Kornimate/medical-research-clean huggingface dataset:
study to evaluate vadadustat for the correction of anemia in participants with non-dialysis-dependent chronic kidney disease

Conditions: Anemia; Non-Dialysis-Dependent Chronic Kidney Disease

Summary: a multicenter, randomized, open-label, active-controlled phase 3 study for the correction of anemia and maintenance of hemoglobin (hb) in participants with non-dialysis-dependent chronic kidney disease (ndd-ckd)

this is a multicenter, randomized, open-label, active-controlled phase 3 study of the efficacy and safety of vadadustat versus darbepoetin alfa for the correction of anemia and maintenance of hb in participants with ndd-ckd

Eligibility criteria:
inclusion criteria: * ≥18 years of age * diagnosis of chronic kidney disease (ckd) with an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 square meter (ml/min/1.73 m\^2) at screening and not expected to start dialysis within 6 months of screening * mean screening hemoglobin \<10.0 grams per deciliter (g/dl) * serum ferritin ≥100 nanograms per milliliter (ng/ml) and transferrin saturation (tsat) ≥20% during screening exclusion criteria: * anemia due to a cause other than ckd or participants with active bleeding or recent blood loss * red blood cell transfusion within 8 weeks prior to randomization. * any erythropoietic stimulating agent within 8 weeks prior to randomization * uncontrolled hypertension * severe heart failure at screening (new york heart association class iv) * acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during screening * hypersensitivity to darbepoetin or vadadustat or to any of their excipients

Keywords: vadadustat akb-6548 chronic kidney disease anemia ckd chronic renal insufficiency renal impairment erythropoietin kidney renal oral anemia treatment hemoglobin hypoxia-inducible factor hif hypoxia-inducible factor prolyl-hydroxylase inhibitor hif-phi efficacy safety phase 3 cardiovascular ndd-ckd
a correlational study: breast cancer-related chest wall lymphedema, quality of life, and shoulder function

Conditions: Breast Carcinoma

Summary: this study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function.

primary objectives: i. determine if there is a correlation to delfin moisture meter compact d reading and quality of life as measured by the lymqol-midline. ii. determine if there is a correlation to delfin moisture meter compact d reading and dash measure of shoulder function. iii. determine how the presence of chest wall lymphedema as determined by physical exam may affect an individual's quality of life as measured by the lymqol-midline assessment. iv. determine how the presence of chest wall lymphedema as determined by physical exam may shoulder function on the effected side, as measured by the disabilities of the arm, shoulder, and hand questionnaire. outline: this is an observational study. patients complete questionnaires and undergo chest wall and breast lymphedema measurements by clinical assessment and using the delfin moisture meter d compact and have their medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * women of any age with diagnosis of any type of breast cancer * breast cancer on unilateral or bilateral side * surgical intervention for treatment of breast cancer exclusion criteria: * previous shoulder injury or known shoulder limitation on affected side
evaluation by a vineland ii scale of long-term development of children with pyridoxine dependent epilepsy

Conditions: Pyridoxine-Dependent Epilepsy

Summary: this study aims to evaluate with the vineland ii scale the long-term neurocognitive development of children above age 3 years with pyridoxine dependent epilepsy related to antiquitine deficiency.

pyridoxine dependent epilepsy related to antiquitine deficiency is a rare and severe genetic epilepsy that usually starts within the first month of life. the treatment is based on high dose of vitamin b6 (pyridoxine) which is usually highly effective to control the seizures. however, most patients show impaired neurodevelopment. ten years ago, international recommendations have changed and a lysine restricted diet was added as an adjunct therapy with the hope to improve neurodevelopment. very few studies have evaluated the cognitive development of these patients in a standardized way, and these studies evaluate very few patients. it seems therefore essential to study in a standardized way the neurocognitive development of these patients in order to evaluate the impact of the care. the vineland adaptative behaviour scale ii has been chosen because it can evaluate a patient whatever the age or the intellectual abilities through a semi-structured questionnaire completed with the parents, and gives a wide view of the neurocognitive development and everyday life autonomy of the patients.

