Kornimate/medical-research-clean huggingface dataset:
grey matter damage at the earliest phase of multiple sclerosis : a longitudinal 7t mri study

Conditions: Multiple Sclerosis

Summary: the present study is an opportunity to assess grey matter damage at the earliest phase of multiple sclerosis (ms) allowing to a better understanding of its origins and its impact and disease severity. this study is a preliminary longitudinal study to precisely depict the kinetic of grey matter damage and the links with disease aggravation. thirty ms patients without time and spatial dissemination criteria (only one symptomatic mri lesion detected) but with oligoclonal bands detected on cerebro spinal fluid analysis will be included for a monocentric transversal mri study at 7t to assess grey matter injury. clinical and neuropsychological assessments will be performed in the population the same day of a multi-parametric mri. a longitudinal clinical and mri follow up will be performed during 2 years.

the present study is an opportunity to assess grey matter damage at the earliest phase of ms allowing to a better understanding of its origins and its impact and disease severity. this study is a preliminary longitudinal study to precisely depict the kinetic of grey matter damage and the links with disease aggravation. thirty ms patients without time and spatial dissemination criteria (only one symptomatic mri lesion detected) but with oligoclonal bands detected on cerebro spinal fluid analysis will be included for a monocentric transversal mri study at 7t to assess grey matter injury. clinical and neuropsychological assessments will be performed in the population the same day of a multi-parametric mri. a longitudinal clinical and mri follow up will be performed during 2 years.

Eligibility criteria:
inclusion criteria: * first presumed inflammatory demyelinating event in the central nervous system involving either the optic nerve, the spinal cord, a brain hemisphere, or the brainstem without spatial and time dissemination criteria * oligoclonal bands on csf analysis * age between 18 and 45 * no previous history of neurological symptoms suggestive of demyelination * no steroids in the month before mri * first mri within six months after the first clinical episode exclusion criteria: * possible alternative diagnoses * previous history of neurological or psychiatric disease * previous administration of immunosuppressive drugs * pregnancy * patient unable to give his consent for the study or patient under tutorship
safety and efficacy of vilazodone in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.


Eligibility criteria:
inclusion criteria: * men and women, 18-70 years of age. * currently meet the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for major depressive disorder. * the patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration. exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control. * patients with a history of meeting dsm-iv-tr criteria for: * any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode * any depressive episode with psychotic or catatonic features * panic disorder with or without agoraphobia * obsessive-compulsive disorder * schizophrenia, schizoaffective, or other psychotic disorder * bulimia or anorexia nervosa * presence of borderline personality disorder or antisocial personality disorder * mental retardation, dementia, amnesia, or other cognitive disorders. * patients who are considered a suicide risk.

Keywords: major depressive disorder depression
laparoscopic burch colposuspension versus modified burch colposuspension

Conditions: Stress Urinary Incontinence; Burch Colposuspention

Summary: this study aims to compare the success rate and complications following laparoscopic standard burch colposuspension and laparoscopic modified burch colposuspension (transobturator tape like)


Eligibility criteria:
inclusion criteria: * women with genuine stress urinary incontinence. * mixed urinary incontinence with predominant stress element. * refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment. exclusion criteria: * mixed incontinence with predominant urge urinary incontinence. * recent pelvic surgery (less than 3 months). * neurogenic lower urinary tract dysfunction. * previous surgery for stress urinary incontinence. * pregnancy * less than 12 months post-partum. * other gynaecologic pathologies affecting bladder functions ( eg, fibroids, ovarian cysts) * genito-urinary malignancy. * current chemo or radiation therapy.

Keywords: stress urinary incontinence burch colposuspension tot
an investigational immuno-therapy study of nivolumab, pomalidomide and dexamethasone combinations in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and effectiveness of several combination therapies for multiple myeloma. upon entry into the study, patients will be randomized (assigned by chance) to receive either: group 1: nivolumab, pomalidomide and dexamethasone or group 2: pomalidomide and dexamethasone or group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone. enrollment is closed for all groups.


Eligibility criteria:
inclusion criteria: * refractory or relapsed and refractory multiple myeloma * measurable disease * have received ≥ 2 lines of prior therapy which must have included an immune modulatory drug (imid) and a proteasome inhibitor alone or in combination exclusion criteria: * solitary bone or extramedullary plasmacytoma disease only * active plasma cell leukemia other protocol defined inclusion/exclusion criteria apply
compassionate use of pozelimab in patients with cd55-deficient protein-losing enteropathy

Conditions: CD55-Deficient Protein-Losing Enteropathy

Summary: the program is to provide access to an experimental drug called pozelimab and to document the long-term safety of pozelimab in patients with protein-losing enteropathy (ple). cd55-deficient ple/chaple disease is a rare inherited disease of the immune system. this can be a life-threatening condition that is usually found when patients are children.


