Kornimate/medical-research-clean huggingface dataset:
durolane sj for treatment of rhizarthrosis

Conditions: Rhizarthrosis

Summary: the main objective of the trial is to assess the clinical changes in terms of physical examination, vas scale and the quick-dash questionnaire, and the biomechanical parameters in terms of mobility of the tmc joint, the grip strength of the hand and lateral pinch strength in patients with rhizarthrosis after administration of viscosupplementation. the secondary objectives of the trial will be to assess the safety of the treatment with viscosupplementation, and the correlation between the clinical and biomechanical changes at the end of the trial.

this is a prospective, open, non-comparative study in 36 subjects with rhizarthrosis, comparing signs and symptoms before and after a single injection of durolane sj in the affected hand. subjects were assessed pre-treatment and at 1, 3, and 6 months post-treatment. this study is associated with a post marketing commitment with the european notified body, bsi, to confirm durolane sj's effectiveness in rhizarthrosis.

Eligibility criteria:
inclusion criteria: * subjects of both sexes aged 18 to 75 years. * diagnosis of grade ii-iii rhizarthrosis in either hand, according to the criteria of eaton and littler. * tmc joint pain lasting longer than 6 months and baseline pain value greater than or equal to 4 on the vas scale (0 to 10) and less than 4 in the contralateral hand joint if there is pain. exclusion criteria: * anticoagulant medication * rheumatic disease involving the wrist, hand and fingers, such as rheumatoid arthritis or gout * active rheumatoid arthritis * previous surgery of the hand * systemic infectious processes * neoplastic disease * subjects with contraindications to hyaluronic acid * subjects with known hypersensitivity to hyaluronic acid or any of the components of the preparation under study * previous hyaluronic acid injections in the hand * subjects likely to miss the clinical follow-up visits * taking of analgesics 24 hours before scheduled clinical assessments * pregnant subjects * any condition that in the opinion of the physician recommends exclusion of the subject
orelabrutinib,rituximab and methotrexate in newly-diagnosed primary central nervous system lymphoma(pcnsl)

Conditions: Primary Central Nervous System Lymphoma

Summary: this is a prospective single arm,multi-center,phase 2 study,and this study is to evaluate the efficacy and safety of orelabrutinib,rituximab combined with high-dose methotrexate(rmo) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma(pcnsl).objective response and complete response are the primary endpoint.

this is a single-arm,multicenter,phase 2 study to evaluate the efficacy and safety of orelabrutinib,rituximab combined with high-dose methotrexate(rmo) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma.the response will be evaluated every 2 cycles.patients who achieved complete remission(cr) or partial remission(pr) will receive further treatment,and there are 6 cycles of rmo regimen for the induction.the patients with stable disease(sd) or progressed disease(pd) will withdraw from the trial and receive salvage regimens.after total 6 induction cycles,the investigators evaluate the efficiency again.after 6 cycles,the patients who receive cr or pr,can tolerate autologous hematopoietic stem cell transplantation(ahsct) will be candidates of high-dose chemotherapy and stem rescue.the patients who achieve cr or pr,cannot tolerate ahsct will go to whole brain radiotherapy or orelabrutinib maintenance.the patients with sd or pd will receive salvage regimen.

Eligibility criteria:
inclusion criteria: * primary central nervous system diffuse large b-cell lymphoma histologically confirmed by brain biopsy; * aged 18-70 years * signature of informed consent; * at least one measurable lesion; * neutropile≥1.5x109/l,hemoglobin≥80g/l,platelets≥75x109/l,billrubin\<2xuln,alt\<4xuln,ast4xuln * the expected survival time is at least 3 months exclusion criteria: * those who have contraindications to any of the components in the orelabrutinib,rituximab and hd-mtx * history of other malignancies that may affect the compliance of the research protocol or the analysis of the results * severe cardiac insufficiency * other antitumor treatments were used * human immunodeficiency virus(hiv)antibody is positive * pregnant or lactating women * researchers consider if anyone not suitable for enrollment.
pf-05208756, moroctocog alfa (af-cc), xyntha for hemophilia a

Conditions: Hemophilia A

Summary: an open-label, single-arm, post- authorization pragmatic clinical trial on the safety and efficacy of xyntha (moroctocog-alfa (af-cc), recombinant fviii) in subjects with hemophilia a in usual care settings in china for approximately 6 months or or approximately 50 exposure days whichever occurs first

the purpose of this post-approval study is to provide supplementary information relating to the use of xyntha (moroctocog-alfa (af-cc), recombinant fviii) in chinese subjects with hemophilia a, especially on the safety and efficacy in different populations of chinese hemophilia a patients, in particular in pediatric patients \<6 years of age, pediatric patients ≥6 to ≤12 years of age, previously untreated patients (pups) , subjects receiving prophylaxis treatment after enrollment in the study, and severe patients (fviii:c \<1%).

