Kornimate/medical-research-clean huggingface dataset:
use of an oral beta-2 agonist in persons with spinal cord injury

Conditions: Spinal Cord Injury

Summary: the primary purpose of this study is to determine the effect of administration of the oral beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings with those obtained in a demographically matched group that will receive placebo. participation in this study will involve 12 weeks of pharmacological intervention during which participants will be randomized to receive either oral albuterol 4mg twice daily or placebo. all investigators and study participants will be blinded to randomization by our research pharmacy. participation in the study will require study subjects to come to our lab for the total of 2 visits (at baseline and after week 12), during which a series of tests will be performed to assess their respiratory muscle strength and pulmonary function.


Eligibility criteria:
inclusion criteria: * chronic spinal cord injury (\>1 year post-injury) * all american spinal injury association (asia) classifications * high paraplegia (level of injury t1-t6) * tetraplegia (level of injury c2-c8, non-ventilator dependent) exclusion criteria: * history of asthma * uncontrolled hypertension or cardiovascular disease * those using beta-2 adrenergic agonists * epilepsy or seizure disorder * hyperthyroidism * chronic corticosteroid use * those taking monoamine oxidase inhibitors or tricyclic antidepressants for depression * hypersensitivity to albuterol or any of its' delete components * pregnancy * use of ergogenic aids or supplements with anabolic characteristics including, but not limited to: * creatine monohydrate * anabolic steroids (e.g., testosterone) * growth hormone and their analogs and/or derivatives

Keywords: spinal cord injury beta-2 agonist respiratory muscle strength pulmonary function test
immune profiling in multiple myeloma

Conditions: Multiple Myeloma

Summary: this study propose to investigate the immune repertoire of mm patients at the time of diagnosis vs. 1st vs. 2nd vs. 3rd relapse. this study will provide insights into the immune status of mm patients before and after disease transformation and help identify patients who will benefit from immunotherapy. it will also allow us to predict the efficacy of these immune-mediated strategies and their associated toxicity. by understanding the immune-microenvironment in mm patients during disease progression, the investigator will be able to better design immunotherapeutic strategies for maximal success.

background: immunotherapy has emerged as a new therapeutic strategy for the treatment of multiple myeloma (mm). the current immune-based strategies include the fda-approved monoclonal antibodies elotuzumab1 and daratumumab2 targeting slamf7 and cd38 respectively, as well as immune approaches undergoing active clinical investigations such as bispecific t-cell engager,3 antibody-drug conjugate4 and cellular therapies like chimeric antigen receptor t cells.5-7 all of these treatment strategies are currently being tested in relapsed and refractory mm. however, mm patients, particularly those in the later stage of the disease, often have an impaired immune system.8-13 given their curative potential, the investigator believe that immunotherapies should be used up front when the patient's immune system is still capable of mounting a normal immune response. here the investigator propose to investigate the immune repertoire of mm patients at the time of diagnosis vs. 1st vs. 2nd vs. 3rd relapse. this study will provide insights into the immune status of mm patients before and after disease transformation and help identify patients who will benefit from immunotherapy. it will also allow us to predict the efficacy of these immune-mediated strategies and their associated toxicity. by understanding the immune-microenvironment in mm patients during disease progression, the investigator will be able to better design immunotherapeutic strategies for maximal success. samples: peripheral blood samples from 20 newly diagnosed, 20 relapsed and/or refractory mm patients and 10 healthy donors will be collected before therapy. an additional peripheral blood sample will be collected at relapse in patients experiencing an early relapse (within 12 months from the start of therapy). the project will include both a retrospective collection and a prospective collection of samples. samples will be used for the current study after informed consent from the patient. the samples will be processed by ficoll paque gradient to isolate peripheral blood mononuclear cells (pbmcs). peripheral blood serum will be collected as well. enrollment time: 9 months

Eligibility criteria:
inclusion criteria: * newly diagnosed mm patients or * refractory mm patients or * healthy donors. esclusion criteria: * not newly diagnosed mm patients or * not refractory mm patients or * no healthy donors.

Keywords: immune transcriptome profile drop-seq immune signatures cytof cytokine profile
efficacy, safety, and tolerability of valbenazine for the treatment of chorea associated with huntington disease

Conditions: Chorea, Huntington

Summary: this is a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine to treat chorea in participants with huntington disease.