Eligibility criteria:
key inclusion criteria: 1. clinical diagnosis of cd55-deficient ple/chaple disease (based on a history of ple), confirmed by biallelic cd55 loss-of-function mutation detected by genotype analysis (frameshift, nonsense mutations) as defined in the protocol 2. written informed consent from parent/guardian for minor patients 3. written assent from minor patients as appropriate (eg, above the age of 6 years or the applicable age per local regulatory requirements) key exclusion criteria: 1. patients who discontinued the prior pozelimab study due to safety or lack of efficacy 2. considered by the treating physician as inappropriate for this program for any reason as defined in the protocol note: other protocol defined inclusion / exclusion criteria apply
morbidity prevalence estimate in stroke

Conditions: Stroke; CVA (Cerebrovascular Accident); CVA; Sequelae; Stroke, Ischemic; Stroke Hemorrhagic; Hemianopia; Hemiplegia; Hemiparesis; Aphasia; Cerebral Infarction; Intracerebral Hemorrhage; Anxiety; Depression; Dysphagia; Dysarthria; Hemispatial Neglect; Mild Cognitive Impairment

Summary: information regarding the likely progress of post-stroke symptoms is vitally important to stroke survivors to allow them to plan for the future and to adjust to life after stroke. moreover, the prevalence of morbidity secondary to stroke is of central importance to health professionals to understand the prognosis of the disease in the patients under their care. additionally, it will also allow commissioners of care, planners and third sector organisations to adapt to and answer the needs of a post-stroke population. currently, the data collected by national audit programmes are concentrated on what can be termed 'process or process of care' data. the utility of these data are in the ability to audit the care received by stroke survivors on stroke units against evidenced standards for care, thus ensuring evidence based practice. nevertheless, process of care is only one form of measuring stroke unit care and the audit programmes collect some limited functional status data, data relating to risk-factor co-morbidities and treatment received data. therefore, the scope of this study is to build on the minimum data set currently collected and to collect post-stroke data in domains not currently collected. the international consortium for health outcomes measurement (ichom) takes important steps to collect data outside of process of care data such as a patient reported outcome data in their minimum outcome data set for stroke \[currently under review\].. nevertheless, the ichom doesn't currently advocate the specific collection of data relating to cognitive impairment or emotional problems secondary to stroke. it is in these important aspects that this study will augment the data set currently advocated by ichom to collect data in the areas of cognitive impairment and emotional problems secondary to stroke. therefore, the aim of this study is to quantify the prevalence of morbidity at six months post-stroke.


Eligibility criteria:
inclusion criteria: * clinically confirmed diagnosis of stroke either; * cerebral infarct (icd i63) \[1\] * intracerebral haemorrhage (icd i61) \[1\] * stroke, not specified as haemorrhage or infarction (icd i64) \[1\] * 18 years of age or older (≥ 18 years old) * received a clinically confirmed diagnosis of stroke within the previous 14 days (stroke diagnosis ≤ 14 days) exclusion criteria: * clinically confirmed diagnosis of any of the following * transient ischaemic attack (icd g45) \[1\] * subarachnoid haemorrhage (icd i60) \[1\] * any condition defined under icd g93 e.g. anoxic brain damage \[1\] * patients receiving or eligible for palliative care.

Keywords: stroke proms cohort
efficacy and safety study of squalamine ophthalmic solution in subjects with neovascular amd

Conditions: Age-related Macular Degeneration

Summary: a phase 3 study of the efficacy and safety of squalamine lactate ophthalmic solution 0.2% twice daily in subjects with neovascular age-related macular degeneration. patients will receive injections of ranibizumab. in addition, patients will receive either squalamine lactate 0.2% eye drops or placebo eye drops. the study duration is approximately 9 months to primary endpoint

phase 3 study of the efficacy and safety of squalamine lactate ophthalmic solution 0.2% twice daily in subjects with neovascular age-related macular degeneration methodology: phase iii, multicenter, randomized, double-masked, placebo-controlled study conducted over 9 months (screening/baseline to week 36): patients will be randomly assigned to one of 2 treatment groups in a 1:1 ratio: * squalamine lactate ophthalmic solution, 0.2% bid + ranibizumab every 4 weeks * placebo ophthalmic solution bid + monthly ranibizumab every 4 weeks