Eligibility criteria:
inclusion criteria: * male and/or female subjects with hemophilia a. * subjects/parents/legal representatives must be able to comply with registry procedures (informed consent/assent process, clinical visits, reporting of infusion and bleed data, reporting of adverse events, etc). * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative, parent(s)/legal guardian) has been informed of all pertinent aspects of the study. exclusion criteria: * presence of any other bleeding disorder in addition to hemophilia a. * treatment with immunomodulatory therapy (e.g., intravenous immunoglobulin, routine systemic corticosteroids, cyclosporins, anti-tnf agents) within 30 days prior to study entry or planned use for the duration of their study participation. * subjects with a past history of, or current factor viii inhibitor. for laboratory-based assessments, any bethesda inhibitor titer greater than the laboratory's normal range or ≥0.6 bu/ml. * subjects with known hypersensitivity to the active substance or to any of the excipients of xyntha. * subjects with a known hypersensitivity to chinese hamster ovary cell proteins. * unwilling or unable to follow the terms of the protocol. * any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation (these conditions include, but are not limited to, inadequate medical history to assure study eligibility; expectation of poor compliance in provision of observations for study-related documentation), in the opinion of the investigator. * participation in other studies involving investigational drug(s) (phases 1-4) within 30 days before the current study begins and/or during study participation (exception for studies on xyntha). * subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are pfizer employees directly involved in the conduct of the study.

Keywords: fviii inhibitor
panel reactive antibody (pra) reduction in sensitized patients awaiting renal transplantation

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to offer panel reactive antibodies \[pra\] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. pra reduction is offered in the following phases: 1. immunological testing 2. transplant nephrectomy 3. pharmacologic therapy 4. plasmapheresis 5. transplant

patients with high level of preformed antibodies (panel reactive antibodies \[pra\]) to donor antigens make identification of a suitable donor difficult. for most transplant centers, 20-35% of patients waiting for a kidney transplant comprise this challenging group. these patients have a wait time of over five years and have many incompatible cross-matches with potential organ donors.

Eligibility criteria:
inclusion criteria: * renal transplant recipients with a potential living donor who is incompatible (t-\&/or b-cell locus) due to recipient high pra or mhc antibodies * pra greater than or equal to 20% within last twelve months * recipient and donor accepted as potential candidates by the lifelink healthcare renal transplant committee exclusion criteria: * patients with known allergy to cytogam(r), cellcept, rapamycin * patients who will receive ivig or cytogam(r) for any cause prior to protocol process * abo incompatibility * patients not capable of following through the treatment for various reasons as determined by treating physicians * any potential recipient who is pregnant or becomes pregnant * exclusion for plasmapheresis: known allergy to ethylene oxide or natural rubber latex. * exclusion for plasmapheresis: intake of ace-inhibitor or angtiotensiin-receptor blockers in the last 24 hours prior to plasma exchange

Keywords: renal transplant pra
pharmacokinetics of tamiflu® (oseltamivir) in patients receiving extracorporeal membrane oxygenation (ecmo)and or continuous venovenous hemodialysis (cvvhd)

Conditions: Critically Ill Renal Failure Requiring CVVHD and Oseltamivir; Critically Ill Requiring ECMO and Oseltamivir

Summary: critically ill patients with flu may receive a drug called oseltamivir. they may also receive medical therapies to support their lung function (extracorporeal membrane oxygenation; ecmo) and kidney function (continuous venovenous hemodialysis; cvvhd). cvvhd and ecmo may remove some oseltamivir from the bloodstream. the purpose of this study is to determine how much oseltamivir gets removed by cvvhd or ecmo in critically ill patients.


Eligibility criteria:
inclusion criteria: * receiving continuous venovenous hemodialysis (cvvhd) or extracorporeal membrane oxygenation (ecmo) * require oseltamivir treatment * informed consent granted exclusion criteria: * pregnant * unable to complete 12 hours of cvvhd or ecmo * \<6 kg body weight * allergy to oseltamivir

Keywords: oseltamivir influenza continuous renal replacement therapy extracorporeal membrane oxygenation pharmacokinetics
changes of macrophage migration inhibitory factor during orthotopic liver transplantation

Conditions: Evidence of Liver Transplantation

Summary: collecting blood, graft liver effluent and urine samples from patients undergoing orthotopic liver transplantation.

aims are to measure macrophage migration inhibitory factor, macrophage migration inhibitory factor ii and its' soluble receptor cd74 in serum, liver graft effluent and urine in and evaluate mif's role in hepatic ischemia/reperfusion injury, postoperative graft function and kidney function.

