Kornimate/medical-research-clean huggingface dataset:
continuous measurement of activity in patients with muscle pathology and in control subjects. actisla part.

Conditions: Amyotrophic Lateral Sclerosis

Summary: actisla is a monocentric academic study. patients with amyotrophic lateral sclerosis may be included on a voluntary basis. the investigators plan to include a group of approximately 20 patients with als. the investigators have planned to assess patient every three months for a year. on each visit, participants will undergo a clinical examination with mrc sum score and ashworth scores. they will perform few tests ( 6-minutes walk test (6mwt), dynamometric measure, electromyography, edinburgh cognitive and behavioural als screen ) and will answer to some questionaires (dysphagia handicap scale, als-sfr-r). after each visit, participants will wear actimyo for one month daily.


Eligibility criteria:
inclusion criteria: * clinically defined or probable diagnosis of als according to el escorial criteria revised with awaji's electro-diagnostic algorithm. * over 18 years old. * signed informed consent * if patient on riluzole, the dosage should be stable for 1 month and continued throughout the study period. exclusion criteria: * patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection. * any other previous or present pathology having an impact on motor function. * recent surgery or trauma (less than 6 months) in the upper or lower limbs. * prior neurological, endocrine, infectious, allergic, or chronic or acute inflammatory pathology in the three weeks preceding inclusion. * patients participating in an interventional clinical trial.

Keywords: actimyo accelerometry daily living
impact of body mass index on outcomes of breast cancer management

Conditions: Obesity and Breast Cancer

Summary: obesity has been linked to an increased risk of developing a number of malignancies, including postmenopausal breast cancer. one of the established risk factors for breast cancer development in post-menopausal women is obesity which has further been linked to breast cancer recurrence and poorer survival in pre- and post-menopausal breast cancer.

the biological mechanisms underlying the association between obesity and breast cancer could involve interacting mediators of hormones, adipocytokines, and inflammatory cytokines which link to cell survival or apoptosis, migration and proliferation. higher level of oestradiol produced in postmenopausal women through aromatization of androgens in the adipose tissues and higher level of insulin, a condition common in obese women, are linked to poorer prognosis in breast cancer. a possible interaction between leptin, insulin and obesity-related markers of inflammation have also been linked to breast cancer outcomes. non-biological mechanisms could include chemotherapy under-dosing in obese women, suboptimal treatment, and obesity-related complications. the impact of body mass index on treatment outcome in patients receiving endocrine therapy, there have been consistent results indicating that the efficacy of aromatase inhibitors vary with body mass index; however, the efficacy of tamoxifen is not body mass index-dependent. in the arimidex, tamoxifen, alone or in combination trial, which compared the efficacy of anastrozole against tamoxifen as an adjuvant treatment for hormone receptor-positive post-menopausal breast cancer patients, anastrozole, a non-steroidal aromatase inhibitor, was significantly less effective in post-menopausal breast cancer patients with a high body mass index, whereas an equal efficacy of tamoxifen was shown across all body mass index levels. observational study. retrospective analysis of data that will be collected from breast cancer patients medical records as body mass index and their response to treatment, progression free survival and overall survival.

Eligibility criteria:
inclusion criteria: * medical records of female patients with breast cancer at clinical oncology and nuclear medicine department, assiut university hospital between (1st jan 2012 and 31st dec 2016), their recorded body mass index and their follow up will be included in the study. exclusion criteria: * patients' medical records that had no documented weight and height. * patients' medical records that had no documented follow up.

Keywords: obesity breast cancer body mass index
individual patient expanded access to ca102n

Conditions: Advanced or Metastatic Colorectal Cancer (mCRC)

Summary: this study is an individual patient expanded access protocol that the subject enrolled had completed the combination treatment of ca102n plus lonsurf for at least 12 cycles.

in the individual patient expanded access, the subject who was enrolled in phase 1 trial (study number: hs-ca102n-101) part 2 (dose expansion) and had completed at least 12 treatment cycles with ca102n combined with trifluridine /tipiracil (lonsurf) will be provided access to treatment with ca102n (0.72 mg/kg nimesulide equivalent of ca102n).

Eligibility criteria:
inclusion criteria: - exclusion criteria: -
support of colonization resistance of the gut microbiota with the synbiotic food supplement nagasin®

Conditions: C. Difficile Enteritis

Summary: double blind, placebo-controlled, parallel, multicentric trial to investigat whether nagasin® can support the colonization resistance against c.difficile.

the aim of this randomized, controlled, double-blind, parallel, multicentric trial is to investigate wether the synbiotic food supplement nagasin® can support the colonization resistance of the gut microbiota after disturbance by antimicrobial treatment. the main question is whether nagasin® can prevent any increase in abundance of c.difficile within the first four weeks after antimicrobial treatment for a c. difficile infection. participants will receive nagasin® or the comparator as a food supplement during the first four weeks after antimicrobial treatment for a c. difficile episode.

