates who demonstrate anemia due to prematurity (most common prematurity complication). however, premature infants reveal a high risk of other acute complications, including brain injury (e.g., intraventricular hemorrhage; ivh), necrotizing enterocolitis (nec), and neonatal respiratory distress syndrome (rds), as well as retinopathy of prematurity (rop) and bronchopulmonary dysplasia (bpd). therefore, prematurity is considered one of the main causes of neonatal deaths. the preterm neonates need transfusion of allogenic whole peripheral blood or any of its components at a time of anemia of prematurity development. in contrast, other prematurity complications do not have effective treatment nor preventive strategies. we will enroll premature neonates born premature (\<34 weeks of gestation) who developed anemia of prematurity and had their own autologous cord blood collected for subsequent transfusion. next, we will test tolerability, safety and efficacy of autogenic whole cord blood infusion and evaluate the frequency of premature complications in neonates after transfusion. besides, this pilot study will test feasibility of technical collection, preparation and infusion of a neonate's own umbilical cord blood within the first 5 days after birth.

Eligibility criteria:
inclusion criteria: * preterm neonates less than 34 weeks of gestation, who developed anemia of prematurity, * available unit of autologous umbilical cord blood exclusion criteria: * major congenital or chromosomal abnormalities, * intrauterine infection, * cyanotic heart defect, * chronic intrauterine hypoxia (defined as growth retardation or pathologies of placental perfusion), * incompatibilities in main blood groups and rh antygen, * lack of parental consent for enrollment to the study, * contraindications for cord blood collection (lack of consent, amniotic fluid leakage for longer than 6 hours or physical complications in the cord blood harvesting).

Keywords: umbilical cord blood autologous umbilical cord blood transfusion prematurity complications infant, premature, diseases infant, newborn, diseases hematologic diseases lung diseases central nervous system diseases gastrointestinal tract diseases vascular diseases retinopathies, neonates prevention,treatment
thymoglobulin in cadaver donor

Conditions: Prevention of Kidney Injury Associated With Brain Death

Summary: to determine the efficacy and security of thymoglobuline in cadaveric donor efficacy: to demonstrate that in cadaveric donor, thymoglobuline diminished graft alloreactivity by decreasing expression of inflammatory markers in graft biopsies security:to demonstrate that the administration of thymoglobulin does not have side effects in renal recipients.

this is randomized controlled multicenter phase ii clinical trial promoted by members from idipaz. at least two hospital (la paz and santa maria from lisbon, will be involved. a per nature pilot study will recruit 10 cadaver donors from each hospital, and randomized half-to-half per center, for study and control groups. the rct initiated in 2009 and finished in 2013. cadaver donor from the study group will receive 3 mg/kg iv. thymoglobulin 3-6 hours prior to organ procurement. the randomization process recruits 1:1 study/control donors. kidney biopsies will be taken from each kidney before transplantation to examine the expression of pro-inflammatory and hla molecules (anti-dr, vcam, icam, e-selectin) at tubular cells by immunohistochemical techniques under blinded conditions. recipients will be managed as usual and expressly followed up for one year, recording the incidence of delayed graft function and rejection and graft survival at the first year. a comparison between the results obtained in kidney biopsies and patients transplanted in each group will permit differentiate whether thymoglobulin administered in cadaver modifies the expression of antigens by kidney tubular cells and the results obtained with transplantation, in terms of graft function, rejection and survival.

Eligibility criteria:
inclusion criteria: * accepted adults cadaveric donors for renal transplant from university hospital la paz( madrid) and from university hospital santa maria (lisbon) * informed consent from relatives for including in the study exclusion criteria: * known allergy to the rabbit proteins * non accepted grafts * family refusal to consent

Keywords: thymoglobulin cadaver donor kidney injury brain death related
the effect of breathing exercise on chemotherapy-induced nausea and vomiting in with autologous hematopoietic stem cell transplantation patients

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: nausea and vomiting are serious problems in patients undergoing autologous stem cell transplantation. it is stated that the incidence of acute and delayed nausea and vomiting is more than 50%, even if the patient has been given antiemetic prophylaxis during the treatment process. breathing is the easiest relaxation exercise applied during the flow in everyday life and also one of the most important and essential parts of other relaxation exercise. the handbooks prepared for the patients undergoing chemotherapy recommend deep breathing exercises in order to prevent their nausea and vomiting. the aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation. research hypotheses ho: respiratory exercise is not effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients. h1: respiratory exercise is effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients. in the literature, no study has been found investigating the effect of breathing exercises on chemotherapy-induced nausea and vomiting for autologous hematopoietic stem cell transplantation patients. the aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation.


