Kornimate/medical-research-clean huggingface dataset:
zoledronic acid for the prevention of bone loss post-bone marrow transplantation for thalassemia major patients

Conditions: Beta-Thalassemia; Bone Marrow Transplantation

Summary: this is prospective randomized, double blind study designed to evaluate the use of zoledronic acid in the prevention prevention of bone loss post allogenic bmt done for beta-thalassemia major patients.


Eligibility criteria:
inclusion criteria: * signed written informed consent. * patients must be 18 years old and over. * diagnosed with beta-thalassemia major * scheduled for allogenic bone marrow transplantation * the date of randomization must be no more than 1 week after bmt. * patients must be accessible for follow-up. * life expectancy of at least 12 months from randomization. exclusion criteria: * patients with any clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip. * patients with a history of fracture with low-density or no associated trauma. * osteoporotic patients with t-score \<= -2.5 * previous treatment with a bisphosphonate. * patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 30 ml/minute or less. * pregnancy and lactation. * women of childbearing potential not on a medically recognized form of contraception. * subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study. * subjects participating simultaneously in studies with unapproved drugs, indications or treatment regimens. * known hypersensitivity to zoledronic acid or bisphosphonates. * patients with prior exposure to anabolic steroids, growth hormone, parathyroid hormone (pth) or other drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate). * serious intercurrent illness * history of metabolic bone diseases * history of corticosteroid treatment for other causes * history of antiepileptic drug treatment * history or surgery at the lumbosacral spine, with or without implantable devices. * any disease of the spine that would preclude the proper acquisition of a lumbar spine dxa. * mental illness that precludes the patient from giving informed consent. * current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures. * recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)

Keywords: thalassemia bmt hsct
3d visualization system for vitreoretinal diseases in highly myopic eyes

Conditions: Patients With Highly Myopic Eyes

Summary: to investigate the surgical outcomes and intraoperative parameters evaluation of 3d visualization system for vitreoretinal diseases in highly myopic eyes

the investigators aimed to compare the safety and efficacy of ngenuity® 3d visualization system (alcon, tx, usa) in vitreoretinal surgery of highly myopic patients with standard binocular microscope pars plana vitrectomy of highly myopic patients. this is a randomized controlled study and will enroll highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery. the enrolled patients will be randomized into "ngenuity® 3d visualization system (alcon, tx, usa) group"(trial group) and "standard binocular microscope pars plana vitrectomy group"(controlled group). the investigators will compare the number of injections of dye (indocyanine green (icg) or brilliant blue g (bbg)), total surgical time, total peeling time, exposure time of dye, power of endoilluminator, the rate of probe bending, surgical time, postoperative intraocular pressure (iop), the rate of wound leakage, hypotony, subconjunctival hemorrhage, vitreous hemorrhage, retinal hemorrhage, and endophthalmitis, best-corrected visual acuity (bcva), structural changes shown on oct and so on between the two groups.

Eligibility criteria:
inclusion criteria: 1. highly myopic patients (axial length ≥ 26mm, no upper limit) 2. patient with vitreoretinal pathology that require vitrectomy who had not received previous icg or bbg-assisted membrane peeling 3. patient aged ≥ 20 years exclusion criteria: 1. patient who had previous icg or bbg-assisted membrane peeling 2. patient who received combined vitrectomy and trabeculectomy 3. patient with endophthalmitis or intraocular foreign body

Keywords: vitreoretinal surgery high myopia pars plana vitrectomy 3d visualization system
a study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of gammanorm® 165 mg/ml administered with two different delivery devices: injections using pump or rapid push

Conditions: Primary Immunodeficiency

Summary: a randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of gammanorm® 165 mg/ml administered with two different delivery devices: injections using pump or rapid push.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years). * presenting with primary immunodeficiency. * having received subcutaneous injections of immunoglobulin at home using an automatic pump or syringe for at least 1 month at the time of inclusion. * for whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of gammanorm® 165 mg/ml at home. * freely given written informed consent from patient. * women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine \[hcg\]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study. exclusion criteria: • participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.
study of imaging characteristics oct of skin lesions requiring biopsy / resection