Eligibility criteria:
inclusion criteria: * c. difficile infection (cdi) diagnosis * antimicrobial treatment (e.g. metronidazole, vancomycin or fidaxomicin) for c. difficile infection at icf * written informed consent by the participant after information about the research project exclusion criteria: * total parenteral nutrition * insulin-dependent (type 1) diabetes * severe disease defined as any of the following: * white blood cell count (wbc) \> 30,000 or \< 1000 cells/mm3 * neutropenia \< 500 x 10\^9 per liter * intensive care unit (icu) patient at time c. difficile infection diagnosed * in case no hematology values are available, presence of severe can be evaluated by the local principal investigator or his designee * is severely immunocompromised as defined by any of the following: * active malignancy receiving severe immunosuppressive chemotherapy with subsequent leukopenia (as defined above) * long-term systemic steroid therapy ≥ 30 mg / d * recipients of stem cell transfer (≤ 12 months) * severe inborn immune deficiency or severe immunosuppressive therapy as evaluated by the investigator * hiv patients with low cd4+ cell count (\< 200 x 10\^9 per liter) * inflammatory bowel disease patients if: * severe ulcerative colitis (classified as endoscopic mayo = 3 (max. 30 days old) or as evaluated by investigator) * severe crohn's disease with acute penetrating complication (abscess and/or actively draining fistulae) or as evaluated by investigator * liver cirrhosis (classified as child c) with clinically significant portal hypertension and/or low thrombocyte count (20 × 10\^9 per liter) * acute pancreatitis * prosthetic heart valves or endocarditis * consumption of other high-dose (\>10\^10 cfu/dose) probiotic products during the study period. * inability to understand and follow study procedures * prosthetic heart valves or endocarditis * consumption of other high-dose (\>10\^10 cfu/dose) probiotic products during the study period. * inability to understand and follow study procedures

Keywords: gut microbiota colonization resistance gut microbiota dysbiosis
clinical electrophysiology assessment for low back pain

Conditions: Non Specific Chronic Low Back Pain

Summary: non specific chronic low back pain (lbp) is a debilitating disorder characterized by tremendous personal and socioeconomic impact, with long-term sick leave, low quality of life, and very high financial costs. evidence suggests that patients with non specific lbp presented with altered muscle activity pattern when compare with healthy people. it has been reviewed that exercise therapy was effective for modulation of muscle dysfunction in chronic low back pain. however, there is a lack of objective assessment of the pain relief in low back pain rehabilitation. clinical application of surface electromyography (emg) may provide a quantitative and objective tool to evaluate the rehabilitation outcome in patients with non specific chronic low back pain before and after treatment. objectives: to verify the usefulness of surface electromyography (emg) in low back pain (lbp) rehabilitation assessment. setting: out-patient physiotherapy musculoskeletal rehabilitation

participants: one hundred adults with non specific chronic low back pain (lbp) will be recruited. methodology: a prospective correlation study between clinical examination and electrophysiology assessment. this project will perform carefully with a definitive chronic low back pain (lbp). firstly, we will compare the surface emg features from patients with lbp to normal data. in addition, the changes in electrophysiology assessment will be compared with clinical assessment by numeric pain rating scale (nprs). this allows us to verify the potential clinical application of surface emg features in physiotherapy progress assessment.

Eligibility criteria:
inclusion criteria: * one hundred persons with non specific low back pain will be recruited consecutively from the specialist outpatient department (sopd) of physiotherapy department of queen elizabeth hospital. subjects will be included in the study if they presented with symptom duration of greater than three months with no radiological abnormality detected. exclusion criteria: * all subjects should be able to provide informed consent and demonstrate sufficient ability to tolerate the experiment procedure to avoid aggravation of symptoms during the experiment procedures. subjects will be excluded if they have any major orthopedic, neurological, circulatory or respiratory conditions, a history or family history of epilepsy, recent or current pregnancies, and previous surgery to the abdomen or back. the back pain history in the previous year will be documented for those eligible subjects.

Keywords: non specific chronic low back pain surface electromyography (emg) neuromuscular function physiotherapy numeric pain rating scale
a phase 1 study of mm-141 in patients with advanced solid tumors

Conditions: Hepatocellular Carcinoma

Summary: this study is a phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating mm-141 at varying dose levels and frequencies.


