Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of intrathecally administered ro7234292 (rg6042) in participants with manifest huntington's disease

Conditions: Huntingtons Disease

Summary: this study will evaluate the efficacy, safety, and biomarker effects of ro7234292 (rg6042) compared with placebo in participants with manifest huntington's disease (hd)


Eligibility criteria:
inclusion criteria: * manifest hd diagnosis, defined as a dcl score of 4 * independence scale (is) score \>= 70 * genetically confirmed disease by direct dna testing with a cap score \>400 * clinical assessment to ensure individual has intact functional independence at baseline to maintain self-care and core activities of daily living (adls). exclusion criteria: * any serious medical condition or clinically significant laboratory, or vital sign abnormality or claustrophobia at screening that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study * pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug

Keywords: hd, rg6042, intrathecal, aso, antisense oligonucleotide
effects of core stability training on gait in multiple sclerosis patients

Conditions: Multiple Sclerosis; Gait Disorders, Neurologic

Summary: gait and mobility are among the functions frequently affected in multiple sclerosis (ms) and have a negative impact on quality of life. strength losses in lower limb muscles, ataxia, sensory problems and fatigue are the most important reasons of walking problems in patients with ms. in addition to loss of strength and tonus problems, especially biomechanical disorders can be seen on foot and this problem affects gatin and balance negatively. the stabilizing muscles, defined as the "core" region and enveloping the body like a corset, are active in the context of postural preparation prior to lower extremity movements and stabilize for the limb movements to be performed. the aim of this study was to investigate the effects of spinal stabilization exercises on walking performance, fatigue, plantar pressure distribution, balance, muscle strength and quality of life in patients with multiple sclerosis.


Eligibility criteria:
inclusion criteria: * older than 18 years old * edss score is between 3-5,5 * patients who did not take corticosteroid therapy within three months * patients who get at least 24 points from the mini mental test were included in the study. exclusion criteria: * patients who had an acute ms attack or had an attack within the last three months. * an orthopedic or systemic problem that would prevent participation in exercises * patients who were using walking orthoses or walking aids were not included in the study.

Keywords: multiple sclerosis gait spinal stabilization exercises plantar pressure distribution rehabilitation
a study to investigate the efficacy and safety of anifrolumab administered as subcutaneous injection and added to standard of care compared with placebo added to standard of care in adult participants with idiopathic inflammatory myopathies (polymyositis and dermatomyositis)

Conditions: Polymyositis, Dermatomyositis

Summary: the purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe idiopathic inflammatory myopathies (iim) \[polymyositis (pm) or dermatomyositis (dm)\] while receiving standard of care (soc) treatment.


Eligibility criteria:
capable of giving informed consent. inclusion criteria: 1. 18 - 75 years old 2. body weight 40 kg - ≤ 100 kg 3. must have "probable" or "definite" diagnosis of pm or dm according to the 2017 acr/eular classification criteria for adult myositis. 4. moderate or severe disease activity per core set measurements. 5. currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose. 6. no history of active tuberculosis or severe covid-19. 7. male and female participants must follow contraception guidelines. exclusion criteria: 1. participants with documented inclusion body myositis (ibm), immune mediation necrotizing myositis (imnm), juvenile myositis (if diagnosed within 10 years prior to signing the icf), drug-induced myositis, cancer associated myositis, amyopathic dm, and non inflammatory myopathies (eg, muscular dystrophies). 2. pm and dm patients at a high risk of malignancy. 3. participants with rapidly progressive interstitial lung disease. 4. participants with severe muscle damage or permanent weakness due to non-pm or non-dm conditions (i.e. stroke) as per the investigator's opinion. 5. any history of severe case of herpes zoster infection 6. history of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, hiv, hbv, active hcv . 7. any clinical cytomegalovirus or epstein-barr virus infection that has not completely resolved within 12 weeks prior to signing the icf. 8. opportunistic infection requiring hospitalization or iv antimicrobial treatment within 3 years prior to randomization. 9. recent non-opportunistic infection requiring hospitalization or anti-infective treatment. 10. recent or concurrent enrollment in another clinical study with an investigational product. 11. lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

Keywords: polymyositis dermatomyositis anifrolumab
long-term safety study of vildagliptin in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. this study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-gi), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in japan.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-gi, or glinides monotherapy * age in the 20 years or over inclusive * hba1c in the range of ≥ 6.5 to ≤ 10% exclusion criteria: * type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * significant heart diseases * significant diabetic complications

Keywords: vildagliptin, type 2 diabetes, hba1c, fasting plasma glucose, long-term safety
patients understanding of prom graphs

Conditions: Orthopedic Disorder

Summary: this study evaluates patients' ability to understand prom scores when presented in graphs. one half will receive one version of the survey, while the other half will receive a second version of the survey.


