Kornimate/medical-research-clean huggingface dataset:
impact of neck and facial exercises on swallowing function in elderly individuals

Conditions: Dysphagia

Summary: the goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

the investigators have designed a simple and user-friendly swallowing rehabilitation training method called "systematic simple swallowing training" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. it has shown promising preliminary efficacy. however, before we can promote its widespread adoption, a series of studies must be conducted to establish its effectiveness. the goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility criteria:
inclusion criteria: * age over 60 years old. * no hospitalization within the past six months. * with clear consciousness and able to cooperate with questionnaires and training. * the elderly people who voluntarily participate and agree to adhere until the end of the study. exclusion criteria: * complicated with severe liver and kidney failure, tumors, or hematological disorders. * physical disability. * difficulty in mobility.
compare two different sclerosing agents in the treatment of venous malformations

Conditions: Venous Malformation

Summary: the purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.

patients with scanty symptoms from their vascular malformation can do well with conservative treatment and / or with aids and adaptations in daily life. compression therapy (elastic stockings), pain medication and good counseling is adequate for many. patients with significant symptoms, however, may require more invasive treatment. previously, it was common with surgical removal, but serious sequelae and frequent recurrence after surgery resulted in caution. today it is more common with intervention radiology treatment with injection of sclerosing agents into existing malformation. this type of therapy almost always requires repeated treatment sequences, sometimes over several months. treatment aims to seal blood vessels in the malformation and / or make the patient as possible symptoms. recurrence occurs frequently and there are many who are not completely free from symptoms. many patients have chronic problems with pain, wounds, bleeding and / or they have a cosmetically disfiguring condition. predicting the performance of a specific type of treatment can be very difficult. until now, there are some studies that have considered the effect of bleomycin / pingyangmycin (china) and ethanol in the treatment of vascular malformations. to our knowledge there is no prospective or retrospective studies that compare the efficacy and side effects of bleomycin and sodium tetradecyl sulfate (fibrovein ™) in the treatment of vm.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of venous malformation * must be able to fill in questionary form * must be able to sign informed consent form exclusion criteria: * kidney disease * lung disease * pregnancy or not willing to safe contraception * allergy to bleomycin or fibrovein
comparison of ibandronate - zoledronate regarding nephrotoxicity in multiple myeloma

Conditions: Multiple Myeloma

Summary: this multicenter, open-label trial will randomize participants with multiple myeloma to a regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity, measured as creatinine clearance (crcl) reduction greater than (\>) 30 percent (%) or an absolute value of 30 milliliters per minute (ml/min) or lower.


Eligibility criteria:
inclusion criteria: * confirmed multiple myeloma, stage ii-iii as per salmon and durie (1975) * indication for biphosphonate therapy exclusion criteria: * previous therapy with ibandronate or zoledronate within the past 12 months * renal insufficiency with serum creatinine \>3.0 mg/dl or \>265 micromoles per liter (µmol/l) or crcl \<30 ml/min * hypersensitivity to ibandronate, zoledronate, or other biphosphonates * presence of secondary malignomas, apart from basaliomas and cervical carcinoma in situ * severe accompanying illness with organ impairment * osteonecrosis of the jaw at the start of the study * life expectancy ≤12 months
optic nerve sheath ultrasound in giant cell arteritis

Conditions: Giant Cell Arteritis; Anterior Ischemic Optic Neuropathy; Optic Neuropathy, Ischemic

Summary: the sonographic assessment of the optic nerve sheath in gca (sonic-gca) study will: 1) assess the performance, in terms of sensitivity and specificity, of the optic nerve sheath diameter (onsd) to detect new-onset, active gca; 2) evaluate the intra- and interobserver reliability of onsd measures; 3) establish if an association exists between the onsd and the presence of gca retinal findings; and 4) evaluate if the onsd is a dynamic biomarker of gca remission and relapse.

sonic-gca is a prospective cohort and validation study conducted in centers of the canadian vasculitis research network (canvasc).