Eligibility criteria:
inclusion criteria: * advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy * eighteen years of age or above * able to understand and sign an informed consent (or have a legal representative who is able to do so) * measurable disease according to recist v1.1 * ecog performance score of 0 or 1 * adequate bone marrow, hepatic, renal and cardiac function * willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of mm-141 exclusion criteria: * active infection or fever \> 38.5°c during screening visits or on the first scheduled day of dosing * symptomatic cns disease * received other recent antitumor therapy * pregnant or breast feeding

Keywords: cancer hepatocellular carcinoma oncology phase i erbb3 igf-1r everolimus gemcitabine abraxane
family studies of uveal coloboma

Conditions: Coloboma

Summary: this study will identify the genes responsible for uveal coloboma, an abnormal development of the eye caused by incomplete closure of a normally-occurring gap in the eye (the optic fissure) after the fifth week of life in a human embryo. there have been studies of families in which more than one person has been affected by this disorder. coloboma occurs in about 1 of 10,000 live births and may cause significant vision loss. researchers seek a better understanding of the genes responsible for this disorder. adults and children who have more than one member of the family with uveal coloboma may be eligible for this study. patients will undergo a detailed medical history and eye examination appropriate for their age. the pupils will be dilated, through the use of eye drops. dilation will continue for 4 to 6 hours, and wearing of sunglasses can reduce temporary glare that many patients may experience in brightly lit areas. in addition, pictures will be taken of the front or back of the eye, a procedure that also involves dilation of the pupils. patients who have coloboma will undergo a complete physical examination. blood samples will be collected, with a total of about 2 tablespoons from patients ages 10 and older and about 1 teaspoon for each 5 pounds of body weight for younger patients. also, patients with coloboma may be asked to undergo x-rays , ultrasound, or other tests that are medically indicated. to have enough dna to study, the researchers may create a cell line to grow more dna. laboratory samples will be coded so that there is no identifying information about participants in this study. no other testing or research will be done on blood samples collected unless patients give permission. the researchers will not provide information about patients' health to other people without your express permission.

objective: to describe phenotypes and find genes causing a developmental and potentially blinding eye condition, uveal coloboma. study population: families where more than one family member has uveal coloboma. both affected and genetically informative, unaffected members of the family will be recruited. design: observational study. outcome measures: clinical examination, genetic mapping and mutation identification.

Eligibility criteria:
* this study will enroll 120 adult and children members of families where more than one individual is reported to have coloboma. affected and unaffected family members will be both enrolled. inclusion criteria: 1. the participant must have any recognizeable form of inherited coloboma. 2. the participant must be a genetically informative member of a family where more than one person is affected by typical uveal coloboma. 3. the participant must be able to comply with the protocol and provide a blood sample. exclusion criteria: 1. the participant has any syndromic form of coloboma likely due to mutations in a known gene.

Keywords: coloboma genetics optic nerve coloboma chorioretinal coloboma iris coloboma uveal coloboma
fixation of osseoti™ porous structure versus pps (porous plasma spray) coating on the g7™ acetabular component for primary total hip arthroplasty

Conditions: Osteoarthritis

Summary: the primary objective of this project is to investigate, using rsa, acetabular implant migration of the osseoti™ g7 acetabular cup in comparison to conventional pps coated g7 acetabular cup, and compare liner wear of thinnest available e1™ liner, allowing for the largest possible femoral head (36mm-44mm) to e1™ liner holding a 32mm femoral head in the g7 acetabular system with endpoint assessment being performed at the 2 year follow-up.


Eligibility criteria:
inclusion criteria: * • participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty. * participants must be 18-75 years of age. * participants must be able to speak and understand danish (or depending on country where patient is enrolled). * participants must be able to give informed consent and be cognitively intact. * participants must be expected to be able to complete all postoperative controls. * participants must not have severe comorbidities, asa-score ≤ 3. exclusion criteria: * terminal illness. * rheumatoid arthritis. * previous fracture of the hip. * osteonecrosis of the hip. * previous infection of the hip. * severe bony deformity warranting the use of non-standard implants. * metastasis in the periarticular bone or proximal femur. * female patients that are pregnant or planning pregnancy during follow-up period * if bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation. * documented osteoporosis with patient in active medical treatment. * comorbidity with altered pain perception (e.g. dm with neuropathy). * participants that develop deep infection in the follow-up period are excluded from the project.
nutrition and growth in very preterm infants

Conditions: Premature; Growth

Summary: this study aims to explore the relation of early nutritional intake, especially oral nutrition intake, with growth and body composition among very preterm or very low birth weight infants.

as the survival of very preterm infants increases, it is important to evaluate their long-term outcomes. nutritional intake during early life was important to the growth and development in infants, especially in preterm infants. studies found that early nutrition exposure in preterm infants can effect scored of griffith mental development scales and body fat percentage at later life. insulin-like growth factor-1, leptin, ghrelin, c-peptide are associated with fat mass in children. and accumulation of fat and insulin resistance (ir) in the early postnatal period are related to metabolism diseases in adulthood. however, previous studies on nutrition and growth or the body composition of preterm infants were mostly completed in developed countries, and no relevant data were available in china. therefore, this study aims to establish a prospective cohort of very preterm infants to observe the effects of nutritional exposure in early life on growth and body composition in later life.

