Kornimate/medical-research-clean huggingface dataset:
photon/proton radiation therapy for carcinoma of the skin of the head and neck

Conditions: Malignant Neoplasm of Skin Head and Neck

Summary: the purpose of this study is to collect information from the questionnaire and your medical records to see what effects the proton radiation has on you and your cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Eligibility criteria:
inclusion criteria: * carcinoma of the skin of the head and neck region with incidental or symptomatic perineural invasion. * biopsy-proven squamous cell carcinoma. * will receive treatment with proton radiation. exclusion criteria: * evidence of distant metastasis. * previous irradiation for head and neck cancer.

Keywords: carcinoma of the skin of the head and neck proton radiation outcomes
safety and efficacy of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in previously untreated advanced or recurrent non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (nsclc). particpants will be randomized to receive 4 cycles of carboplatin (c)/paclitaxel (p) and either pictilisib or placebo, with (participants with non-squamous nsclc) or without (participants with squamous nsclc) bevacizumab (b). anticipated time on study treatment is until disease progression or intolerable toxicity occurs. participants in placebo arms with disease progression may cross over to open-label active pictilisib.


Eligibility criteria:
inclusion criteria: * histologically documented advanced (stage iv) or recurrent squamous (arms a and b) or non-squamous (arms c, d, e, and f) non-small cell lung cancer (nsclc) * consent to the collection of an archival formalin-fixed paraffin-embedded (ffpe) block or freshly cut unstained tumor slides from archival tumor tissue or a newly collected tumor sample * eastern cooperative oncology group (ecog) performance status of 0 or 1 * disease that is measurable per response evaluation criteria in solid tumors (recist) v1.1 * adequate hematologic and end organ function * use of two effective forms of contraception exclusion criteria: * nsclc with documented epidermal growth factor receptor (egfr) mutation associated with response to egfr inhibitors or documented fusion gene involving anaplastic lymphoma kinase (alk) gene * prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) before day 1 of cycle 1 for the treatment of advanced (stage iv) or recurrent nsclc * known central nervous system (cns) disease except for treated brain metastases * type i diabetes * type ii diabetes requiring chronic therapy with insulin * any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications * medical conditions that would contraindicate bevacizumab therapy in non-squamous nsclc (arms c, d, e, and f)
open label study of subcutaneous homoharringtonine (omacetaxine mepesuccinate) in patients with advanced cml

Conditions: Chronic Myeloid Leukemia

Summary: a phase ii open-label trial of subcutaneous hht (omacetaxine mepesuccinate) in the treatment of patients who are resistant to or intolerant to tyrosine kinase inhibitors.

this will be an open label, multicenter study of subcutaneous hht (omacetaxine mepesuccinate) therapy of patients with chronic myeloid leukemia (cml) in chronic, accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy. patients will be treated with induction course cycles consisting of subcutaneous (sc) hht 1.25 mg/m² twice daily for 14 consecutive days every 28 days. patients will be evaluated every 7 days with complete blood and platelet counts while undergoing induction therapy; the number of consecutive doses of hht or intervals between subsequent cycles may be adjusted, as clinically indicated, according to guidelines provided in the treatment plan.

Eligibility criteria:
inclusion criteria: * male or female patients, age 18 years or older * philadelphia chromosome (ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase * patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least two tyrosine kinase inhibitors (tki's). failure of tki treatment may either be primary (never achieved a response) or secondary resistance (loss of response). * acceptable renal and liver function * eastern cooperative oncology group (ecog) performance status 0-2. * sexually active patients and their partners must use an effective double barrier method of contraception exclusion criteria: * new york heart association classification (nyha) class iii or iv heart disease, active ischemia or any other uncontrolled cardiac condition * myocardial infarction in the previous 12 weeks. * other concurrent illness which would preclude study conduct and assessment * uncontrolled and active infection, and positive hiv or positive htlv i/ii status, whether on treatment or not. * pregnant or lactating. * any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol. * lymphoid ph+ blast crisis * patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent

Keywords: cml hht homoharringtonine omacetaxine
efficacy and safety of alfacalcidol compared to calcitriol for treatment of secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism; End Stage Renal Disease

Summary: this study was performed to determine whether calcitriol provides a therapeutic advantage to alfacalcidol for treatment of secondary hyperparathyroidism in esrd patients.

