Kornimate/medical-research-clean huggingface dataset:
testing the decision aid: supporting patient decisions about upper extremity surgery in cervical sci

Conditions: Cervical Spinal Cord Injury; Tetraplegia

Summary: purpose: the objective of this study is to assess a newly created decision support intervention (dsi) or decision aid (da) for people with spinal cord injury (sci) to learn about and consider upper extremity reconstructive surgery to help them choose a course of treatment that most aligns with their values.

the overarching aim of this project is to define key information about improvement of upper extremity function after sci (time and extent of recovery, outcome of surgical and non-surgical interventions and the experience thereof) and communicate this information to patients and clinicians to support their treatment decisions. this particular aim 3 of the overall project will assess a newly developed dsi/da tool in a pre-/post- pilot study of people with sci hoping to restore upper extremity function in cervical sci. using information from prior aims of this project, a de novo tool has been created and will be tested. this study will measure participant knowledge of their condition and treatment options, and decisional conflict. participant feedback, demographics, and health-literacy information will be collected to help improve and refine the da before it is made widely available to the public.

Eligibility criteria:
inclusion criteria: 1. adult subjects (≥18 years to ≤80 years) with mid-cervical level sci (minimum 6 months and maximum 20 years post-injury). 2. must have limited use of their hands. 3. wheelchair dependent for mobility. 4. ability to read, speak and understand english. exclusion criteria: 1) previous treatment with nerve or tendon transfer surgery.

Keywords: nerve transfer surgery tendon transfer surgery decision support intervention
caregiver: a trial to improve the burden and distress of caring for persons with decompensated cirrhosis

Conditions: Caregivers

Summary: the goal of this study is to enroll caretakers of patients with decompensated cirrhosis to determine if written emotional disclosure or resilience training interventions reduce distress and burden among primary informal caregivers. caretakers that meet eligibility will complete baseline assessments in person, or if necessary, over the phone and be randomized to be in one of three arms of this study. materials specific to each study arm will be mailed to the caretakers home along with instructions. overall, the study will take approximately 2 months and a qualitative interview will also be completed around 3-6 months post-baseline.


Eligibility criteria:
inclusion criteria: * primary informal caregiver for a patient with a clinical diagnosis of decompensated cirrhosis with either of the following three clinical criteria: 1. child-turcotte pugh (ctp) class a/b/c cirrhosis with an all cause hospitalization within the previous 30 days. 2. ctp class b or c cirrhosis with one of the following within the prior 6 months from the date of enrollment: 1. ascites (requiring paracentesis or diuretics) 2. overt hepatic encephalopathy (requiring lactulose or rifaximin/flagyl/neomycin) 3. spontaneous bacterial peritonitis (sbp) 4. hepatic hydrothorax (requiring diuretics or thoracentesis) 5. variceal bleed (with 1 or more recurrences) 3. hepatocellular carcinoma (hcc) 1. any barcelona clinic liver cancer (bclc) stage with ctp class b or c 2. bclc stage c or d with ctp class a exclusion criteria: * non-english speaking * unable or unwilling to provide verbal consent * severe cognitive impairment * caregiver is participating in another interventional study * caregiver has used a personal diary within the past 12 months

Keywords: cirrhosis hepatic encephalopathy ascites varices liver disease resilience training expressive writing
patient-based care versus standard care for patients with heds/hsd and multidirectional shoulder instability

Conditions: Hypermobile Ehlers-Danlos Syndrome; Hypermobility Syndrome; Multidirectional Subluxation of Shoulder

Summary: for heds or hsd patients with mdi, a multidisciplinary treatment approach is suggested. as follows, physiotherapy plays a key role in this integrative management. nevertheless, knowledge regarding eds is limited among health care professionals. consequently, evidence-based treatment approaches for the heds/hsd population are scarce. therefore, the aim of this study is to compare two different home-based exercise programs in order to increase our knowledge regarding treatment options, and to gain insight in safe, effective exercises for the unstable shoulder in this study population.

