Kornimate/medical-research-clean huggingface dataset:
a dose escalation study of ibi302 in patients with wet age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: this study is designed for single-center, open-label, dose escalation phase i trial to evaluate the safety and tolerability of a single intravitreal injection of ibi302 in patients with wet amd.


Eligibility criteria:
inclusion criteria: 1. male or female patient ≥ 50 yrs. of age. 2. active subfoveal cnv secondary to wet amd, with lesion size ≤ 12 optic discs in the study eye. 3. bcva score of 10-73 letters using etdrs charts (in 4 meters) in the study eye. 4. central macular sub-field thickness according to oct of at least 250 micron. 5. clear stereoscopic fundus photography is obtained while the lens or other media is clear. 6. female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 3 months after the end of treatment. 7. willing and able to sign informed consent form and comply with visit and study procedures per protocol. exclusion criteria: 1. presence of other causes of cnv other than wet amd in the study eye. 2. presence of active diabetic retinopathy in the study eye. 3. presence of uncontrolled glaucoma in the study eye (defined as iop≥30mmhg despite the standardized treatment). 4. prior retinal detachment in the study eye. 5. prior any treatment of following in the study eye: 1. anti-vegf therapy within 6 months prior to screening; 2. anti-complement therapy; 3. laser photocoagulation; 4. photodynamic therapy; 5. transpupillary thermotherapy 6. intraocular surgery; 7. intraocular or periocular glucocorticoid injection therapy within 6 months prior to enrollment; 6. presence of any non-amd disease that may affect visual acuity in the study eye 7. prior anti-vegf therapy within 1 month before study drug administration or plan of above anti-vegf therapy in the non-study eye during the whole study. 8. oral steroid drugs within 1 month before study drug administration. 9. presence of active intraocular or periocular inflammation or infection. 10. diabetic patients have any of the following conditions: 1. microvascular and macrovascular complications; 2. hba1c\>7.5% when screening; 3. receiving more than two oral hypoglycemic agents; 4. receiving insulin or glp-1 receptor agonist; 11. hypertension (defined as systolic blood pressure \>140 mmhg or diastolic blood pressure \>90 mmhg despite standard treatment); 12. presence of any following laboratory abnormality: 1. plt\<100×109/l, inr≥1.5uln, aptt≥ 10 seconds more than uln; 2. alt or ast \>2uln; 3. cr or ur\>1.5uln; 13. large or medium surgery, or unhealed surgical incisions, ulcers or fractures within 1 month before study drug administration.
ideal dose of phenylephrine to treat low blood pressure during cesarean section

Conditions: Hypotension; Nausea

Summary: the purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in cesarean section in 95 % of our patients. an adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery.

the purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in cs in 95 % of our patients. the study will be conducted in a randomized double-blinded fashion. this dose-response study will be conducted as per the up-down sequential allocation method, modified by the narayana rule, designed to cluster the results around the ed95. blood pressure will be monitored every minute from intrathecal injection to the delivery of the child. phenylephrine will be administered every time the blood pressure is equal to or lower than the control value.hypotension will be defined as a sbp less than 80 % of the baseline value, in which case the treatment will be a failure. hypertension will be defined as a sbp more than 120 % of baseline value. if a patient presents hypertension for two consecutive measurements, the case will be considered a drop out.an adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery. the results of this study will define the minimum effective dose of phenylephrine to prevent post-spinal hypotension and nausea/vomiting secondary to hypotension in cesarean section, thus optimizing the safety profile with respect to maternal and fetal side effects of this vasopressor.

Eligibility criteria:
inclusion criteria: * elective cs under spinal anesthesia * normal singleton pregnancy beyond 36 weeks gestation * asa physical status i/ii * weight 50-100 kg, height 150-180 cm * age over 18 years exclusion criteria: * patient refusal * allergy or hypersensitivity to phenylephrine * preexisting or pregnancy-induced hypertension * cardiovascular or cerebrovascular disease * fetal abnormalities * history of diabetes, excluding gestational diabetes

Keywords: spinal cesarean section hypotension nausea vomiting phenylephrine
serratus anterior plane block: post-operative analgesia in video-assisted thoracic surgery

Conditions: Regional Anesthesia; Thoracic Surgery; Post-operative Pain; Post-operative Chronic Pain; Pharmacokinetic Analysis; Serratus Anterior Plane Block

Summary: the objective of the study is to compare the efficacy of the serratus anterior plane block (spb) realised in its deep plane, with a multi-holed catheter in place for twenty four hours, to a standard intravenous analgesia for small videoassisted thoracic surgery interventions. the objective is also to evaluate the resorption rate of local anesthetic at this level, and make a population pharmacokinetic analysis.