secondary hyperparathyroidism has a significant impact on morbidity and mortality in advanced chronic kidney disease (ckd).both nonselective and selective vitamin d receptor activators (vdras) are demonstrated in many studies for their efficacy on suppression of pth. most of them are quite expensive and unavailable in many countries. calcitriol and alfacalcidol are less expensive and worldwidely distributed. there is only one short-term study which directly compares these two drugs. this study demonstrates that calcitriol is superior to alfacalcidol. however, alfacalcidol is a prohormone of calcitriol. it has to be converted by 25-hydroxylase at the liver to generate 1,25-dihydroxyvitamin d3 to act on target cells. many pharmacokinetics studies demonstrate that alfacalcidol has lower auc compared to calcitriol if they are administered in the same dose. therefore, the authors hypothesize that alfacalcidol may be equivalently efficacious as calcitriol if its dose is adjusted according to the pharmacokinetics studies.

Eligibility criteria:
inclusion criteria: * chronic hemodialysis patients who underwent scheduled hemodialysis for at least 3 months with secondary hyperparathyroidism (intact pth levels \> 300 pg/ml) exclusion criteria: * (1) age \ 10.2 mg/dl or serum phosphate \>6 mg/dl after adjusting dialysate calcium and phosphate binders (5) diameter of parathyroid gland \>10 mm (6) pregnancy or lactation (7) liver cirrhosis (8) active kidney transplantation (9) previous parathyroidectomy (10) malignancy or chronic infection/inflammation.
lung function, exercise capacity, and serology responses in patients with covid-19

Conditions: Lung Function; Exercise Capacity; Quality of Life; Covid19

Summary: (a) objectives 1. to assess the full lung function, exercise capacity, quality of life in patients with covid-19 over 2 years. 2. to assess the longevity of the serology response to sars-cov2. 3. to investigate the association of the neutralization titer in plasma from different vaccinated cohorts to its protection of infection using in vivo model 4. to investigate the sars-cov-2 specific cellular and humoral immunities as well as their determinant factors from community subjects who have received different types of covid-19 vaccines. 5. to assess the third booster dose for subjects who have poor antibody response despite having received two doses of coronavac (sinovac)

the health conditions of adults (n=300) who recovered from varying severity of covid-19 will be assessed and their blood are collected at 6, 12, 24 and 36 months after discharge. the assessment package includes: lung function tests, 6-min walk distance, chest radiographs/ct, and sf36 general health questionnaire. blood samples from community cohorts will be collected from before and up to 36 months after receiving one of the three covid-19 vaccines (n=200 per vaccine type). the kinetics of sars-cov-2 specific humoral and cellular immunities from both convalescent and vaccinated cohorts are determined by neutralization assay and by measuring specific t cell responses upon stimulation of sars-cov-2 specific peptide library respectively. the antiviral level of the human plasma with various neutralization titer collected from different vaccinated cohorts will be tested in mouse model and adcc assay.

Eligibility criteria:
inclusion criteria: patients who have been discharged from hospital following treatment for covid-19 - exclusion criteria: unwilling to be follow up -
how avatar can enhance autobiographical memory of patients with substance use disorder

Conditions: Substance Use Disorder (SUD)

Summary: the goal of this study is to investigate whether the use of artificial intelligence platforms can promote the retrieval of specific positive autobiographical memories.

the decision to focus on the retrieval of positive autobiographical memories was made for ethical reasons and is not tied to any specific research hypothesis. specifically, the study aims to assess whether artificial intelligence facilitates the sharing of personal experiences and reflection on autobiographical memories related to substance use disorders, taking into account the potential influence of individual characteristics such as recent mood state, and overall memory functioning.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of substance use disorder * admitted to the drug rehabilitation center for at least 3 months * aged 18 years or older exclusion criteria: * previous neurological pathologies * previous cognitive deficits

Keywords: autobiographical memory substance use disorder
a cohort trial comparing autologel therapy to usual and customary care in venous leg ulcers

Conditions: Venous Leg Ulcer

Summary: the aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, cohort-controlled trial in which venous leg ulcers (vlu)n will be treated using autologel and case-matched against a concurrent cohort of patients receiving undefined usual and customary care (ucc)

recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. while treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. autologel is a platelet-rich plasma (prp) gel used in the treatment of non-healing chronic wounds. the aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, open-label trial in which venous leg ulcers will be treated using autologel and standard of care and case-matched against a concurrent cohort of patients receiving undefined usual and customary care

