Kornimate/medical-research-clean huggingface dataset:
ireland natalizumab (tysabri) observational program

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (tysabri) in participants with relapsing remitting multiple sclerosis (rrms) in a clinical practice setting.

itop is a retrospective and prospective irish observational study of participants receiving natalizumab, with each participant to be followed for 3 years. this study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of natalizumab with marketed use. collection of efficacy and safety data at 6- monthly intervals to coincide with regular clinic visits and routine clinical practice will therefore be undertaken during the itop observational period.

Eligibility criteria:
key inclusion criteria: * must give written informed consent and assent, as applicable. * decision to treat with natalizumab must precede enrollment. * patient characteristics and contraindications to treatment with natalizumab in accordance with prescribing information. * must be receiving natalizumab (tysabri) for the treatment of rrms in accordance with the natalizumab indication statement. * must have a documented diagnosis of relapsing remitting multiple sclerosis (rrms). note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: ireland natalizumab
effects of flaxseed flour in appetite sensations, lipid profile and pressure levels among overweighed and obese women

Conditions: Adult Women; Overweight; Obese

Summary: inclusion of foods rich in fiber, such as flaxseed, is a nutritional strategy for treating obesity. the hypothesis of this study is to compare the effects of three types of flaxseed flour - whole brown flaxseed flour, brown defatted flaxseed flour and golden flaxseed flour in the sensations of appetite and satiety, lipid profile, pressure levels and associated costs in overweight and obese women.


Eligibility criteria:
inclusion criteria: * adult women exclusion criteria: * women diabetic * menopausal * smokers * pregnant * using anorectic and satiogenic drugs

Keywords: flaxseed women obesity no smokers
neuroprotective effects of acth4-10pro8-gly9-pro10

Conditions: Ketamine-Induced Neurotoxicity

Summary: the compound acth4-10pro8-gly9-pro10 is a synthetic analog molecule of an adrenocorticotropic hormone (acth) short fragment. that is free from hormonal effects and has neuromodulatory effects. we investigate the neuroprotective effects of acth4-10pro8-gly9-pro10 can lessen neurotoxicity against ketamine in neonatal rats by looking at bdnf expression in the cortex and hippocampus tissue as well as bdnf blood levels.

the compound acth4-10pro8-gly9-pro10 is a synthetic analog molecule of a short fragment of adrenocorticotropic hormone (acth). it is free from hormonal effects and has neuromodulatory effects. the immune-modulating and neurotrophic activity of the drug were shown to balance the state of anti-inflammatory and trophic factors (il-io, tnf-a, tgf-pl, bdnf, ngf) over proinflammatory factors (il-ip, il-8, crp, le) to increase the anti-apoptotic defense (bcl-2 elevation), as well as to reduce the peroxidation process (increased sod activity). acth4-10pro8-gly9-pro10 also has neuromodulator characteristics to function as a neuroprotector in inhibiting the apoptotic process. modulation by acth4-10pro8-gly9-pro10 will increase the levels of bdnf thereby inhibiting the process of apoptosis. based on research by gusev and skvortsova, ischemic stroke patients who were given acth4-10pro8-gly9-pro10 showed increased levels of bdnf, decreased mortality, and reduced length of stay. based on the description above, the researcher was interested in analyzing the effect of the administration of acth4-10pro8-gly9-pro10 on ketamine neurotoxicity in neonatal rats by assessing the level of bdnf.

Eligibility criteria:
inclusion criteria: * rattus norvegicus rats * male, seven days old, weighing 15-20 grams * spraque-dawley strain, obtained from the experimental animal care unit exclusion criteria: * animals that behave aggressively in observation by attacking other groups

Keywords: acth4-10pro8-gly9-pro10 bdnf ketamine-induced neurotoxicity apoptosis
intermittent theta burst stimulation on anhedonia in depression

Conditions: Depression; Electroencephalography; Transcranial Magnetic Stimulation

Summary: study comparing the efficacy of two tms patterns (intermittent theta-burst stimulation, itbs, and repetitive transcranial magnetic stimulation, rtms) in treating anhedonia and their associated brain network mechanisms.