the main purpose of this study was to evaluate the value of two telerehabilitation exercise programs for treating multidirectional shoulder instability (mdi) in patients diagnosed with the hypermobile type of the ehlers-danlos syndrome (heds) or hypermobility spectrum disorders (hsd). patients were randomly assigned to either the control group (b: evidence-based tailored care) or the experimental group (a: evidence-based standard care). both groups received a home-based exercise program of 24 weeks. the primary outcome measure was the western ontario shoulder index (wosi). secondary outcomes included the disabilities of the arm, shoulder and hand (dash), tampa scale for kinesiophobia (tsk), patient-specific functional scale (psfs), global rating of change (groc), and pain pressure thresholds (ppts). outcomes were assessed at baseline, after 6 weeks, 12 weeks, and at the end of the study (24 weeks).

Eligibility criteria:
inclusion criteria: * female * 18-65 years * patients diagnosed by a medical doctor with generalized hsd or heds, according to the diagnostic criteria for heds and hsd as stated in the recently published international classification for the ehlers-danlos syndromes * patients diagnosed with multidirctional shoulder instability (mdi): the diagnosis of mdi was confirmed when 1) patients reported symptoms of shoulder instability in daily life (e.g. recurrent subluxations) without a traumatic onset; 2) patients scored positive on shoulder laxity and instability tests (i.e. sulcus sign, anterior and posterior load and shift, posterior jerk, gagey hyperabduction test, passive and active external rotation in supine, apprehension and relocation test) in at least two directions; 3) patients had shoulder pain for at least three months prior to the study. exclusion criteria: * pregnancy during study participation * patients who started a new physiotherapeutic treatment in the 2 weeks prior to the study

Keywords: hypermobile ehlers-danlos syndrome hypermobility spectrum disorder mutlidirectional shoulder instability telerehabilitation
the effect of continuous egg supplement on personalized nutri-omics in primary school children (si-egg study)

Conditions: Malnutrition, Child

Summary: this research compares the effects of one-year continuous whole egg supplement vs. egg yolk substitutes and control on anthropometry, biochemical blood parameters, metabolic enzymes and microbiome data in primary school children.

this research study determine the long-term effects of egg supplementation on growth, blood lipoproteins, blood proteins, nutritional status, metabolic enzymes and microbiomes in children, enrolling in the school lunch program.

Eligibility criteria:
inclusion criteria: 1. aged between 8-14 years exclusion criteria: 1. allergic of eggs 2. people who cannot continue to follow up the protocol 4. having contra-indication i.e. problems with blood clotting

Keywords: malnutrition whole egg consumption primary school student growth
motivational interviewing for colonoscopy

Conditions: Colorectal Cancer

Summary: the purpose of this study is to begin to examine the efficacy of a motivational interviewing intervention to increase african americans' screening colonoscopy rates. the results from this pilot study will allow us to estimate the magnitude of the intervention and mediation effect sizes.

compared to other racial groups, african americans have the highest colorectal cancer (crc) morbidity and mortality rates. screening colonoscopy can aid in the early detection and prevention of crc. a motivational interviewing (mi) intervention holds strong promise to increase african americans' screening colonoscopy adherence and, by doing so, decrease crc disparities. there is a great need to conduct a randomized clinical trial (rct) that tests the efficacy of an mi intervention to increase screening colonoscopy adherence in african americans. the first critical and necessary step in this line of research is to pilot test such an rct. objective/hypotheses: the primary objective of the proposed study is to conduct pilot testing for a future rct which will formally test the effects of mi on screening colonoscopy adherence in african americans. the results from this pilot study will directly inform the development of a future rct. specific aims: 1) to estimate the magnitude of the mi intervention effect size; and 2) to estimate the magnitude of the mediation effect sizes (drawn from self determination theory).