Eligibility criteria:
inclusion criteria: * end stage liver disease, chronic liver failure, orthotopic liver transplantation exclusion criteria: * combined transplantations (liver plus kidney or lung), age under 18 y, acute liver failure
evaluating changes in synovial fluid before and after gae for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the goal of this clinical trial is to learn if genicular artery embolization (gae) can improve knee pain and decrease inflammation in adults with knee osteoarthritis. the main question it aims to answer is: - does the gae procedure improve knee pain and decrease inflammation? researchers will compare synovial fluid samples taken from the knee before and after the procedure. participants will: * have a contrast enhanced mri before and after the procedure * complete performance-based measures before and after the procedure * complete questionnaires before and after the procedure


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * planned to undergo genicular artery embolization to treat knee osteoarthritis. * osteoarthritis on knee radiograph (kellgren-lawrence score 1-3) within the last 6 months * persistent moderate to severe knee pain (visual analog scale \[vas\] \>3) for at least 6 months * pain refractory or intolerant to conservative therapies (e.g. analgesia, exercise, weight-loss, joint injections, physical therapy) * bmi \< 35 kg / m2 * stated willingness to comply with study procedures and availability for the duration of the study exclusion criteria: * coagulation disturbances not normalized by medical treatment (inr \>1.8 and platelets \<50 x 10\^9/l) * receiving medications for anticoagulation which cannot safely be held for the procedure (e.g asa for 5 days, lovenox for 24 hours, eliquis for 4-6 days depending on creatinine clearance * allergy to iodinated contrast agents not responsive to steroid premedication regimen * active knee joint infection * acute knee injury with surgical indication (mri evidence of acute fracture or ligamentous injury of the knee) * prior total or partial knee replacement in the subject knee * intra-articular steroid injection within 2 months * untreated lower extremity vascular arterial disease * untreated venous insufficiency * presence of medical condition with life expectancy less than 6 months * patients who have undergone previous lower extremity embolization * patients with renal insufficiency based on an estimated gfr\<45 ml/min who are not already on hemodialysis * patients who are pregnant or intend to become pregnant within 6 months of the procedure * american society of anesthesiologists classification \> 3 * less than 3 mm of synovial fluid in the lateral suprapatellar recess on mri or us
efficacy and safety of 6 months treatment with paricalcitol injection or oral in patients with secondary hyperparathyroidism on dialysis

Conditions: Secondary Hyperparathyroidism; Dialysis

Summary: prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis.


Eligibility criteria:
inclusion criteria: * patients \>=18 years with secondary hyperparathyroidism (ipth \>= 300 pg/ml) * patients in a chronic hemodialysis or peritoneal dialysis program previously treated with vitamin d metabolites or without previous treatment * patients in which treatment with paricalcitol injection or oral is clinically indicated according to the criteria of the participating investigator * patients providing their signed informed consent to participate in the trial exclusion criteria: * patients with severe hyperparathyroidism (ipth \> 3,000 pg/ml) * patients with hypercalcaemia (calcium \>=11.0 mg/dl, adjusted according to albumin level), hyperphosphataemia (phosphorus \>= 6.5 mg/dl) or patients with calcium x phosphorus \>= 70 * known hypersensitivity and/or toxicity to vitamin d metabolites and/or other product ingredients * patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies * patients who cannot tolerate or take phosphorus binders that do not contain calcium and/or aluminum * patients that in the opinion of the investigator, for any reason, are not good candidates for therapy with synthetic analogues of vitamin d

Keywords: dialysis hyperparathyroidism zemplar
a prospective study to evaluate the role of t-cell dysfunction in patients who present symptoms associated with long covid, lyme disease and myalic encephalomyelitis / chronic fatigue syndrome using the vira immune fluorospot t cell assay

Conditions: Long COVID; PTLDs; Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (ICD-10 G93.3)

Summary: this is a longitudinal observational study recruiting individuals that have attended three clinical sites with symptoms associated with a diagnosis of long covid, ptlds or me/cfs. the study will be a multi-centre study, with up to 160 male and female participants enrolled. participants that experience symptoms considered to be associated with a diagnosis of long covid, ptlds or me/cfs will consent to the study, and attend for two study visits (at study entry and 6 months) to complete a questionnaire related to their symptoms, and to have a blood sample taken. blood samples will be taken either at the clinical site or at the participant's home if they are unable to attend due to the severity of their illness. . participants will be allocated to one of the following groups: group 1: long covid group 2: me/cfs group 3: ptlds group 4: healthy control


