Kornimate/medical-research-clean huggingface dataset:
assessment of ank-700 in patients with relapsing remitting multiple sclerosis

Conditions: Multiple Sclerosis (MS); Relapsing Remitting Multiple Sclerosis

Summary: a safety study of ank-700 in patients with relapsing remitting multiple sclerosis. the study has two parts: part a - first in human study in which patients receive a single dose of ank-700 part b - patients will receive three doses of either ank-700 or placebo

study ank-700-01 is a phase 1, fih study designed to evaluate the safety and tolerability of ank-700 in patients with relapsing remitting multiple sclerosis (rrms). an overview of the two parts and proposed dose groups is given below: part a (sad): patients will receive a single dose of ank-700. part b (mad): patients will receive three doses of either ank-700 or placebo.

Eligibility criteria:
inclusion criteria: * diagnosed with rrms per revised mcdonald criteria (2017) with an edss score ≤ 6.5 at screening * neurologically stable with no evidence of relapse within the 28 days before signing the informed consent form (icf) * either not currently receiving disease modifying ms therapy, or currently using fumarate drugs (dimethyl fumarate or diroximel fumarate) * patients must use a highly effective method of birth control or are sterile or postmenopausal as confirmed by study investigator * patient has signed and understands the icf exclusion criteria: * diagnosis of primary progressive ms or secondary progressive ms * uncontrolled or significant medical conditions (including active infection or chronic hepatitis) which, in the opinion of the investigator, preclude participation * patients treated with glatiramer acetate, parenteral steroids or adrenocorticotropic hormone, β-interferon, plasma exchange within the 3 months prior to first dose * patients treated with sphingosine-1-phospate receptor modulators such as fingolimod, ozanimod, or siponimod within 6 months prior to first dose * patients treated with cytotoxic agents (including, but not limited to, cladribine, mitoxantrone, cyclophosphamide, azathioprine, and methotrexate), laquinimod, teriflunomide, or iv gamma globulin within 12 months prior to first dose * patients treated with monoclonal antibody therapy (including natalizumab, daclizumab, rituximab, ofatumumab, and ocrelizumab) within 24 months prior to first dose * patients previously treated with alemtuzumab, total lymphoid irradiation, mesenchymal stem cell or hematopoietic stem cell transplantation, or tolerance-inducing therapies for ms * contraindication to or inability to undergo gadolinium-enhanced magnetic resonance imaging (mri) scan * use of any investigational drug or experimental procedure within previous 6 months that would interfere with the assessment of ank-700 * patients who are pregnant or breastfeeding * patients receiving any vaccination within 28 days prior to first dose * patient does not agree to limit alcohol intake to 2 drink equivalents or less per day during the study

Keywords: autoimmune multiple sclerosis (ms) relapsing remitting ms
dexamethasone and ondansetron versus placebo for postoperative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: the investigators want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.

obese patients having bariatric surgery have frequently postoperative nausea and vomiting (ponv). we want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia. two groups to be studied: one will receive 4 mg dexamethasone at the end of the anesthetic induction and 4 mg ondansetron at the end of the surgical procedure, one will receive normal saline. one hundred twenty consecutive patients meeting the inclusion and exclusion criteria and who give written informed consent to participate in the study will be randomly assigned to one of two experimental groups using a 1:1 ratio. patients will be continuously monitored in the post anesthesia care unit (pacu) and the medical floor for a total of 24 hours post operatively. episodes of nausea, vomiting and administration of rescue therapy for either nausea or vomiting will be recorded and time stamped. in addition, severity of nausea will be evaluated by the patient using a standard verbal response scale (vrs) ranging from 0-10, 0 being no nausea and 10 being severe nausea. rescue therapy for ponv episodes will consist of 4 mg ondansetron followed by 0.625 mg droperidol if necessary.

Eligibility criteria:
inclusion criteria: * adult patients aged 18-75 years * scheduled for bariatric surgery under total intra-venous closed-loop anesthesia * apfel score equal or greater than 2 * consenting to participate in the study exclusion criteria: * pregnant, breast feeding women * allergy * contraindication to dexamethasone * contraindication to ondansetron * contraindication to propofol, remifentanil, morphine, ketoprofen * limit to the use of bispectral index

Keywords: anesthesiology complications closed-loop
efficacy and safety study of a combination product [drug:bci-024 (buspirone) and drug:bci-049 (melatonin)] to treat major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of drug bci-024 (buspirone) and drug bci-049 (melatonin), in reducing symptoms of depression in patients with major depressive disorder. the safety and tolerability of the combination product will also be evaluated as measured by adverse events and vital signs.

approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria will be randomized in the study.