Eligibility criteria:
inclusion criteria: * self-identified as african american * aged 50 years or older * attended a non-acute visit with a primary care physician * received a primary care physician referral for a screening colonoscopy * deemed eligible for an open access screening colonoscopy * agreed to have a screening colonoscopy conducted at mount sinai * english speaking exclusion criteria: * personal history of crc or chronic gi disorder

Keywords: motivational interviewing screening colonoscopy cancer prevention
effect of loaded functional training on hemiplegic cerebral palsy

Conditions: Hemiplegic Cerebral Palsy

Summary: weakness of lower limb is common in cp children


Eligibility criteria:
inclusion criteria: * age 10-12 * level i,ii according to gmfcm * able to follow and understand instructions exclusion criteria: * visual and respiratory disorder
short-course radiotherapy with induction and consolidation chemotherapy in patients with locally advanced rectal cancer

Conditions: Rectal Cancer; Total Neoadjuvant Treatment

Summary: short-course radiotherapy followed by consolidation chemotherapy has shown a better response rate when compared to chemoradiotherapy treatment. in addition, recent studies have shown better tolerance with total neoadjuvant treatment, with induction or consolidation chemotherapy. induction chemotherapy could reduce the size of the tumor, treat micrometastases early and allow treatment to start immediately (avoiding potential delays in waiting for radiotherapy). while consolidation chemotherapy allows longer waiting times for surgery, with higher response rates.

methods: this trial aim to evaluate induction treatment with capox, followed by short-course radiotherapy consolidation chemotherapy with capox. after 5-7 weeks, patients will be evaluate by mri. patients with incomplete clinical response will be referred to immediate surgery and patients with complete clinical response will be managed with "watch and wait" approach. patients with progression disease during the treatment phase will be withdrawn from the study and will receive their treatment according to the investigator's judgment. the sample size was calculated according to simon's optimal two-stage design. accordingly, 21 patients must be included in each group during the first stage and 24 during the second stage. treatment regimen will be considered effective if 9 or more patients show good response (final analysis), reaching 80% power with an alpha of 0.10 level of significance.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of mid or low rectum * locally advanced rectal cancer with one of the high-risk factors confirmed by high-resolution thin-slice magnetic resonance image (3 mm) tumors extending to within 1 mm of, or beyond the mesorectal fascia; tumor extending 5 mm or more into perirectal fat; resectable ct4 tumors; lower third; nodal involvement; extramural vascular invasion * ecog performance status of 0-2 * an informed consent has been signed by the patient exclusion criteria: * upper rectal cancer * metastatic disease * the patient received any previous therapy for colorectal cancer or another malignancy * other malignant tumours within the last 5 years except cervical carcinoma in situ and basal cell carcinoma of the skin * previous thromboembolic or haemorrhagic events within 6 months prior to registration * patients with malabsorption syndrome or difficulties in swallowing * the patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy * pregnant of breastfeeding women * the patient who participate in another clinical trial, or receives any drug for the trial * uncontrolled peripheral neuropathy (more than grade 2)

Keywords: rectal cancer
brain fuel - morning nutrition and cognitive function

Conditions: Obese; Healthy

Summary: this study will help us learn more about how what a child eats can affect how their brain works.

following a high protein/low carbohydrate meal brain activation and performance measurements will differ from those following a high carbohydrate/low protein meal and executive functioning will be affected.

Eligibility criteria:
inclusion criteria: * 9-10 yr, 3rd to 5th grade * obese * right hand dominance * report eating breakfast at least 4 days/week * able to hear at least 20db stimulus * visual acuity must be at least 20/40 * biological mother available to attend visit exclusion criteria: * full scale iq \<80 * children taking medications or having chronic illness/disorders
early and late implant failure

Conditions: Dental Implant Failed; Peri-Implantitis

Summary: the aim of this study was to evaluate the early and late implant loss rate in a sample of patients who had received implant-supportive restorative therapy in a university setting. moreover, the study aimed to identify patient- and implant-related variables for implant failure