Eligibility criteria:
persistent symptoms for groups 1-3 for consistency. inclusion criteria: 1. aged 18 years or older 2. history of acute covid-19 infection (medically recorded) 3. symptoms of fatigue and, shortness of breath and/or, joint pain and/or, problems with memory and concentration which have been present for more than a period of 6 months post infection 4. nonsteroidal anti-inflammatory drugs (nsaids such as ibuprofen, diclofenac, aspirin, etc.) must have been stopped at least 48 hours prior to admission to the clinical research centre (evaluation through questionnaire). 5. willing and able to sign the icf and comply with study procedures. exclusion criteria: 1. taking immunosuppressive medication (including corticosteroids), or receiving chemotherapy, cytokine or anti-cytokine therapy, or antithrombotic medication (evaluation through questionnaire). 2. significant and/or acute illness within 5 days prior to admission that may impact safety assessments, in the opinion of the investigator. 3. participants who are, in the opinion of the investigator, not suitable for enrolment for another reason. for example, participants with: cognitive impairment or severe mental health conditions that might affect their ability to provide informed consent or follow study procedures; non-adherence risk where participants are unlikely to follow study protocols; participants with other chronic inflammatory conditions not under investigation e.g. inflammatory bowel disease, copd that may have immune profiles that differ from the study's intended populationi
mirror therapy with cutaneous electrical sensory stimulation on lower limb motor functions in stroke

Conditions: Stroke

Summary: this study aims to evaluate the effectiveness of concurrent mirror therapy (mt) and transcutaneous electrical nerve stimulation (tens) in augmenting the efficacy of the lower limb task-oriented training in people with stroke. it is hypothesize that mt combined with tens would be superior to sham-mirror therapy with tens, or mt with placebo-tens, or control training only in improving lower limb motor functions and walking ability in people with stroke when combined with the lower limb task-oriented training.

the application of transcutaneous electrical nerve stimulation (tens) over a paretic lower limb could augment the effects of task-oriented exercise therapy on lower limb motor function in people with stroke, possibly through increased excitability of sensorimotor cortex. in mirror therapy (mt), the intact limb performs motor tasks while its mirror reflection is superimposed over the covered paretic limb, creating a visual illusion of enhanced function over the paretic limb. the visual input during mt could substitute for reduced proprioceptive inputs and increase spatial attention of the paretic limb, which could improve motor function of the paretic limb, possibly through increased cortical activity in the lesioned hemisphere and mirror neurone system. the next question concerns whether mt could be combined with tens and whether their synergetic effects could maximise the motor output of paretic limbs in people with stroke.

Eligibility criteria:
inclusion criteria: 1. have had a single stroke with ischemic brain injury or intracerebral haemorrhage diagnosed by magnetic resonance imaging or computed tomography within the previous 6 to 36 months; 2. have at least 5 degrees of active ankle dorsiflexion in the antigravity position; 3. are able to walk 10 m independently with or without a walking aid; 4. are able to score 6 or higher out of 10 on the abbreviated mental test; 5. have no unilateral neglect, hemianopia or apraxia; 6. have no skin allergy (e.g. redness or itchiness to the electrical stimulation pads) to electrical stimulation or electrodes; and 7. are able to follow instructions and give informed consent. exclusion criteria: 1. have any additional medical, cardiovascular or orthopaedic condition that would hinder proper treatment or assessment; 2. have visual deficits that may hinder them from benefiting from the mirror visual feedback; 3. have receptive dysphasia; or 4. are involved in drug studies or other clinical trials.

Keywords: mirror therapy transcutaneous electric nerve stimulation rehabilitation
effect of laser therapy versus anterior re-positioning splint in the treatment of disc displacement with reduction

Conditions: Temporomandibular Joint Disorders

Summary: comparing the effects of laser therapy with anterior re-positioning splint and a placebo group on clinical signs and symptoms of temporo-mandibular dis-function and assessing articular disc morphology and configuration with magnetic resonance imaging.

to compare the clinical effects of laser therapy as assessed with research diagnostic criteria of temporo-mandibular disorders to a group that received anterior re-positioning splint therapy and a control group that received placebo laser. diagnosis for disc displacement with reduction was performed with magnetic resonance imaging before treatment. assessment of the clinical and mri findings was again performed after a 3 months observation period.

Eligibility criteria:
inclusion criteria: 1. patients having tmd in the form of disc displacement with reduction as verified from signs and symptoms during clinical examination and confirmed from the mri. 2. good general health: the patient must be medically free from any systemic disease or health problems. 3. adult patients 18 years old and above. 4. no previous orthodontic treatment. 5. no previous tmj treatment or surgery. exclusion criteria: 1. patients with multiple missing posterior teeth. 2. muscle pain due to systemic disease. 3. dental related pain. 4. congenital abnormality, neoplasia or acute trauma. 5. previous tmj treatment or surgery. 6. any medical condition that prohibits mri acquisition.

Keywords: laser therapy anterior re-positioning splint