anhedonia is a core feature in major depressive disorders, severely affecting up to 70% patients and remaining untreated after traditional antidepressants therapies. in previous work, the investigators provided clinical evidence for the therapeutic efficacy of personalized rtms in treating anhedonia. however, the key practical question is whether personalized, connectivity-guided itbs performs comparably to the existing standard rtms about the clinical efficacy. this study was designed as a double-blind controlled trial to investigate the intervention effect of itbs stimulation on anhedonia in depressed patients. 33 subjects were included, 17 participated in conventional 10 hz-rtms treatment and 16 in itbs treatment. using the subjects' mri imaging data of the nucleus accumbens (nacc) as a seed point, individualized left dorsolateral prefrontal cortex (ldlpfc) targets were calculated from brain imaging data. patients received once-daily treatment for 15 days. clinical symptoms, behavioral and eeg assessments were performed before and after treatment. clinical assessments included the hamilton anxiety scale (hama), the hamilton depression rating scale (hamd), the beck depression inventory (bdi), the temporal experience of pleasure scale (teps), and apathy evaluation scale (aes); behavioral and eeg data were collected by the monetary paradigm. one month after the end of the intervention, follow-up bdi, teps, and aes symptom data were collected by electronic scales. this study focused on the analysis of scale, behavioral, and eeg data of subjects .

Eligibility criteria:
inclusion criteria: diagnosed by more than two clinical psychiatrists, using the dsm-5 diagnostic criteria for depression. the self-report apathy evaluation scale score was more than 37 and the the temporal experience of pleasure scale score was less than 76. consistent medical therapeutic plan for ≥4 weeks or no history of antidepressant drugs before rtms treatment. aged between 16 and 50 years old. exclusion criteria: participants with unstable physical conditions, pregnancy or those that were breastfeeding. metal implants on or inside the head. increased intracranial pressure from cerebral infarction or brain injury. a history of substance abuse or major psychiatric diseases other than depression and current use of psychoactive drug.

Keywords: anhedonia; intermittent theta burst stimulation
auris robotic endoscopy system for bronchoscopy

Conditions: Lung Cancer

Summary: in this study, the performance related to the use of the novel robotic endoscopy platform during bronchoscopic procedures will be evaluated.

the early and accurate diagnosis of lung cancer is critical. however, many peripheral lung lesions are beyond the reach of conventional bronchoscopes. additionally, alternative techniques, such as ct-guided or surgical biopsy, can carry increased risks to the patient. diagnostic yield of flexible bronchoscopy is limited by its inability to guide biopsy instruments directly to the lesion. varying technologies have been proposed to guide endobronchial biopsies, such as electromagnetic navigation, endobronchial ultrasound (ebus) and computed tomography fluoroscopy. however, the correlation of real-time guidance and the ability to precisely direct a biopsy instrument is critical to biopsy success. in this study , the novel robotic endoscopy platform and its accessories will be used to provide bronchoscopic visualization of and access to patient airways for diagnostic procedures. commercially available biopsy instruments will be used to acquire tissue for diagnostic purposes.

Eligibility criteria:
inclusion criteria: 1. 18 to 80 years of age; 2. capable and willing to give informed consent; 3. acceptable candidate for an elective, non-emergent bronchoscopic procedure; 4. solid peripheral lung lesions suspected of malignancy, between 1.5-7cm in size identified on thin slice ct scan with 30 days of the intended bronchoscopy exclusion criteria: 1. medical contraindication to bronchoscopy; 2. ground glass opacity lesions on pre-procedure ct 3. participation in any other clinical trial 30 days before and throughout the duration of the study; 4. uncontrolled or irreversible coagulopathy; 5. female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test; 6. ct scan done over a month before the bronchoscopy procedure. intra-procedure exclusion criteria: any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the patient's best interest.
study of the role of g72 in amyotrophic lateral sclerosis: biomarker discovery and mechanism investigation

Conditions: Amyotrophic Lateral Sclerosis; Alzheimer Disease; Parkinson's Disease

Summary: g72 gene is located on the common linkage locus in bipolar disorder and schizophrenia, and it encodes d-amino acid oxidase activator (daoa). there are evidences that elucidated g72 and d-amino acid oxidase(dao) together playing a critical role in the pathophysiology of schizophrenia. recently, reports discovered missense mutations in the dao (r199w dao and r38h dao) are associated with familial amyotrophic lateral sclerosis (fals), and our preliminary data showed that the level of g72 autoantibody decreases in patients with als compared with normal control. thus, we want to find out whether g72 plays a role in als and neurodegenerative diseases including alzheimer disease and parkinson's disease. first, we detect g72 protein and its autoantibody in sera of neurodegenerative diseases patients using elisa and western blotting, and the data are compared with normal control. we hypothesize the levels of g72 protein and its autoantibody in neurodegenerative diseases are less than those in normal control. then, we extract genomic dna of neurodegenerative diseases patients, and use polymerase chain reaction(pcr) to detect single nucleotide polymorphism (snp) of g72. we aim to detect g72 missense snp variants presented in als, ad and pd.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of alzheimer's disease, parkinson's disease and amyotrophic lateral sclerosis exclusion criteria: -