Eligibility criteria:
inclusion criteria: * age above 3 years old * pyridoxine dependent epilepsy genetic diagnosis (mutation in aldh7a1 gene) * no objection of the patient or his legal representatives. exclusion criteria: * poor understanding of french language.
tpf concurrent chemo-radiotherapy plus immunotherapy for local advanced esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the goal of this clinical trial is to learn if immune microenvironment modification could improve the effect of chemoradiotherapy for patients with local advanced esophageal squamous cell carcinoma. the main questions it aims to answer are: 1. does immune microenvironment could be modified by medium dose of three drugs (paclitaxel, cisplatin, 5-fu), pd1 checkpoint inhibitor, probiotics, and thymosin α1？ 2. does induction and consolidation of pd1 checkpoint inhibitor improve the effect of chemoradiotherapy for patients with esophageal cancer? this is a single arm study. participants will: 1. take one cycle of induction chemotherapy (paclitaxel, cisplatin, 5-fu) and immunotherapy (sintilimab), two cycle of concurrent chemoradiotherapy, one cycle of consolidation chemo-immunotherapy, and then 1 year of immunotherapy. 2. take probiotics (clostridium butyricum) for 1 year and thymosin alpha-1 daily during radiotherapy.

concurrent chemoradiotherapy is the standard treatment for patients with inoperable local advanced esophageal squamous cell carcinoma. however, over half of patients will relapse. how to improve effects? we focus on tumor microenvironment transformation by three drug chemotherapy, pd1 inhibitor, probiotics, and thymosin α1，and intent to improve radiosensitivity and reduce recurrence.

Eligibility criteria:
inclusion criteria: 1. sign written informed consent before implementing any trial related procedures; 2. age range from 18 to 80 years old; 3. stage ii-iii and stage iv esophageal squamous cell carcinoma with only extraregional lymph node metastasis determined by histopathology; 4. inability to undergo surgical resection or patient refusal to undergo surgery; 5. ecog ps 0-1; 6. expected survival time\>3 months; 7. sufficient organ function is required for the subject to meet laboratory indicators exclusion criteria: 1. after esophageal or tracheal stent implantation surgery; 2. due to the obvious invasion of tumors into adjacent organs (arteries or trachea) of the esophageal lesion, there is a higher risk of patients at risk of bleeding or perforation, or those who have formed fistulas; 3. diagnosed as malignant diseases other than esophageal cancer within 3 years prior to initial administration (excluding those that have undergone curative treatment) 4. currently participating in intervention clinical research treatment, or having received other treatments within 4 weeks prior to initial administration researching drugs or using research instruments for treatment; 5. previously received the following therapies: anti-pd-1, anti-pd-l1, or anti-pd-l2 drugs, or targeting another stimulus or synergistic inhibition of t cell receptors (such as ctla-4, ox-40, cd137) medications;
superficial basal cell cancer's photodynamic therapy: comparing three photosensitizers: hal and bf-200 ala versus mal

Conditions: Neoplasms, Basal Cell; Carcinoma, Basal Cell; Photochemotherapy; Photosensitizing Agents

Summary: this pilot study compares three photosensitisers, hexylaminolevulinate (hal) and aminolevulinic acid nano emulsion (bf-200 ala) to methylaminolevulinate (mal) in photodynamic therapy of superficially growing basal cell carcinomas. study is conducted using randomised prospective double blinded comparing design. fluorescence is measured in a.u. (arbitrary unit) with standardised set-up before and after the exposure. efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.

study recruits volunteering patients, who are referred to the department of dermatology and allergology, päijät-häme central hospital, lahti, with 99 clinically assessed superficial basal cell carcinoma on the body area, not face and scalp. diagnoses is confirmed histologically by punch biopsies and hyperspectral images are taken before the biopsies. the lesions are randomised in three groups: interventions hal and bf-200 ala and comparator mal. photodynamic therapy is given by the standard procedure. fluorescence is measured in a.u. (arbitrary unit) with standardised set-up, with wood's light, digital camera and a yellow lens, before and after the exposure. pain is measured in vas-scale before, during and after the exposure. efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.

Eligibility criteria:
inclusion criteria: * superficial basal cell carcinomas on body area (clinically assessed to be mainly superficially growing and later on a biopsy proven sbcc or thin nbcc) * lesions accepted needs to be 10 cm apart from each other exclusion criteria: * pigmented, morpheaform, infiltrative or nodular basal cell carcinomas * lesions that are in face and scalp area * pregnancy * breast feeding * allergy to photosensitizer * phorphyria or photosensitivity
clinical significance of detecting cea and ck20 mrna-positive cells in colorectal cancer patients

Conditions: Colorectal Cancer; Circulating Tumor Cell

Summary: to determine whether the presence of circulating/disseminated tumor cells (ctcs/dtcs) in the blood and bone marrow of colorectal cancer (crc) patients with localized disease is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics.


Eligibility criteria:
inclusion criteria: - colorectal adenocarcinoma exclusion criteria: * prior neoadjuvant chemoradiotherapy * prior colorectal cancer * cancer duplicity

Keywords: prognostic significance
ozonated water in treatment of denture stomatitis

Conditions: Denture Stomatitis

Summary: the effect of ozonated water on the treatment of oral stomatitis associated with complete denture wearer in comparison to chlorhexidine mouthwash

compete denture wearers having oral denture stomatitis were divided into two groups. group i used ozonated water while group ii used chlorhexidine mouthwash. the growth of candida albicans, the degree inflammation and pain grade were evaluated before starting the treatment then every week till one month. also

Eligibility criteria:
inclusion criteria: * completely edentulous male patients wearing heat cured acrylic resin removable prosthesis. * patients having denture associated oral stomatitis. * healthy patients free of any systemic diseases. exclusion criteria: * smoker patients. * patients suffering from any auto immune or systemic diseases, temporo-mandibular joint disorder ( tmj disorders and parafunctional oral habits. * patients with a history of radiotherapy or chemotherapy. * patients having oral lesions.

