Kornimate/medical-research-clean huggingface dataset:
study of the efficacy of percutaneous implantation of autologous myoblasts in patients with old infarction

Conditions: Old Myocardial Infarction

Summary: the purpose of this study is compare the improvement in global and regional cardiac function measured by echocardiography and magnetic resonance in patients with old myocardial infarction subject to cardiac catheterisation with percutaneous endocavity implantation of autologous myoblasts.

ischaemic heart disease is one of the main causes of mortality and morbidity. in particular, myocardial infarction (mi) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. in the last few years, new treatments have been developed for the acute phase of myocardial infarction.we have managed to slow down disease progression with these new treatments, but it continues to the development of end stage heart failure. this study tries to determine the benefit of cell cardiomyoplasty with autologous myoblasts in patients with old mi.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of myocardial infarction, absence of viability. * ejection fraction under 40% or 45% in symptomatic patients * aged from 30-80 years old. * negative pregnancy test (women of childbearing age) * informed consent granted exclusion criteria: * prior history of tachycardia or ventricular fibrillation (except in the acute phase of mi). * myocardial infarction with more than 10 years of evolution. * patients positive for hiv, hbv or hcb. * patients with organ dysfunction: liver and kidney function * history of cancer or prior treatment with chemotherapy. * the patient should not suffer from any concomitant severe and/or uncontrolled medical condition. * patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol. * pregnant or beast feeding women.

Keywords: percutaneous implantation of autologous myoblasts
femoroacetabular impingement (fai): the effectiveness of physical therapy

Conditions: Femoroacetabular Impingement

Summary: the treatment of femoroacetabular impingement has evolved over the last several years. as the number of arthroscopic hip operations has risen over the last few years, so has the level controversy in regards to the appropriate initial management. there have been many recent advances in clinical diagnosis, advanced imaging techniques, improved indications for surgery and improved arthroscopic techniques which have led to improved clinical outcomes, but the effectiveness of physical therapy remains unknown.

the treatment of femoroacetabular impingement has evolved over the last several years. as the number of arthroscopic hip operations has risen over the last few years, so has the level controversy in regards to the appropriate initial management. there have been many recent advances in clinical diagnosis, advanced imaging techniques, improved indications for surgery and improved arthroscopic techniques which have led to improved clinical outcomes, but the effectiveness of physical therapy remains unknown. a paucity of evidence exists in regards to the non-operative treatment of fai. several insurance companies are now requiring three to six months of physical therapy prior to approval for surgery. there is not a single study that has objectively evaluated the effectiveness of physical therapy in the avoidance of surgical intervention. the investigators plan to evaluate this using an electronic outcomes data collection system. the hypothesis is that the majority of patients will not see a significant enough improvement with physical therapy to avoid surgery, especially in a subset of patients such as those with sub spine impingement. the investigators plan to prospectively collect data for three years and monitor the outcome of each hip patient, especially those treated with physical therapy as an initial treatment and there potential avoidance of surgery.

Eligibility criteria:
inclusion criteria: 1. symptoms consistent with femoroacetabular impingement (fai) 2. a physical exam consistent with fai 3. radiographic measurements consistent with the diagnosis including an anterior pincer lesion and/or a alpha angle greater than 55 degrees exclusion criteria: 1. subjects do not have fai by physical exam and radiographic parameters 2. joint space \<2mm 3. have had prior physical therapy for fai 4. have had prior hip surgery.
window of trainability in relation to surgical correction of foot deformity

Conditions: Stroke

Summary: background: stroke is the leading cause of disability in the western world. in chronic stroke patients, foot deformity such as pes equinovarus is among the most important underlying motor deficits, due to imbalance of muscle strength and activity around the ankle and tarsal joints. both nationally and internationally, there is relative underuse of surgical treatment options, although in our clinical experience this often has the best outcome. in addition to positive clinical experiences with surgical interventions, we have experienced that before surgery, there is limited effect of gait training on gait capacity. however, we have experienced that after surgery, the restored normal ankle-foot position creates a new window for training opportunities to further improve gait capacity. therefore, in this exploratory proof of principle study we aim to investigate the effect of surgical correction of post-stroke foot deformity on the (potential) improvement of gait capacity after gait training. based on clinical experiences, we expect that after surgery, gait training results in a larger improvement in gait capacity compared to before the surgical intervention due to the increased possibilities to improve balance control. objective: the primary objective of this study is to compare the effect of gait training on gait capacity (stepping performance, gait adaptability and dynamic balance) before and after surgical correction of post-stroke foot deformity. study design: exploratory proof of principle study with repeated-measures. study population: fifteen stroke patients with disabling foot deformity will be recruited from the gait expertise center (lec) of the sint maartenskliniek and radboudumc. intervention: all patients will receive two gait training interventions, each consisting of twelve one hour training sessions. the training sessions will be focussed on improving gait capacity. main study parameters/endpoints: primary outcomes will be gait adaptability as measured with the emory function ambulation profile (e-fap), stepping performance as measured with the timed-up-and-go test (tug) and dynamic balance as measured with the margin of stability (mos).