Keywords: amyotrophic lateral sclerosis g72 snp
comparing autologous peripheral blood stem cell to bone marrow transplantation for recurrent non-hodgkin's lymphoma

Conditions: Lymphoma

Summary: the purpose of this study is to evaluate the difference in relapse rates and long term event free survival in patients with intermediate grade or immunoblastic non-hodgkin's lymphoma (nhl) whose marrow is not obviously involved with nhl who are randomized to receive either an autologous bone marrow (abmt) or peripheral stem cell transplant (psct). all patients with intermediate grade nhl with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and abmt are eligible for this study. patients who are eligible will be randomized to either psct or abmt at the time of enrollment into our transplant program.

these patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (beac) with autologous hematopoietic rescue. the patients will be stratified according to good and poor prognosis category and relapsed vs. first partial response categories. the patients will have bone marrow or peripheral stem cells collected according to standard protocols. a standardized hematopoietic growth factor will be used for mobilization and post-transplant. the patients' psc or bone marrow (bm) product will be assayed via invitro-culture techniques for occult tumor, and by molecular biologic assays. the patients' outcome for transplantation will be evaluated with response to transplantation, relapse rates and event free survival being the measured end points.

Eligibility criteria:
inclusion criteria: * age 16-65 * intermediate grade non-hodgkin's lymphoma (international working formulation - follicular large cell, diffuse small cleaved, diffuse mixed, diffuse large cell, and immunoblastic) with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and abmt. these criteria are in each specific high-dose therapy protocol (i.e. karnofsky performance status \> 70, adequate organ function, hiv and hepatitis b negative, etc.). these patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (beac) with autologous hematopoietic rescue. exclusion criteria: * patients with bone marrow histologically involved with tumor or with a bone marrow abnormality making bone marrow harvest not possible. * patients whose tumor is rapidly growing which may preclude the extra time involved with the psc collection process. * patients who do not otherwise meet high-dose therapy and transplantation entry criteria.

Keywords: nhl non hodgkins lymphoma bmt bone marrow transplant pbsct peripheral blood stem cell transplant psct
real-world efficacy of evoke® closed-loop spinal cord stimulation (cl-scs) therapy in chronic pain patients (ultra).

Conditions: Pain; Chronic Pain; Neuropathic Pain

Summary: this observational, prospective data collection is designed to evaluate the efficacy of cl-scs therapy in real-world patients suffering from chronic pain.


Eligibility criteria:
inclusion criteria: be 18 years of age or older at the time of enrollment. diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months. subject has a minimum visual analog scale (vas) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline. be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician. be willing and capable of giving informed consent. be willing and able to comply with study-related requirements, procedures, and visits. exclusion criteria: subject is pregnant or nursing. have a medical condition or pain in other area(s), not intended to be treated with scs, that could interfere with study procedures, as determined by the investigator. have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes. have an existing drug pump and/or scs system or another active implantable device such as a pacemaker, deep brain stimulator (dbs), or sacral nerve stimulator (sns). have prior experience with scs. be concomitantly participating in another clinical study.

Keywords: saluda spinal cord stimulation
assessment of the clinical course of dyspnea in acute heart failure patients

Conditions: Acute Heart Failure; Dyspnea

Summary: acute heart failure (ahf) is defined as a gradual or rapid change in heart failure (hf) signs and symptoms, such as shortness of breath (also called dyspnea or breathlessness), leg swelling, fatigue, breathlessness with exertion, trouble sleeping flat at night, and weight gain resulting in a need for urgent therapy. ahf results in over 1 million hospitalizations every year, resulting in an enormous public health burden. approximately 1/3rd of patients will either be re-hospitalized or die within three months, and the resultant financial costs are large. as such, improving outcomes for ahf patients is critically important. shortness of breath is the most common reason why patients with ahf present to the er. as such, understanding how severe this symptom is, how much it improves with current treatments is very important to both patients and physicians. the purpose of this study is to determine the degree to which your shortness of breath improves during the first few days of hospitalization and its association with how fast you are breathing.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * ahfs is the primary working diagnosis for er management and treatment with planned admission * have received iv diuretic therapy * enrolled within 3 hours of initial diuretic dose exclusion criteria: * bnp level is ≤ 300 pg/ml (may be initially enrolled and then will be excluded for second assessment) * transplant recipients of any kind * fever \> 101.5 * severe lung disease (required home o2 or daily oral steroids) * any acs event within last 30 days * life expectancy less than 12 months for any reason * current treatment for any malignancy of any kind * cardiogenic shock and/or requiring iv inotropic therapy * pregnant or recently pregnant within last 90 days * inability to give appropriate written consent

