Kornimate/medical-research-clean huggingface dataset:
aliskiren for immunoglobulin a (iga) nephropathy

Conditions: IgA Nephropathy

Summary: immunoglobulin a (iga) nephropathy is the most common type of primary glomerulonephritis in the world. current treatment with angiotensin converting enzyme (ace) inhibitor and angiotensin receptor blocker (arb) is not entirely effective. aliskiren, a direct renin inhibitor, acts on the rate limiting step of the renin-angiotensin axis. in addition to lowering the blood pressure, recent study in diabetic nephropathy suggests an independent anti-proteinuric effect. the investigators plan to conduct a randomized placebo-control cross-over study to evaluate the safety and efficacy of aliskiren in the treatment of iga nephropathy. the investigators plan to recruit 57 patients with biopsy-proven iga nephropathy and persistent proteinuria despite conventional therapy. they will be randomized to aliskiren for 16 weeks or no treatment, followed by cross over to the other arm after a washout period. proteinuria, albuminuria, renal function, serum and urinary markers will be quantified. this study will explore the potential anti-proteinuric effect of aliskiren in the treatment of iga nephropathy, which has no specific treatment at present.


Eligibility criteria:
inclusion criteria: * aged 18-65 years * requires anti-hypertensive therapy * renal biopsy within the past 3 years and confirmed the diagnosis of iga nephropathy * proteinuria \> 1 g/day (or proteinuria \> 1 g/g-cr) in 3 consecutive samples within 12 weeks despite ace inhibitor or arb treatment for at least 3 months * estimated glomerular filtration rate \> 30 ml/min/1.73m2 * willingness to give written consent and comply with the study protocol exclusion criteria: * patients who are diabetic, and patients with systemic diseases that may cause iga nephropathy or another nephropathy. * pregnancy, lactating or childbearing potential without effective method of birth control * severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication * history of malignancy, including leukemia and lymphoma within the past 2 years * systemic infection requiring therapy at study entry * any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension * history of drug or alcohol abuse within past 2 years * participation in any previous trial on aliskiren or other renin inhibitor * previous treatment with fish oil, steroid, cytotoxic agents, or aldosterone antagonist * history of treatment with other drugs that may affect proteinuria within past 2 years * patients receiving treatment of corticosteroid * on other investigational drugs within last 30 days * history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study * history of non-compliance * known history of sensitivity or allergy to aliskiren or other renin inhibitor

Keywords: proteinuria renal failure glomerulonephritis
intra-muscular botulinum toxin a in chronic athletic pubalgia

Conditions: Athletic Pubalgia

Summary: chronic athletic pubalgia is a frequent sport condition in which the effectiveness of medical treatment has not been proven. intra-muscular injection of botulinum toxin a may have positive effects on pain in some chronic tendinitis. the investigators hypothesized that similar analgesic effect of intra-muscular botulinum toxin a may be observed in individuals with chronic ap. in the present study, the investigators aimed to describe the short-term evolution of pain and of activity limitations and quality of life, after an injection of the adductor longus with botulinum toxin a, in individuals with chronic ap, for whom medical and/or surgical treatments have failed.

the investigators included consecutive individuals with chronic athletic pubalgia for whom medical and/or surgical treatments have failed and who were treated with an intra-muscular injection of botulinum toxin a under ultrasound guidance. participants were assessed 50 days after injection for pain using a numerical rating scale (nrs) (0, no pain, and 100, maximal pain) and for activity limitations and quality of life using the copenhagen hip and groin outcome score (hagos) (0, worse outcome, and 100, most favorable outcome). participants were also asked to self-report adverse events.

Eligibility criteria:
inclusion criteria: * chronic ap * symptom duration ≥ 3 months * consistent clinical and magnetic resonance imaging findings according to the clinician * failure of medical and/or surgical treatments with persistent pain and inability to return to play * treatment with an intra-muscular injection of botulinum toxin a injection exclusion criteria: * age under 18 years * ongoing pregnancy or breastfeeding * treatments by anticoagulants * muscular disorder (e.g. polymyositis, myopathy or other neuromuscular conditions) * guardianship or curatorship * individuals who had received botulinum toxin type a treatment for less than one year

Keywords: chronic athletic pubalgia botulinum toxin groin pain adductor enthesopathy
steroids and surfactant in extremely low gestation age infants dose escalation trial

Conditions: Bronchopulmonary Dysplasia (BPD)

Summary: this is a phase i/ii open-label study to determine the lowest, safe, effective dose of budesonide given with calfactant as the vehicle.

this is a phase i/ii open-label study to determine the lowest safe, effective dose of budesonide given with calfactant as the vehicle; the investigators will perform an unblinded dose escalation study. the investigators will administer four dosing levels of budesonide suspended in calfactant beginning with 0.025 mg/kg of budesonide administered to 8 extremely low gestational age newborns (elgans) who are intubated at 3-10 days of age. daily doses (at the same dosage) will be administered to infants who remain intubated for a potential of 5 total doses in each patient. subsequent groups of 8 infants each will receive 0.05 mg/kg, 0.10 mg/kg, and 0.15 mg/kg of budesonide in calfactant (up to 5 total doses in each patient). a total of up to 32 infants will be enrolled in the trial. the investigators will evaluate the clinical, laboratory and safety data from each group of treated infants to 28 days of age before moving to the next dosing level of budesonide.