Eligibility criteria:
inclusion criteria: * infants born with a gestational age \>=28 weeks and \ =1000g and \<1500g; * infants admitted to neonatal intensive care unit (nicu) of children's hospital of fudan university within 24h after birth. exclusion criteria: * major congenital anomalies or heredity metabolic diseases; * severe disease or abdominal surgery during hospitalization; * death during hospitalization or discharge without medical advice; * small for gestational age.
verification of xapport: a decision support app for physicians used for patients anticoagulated with rivaroxaban in terms of anticoagulation management in elective surgery: verification process of medical decision algorithm

Conditions: Atrial Fibrillation; Venous Thromboembolism; Pulmonary Embolism

Summary: this study shall determine whether xapport - a mobile device app based on different guidelines, the summary of product characteristics of rivaroxaban, and clinical facts and practice - provides adequate guidance to physicians attending patients undergoing elective surgery, who have to interrupt treatment with rivaroxaban for surgery, in deciding how to approach the pre- and postoperative management of anticoagulation.

study design: "retrospective/prospective" observational study

Eligibility criteria:
inclusion criteria: * female or male patient ≥18 years who provided signed and dated informed consent to the use of their medical data * patient was treated with rivaroxaban before and after surgery because of non-valvular atrial fibrillation (nvaf) or venous thromboembolism/pulmonary embolism (vte/pe) * elective surgery in a department of general surgery or orthopedics / trauma surgery was performed within the last 12 months before study start * the patient has been discharged from hospital * patient's medical records are available for data entry exclusion criteria: * patient participated in an interventional drug study within 3 months prior to the surgery and discharge from hospital
a study to compare the adhesiveness of 2 different rotigotine patches used for the treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: the primary objective of the study is to compare the adhesiveness of 2 different patch formulations of rotigotine using the largest patch size of 40 cm\^2, under the assumption that both patch formulations show similar adhesiveness properties.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of idiopathic parkinson's disease * subject has been on continuous treatment with commercially available rotigotine transdermal patches (neupro®) for at least 3 months prior to enrollment * subject has been taking a stable rotigotine dose including an 8 mg/24 hours (40 cm\^2) patch for at least 2 weeks prior to enrollment exclusion criteria: * subject has any medical or psychiatric condition which, in the opinion of the investigator, could jeopardize or would compromise the subject's well-being or ability to participate in this study * subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis * subject has a history or present condition of an atopic or eczematous dermatitis, psoriasis, or an active skin disease * subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either question 4 or question 5 of the columbia-suicide severity rating scale (c-ssrs) at screening (visit 1) or baseline (visit 2)

Keywords: rotigotine patch neupro parkinson's disease
lucentis to treat retinopathy of prematurity (rop) 3 plus disease

Conditions: Retinopathy of Prematurity

Summary: retinopathy of prematurity (rop) is a neovascular retinal disorder of premature born children, characterized by the development of retinal neovascularisation, macular dragging and eventually retinal detachment. rop is a leading cause for childhood blindness, especially in developing countries. vascular endothelial growth factor (vegf) plays an important role in the development of the disease. recently, the beat rop study tested the efficacy of intravitreal bevacizumab for stage 3 plus rop in a prospective, controlled, randomized, stratified, multicenter trial. authors found that bevacizumab showed a significant benefit for zone i but not zone ii disease, with continuation of peripheral retinal vessel growths after treatment. the authors also concluded that safety could not be assessed due to the small sample size. other authors raised concerns regarding the results of the beat rop study and the safety of bevacizumab. the investigators suspected a better safety profile for ranibizumab to treat stage 3 plus rop. here we present the outcome of 6 eyes with rop stage 3 plus treated with a single injection of ranibizumab.

the outcome of six eyes with rop stage 3 plus treated with one single intravitreal injection of ranibizumab is presented. safety issues and side affects are discussed. follow up was 6 months.

Eligibility criteria:
inclusion criteria: * rop stage 3 plus disease exclusion criteria: * severe systemic co-morbidity that did not allow systemic sedation for injection, or were antivegf (vascual endothelial growth factor) therapy was contra-indicated

Keywords: ranibizumab intravitreal therapy rop plus disease stage 3 plus