Keywords: dyspnea shortness of breath respiratory rate orthopnea
long term safety study of (vit45) extension study: treatment of anemia in non-dialysis dependent chronic kidney disease

Conditions: Anemia

Summary: the primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing vit45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (ndd-ckd). this study is a long term extension to protocol 1vit04004 (nct00317239).

the primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing vit45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (ndd-ckd). this study is a long term extension to protocol 1vit04004. in this study patients that complete protocol 1vit 04004 or are discontinued will be offered to participate in this extension study.

Eligibility criteria:
inclusion criteria: * subjects who completed or discontinued protocol 1vit04004 exclusion criteria: * known hypersensitivity reaction to vit-45 * anemia not related to ckd * chronic, serious infection * recent iv iron other than study drug in past 12 weeks * recent blood loss within the last 12 weeks * need for surgery or dialysis * female subjects who are pregnant or lactating

Keywords: anemia ckd chronic kidney disease iron maintenance dose
multiple oncological serial scans study

Conditions: Breast Cancer

Summary: this is a pilot study comparing the appearance and volume of the post surgical region in the intact breast, as determined by 3 modalities: computed xray tomography (ct), 3 dimensional ultrasound (uss), magnetic resonance imaging (mri) after breast conserving surgery and during whole breast irradiation.

consenting patients who have undergone breast conserving surgery and who are planned to receive radiotherapy will have their first mri and ct scan within 2 weeks of treatment planning. this will be followed by 3 weeks radiotherapy treatment. 3d ultrasound scans will be performed in the first 2 weeks before radiotherapy, during the 2nd and 3rd weeks of radiotherapy and in the 2 weeks following radiotherapy.following the radiotherapy patients will undergo both ct and mri scans within 2 weeks of treatment completion.the whole process should take approximately 10 weeks.in this study the ct scans, mri scan + uss are above standard care and are the additional interventions in this study group.

Eligibility criteria:
inclusion criteria: all female patients who, after breast conserving surgery, are to undergo whole breast irradiation with or without a boost. ten patients will be for planned radiotherapy following both breast conservation surgery and chemotherapy and ten will be for planned radiotherapy following breast conservation surgery alone aged between 18 and 80years. - exclusion criteria: mastectomy t3 or t4 and n3 cases patients who have not undergone surgery severely claustrophobic patients patients unable to lie flat patients with any contraindications to mri -

Keywords: cancer, breast, radiotherapy, boost
brinzolamide/brimonidine combination vs brimonidine 0.2% in the prevention of iop rise after nd-yag laser capsulotomy

Conditions: Posterior Capsule Opacification; Ocular Hypertension

Summary: to compare the efficacy of a brinzolamide/brimonidine fixed combination (fc) with brimonidine 0.2% in preventing intraocular pressure (iop) elevations after neodymium: yttrium-aluminum-garnet (nd:yag) laser posterior capsulotomy.

in this prospective, randomized, double masked clinical trial, patients scheduled to undergo nd:yag laser posterior capsulotomy for posterior capsule opacification are randomized in 3 groups. the brimonidine group receives 1 drop of brimonidine 0.2%. the brinzolamide/brimonidine group receives 1 drop of brinzolamide 1%/brimonidine 0.2% fixed combination. the control group receives artificial tears. all groups are administered a single drop instillation, approximately one hour before nd:yag application. intraocular pressure measurements are performed before treatment (baseline) and at the 1, 3, 24 hours and 1 week post treatment. dexamethasone ophthalmic drops are prescribed q.i.d. for one week after the procedure.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo laser posterior capsulotomy due to posterior capsule opacification (pco) after uneventful phacoemulsification cataract extraction with implantation of posterior chamber intraocular lenses (iol/pc). exclusion criteria: * baseline iop greater than 21mmhg * glaucomatous eyes, already under treatment with anti glaucomatic medications * intraocular surgery except for uncomplicated cataract surgery * previous photorefractive surgery * active ocular inflammation or infection * patients under systemic administration of medications known to affect iop * patients with severe respiratory or cardiovascular disease * pregnant or breast feeding women, and individuals with known hypersensitivity or contraindication for administration of the medications tested * a measurement of iop \> 30 mmhg at any time point of the study, or an increase from baseline \>20 mmhg

Keywords: nd-yag capsulotomy ocular hypertension brimonidine brinzolamide