Kornimate/medical-research-clean huggingface dataset:
mdr - g7 neutral and g7 freedom constrained neutral acetabular liners

Conditions: Hip Osteoarthritis; Hip Disease; Hip Fractures; Hip Injuries

Summary: the objective of this consecutive series pmcf study is to collect data confirming safety, performance and clinical benefits of the g7 freedom constrained liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. since g7 acetabular cup system has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.

the objective of this consecutive series pmcf study is to collect data confirming safety, performance and clinical benefits of the g7 freedom constrained liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. since g7 acetabular cup system has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient. the primary objective is to confirm safety of the study products. this will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. relationship of the events to either implant or instrumentation should be specified. the secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (proms).

Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older and skeletally mature * patient must be willing and able to sign institution review board (irb) approved informed consent * noninflammatory degenerative joint disease including: * osteoarthritis * avascular necrosis * rheumatoid arthritis * correction of functional deformity * treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other -techniques * high risk of dislocation due to: * history of prior dislocation * bone loss * joint or soft tissue laxity * neuromuscular disease * intraoperative instability * revision procedures where other treatment or devices have failed exclusion criteria: * off-label use * infection and/or distant foci of infections which may spread to the implant site * sepsis * osteomyelitis * uncooperative patient or patient with neurologic disorders who are incapable of following directions * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy or neuromuscular disease * patient is known to be pregnant or nursing * patient is a prisoner * patient is a known alcohol or drug abuser * patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent * patient is unwilling to sign an informed consent
portal vein resection in pancreatic neuroendocrine tumours

Conditions: Pancreas Neoplasm; Neuroendocrine Tumors

Summary: the limited evidence on the value of portal vein resection in patients with borderline resectable and/or locally advanced pannens is an incentive to carry out a retrospective multicentre study amongst centres with specific interest in the management of pannens and with experience on vascular reconstruction. unlike previous studies on pancreatic cancer, it is more difficult to standardise the comparative parameters as the definition of borderline resectable disease has never been published for pannens. similarly, different histological classifications make impossible to collect data exclusively on t3 tumours. therefore, we aim to compare the short and long-term outcomes (including the impact of the histological depth of vascular invasion on survival) between patients undergoing standard pd and pd with portal vein resection for pannens, (regardless of t stage), by collecting and analysing retrospective data in this single centre study


Eligibility criteria:
inclusion criteria: all patients undergoing pancreaticoduodenectomy (whipple's or pylorus preserving pancreaticoduodenectomy) for sporadic pannens of the head of the pancreas of any stage (r0 or r1 resections) operated from 1st january 2007 up to 31st december 2016 inclusive. exclusion criteria: * multiple neuroendocrine neoplasia (men) syndrome or other genetic background * age \<18 years old * total pancreatectomy or different operation rather than pd * r2 resections

Keywords: portal vein resection pancreatic surgery
antero-posterior knee stability

Conditions: Osteoarthritis; Total Knee Arthroplasty; Stability; Knee Osteoarthritis

Summary: a retrospective one-time evaluation of total knee patients one year or more postoperative, to compare antero-posterior (ap) stability with the telos stress device/stress x-rays and clinical outcomes. multiple implant brand/models will be included in the study.


Eligibility criteria:
inclusion criteria: * patients willing to sign the informed consent. * patients able to comply with study requirements including stress x-rays and self-evaluations. * male and non-pregnant females ages 21 - 80 years of age at the time of surgery. * patients who have undergone a primary total knee replacement, are one year or greater postoperative, and are not having any evidence of failure of their implants. * patients with a diagnosis of osteoarthritis (oa), traumatic arthritis (ta), or avascular necrosis (avn). * patients with intact collateral ligaments. * range of motion within five degrees of full extension and a minimum of 120 degrees of flexion. exclusion criteria: * patients with inflammatory arthritis. * patients that are morbidly obese, body mass index (bmi) \> 40. * patients that have had a high tibial osteotomy or femoral osteotomy. * patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * patients with a systemic or metabolic disorder leading to progressive bone deterioration. * patients that are immunologically compromised, or receiving chronic steroids (\>30 days), excluding inhalers. * patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis. * patients with knee fusion to the affected joint. * patients with an active or suspected latent infection in or about the knee joint. * patients that are prisoners.
magnesium sulfate in obese preeclamptics

