Kornimate/medical-research-clean huggingface dataset:
covadis pilot trial: coseal in ventricular assist devices

Conditions: End-stage Heart Failure Awaiting VAD Implantation

Summary: the objective of this controlled, non-randomized, single-center pilot study (coseal arm prospective)study is to evaluate the efficacy of the synthetic surgical hydrogel coseal® in the prevention of cardiac adhesion formation in patients submitted to vad procedures.

in the past decade the use of ventricular assist devices) (vads) for bridging to heart transplantation (htx) or, in some cases, to recovery of the ventricular function has increased and, during the same time, the duration of the implantation period has lengthened dramatically. when removing vads after a long period, surgeons face severe pericardial adhesions at the mediastinum level and of the surrounding tissue due to the inflammatory response. during resternotomy, dissection of these adhesions increases surgical time and can be a source of lesions on the cardiac or vascular structures and of severe bleeding at the moment of transplantation or when the device is removed. many products have been used to prevent or reduce adhesions but an ideal antiadhesive treatment has remained elusive. coseal®, a licensed synthetic hydrogel (baxter, usa) has been shown to reduce pericardial adhesions in a limited series of reoperations.

Eligibility criteria:
inclusion criteria (coseal group): 1. written informed consent obtained from the subject prior to participation in the study 2. at least 18 years of age 3. subjects with indication for lvad implantation, meeting the requirements for lvad implantation. patients for whom the investigator anticipates lvad removal not earlier than 6 weeks after lvad implantation. inclusion criteria (coseal control group): 1. written informed consent obtained from the subject prior to participation in the study 2. at least 18 years of age 3. subjects who had a lvad for more than 6 weeks. exclusion criteria (coseal group): 1. concomitant use of any other anti-adhesion product 2. immune system disorders, immuno-deficiencies or immuno-suppression 3. known hypersensitivity to components of the study product 4. patients concurrently participating in another clinical trial for adhesion prevention or sealing evaluation and having received such an investigational drug or device within the previous 30 days 5. patients who were previously subject to another lvad implantation/explantation 6. pregnant or breast-feeding women. exclusion criteria (co seal control group): 1. known use of any other anti-adhesion product during vad implantation 2. immune system disorders, immuno-deficiencies or immuno-suppression 3. patients concurrently participating in another clinical trial for adhesion prevention or sealing evaluation and having received such an investigational drug or device within the previous 30 days 4. patients who were previously subject to another lvad implantation/explantation 5. pregnant or breast-feeding women.

Keywords: end stage heart failure heart transplantation ventricular assist device patients with end stage heart failure awaiting heart transplantation
bioclinical evaluation of 2 biomarkers of aviremic hiv-1 in cd4+ t cells of adults undergoing treatment

Conditions: HIV-1-infection

Summary: the authors hypothesize that there is a correlation between the percentage of cd4+ t cells expressing cd32a and/or x and the quantity of dna found in peripheral blood mononuclear cells in patients infected with hiv-1. also, that there is a correlation between expression of cd32a and/or x and proviral load.


Eligibility criteria:
inclusion criteria: * patient infected with aviremic hiv-1 (\<20 copies of hiv-1 rna/ml plasma) undergoing antiretroviral treatment for at least 2 years * patient has known duration of infection and treatment * patient has known pretherapeutic cd4+ t cell count and viremia * patient has known cd4+ t cell count, residual viremia and cd4/cd8 ratio for previous 2 years * patient weighs at least 56kg * the patient is not opposed to their inclusion in the study * the patient must be a member or beneficiary of a health insurance plan * patient at least 18 years old exclusion criteria: * patient has an acute infection * the subject has already been included in the study or is in a period of exclusion determined by a previous study * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient is pregnant, parturient or breastfeeding
statement of care of anemia in delivering patients at nord franche-comte hospital

Conditions: Pregnancy Anemia

Summary: anemia is a common pregnancy condition that has multiple origins. its frequency and severity seem to be increasing, despite the existing management recommendations and the awareness of health professionals. the objective of this study is to make a statement of this pathology within our establishment, to evaluate the proportion of patients presenting this pathology and to highlight possible risk factors.


Eligibility criteria:
inclusion criteria: * \> 18 years * delivery at nord franche-comte hospital * delivery ≥ 32 weeks of amenorrhea * informed patient and non-opposition of participation exclusion criteria: * protected adults (patients under guardianship, curatorship, safeguard of justice or under family authorization) * medical interruption of pregnancy * patients with fetal death in utero or neonatal death * minor patients * premature delivery before 32 weeks
effect of shockwave therapy on cervical myofascial syndrome in lactating women

Conditions: Cervical Myofascial Pain Syndrome

Summary: the aim of the study is to determine the effect of shockwave therapy on cervical myofascial pain syndrome in lactating women

neck and shoulder pain was 73,1%,one fourth of which occurred after birth.the most common area was the superior part of the trapezius.the symptoms of patients are pain, stiffness and limited range of motion (rom).