Eligibility criteria:
inclusion criteria: * \> 6 months post onset * 18 years or older * functional ambulation classification (fac) =\> 3: the patient is able to walk without physical support * will undergo a surgical correction of foot deformity exclusion criteria: * suffers from any other disorder that seriously affects gait capacity
functional abilities in rett syndrome

Conditions: Rett Syndrome

Summary: the purpose of this study is to evaluate and determinate the functional abilities in rett syndrome conforming to the established pediatric evaluation of disability inventory (pedi).

rett syndrome (rs) is a progressive neurological disturbance of genetic cause that affects females almost exclusively. it is caused by mutations, usually sporadic, of the mecp2 gene located in the x chromosome. in consequence to the serious cognitive and motor compromise, the rs patients have great difficulty in accomplishing day-to-day tasks. the objective of this work is to evaluate the functional abilities in rs to help therapists in theirs treatments programs.

Eligibility criteria:
inclusion criteria: * patients with rett syndrome that matched the criteria for the classic form of the disease exclusion criteria: * any other disease; * rett syndrome associated with other disease * rett syndrome that not that matched the criteria for the classic form of the disease

Keywords: rett syndrome selfcare mobility limitation interpersonal relations this study avaliated patients with rett syndrome
cell therapy for coronary heart disease

Conditions: Coronary Artery Disease

Summary: impaired contractile function after a heart attack and due to coronary heart disease is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy. the aim of the current trial is to investigate whether infusion of progenitor cells into the coronary artery supplying the most dyskinetic left ventricular area may improve left ventricular contractile function, compared to no cell infusion in the control group, in patients with old (\>= 3 months) myocardial infarction.

* the study is an open-label, controlled, randomized single-center trial. * patients post myocardial infarction (\>= 3 months) with a patent infarct-related artery are included. * bone marrow-derived progenitor cells are aspirated under local anaesthesia, and after cell processing, are infused into the patent infarct-related artery during stop flow within the same day. blood-derived progenitor cells are isolated out of 250ml peripheral venous blood, and after cell processing and 3 days culture, are infused into the patent infarct-related artery during stop flow. in addition, left ventricular angiography is performed. in the control group coronary angiography and left ventricular angiography without any intracoronary infusion are performed. * after 3 months, left ventricular angiography is repeated, and patients of the control group cross-over to active treatment with progenitor cells, whereas patients initially treated with progenitor cells cross-over to the alternate cell type. * the primary endpoint is the change in quantitative global left ventricular ejection fraction in lv angiography between the groups.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 80 * patients post-myocardial infarction (\> 3 months old) or with diffuse ischemic chd * signed informed consent exclusion criteria: - existing neoplastic disease or signs of tumor recurrence within the last 5 years * active infection * active internal bleeding * stroke within the past 2 years * surgery or trauma within the past two months * uncontrolled hypertension over 160/100 * arteriovenous malformations or aneurysms * hiv infection * signs of significant kidney or liver failure (creatinine \> 2.0 mg/dl, got \> 2 x upper standard value) * thrombopenia (\< 100,000) * anemia (hemoglobin \< 8.5 g/dl) * mental retardation * participation in another clinical study * women of childbearing age * chronic inflammatory disease

Keywords: chronic heart failure myocardial infarction
the effects of acupuncture on insomnia among midlife women

Conditions: Menopause Syndrome

Summary: aims: to explore the effects of acupuncture on the improvement of insomnia, fatigue, depression and menopausal symptoms among midlife women.

this research is a study with a randomized clinical trial. participants were 40-60 years old with a sleep disturbance which persists more than one month. twenty participants were randomly assigned into the experimental and control groups. the experimental group received acupuncture treatment (taichong, shenmen, neiguan points) twice a week, total three weeks, plus sleep hygiene guidance; the control group received subcutaneous acupuncture (non-therapeutic acupuncture points) twice a week, total three weeks and given sleep health guidance. all participants received pre-test and post-test, including sleep multiple physiological examination (psg), pittsburgh sleep quality table, epworth sleepiness scale, hospital anxiety depression scale, menopausal symptom questionnaire, sleep disturbance comprehensive scale, and wore actiwatch for three days. data analysis was performed using spss.