Eligibility criteria:
inclusion criteria: * least 18-years-old, * autologous hematopoietic stem cell transplantation and take high-dose chemotherapy, * not have any communicative problems, * not have coronavirus disease (covid-19) disease or respiratory disease, * hb value of 10 and above and * knowing how to read, write, and speak turkish exclusion criteria: * have respiratory disease and coronavirus disease (covid-19), * having any communication and psychiatric problem, * not knowing how to read, write, and speak turkish, * not wanting to participate in the study and have anemia.

Keywords: nausea vomiting breathing exercise autologous hematopoietic stem cell transplantation chemotherapy
linx reflux management system or fundoplication clinical study in patients with hiatal hernia >3 cm

Conditions: Hiatal Hernia Large; Gastro Esophageal Reflux; Hiatal Hernia; Hiatal Hernia, Paraesophageal; Reflux, Gastroesophageal; Reflux Acid

Summary: the cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and magnetic sphincter augmentation or fundoplication construction more than 2 years prior to initial study visit.

the cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and anti-reflux surgery with either magnetic sphincter augmentation (msa) using linx placement or fundoplication construction more than 2 years prior to initial study visit. subjects will be enrolled by invitation only by participating investigators. enrollment will consist of 300 linx msa patients and 150 fundoplication patients with a total of 450 from 4 sites within the united states. data will be collected for up to 6 years.the primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo hiatal hernia repair of a large (\>3 cm) hernia with linx® device placement, and to compare this with hiatal hernia recurrence rates in patients who underwent hiatal hernia repair with fundoplication.

Eligibility criteria:
inclusion criteria: 1. subject must be at least 21 years of age and at least the minimum age of majority according to applicable state law. 2. underwent primary index procedure of laparoscopic repair of a hiatal hernia larger than 3 cm with placement of a linx® device or construction of a fundoplication for reflux control more than 2 years prior to his/her enrollment or has completed 1 or 2 of the barium swallows and gerd-hrqls within study time points with or without hiatal hernia recurrence. 3. subject is willing and able to cooperate with follow-up examinations. 4. subject has been informed of the study procedures and treatment and has signed an informed consent. exclusion criteria: 1. the surgical procedure was completed as an emergency procedure 2. currently being treated with another investigational drug or investigational device 3. suspected or confirmed esophageal or gastric cancer 4. subject has barrett's esophagus \>3cm 5. cannot understand trial requirements or is unable to comply with follow-up schedule 6. pregnant or plans to become pregnant during the course of the study 7. medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years) 8. diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.

Keywords: gerd linx fundoplication msa magnetic sphincter augmentation msad magnetic sphincter augmentation device
neuromuscular electrical stimulation versus intermittent pneumatic compression for blood flow

Conditions: Venous Thrombosis

Summary: deep vein thrombosis (dvt) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. it involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. three mechanisms underlie dvt, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as virchow's triad. intermittent pneumatic compression (ipc) and neuromuscular electrical stimulation (nmes) have been shown to improve lower limb blood flow. however, few studies have directly compared the two methods and those that have, have used outdated nmes devices. the objective of this study is to compare the effectiveness of a modern nmes device to intermittent pneumatic compression in terms of blood flow.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * history of heart/respiratory problems * pregnancy * presence of implants, including cardiac pacemakers and orthopaedic implants * history of neurological disorder * history of severe arterial disease or known dermatological problems * under 18 years of age or over 40 years of age

Keywords: deep vein thrombosis neuromuscular electrical stimulation intermittent pneumatic compression doppler ultrasound
tifacogin for the treatment of patients with severe community-acquired pneumonia

Conditions: Pneumonia

Summary: the purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.