Eligibility criteria:
inclusion criteria: 1. \> 23 0/7 and \< 27 6/7 weeks of gestational age based on center's best estimate of due date (using earliest obstetrical ultrasound, last menstrual period, examination, and other pertinent available information) 2. day of life 3-14 from the date and time of delivery, with the date of birth being dol 0 3. intubated and mechanically ventilated and do not anticipate extubation in next 24 hours exclusion criteria: 1. serious congenital malformations or chromosomal abnormality 2. likely to be extubated in next 24 hours 3. clinically unstable 4. infants who have received systemic steroids prior to dosing with study medication. 5. infants who have received indocin, ibuprofen, or acetaminophen ≤ 96 hours prior to enrollment window ending

Keywords: bronchopulmonary dysplasia pulmonary surfactant steroids extremely low gestational age
potential role of cd9 and implication of motility process in pathogenesis of tel/alm1-positive all relapses (lal tel/alm1 and cd9).

Conditions: Acute Lymphoblastic Leukemia (ALL)

Summary: down regulation of cd9 in tel/aml1-positive all is addressed in motility assays to explore its role in b-all pathogenesis and its potential implication in relapses (and prognosis).

1. assess of the impact of cd9 expression level on motility assays (migration and adhesion) we have initiated motility assays (fibronectin adhesion experiments and cxcl12 chemoattracted migration tests with modified boyden chamber technique) using the cd9 positive tel/aml1-positive cell line reh and the cd9 negative cell line raji (wild or transfected with cd9 cdna). data will be analyzed in combination with blocking antibodies and chemical antagonist according to the level of cd9 (transcript and protein) and of cxcr4. protein quantifications will be performed by flow cytometry and western blot. interactions will be explored by confocal microscopy and biological pathways by immunoblot. adhesion results will be validated on patient samples of b-all. 2. post-transcriptional regulation of cd9 in tel/aml1-positive all to identify mirnas that are potentially deregulated in tel/aml1-positive acute lymphoblastic leukaemia and especially to screen for cd9 -targeted mirnas, we will use a taqman ®microrna arrays approach allowing the simultaneous measurement of about 760 human mirna. small rna will be extracted from bone marrow samples of twenty childhood b-all to screen mirnas which are differentially expressed between cd9-positive and cd9-negative all and further compared with mirnas which were predicted to target cd9 in databases. validation of the selection will be performed by single q-pcr for selected mirnas using a novel cohort of ten bone marrow samples. transfection assays and luciferase assays will be further realized to confirm that the differential mirnas really target and affect cd9 expression .

Eligibility criteria:
inclusion criteria: * patients \> 1 year and ≤18 years * with b-all diagnosis * registered in rennes for treatment * written informed consent signed by all patients or their parents or legal guardian exclusion criteria: * refusal to participate * inherited cytogenetic abnormalities

Keywords: tel/alm1_positive all relapses
spinal anesthesia for robotic assisted laparoscopic prostatectomy

Conditions: Prostate Cancer Surgery

Summary: we hypothesised that spinal anesthesia as an adjunct to general anesthesia would facilitate faster recovery and less pain in patients undergoing laparoscopic robotic prostatectomy. a double-blind placebo-controlled study was subsequently designed.

patients were allocated to either intrathecal injection of bupivacaine/morphine or a sham spinal procedure. all patients were placed in a sitting position and the skin over the lumbar region of the back was disinfected with chlorhexidine and draped sterile. in the intervention group the skin was infiltrated with 5 ml of lidocaine 10 mg/ml and a sterile 27-gauge pencil-point needle (pajunk, ga, usa) was subsequently entered into the intrathecal space at the l2-3 or l3-4 interspace. after obtaining return of cerebrospinal fluid, hyperbaric bupivacaine 5 mg/ml 1,5 ml (7,5 mg) and morphine 200 µg/ml, 0.5 ml (100 µg) was injected intrathecally. patients in the placebo group received an identical treatment as the patients in the intervention group, except for the intrathecal injection. after the skin was infiltrated with 5 ml of lidocaine 10 mg/ml, the attending anesthesiologist pressed one finger at the skin and talked as if she was giving an intrathecal injection at the l3-4 interspace. all patients were treated by the same anesthesiologist (ma).