Conditions: Preeclampsia

Summary: the purpose of this study is to learn how medications participant will receive in the course of their delivery are metabolized (broken down by the body). the investigators hope to learn more about the way drugs are metabolized by pregnant women, and how those drugs are distributed in the blood and body compartments and cleared in the urine, and how maternal body weight affects the metabolism. with this information the investigators will be able to develop a treatment regimen considering factors in the body that affect magnesium levels so that the investigators can improve treatment of pregnant women. the goal of the study is to understand how different dosing of magnesium sulfate affects blood levels of the magnesium in larger women.

the purpose of this study is to learn how medications participant will receive in the course of their delivery are metabolized (broken down by the body). the investigators hope to learn more about the way drugs are metabolized by pregnant women, and how those drugs are distributed in the blood and body compartments and cleared in the urine, and how maternal body weight affects the metabolism. with this information the investigators will be able to develop a treatment regimen considering factors in the body that affect magnesium levels so that the investigators can improve treatment of pregnant women. the goal of the study is to understand how different dosing of magnesium sulfate affects blood levels of the magnesium in larger women. magnesium sulfate is generally given to patients to protect the mother against seizures in the case of preeclampsia. different hospitals in the united states use different doses of magnesium sulfate. participants will receive one of two accepted doses of magnesium sulfate for preeclampsia. the dose is usually 4g - 6g at the start, with another dose of 2-3 g every hour until 24 hours after delivery. participants will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete. participants will receive magnesium sulfate in the course of their normal clinical care whether or not they participate in this study.

Eligibility criteria:
inclusion criteria: * pregnant women who are ages 18-45 * 32-42 weeks' pregnant * prescribed magnesium sulfate for preeclampsia * bmi ≥35 kg/m2 exclusion criteria: * pregnant women \< 32 weeks' pregnant * women who are on dialysis
evaluation of the impact of red blood cell exchange on thrombo-inflammation in sickle cell disease

Conditions: Sickle Cell Disease

Summary: sickle cell disease is the most common inherited blood disorder worldwide. it is a hemoglobinopathy characterized by chronic hemolysis, endotheliopathy, coagulation activation, and chronic inflammation. it is a multisystemic disease leading to acute (vaso-occlusive crisis, acute chest syndrome, stroke...) and chronic complications with multiorgan damage. thrombo-inflammation is defined by the cooperation and interaction between hemostasis and the innate immune system. the platelet represents the cornerstone of this phenomenon, being at the interface of these two systems. in sickle cell disease, platelets are activated and release cytokines, leading to a pro-coagulant and pro-inflammatory state. transfusion, whether occasional or chronic, is a major sickle cell disease treatment. it is common to distinguish simple transfusion from exchange transfusion. the latter involves replacing a given volume of sickle red blood cells with healthy red blood cells. exchange transfusion allows avoiding an excessive increase in hemoglobin. the decrease of hemoglobin s under 30% achieved by red blood cell exchange reduces the risk of stroke by more than 90% in children with cerebral vasculopathy. moreover, transfusion can be used in acute complications such as vaso-occlusive crisis and acute chest syndrome. despite this efficacy, a subgroup of patients is not totally protected against acute and chronic complications. the persistence of chronic inflammation is suggested. to date, it is not known if red blood cell exchange can reduce the thrombo-inflammatory dynamic in sickle cell disease. the aim of this study is to evaluate the impact of red blood cell exchange on thrombo-inflammatory parameters in 20 adult sickle cell patients (10 patients on manual exchange and 10 patients on automatized exchange).

prospective observational cohort with additional blood samples. this study is monocentric.

Eligibility criteria:
inclusion criteria: * sickled cell disease patient with ss or s/beta thalassemia genotype * red blood cell exchange \> 3 months * up-to-date social security coverage * patient able to understand the purpose and constraints of the research project * patient has read the study information leaflet and does not object to the research. exclusion criteria: * thrombopenia \< 50 g/l * non-steroidal anti-inflammatory drugs \< 7 days before enrolment * anti-platelet agents \< 7 days before enrolment * pregnancy or breastfeeding * patient objects to take part in the study * patient under guardianship, curatorship or safeguard of justice * patients with ongoing clinical trial requiring collection of additional blood samples

Keywords: thrombo-inflammation red blood cell exchange
dose-escalation study to evaluate the safety and tolerability of gx-i7 in patients with glioblastoma

Conditions: Newly Diagnosed Glioblastoma

Summary: patients will be enrolled in two stages: * dose-escalation stage: approximately 12-24 patients will be enrolled.

detailed description: • dose-escalation stage : designed as classical 3+3 to determine mtd(maximum tolerable dose), rp2d(recommended phase 2 dose) and dlt(dose-limiting toxicity)s to evaluate approximately four dose levels of gx-i7 * pre-determined dose(level i)\~ pre-determined dose(level iv)