Eligibility criteria:
inclusion criteria: * subjects will be male and female subjects between the ages of 18 to 65 meeting the diagnostic and statistical manual of mental disorders-iv-text revision (dsm-iv-tr) criteria for major depressive disorder with a quick inventory of depressive symptomatology-16 item self report (qids-sr16) score of \>14 at the screening and baseline visits. * female subjects must be on a stable and medically reliable form of birth control, must agree to continue use of this birth control during the study, and must have negative urine pregnancy tests at the screening visit. exclusion criteria: * subjects with any other psychiatric axis-i disorder as a principal diagnosis within 6 months of screening or subjects with a history of obsessive compulsive disorder, psychotic disorder, bipolar disorder, or mental retardation at any time are not eligible for the study. * subjects who pose a suicidal risk or who have a history of eating disorder or substance dependence within 6 months of screening, or a history of substance abuse within 3 months of screening are also ineligible. * subjects with clinically significant abnormalities on any screening or baseline assessments, including laboratory tests, are excluded. * subjects with a known intolerance to either buspirone or melatonin are excluded, as are subjects with clinically significant medical or psychiatric conditions that might be detrimental to the subject should they participate in the study. * subjects who have used selective serotonin reuptake inhibitors (ssris) within 2 weeks of screening (within 4 weeks for fluoxetine) are excluded as are subjects requiring concomitant use of antipsychotic and anxiolytic medications and any drugs with known psychotropic properties. concomitant medications that are not excluded by the protocol and that are taken chronically must be at a stable dosage for at least 4 weeks prior to screening.

Keywords: depression
chronic neuropathic pain after lung surgery: prevalence and predictive factors

Conditions: Pain

Summary: chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. surgical approach as well as other factors (genetic, psychological) could have a major and independent role in the development of the post operative pain.the main objective of this study is to identify genetic and psychological profile (cognitive and emotional) of patients who develop chronic pain after lung surgery.


Eligibility criteria:
inclusion criteria: * undergoing lung resection surgery. * 18 years and older (without superior limit); * affiliated to french "securité sociale" exclusion criteria: * emergency procedure * litigation or search for compensation; * previous intervention in the same region; * peripheral neurological pathology (polyneuropathy) or central (brain damage, multiple sclerosis ...) that may interfere with the evaluation of the post-operative pain * participation in another biomedical research protocol if there is an incompatibility with the present protocol. * mental disability * vulnerable person within the meaning of french law, * poor understanding of french.

Keywords: lung surgery
effectiveness and safety of adalimumab in rheumatoid arthritis patients in routine clinical practice

Conditions: Rheumatoid Arthritis

Summary: observation of safety, tolerability and effectiveness of adalimumab (humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period.

patients with rheumatoid arthritis and started treatment with adalimumab in a normal clinical setting according to the label were documented. the follow-up observation period was for 5 years and focused on safety information and maintenance of efficacy during the normal clinical setting. follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.

Eligibility criteria:
inclusion criteria: * moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including methotrexate. * moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before. * in case of incompatibility with methotrexate, adalimumab can be used as monotherapy exclusion criteria: * hypersensitivity against the drug or one of the other ingredients; active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections); moderate to severe cardiac insufficiency

Keywords: safety rheumatoid arthritis effectiveness
a study to assess the effect of ro4607381 in patients with relatively low levels of high density lipoprotein-cholesterol (hdl-c)

Conditions: Dyslipidemia

Summary: this 4 arm study will evaluate the efficacy and safety of ro4607381 when co-administered with pravastatin in patients with low or relatively low hdl-c levels. patients will be randomised to one of 4 groups to receive either ro4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.all patients will also receive pravastatin 40mg po daily for 12 weeks.the anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients 18-75 years of age; * dyslipidemic patients with low or relatively low hdl-c levels during treatment with pravastatin. exclusion criteria: * women who are pregnant, breastfeeding, or of child-bearing potential; * morbid obesity; * uncontrolled hypertension; * poorly controlled or insulin-treated diabetes; * high creatinine levels or history of statin-associated myopathy.
xuanwuh acute ischemic stroke registry