in this study, 20 patients will be randomly assigned to one of two groups: ten patients will have a serratus anterior plane block (spb), with a first ropivacaine 0,375% bolus (0,4ml/kg), followed by an infusion of ropivacaine 0,2% at a 10ml/hr rate, through a multi-holed catheter located under the serratus anterior muscle, for a duration of 24 hours. the other group will have a standard intravenous analgesia with a pca morphine-dehydrobenzperidol pump. anesthesia protocol will be standardized. except the infusion of ropivacaine for the spb, per operative anesthesia and post operative analgesia will be the same for every usual patients. the investigators will evaluate post operative pain based on the visual analog scale, 24 hours morphine consumption, sensitivity of concerned territory. the investigators will also evaluate post operative chronic pain by assessing pain two months post operatively, completing two questionnaires of neuropathic pain: dn4 and qdsa short form. finally, ropivacaine blood concentrations will be dosed by multiple blood samples taken over 24 hours after realizing the spb, in order to make a population pharmacokinetic analysis, and evaluate the degree of ropivacaine resorption at this level.

Eligibility criteria:
inclusion criteria: american society of anesthesiologists physic status 1, 2 and 3 who require surgical video-assisted thoracoscopy or video assisted thoracic surgery without mini-thoracotomy 1. lung pathologies: * biopsies * symphysis, pleurectomy * emphysema bullae resection 2. pleural pathologies: * biopsies * collections, intra pleural effusion 3. mediastinal pathologies: * adenopathy staging * cysts * sympathectomy t2-t5 * vagotomy * splanchnicectomy exclusion criteria: 1. refusal 2. allergy to local anesthetic - contra-indication to the use of ropivacaine 3. pregnancy 4. liver failure 5. severe kidney disease (gfr \< 15ml/min) 6. chronic intake of opioids 7. neurological or psychiatric disorders interfering with pain assessment 8. severe and morbid obesity (bmi \> 35)
mcrci® stem cell treatment for diffuse coronary artery disease

Conditions: Coronary Artery Disease

Summary: safety evaluation of intra-coronary administration of mcrci® stem cells in patients with diffuse coronary artery disease.


Eligibility criteria:
inclusion criteria: * patients with diffuse coronary artery disease * age 20\~80 * participants have received proper medication * canadian cardiovascular society class ii- iv angina. exclusion criteria: * age \ 80 * pregnant or breast feeding * positive adventitious infection (such as hiv, hepatitis ) * history of myocardial infarction within past 3 months * severe aortic or mitral valve narrowing * short of breath unable to receive pci examination or treatment * malignant tumor * hematopoietic dysplasia * severe organ disease with less than 1 year of life expectancy * chronic kidney disease with ccr\<20ml/min * kiney disease on renal dialysis.
predictive role and hur mechanisms of regulation in the brain tumours

Conditions: Brain Tumours

Summary: the hur protein binds to au-rich elements in the untranslated 3' region of messenger rna, thus allowing their stabilization. its targets include multiple cell cycle regulating proteins, cytokines and growth factors. in some cancers, its overall expression level but especially its cytoplasmic expression are correlated to a higher grade and constitute a poor prognostic factor. to date, hur's deregulation mechanisms remain poorly understood. a few experimental studies have shown the role of certain microarns, or of post-translational modifications. in brain tumours, hur expression, its prognostic value and its deregulation mechanisms have been little studied to date. the first part of the project will be a monocentric retrospective study of human brain tumour samples collected during biopsies or surgical removal. we will first evaluate hur expression in 140 brain tumors, including 40 meningiomas and 100 gliomas of increasing grade, and look for a correlation with histological grade and survival. we will then apprehend the consequences of its deregulation by analyzing different factors involved in the cell cycle and stress response markers. finally, we will study the mechanisms of hur deregulation by analyzing the expression level of several micrornas (mir16, mir519) and the methylation state of hur. the second part of the project will focus on cell lines from human brain tumours. we will first attempt to confirm the interactions between hur and markers involved in the cell cycle and stress response, then the regulation of hur by its methylation and by micrornas (mir16 and mir519). we would also like to study the consequences of hur inhibition and overexpression on cell proliferation, under various conditions of induced stress (pharmacological agents, physical stress). finally, we will study the consequences of an experimental vitamin b12 deficiency on hur expression and tumor cell adaptation to stress.