Eligibility criteria:
inclusion criteria are: 1. adult patient aged \> 50 years; 2. referred for suspected, new-onset cranial gca; 3. ability to understand and provide a written informed consent. exclusion criteria: 1. referral for a suspected gca relapse; 2. current use of systemic glucocorticoids for ≥ 14 consecutive days in the previous 30 days; 3. known previous medical history of conditions which may affect the onsd, such as optic nerve diseases, demyelinating diseases, or any conditions associated with intracranial hypertension; 4. known underlying condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.
study on psychoeducation enhancing results of adherence in schizophrenia

Conditions: Patient Non-Compliance; Schizophrenia and Related Disorders

Summary: background: psychosis in the spectrum of schizophrenia (pss) are severe mental disorders, with a high impact on disability and participation. poor adherence to pharmacotherapy negatively impacts on the course and outcome of pss. non-adherence in these patients is 41 to 50%, and it is predictive of a higher risk of relapse and readmission up to 5-time higher than in adherent patients. falloon et al. developed a psychoeducation program (fpp) aimed at improving communication and problem-solving abilities in patients and their families. past studies reported a statistically significant reduction of the risk of relapse in patients receiving the fpp, but did not take into account effects on adherence. objectives: to evaluate changes in adherence to pharmacotherapy in a sample of patients diagnosed with pss (icd-10: f20 to f29), by comparing a group exposed to the fpp with another group exposed to a treatment with generic informative prospects on the disorders provided with same attendance frequency as the fpp (generic treatment - gt). methods: 340 patients with pss, from 10 participating units distributed in the territory of the italian national health system, will be enrolled, with allocation 1:1. the sample will be randomized into an exposed group (to fpp) and an unexposed group. adherence will be assessed on a three-monthly basis with blood levels of the primary prescribed drug by high pressure liquid chromatography, with a self-report, the medication adherence questionnaire, and concurrently with the administration of a 4-item interview, based on a modified version of the adherence interview. survival analyses will be performed using kaplan-meier method, followed by log-rank test, defining as terminal events both the start of non-adherence and/or the first relapse or readmission episode. intention-to-treat will be applied in considering the primary and secondary outcomes. multiple imputations will be applied to integrate missing data. expected results: median prevalence of non-adherence to pharmacotherapy in patients already in contact with a psychiatric service is 47%; effect size of psychosocial treatment on various outcomes, including relapse, readmission and adherence to drug is 0.48 of the standard deviation (sd), with 95% c.i.=0.10 to 0.85. the intervention is expected to produce a change in the prevalence of non-adherence to drug in the exposed group with an effect size of 0.45 sd.


Eligibility criteria:
inclusion criteria: * diagnosis of psychosis in the spectrum of schizophrenia (icd-10: f20 to f29); -age from 18 to 55; * being in care for 2 years or more. exclusion criteria: * mental retardation, or any severe cognitive impairment; * psychosis due to substance abuse or to a medical condition; * affective psychosis; * comorbid substance dependence; * patient does not understand italian language; * pharmacotherapy with depot.

Keywords: adherence psychoeducation pharmacotherapy schizophrenia family support
cervical cancer prevention for black adults

Conditions: Cervical Cancer

Summary: the goal of this study is to develop and pilot test an intervention, entitled health is wealth: a cervical health program, designed to promote screening and reduce perceived barriers to cervical cancer (cc) screening. aim 1: examine general awareness and cultural factors (fatalism, religiosity/spirituality, temporal orientation, medical mistrust, and acculturation) related to cancer control and prevention among african americans (aa) and sub saharan african (sai) immigrants. aim 2: examine the socioecological barriers and facilitators to cc screening and self-sampling to inform tailoring of an evidenced based cervical health program to promote cc screening. aim 3: assess feasibility, acceptability, and preliminary efficacy in a pilot test of the health is wealth: a cervical health program among 30 aa and 30 sai women using quasi-experimental design. this study will take place in 2 phases.

in phase 1, the investigators will conduct a cross-sectional survey with 150 black men and women to examine factors impacting cervical cancer screening. also, as part of phase 1, aim 2 employs focus groups and a quantitative health belief model checklist with 30 participants to guide development of a tailored intervention. in phase 2, aim 3 will assess feasibility, acceptability, and preliminary efficacy of the health is wealth: a cervical health program intervention among 30 african american and 30 sub-saharan african immigrant women.