Eligibility criteria:
\[inclusion criteria\] 1. ability to understand and willingness to sign a written informed consent document (icf). 2. age ≥ 19 years 3. able to comply with the study protocol, in the investigator's judgment 4. eastern cooperative oncology group (ecog) performance status of 0 or 1. \[exclusion criteria\] general exclusion criteria 1. unable to comply with study and follow-up procedures 2. is pregnant or breastfeeding 3. have clinically significant cardiac disease (new york heart association, class ii or greater) including myocardial infarction, unstable arrhythmias, and/or unstable angina in the past 3 months 4. have clinically significant liver disease, including alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse

Keywords: phase 1b
the characteristic of axial pain and eeg analysis of patients after laminoplasty

Conditions: Cervical Myelopathy

Summary: the characteristic of axial pain and eeg analysis of patients after laminoplasty

the characteristic of axial pain after open-door laminoplasty in patients with degenerative cervical spine myelopathy and the correlation with electroencephalogram analysis: a prospective cohort study.

Eligibility criteria:
inclusion criteria: * age: 18\~70 years. * diagnosed as degenerative cervical spine myelopathy. * must receive c3-c7 open-door laminoplasty. * agree to join this study and sign the informed consent. exclusion criteria: * severe cervical spine kyphosis. * cervical spine radiculopathy. * laminoplasty with fusion. * cervical spine anterior column lesion because of tumor, trauma or infection. * severe osteoporosis. * morbid obesity. * patients with mental disorder. * pregnancy. * history of infection within last 3 months. * severe nervous system disease. * abnormal laboratory report of liver function, kidney function and hematologic system. * poor compliance. * patients with other surgical contraindications. * patients with intemperance or taking drugs. * patients who joined other study within the last 3 months. * patients with a chief complaint of neck pain (vas score ≥3 points). * left handedness.

Keywords: cervical myelopathy axial pain electroencephalogram analysis
ultrasound and peripheral nerve stimulator guided femoral nerve block

Conditions: Spinal Cord Injuries

Summary: a pre-post descriptive study was performed to examine the immediate effects of ultrasound (us) guided femoral nerve block with phenol (ugfnbwp) in managing lower limb spasticity of individuals with traumatic spinal cord injury (sci).

study design: a pre-post descriptive study was performed. objectives: to examine the immediate effects of ultrasound (us) guided femoral nerve block with phenol (ugfnbwp) in managing lower limb spasticity of individuals with traumatic spinal cord injury (sci). setting: ankara, turkey methods: nineteen patients with traumatic sci presenting with lower extremity spasticity were treated with ugfnbwp. modified ashworth scale (mas) of hip flexion and knee extension, functional independence measure (fim) motor subscale, difficulty of catheterization (doc), hygiene score (hs), spasm frequency (sf), sleep quality (sq) and patient satisfaction (ps) were measured in all patients prior to treatment, at first week and second month.

Eligibility criteria:
inclusion criteria: * traumatic etiology * duration of spinal cord injury more than twelve months * spasticity of hip flexor and/or knee extensor muscle * use of any oral medications to reduce spasticity at stable doses for at least one month before first assessment * the patients have to accept to continue same dose until end of the last assessment * medical clearance to participate exclusion criteria: * having established contracture of the knee/hip joint * aged over 65 years * history of surgery for knee/hip disorders * non-traumatic etiology

Keywords: nerve block
iodobenzylguanidine meta-i131 and topotecan in young patients with refractory or relapsed metastatic neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: radioactive drugs, such as iodobenzylguanidine meta-i131, may carry radiation directly to tumor cells and not harm normal cells. drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. a stem cell transplant may be able to replace the cells that were destroyed by iodobenzylguanidine meta-i131 and topotecan hydrochloride. purpose: this phase ii trial is studying the side effects of iodobenzylguanidine meta-i131 given together with topotecan hydrochloride and to see how well it works in treating young patients with refractory or relapsed metastatic neuroblastoma.