Conditions: Acute Ischemic Stroke

Summary: acute ischemic stroke registry--xuanwu hospital(xsr) is an academic, independent, prospective, single center, observational registry study. consecutive acute ischemic stroke patients assessed in stroke "green channel" of xuanwu hospital(china) will be enrolled in our study. patients receive regular treatment and data will be collected as part of clinical routine. baseline clinical and procedural information as well clinical follow-up information during in-hospital stay, and up to 90 days of stroke onset are collected. data collected include demographics, national institute of health stroke scale (nihss) on admission, pre-treatment aspects, information on timing and success of thrombolysis or thrombectomy, procedural complications, intracranial hemorrhage, and functional outcome.the study aim to investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients in "green channel",and verify the effect of the improvement of "green channel" process in the diagnosis and treatment of patients with acute ischemic stroke.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute ischemic stroke or transient ischemic attack(tia) * age \>18 years * ethic approval in process * receiving assessment in stroke "green channel" of xuanwu hospital exclusion criteria: * non-acute ischemic stroke

Keywords: stroke cerebrovascular disease
systemic targeted adaptive radiotherapy of neuroendocrine tumors.

Conditions: Neuroendocrine Tumors

Summary: there are several ways of personalizing prrt (peptide receptor radionuclide treatment) in nen (neuroendocrine neoplasia). nevertheless, the current treatment regimen is not personalized. this trial aims to compare personalized prrt to non-personalized prrt in terms of safety, efficacy and resource demands in order to optimize treatment outcomes in an evidence-based manner in future.


Eligibility criteria:
inclusion criteria: * age ≥18 years * written informed consent * eastern cooperative oncology group (ecog) 0-1 * presence of histologically confirmed, advanced, well-differentiated, inoperable neuroendocrine tumors (net) of any primary tumor origin and any grade, except for pheochromocytoma and paraganglioma. * somatostatine receptor (sstr)-expression in tumor lesions \> basal liver uptake on 68ga-dota-pet * radiologically progressive disease within the last 1-24 months according to common clinical criteria and confirmed by the institutional multidisciplinary conference for the treatment of nets. the ct/mri that shows tumor progression compared to screening/baseline must have been performed 1-24 months earlier. * all previous anti-tumor treatment except ssa must be terminated at least 4 weeks before start of treatment within the trial. * measurable disease according to recist v 1.1 * given the available, approved anti-tumor treatments and the specific characteristics of the patient and the tumor, the investigator judges peptide receptor radionuclide therapy (prrt) to be the treatment of choice * gfr \> 50 ml/min/1.73 m2 as determined by iohexol- or 51cr-edta clearance, calculated according to a combination of lmr18 and capa formulas, or equally accurate method * hemoglobin \> 90 g/l, platelets \>100 x109/l, leukocytes \> 3.0x109/l, neutrophils \> 1.5 x109/l, aspartate transaminase (asat)/alanine aminotransferase (alat) \ 25 g/l * for women of child-bearing potential, highly effective contraception should be used from the time of inclusion up to at least six months after the end of treatment (eot) visit. exclusion criteria: * pregnancy or lactation * previous treatment with prrt * concomitant systemic anti-tumor therapy other than somatostatin analogue (ssa) * contraindications for treatment with capecitabine according to the approved label. * discordance between ct/mri/18f-fdg-pet and 68ga-dota-pet, with evidence of tumor lesions without uptake on 68ga-dotatoc. * any other serious, uncontrolled medical or psychiatric condition that, in the opinion of the investigator, precludes the patient from participation in the trial * unwillingness, or inability, to participate in any part of the trial procedures or treatments.

Keywords: neuroendocrine tumors radionuclide therapy personalized radionuclide therapy 177lu-dotatoc capecitabine dosimetry-based radionuclide therapy somatostatin receptor lutetium beta- and gamma-emitting radionuclide translational research
comparison of the acute effects of different warm-up protocols in overhead athletes with posterior shoulder tightness

Conditions: Posterior Shoulder Tightness

Summary: the aim of this study is to investigate the immediate effects of different warm-up protocols on shoulder mobility, muscle stiffness, muscle power performance, shoulder functional ability and shoulder endurance in overhead athletes with posterior shoulder tightness


Eligibility criteria:
inclusion criteria: * recreational or amateur athletes between the ages of 18 and 40 * training time exceeding four hours per week * shoulder internal rotation is reduced by more than 15 degrees compared to the non-dominant side, or the sum of shoulder external rotation and internal rotation is less than 15 degrees compared to the non-dominant side or shoulder horizontal adduction is reduced by move than 15 degrees compared to the non-dominant side exclusion criteria: * shoulder pain within the past three months * history of shoulder fracture, dislocation, or soft tissue tear surgery in the past * contraindications for massage include: open wounds in the treatment area, skin cancer, infections in the treatment area, and severe edema