Eligibility criteria:
inclusion criteria: - prostate cancer exclusion criteria: * benign prostate disease

Keywords: spinal anesthesia robotic assisted prostatectomy postoperative pain
study of dalotuzumab (mk-0646) in combination with cetuximab and irinotecan in metastatic colorectal cancer (mk-0646-004)

Conditions: Metastatic Colorectal Cancer

Summary: this study will compare the safety and efficacy of dalotuzumab (mk-0646) in combination with cetuximab and irinotecan in treating participants with wild type kras (wtkras) metastatic colorectal cancer (crc) compared to cetuximab and irinotecan alone. the primary study hypothesis is that administration of dalotuzumab in combination with cetuximab and irinotecan to participants with metastatic crc expressing the wtkras genotype improves overall survival or progression-free survival compared to participants treated with cetuximab and irinotecan alone.

dalotuzumab is a humanized monoclonal antibody (mab) that targets the insulin-like growth factor type 1 receptor-1 (igf-1r). dalotuzumab may act through inhibition of insulin-like growth factor-1 (igf-1)-mediated cell signaling to cause reductions in tumor growth and spread antibody dependent cell-mediated cytotoxicity. in preclinical studies, dalotuzumab improved the activity of an anti-epidermal growth factor receptor (egfr) mab and the activity of erlotinib, a small molecule inhibitor of egfr. all eligible participants will receive cetuximab 400 mg/m\^2 infusion over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 over 60-120 minutes along with irinotecan infusion over 30-90 minutes. dosage of irinotecan will be the same as most recent pre-study therapy. participants will then be assigned to one of three treatment double-blind arms.

Eligibility criteria:
inclusion criteria: * participant must have confirmed wtkras crc. * participant must have previously failed both irinotecan and oxaliplatin containing regimens, and should have progressed on or within 3 months of completing their last line of therapy with objective evidence of progression as verified by previous radiologic scans. exclusion criteria: * participant has had cancer treatment within 2 weeks before the first dose of study drug(s) or if the side effects from the drugs have not gone down to a certain level 2 weeks before the first dose of study drugs. * participant has had a bad side effect to irinotecan therapy. * participant has human immunodeficiency virus (hiv). * participant has hepatitis b or c. * participant is pregnant or breast feeding or planning to have a child while on this study.
wrex outcome study

Conditions: Muscular Dystrophy; Arthrogryposis; Spinal Muscular Atrophy

Summary: this study is to evaluate how the wilmington robotic exoskeleton (wrex) is working for children who are using the wrex, or have used it in the past. the survey consists of a set of questions a) performed online and b) performed over the phone.

the wrex (wilmington robotic exoskeleton) is being used by many children with neuromuscular conditions such as arthrogryposis and muscular dystrophy. nemours/a.i. dupont hospital for children alone has provided a wrex for about 80 children in the last 3 years. this is being done through the orthopedic and muscle clinics in the hospital. we would like to perform a retrospective study to see how well the children are doing with the wrex. we propose getting this feedback through a survey administered to families using the wrex. the survey will be performed in two parts. 1) a phone survey will use the canadian occupational performance measure (copm). 2) an online survey with additional questions. the parents are asked to submit answers on behalf of the children if they are unable to.

Eligibility criteria:
inclusion criteria: * neuromuscular disease * use the wilmington robotic exoskeleton exclusion criteria: * people who do not use the wilmington robotic exoskeleton
triage nurse initiated radiographs according to oar

Conditions: Ankle Fracture

Summary: the purpose of the study is to help doctors in emergency departments know whether triage nurse initiated radiographs, in accordance to the ottawa ankle rule, before emergency physician assessment will shorten emergency patients' visit. the investigators will examine the number of missed fractures between the two groups, the emergency physicians' willingness to apply oar and triage nurses' satisfaction.