Eligibility criteria:
inclusion criteria: 1. medicare/medicaid eligible 2. ≥18 years of age 3. proven venous disease 4. the largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) that is located between and including the knee and the ankle 5. for subjects with potentially multiple eligible vlus, the largest ulcer will be selected. there must be at least 4 cm between the index ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure) 6. debrided ulcer size between 2 cm2 and 200 cm2 7. demonstrated adequate compression regimen 8. duration ≥ 1 month at first visit 9. subject must be willing to comply with the protocol, which will be assessed by enrolling clinician. exclusion criteria: 1. subjects known to be sensitive to autologel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin 2. presence of another wound that is concurrently treated and might interfere with treatment of index wound by autologel 3. ulcer not of vlu pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology) 4. any malignancy other than non-melanoma skin cancer 5. subjects who are cognitively impaired and do not have a healthcare proxy 6. serum albumin of less than 2.5 g/dl 7. plasma platelet count of less than 100 x 109/l 8. hemoglobin of less than 10.5 g/dl 9. subject has inadequate venous access for repeated blood draw required for autologel administration

Keywords: venous leg ulcers non healing wounds
a clinical study to test efficacy and safety of repeat doses of cntx-4975-05 in patients with osteoarthritis knee pain

Conditions: Osteoarthritis, Knee

Summary: this is a randomized, double-blind, placebo-controlled, 2-injection, 52-week study to evaluate the efficacy and safety of intra-articular injections of cntx-4975-05 in subjects with chronic, moderate-to-severe osteoarthritis knee pain.


Eligibility criteria:
key inclusion criteria: * male or female subjects between 40 and 95 years of age (inclusive) at the time of the screening visit with the ability to comply with answering the electronic diary using the study- provided tablet computers. * confirmation of osteoarthritis (oa) of the knee. * confirmation of the oa of the index knee. * moderate to severe pain in the index knee associated with oa must be stable for a minimum of 6 months prior to screening, as assessed by the investigator. * body mass index (bmi) ≤45 kg/m\^2 * must have failed 2 or more prior therapies. exclusion criteria: * joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months. * prior arthroscopic surgery of the index knee within 6 months of screening. * any painful conditions of the index knee due to joint disease other than the oa. * periarticular pain from any cause. * other chronic pain anywhere in the body that requires the use of analgesic medications. * instability of the index knee. * misalignment (\>10 degrees varus or valgus) of the index knee on standing. * documented history of neuropathic arthropathy or finding of bony fragmentation in the index knee with imaging. * physical/ occupational/ chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 30 days of screening, or need for such therapy during the study. * plans to have surgery, other invasive procedures, or ia injections while participating in the study. * has used topical capsaicin on the index knee within 90 days of screening. * current use of opioids for any condition other than for oa of the index knee. * corticosteroid injection into the index knee within 90 days of screening. * received ia viscosupplementation (eg, synvisc®, hyalgan®) within 90 days of screening.

Keywords: osteoarthritis knee pain
loteprednol vs prednisolone for the treatment of intraocular inflammation following cataract surgery in children.

Conditions: Cataract

Summary: the objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.

the objective of this study is to compare the efficacy and safety of topical loteprednol etabonate (le), 0.5%, to prednisolone acetate 1%, for the treatment of postoperative inflammation following ocular surgery for childhood cataract.

Eligibility criteria:
inclusion criteria: * subject is a candidate for routine, uncomplicated surgery for childhood cataract exclusion criteria: * subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the investigator's opinion, may preclude study treatment or follow-up. * subjects with glaucoma, ocular hypertension, or those receiving intraocular pressure (iop) lowering therapy in either eye or systemically. * subjects with a history of steroid-induced iop elevation in either eye. * subjects who have known hypersensitivity or other contraindication to the study drug(s) or any components in the drug formulation.

Keywords: pediatric cataract
diclofenac im versus tramadol iv in acute renal colic, rct

Conditions: Acute Renal Colic

Summary: patients presented with acute pain from renal colic, the standard of care are prescribed nsaids, most common drug used is intramuscular (im) diclofenac injected at the gluteal muscle. due to adverse effects in some patients, the nursing council has banned the injection by nurses. since then, there has been a change in treatment by using intravascular (iv) tramadol. according to various research, diclofenac has a higher efficacy in controlling pain compared to other medications. in clinical practice, tramadol has less efficacy of decreasing pain and a longer onset of action. at presence, there has been no research performed comparing the efficacy between these two drugs especially from the viewpoint of time dimension.

to compare the efficacy diclofenac 75 mg im versus tramadol 50 mg iv in patients with acute pain from renal colic.