Keywords: posterior shoulder tightness
tdcs for increasing exercise adherence in depressed individuals

Conditions: Depression; Physical Activity

Summary: the purpose of this study is to examine the efficacy of tdcs (transcranial direct current stimulation) for increasing exercise adherence among low active individuals with elevated depressive symptoms. the investigators expect that this project will contribute much needed knowledge about the role that tdcs can play in changing the affective experience of exercise.

exercise adherence is a significant public health problem. affective experiences during exercise predict long-term physical activity (pa) levels. therefore, approaches to improving the affective experience of exercise are both important and likely to have high impact. this may be particularly true among individuals with elevated depressive symptoms due to their tendency toward more negative and less positive affect. tdcs is a noninvasive brain stimulation approach with a growing body of literature supporting its effects on cognitive and emotional processing in varied populations, including some support for those with depression. in addition, there is recent increased interest in utilizing tdcs in the context of exercise (see above) and in obesity prevention. while the effects of tdcs on behavioral and cognitive functioning are still developing, promising findings have emerged for tdcs used in repeated combination with a behavioral or cognitive intervention. given that tdcs is relatively safe, inexpensive, and portable, individuals who struggle with enjoying exercise could be afforded a practical option for increasing and maintaining physical activity levels. we propose to conduct a pilot randomized controlled trial of tdcs versus sham delivered 3x/week for 8 weeks in the context of a supervised aerobic exercise (ae) program among 72 low-active individuals with elevated depressive symptoms. follow-up assessments will be conducted at end of treatment, 3, and 6 months.

Eligibility criteria:
inclusion criteria: * be between 18 and 65 years of age * be low active * have elevated levels of depressive symptoms * interested in starting an exercise program in the next month exclusion criteria: * history of mania or hypomania * current psychotic disorder * current dsm-5 diagnosis of an eating disorder * dsm-5 moderate and severe substance use disorder * current suicidality or homicidality * current dsm-5 diagnosis of major depressive disorder that is not currently being treated with pharmacotherapy or psychotherapy * physical disabilities or medical problems that would prevent participation in moderate intensity exercise or may be contraindicated for tdcs * current pregnancy or intent to become pregnant during the next 8 weeks * pacemaker or metal implanted in the cranial cavity
observational study on the effect of switch to lurasidone in subjects with schizophrenia"

Conditions: Schizophrenia

Summary: the aim of this study is observation, in an italian real-world setting, of metabolic effects in patients with schizophrenia who will switch from any mono-therapy or poly-therapy antipsychotic regimen to monotherapy with lurasidone or to one of the other four most used atypical antipsychotics.

the aim of this study is the observation, in psychiatric italian real-world settings, of metabolic effects, effectiveness, side effects and therapeutic adherence in patients with schizophrenia who switched, for any reason (efficacy, safety, metabolic problems, therapeutic adherence or patient's request), from any mono-therapy or poly-therapy antipsychotic regimen to monotherapy with lurasidone or with one of the four most used atypical antipsychotics in italy (aripiprazole, olanzapine, quetiapine, risperidone). patient's past medical and psychiatric history of the last 12 months will be also evaluated.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of schizophrenia according to dsm-5. * patients who gave their written consent for participation in the study and for personal data processing and willing to comply with all study procedures. * male and female patients ≥ of 18 years old at baseline. * patients treated or in treatment with any typical or atypical antipsychotic monotherapy or polytherapy. * patients switched from the pre-existing therapy to lurasidone, aripiprazole, olanzapine, quetiapine or risperidone in monotherapy within the preceding 2 weeks. the date of the switch is considered as baseline. exclusion criteria: * female patients who are pregnant or lactating * patients fulfilling dsm-5 criteria for diagnosis of bipolar disorder and/or dementia. * amphetamines and/or opiates abuse or dependence , as defined by dsm-5 criteria. * patients with no history of antipsychotics use. * patients recruited in another study as follows: * currently enrolled in any pharmacological or non-pharmacological, interventional or observational study: * who participated in the last 30 days to any observational or no-profit interventional study; * who participated in the last 12 months to any interventional commercially sponsored study.

Keywords: schizophrenia lurasidone antipsychotics metabolic syndrome switch