Kornimate/medical-research-clean huggingface dataset:
comparison of efficacy in sbrt of hcc ≤5 cm with or without tace

Conditions: Small Hepatocellular Carcinoma; Stereotactic Body Radiation Therapy; Transcatheter Arterial Chemoembolization

Summary: the study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.the investigators will optimize the combined treatment schedule of sbrt for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.


Eligibility criteria:
inclusion criteria: * primary hcc diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of hcc or by pathology * single lesion and longest tumor diameter ≤ 5.0 cm * cp-a or b classification * eastern cooperative oncology group (ecog) score 0-1; * distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm * unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc. * rejecting other therapies such as resection, liver transplantation, etc. * platelet count≥50 × 109/l, white blood count≥1.5 × 109/l * patients infected with hepatitis b virus who are treated with adefovir or entecavir; patients infected with hepatitis c virus whose hcv dna are negative. exclusion criteria: * tumor thrombus * lymph node involvement * extrahepatic metastasis

Keywords: cyberknife sbrt tace prognosis
supartz versus placebo in osteoarthritis of the shoulder

Conditions: Osteoarthritis of the Shoulder

Summary: this clinical trial is to determine the safety and effectiveness of three injections of supartz (sodium hyaluronate) compared with phosphate buffered saline (pbs) for the treatment of glenohumeral osteoarthritis of the shoulder. the trial contains two phases. phase i is 26 weeks, double blinded, and subjects are randomized to either supartz or pbs treatment. phase ii is 26 weeks (total 52 weeks) and open-label so all subjects will receive supartz injections only.

phase 3 study: multi-center, randomized, double blinded, two phase study to determine the safety and efficacy of 3 injections of supartz for osteoarthritis of the shoulder

Eligibility criteria:
inclusion criteria: * glenohumeral osteoarthritis (oa) confirmed by radiograph * limitation of shoulder motion in at least one direction * retained active range of motion of at least 30% in all directions exclusion criteria: * full thickness rotator cuff tear or rotator cuff tendinopathy * frozen shoulder * female who is pregnant or lactating

Keywords: osteoarthritis shoulder hyaluronic acid (ha)
treatment of advanced aids patients with dextrin sulfate

Conditions: HIV Infections

Summary: the purpose of this study is to look at the safety and effectiveness of dextrin sulfate in aids patients who have failed conventional anti-hiv treatment.

patients have intraperitoneal (ip) catheter placement done at study entry. infusion with the carrier vehicle (icodextrin 4%) begins 2 weeks later, and 2 days after that, treatment with dextrin sulphate (ds) commences. ds is given three times per week. a nurse delivers initial treatments and the patient and caregiver will be trained to give subsequent treatments until ds has been given a total of 8 weeks. patient evaluations are done regularly during treatment and observation continues for 24 weeks.

Eligibility criteria:
inclusion criteria patients may be eligible for this trial if they: * are hiv-positive. * have been diagnosed with aids and are under treatment to prevent opportunistic (aids-related) infection. * have had a cd4 cell count greater than 50 microl for at least the past 3 months. * have had a viral load of at least 50,000 copies/ml for at least the past 3 months. * have used up all other treatment options. * are able to understand and give written consent. exclusion criteria patients may not be eligible for this trial if they: * have been in any other study in the 6 weeks before beginning this study. * have an active, opportunistic infection or other infection. * have any other long-term medical condition or nervous disorder that might make it difficult for them to finish the study.

Keywords: anti-hiv agents viral load dextrin 2-sulfate infusions, parenteral
protein consumption in critically ill patients

Conditions: Critical Illness; Dietary Modification

Summary: a retrospective study of protein intake and needs as well as outcomes in critically ill adult patients. data will be collected for up to 7 days of icu stay.

this retrospective study of critically ill adults receiving enteral nutrition will assess the ability to meet estimated protein and energy needs via enteral nutrition.

Eligibility criteria:
inclusion criteria: * adult patients (age ≥18 years) * admitted to the icu * administered at least one dose of enteral formula exclusion criteria: * receiving exclusive oral or exclusive parenteral nutrition
use of accessory device amplifeye during average risk screening colonoscopy to increase adenoma detection rate

Conditions: Colonic Polyps

Summary: the purpose of this investigator-initiated study is to determine whether the use of an accessory device called amplifeye can improve colonoscopy quality in patients who are undergoing average risk colorectal cancer screening. primary end point is adenoma detection rates.


