Kornimate/medical-research-clean huggingface dataset:
study of a novel interposition supraciliary implant in patients with open angle glaucoma (safari 2)

Conditions: Glaucoma, Open-Angle

Summary: the purpose of this study is to evaluate the safety and effectiveness of implanting 2 novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (iop) in patients with primary open angle glaucoma (poag) who have failed at least one class of topical medical therapy

20 patients will be included in this 6 months interventional study. all patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of 2 interposition supraciliary permanent devices. several patient data like iop, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up. purpose is to ensure device safety, and verify iop and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Eligibility criteria:
inclusion criteria: * diagnosis of poag schafer 3 or 4 * medicated iop ≥ 21 exclusion criteria: - inflammatory, congenital, traumatic, neovascular, ice syndrome, angle closure and schaffer 1 and 2 glaucoma
pedi-reavasc resonance imaging of infants with hypoxic ischemic encephalopathy after hypothermia treatment.

Conditions: Encephalopathy, Hypoxic-Ischemic

Summary: this study is a prospective, observational, single-center study to assess the correlation between rs-fmri measures and clinical measures of standard mri, nirs, eeg and clinical scores. the target population was neonates with hie referred to mri after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours. a one-year clinical and imaging follow-up is planned. as the aim of the present study is to assess the predictiveness of the outcome one year after the hie event, no follow-up is planned.


Eligibility criteria:
inclusion criteria: newborns at 36 weeks gestation or more, with hie treated with therapeutic hypothermia will be prospectively included. exclusion criteria: * lack of parental consent * congenital anomalies that make hypothermia treatment not indicated * coagulopathy with active bleeding
observational study in patients who underwent an haploidentical transplantation with t-repleted bone marrow

Conditions: Hematologic Malignancy

Summary: outcome evaluation in patients who underwent transplantation with t-repleted bone marrow after post-transplantation cyclophosphamide

patients who underwent transplantation with t-repleted bone marrow haploidentical transplantation will be analyzed considering toxicity incidence (gvhd, infective complications, graft-failure incidence and trm)and efficacy variables (overall survival, progression free survival and relapse incidence)

Eligibility criteria:
inclusion criteria: - patients affected by hematologic neoplasia who underwent a haploidentical transplantation (2-3 mismatches) from a familiar donor, with non-ex vivo manipulated bone marrow and post-transplantation cyclophosphamide exclusion criteria: * ex vivo manipulated bone marrow transplantation * use of antilymphocyte serum during conditioning
study of cm313(sc) injection in subjects with relapsed/refractory aplastic anemia

Conditions: Aplastic Anemia

Summary: this is a randomized, open-label, phase ib/ii clinical study to evaluate the safety, tolerability and preliminary efficacy of cm313(sc) injection in patients with relapsed/refractory aplastic anemia


Eligibility criteria:
inclusion criteria: 1. diagnosis of idiopathic aplastic anemia. 2. patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol. 3. male or female, age≥18 years. 4. the eastern cooperative oncology group (ecog) physical status score ≤2. 5. willing and able to comply with the requirements for this study and written informed consent. exclusion criteria: 1. the inherited bone marrow failure syndromes. 2. previously treated with the anti-cd38 monoclonal antibody. 3. have an allergy to humanized monoclonal antibody or any part of cm313. 4. pregnant or breastfeeding females, or females planning to become pregnant during the study. 5. any condition considered to be ineligible for the study by the investigator.
outcomes of prophylaxis with emicizumab in children with severe hemophilia a in ivory coast

Conditions: Hemophilia A

Summary: assessment of the outcomes of prophylaxis with emicizumab in children with severe hemophilia a in ivory coast

assessment of the outcomes of prophylaxis with emicizumab in children with severe hemophilia a in ivory coast. duration of the study: 1 year after initiation of prophylaxis with emicizumab inclusion criteria: boys aged \> 2 years, affected with severe hemophilia a with or without inhibitors evaluated outcomes: annual bleeding rate, days of absence from school, the need for additional facteur viii consumption, satisfaction about the treatment and quality of life. tools used to assess quality of life are the ivoirian version of the canadian haemophilia outcomes-kids' life assessment tool version 2 (cho-klat) and eq-5d the satisfaction of the parents will be assessed using the patients' global impression of change scale (pgic).