Keywords: ozonated water denture stomatitis chlorhexidine mouthwash
repetitive transcranial magnetic stimulation to people with cannabis use disorder (stop-c-rtms x cud)

Conditions: Cannabis Use Disorder; Repetitive Transcranial Magnetic Stimulation

Summary: this study is to explore if repetitive transcrinal magnetic stimulation (rtms) with different stimulation schedules will be equally effective in reducing carving, frequency of cannabis use, and the severity of cannabis use disorder in participants suffering from cannabis use disorder (cud). the investigators assume the hypotheses as: 1. multiple rtms sessions can reduce craving for cannabis, severity of cud, frequency and amount of cannabis use. 2. different rtms treatment schedules have differences in reducing the craving for cannabis and severity of cud, and prolonging relapse of cannabis use.


Eligibility criteria:
inclusion criteria: * able to read and communicate in english and/or chinese stop-c-rtms x cud * able to give informed consent * using cannabis or marijuana as the primary psychoactive substance of abuse * diagnosed with cannabis use disorder according to the diagnostic and statistical manual of mental disorders 5th edition (dsm-5) by the structured clinical interview for dsm-5 disorders (scid-5) exclusion criteria: * age \<18 years old * unable to read english or chinese * unable to give informed consent * had been diagnosed with the following disorders, including neurodevelopmental disorders, dsm-5 defined substance use disorder greater than moderate in severity, and neurocognitive disorders * contra-indicated to have rtms, including subjects with electronic and/or magnetic implants (e.g. pacemaker, implantable cardioverter defibrillator \[icd\], cerebral shunts, cochlear implant, etc.), with metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.), pregnant, with any known or history of neurological conditions including cerebral vascular accidents, epilepsy, brain tumor or space occupying lesion, poorly controlled or unstable diabetes mellitus, and receiving unstable dose(s) of antipsychotics, antidepressants, benzodiazepines and/or anticonvulsants in the past 6 months

Keywords: cannabis tms
biochemical factors for a dry eyed population

Conditions: Dry Eye

Summary: the purpose of this study is to compare various symptoms and signs of dry-eye as well as stratify characteristics of the tear film in a group of dry-eyed individuals in comparison to a group of non-dry-eyed people. dry-eye is a condition that significantly impacts the quality of life of the sufferer. these are people who are predominantly female and in the older age groups. determining what characterises a person with dry-eyes is of importance to understanding the disease process.

dry eye is a multifactorial disease that results in a wide variety of signs and symptoms, which are often poorly correlated. recent work has shown that not only are there changes in the composition of the tear film (including cytokines and the presence of various mucin species and tear film proteins) but also quantifiable changes in both the structure and function of the ocular surface, including corneal sensitivity and the appearance of the epithelial cells and the sub-basal neural network. to-date, no published study has attempted to correlate various clinical and morphological changes found in dry eye with tear film and ocular surface biomarkers.

Eligibility criteria:
inclusion criteria: a person is eligible for inclusion in the study, for the dry eye group or control, if she: 1. is caucasian, and has full legal capacity to volunteer. 2. is post-menopausal, with menses ceasing more than 12 months ago. 3. has moderate or severe dry eye symptoms based on dry eye questionnaire and half of the time wants to use eye drops for dry eye symptoms (dry eye group) 4. has read, understood and signed an information consent letter. 5. is willing and able to follow instructions and maintain the appointment schedule. 6. has clear corneas and no active ocular disease. 7. has had an ocular examination in the last two years. exclusion criteria: 1. is on hormone replacement therapy (hrt). 2. ceased menses due to autoimmune disorders, mumps, chemotherapy, pelvic irradiation or smoking. 3. has rheumatoid arthritis, diabetes, sjogren's syndrome or any other systemic disease affecting ocular health. 4. is using any systemic or topical medications (other than eye drops for dry eye symptoms) that may affect ocular health and neuroendocrine system function. 5. has undergone corneal refractive surgery. 6. is aphakic. 7. has any active ocular disease. 8. has known sensitivity to the diagnostic pharmaceuticals to be used in the study. 9. is participating in any other type of clinical or research study. 10. is a contact lens wearer. 11. has blepharitis.