Eligibility criteria:
inclusion criteria * grade i and ii meningiomas (who) * diffuse grade ii glioma (astrocytoma, oligodendroglioma) * grade iii anaplastic gliomas (astrocytomas and anaplastic oligodendrogliomas) * grade iv glioblastoma
evaluation of the safety and efficacy of carbon dioxide (co2) acupulse laser treatment on urinary stress incontinence.

Conditions: Exposure Laser

Summary: the study is intended to assess the safety and efficacy of co2 acupulse laser treatment in patients with stress urinary incontinence (sui). eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 follow up visits, at 1, 3, 6, and 12 months following the last treatment.

following a screening visit, eligible subjects will be enrolled into the study. eligibility will be decided depending on the level of sui the patient has. each subject will receive either 3 laser or sham treatments 4 weeks apart and 4 follow up visits, at 1, 3, 6, and 12 months following the last treatment. further demographic information and patient history will be obtained from the subjects' electronical files.

Eligibility criteria:
inclusion criteria: * negative urine culture. * positive cough test. * normal papanicolaou (pap) test from the past 3 years. exclusion criteria: * signs, symptoms or validated test results indicating possible urgency urinary incontinence or mixed urinary incontinence. * overactive bladder. * previous bulking injections. * previous transvaginal mesh implant. * previous surgery for stress urinary incontinence. * presence of pelvic organ prolapse. * presence of an active or recurring genital infection or urinary tract infection. * previous laser-based or other energy-based treatments for gynecological indications. * vaginal bleeding of unknown reason. * pregnancy. * current pelvic floor physiotherapy. * current treatment with local or systemic hormone replacement therapy.
multicenter study in postmenopausal women with osteoporosis, alvobond

Conditions: Osteoporosis, Postmenopausal

Summary: this is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (pd) and pharmacokinetic (pk) profiles of avt03 and us-prolia in postmenopausal women with osteoporosis.

after the screening activities, eligible subjects were randomized to receive either avt03 60 mg or prolia® 60 mg, administered as a subcutaneous (s.c.) injection on day 1 and at month 6. at month 12, subjects in avt03 treatment group will received a third dose of avt03 60 mg administered s.c. while subjects in prolia® treatment group will were be re-randomized 1:1 to receive either prolia 60 mg or avt03 60 mg administered as a subcutaneous injection. afterwards, the subjects will be followed until the end of study (eos) visit.

Eligibility criteria:
1. postmenopausal women with osteoporosis willing to sign an informed consent form (icf)and able to undergo protocol related procedures. 2. a baseline dual-energy x-ray absorptiometry (dxa) scan with a t score ≤-2.5 and * 4.0 at the ls (l1 to l4)and/or, total hip, and/or femoral neck. 3. age: ≥50 years. 4. female subject is postmenopausal according to 1 of the following criteria: 1. spontaneous amenorrhea for ≥12 consecutive months 2. biochemical criteria of menopause, follicle-stimulating hormone, \>40 iu/l except surgically sterile 3. having had bilateral oophorectomy ≥6 weeks prior to screening 5. willing to receive calcium plus vitamin d supplements. 6. at least 2 consecutive evaluable lumbar vertebrae and at least 1 evaluable hip. exclusion criteria 1. evidence of clinically relevant pathology, especially prior diagnosis of bone disease, or any uncontrolled condition that will affect bone metabolism 2. history and/or presence of 1 severe or more than 1 moderate vertebral fractures confirmed by x-ray. 3. history of hip fracture 4. presence of active healing fractures 5. osteonecrosis of the jaw (onj) or risk factors for onj such as invasive dental procedures 6. evidence of hypo/hypercalcemia at screening 7. known vitamin d deficiency 8. known intolerance to calcium and vitamin d supplement.

Keywords: postmenopausal osteoporosis, denosumab, alvotech
chewing in children with repaired esophageal atresia-tracheoesophageal fistula

Conditions: Chewing Problem

Summary: the investigators aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (ea-tef). patients with repaired ea-tef will be evaluated for age, sex, type of atresia. each child will be required to bite and chew a standardized biscuit. chewing function will be scored with the karaduman chewing performance scale (kcps). the international dysphagia diet standardisation initiative (iddsi) will be used to determine the tolerated food texture of children.

the diet of children with normal feeding skills includes a combination of liquid, semisolid and/or solid foods. chewing dysfunction (cd) in children may cause restrictions in solid food intake, thereby may result in insufficient food intake and delay in growth. it is aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (ea-tef). patients with repaired ea-tef will be evaluated for age, sex, type of atresia. each child will be required to bite and chew a standardized biscuit. chewing function will be scored with the karaduman chewing performance scale (kcps). the international dysphagia diet standardisation initiative (iddsi) will be used to determine the tolerated food texture of children.