Eligibility criteria:
inclusion criteria: * patient at stanford clinics * orthopaedic condition exclusion criteria: -
impact of cytomegalovirus (cmv) replication over hepatitis c recurrence in liver transplant recipients

Conditions: Cytomegalovirus Infection; Hepatitis C

Summary: the relationship between cytomegalovirus infection and recurrence of hepatitis c in liver transplant recipients remains controversial. although some studies (teixeira et al., 2000; singh et al., 2005)have not found an association between recurrence of hepatitis c and cmv infection, studies such as rosen et al. show that 50% of patients with cmv infection suffered cirrhosis durig follow-up period, while between not-infected patients the rate was 11%. to clarify this question, a non-interventional study will be carried out in order to assess if cmv replication is a risk factor for graft dysfunction in liver transplant recipients.


Eligibility criteria:
inclusion criteria: * men or women who underwent liver transplantation after hepatopathy caused by hcv, confirmed by pre-transplantation detection of hcv rna * age \> 18 years old exclusion criteria: * patients co-infected with hbv or hiv * patients who show other causes of liver disease

Keywords: cytomegalovirus liver transplantation hepatitis c virus patients who underwent first liver transplantation due to hepatopathy caused by hcv,confirmed by detection of hcv rna previously to transplantation
evaluate the reconstruction of digital nerve defects in humans using an implanted silk nerve guide

Conditions: Peripheral Nerve Injury Digital Nerve Hand

Summary: the goal of this study is to ascertain the feasibility and safety of the procedure using silkbridge - a biocompatible silk fibroin-based scaffold - for the regeneration of sensory nerve fibres and follow it up together with the reinnervation of the target organs (sensory receptors in the skin).

this is a pre-market, monocentre, first-in-human pilot on adult patients with digital nerve defects. category c clinical trial, medical devices. the study will be performed in switzerland. silkbridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments. silkbridge will provide surgeons with an implant with unique features, such as easy suturability, full biocompatibility and specific biomimetic properties that enhance cells adhesion and integration of the device with the surrounding tissue. the study will have a 12 months and 1 week duration per patient, including the follow-up period, and with an expected enrollment period of 15 months. the study will evaluate 15 adult patients, aged 18-65 years, diagnosed with digital nerve defects (\> 5 mm gap) in whom surgical repair may not allow direct suture.

Eligibility criteria:
inclusion criteria: * male \& female patients between 18 and 65 years of age * a traumatic injury or a post-traumatic neuroma of a digital nerve on the palmar side of the hand, between the metacarpophalangeal joint and the distal interphalangeal joint * single lesion per finger * nerve defect of \>5mm * nerve treatment initiated within 24 months after nerve injury * signed informed consent exclusion criteria: * disorders known to affect the peripheral nervous system, such as, but not only, diabetes mellitus, chronic heavy alcohol use, or toxic nerve lesions, or any polyneuropathy * an additional injury that could compromise nerve regeneration * clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, metabolic, hematologic, autoimmune, or any systemic disease, which may make implementation/interpretation of the protocol or results difficult * previous conditions of the hand that could affect the healing of the actual nerve injury * complete amputation injury * extensive crush injury * grossly contaminated wound * receiving immunosuppressive or antineoplastic agents within 30 days prior to the enrolment * known to be hiv positive * known pregnant and lactating females * participated in another clinical investigation using an investigational new drug or device (or in the present study) within 30 days prior to enrolment into this investigation * uncooperative or unsuitable, e.g. language problems or a suspicion to be unable to attend follow up appointments, for completion of the investigation * absence of a healthy opposite finger * suspected allergy to silk * need of emergency surgery (within 24 hours from injury)

Keywords: peripheral nerve injury nerve guide silk fibroin silk nerve regeneration
clinical trial of mk0683 in combination with fda approved cancer drugs in patients with advanced nsclc (mk0683-058)

Conditions: Non-Small Cell Lung Cancer

Summary: this is a clinical trial to determine the safety and tolerability of mk0683 in combination with gemcitabine and cisplatin and/or carboplatin.