Eligibility criteria:
inclusion criteria: severe hemophilia a with or without inhibitors - exclusion criteria: parents refusal -
clinical study of pan-cancer dna methylation test in plasma

Conditions: Cancer

Summary: we intend to establish an efficient method for plasma cfdna extraction and bisulfite transformation to facilitate the detection of dna methylation status using multiplex fluorescence pcr. meanwhile, we expect to identify several plasma methylation markers that can be highly sensitive for multi-cancer detection. finally, we will provide a pan-cancer blood test that is easy to operate, low cost, accurate and easy to promote.


Eligibility criteria:
inclusion criteria: - (1)age \>= 18 years. (2) with high suspicion of cancer diagnosed by endoscopy, other imaging examinations, pathological examinations, etc. (3) no treatment with radiotherapy or chemotherapy. exclusion criteria: * (1) received antineoplastic treatment such as radiation/chemotherapy. (2) not preserved as required. (3) contaminated or volume is insufficient. (4) unclear pathological results (5) incomplete patient information.

Keywords: colorectal cancer liver cancer squamous cell carcinoma of the head and neck esophageal carcinoma pancreatic cancer ovarian cancer bladder cancer cervical cancer lung cancer stomach cancer
a study of long-term administration of mometasone furoate nasal spray in pediatric subjects with perennial allergic rhinitis (study p06333am1)

Conditions: Rhinitis, Allergic, Perennial

Summary: mometasone furoate nasal spray (mfns) is a once-a-day product. this is a multi-center, open-label study of mfns in children with perennial allergic rhinitis. mfns will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. at each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. the presence/absence of serious adverse events and trial procedure-related aes will be reviewed 30 days after the end of the follow-up.


Eligibility criteria:
inclusion criteria: * subjects having symptoms of perennial allergic rhinitis of moderate to severe degree. * subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen). * male or female outpatients aged 3 to 15 years at the time of providing informed consent. exclusion criteria: * subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration * subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics * subjects with repeated epistaxis * subjects with coexisting fungal infection in nasal/sinus cavity * subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray * subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor. * subjects allergic to pollen (cedar, japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period
an open-label phase i/ii study of jr-446 in mucopolysaccharidosis type iiib

Conditions: Mucopolysaccharidosis III-B

Summary: a phase i/ ii, open-label study, designed to evaluate the safety and explore efficacy of the study drug in development for the treatment of mps iiib patients.


Eligibility criteria:
inclusion criteria: * chronological age of \<18 years * confirmed diagnosis of mps iiib exclusion criteria: * prior experience to gene therapy or hsct with successful engraftment * past use of another investigational drug or product in last 4 months or 5 half-lives (whichever is longer) before signing icf * current participation in a clinical trial or past participation (within 30 days of enrolment into this study) in a study involving invasive procedures * past use of genistein or kineret (anakinra) within 4 months before signing icf * serious drug allergy or hypersensitivity * contraindication for lumbar puncture or mri * history of bleeding disorder or current use of medications that, in the opinion of the investigator, place them at risk of bleeding following lumbar puncture the above information is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.
osteoporotic vertebral fractures and exercise

Conditions: Exercise Addiction; Vertebral Fracture

Summary: physiotherapy has an important place in the treatment of osteoporotic vertebral fractures. therapeutic exercise is often recommended for patients with vertebral fractures to reduce pain and restore functional movement. there is not enough evidence in the literature to determine the effects of long-term exercise on osteoporotic fractures and their side effects. therefore, the aim of this study is to evaluate the effectiveness of 12-week exercise training in patients with osteoporotic vertebral fractures.

osteoporotic vertebral fractures are associated with increased morbidity (eg, pain, poor quality of life) and mortality. therapeutic exercise is a conservative non-pharmacological treatment that is often recommended for patients with vertebral fractures to reduce pain and restore functional movement. there are preliminary studies showing that exercise may have an important role in improving quality of life and reducing the risk of re-fracture in these individuals. there are several reports of pain relief after short-term (6-10 weeks) exercise programs in people with spinal fractures, suggesting that there is uncertainty in the effects reported after longer-term (12-24 weeks) exercise. data are scarce and there are only four studies examining this question, and one is a multi-component physical therapy intervention that includes exercise. not all studies have examined individuals with severe pain at baseline. the quality assessment of the evidence for the effects of exercise on pain is very low. there is insufficient evidence in the literature to determine the effects of exercise on osteoporotic fractures and their side effects. therefore, the aim of the study is to evaluate the effectiveness of 12-week resistance and balance exercises in patients with osteoporotic vertebral fractures.the group of patients who will exercise will be compared with individuals who do not receive any treatment or exercise. it is aimed to reveal the effects of exercise on pain, physical performance, quality of life, depression, loss of function, kinesiophobia and sleep quality.

