Kornimate/medical-research-clean huggingface dataset:
decreasing loneliness in older adults

Conditions: Loneliness; Social Isolation

Summary: the purposes of this study are: (1) decrease loneliness and social isolation and increase social competence and social integration of older adults experiencing loneliness; (2) examine an intervention process grounded in a theoretical model that was developed in a previous study. the intervention process is tailored to the participants' barriers and abilities, and includes up to 10 personal meetings with an activities counselor and several group meetings.


Eligibility criteria:
inclusion criteria: * age 65 or over * residing in the tel aviv region exclusion criteria: * having known mental illness including schizophrenia, depression, bipolar disorder, and dementia

Keywords: loneliness social isolation depression older adults social competence social integration
topical timolol gel for the treatment of infantile hemangiomas

Conditions: Hemangioma

Summary: we plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming solution is for infantile hemangiomas (ih) and the response of hemangiomas to timolol maleate 0.5% . our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate infantile hemangiomas.

subjects will be assigned to open label timolol maleate 0.5%. parents will be instructed to place 1 to 2 drops twice a day in the center of the hemangioma. subjects are expected to use the study drug as directed every day for a 4 month period. subjects will be assessed at baseline, 2 weeks, 4 weeks, and every 4 weeks thereafter for a total of 5 months. physical exam, photographs to compare size and color intensity, and a scale of improvement will be completed at each visit. parents will complete a quality of life questionnaire regarding their child's hemangioma and its impact on quality of life. subjects who have evidence of worsening would be removed from the study and transferred to the clinic for evaluation and treatment.

Eligibility criteria:
inclusion criteria: * written informed permission for study participation and the use of the patient's images are obtained from the patient's parent(s) or guardian(s), * the patient is between 7 days and 6 months of age at the time of enrollment, * and a proliferating hoi not requiring systemic therapy is present anywhere on the body, multiple hemangiomas may be treated on same child, if the hemangioma meets this criteria. exclusion criteria: * patients who are not otherwise generally healthy; * at risk for imminent ulceration, life-threatening, function-threatening, or ulcerated; * patients who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers; * patients who have previously been treated for his/her hoi, including any surgical and/or medical procedures; * patients whose mothers have been breastfeeding the patient while also being treated with beta-blockers, systemic corticosteroids, vincristine or alpha-interferon; * patients who have previously experienced any anaphylactic reactions; patients with an unclear diagnosis of hoi; * patients participating in another clinical study or living in the same household as an infant already participating in this study; * patients born prematurely who have not yet reached his/her term equivalent age; and patients with parent(s) or guardian(s) who cannot be contacted by telephone in case of emergency.

Keywords: hemangioma birthmark strawberry hemangioma timolol
an observational study of methoxy polyethylene glycol-epoetin beta (mircera) in stage v chronic kidney disease participants on hemodialysis

Conditions: Anemia

Summary: this observational study will evaluate the efficacy and use of methoxy polyethylene glycol-epoetin beta (mircera) in participants with stage v chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. the therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.


Eligibility criteria:
inclusion criteria: * participants with chronic renal anemia with stage v chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dl) * participants had to be receiving an esa prior to entering the study * female participants of childbearing age had to be using effective contraceptive methods exclusion criteria: * as per approved package insert * any contraindication to esa treatment
screening microorganism of cryptogenic mechanical pneumonia through next generation sequencing to lung tissue fluid

Conditions: Cryptogenic Organizing Pneumonia; Idiopathic Interstitial Pneumonias

Summary: the etiology of cryptogenic organizing pneumonia (cop)was not clear, but previous studies have shown that in some patients, some pathogen could be detected in bronchoalveolar lavage fluid (balf), and may be one of the causes of cop. this study aimed to screen the pathogenic microorganisms in balf and lung puncture fluid of the patients with cop through the next-generation sequencing to further clarify the correlation between the incidence of cop and pathogenic microorganisms.