Eligibility criteria:
inclusion criteria: * diagnosis of community-acquired pneumonia supported by additional clinical, radiological, and microbiological evidence * pneumonia of sufficient severity to require icu admission and management exclusion criteria: * pregnancy * weight over 150 kg * patients at increased risk of bleeding * treatment with drotrecogin alfa or anticipated need for drotrecogin alfa * treatment with heparin or anticipated need for heparin
a study of early immunologic response in asian patients with chronic hepatitis b, treated with pegasys (peginterferon alfa-2a (40kd)), nucleoside analogues, or both

Conditions: Hepatitis B, Chronic

Summary: this open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve asian male patients with chronic hepatitis b after initiation of treatment with pegasys or tenofovir or pegasys plus tenofovir. patients will be randomized to one of 4 cohorts to receive either pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally daily) or both or no treatment for 2 weeks. after 2 weeks on study treatment, patients may opt to receive standard of care treatment with pegasys. target sample size is \<50.


Eligibility criteria:
inclusion criteria: * male adults of southeast and/or east asian origin, 18-55 years of age * hbeag-positive chronic hepatitis b * detectable hbv dna exclusion criteria: * prior antiviral therapy for chronic hepatitis b * evidence of bridging fibrosis, cirrhosis or decompensated liver disease * positive test at screening for hav (igm), hcv, hdv or hiv * history or evidence of medical condition associated with chronic liver disease * antineoplastic or immunomodulatory treatment \</=6 months prior to first dose of study drug
s&p of q-fix™ all-suture anchor system

Conditions: Bankart Lesion; Acetabular Labrum Tear; SLAP Lesion; Acromioclavicular Sprain; Capsular Shift/Capsulolabral Reconstruction; Deltoid Repair; Rotator Cuff Repair; Bicep Tendinitis; Extra-capsular Repair; Medial Collateral Ligament; Lateal Collateral Ligament; Posterior Oblique Ligament; IBT; Vastus Medialis; Obliquus Advancement; Joint Capsule Closure

Summary: post-market clinical follow-up needed to address existing clinical data and gaps on the existing q-fix™ device and meet existing mdd/meddev requirements


Eligibility criteria:
inclusion criteria: * subject has undergone arthroscopic or open soft tissue repair with q-fix™ all-suture anchor system * subject was ≥ 13 of age at time of surgery exclusion criteria: * subject is ≤ 6 months post-operative * subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
single versus double row suture anchor repair in medium to large rotator cuff tears

Conditions: Rotator Cuff Tear

Summary: the purpose of this study is to determine whether double row repair is better in healing than traditional single row repair in arthroscopic rotator cuff repair. our null hypothesis is there are no differences in clinical and structural results


Eligibility criteria:
inclusion criteria: * rotator cuff tears * tear size between 2cm\~4cm exclusion criteria: * subscapularis tear requiring repair * open repair * any prior history of surgery on the affected shoulder * any fracture history around shoulder girdle(clavicle, humerus, acromion) * glenohumeral joint arthritis * inflammatory arthropathy

Keywords: rotator cuff tear arthroscopic repair single row repair double row repair retear rate
a pilot study of topical antiflammin-2 for psoriasis

Conditions: Psoriasis

Summary: this study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase a2 (pla2) inhibitor, in the treatment of chronic plaque psoriasis. antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion.

this study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase a2 (pla2) inhibitor, in the treatment of chronic plaque psoriasis. antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion.

Eligibility criteria:
patients must be age 18 or older. patients male or female must use contraception if of childbearing age. no men and women actively attempting to conceive a child during the time of drug testing. no pregnant or nursing women. patients must be otherwise healthy, immunocompetent, ambulatory patients with psoriasis who have more than 5 percent of their body surface area involved with the disease or who have localized disabling psoriasis. have failed one prior topical treatment regimen including topical cortiscosteroids, coat tar preparations, or ultraviolet light. an ambulatory performance status of 0,1,2 (ecog scale). ability to participate in an out -patient study and to provide informed consent. creatinine less than 2.0 mg/100ml. bilirubin less than or equal to 1.5 mg/100ml; prothrombin time less than or equal to 1.3 times control. wbc greater than 3000/mm(3), granulocytes greater than 1500/mm(3), platelets greater than 100,000/mm(3). no clinically significant cardiac disease. no patients with previously documented serious infectious diseases such as pneumocystis pneumonia, mycobacterium avium infection, etc. which would suggest clinically evident immunodeficiency. no systemic treatment for psoriasis (methotrexate, puva, uvb, cyclosporine, etc.) and topical treatments (corticosteroids, tar, anthralin, etc.) during the four weeks prior to study entry, and topical treatment during the two weeks prior to study entry.

Keywords: inflammation lipocortin phospholipase a-2 skin uteroglobin psoriasis