Eligibility criteria:
inclusion criteria: * women aged 40-60 years * complaints of insomnia symptoms in the past month that lasted for at least one week, such as difficulty falling asleep, waking up easily in the middle of the night, unable to fall asleep after waking up, still not getting enough sleep after waking up in the morning * the score of sleep disorder on the pittsburgh sleep quality scale was more than 5 points exclusion criteria: * history of psychiatric disorders * history of sleep apnea or nocturnal myoclonus * center or neurodegenerative disease * cancer * melatonin or sleeping pills use in the past month

Keywords: midlife women acupuncture insomnia polysomnography
a study to assess the pharmacokinetic profile of prazosin and cyproheptadine

Conditions: Alcohol Use Disorder

Summary: the study is an open-label, randomized,2-period, single dose, crossover study in 8 healthy male/female volunteers. subjects will be randomized to the following sequences: (a) period 1: kt110 - wash-out period - period 2: alpress and periactin marketed tablets ; or (b) period 1: alpress and periactin marketed tablets - wash-out period - period 2: kt110


Eligibility criteria:
inclusion criteria: * healthy male/female subject * females of childbearing potential and male participant must agree to use an adequate and highly effective method of contraception * negative serum pregnancy test at screening for woman of childbearing potential only * non-smoker subject or smoker of not more than 5 cigarettes a day * body mass index (bmi) between 18.5 and 30 kg/m2 inclusive, at screening exclusion criteria: * any contraindication to prazosin or cyproheptadine treatments; * frequent headaches and / or migraine, recurrent nausea and / or vomiting; * symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease equal to or greater than 20 mmhg in systolic blood pressure (sbp) and a decrease equal to or greater than 10 mmhg in diastolic blood pressure (dbp) within two minutes of changing from supine to standing position; * blood donation (including as part of a clinical trial) in the 2 months before administration * any drug intake (except paracetamol or contraception) during the month prior to the first administration; * history or presence of drug or alcohol abuse (alcohol consumption \> 40 grams / day) * excessive consumption of beverages with xanthine bases (\> 4 cups or glasses / day); * positive hepatitis b surface (hbs) antigen or anti hepatitis c virus (hcv) antibody, or positive results for human immunodeficiency virus (hiv) 1 or 2 tests * positive results of screening for drugs of abuse
longitudinal follow-up of patients with chronic inflammatory rheumatisms (cirs) vaccinated against covid-19 compared to patients refusing vaccination

Conditions: Rheumatic Diseases; SARS-CoV Infection; COVID-19

Summary: to date, studies on sars-cov2and vaccines have been mostly from the general population not exposed to immunosuppressants. the efficacy and safety of covid-19 vaccines need to be evaluated in these populations.

longitudinal, comparative, controlled, observational multicenter study based on a cohort of 1500 sars-cov-2 seronegative patients with cirs from the covid-ric1 cohort: 750 accepting vaccination and 750 refusing vaccination matched on age (+/-10 years), gender, rheumatism and recruiting center. schedule: 4 visits over a 12-month period. an observational routine care study was initiated in 15 french hospitals to assess the sars-cov-2 seroprevalence in france in a population with cirs. the project plans to screen 5000 cirs patients. the covid-ric3 study will thus be proposed to these pre-screened subjects according to their agreement or refusal to be vaccinated against covid-19 based on a question asked at the time of their inclusion in covid-ric1. the efficacy and safety of the sars-cov2 vaccines as well as the vaccine-induced humoral immune responses and their maintenance over time in immunosuppressed patients with cirs are essential to guide vaccine recommendations in these specific immunocompromised populations in terms of "boost" or booster.

Eligibility criteria:
inclusion criteria: * adult ≥ 18 years old, * chronic inflammatory arthritis: rheumatoid arthritis, psoriatic arthritis, axial spa, diagnosed by a rheumatologist * having a negative serology for sars-cov-2 infection upon inclusion in covid-ric1. * under csdmard (conventional synthetic disease-modifying antirheumatic drug), biotherapy, jak inhibitor or under symptomatic treatment such as nsaids or corticosteroids alone or in combination with a dmard (disease-modifying antirheumatic drug) * subject having signed a consent * affiliated with social security * having accepted or agreed to be vaccinated against covid-19 (for vaccine group) * having refused to be vaccinated against covid-19 (for non-vaccine group) exclusion criteria: * adult patient under legal protection (guardian, curator) * patient vaccinated with an anti-sars-cov-2 vaccine before the serological test * refusal to be vaccinated (for vaccine group) * acceptance to be vaccinated (for non-vaccine group)) * refusal to participate in the study * pregnancy and breast feeding
serum a.actinomycetemcomitans antibodies and periodontitis

Conditions: Periodontal Diseases

Summary: the aim of this study was to analyze the association between serum a.actinomycetemcomitans antibodies in patients with periodontitis. furthermore, the objective was to determine if the periodontitis influenced serum igg a.actinomycetemcomitans antibodies levels

53 patients with periodontitis and 48 healthy subjects (hs) were enrolled in the present study. enrolled patients were examined and characterized for clinical and blood samples analysis and a.actinomycetemcomitans antibodies were expressed and evaluated enzyme-linked immunosorbent assay (elisa) units (eu). the spearman correlation test and jonckheere-terpstra test were applied in order to assess the interdependence between serum igg a.actinomycetemcomitans antibodies and clinical periodontal parameters.