Eligibility criteria:
inclusion criteria: 1. age over 18 years 2. acute pain in renal/ureteric colic 3. pain score more than 4 4. confirmation diagnosis by ultrasound bedside exclusion criteria: 1. refused to participate in the research 2. pregnancy 3. contraindicated of diclofenac or tramadol 4. urinary tract infection 5. skin infection at buttock area 6. acute kidney injury 7. ckd stage iii, iv, v 8. bilateral severe hydronephrosis 9. physician refusal

Keywords: diclofenac im versus tramadol iv in acute renal colic, rct
efficacy of >your< iron syrup supplementation in children with dietary iron deficiency

Conditions: Iron-deficiency

Summary: the study evaluates the efficacy and safety of \>your\ your\ your\< iron syrup or placebo.


Eligibility criteria:
inclusion criteria: * age 9 months to 6 years (inclusive). * signed informed consent for screening and for enrollment (parent or legal guardian). * iron deficiency with or without mild microcytic anemia not requiring treatment (ferritin ≤20 µg/l and hb ≥ 100 g/l in a capillary blood sample). exclusion criteria: * hb \<100 g/l. * anemia due to a cause other than iron deficiency. * vegan diet. * any known concomitant chronic disease (e. g., chronic inflammation, chronic inflammatory bowel disease, malignancy, kidney and/or liver malfunction, lead poisoning). * any known allergies to the components of the investigational product. * any known medical, physical, or psychological condition that, in the opinion of the investigator, is incompatible with consumption of the investigational product and/or with the conduct of the study. * participation in another clinical study less than 1 month before enrollment or current participation in another clinical study. * current consumption of iron-containing medicines or dietary supplements.

Keywords: iron supplement iron deficiency >your< iron syrup
daily vinegar ingestion and 24-hour blood glucose control

Conditions: Glucose Intolerance

Summary: when linking dietary interventions and blood glucose management, much of the existing research - particularly studies exploring the effects of vinegar - has relied on discrete readings from the conventional testing methods: blood samples or glucometers. these methods lack the capacity to provide insights into blood glucose dynamics 24/7. recognizing this gap, the current study aims to utilize continuous glucose monitoring to examine the impact of daily vinegar ingestion on glucose variability in adults identified as glucose intolerant.

participants are randomly assigned to either group a or group b using the microsoft excel randomization function. group a will be instructed to consume 4 tablespoons of red wine vinegar (2 tablespoons diluted in water at the start of the lunch and the dinner meals) for the first 4 days of the trial. conversely, participants in group b will ingest the placebo for the initial 4 days, ingesting one pill daily upon waking in the morning. on days 5-9, participants will switch to the opposite treatment. the red wine vinegar dosage (4 tablespoons containing 3.5 g acetic acid - this is the amount of acetic acid in a large 4-inch dill pickle), and the placebo vinegar pill dosage (one pill containing 0.022 g acetic acid) will be taken daily during the trial. on visit 1, anthropometric measurements, including height, weight, and body composition (lean fat mass and body fat mass), will be measured, and the continuous glucose monitor will be placed on the upper arm. the participants will be instructed to fast \>8 hours (no food or beverages with the exception of water) ahead of visit 1. to ensure accurate use and data collection, researchers discussed the operation of cgm devices and that these waterproof devices are to be continuously worn during the entire 9-day trial and will be removed on day 9 (visit 2).

Eligibility criteria:
inclusion criteria: * glucose intolerance (defined as one of the following: fasting glucose \>99 mg/dl; diagnosis of prediabetes or diabetes; history of gestational diabetes) * 18 years of age or older * sedentary or moderately active (defined as a score ≤ 24 on the godin-shepard leisure time physical activity questionnaire) exclusion criteria: * currently adhering to a non-typical diet that would impact carbohydrate intake (including weight loss diets) * medication/drug use that has not been consistent for the previous 3 months or will be discontinued during the trial * any acute illness * regular smokers, pregnant or lactating women, or individuals taking insulin * unwilling to tolerate vinegar ingestion

Keywords: glucose continuous glucose monitoring vinegar