objectives: primary * determine the antitumor activity of iodobenzylguanidine meta-i131 (\^131i-mibg) and topotecan in young patients with refractory or relapsed metastatic neuroblastoma. secondary * determine the hematological and extra-hematological toxicities of this regimen. outline: this is a multicenter study. during the 21 days before treatment begins, autologous peripheral blood stem cells (pbsc) are collected. patients receive topotecan hydrochloride iv over 30 minutes daily on days 1-5 and iodobenzylguanidine meta-\^131i iv over 2 hours on day 1. treatment repeats every 21 days for 2 courses. patients also undergo total-body irradiation. on day 10 of the second course, autologous pbsc are reinfused. after completion of study therapy, patients are followed at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed neuroblastoma * metastatic disease that is recurrent or refractory to induction therapy * primary or metastatic tumor target with mibg fixation (tumor/soft tissue) \> 2 * autologous bone marrow or peripheral blood stem cells must be available * who performance status (ps) 0-1 or lansky ps 70-100% * life expectancy \> 2 months * anc ≥ 1,000/mm³ * platelet count ≥ 100,000/mm³ * creatinine clearance normal for age * not pregnant or nursing * fertile patients must use effective contraception * no prior hypersensitivity to topotecan or its excipients * no toxicity to other organs ≥ nci-ctcae v3.0 grade 2 * no other debilitating disease * no hiv positivity * more than 30 days since prior external-beam radiation (6 weeks if cranio-spinal, abdominal, or pulmonary) * at least 3 weeks since prior chemotherapy (6 weeks for mitomycin c or nitrosoureas) * no other contraindicated biologic therapy that cannot be discontinued for ≥ 4 courses during mibg therapy exclusion criteria: * pregnancy or breastfeeding women * hiv positive * participation to another phase i,ii or iii clinical trial * other invalidating pathology * concomitant treatment interfering with mibg * hypersensibility to topotecan

Keywords: disseminated neuroblastoma localized unresectable neuroblastoma recurrent neuroblastoma stage 4s neuroblastoma
paclitaxel plus capecitabine with capecitabine maintenance treatment in metastatic adenocarcinoma of the stomach or esophagogastric junction

Conditions: Advanced Gastric Cancer

Summary: the purpose of this study is to investigate whether paclitaxel plus capecitabine with capecitabine maintenance treatment as 1st line treatment in he advanced gastric cancer is effective and safe.


Eligibility criteria:
inclusion criteria: * having signed informed consent * age≥ 18 years old * histologically confirmed gastric adenocarcinoma * unresectable recurrent or metastatic disease * previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months * previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months. * measurable disease according to the recist criteria * karnofsky performance status ≥60 * life expectancy of ≥2 month * no prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks * alt and ast\<2.5 times uln (≤5 times uln in patients with liver metastases) * serum albumin level ≥3.0g/dl * serum akp \< 2.5 times uln * serum creatinine \<uln, and ccr \< 60ml/min * bilirubin level \< 1.5 uln * wbc\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, hb\>9g/dl exclusion criteria: * brain metastasis (known or suspected) * previous systemic therapy for metastatic gastric cancer * inability to take oral medication * previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy * surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry * contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. * allergic constitution or allergic history to protium biologic product or any investigating agents. * severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ecg findings, cardiac infarction , or retractable hypertension. * pregnancy or lactation period * any investigational agent within the past 28 days * other previous malignancy within 5 year, except non-melanoma skin cancer * previous adjuvant therapy with capecitabine+platinum, * pre-existing neuropathy\>grade 1 * legal incapacity
early weight bearing in distal femur fractures

Conditions: Distal Femur Fracture

Summary: assessment of the effect of double plating and single lateral plating on early weight bearing as a primary outcome and improving union and decreasing complications as secondary outcomes.


Eligibility criteria:
inclusion criteria: * skeletally mature patients. * distal femur fracture type a2, a3, c1, c2 by x-ray (arbeitsgemeinschaft für osteosynthesefragen classification). * injury severity score below 15. * controlled comorbidities. * fresh fractures: within 3 weeks of trauma. exclusion criteria: * distal femur fractures type a1, b, c3 and a2 if there is a medial wedge. * open fracture grade 3 gustilo anderson classification.
effect of different dosages of dark chocolate on arterial blood pressure in cardiovascular high-risk patients

Conditions: Hypertension

Summary: low habitual intake of low-dose dark chocolate (6 g/day) has been shown to have a beneficial effect on arterial blood pressure in one previous study. the trial will assess if ingestion of a higher but still moderate dose (25 g/day) over 3 months will have a more pronounced effect. the population will consist of cardiovascular high-risk patients only (who will potentially benefit most from blood-pressure lowering).


Eligibility criteria:
inclusion criteria: * age \> 18 years * mean ambulatory blood pressure 125-146 mmhg and/or 80-89 mmhg * high cardiovascular risk profile (one or more of the following: cad, pad, carotid stenosis, diabetes) * informed consent exclusion criteria: * habituary intake of dark chocolate or cocoa products * mean ambulatory blood pressure 147 mmhg or greater and/or 90 mmhg or greater * pregnancy * uncontrolled diabetes * severe comorbidity * change in blood pressure medication within last 6 weeks * participation in another trial