the cause of cryptogenic organizing pneumonia (cop) was unknown, but studies had shown that certain bacteria, viruses, or specific pathogens could be detected in bronchoalveolar lavage fluid (balf) in some patients, and these pathogenic microorganisms may be the cause of cop. specimens were obtained by conventional methods (sputum, blood, balf or lung puncture fluid) for microbiological detection. due to the influence of the quality of acquired specimens, specimen preservation and transportation which were influenced by external factors, many patients did not get good test results, which affected the diagnosis and subsequent treatment of patients. next-generation sequencing (ngs) which could determine hundreds of thousands to millions of dna molecules in parallel at one time, and efficiently sequence or fragment of pathogenic microorganisms. ngs had greatly improved the detection rate of pathogenic microorganisms. this study aimed to screen pathogenic microorganisms in balf and lung puncture fluid of cop patients by ngs, and further clarify the correlation between occurrence of cop and pathogenic microorganisms.

Eligibility criteria:
inclusion criteria: 1. the patient was older than 18 years old. 2. the patient was organizing pneumonia (op) through pathology. 3. the patient was diagnosed as op from clear cause through routine detection. 4. chest ct shows consolidation or ground glass exclusion criteria: 1. the patient has specific characteristics of connective tissue disease or autoimmune disease. 2. the patient has a clear other cause of op. 3. the patient has severe systemic diseases of heart, brain, liver, kidney and so on, and cannot tolerate invasive examination 4. the patient disapproves of invasive testing

Keywords: cryptogenic organizing pneumonia next-generation sequencing
farapulse workflow assessment registry

Conditions: Atrial Fibrillation (AF)

Summary: the study is designed to determine the best practices in the patient pathway, and to analyze pre-procedural, procedural and follow-up workflow data related with ablation of atrial fibrillation where the farapulse™ pulsed field ablation system is used in a commercial and standard of care setting. workflow-related variables, inclusive of pre-procedural imaging, methods of transseptal access, anesthesia/sedation technique, intracardiac mapping, ablation settings, dosing strategy, lesion sets and general procedure management, will be used to identify predominant workflow schemes that will be associated with patient demographics, procedure-related complications (safety parameters), and one-year effectiveness parameters. the study data can be used for procedural workflow optimization when using pulsed field ablation for the ablation treatment of atrial fibrillation based on patient demographics, cardiac anatomy and arrhythmia characteristics.


Eligibility criteria:
inclusion criteria: * subjects are prospectively planned and intended to be treated with the farapulse™ pulsed field ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care * subjects who are willing and capable of providing informed consent * subjects who are willing and capable of participating to this registry at an approved clinical investigational center * subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law exclusion criteria: * subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. exceptions are when the subject is participating in a mandatory governmental registry, or a purely observational registry, that do not interfere with the current study * prior left atrium ablation

Keywords: catheter ablation pulsed field ablation farapulse workflow assessment
confirmatory study of dsp-5423p in patients with schizophrenia

Conditions: Schizophrenia

Summary: the primary objective of the study is to evaluate the efficacy of dsp-5423p compared with placebo in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * patients who have schizophrenia diagnosed by dsm-5, diagnostic criteria * patients who are aged 18 years or older at informed consent * patient understands the objectives and procedures of the study and who provide written voluntarily consent to participate in the study, etc. exclusion criteria: * patients who fall under a contraindication listed in the blonanserin (lonasen) package insert * patients with parkinson disease * patients who previously received blonanserin, etc.
registry for analysis of compliance in colombian participants with rheumatoid arthritis exposed to golimumab

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to describe adherence to golimumab in colombian participants with rheumatoid arthritis (ra) experiencing adequate treatment response, in a real-world clinical settings.

this is a multi-center (when more than one hospital or medical school team work on a medical research study), non-interventional, prospective cohort study that will enroll participants with ra in colombia, for whom the treating physician has decided to treat with golimumab prior to enrolment. all participants will be observed for adherence to golimumab treatment for 24 months from study start (week 0), and recommended follow up assessments will be every 3 months. any changes including addition of new medications or dose modifications of existing medications will be entirely according to the treating physician's judgment. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants with moderate to severe ra for whom the physician had decided to treat with golimumab according to the local product label, with the first dose being administered between 12 and 26 weeks prior to study enrollment * participants who have achieved an adequate therapeutic response to regular doses of golimumab, within 12 to 26 weeks of treatment * participants should be evaluated for tuberculosis (tb) exposure/risk factors or managed for active and latent tb (per local requirements and according to the local product label) * participants who have been evaluated for active/latent hepatitis b virus (hbv) and hepatitis c virus (hcv) * participants for whom, since golimumab initiation, a complete medical record is available exclusion criteria: * participants who have received and terminated golimumab treatment in the past * participants that have been treated with golimumab for more than 26 weeks prior to enrolment in the study * participants with use of any other investigational agent less than or equal to 30 days before starting treatment with golimumab * participants with suspected latent tb, having not received prophylactic treatment of at least 4 weeks * participants with suspected or active tb * participants with active/latent hbv or hcv