Eligibility criteria:
inclusion criteria: * all adult patients greater than or at 50 years of age who are referred for average risk screening colonoscopy. exclusion criteria: * any pregnant patient * patient's that are unable to provide consent for themselves * any patient undergoing diagnostic colonoscopy (ibd, rectal bleeding, recent change in bowel habits, etc.) * any patient undergoing surveillance (prior history of polyps or colorectal cancer) * any patient undergoing high risk screening colonoscopy (family history of colon cancer in first degree family member \<65 years of age, or co-existing conditions that pre-dispose to colon cancer such as polyposis syndromes, psc or ibd) * prior history of any cancer * current or past immunosuppression (due to either infection or medications) * coagulation disorder or use of anti-coagulation or anti-platelet therapy other than aspirin within 5-7 days of procedure * colonic strictures * suspected intestinal obstruction or colonic pseudo-obstruction * history of colon resection * active infection * active inflammation (including diverticulitis)
wroclaw out-of-hospital cardiac arrest registry

Conditions: Out-Of-Hospital Cardiac Arrest

Summary: the purpose of this study is to assess the efficacy of institutionalized care program of patients with out-of-hospital cardiac arrest.

patients with out-of-hospital cardiac arrest included in the program will be treated with extracorporeal membrane oxygenation (ecmo) assisted cardiopulmonary resuscitation (cpr) with additional invasive procedures including coronary/pulmonary angiography and intervention. this type of treatment was not provided in institutionalized fashion in wroclaw, poland. implementation of this program should improve survival in out-of-hospital cardiac arrest patients, which currently is less than 10%.

Eligibility criteria:
inclusion criteria: * age \< 60 years * witnessed sudden cardiac arrest with immediate cpr * supposed cardiac cause of the event * ventricular fibrillation (vf) or pulseless ventricular tachycardia (vt) at first medical contact with 3 unsuccessful defibrillations (no rosc) * cpr conducted with lund university cardiopulmonary assist system (lucas™) * estimated transfer time from the scene to the emergency department \< 30 minutes. * end tidal carbon dioxide (etco2) \> 10 mmhg exclusion criteria: * total presumed time from 112 call to ecmo implantation longer than 60 minutes * age \ 60 years old; * non-shockable initial rhythm * unavailability of the automated cpr device * unavailability of the catheterisation laboratory * severe concomitant illness with decreased life expectancy * severe body injury * severe active bleeding * drowning * terminal cancer

Keywords: cardiac arrest, ecmo, ecmo-cpr
the heart study (healthy eating and recovery together)

Conditions: Head and Neck Cancer; Survivorship; Nutrition Aspect of Cancer

Summary: head and neck cancer survivors and their primary caregivers (n=25 dyads) will be enrolled to pilot test a nutrition support system with a care planning clinic visit and a caregiver mobile app. participants will be asked to complete baseline and 6-week follow-up surveys. the clinic session (offered in person or remotely) will include a needs assessment and a tailored care plan with information, educational materials and referrals about participants' symptoms, behaviors, social concerns and caregiving tasks. after the visit, the program will provide an app for caregivers with follow-up resources and mobile support for one month.

the long-term goal of this research is to improve physical, emotional and social post-treatment outcomes in head and neck cancer survivors and caregivers by implementing a nutrition-focused mobile-support program to prepare and support caregivers after treatment. head and neck cancer survivors and their primary caregivers (n=25 dyads) will be recruited to a single-arm intervention study to evaluate the feasibility, acceptability and short-term effects of a nutrition-focused mobile support system. the intervention includes 1) a clinic visit (offered in-person or virtually) with a tablet-based needs assessment at the end of or after completing treatment which will generate 2) a tailored care plan with messages, educational materials and referrals mapped to survivor and caregiver-endorsed concerns and 3) a caregiver app with encouragement, reminders and tips delivered through messaging and peer videos. participants will complete baseline and 6-week follow-up surveys.

Eligibility criteria:
patient inclusion criteria: * 18 years and older * patients with stage i-ivb hnc of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers and cutaneous cancers of the head and neck region) * in the last two weeks of treatment to 3 months following completion of primary treatment (i.e., any combination of surgery, chemotherapy and radiation therapy) within the past 3 months * experienced nutritional challenges at the end of treatment as assessed in a 6-item screener patient exclusion criteria: * head and neck cancer patients who do not undergo treatment * patients who do not read or understand english * patients who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider * patients who do not have a smartphone for use in the study caregiver inclusion criteria: * 18 years and older * provide care for a loved one with stage i-ivb head and neck cancer who has completed treatment caregiver exclusion criteria: * caregivers who do not read or understand english * caregivers who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider

Keywords: mhealth head and neck cancer survivorship caregiver
danhong injection in the treatment of unstable angina pectoris

Conditions: Unstable Angina Pectoris

Summary: the purpose of this study is to determine the efficacy and safety of danhong injection in the treatment of unstable angina pectoris.