Eligibility criteria:
inclusion criteria: * men and women over 18 years old * partially or totally edentulous patients with at least one implant placed at the university and at least 7 years before. * cemented, screwed, or mechanically retained prosthesis. * single and partial prostheses, as well as complete arch prosthesis (fixed and removable). exclusion criteria: -

Keywords: dental implant survival implant failure early implant failure late implant failure
use of probiotics in oral health of patients with dental implants

Conditions: Mucositis

Summary: the aim of this study was evaluate the effects of the oral probiotic lactobacillus reuteri prodentis upon the peri-implant health of edentulous patients with dental implants and peri-implant mucositis, establishing comparisons versus implants without peri-implant disease. the hypothesis of the study is that using these probiotics are going to improve the periimplant health.

a double-blind, placebo-controlled, prospective cross-over study was made. all the patients were edentulous and were divided into two groups: a) with no peri-implant disease; b) with peri-implant mucositis affecting one or more implants. patients with peri-implantitis were excluded. all patients in both groups initially received the oral probiotic lactobacillus reuteri prodentis, followed by placebo. only the supervisor of the study knew this information; clinical examiner and patients were blind. were studied: crevicular fluid volume, modified plaque index, probing depth, modified gingival index, and concentrations of interleukin 1β, interleukin 6 and interleukin 8, and bacterial load.

Eligibility criteria:
inclusion criteria: * totally edentulous patients subjected to dental implant rehabilitation in one or both arches * prosthetic restoration in function for at least 24 months * healthy individuals without known disease exclusion criteria: * patients receiving any kind of local or systemic decontamination treatment of the oral cavity (e.g., antibiotics or rinses) in the last 3 months, or periodontal treatment in the last 6 months * uncontrolled periodontal disease * patients with immune deficiencies, diabetes, rheumatoid disease, head and neck radiotherapy, bisphosphonate treatment, chemotherapy or anticoagulation * patients with dental implants presenting intraoral exposure of the rough portion of any implant * smokers * incomplete protocols due to a lack of patient cooperation: a) failure to follow the treatment instructions; b) failure to report to the visit after one month of follow-up * failure to provide informed consent to participation the study * patients presenting at least one implant with peri-implantitis

Keywords: dental implants probiotics lactobacillus reuteri periimplant mucositis cytokines bacterial load
effect of dietary macronutrient composition

Conditions: Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Obesity

Summary: the purpose of this study is to understand why hispanics who are overweight have a higher incidence of fatty liver disease.

obesity is a major factor driving the increased prevalence of hepatic steatosis in the us. however, little is known regarding the relationship between dietary intake and hepatic fat deposition or about the factors that promote loss of hepatic steatosis. here, the investigators will determine how differences in dietary composition affect the development and regression of fatty liver. the investigators hypothesize that hispanic subjects with metabolic syndrome will have higher liver fat synthesis rates compared to african american subjects. using detailed in vivo, serial measurements of fuel metabolism (gc/ms and nmr) fatty acid metabolism will be measured in the liver and periphery. this will be the first study in which these two methodologies are used together to assess both glucose and fatty acid metabolism in the same subjects. subjects will be tested before and after a dietary weight-loss intervention producing 6% body weight loss over 5 months. the specific aims are as follows: aim 1: determine the contribution of peripheral and dietary fat to liver-tg in hispanics and african americans with metabolic syndrome. hypothesis: de novo lipogenesis will contribute to liver-tg in greater quantities compared to african americans. aim 2: determine the effects of low-cho and low-fat diets on liver fat regression. hypothesis: compared to a low-fat diet, a low-cho diet will markedly decrease markers of inflammation coincident with greater improvements in insulin sensitivity as assessed by an intravenous glucose tolerance test.