Eligibility criteria:
inclusion criteria: * age ≥ 50 years * a diagnosis of choroid neovascularization (cnv) secondary to amd with cnv comprising at least 50% of the total lesion area on fluorescein angiography (fa) * central subfield thickness (spectral domain (sd)-oct central 1 mm) of ≥ 300 μm * best-corrected visual acuity (bcva) 20/40 to 20/320 (73- to 24-letter score on the early treatment of diabetic retinopathy study \[etdrs\] chart) exclusion criteria: * neovascularization secondary to any other condition than amd in the study eye; blood occupying greater than 50% of the amd lesion, or blood \> 1.0 sq. mm underlying the fovea * pigment epithelial detachment (ped) without associated subretinal fluid and/or cystic retinal changes * clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye * confounding ocular conditions in the study eye which will affect interpretation of oct, va or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease) * fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing va improvement * uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye

Keywords: amd, cnv, choroidal neovascularization, retinal eye disease
open label of thalidomide in treatment of women with chronic pelvic pain associated with endometriosis

Conditions: Endometriosis

Summary: patients will undergo a standard history and physical examination detailing objective clinical exam findings performed by one of the co-investigators. the research coordinator will obtain baseline values for intensity of pain, quality of life, and coping strategies. baseline serum levels inflammatory markers will then be measured. over the course of 12 weeks thalidomide will be titrated as tolerated to achieve a minimum of a 30% reduction of pain on vas from week 2.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. histologically/laparoscopically confirmed endometriosis 3. chronic pelvic pain defined as non-menstrual pain for at least two weeks in the previous month for at least 6 months 4. vas of 6 or more at baseline 5. failure, completion or intolerance of standard treatment modalities (oral contraceptive therapy, danazol, depo-provera, depo-lupron) 6. patients must give written informed consent. 7. patients must be willing and able to comply with the fda-mandated s.t.e.p.s.® program. exclusion criteria: 1. pregnant and/or lactating female 2. users of other angiogenesis inhibitors 3. current use of rifampin, rifabutin, barbiturates, glucocorticoids, phenytoin, carbamazepine, chlorpromazine, reserpine, penicillin derivatives, or st. johns wart in user of oral contraceptive therapy 4. use of aromatase inhibitors, etanercept (enbrel), gnrh agonists (depo-lupron), and danazol within the past 3 months 5. use of norethindrone acetate (aygestin) in the prior month 6. seizure disorder 7. hepatitis, or any active infection (upper respiratory infection, pid, etc) 8. history of thromboembolic disease. 9. baseline neutropenia (anc \< 1000/mm\^3) 10. any severe physical or metal illness that would interfere with the completion of the protocol 11. illicit drug or alcohol abuse
safety and efficacy study of tru-016 plus bendamustine vs. bendamustine in relapsed chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: the objective of the first part of the study is to determine a safe dose of tru-016 that can be used in combination with bendamustine in patients with relapsed cll. the objectives of the second part of the study are to compare the safety and efficacy of tru-016 in combination with bendamustine to bendamustine alone in patients with relapsed cll.

this study consisted of two parts. the initial dose escalation stage was a phase 1b study evaluating the safety and tolerability of two doses of tru-016 administered in combination with bendamustine to patients with relapsed chronic lymphocytic leukemia (cll). in the randomized phase 2 stage of the study, the efficacy and safety of the selected dose of 20 mg/kg tru-016 combined with bendamustine was compared to bendamustine alone. the pharmacokinetics and pharmacodynamics of tru-016 and the development of antibodies to tru-016 were evaluated in both phases of the study.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsed cll with 1 to 3 prior treatments * demonstrated active disease requiring treatment * no prior bendamustine treatment * not refractory to fludarabine or other purines, either as a single agent or in combination * age \>/=18 years; male or female * eastern cooperative oncology group (ecog) performance status of \</= 2 * creatinine clearance \> 40 ml/min * absolute neutrophil count (anc) \>/= 1,200/mm3 * platelets \>/= 75,000/mm3 * lymphocytes \>/= 5,000/mm3 in phase 1b exclusion criteria: * treatment with rituximab or other b-cell depleting agent within 30 days or alemtuzumab within 12 weeks * previous anticancer therapy within 30 days * refractory to prior fludarabine or other purine analog therapy either as a single agent or in combination * receipt of prior bendamustine or tru-016 * receipt of an investigational therapy or major surgery within 30 days * previous or concurrent additional malignancy (some exceptions apply) * any significant concurrent medical diseases or conditions * positive serology for hiv or hepatitis c, hepatitis b surface antigen positive or hepatitis b core antibody positive. * pregnant or breast feeding * drug or alcohol abuse * allergic to mannitol