Eligibility criteria:
inclusion criteria: * multipara two months after labor. * number of parity not more than 3. * age range 25_35.bmi less than 35 kg/m2 exclusion criteria: * diabetic women * women with malignancy * neck pain from other conditions such as(spinal * instability, spinal fracture, spinal cord compression,inflammatory disease, spinal infection, congenital postural deformity
combined infusion of cytotoxic t-lymphocytes and vaccination

Conditions: Complication of Transplant

Summary: to assess the safety and biological efficacy of prophylactically administered donor-derived multi-infection specific cytotoxic t lymphocytes (ctls) (targeting cytomegalovirus (cmv), adenovirus (adv), epstein barr virus (ebv), varicella-zoster virus (vzv), influenza (flu), bk virus (bkv), and aspergillus (asp)) combined with early immunisation with influenza and vzv vaccines for the prevention of viral and fungal infection following allogeneic blood or marrow stem cell transplantation.

the study will analyse the safety and biological efficacy of administering the investigational products (donor-derived t cells stimulated with viral and fungal antigen expressing dc combined with flu and vzv immunisation), for the prophylaxis of viral and fungal reactivation and/or infection following allogeneic blood or marrow transplantation. the cells will be given prophylactically a minimum of 28 days after transplantation followed by administration of the flu and vzv vaccines 24 to 72 hours later. the aims are to study the safety of combining ctl infusions and vaccination as well as their effect on reconstitution of infection-specific immunity, viral and aspergillus reactivation and infection rates after transplantation, viral load, and use of antiviral and antifungal pharmacotherapy for specific infections. the investigators will also evaluate the safety of infusions and vaccinations with respect to the development adverse events within the first 12 months post transplant.

Eligibility criteria:
inclusion criteria: * patients undergoing myeloablative or non-myeloablative allogeneic transplantation from an hla (a, b and dr) identical or 1-3 antigen mismatched family or unrelated donor. * transplant performed for any type of non-malignant condition or haematological malignancy including but not limited to acute and chronic leukaemia, myelodysplasia, non hodkgins and hodgkin lymphoma or myeloma. * recipients of peripheral blood or bone marrow stem cells. * adequate hepatic and renal function (\< 3 x upper limit of normal for ast (sgot), alt (sgpt), \< 2 x upper limit of normal for total bilirubin, serum creatinine). * estimated life expectancy of at least 6 months. * patient (or legal representative) has given informed consent exclusion criteria: * use of anti-lymphocyte globulin (alg, atg, campath or other broad spectrum lymphocyte antibody) given in the 4 weeks immediately prior to infusion or planned within 4 weeks after infusion. * grade ii or greater graft versus host disease within 1 week prior to infusion. * prednisone or methylprednisone at a dose of \> 1 mg/kg (or equivalent in other steroid preparations) administered within 72 hours prior to cell infusion. * allergies to eggs or components of the fluvax or varivax vaccines. * privately insured in or outpatients

Keywords: infection
liposomal bupivacaine pharmacokinetic study after median sternotomy incision infiltration in a pediatric cardiac surgery

Conditions: Cardiac Conditions

Summary: the purpose of the study is to determine the plasma concentration of bupivacaine at various time points after exparel (bupivacaine liposome injectable suspension, pacira pharmaceuticals, inc., parsippany, nj) is injected subcutaneously for median sternotomy incisions in pediatric cardiac surgery patients.

to determine the pharmacokinetic profile and peak bupivacaine plasma concentration with the use of an exparel/bupivacaine mixture in children ages two through seventeen (cohort i). cohort ii covers ages 2 \<6. we will be collecting blood samples at different times during 96 hours or until the patient is discharged from the hospital. there will be two different groups participating in the study alternating the times in which the blood samples will be collected. we hypothesize that peak plasma concentration will be significantly less than the toxic plasma concentration.

Eligibility criteria:
inclusion criteria: * every elective pediatric surgery patient ages two through seventeen years old, inclusive. exclusion criteria: * patients who fall outside of the age range for the study will be excluded. -patients known to have had an anaphylactic or severe reaction to the drug or its components will not be enrolled. any with significant liver disease will also be excluded. emergency patients will be excluded. pregnant patients will be excluded.