Eligibility criteria:
inclusion criteria: * elevated serum alt or metabolic syndrome * african american or hispanic * nondiabetic * men or women * smokers and nonsmokers * pre- and post-menopausal (+/- hrt) * stable body weight * age 20-65 years * bmi between 25-45 kg/m2 exclusion criteria: * diabetes or pregnancy * ethanol intake: males \> 140 g/week, females \> 70 g/week * chronic hepatitis b or chronic hepatitis c * hemochromatosis or wilson's disease * autoimmune hepatitis or primary biliary cirrhosis

Keywords: metabolic syndrome non-alcoholic fatty liver disease obesity metabolism stable isotopes dietary weight loss
a trial assessing las34273 in moderate to severe stable chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: to evaluate the efficacy and safety of las 34273 compared to placebo in patients with moderate to severe copd during one year of treatment.


Eligibility criteria:
inclusion criteria: * males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable copd exclusion criteria: * history or current diagnosis of asthma, recent respiratory tract infection or acute copd exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma

Keywords: copd lung function exacerbations quality of life
quality of life after breast cancer surgery

Conditions: Breast Cancer Surgery; Quality of Life

Summary: the goal of this observational study is to prospectively collect data on quality of life after oncoplastic breast surgery. participants will be followed-up and answer quality of life questionnaire for a duration of 5 years after surgery.


Eligibility criteria:
inclusion criteria: * patient aged 18 or over * patient with breast cancer of any stage (including in situ) or healthy individual at high personal risk. * patient requiring breast surgery under general anesthesia, whether for therapeutic or prophylactic purposes. * patient capable, in the opinion of the investigator, of complying with the requirements and restrictions of the study. * patient with a computer, tablet or smartphone connected to the internet. * patient followed in the center on a regular basis according to standard recommendations. exclusion criteria: * patient requiring surgical intervention under local anesthesia only. * patient requiring surgery for the installation or removal of an chemotherapy implantable port only. * patients with a history of cancer other than breast cancer. patients with a history of cancer more than three years old are eligible if they are treated and considered cured. patients with a history of cervical carcinoma in situ or non-melanoma skin carcinoma are eligible. * impossibility of being subject to regular monitoring for geographical, social or psychological reasons. * patient under protective measure

Keywords: breast cancer oncoplastic surgery quality of life quality of recovery
clinical trial to evaluate efficacy and safety of acellbia® (jsc "biocad") with methotrexate in first line biological therapy of patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the mail goal of this study is to establish superiority in efficacy of acellbia® applied in a dose of 600 mg (day 1 and day 15) in combination with methotrexate in patients with active ra seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.


Eligibility criteria:
inclusion criteria: written informed consent. age from 18 to 80 years. rheumatoid arthritis diagnosed at least 6 months before informed consent signing presence of more than 8 swollen and more than 8 painful joints at screening. c-reactive protein 7 mg/l or more and/or erythrocyte sedimentation rate 28 mm/hour or more. antibodies to citrullinated cyclic peptide 20 u/ml or more and/or rheumatoid factor-igm higher than upper normal limit. documented regular methotrexate intake for 12 weeks, stable dose from 10 to 25 mg/week during last 4 weeks before signing informed consent. exclusion criteria: methotrexate intolerance. felty's syndrome. patient functional status - iv class according to acr. previous use of biologic drugs to treat rheumatoid arthritis, biologic drugs that deplete cd20-lymphocytes, azathioprine use in the last 28 days prior to informed consent signing, leflunomide use in the last 8 weeks prior to informed consent signing, sulphasalazine/hydroxyquinoline use in the last 28 days prior to informed consent signing, intraarticular use of corticosteroids in the last 4 weeks prior to informed consent signing, patient requires prednisolone (or analogues) in a dose more than 10 mg/day or dose is unstable during 4 weeks prior to informed consent signing, requirement in non-steroid antiinflammatory drugs if their dose was not stable during last 8 weeks prior to informed consent signing. patient has inflammatory joint disease otherwise than rheumatoid arthritis or systemic autoimmune diseases. full list of inclusion and exclusion criteria can be found in study protocol.

Keywords: rheumatoid arthritis rheumatism acellbia methotrexate biologic therapy monoclonal antibody rituximab