Eligibility criteria:
inclusion criteria: 1. have a clinical diagnosis of huntington disease (hd) with chorea 2. be able to walk, with or without the assistance of a person or device 3. participants of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently while participating in the study until 30 days (females) or 90 days (males) after the last dose of the study drug 4. be able to read and understand english exclusion criteria: 1. have a history of previously established therapy with a vmat2 inhibitor, in the judgement of the investigator 2. have difficulty swallowing 3. are currently pregnant or breastfeeding 4. have a known history of long qt syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular block, uncontrolled bradyarrhythmia, or heart failure 5. have an unstable or serious medical or psychiatric illness 6. have a significant risk of suicidal behavior 7. have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening 8. if taking antidepressant therapy, be on a stable regimen 9. have received gene therapy at any time 10. have received an investigational drug in a clinical study within 30 days of the baseline visit or plan to use such investigational drug (other than valbenazine) during the study 11. have had a blood loss ≥550 milliliters (ml) or donated blood within 30 days before the baseline visit 12. had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome

Keywords: huntington's huntington chorea movement disorder valbenazine hd tetrabenazine vmat2-inhibitor
lurasidone and cognition in bipolar i disorder

Conditions: Bipolar I Disorder

Summary: this is a 6 week, randomized, open-label, parallel group study in patients with bipolar-i disorder (manic depression), who are in remission from an episode. participants who show cognitive impairment at baseline will be randomized to receive open-label lurasidone added on to their current medication(s) or continue their usual treatment for 6 weeks. participants will have 3 clinical visits and 2 telephone appointments during the study. given the preliminary evidence for efficacy of lurasidone in improving cognition in schizophrenia, we propose to examine the efficacy of lurasidone in improving cognition in bipolar patients.


Eligibility criteria:
inclusion criteria: 1. all patients must be taking either lithium or valproate or one of the atypical antipsychotics for mood stabilization. 2. patients who show cognitive impairments (-0.25 standard deviations (sd) or below) on either the trail making test- trial b (tmt-b) or california verbal learning test (cvlt) trials 1 to 5, or cvlt long delay free recall, at baseline visit. 3. males or females aged 19 to 65 years inclusive. 4. diagnostic and statistical manual iv edition (dsm-iv tr) diagnosis of bipolar type i disorder, with or without a history of psychosis. 5. clinically stable with a montgomery asberg depression rating scale (madrs) and young mania rating scale (ymrs) score less than or equal to 8. 6. a sufficient level of english using a language screening questionnaire. 7. capability of understanding, consenting to, and complying with the requirements of the study. exclusion criteria: 1. a history of unstable or inadequately treated medical illnesses, including moderate to severe brain injury, or neurological illnesses impacting cognitive function. 2. treatment with electroconvulsive therapy (ect) within eight weeks prior to enrolment; or treatment with an experimental drug within 30 days prior to enrolment. 3. axis i diagnosis of substance abuse or dependence within the past month. 4. significant risk of harm to self or others, in the opinion of the investigator. 5. pregnancy or lactation in female subjects. 6. liver function tests (ast and alt) three times the upper limit of normal. -

Keywords: bipolar disorder cognition euthymic lurasidone
symbicort smart (symbicort maintenance and reliever therapy)

Conditions: Asthma

Summary: the purpose of this study is to investigate the extent of symbicort use in patients prescribed symbicort as maintenance and reliever therapy.


Eligibility criteria:
inclusion criteria: * asthma patients prescribed symbicort as maintenance and reliever therapy, according to the label, before inclusion in this program. exclusion criteria: * since this programme intends to describe symbicort use in routine clinical practice when prescribed as symbicort maintenance and reliever therapy, there are no programme specific exclusion criteria, other than: involvement in the planning and conduct of the programme (applies to both astrazeneca staff or staff at the investigational site)

Keywords: asthma symbicort smart inhaler compliance naturalistic observational
observational registry on the harpoon device

Conditions: Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse

Summary: to collect data on the harpoon™ mitral valve repair system for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.

this is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.

Eligibility criteria:
inclusion criteria: * subjects who are clinically suitable for treatment with the harpoon™ system, as per the instructions for use (ifu), will be evaluated for inclusion in the registry. exclusion criteria: * n/a

Keywords: mitral valve mid-segment posterior leaflet prolapse of the mitral valve heart valve chordae tendinae valve disease mitral regurgitation harpoon mitral valve repair posterior leaflet prolapse beating heart intervention heart disease cardiovascular disease
development of a transdiagnostic intervention for adolescents at risk for serious mental illness

Conditions: Anxiety Disorders; Psychotic Disorders; Depressive Disorder; Psychosocial Functioning

Summary: this research study aims to develop a brief group-based treatment called resilience training for teens, then to test how well it protects high school students with mild symptoms of depression, anxiety, or having unusual feelings from developing mental illnesses.