Keywords: pediatric cardiac surgery median sternotomy incision
a prospective, open label study evaluating juvéderm® volbella with lidocaine treatment for the correction of skin depressions in the infra-orbital area

Conditions: Infra-orbital Skin Depressions

Summary: a prospective, open label, study evaluating juvéderm® volbella with lidocaine treatment for the correction of skin depressions in the infra-orbital area (under the eyes)


Eligibility criteria:
inclusion criteria: * has grade \> 0 at screening within each eye (bilateral skin depression in the infra-orbital area), as evaluated by the evaluating investigator (ei) using airs * agree to refrain from undergoing other antiwrinkle/volumizing treatments in the upper two-thirds of the face (eyebrow to cheeks/cheekbones) for the duration of the study exclusion criteria: * has undergone cosmetic facial procedures \[e.g., face-lift, or other surgeries which may alter the appearance of the infra-orbital area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy\] anywhere in the face, or vistabel® cosmetic injections in the peri-orbital area, within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. note: prior treatment with ha fillers and/or collagen is allowed, provided the treatment was administered more than 12 months prior to study entry * has undergone volumizing of the mid face within 12 months prior to study entry * has ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, poly-l-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the infra-orbital area, or be planning to be implanted with any of these products at any time during the study * have a history of skin cancer * have a history of hypertrophic scarring * have a subcutaneous retaining structure on the face (e.g., meshing, gold strand)
a study of molidustat for correction of renal anemia in non-dialysis subjects

Conditions: Anemia; Renal Insufficiency, Chronic

Summary: the purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects with renal anemia who are not treated with erythropoiesis-stimulating agents (esas).


Eligibility criteria:
inclusion criteria: * subjects with estimated glomerular filtration rate (egfr)\< 60 ml/min/1.73m\^2 (chronic kidney disease \[ckd\] stages 3 to 5) * body weight \> 40 and ≤ 160 kg at screening * male or female subject ≥ 20 years of age at screening * not on dialysis and not expected to start dialysis during the study period * not treated with esas and/or hif-ph inhibitors within 8 weeks prior to randomization * mean of the last 2 central laboratory hb levels during the screening period must be ≥ 8.0 and \< 11.0 g/dl (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be \< 1.2 g/dl) and the last measurements must be taken within 14 days prior to randomization * ferritin ≥ 50 ng/ml at screening exclusion criteria: * new york heart association (nyha) class iii or iv congestive heart failure * history of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization * sustained and poorly controlled arterial hypertension (defined as systolic bp≥ 180mmhg or diastolic bp ≥ 110mmhg) or hypotension (defined as systolic bp \< 90mmhg) at randomization * proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)
treatment outcome in eating disorders

Conditions: Eating Disorder

Summary: do the current eating disorder treatments, i.e., family-based treatment (fbt) and enhanced cognitive behavioral therapy (cbt-e), offered at the center for the treatment of eating disorders (cted) demonstrate effectiveness? specifically, which type of treatment is most effective for which diagnoses? participants with anorexia nervosa (an), bulimia nervosa (bn), other specified feeding or eating disorder (osfed), or unspecified feeding or eating disorder (ufed) in this study will self select one of the two treatment groups, fbt or cbt-e. additionally, does family-based treatment (fbt) modified for avoidant/restrictive food intake disorder (arfid) and family-based treatment (fbt) combined with the unified protocol (up) for transdiagnostic treatment of emotional disorders (fbt+up for arfid) demonstrate effectiveness for patients with an avoidant/restrictive food intake disorder (arfid) diagnosis?

given a significant number of patients who presented for treatment at the center for the treatment of eating disorders (cted) and were enrolled in this effectiveness study met criteria for a diagnosis of avoidant/restrictive food intake disorder (arfid), and because there are currently no randomized control trials systematically evaluating children/adolescents with arfid, a secondary aim was added to this study. the secondary aim will evaluate the preliminary effectiveness of two treatment groups including: family-based treatment (fbt) modified for arfid and family-based treatment (fbt) combined with the unified protocol (up) for transdiagnostic treatment of emotional disorders (fbt+up for arfid) for arfid patients.

Eligibility criteria:
inclusion criteria: * patients must be at least 6 years of age, attending the cted clinic for outpatient treatment of a diagnostic and statistical manual, 5th edition (dsm-5) diagnosed eating disorder in order to be included in this study. exclusion criteria: * participants who are receiving inpatient services only and will not return to cted for outpatient treatment. * participants with a co-morbid medical disorder known to influence eating or weight. * participants presenting with a significant psychotic disorder. * participants who are acutely suicidal. * participants who demonstrate significant substance abuse and/or substance dependence.