Eligibility criteria:
inclusion criteria: * patient must have a histologically-confirmed metastatic or locally advanced non-small cell lung cancer that has not been previously treated with systemic chemotherapy or has received non-platinum and non-gemcitabine based neoadjuvant or adjuvant chemotherapy if the last dose was at least 6 months prior to study enrollment exclusion criteria: * patient who has had chemotherapy, radiotherapy, or biological therapy prior to entering the study, except for adjuvant or neoadjuvant chemotherapy, as allowed for treatment of a tumor

Keywords: advanced stage iiib/iv non-small cell lung cancer
a safety study of intravenous immunoglobulin in patients with chronic immune thrombocytopenic purpura (itp)

Conditions: Immune Thrombocytopenic Purpura

Summary: it is known that intravenous immunoglobulins can induce hemolysis, but the mechanism is not known in detail. the primary objective of this study was to investigate the specificity of antigens on red blood cells in patients with chronic immune thrombocytopenic purpura (itp) who have shown signs of clinically relevant hemolysis following treatment with the intravenous immunoglobin privigen®. the study was to explore potential mechanisms of hemolysis by analysis of the specificity of the antibodies possibly involved. to distinguish between clinically non-relevant hemolysis and a relevant intravascular hemolysis, an independent adjudication by a committee was performed for each patient with signs of hemolysis determined in the laboratory or in the clinic. this study was requested as a post-marketing commitment study by the united states food and drug administration (fda). by september 2014, no case of clinically significant intravascular hemolysis was found, and the fda agreed to halt the study and analyze all hemolysis-relevant endpoints using fda criteria for hemolysis in addition to analyses planned in the protocol. the study was not restarted.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic itp * age of 18 to 65 years * platelet count of ≤ 30 x 10\^9/l at screening exclusion criteria: * planned splenectomy throughout the study period * treatment with immunoglobulin g for intravenous administration (ivig) or anti-d immunoglobulin within 3 weeks prior to screening * use of drugs that have any pharmacological effect on the blood clotting system within 3 weeks prior to screening * known allergy or other severe reactions to blood products including intolerability to previous ivig * known hyperprolinemia * red blood cell transfusion or erythropoietin treatment within the last 14 days

Keywords: itp
registry for degenerative spinal disease (rdsd)

Conditions: Degeneration Spine; Surgery

Summary: the outcome after spinal surgery is important and the evidence is critical to develop treatment. the purpose of this study is to make a prospective registry of database for further research.

the outcome after spinal surgery is important and the evidence is critical to develop treatment. the purpose of this study is to make a prospective registry of database for further research. included patients degenerative cervical spinal disease. degenerative lumbar spinal disease.

Eligibility criteria:
inclusion criteria: * degenerative lumbar spinal disease. * degenerative cervical spinal disease exclusion criteria: * combined progressive cancer disease

Keywords: spine outcomes degeneration spine surgery
ai in primary care spirometry pathways for diagnosis of lung disease (april)

Conditions: Lung Diseases

Summary: to investigate the feasibility of performing a future real-world randomised controlled trial to determine the clinical effectiveness of artiq.spiro in supporting diagnostic performance of primary care staff in the interpretation of spirometry

this is a feasibility study for a larger multicentre randomised controlled trial (rct) assessing the impact of the artiq.spiro software on diagnostic accuracy, care processes, patient and health economic outcomes. the primary objective of this study is to assess the feasibility of a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry. endpoints of the current study will be focused on feasibility and acceptability outcomes. secondary objectives of this study are to collect data on potential clinical and health economic endpoints for a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry. this will help determine the primary endpoint for a future trial and provide data to support a sample size calculation to ensure that any future trial will have adequate power. this is a mixed methods randomised controlled feasibility trial. in pico format: population: individuals with respiratory symptoms referred clinically for primary care spirometry in hillingdon, leicestershire, west hampshire. intervention: local primary care spirometry pathway supported by additional artificial intelligence enabled software (artiq.spiro) control: local primary care spirometry alone. outcomes: feasibility outcomes with a particular focus on recruitment and retention, and acceptability of intervention and trial design. clinical outcomes including referrer diagnostic performance and patient health status. health economic outcomes including health care usage and economic modelling. all participants will undergo their locally agreed spirometry pathway.

Eligibility criteria:
inclusion criteria: * adults ≥18 years, irrespective of sex, ethnicity, disability, sexual orientation, marital status, educational level, * referral by gp or nominated representative for primary care spirometry during study period. * patients able to provide informed consent. exclusion criteria: * age \<18yrs; absolute contraindication to spirometry. * any locally defined exclusion to spirometry.
effectiveness and safety of smart [spastic muscle palpation by anatomic landscape for bont-a (botulinumtoxin-a) injection to reduce muscle tone] bont-a therapy with dysport® in patients with post-stroke chronic upper limb spasticity (uls) in real-life setting.

Conditions: Post-Stroke Chronic Upper Limb Spasticity

Summary: the purpose of this study is to collect data for dysport® smart bont-a therapy usage in an office-based setting in post-stroke participants with chronic (\> 6 months) focal upper limb spasticity who have been under stable oral antispastics treatment or patients with no current anti-spasticity treatment.