Eligibility criteria:
inclusion criteria: * currently enrolled in 9th through 12th grade and between the ages of 14 and 19 * endorsed at least one psychotic experience * provided contact information * have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18) * have a parent or legal guardian who is able and willing to participate in a parent session * competent and willing to provide written informed assent (if under the age of 18) or consent (if age 18 or older) * able to communicate in english exclusion criteria: * currently prescribed psychotropic medication (not including medications for attention deficit/hyperactivity disorder), regardless of adherence * currently obtaining psychotherapeutic intervention
femoral vs radial approach and mri evaluation of strokes

Conditions: Aortic Stenosis

Summary: symptomatic cerebral infarction following cardiac catheterization is rare but silent brain injury could occur at an unexpectedly high rate. one study has found that up to 22% of patients with severe aortic stenosis who have undergone retrograde catheterization of the valve can be identified as having new ischemic lesions as detected by diffusion-weighted (dw) magnetic resonance imaging (mri). during cardiac catheterization, cerebral microembolism as detected by tcd has frequently been observed, but whether it is clinically relevant remains unknown . however, recent studies have suggested that some of these microemboli could be responsible for acute brain injury, as documented by dw mri. indeed the high sensitivity of dw mri suggests that this technique could allow an improved estimate of cerebral ischemic events associated with cardiovascular-catheter procedures. we therefore decided to perform dw mri before and after cardiac catheterization to prospectively assess both clinically silent and apparent cerebral embolisms for the first time in a multicenter trial. furthermore, a randomization between radial and femoral access will allow assessment of risk of silent brain injury associated with the different vascular access sites.


Eligibility criteria:
inclusion criteria: * patient with significant aortic valve stenosis before planned surgery. exclusion criteria: * contraindication to mri or inability to give written informed consent.

Keywords: aortic stenosis radial femoral vascular access site embolism cerebral mri stroke
rilvegostomig + chemotherapy as adjuvant therapy for biliary tract cancer after resection (artemide-biliary01)

Conditions: Biliary Tract Cancer

Summary: a global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with btc after surgical resection with curative intent.

this is a phase iii, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, s-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with btc after resection with curative intent. this study will be conducted in patients with btc who are at risk of recurrence after resection with curative intent.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (cca) or muscle invasive gallbladder cancer (gbc)) after macroscopically complete resection (r0 or r1) * provision of a tumor sample collected at surgical resection. * randomization within 12 weeks after resection with adequate healing and removal of drains. * confirmed to be disease-free by imaging within 28 days prior to randomization. * eastern cooperative oncology group performance status of 0 or 1 exclusion criteria: * participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis. * ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors. * any anti-cancer therapy for btc prior to surgery * active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease * current or prior use of immunosuppressive medication within 14 days before the first dose * thromboembolic event within 3 months * active hbv or hcv infection unless treated.

Keywords: adenocarcinoma of the biliary tract biliary tract cancer gall bladder cancer intrahepatic cholangiocarcinoma distal cholangiocarcinoma perihilar cholangiocarcinoma klatskin tumors bile duct cancer immunotherapy cholangiocarcinoma rilvegostomig s-1 gemcitabine/cisplatin capecitabine
women's evaluation of the childbirth experience: from pregnancy to postpartum

Conditions: Childbirth Problems; Pregnancy Related; Behavior Problem

Summary: women report inappropriate health professional behaviour towards them during pregnancy or childbirth on social networks. however, to date, no data are available to estimate the number of women concerned. these data are necessary to characterize these behaviours to get out of this polemic and build a reflection on the improvement of the patient relationship and the emotional security of women.


Eligibility criteria:
inclusion criteria: * major women * who understand french language exclusion criteria: * women refusing to participate * having given birth at home * whose fetus or newborn has died
sitagliptin metformin/pparg agonist combination therapy add-on (0431-052)

Conditions: Type 2 Diabetes Mellitus

Summary: a clinical study to determine the safety and efficacy of sitagliptin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin/peroxisome proliferator-activated receptor gamma (pparg) agonist combination therapy.