Eligibility criteria:
inclusion criteria: * presence of at least 15 teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.
acb + ipack block with or without local infiltration in ra-tka

Conditions: Knee Arthropathy

Summary: the purpose of this study is to compare the outcomes of an adductor canal block (acb) + interspace between the popliteal artery and the capsule of the knee (ipack) block along with a single intraoperative injection of a standard local anesthetic that includes ropivacaine, epinephrine, ketorolac, clonidine and saline to an acb + ipack block without the intraoperative injection of a standard local anesthetic in patients undergoing robotic arm-assisted tka (ra-tka).


Eligibility criteria:
inclusion criteria: 1. patient is over the age of 21 2. patient is scheduled to undergo a unilateral, primary tka, secondary to osteoarthritis 3. patient agrees to participate as a study subject and signs the informed consent and research authorization documents 4. patient is able to read and speak english. exclusion criteria: 1. patient is under the age of 21 2. patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis) 3. patient is scheduled to undergo a bilateral tka surgery 4. patient is unable to read and speak english
novel antineuronal antibodies in gastrointestinal motility disorders

Conditions: Autoimmune Gastrointestinal Dysmotility

Summary: gastrointestinal motility disorders represent a heterogeneous group of neuromuscular diseases of the enteric nervous systems. while autoimmune neuromuscular diseases of the central nervous system (cns) are well described, the role of autoimmunity in enteric nervous system (ens) has been less studied. approximately 10% of patients with unexplained gastrointestinal dysmotility diseases have positive serum autoantibodies to peripheral nervous system proteins, suggesting an autoimmune mechanism targeting the enteric nervous system. the investigator's aim is to identify novel anti neuronal antibodies that contribute to autoimmune gastrointestinal motility disorders by analyzing the serum of patients with abnormal gastrointestinal motility.

autoimmune gastrointestinal dysmotility (agid) represents a subset of autoimmune disorders that affect the motor function of the gastrointestinal tract. it will often result in refractory gastrointestinal symptoms and poor quality of life. approximately 10% of patients with unexplained gastrointestinal dysmotility diseases have positive serum autoantibodies to peripheral nervous system gangliosides and glycoproteins, which may be suggestive of an autoimmune mechanism targeting the enteric nervous system. the diagnosis is often made clinically in patients with gastrointestinal dysmotility in the context of primary autoimmune disease or a paraneoplastic syndrome. to date, specific diagnostic tests for agid disorders do not exist. this study will aim to find whether patients with symptomatic autoimmune gastrointestinal dysmotility (agid) will have a specific antigen and/or antibody causing the symptoms. the study will also aim to find whether patients with positive autoantibody titers will frequently have positive tilt-table testing (autonomic dysfunction). the goal of this study is to determine the prevalence of autoimmune antibodies in patients presenting with unexplained gi dysmotility and refractory symptoms, and to examine the outcome (safety, tolerability, and clinical improvement) in a pilot cohort of such patients with a serum screening for antigens, antibodies, and validated questionnaires. this will be a prospective pilot study.

Eligibility criteria:
inclusion criteria: * males and females \>13 years old. * patient referred to the gi motility clinic for suspected enteric dysmotility based on chronic refractory gastrointestinal symptoms * english proficiency and literacy sufficient to sign consent. exclusion criteria: * pregnancy documented with a serum or urine pregnancy test. if participants believe that they are pregnant, they will need to notify a study physician who will order a serum or urine test for pregnancy and remove them from the study if the test results come back positive.
a sub-study to lmf237a2302 to assess the effect of 24 weeks treatment with initial combination of vildagliptin plus metformin

Conditions: Diabetes Mellitus, Type 2

Summary: this study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of hba1c and/or fasting plasma glucose.


Eligibility criteria:
inclusion criteria: * male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes * diagnosis of type 2 diabetes for at least 4 weeks prior to study entry * body mass index 22-40 kg/meter squared * hba1c \> 11% and/or fpg \>270 mg/dl exclusion criteria: * pregnant or lactating female * history of type 1 diabetes * evidence of significant diabetic complications * treatment with insulin or any other oral antidiabetic agent other protocol-defined inclusion/exclusion criteria may apply.

Keywords: metformin vildagliptin initial combination