Keywords: rheumatoid arthritis golimumab observational compliance
efficacy, safety, and tolerability of darifenacin in patients aged > 65 years with overactive bladder

Conditions: Overactive Bladder

Summary: the objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged \>ý 65 years with oab.


Eligibility criteria:
inclusion criteria: * symptoms of oab for at least six months prior to visit 3 * symptoms of oab during the 7 day diary period immediately preceding visit 3: * ≥ 1 uuie on average per day and * ≥ 10 episodes of micturition on average per day exclusion criteria: * a total daily urinary volume \> 3000 ml or a mean volume voided per micturition of \> 300 ml as verified in the micturition diary before randomization * post-void residual (pvr) urinary volume \> 100 ml * clinically significant stress urinary incontinence as determined by the investigator * clinically significant bladder outlet obstruction as determined by the investigator * concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (child pugh b and c), severe ulcerative colitis, toxic megacolon. other protocol inclusion / exclusion criteria may apply

Keywords: overactive bladder, darifenacin, m3 muscarinic receptor antagonist, elderly population
kinesiotape and core exercises in federated boxers

Conditions: Low Back Pain

Summary: introduction. nonspecific lumbar pain is a very common cause of sports decline in boxers, possibly due to the repetitive movements of flexion and rotation in their sport, so the investigators believe it is interesting to seek an intervention that helps these athletes to reduce their incidence. aim. to improve non-specific low back pain, range of motion of trunk flexion; the muscular resistance of the spinal erectors and the subjective perception of the effort in federated boxers older than 18 years. study design. randomized, multicentric and double-blind clinical trial with follow-up period. methods. 60 federated boxers of legal age will be recruited, who will be randomly assigned to the study groups: experimental (core and kinesiotape® exercises) and control (core exercises and kinesiotape® tubes without tension). the intervention will last 4 weeks, with 2 weekly sessions, lasting 35 minutes. three evaluations will be carried out (pre-treatment, post-treatment and follow-up) for the dependent variables. the analysis of normality will be carried out with the kolmogorov smirnov test and in case of homogeneity of the sample, with the t-student test of related samples and the anova of repeated means, the difference between the evaluations and the intra e effect will be calculated. intersubject, respectively. expected results. it is expected to observe the effectiveness of the core and kinesiotape® exercises in the perception of nonspecific lumbar pain, the range of movement of trunk flexion and lumbar resistance, and the perception of effort.


Eligibility criteria:
inclusion criteria: * federated boxers * over 18 years * male * with non-specific back pain that does not incapacitate them for the realization of their sport or work activity. exclusion criteria: * federated boxers with lumbar injury with medical diagnosis * who are or have been treated by pharmacological or physiotherapy in the last 6 months * presenting allergies or alterations of the skin * not sign the informed consent document.

Keywords: boxing injuries physiotherapy kinesiotape core low back pain
systems oncology approach to optimize ovarian cancer treatment

Conditions: Ovarian Cancer

Summary: the overall aim is to identify effective therapeutic strategies to ovarian cancer (oc) using serial tumor, ascites and blood samples, and carry out state-of-the-art sequencing approaches, functional assays and associated bioinformatics to understand mechanisms behind chemoresistance in oc and identify new treatment options for oc patients. in this observational trial, we will systematically collect, analyze and interpret functional, molecular and clinical data from real-world ovarian cancer patients.