overcrowding in the emergency department (ed) has been an ongoing issue for many hospitals in north america. numerous strategies have been implemented and explored in hopes of reducing wait times and length of stay. the ottawa ankle rules are one such strategy developed and proven to reduce cost and wait time without patient dissatisfaction and missed fractures. as a result, they have gained widespread acceptance from emergency physicians around the world. since the implementation of the ottawa ankle rules (oar), numerous studies have examined nurses' application and interpretation of these rules. it has been shown that nurses' application of the rule yield similar sensitivity and negative predictability for diagnosis of fractures as physicians. it is believed that emergency nurses can make accurate assessment in the determination of the patients who require radiographs. what is unclear, however, is whether or not triage nurse initiated radiographs shortens patients' length of stay in the emergency department, a factor inversely correlated to patient satisfaction. only a couple of studies have looked at this issue in the context of the ottawa ankle rules. one is a retrospective study conducted at an a\&e department in a small city while the other, although randomized prospectively, was carried out in an urgent care center rather than in a busy academic tertiary care hospital. our primary objective for this study is to investigate the median length of stay of patients presenting to a tertiary care academic center with blunt ankle injuries and assess whether triage nurse initiated radiographs in accordance to the ottawa ankle rules would shorten their stay versus current standard of care. presently, the emergency physician orders the x-ray at the time of patient encounter.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 19 presenting with an isolated blunt ankle injury exclusion criteria: * injury \>10 days * isolated skin injury * referred patient with outside x-ray * obvious fracture or deformity * polytrauma * pregnancy * diminished sensation due to neurological deficit * uncooperative, intoxicated or patients with altered mental status * patients returning for reassessment of same injury * injury due to or suspicious for domestic violence

Keywords: triage nurse ottawa ankle rules
evaluation of the abutment type following oral implants in terms of the surrounding bone height

Conditions: Missing Teeth

Summary: compare two different types of abutments (molded abutments and computer-designed 3d printed abutments) in terms of the amount of bone loss, and depth of periodontal pockets around the implant during different periods.

in the past few years, the number of research conducted on the designs of abutments and materials has increased. often, the restoration is done over the implant using standard abutments that the implant company prefabricated, but due to the problems facing the dentist from the occurrence of bone absorption, an increase in the depth of the pocket after restoration, other types of abutment design methods have been introduced as needed (molded abutment made by lost wax technique and computer-designed abutment made using a 3d laser printer), those customised abutments were made special for each patient depending on their conditions.

Eligibility criteria:
inclusion criteria: * the patient's age is greater than 20 years and younger than 50 * good oral health * absence of systemic diseases that may affect the healing of surrounding tissues, such as diabetes. exclusion criteria: * the presence of non-functional habits such as stridor * acute or acute periodontitis, previous loss of implants * poor general health conditions * previous radiotherapy in the head and neck area * mental incompetence * orthodontic treatment

Keywords: dental implant 3d printed abutment molded abutment
recombinant human c1 inhibitor for the treatment of early antibody-mediated rejection in renal transplantation

Conditions: Graft Rejection; Kidney Transplantation

Summary: the purpose of this study will be to assess the safety, tolerability, and efficacy of rhc1inh in renal transplant recipients with biopsy-confirmed antibody-mediated rejection (amr) within 30 days of renal transplantation. this study will combine the investigational drug rhc1inh with a standard regimen of plasmapheresis (pp) and intravenous immune globulin (ivig) and compare this to pp and ivig alone.

this is an investigator-initiated, prospective, open-label, randomized, adaptive design study to enroll 30 adult renal transplant recipients with biopsy-confirmed amr within 30 days post transplantation. after informed consent is obtained and study eligibility is confirmed, subjects will be enrolled immediately after biopsy confirmation of amr and positive donor specific antibody (dsa). subjects will then be randomized into one of two treatment groups (soc \[control\] or rhc1inh). an initial cohort of 8 subjects (3 soc, 5 rhc1inh) will receive intensive safety monitoring of the coagulation system and for thromboembolic events.

Eligibility criteria:
inclusion criteria: * recipients of renal transplantation within 30 days prior to enrollment. * amr documented by light microscopic changes and immunohistochemical c4d staining on renal biopsy within 30 days post-transplant. * positive dsa as detected by magnetic microbeads using a luminex® system. * age ≥ 18 years. * women of child-bearing potential (cbp) must have negative pregnancy test at screening. * women of cbp and men with sexual partners of cbp must agree to use a medically acceptable method of contraception throughout the study and for 3 months following discontinuation of assigned treatment. * subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent. exclusion criteria: * recipients of multi-organ transplants. * recipients with previous early amr. * recipients with a known hypersensitivity to c1inh, rabbit anti-thymocyte globulin, or any rabbit protein. * history of malignancy within 3 years of enrollment (except for adequately treated basal cell or squamous cell carcinoma of the skin). * subjects who are positive for hepatitis c, hepatitis b surface antigen, or hiv at the time of transplant. * subjects who are actively taking an investigational drug. * subjects with a history of a psychological illness or condition that could interfere with the subject's ability to understand the requirements of the study. * female subjects who are pregnant or nursing. * subjects with hemodynamic instability, as defined by a mean arterial pressure (map) \ 110 mmhg; or requirement of vasopressors to maintain a map of 60 mmhg; or requirement of iv vasodilators for hypertensive emergency; or acute pulmonary edema. * subjects with known active infection at the time of enrollment. * biopsy-confirmed concurrent cellular rejection requiring polyclonal antibody therapy (i.e., all grades other than banff 1a and 1b will be excluded).