Eligibility criteria:
inclusion criteria: * ambulatory, * 55 years and over, * a minimum pain score of 3 in the short form mc-gill, which we will use for pain assessment. * able to use mobile phone by himself or with the support of his family, * having at least one vertebral fracture at least 6 months ago as a result of x-ray, * it was defined as having osteoporosis (lumbar spine dexa t score \<-2.5). exclusion criteria: * metabolic disease that will prevent participation in exercise, * pain at a level that prevents participation in exercise (a score above 7 in short form mc gill) * severe cardiovascular or pulmonary diseases (such as uncontrolled hypertension, resting heart rate 100 beats/min), * psychiatric diseases * determined as a recent fracture history

Keywords: exercise geriatrics vertebral fracture pain
validation of a brain-computer interface for stroke neurological upper limb rehabilitation

Conditions: Stroke, Ischemic; Stroke

Summary: the study's main goal is to determine if clinical and physiological effects of a brain-computer interface intervention for the neurorehabilitation of stroke patients' upper limb are greater than the effects of a sham robotic feedback. for this purpose a randomized controlled trial will be performed to compare somatosensory sham robotic feedback with the same somatosensory feedback controlled with the brain-computer interface output.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of first ischemic stroke * time since stroke onset higher than 3 months and lower than 24 months * hand paresis * normal or corrected to normal vision * without previous diagnosed neurological diseases exclusion criteria: * clinical diagnosis of severe aphasia * clinical diagnosis of severe depression * clinical diagnosis of severe attention deficits * previous diagnosis of traumatic brain injury * previous diagnosis of spinal cord injury * previous diagnosis of peripheral nerve injury

Keywords: brain-computer interface robotic orthosis hemiparesis motor rehabilitation
study of sunitinib plus folfox in patients with solid tumors

Conditions: Colorectal Neoplasms; Neoplasms

Summary: this study determined the maximum tolerated dose and safety of su011248 (sunitinib malate, sutent) in combination with folfox \[leucovorin + fluorouracil (5-fu) + oxaliplatin\]. three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (schedule 2/2, schedule 4/2, and continuous dosing) were tested in patients with advanced solid tumors, including colorectal cancer.

study design: treatment, single group assignment (7 cohorts), open label, non-randomized, safety study.

Eligibility criteria:
inclusion criteria: * advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry will be limited to patients wtih adenocarcinoma of the colon or rectum) * eastern cooperative oncology group (ecog) 0 or 1 exclusion criteria: * prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens * prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens * for colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting

Keywords: advanced solid tumors, colorectal cancer, sunitinib (sutent), folfox
a brief parent-based sleep intervention for children with autism spectrum disorder

Conditions: ASD; Insomnia

Summary: sleep problems are very common in children with asd, with a prevalence rate as high as 78%, and often pose significant challenges and stress to the families. sleep problems in children with asd are strongly associated with the exacerbation of daytime symptoms, and poor parental sleep quality and mental health. the present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with asd (aged 3-6). eligible participants will be randomised to either intervention (three consultation sessions and four follow-up phone calls) or waiting-list control condition. assessments will be conducted at pre-treatment (baseline), and one-week after the intervention (post-treatment).