Keywords: family-based treatment enhanced cognitive behavioral therapy anorexia nervosa other specified feeding or eating disorder bulimia nervosa unspecified feeding or eating disorder avoidant/restrictive food intake disorder unified protocol for the transdiagnostic treatment of emotional disorders in children and adolescents
brilinta dayu study

Conditions: Acute Coronary Syndrome

Summary: a multicenter, single arm, open label, phase iv study to evaluate safety and to describe the incidence of major cardiovascular events of ticagrelor in chinese patients with acute coronary syndrome


Eligibility criteria:
inclusion criteria: * 1. female or male aged at least 18 years 2.index event of non-st or st segment elevation acs 3.a patient who is considered as ethnic chinese exclusion criteria: * 1. with coagulation disorder 2.index event is an acute complication of pci 3.patient has planned for an urgent coronary artery bypass graft (cabg) within 7days from the enrolment 4.oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped 5.increased risk of bradycardic events 6. concomitant oral or intravenous therapy (see examples below) with strong cyp3a inhibitors, cyp3a substrates with narrow therapeutic indices, or strong cyp3a inducers 7.increased risk of bradycardic events (eg, no pacemaker and known sick sinus syndrome, second degree a-v block, third degree a-v block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker). 8.known clinically important thrombocytopenia 9.known clinically important anaemia
combination chemotherapy plus radiation therapy in treating patients with anaplastic astrocytoma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining more than one drug with radiation therapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed anaplastic astrocytoma.

objectives: i. determine the efficacy of carmustine, cisplatin, and etoposide given prior to and during radiotherapy in patients with anaplastic astrocytoma. ii. assess the toxic effects associated with this regimen in these patients. iii. evaluate this regimen in terms of fatigue, depression, excessive daytime somnolence, and quality of life in these patients. outline: patients receive carmustine iv over 1 hour on days 1-3, oral etoposide on days 1-21 and 29-49, and cisplatin iv over 1-2 hours on days 1-3 and 29-31. treatment repeats every 8 weeks for 3 courses. patients receive radiotherapy concurrently with the third course of chemotherapy. quality of life is assessed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. patients are followed every 3 months for 5 years and then annually thereafter. projected accrual: a total of 28 patients will be accrued for this study within 20 months.

Eligibility criteria:
disease characteristics: histologically confirmed, newly diagnosed, anaplastic astrocytoma no oligodendrogliomas or oligoastrocytomas patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: wbc at least 3500/mm3 platelet count at least 130,000/mm3 hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) sgot no greater than 2 times uln renal: creatinine no greater than 0.5 mg/dl other: not pregnant or nursing fertile patients must use effective contraception no uncontrolled infection no concurrent malignant disease or major medical problem except superficial skin cancers prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 5 years since prior chemotherapy endocrine therapy: concurrent corticosteroids allowed radiotherapy: at least 5 years since prior radiotherapy surgery: not specified

Keywords: adult anaplastic astrocytoma
rota china registry

Conditions: Coronary Artery Disease

Summary: rotational atherectomy (ra) facilitates percutaneous coronary intervention for complex de novo lesions with severe calcification. some observational studies and a small randomized trial indicated that a strategy of routine ra did not conferred reduction in restenosis or mace, but these studies are limited by missing follow-up, insufficient power to compare outcomes, and confounding factors in the ra group (long lesion length, etc.). with recent developments in medical therapy, advances in design and delivery of drug-eluting stents (des), and advances in noninvasive and intravascular coronary imaging, the use of ra in current real-world practice remains to be well determined. we aimed to compile real-world clinical outcomes data for the rotablatortm rotational atherectomy system in routine clinical practice in china.


Eligibility criteria:
inclusion criteria: * age ≥18 years old * subject who is clinically indicated for pci/stenting * written informed consent * subject is willing to comply with all protocol-required follow-up evaluation * subject must meet one of following angiographic/procedural inclusion criteria: * target lesion is moderately to severely calcified by visual estimate * unsuccessful balloon dilatation of the target lesion * unsuccessful passage of device(s) (microcatheter, balloon, or stent) across the target lesion exclusion criteria: * subject has clinical symptoms and/or electrocardiogram (ecg) changes consistent with acute mi within 2 weeks * subject has any of the following angiographic findings: * thrombus present in the target vessel (by visual estimate) * significant dissection present in the target vessel (nhlbi types c-f) * lesion angulation \> 60°(by visual estimate)

Keywords: coronary artery disease percutaneous coronary intervention rotational atherectomy
efficacy and safety of asf-1096 cream 0.5% in the treatment of discoid lupus erythematosus (dle) lesions

Conditions: Discoid Lupus Erythematosus

Summary: lupus erythematosus (le) is an autoimmune disorder that includes a broad spectrum of clinical forms. one of these forms, discoid lupus erythematosus (dle) is a chronic disfiguring disease confined to the skin. the aim of this pivotal trial is to investigate the efficacy and safety of asf-1096 cream 0.5% in the treatment of patients with dle or sle presenting newly developed discoid lesions.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of either dle or sle * histological results from biopsy confirming the diagnosis (biopsy can be taken at screening) * is prepared to grant authorised persons access to the medical records * has signed informed consent exclusion criteria: * has an active skin disease other than dle or another progressive or serious disease that interferes with the study outcome * has scarring at the target lesion * systemic treatment of sle

Keywords: discoid lupus erythematosus