Conditions: Mixed Tumor, Malignant; Biopsy; Resection; Carcinoma; Keratosis

Summary: the diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures such as biopsy or excision in order to analyze the structure and appearance of the fabric pathologists. with recent advances in optical and electronic fields, considerable efforts were produced to build high-performance optical instruments, able to transcribe the internal structure of the skin with varying degrees of depth and variable resolution. the imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and in real time. this area is booming and new optical instruments are created to eventually be able to offer a reliable alternative to invasive techniques. the optical properties of different tissues have been studied for several years by different research groups: the coefficient of light absorption by the tissue both in vivo and in vitro, the coefficient of light scattering or the index refractive were characterized in various tissues that make up the skin. other studies have focused on melanoma detection by multispectral optical techniques, or via the technique of optical coherence tomography (oct) performed on lesions suspicious for cancer, but without linking criteria between these two techniques. however, no study to date and to our knowledge has been able to demonstrate the different optical parameters obtained with oct and can be directly connected to known and histopathological parameters commonly used in the diagnosis of lesions skin. this study aims to verify if it is possible to determine the parameters measured in oct that would discriminate between benign and malignant lesions.


Eligibility criteria:
inclusion criteria: * patients with suspicious skin lesions of malignant tumor (mostly non-melanoma: basal cell carcinoma, epidermoid carcinoma and actinic keratoses, or melanoma: melanoma, nevi) requiring biopsy / surgical excision; * consent signed exclusion criteria: * any dermatosis, hyperalgesic lesion, and / or infected and / or topography making it impossible measurements; * pregnant and nursing women * patients under tutorship or curatorship
meloxicam solumatrix® capsules vs meloxicam tablets to treat osteoarthritis pain

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the safety and efficacy of a low dose and a high dose of meloxicam solumatrix® capsules versus meloxicam tablets for the treatment of pain due to osteoarthritis of the knee or hip.


Eligibility criteria:
inclusion criteria: * primary diagnosis of functional class i-iii osteoarthritis (oa) of the hip or knee * chronic user of nonsteroidal anti-inflammatory drugs (nsaids) and/or acetaminophen for oa pain * discontinued all analgesic therapy at screening * for women of childbearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control * ability to ambulate exclusion criteria: * history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nsaids, including meloxicam * requires regular (more than 2 doses per week) use of opioid or opioid combination products to control oa pain of the knee or hip * clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease * significant difficulties swallowing capsules/tablets or unable to tolerate oral medication * previous participation in another clinical study of meloxicam capsules or received any investigational drug or device or investigational therapy within 30 days before screening
acceptability and feasibility of an act-based group to improve diabetes self-management

Conditions: Type 1 Diabetes Mellitus

Summary: individuals with diabetes often report that difficult thoughts and feelings about diabetes interfere with making healthy choices with regards to diabetes management. the purpose of this study is to evaluate a diabetes self-management group based on acceptance and commitment therapy (act). act is a new behavior therapy that has been found to be useful in treating psychological and behavioral difficulties. we are interested in whether individuals with diabetes will like an act-based diabetes management group and whether they find the group helpful.

the goal of the current study is to assess the acceptability and feasibility of an acceptance-based group to improve diabetes self-management among individuals with type 1 diabetes. interested individuals will participate in a weekly acceptance-based therapy group focusing on improving diabetes management (e.g., adherence to dietary recommendations, appropriate insulin dosing) for a total of 8 weeks. participants will also be asked to complete questionnaires both pre and post treatment. questionnaires will assess diabetes management and acceptability of the group (post treatment only). regular medical monitoring is required for participation in the current study. participants will be asked to provide consent to contact their current medical provider in order to confirm that the participant's is receiving regular medical monitoring for diabetes care and that providers are aware of their patient's participation in group.

Eligibility criteria:
inclusion criteria: * age 18-65 * diagnosed with type 1 diabetes * currently monitored by a physician for their diabetes exclusion criteria: * current or history of psychosis or mania * current substance abuse * non-english speaking * deficits in intellectual functioning that preclude informed consent

Keywords: type 1 diabetes
acceptability of human papillomavirus (hpv) self-sampling tools for cervical cancer prevention

Conditions: Cervical Cancer

Summary: the proposed study aims to increase hpv screening behaviors in jamaican women by examining the acceptability of hpv deoxyribonucleic acid (dna) self-sampling tools, and to determine the most culturally appropriate and effective message design for promoting such a tool in this context.


Eligibility criteria:
inclusion criteria: * jamaican women, aged 30 to 65. exclusion criteria: * women who report having had a hysterectomy, * have had a history of cervical cancer, * women who are currently up-to-date on cervical cancer screening (have had a pap in the last 3 years or have had a pap smear/hpv co-test within the past 5 years), * adults unable to consent, children, pregnant women and prisoners.