Eligibility criteria:
inclusion criteria: * self-identify as black woman (african american or sub-saharan african immigrant) * no pap smear within the last three years or no pap smear/hpv co-test within past five years * able to speak and write in english * reside in kentucky exclusion criteria: * do not self-identify as black woman (african american or sub-saharan african immigrant) * history of hysterectomy * history of cervical cancer * being pregnant * unable to speak and write in english * do not reside in kentucky

Keywords: cervical cancer screening hpv self-sampling african american sub-saharan african immigrants
evaluation of a family intervention program for the management of overweight or obese children

Conditions: Overweight; Obesity; Children

Summary: objectives: to evaluate the effectiveness of the nereu program compared to standard care (advice on increased physical activity and nutrition) such as a health intervention tool for the childhood obesity management methods/design: the study design is a randomized controlled multicenter clinical trial using two types of treatment. population and sample: children 6 to 12 years with overweight or obesity, according to the z score of body mass index (bmi z) \>= 1 for age and gender defined by international obesity task force (iotf). it is considered necessary to recruit 100 children: 50 control group (cg) and 50 intervention (ig). study intervention: nereu group: 8 month intervention with 3 weekly training sessions doing physical exercise for children and a weekly session for parents of physical activity and healthy eating habits and behaviour strategies, that involves both parental and child participation. the control group will receive a monthly session of healthy physical and eating habits. main outcome measures: improvement of bmi z, physical activity and nutrition habits, behaviour components and quality life related to health at the end, 6 and 12 months after intervention.


Eligibility criteria:
inclusion criteria: * children aged between 6 to 12 years old * overweight or obese according to the iotf criteria exclusion criteria: * medical co-morbidities: diabetes mellitus or hypercholesterolemia or cardiovascular disease that could be contraindicate the sport practice. * use of medication that might have an effect on weight loss. * previous enrolment in another similar treatment program based on reducing obesity.

Keywords: overweight obesity children behaviour physical activity nutrition
intrauterine autologous prp infusion compared to hrt for enhancing endometrial thickness in patients undergoing icsi

Conditions: Infertility

Summary: successful embryo implantation needs an optimum embryonic development with a receptive endometrium. endometrial thickness is an independant factor for endometrial receiptivity. the aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison with standard hormonal therapy.

this is a single blinded randomized trial comparing the effect of of platlet rich plasma versus hormonal therapy on endometrial thickness and consequently endometrial receptivity. the primary endpoint of this trial is clinical pregnancy rate.

Eligibility criteria:
inclusion criteria: * patients undergoing icsi * endometrial thickness less than 7 mm on early follicular phase exclusion criteria: -
the prognostic role of the right ventricle in patients with heart failure or congenital heart disease

Conditions: Heart Failure

Summary: the objectives are 1. to validate quantification of 2d and 3d right ventricular strian measurements of right ventricular performance in cross comparison to cardiac mri and to evaluate its relation to right ventricular fibrosis. 2. to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.


Eligibility criteria:
inclusion criteria: * adult patients with heart failure exclusion criteria: * renal failure * contraindications to cardiac mri

Keywords: strain mri echocardiography
adult stem cell therapy for repairing articular cartilage in gonarthrosis

Conditions: Osteoarthritis, Knee; Knee Injuries; Joint Diseases; Rheumatic Diseases; Cartilage Diseases

Summary: this is a prospective, open-label, single-dose, single-arm phase i-ii study in which 15 patients diagnosed with gonarthrosis grade ii-iii (kellgren and lawrence) will enter the study with the primary objective of assessing the feasibility and safety of the knee articular infiltration of autologous bone marrow mesenchymal stem cells (msc). secondary objectives are to assess the efficacy by imaging procedures and clinical questionnaires. msc obtained from each patient's bone marrow will be isolated and expanded "ex-vivo" under gmp conditions at xcelia-división de terapias avanzadas del banc de sang i teixits. after 21 days, patients will be implanted a single-dose of approximately 40 millions of autologous msc in the knee by articular injection, and followed up for 12 month. articular cartilage changes will be determined by t2-weighted mri (cartigram) at 6 and 12 month. clinical assessment will measure the pain by the visual analogue scale (vas), the self-reported functional status by heath assessment questionnaire (haq), and the quality of life by short form 36 questionnaire (sf-36) at 3, 6 and 12 month. the working hypothesis proposes that the expected regenerative articular cartilage effect of the msc will be produced to a measurable degree by imaging procedures and clinical questionnaires.