Keywords: cll tru-016 chronic lymphocytic leukemia relapsed cll bendamustine
de-111 against tafluprost ophthalmic solution 0.0015% alone and concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: de-111 ophthalmic solution will be evaluated for superiority in comparison with tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with tafluprost 0.0015% and timolol ophthalmic solution 0.5% used concomitantly, in iop(intraocular pressure) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. safety will be compared and evaluated as well.


Eligibility criteria:
inclusion criteria: * diagnosed with primary open angle glaucoma or ocular hypertension * provided signed, written informed consent * 20 years of age and older * if a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. exclusion criteria: * females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. * presence of any abnormality or significant illness that could be expected to interfere with the study.

Keywords: primary open angle glaucoma or ocular hypertension
efficacy of vitamin c injection on fatigue in workers after work

Conditions: Fatigue

Summary: fatigue is one of the most frequently observed symptoms for company workers, and oxidative stress is regarded as one of its cause. vitamin c is a well-known antioxidant, and the investigators seek for evidence of the efficacy of high dose vitamin c parenteral supplement on fatigue symptoms of company workers after work.

previous studies dealing with vitamin c were focusing on terminal cancer patients or those with chronic fatigue syndrome. since used drug dosage and the ways of administering vitamin c were not identical, the results were not consistent throughout those studies. this study is aimed to evaluate the efficacy of high dose vitamin c with parenteral supplement on relieving fatigue for apparently healthy volunteers.

Eligibility criteria:
inclusion criteria: * company workers working at least 5 days a week from morning to evening * volunteers who provided written informed consent exclusion criteria: * acute illness * chronic disease such as diabetes, hypertension, liver disease, or renal disease * previous history of renal stone or gout * pregnant or lactating women * hypersensitivity to vitamins or intravenous injections * history of vitamin supplements orally or parenterally within 2 days

Keywords: fatigue ascorbic acid oxidative stress
usefulness of biclamp forceps for liver resection: a randomized clinical trial

Conditions: Hepatobiliary Disease

Summary: the purpose of this study is to compare short-term and long-term efficacy of biclamp forceps hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic resection.

background: blood loss and the need for blood transfusions during the liver transection have shown to be correlated with higher morbidity and mortality rates and with worsen prognosis. various devices of liver parenchymal transection have been developed with a view to reducing the intraoperative blood loss. however, to the present there is no randomized controlled trial evaluating the technique of biclamp forceps during the liver transection. the goal of the present study was to evaluate the safety and effectiveness of biclamp forceps transection in comparison to the clamp crushing technique in patients offered liver resection. intervention: one hundred patients with hepatobiliary disease need undergo hepatectomy at anhui medical university were selected and divided into biclamp forceps hepatectomy group and clamp-crushing hepatectomy group, each group contains 50 cases. results: 1. clinical data include: blood loss during liver transection, total blood loss, blood transfusion, hospital stay, morbidity, mortality, biliary leakage, postoperative liver function, liver transection time, operation time, resection margins, need for portal trial clamping. 2. statistical method: groups t-test, univariate/multivariate analysis, logistic regression analysis, mixed linear regression and cox survival analysis were used.

Eligibility criteria:
inclusion criteria: * both male and female, aged 18 or older * patients scheduled to undergo hepatic resection for some benign or malignant hepatobiliary disease * child-pugh class a or b liver function * biclamp forceps hepatectomy and clamp-crushing feasible based on preoperative imaging * no tumor invasion the main vein, hepatic artery and vein and major inferior vena cava * no extrahepatic metastasis * voluntary participation in the study, and informed consent. exclusion criteria: * age \ 65 years , pregnant or lactating women * preoperative liver function evaluation: child-pugh c grade * laparoscopic hepatectomy * extrahepatic metastasis * tumor invasion the main vein, hepatic artery and vein and major inferior vena cava * the patient refused to sign the informed consent form

Keywords: biclamp forceps hepatectomy clamp crushing technique liver parenchyma transection randomized controlled trial