Eligibility criteria:
inclusion criteria: * children with repaired esophageal atresia-tracheoesophageal fistula, without airway aspiration, intact airway closure exclusion criteria: * children without repaired esophageal atresia-tracheoesophageal fistula, with airway aspiration, insufficient airway closure
oct and oct-a afer diabetic vitrectomy in pdr

Conditions: Proliferative Diabetic Retinopathy

Summary: detection of any structural or vascular changes at the macula after pars plana vitrectomy ( ppv ) in cases with complicated proliferative diabetic retinopathy ( pdr )


Eligibility criteria:
inclusion criteria: * cases with complicated pdr as persistant vitreous hemorrhage or tractional retinal detachment involving or threatening the macula underwent ppv with or without ilm peeling exclusion criteria: * eyes with media opacity after ppv not allowing imaging of the macula
efficacy and safety of astragalus for non-motor symptoms of α-synucleinopathy

Conditions: Parkinsonism

Summary: α-synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom. however, there is still a lack of research on the treatment for non-motor symptoms of α-synucleinopathy, especially autonomic dysfunctions such as orthostatic hypotension. efficacy and safety of astragalus for non-motor symptoms of α-synucleinopathy will be assessed by an open-label self-controlled before-and-after study.


Eligibility criteria:
inclusion criteria: * participants with a clinical diagnosis of pd, msa and dlb, with orthostatic hypotension. * participants with cognitive disorder. * adults signed informed consents. exclusion criteria: * patients with history of astragalus allergy. * patients with secondary parkinsonism that cannot be excluded. * patients with diseases that may cause other types of hypotension or similar symptoms/signs because of hypotension * patients with other medical conditions requiring treatments that may affect blood pressure. * patients with other neurological disorders. * patients with serious comorbidities and immune diseases. * uncooperative patients. * pregnant or lactating women.
equine-assisted therapy and anorexia nervosa

Conditions: Anorexia Nervosa; Equine-Assisted Therapy

Summary: background: severe anorexia nervosa is a complex psychiatric pathology with limited therapeutic tools to reduce morbidity and mortality. equine-assisted therapy could provide additional therapeutic benefits. objectives : the investigators aimed to explore the effects of equine assisted therapy on the experience of adolescents with severe anorexia nervosa. méthods : using a qualitative approach based on interpretative phenomenological analysis, the investigators conducted semi-structured interviews with nine participants who had taken part in equine-assisted therapy sessions.


Eligibility criteria:
inclusion criteria: * having participated in at least 2 equine-assisted therapy sessions * being or having been hospitalised between 2016 and 2022 in the psychiatric hospitalisation unit of the institut mutualiste montsouris (paris) * icd 10 diagnosis f50.0/ f.50.1 * female gender * age between 13 and 25 * fluent french * consent (including parents if minor participant) exclusion criteria: * having been under the care of c. lepy (resident) during hospitalisation at the institut mutualiste montsouris (paris) * refusal to participate on the part of the participant or the holder of parental authority.

Keywords: anorexia nervosa equine-assisted therapy animal-assisted therapy complementary therapy health care
demineralized bone allograft fibers versus particulate in sinus augmentation

Conditions: Bone Loss in Jaw

Summary: the purpose of this clinical trial is to assess if the addition of dfdba fibers to dbbm results in greater vital bone formation than the addition of dfdba particles to dbbm. the study team will examine the effects of the addition of dfdba fibers to dbbm on vital bone formation. specifically, we will assess histologically the percent vital bone formation with each of the groups during implant placement, six months after the sinus augmentation procedure. we will also evaluate the radiographic volume achieved with both groups of materials.

this entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. patients needing maxillary sinus augmentation will be enrolled. there will be two subject groups in this study both of which will randomized to one of two standard care procedures. no risk or benefit is expected from being assigned to either group as both procedures are both standard care. in both groups a bone sample (core) will be obtained as a by-product of implant placement. bone will not be extracted solely for research purposes, the bone sample attained for research will only be from bone left over after the soc implant placement. allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.

Eligibility criteria:
inclusion criteria: * patients between age 18 and 89 * patients needing sinus augmentation to support implant placement in the posterior maxilla * patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report * female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential. exclusion criteria: * patients who disclose that they will not be able to cooperate with the follow-up schedule. * patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report) * pregnant women or women intending to become pregnant during study period * smokers who smoke \> 10 cigarettes per day

Keywords: tooth loss bone resorption xenograft allograft