Eligibility criteria:
inclusion criteria: * male or female patients ≥18 years with the capacity to consent. * subjects with a post-stroke medium to severe focal upper limb spasticity for at least 6 months. medium to severe focal upper limb spasticity is defined as mas ≥2 in the ptmg and das ≥2 in the ptt. * cohort according to smart guidelines. the smart injection concept is designed to be used only in patients suffering from simple patterns ("easy to diagnose spasticity pattern") of adult uls, where abobotulinumtoxin-a (abobont-a) (dysport®) injection can be simplified, by recognizing common spasticity patterns and key muscles for injection, identifying those muscles by palpation, and appropriate injection points of the suggested muscles using anatomic landmarks. * subjects with treatment goals as reduction of pain, reduction of muscle tone, improvement of care (hygiene/dressing) and/or improvement of passive motion. * subjects with the intention to be treated with dysport® according to the current local summary of product characteristics (smpc) (germany) and injection according to smart must be taken prior to the entry in the study. * physiotherapy should remain unchanged within 4 weeks before study start. exclusion criteria: * patients treated with intrathecal baclofen or bont-a within the last 6 months * if treated with oral spasticity medication, change of oral spasticity medication within the last 4 weeks * patients with active hand functions or patients with treatment goals of active functions. * patients with any contraindication for dysport® according to smpc. * patients in whom smart therapy is not appropriate (e.g. spasticity pattern other than specified in smart guidelines). * participation in an interventional trial at the same time and/or within 3 months before baseline. * diagnosed contracture/contracted muscle.
peginterferon α-2b injection for the treatment of pediatric rsv bronchiolitis

Conditions: Bronchiolitis

Summary: this is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of inhaled peginterferon α-2b injection compared to recombinant human interferon α2b in the treatment of pediatric respiratory syncytial virus bronchiolitis.


Eligibility criteria:
inclusion criteria: 1. the guardian of the child is able to understand the content, requirements, and limitations of the protocol, fully understands the possible adverse reactions that may occur during the study, is willing to complete the follow-up as required, and voluntarily signs the informed consent form before the start of the study. 2. the child's age is 6 months or older but no more than 2 years old (including the critical value) at the time of signing the informed consent, and the gender is not specified. 3. positive viral detection in nasopharyngeal swab. 4. presence of rapid breathing, wheezing, moist rales and/or wheezing sounds in the lungs; with or without chest imaging showing signs of hyperinflation, patchy infiltrates, localized atelectasis, and peribronchitis. 5. the severity of the illness is mild or moderate (evaluation criteria see appendix 1: wang bronchiolitis scoring standard). 6. the time from the onset of the child's illness to the signing of the informed consent form is within 72 hours (the appearance of symptoms and signs related to rsv bronchiolitis does not exceed 72 hours from the signing of the informed consent, including but not limited to: tachypnea, wheezing, hypoxemia, dyspnea, fever). 7. no use of other antiviral drugs or immunomodulators within 3 weeks before randomization. exclusion criteria: 1. extreme restlessness, drowsiness, coma, and possibly requiring mechanical ventilation assistance for breathing. 2. presence of other chronic severe diseases such as cardiac insufficiency, respiratory insufficiency, liver insufficiency, renal insufficiency, and severe malnutrition. 3. having autoimmune diseases such as systemic lupus erythematosus or psoriasis, or immunodeficiency diseases. 4. having epilepsy or other disorders of central nervous system function. 5. the investigator's comprehensive judgment suspects a concurrent bacterial infection. 6. clinical diagnosis of myocarditis or suspected myocarditis (diagnostic criteria see appendix 2: diagnostic recommendations for myocarditis in children). 7. known or suspected allergy to interferon or excipients. 8. participation in other interventional clinical trials within 3 months prior to screening, or planning to participate in other clinical trials during the study period. (9) a history of pneumonia in the past 3 months. (10) other conditions deemed unsuitable for inclusion by the investigator.

Keywords: bronchiolitis peginterferon α-2b respiratory syncytial virus
effect of coadministration of ume paste (prunus mume) and ginger powder

Conditions: Prediabetes

Summary: this study is designed to evaluate the effect of ume paste and ginger powder on glucose metabolism in prediabetic subjects.


Eligibility criteria:
inclusion criteria: * fasting plasma glucose 105-125 mg/dl exclusion criteria: * taking anti-diabetic drugs * taking drugs or functional food that may affect blood glucose level * pregnant or nursing a child * participation in any clinical trial within 90 days of the commencement of the trial * renal or hepatic dysfunction * heart disease * history of severe disease and/or major surgery