Eligibility criteria:
inclusion criteria: * parents/caregivers (aged 21 or above) of preschool children (aged 3 to 6 years old) with a clinical diagnosis of asd attending paediatric developmental clinic or clinical psychology service at the duchess of kent child assessment centre (dkcac) * clinical diagnosis of asd would be made by either a pediatrician or a clinical psychologist, using at least one of the following diagnostic tools: childhood autism rating scale, second edition (cars-2), autism diagnostic observation schedule, second edition (ados-2), autism diagnostic interview-revised (adi-r) and clinical interview based on diagnostic criteria of asd depicted in the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5). exclusion criteria: - parent/caregiver of children with diagnosed co-morbid neurological, psychiatric or medical conditions which could have affected their sleep, such as obstructive sleep apnea, epilepsy, childhood anxiety disorder

Keywords: sleep asd insomnia behavioral intervention
evaluation of the role of inflammatory and structural ultrasound abnormalities by explaining the perspective of patients with psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the perspective of the patient is defined by the patient reported outcomes (pros). this is a main part of the care in psoriatic arthritis. however , pros can be influenced by environmental parameters. ultrasound represents an objective instrument in the context of psoriatic rheumatism (rhpso) care because it measures inflammatory activity and structural damage at joint and periarticular level. it is the first study to evaluate the role of inflammatory and structural ultrasound abnormalities as a cause of modification of the patient's perspective measured by pros in patients with rhpso.

it is an interventional study. patients will be enrolled in the rheumatology department of ambroise paré hospital in collaboration with the dermatology departments of the hospital. all patients with psoriatic arthritis, beginner or established, or patients with psoriasis suspecting the beginning of rheumatism who will consult or are already followed in those departments and give their approval for the study will undergo * a clinical rheumatologic assessment (number of painful or swollen joints, enthesitic pain, inflammatory spinal pain) * an ultrasound assessment (peripheral joints, tendon and enthesitic structures and nails). those assessment will be made the same day of their consult in one those departments. they will be asked to complete questionnaires (pros) on the overall assessment of the disease, pain, quality of life, tiredness, physical limitation / disability and the impact of the disease.

Eligibility criteria:
inclusion criteria: * patients of both genders above 18 years old * capable of adhering to the protocol * consent given * present one of those disease: * rhpso (confirmed diagnosis) according to the classification for psoriatic arthritis criteria (caspar) * rheumatoid arthritis according to acr/eular criteria (american college of rheumatology/ european league against rheumatism) * digital osteoarthritis according to american college of rheumatology (acr) criteria * cutaneous psoriasis * having signed a consent form * affiliated to a regimen of health insurance exclusion criteria: * patient refusing the study * the association of two rheumatic diseases (for example: psoriatic arthritis and gout, rheumatoid arthritis and arthritis etc) * the association of another chronic pathology likely to lead to joint manifestations (systemic diseases, bowel chronic inflammatory diseases, overload diseases, ...) * patient under trusteeship or protection of vulnerable adults * pregnant or nursing women
study of ly2409021 in participants with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: this study involves taking a single dose of 100 milligrams (mg) or 300 mg ly2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. the study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. this study includes a 7-day hospitalization period at the clinical research unit (cru) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the cru.


Eligibility criteria:
inclusion criteria: * have had type 1 diabetes mellitus (t1dm) based on the world health organization classification for at least 1 year and have a daily insulin dose ≤1.5 international units (iu) per kilogram (kg) of body weight * have a glycated hemoglobin a1c (hba1c) of no greater than 9.0% as measured at screening * have a body mass index (bmi) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m\^2) * have given written informed consent approved by lilly exclusion criteria: * received any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to screening * have had more than 1 episode of severe hypoglycemia within 3 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness * are pregnant or intend to become pregnant during the course of the study * women who are breastfeeding * have a history of stroke, myocardial infarction, heart failure, unstable angina, or a coronary revascularization procedure within 6 months of screening * have fasting triglycerides \>500 milligrams per deciliter (mg/dl) (5.65 millimoles per liter \[mmol/l\]) * have obvious clinical signs, symptoms, or laboratory evidence of liver disease (alanine transaminase \[alt\] or aspartate transaminase \[ast\] greater than 2 times the upper limit of normal at screening) * have a history of renal transplantation or are currently receiving renal dialysis or have a screening creatinine \>2.0 mg/dl (177 micromoles per liter \[μmol/l\]) * have had any other disease, illness, or condition (including known diabetic autonomic neuropathy, drug or alcohol abuse, or psychiatric disorder) within the 6 months prior to screening that precludes the participant from following and completing the study or could increase their risk for hypoglycemia, according to the investigator's judgment * are currently enrolled in, have completed, or have discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study