Eligibility criteria:
inclusion criteria: * female or male inpatients. * age: 35 - 75 years. * patients with clinical diagnosis of unstable stable angina according to china guideline for the diagnosis and treatment of unstable angina (ua) and non-st-elevation myocardial infarction (nstemi) (2007) issued by chinese society of cardiology of chinese medical association, including one of the following conditions. * clinical diagnosis of "xueyu zheng" (blood stasis syndrome) as the scores of chinese medicine symptoms scales of "xueyu zheng" in ua ≥ 15. the chinese medicine symptoms scales of "xueyu zheng" is a 6-item questionnaire including the symtoms as following: (1)chest pain-10, (2)chest distress-10, (3) palpitation-5, (4)purple or dark lip-5, (5) purple or dark tongue-5, (6) unsmooth pulse-5. * patient is willing to participate voluntarily and to sign a written patient informed consent. exclusion criteria: * patients with severe heart failure (ef\<35%); * patients with history of infection, fever, trauma, surgery(exclude pci) and inflammation in the past month; * patients with active tuberculosis or rheumatological disorders; * patients with renal dysfunction (male: ccr\>2.5mg/dl; female: ccr\>2.0mg/dl); * patients with liver dysfunction (any value of serum aminotransferase more than triple normal value); * patients with history of hematopoietic system diseases; * patients with mental disorder; * patients with history of drug-induced bleeding or history of bleeding caused by warfarin; * patients with malignant tumor; * patients with history of organ transplant; * woman with pregnancy, lactation or positive result of pregnancy test; * patients who is participating in other trials or has been participated in other trials in recent 3 months; * patients who were unable to participate in the study as judged by investigator.

Keywords: unstable angina pectoris randomized controlled trial traditional chinese medicine
glutathione-rich foods for type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this research study is to find out whether certain plant-based foods may be beneficial for individuals with type 2 diabetes. to meet the goal, study participants will be fed known amounts of foods and nutrients. before and after participants have eaten the food, they will self-measure height, weight, and waist circumference and study staff will administer questionnaires. blood samples will be taken at a local lab to measure blood sugar and blood lipids.all study appointments will be conducted online.

this research study is a randomized, controlled trial that will evaluate whether diet and nutrition education on, and short-term partial feeding of, specific plant foods high in the antioxidant glutathione will impact total glutathione status, gamma-glutamyltransferase (ggt) activity, glucose control or insulin sensitivity in people with type 2 diabetes. dietary education will include information on plant sources of glutathione, as well as, cooking methods to reduce glycation and lipid peroxidation during cooking, which may indirectly alter glutathione status by reduce demand for elimination of these compounds. participants will be randomized to one of two groups: the educational intervention plus partial feeding of two small meals per day vs. a wait list control group that will receive standard advice on nutrition for diabetes. after 12 weeks, the intervention group will no longer receive foods, but will be followed for 12 additional weeks to determine if lasting effects are achieved. after 12 weeks, the control group will receive access to the educational materials, but will not receive study foods, to see if the educational intervention alone impacts food/nutrition choices. both groups will have lab measures (as described above) again after this additional 12 weeks, for a total duration of 24 weeks in the trial.

Eligibility criteria:
inclusion criteria: * men and women * ages 18 to 65 * type 2 diabetes * free of self-reported acute and confounding chronic diseases (e.g., heart failure, kidney disease, liver disease, gastrointestinal disorder) based on a standardized medical history questionnaire * free of alcoholism, smoking and major cardiovascular event with the past 6 months * not on insulin to help manage diabetes * planning on staying in the san diego area for the next 6 months * willing to select plant-based foods from a "menu" and eat the selected foods provided by the study team * have access to the internet and a computer * willing to view 4 weekly educational classes online, followed by periodic telephone and email contacts * agree to schedule and complete periodic questionnaires and measurements during up to four total online appointments exclusion criteria: * alcoholism, smoking and recent cardiovascular events * individuals will be excluded if they report any dietary restrictions, allergies or preferences * unsuitability based on screening visit

Keywords: type 2 diabetes glutathione nutrition
evaluate the effect and safety of pu yang wan wu tang and western medicine on chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: the indication of pu yang wan wu tang is stroke sequelae, such as half body paralysis, aphasia and muscle weakness. pu yang wan wu tang is proved to have the effect of protecting nerve and blood vessel, anti-inflammation, anti-coagulation, dilating peripheral vessel, promot-ing micro circulation, improving hemodynamics, and activating central nerve system. huangqi could attenuate podocyte injury by regulating the expression and distribu-tion of nephrin and podocin. huangqi and danggui are associated with fewer infiltra-tion of macrophages and limitation of renal intrinsic cell activation, which may lead to earlier and persistent reduction of proteinuria. this research will use the compound chinese medicine, pu yang wan wu tang. those treatments combined western medicine to assess the efficacy and drug safety on the ckd cases. series of blood and urine were collected regularly during study to prove the role of chinese medicine in the treatment of ckd, and to assess their drug safety. the final goal of the plan is to establish the new indication of pu yang wan wu tang and enhance the interaction and cooperation between chinese and western medicine.