Keywords: hpv self-sampling culture message design health communication jamaica
observational study of rituxan in rheumatoid arthritis patients in routine clinical practice

Conditions: Rheumatoid Arthritis

Summary: this study was designed to gather data regarding the efficacy and safety of rituxan in clinical practice whereby patients may present with concomitant medical conditions, medications as well as varying presentations of rheumatoid arthritis not always captured within the "purer" population seen in an industry sponsored clinical trial.


Eligibility criteria:
inclusion criteria: * subjects with active rheumatoid arthritis as defined by acr criteria * \> 18 years of age at time of consent * able to start rituxan therapy per the approved product monograph within approximately 30 days of confirmed enrollment exclusion criteria: * known type 1 hypersensitivity or anaphylactic reactions to murine proteins, chinese hamster ovary cell proteins or to any component of ritxan as per approved product monograph * presence of any significant and or uncontrolled medical condition, which in the investigator's opinion, precludes the use of rituxan as outlined in the product monograph
hyperbaric oxygen in lower leg trauma

Conditions: Tibial Fracture; Soft Tissue Injury

Summary: study hypothesis :hyperbaric oxygen may prevent complications and improve outcomes in severe lower limb trauma. we propose to investigate this hypothesis by conducting an international multi centre randomised control trial of standard trauma/orthopaedic care with or without a concurrent course of hyperbaric oxygen treatments.

a randomised controlled trial was undertaken on using hyperbaric oxygen in addition to standard orthopaedic trauma care in severe lower leg injury, defined as an open tibial fracture with severe soft tissue injury. the control arm subjects received standard hospital trauma care whilst the intervention group received standard trauma care with the addition of hyperbaric oxygen therapy with the aim of providing 12 hbot sessions over the first 9 days of hospital care. the primary outcome measure was the incidence of wound necrosis and/or wound infection as assessed at day 14, with secondary outcomes of wound closure, wound complications, infections and delayed bone union at 12 months plus quality of life and functional questionnaire outcomes at 12 months and 2 years. the detailed study protocol was published in in june 2015 and the results were published in september 2022. both publications are open access (see references section for publication details)

Eligibility criteria:
inclusion criteria: * acute fracture of the tibia with significant soft tissue injury of gustilo grade 3 * enrolment within 48 hours of injury with expectation of commencement of hbo therapy within 48 hours of injury * valid consent exclusion criteria: * significant head injury * injuries incompatible with hbo * resuscitation requirements incompatible with hbo * follow up not possible * hyperbaric contra indications

Keywords: hyperbaric oxygen crush injury tibial fracture gustillo 3 soft tissue injury complications outcomes randomised controlled trial
randomized, double-blind, dose-range-finding, phase 2 study of linaclotide administered to patients with irritable bowel syndrome with constipation (ibs-c)

Conditions: Irritable Bowel Syndrome With Constipation

Summary: the purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for ibs-c.


Eligibility criteria:
inclusion criteria: * must not be pregnant or breastfeeding and agree to use birth control; * completion of a negative colonoscopy as per american gastroenterology association (aga) criteria and no clinically-significant laboratory or physical examination findings; * meets protocol-defined criteria for ibs-c, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria; * demonstrates english fluency and has access to a touch-tone telephone. exclusion criteria: * recent history of mushy or watery stools; * various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study; * clinically-significant alarm symptoms; * secondary causes of constipation or evacuation disorders; * surgery to the gastrointestinal tract; * usage of prohibited medications.

Keywords: irritable bowel syndrome with constipation ibs irritable bowel syndrome linaclotide acetate linaclotide md-1100
a danish audit of small bowel obstruction

Conditions: Bowel Obstruction Small

Summary: small bowel obstruction (sbo) is a common and potentially life-threatening acute surgical condition. a minority of patients present with a clear indication for urgent surgical intervention, either on the basis of clinical or radiological assessment (clinical signs of peritonitis/sepsis; suspicion of bowel ischaemia; closed loop obstructions; irreducible herniae etc.). however, the optimal management of the remaining patients, the majority of whom present with sbo caused by abdominal adhesions, remains a topic of international debate with practice varying in different healthcare systems. this multicentre, prospective, observational study aims to describe the current management of patients admitted with sbo in 6 acute hospitals (bispebjerg, herlev, hillerød, hvidovre, køge, slagelse) on the island of sjælland, denmark, which accounts for a 1/3 of the total danish population.