Eligibility criteria:
inclusion criteria: * patient has type 2 diabetes mellitus * patient is inadequately controlled while taking two oral antidiabetic medications exclusion criteria: * patient has a history of type 1 diabetes mellitus or history of ketoacidosis * patient required insulin therapy within the prior 3 months * patient has been taking byetta (r) (exenatide) within the prior 3 months

Keywords: type 2 diabetes mellitus
evaluation of a cohort of patients with ehlers-danlos syndrome treated with orthopedic surgery (sed-eval)

Conditions: Ehlers-Danlos Syndrome

Summary: the aim of this study is to assess the joint involvement (shoulder - ankle - knee - elbow - wrist) in patients with ehlers-danlos syndrome and treated by surgery.


Eligibility criteria:
inclusion criteria: * patient over 18 years-old suffering from ehlers-danlos syndrome and belonging to the eds cohort of raymond poincaré hospital in garches * patient with joint involvement of the shoulder treated by surgery * patient with ankle joint damage treated by surgery * patient with joint damage to the knee treated by surgery * patient with elbow joint damage treated by surgery * patient with joint involvement of the wrist treated by surgery * patient affiliated or beneficiary of a social security scheme * patient who has been informed of the research and does not object to the use of his data. exclusion criteria: * patient objecting to the use of their data
the effect of three different analgesic techniques on the incidence of postoperative nausea and vomiting

Conditions: Post Operative Nausea and Vomiting

Summary: postoperative nausea and vomiting (ponv) is a distressing adverse effect that may result in postoperative complications including bleeding, wound dehiscence, aspiration pneumonitis, as well as fluid and electrolyte imbalances incidence of ponv after general anesthesia is about 30% in all post-surgical patients but up to 80% in high-risk patients despite advances in anesthetics and anesthesia techniques

postoperative nausea and vomiting (ponv) is a distressing adverse effect that may result in postoperative complications including bleeding, wound dehiscence, aspiration pneumonitis, as well as fluid and electrolyte imbalances. the incidence of ponv after general anesthesia is about 30% in all post-surgical patients but up to 80% in high-risk patients despite advances in anesthetics and anesthesia techniques. despite new antiemetic drugs the overall incidences remain high especially in subjects with increased patient-related risk-factors such as in female gender, non-smoking status, a history of motion sickness or previous ponv, inhalational anesthetics, certain types of surgery, and opioid use. scleral buckling (sb) which is still thought to be the most efficacious and cost-effective primary procedure for the treatment of uncomplicated retinal detachment is often associated with postoperative pain as well as nausea and vomiting. preoperative injections of local anesthetics via retrobulbar, peribulbar, or subtenon routes in patients undergoing vitreoretinal surgery under general anesthesia (ga) have been reported to reduce postoperative pain, nausea, and vomiting. topical lidocaine drops have also has been used intraoperatively to decrease the incidence and severity of the ocr and to prevent pain and ponv after strabismus surgery and vitrectomy without scleral buckling . the current study was designed to compare the effect of three different analgesic techniques ; iv analgesia , peribulbar block and topical xylocaine jel on the incidence of ponv after scleral buckling under general anesthesia.

Eligibility criteria:
inclusion criteria: * males or females * aged between 18-80 years * asa physical status ι\&ii -indicated for repair of retinal detachment with scleral buckling. - exclusion criteria: * patients with cardiac, liver and/or kidney diseases * coagulation defects or receiving anticoagulants * hypersensitivity to the used drugs * history of motion sickness or ponv * diabetes mellitus * gastrointestinal disease * smokers * menstruating ladies * asa status more than ii

Keywords: nausea, vomiting
arginine plaque metabolism pilot clinical study

Conditions: Plaque, Dental

Summary: proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.


Eligibility criteria:
inclusion criteria: * signed informed consent form. * male and female subjects aged 18-70 years, inclusive. * availability for the nine-week duration of the clinical research study. * good general health based on the opinion of the study investigator * good general health exclusion criteria: * moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study. * five or more carious lesions requiring immediate care. * concurrent participation in any other oral care clinical study or test panel. * self-reported pregnant or lactating women. * dental prophylaxis received in the past four weeks prior to baseline examinations * history of tobacco use-smoking, vaping and chewing tobacco * presence of orthodontic bands, presence of partial removable dentures * tumor(s) of the soft or hard tissues of the oral cavity * use of antibiotics or stain inducing medications any time during the two month prior to entry into the study * use of oral care products containing antimicrobials (zn, sn, cpc, triclosan, alcohol containing mouthwash, etc

Keywords: saliva