Eligibility criteria:
inclusion criteria: * participants' age is between 20 to 80 years. * participants ckd stage are from 2 to 4(egfr from 89 to 15) * participants under regular western medicine therapy. * participants who agree to follow the trial protocol. * participants who can complete the study treatment and assessments. exclusion criteria: * participants who are already under hemodialysis, peritoneal dialysis or kidney transplant. * participants who are participating in other clinical trials. * participants with hematopoietic system diseases, severe psychiatric or psychological disorder, or cancer. * women who are pregnant.
prostaglandin analog eyelash serum and ocular surface health: a prospective study

Conditions: Dry Eye

Summary: this prospective interventional study investigates the effects of a prostaglandin analog-based eyelash serum on ocular surface integrity, tear film stability, and eyelash growth over six weeks. nineteen healthy female participants applied the serum daily, with clinical assessments performed at baseline and post-treatment. the study adhered to ethical guidelines, and parameters such as tear film stability, tear volume, ocular hyperemia, and eyelash characteristics were evaluated.


Eligibility criteria:
inclusion criteria: * female individuals aged 18 to 30 years. * corrected distance visual acuity (cdva) of 0.10 logmar or better in both eyes. * fitzpatrick skin type iii or lower. * no active dermatological conditions affecting the periocular area. * regular use of cosmetic products (e.g., mascara, eyeliner, or eyeshadow) with no history of intolerance. * willingness and ability to follow the serum application protocol for six weeks. exclusion criteria: * history or diagnosis of dry eye disease or other ocular surface disorders. * previous ocular surgery, trauma, or systemic conditions affecting ocular surface function. * use of topical or systemic medications that could impact tear film stability. * documented hypersensitivity or allergic reactions to cosmetic or ophthalmic products. * presence of eyelid disorders that could interfere with eyelash growth (e.g., blepharitis, trichiasis). * use of growth-enhancing serums within the past three months. * pregnancy or breastfeeding at the time of enrollment.

Keywords: prostaglandin analog eyelash growth ocular surface tear film stability ophthalmic safety
an open-label extension trial to assess the safety and tolerability of long term treatment of rotigotine in subjects with idiopathic parkinson's disease

Conditions: Idiopathic Parkinson's Disease

Summary: the objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic pd.

this is the open-label extension to the open-label trials sp824 (nct00242008), sp825 (nct00243971), and sp826 (nct00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic parkinson's disease.

Eligibility criteria:
inclusion criteria: * subjects who have completed treatment in one of the sp824 (nct00242008), sp825 (nct00243971), or sp826 (nct00243945) trials exclusion criteria: * subjects who had an ongoing serious adverse event from the previous ole trial that was assessed as related to study medication

Keywords: rotigotine neupro®
a study of vatiquinone for the treatment of participants with friedreich ataxia

Conditions: Friedreich Ataxia

Summary: the primary objective of the study is to assess the pharmacokinetics (pk) and safety of vatiquinone administered in participants with friedreich ataxia (fa) younger than 7 years.


Eligibility criteria:
inclusion criteria: * friedreich ataxia diagnosis (homozygous for gaa repeat expansion in intron-1 of fxn gene), confirmed by clinical genetic testing. * must be able to abstain from anticoagulants and any aspirin (including 81 mg) for 30 days before the baseline visit and for the duration of the study; any possible discontinuation of anticoagulants should be monitored and indicated by a specialist (for example, cardiologist, neurologist, or hematologist), and discontinuation will be noted by the prescribing physician. * must be able to abstain from strong cytochrome p450 (cyp) 3a4 inducers/inhibitors (for example, ketoconazole, rifampin, st. john's wort, grapefruit juice, or any grapefruit product) for at least 30 days prior to enrollment and for the duration of the study. * must be able to take vatiquinone oral solution with food. exclusion criteria: * previous treatment with vatiquinone. * allergy to vatiquinone or sesame oil. * ejection fraction \<50%. * participation in any other interventional clinical trial or receipt of any study drug in any other clinical trial within 60 days prior to the baseline visit. participants may be rescreened after the exclusionary period of 60 days has passed. * concomitant use of interventional coq10, vitamin e, or any approved or non-approved medication for fa within 30 days prior to the baseline visit. these prohibited medications can be discontinued at the screening visit. note: other inclusion and exclusion criteria may apply.