Eligibility criteria:
inclusion criteria: 1. gonarthrosis grade ii-iii of kellgren and lawrence assessed by two observers 2. chronic knee pain with mechanical characteristics 3. absence of local or systemic septic process 4. haematological and biochemical laboratory tests without significant alterations that contraindicate treatment. 5. informed consent form signed by the patient 6. the patient is able to understand the nature of the study exclusion criteria: 1. patients \< 18 years or legally dependent 2. patients \>65 years 3. previous surgery of the knee 4. intraarticular treatment in the past 6 month 5. knee ligament or meniscus rupture observed by mri 6. any sign of infection 7. positive serology for hiv-1 or hiv-2, hepatitis b (hbsag), hepatitis c (anti-hcv-ab) and syphilis. 8. congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results. 9. overweight expressed as body mass index (bmi) greater than 30.5 (obesity grade ii). bmi estimated as mass (kg) / corporal surface (m2). 10. pregnant women or intend to become pregnant or breast-feeding 11. neoplasia 12. immunosuppressive states 13. participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study. 14. other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Keywords: cell therapy regenerative therapy advance therapy bone marrow mesenchymal stem cell autologous interventional clinical trial osteoarthrosis osteoarthritis knee
study of abatacept in the treatment of hospitalized covid-19 participants with respiratory compromise

Conditions: COVID-19; SARS-CoV-2

Summary: the purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized covid-19 participants with respiratory compromise.


Eligibility criteria:
inclusion criteria: * a confirmed virological diagnosis of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection (by reverse-transcription polymerase chain reaction (rt-pcr)). * hospitalized (or in the emergency department awaiting a bed after hospitalization) * respiratory compromise as defined by requirement of oxygen supplementation to maintain oxygen saturation ≥ 93% but not requiring mechanical ventilation * abnormal chest x-ray consistent with covid-19 and not indicating other serious medical condition that would serve as an exclusionary criteria * women and men must agree to follow specific methods of contraception, if applicable exclusion criteria: * women who are breastfeeding * recent acute infection defined as: i) any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics (not covid-19 related) ii) any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy * history of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis) * prior exposure to bms-188667 (abatacept) other protocol-defined inclusion/exclusion criteria apply

Keywords: coronavirus disease 2019 (covid-19) coronavirus coronavirus infections severe acute respiratory syndrome coronavirus 2 (sars-cov-2)
post-pma approval study: 10 year follow-up ide subjects

Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Summary: primary endpoint of this study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among cormet procedures enrolled inthe pre-market ide.

maintaining "at least good clinical status" will be determined based upon the composite clinical success (ccs) criterion which includes no revision, removal, or replacement of any device component and a harris hip total score of greater or equal to 80 points.

Eligibility criteria:
inclusion criteria: * subjects enrolled in the cormet ide study at the 5 identified clinical sites * individuals who agree to participate in the study by signing the informed patient consent form exclusion criteria: * none

Keywords: hip resurfacing osteoarthritis avascular necrosis rheumatoid arthritis
a study of rofecoxib in familial adenomatous polyposis (fap) (0966-205)(terminated)

Conditions: Adenomatous Polyposis Coli

Summary: a study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with familial adenomatous polyposis.


Eligibility criteria:
inclusion criteria: * males or females at least 18 years of age with familial adenomatous polyposis.

Keywords: osteoarthritis cancer pain
acute cardiovascular responses to two types of exercise

Conditions: Aerobic Exercise

Summary: the purpose of this research was to explore potential differences in acute cardiovascular responses between two conditions: 1) moderate-intensity cycle ergometer exercise; and 2) moderate-intensity cycle ergometer exercise with nmes. young, healthy, physically active participants were recruited for this study.


Eligibility criteria:
inclusion criteria: * healthy * performing aerobic activity greater than or equal to three times per week at any intensity exclusion criteria: * had lower body musculoskeletal injuries recently (within the past 6 months) * health conditions that may place risk to the individual such as those with respiratory issues, hypertension, chronic atrial fibrillation, valvular diseases, heart disease; or obstructive cardiomyopathy * if taking pharmacological drugs, performance-enhancing drugs, recreational drugs, nutritional supplements, or smoked nicotine