this is a prospective, non-interventional observational study of the management and outcomes of patients admitted with sbo in denmark. relevant clinicopathological demographics will be retrieved from consenting patients' medical records. an initial analysis will be performed once these patients have reached 90 days follow-up after the start of treatment. the long-term outcomes of treatment will be assessed with further analyses at 1, 3 and 5 years follow-up.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * radiological or clinical diagnosis of mechanical sbo * admitted to one of the 6 participating centres exclusion criteria: * sbo presenting within 30 days of a previous abdominal operation

Keywords: small bowel obstruction
magnesium associated with morphine for cancer pain relief

Conditions: Cancer-related Problem/Condition

Summary: this study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain.

the study is prospective, randomized, double-blind. the patients will be allocated into two groups. after approval by the ethics committee and signed informed consent, 40 patients, aged \> 18 years of both genders with cancer pain, will be studied. the patients in group 1 (n = 20) will receive a dose of magnesium sulfate (65 mg) po twice daily. patients in group 2 (n = 20) will receive placebo twice a day. the mg and placebo capsules are identical. everyone will receive morphine as needed. will be recorded: tumor location, factors which worsen the pain, quality of pain. pain intensity will be assessed by numerical scale from zero to 10 at t0 (first visit) and after 1, 2, 3. and 4wk. the patient will note the intensity of pain and side effects at home. functional performance assessment will bes done by the karnofsky performance status scale. quality of life will be assessed by the qlq-c30.

Eligibility criteria:
inclusion criteria: * after approval by the ethics committee and signed informed consent, * 40 patients, \> 18 years, with cancer pain, and taking morphine (third step of the analgesic ladder recommended by who) were studied exclusion criteria: * were excluded from the study patients with hypersensitivity to drugs and pregnant

Keywords: cancer pain magnesiun
effect of modulation of tens in pain after cesarean section

Conditions: Pain

Summary: the aim of the study was to evaluate the analgesic effect of transcutaneous electrical nerve stimulation high (100 hz) and low (4 hz) frequency in postpartum pain after cesarean section.

mothers were randomly divided into three groups (g100, g4 and placebo (gp) - appliance off) and evaluated by nrs (numeric rating scale) before, immediately after application of tens, and every 20 minutes until he was one hour after the application of electroanalgesia, to verify its effectiveness over time.

Eligibility criteria:
inclusion criteria: * aged 18 years * present pain at the site of surgical incision less than three according to category numerical scale (nrs) * literate oriented as to time and space * with spinal anesthesia before surgery * incision pfannenstiel type with absence of genitourinary pathology * primiparous or multiparous exclusion criteria: * patients with abnormal sensitivity to clinical examination * demyelinating diseases * spinal cord injury * hemorrhage * infection * fever * anesthetic complications * hypertension, mammary, intolerance, irritation or strong discomfort at the injection site caused by tens

Keywords: cesarean section pain transcutaneous electrical nerve stimulation postpartum period
conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide qrs: consyst-crt.

Conditions: Resynchronization Therapy; Conduction System Pacing

Summary: conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide qrs (consyst-crt randomized clinical trial) is a non-inferiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant, heart failure hospitalizations, and left ventricular ejection fraction (lvef) improvement \<5 points.

to date, studies have shown that conduction system pacing could get similar clinical and echocardiographic responses to those obtained with biventricular therapy. this study will randomize 130 patients to a strategy of biventricular pacing versus conduction system pacing. consyst-crt study will analyze the following parameters in the 2 groups: left ventricular ejection fraction, ventricular volumes, echocardiographic response (\>=15% decrease in left ventricular end-systolic volume), nyha functional class, heart failure hospitalization, all-cause mortality, cardiac transplant, qrs shortening, echocardiographic asynchrony (septal flash). clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year. the first 70 patients have been recruited in the context of the levelat study (clinicaltrials.gov identifier: nct04054895)

Eligibility criteria:
inclusion criteria: * the patient must indicate their acceptance to participate in the study by signing an informed consent document. * the patient must be ≥ 18 years of age. * left bundle branch block, qrs ≥130 and lvef \<=35%. no indication of stimulation for av block. * non-left bundle branch block, qrs ≥150 and lvef \<=35%. * patients with indication of resynchronization therapy for ventricular dysfunction (lvef \<40%) and indication of cardiac pacing for av block. * lvef \ =130 ms, provided a strategy to ensure biventricular capture is in place. exclusion criteria: * myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months. * pregnancy. * participating currently in a clinical investigation that includes an active treatment.

Keywords: resynchronization therapy biventricular pacing conduction system pacing