Eligibility criteria:
inclusion criteria: * patients diagnosed with ovarian cancer * available tumor tissue/blood samples exclusion criteria: * inability to consent to the study
proximal femoral nail antirotation™ (pfna) versus gamma nail 3™ (gamma3) for intramedullary nailing of unstable trochanteric fractures

Conditions: Unstable Trochanteric Fractures

Summary: the purpose of this study is to compare rates of any fracture fixation complication and revision rates after intramedullary fixation of unstable trochanteric fractures between the proximal femoral nail antirotation™ (pfna)(investigational group) and gamma nail 3™ (gamma3) (control group).

intramedullary nailing of unstable per- and subtrochanteric femoral fractures is a standard procedure in trauma and orthopaedic surgery. unstable fractures treated with intramedullary nailing carry the risk of fracture fixation complications. the pfna (synthes) has evolved from the original pfn design, featuring a novel antirotation screw. apart from the prevention of excess rotational forces, this supporting element may enhance the overall stability of the construct, thus potentially reducing fracture fixation complications. empirical information about the fracture fixation complication rates of the pfna device is not available. the primary objective of this study is to compare the 1-year fracture fixation rates between the pfna and gamma nail 3™ (stryker). secondary objectives of the study are to compare differences in functional outcomes, quality of life outcomes, safety, radiological outcomes, handling and perceived effectiveness between the devices.

Eligibility criteria:
inclusion criteria: * age 55 years and more * patients with isolated, unstable, closed or type 1 open trochanteric fractures, classified as ao 31-a2 or ao 31-a3 * definitive primary fracture treatment with pfna or gamma3 (defined intable 1) within three days after the index event * signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups exclusion criteria: * pathologic fracture of any other cause than osteoporosis * patients or legal guardian refusing to sign the informed consent form * multiple trauma * type 2 and 3 open fractures * drug or alcohol abuse * wound and/or bone healing disorders of any other cause than diabetes mellitus or smoking * active malignancy * expected life expectancy ≤ 3 months * inability to walk independently prior to injury event (use of one stick is allowed. not meeting inclusion criteria are bedridden, wheel-chair ridden and walker dependent subjects) * neurological and psychiatric disorders that would preclude reliable assessment (eg,, parkinson disease, multiple sclerosis, severe depression) * rheumatoid arthritis

Keywords: femoral fractures [mesh] hip fractures [mesh] trochanteric fractures (femoral neck fractures [mesh]) intramedullary nailing (fracture fixation, intramedullary [mesh]) complex femoral fractures femoral nail surgical treatment (surgical procedures, operative [mesh]) complications
mom's pain (methylene blue for oral mucositis' pain)

Conditions: Malignant Neoplasm; Oral Pain; Stomatitis

Summary: this phase ii trial studies how well methylene blue works in treating patients with cancer and pain associated with oral mucositis. methylene blue may relieve pain associated with oral mucositis.

primary objectives: i. to evaluate the efficacy of methylene blue (mb) in reducing the severity of mucositis-related pain, measured by numeric rating scale (nrs), in cancer patients who underwent or are undergoing chemotherapy or radiation therapy. outline: patients are randomized to 1 of 4 groups. group 1: patients receive lower dose methylene blue orally (po) to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. group 2: patients receive medium dose methylene blue po to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. group 3: patients receive higher dose methylene blue po to swish and spit for 5 minutes every 6 hours then receive standard of care therapy. group 4: patients receive standard of care therapy. after completion of study treatment, patients are followed up at 1, 2, 7, and 30 days.

Eligibility criteria:
inclusion criteria: * patients with a cancer diagnosis, receiving chemotherapy, radiation therapy or the combination * patients with a current diagnosis of oral mucositis * patients with pain and oral dysfunction associated with oral mucositis despite conventional therapy * voluntary written consent * patient must agree to use of contraception or abstinence from sex during the treatment period and for 30 days after patient's last dose exclusion criteria: * patients with known allergy to mb * patients taking medications with known significant drug interactions * pregnant or lactating patients * patients who are cognitively impaired and unable to consent for the study * patients with risk of broncho-aspiration based on documented swallowing test by a speech pathologist (if available) * patients with known history of g6pd deficiency * patients undergoing any other experimental intervention for oral mucositis * patients who have no pain or impairment in oral function, patients who are not symptomatic * patients with head and neck cancer * patients on serotonergic drugs