Keywords: postmenopausal non dry eye
postural based telerehabilitation in mechanic neck pain

Conditions: Neck Pain; Telerehabilitation; Postural; Defect

Summary: it has been reported that staying in the same posture for a long time causes musculoskeletal system problems, and the use of mobile phones and other electronic devices continuously, especially in the internet age, causes postural problems in many people. physiotherapy applications including strengthening, stretching, yoga, pain-oriented applications, and behavioral treatments are performed for an ideal posture to regulate postural problems. when the literature is examined, it has been seen that the studies carried out after the covid 19 pandemic have developed especially in the direction of telerehabilitation, but there is a need for studies showing the effect of exercise applications developed for individuals with mechanical neck pain. this study was conducted to investigate the effect of 12-week telerehabilitation on posture, energy consumption, and performance in individuals with mechanical neck pain.

this cross-sectional study was conducted at the faculty of physiotherapy and rehabilitation, university of health sciences. all evaluations were performed in the university physiotherapy laboratories. all of the participants were informed about the study and provided written informed consent. this study was performed in accordance with the 1964 helsinki declaration, its later amendments.110 people over the age of 18 were included in the study. posture-oriented exercises were applied online 3 times a week for 12 weeks. postural measurements, performance, and energy consumption levels were determined for each participant before and after the intervention. craniovertebral angle and shoulder angle were measured with a smartphone application and muscle shortness was measured with clinical tests among postural measurements. performance measurement was evaluated with the 6-minute walking test, and energy consumption was evaluated with the physiological cost index. individuals diagnosed with mechanical neck pain who applied to the university's wellness center for exercise between september 2021 and december 2021 were determined by physiotherapists who are experts in their fields. a cross-sectional selection of 110 individuals met the inclusion criteria. this study was conducted with assessments made before and after posture-based telerehabilitation.

Eligibility criteria:
inclusion criteria: * inclusion criteria were being aged 18 years or over, * volunteering to take part in the study, * being a student of online education, * without a history of any neurological or orthopedic problem, * with resting neck pain (as measured by the visual analogue scale) lasting ≤30 days and that is aggravated by movement without extending distal to the shoulders. exclusion criteria: * the exclusion criteria were neck pain that included inflammatory rheumatological diseases, malignancy, or structural deformity, previous surgery related to the cervical spine, * severe referred pain (greater than 7 on a 0-to-10 visual analogue scale-vas).

Keywords: neck pain telerahabilitation posture
the mediating effects of decentering on self-management of stress and end of life planning

Conditions: Stage IV Gastrointestinal Cancer; Advanced Gynecological Cancer

Summary: caregivers of persons with cancer may face many challenges as they support and care for a person receiving treatment. sometimes having to help make treatment decisions for a patient can cause distress for caregivers. the purpose of this study is to evaluate 2 different electronic approaches to providing support for a caregiver. one group will have access to an on-line program with videos, providing education on decision making strategies for caregivers of patients with cancer, to watch and a daily meditation application and the other group will have access to the daily meditation application. investigators will randomly assign participants to each group.

investigators will conduct a randomized trial pilot study to examine two arms of the intervention among 20 caregivers of patients with advanced cancer. investigators will collect mixed methods data to describe changes in proximal and distal outcomes. investigators have chosen the time points to capture neural and behavioral changes associated with the intervention and to capture end of life quality of life (qol) for a majority of caregivers after death of their loved one. investigators aim to: 1. evaluate the short and longer-term effects of the end of life care with medication (eol_m) and meditation only (m_only) interventions on stress reduction and end of life (eol) planning behaviors and determine if there are different effects between eol_m and m_ only interventions. 2. evaluate the short-term and long-term effects of the intervention on caregiver distress, decisional regret, and eol values and goals of care for treatment. 3. evaluate the impact of decentering on the association between the interventions, self-management behaviors (stress reduction and eol planning behaviors) and distress, anxiety, concordance between eol values and goals of care for treatment, decisional regret and satisfaction with eol care. 4. describe the neural activity processes that are associated with increased self-management activities.

Eligibility criteria:
inclusion criteria: * caregivers of patients who have been diagnosed with stage iv gastrointestinal (gi) cancer * coming with the patient at the seidman comprehensive cancer center at university hospitals case medical center (uhcmc) * have access to the internet and a computer, tablet, or smart phone, and * speak and comprehend english. exclusion criteria: * currently practicing mindfulness-based interventions (yoga, meditation, deep breathing) * require psychotherapy within the last three months * have a history of dementia, major neurological illness * pregnant * history of a medical condition or procedure that is contraindicated for functional magnetic resonance imaging (fmri) scanning (i.e. cardiac pacemaker, sternal wires, or metal implants); and * claustrophobia requiring anxiolytics or sedation; or * expect to relocate from northeast, ohio within 2 months

Keywords: caregiver end of life