Kornimate/medical-research-clean huggingface dataset:
cognitive function in melanoma patients treated with adjuvant immune checkpoint inhibitors

Conditions: Melanoma; Cognitive Impairment; Fatigue; Sleep; Depression, Anxiety; Quality of Life; Inflammation; Sickness Behavior; Cancer-related Cognitive Impairment

Summary: immune checkpoint inhibitors (icis) are a group of novel immunotherapies that boost the body's own defense against the cancer by improving the immune system's ability to recognize and destroy cancer cells. while it is relatively well-documented that conventional cancer treatments (e.g., chemotherapy) are associated with cognitive impairment, virtually nothing is yet known about effects on cognition during and after ici treatment. due to significantly improved survival rates after ici treatments, it becomes important to map possible adverse effects associated with these treatments. the investigators therefore investigate possible changes in cognitive function in a group of cancer patients from prior to ici treatment to nine months later. a gender- and age- matched healthy control group will serve as a comparison. the study has the potential to broaden our understanding of associations between cognition, the brain, and the immune system and to provide clinically relevant knowledge about possible cognitive impairments associated with immunotherapy.

this controlled prospective observational study will include two groups with a total of 84 participants. a total of 42 patients diagnosed with melanoma, referred to treatment with ici will be enrolled in the study and examined prior to treatment with ici (baseline), at eight weeks following baseline (t2), at 24 weeks following baseline (t3) and 12 weeks after treatment completed (t4). a total of 42 gender- and age- matched healthy controls will be included and assessed at similar time points. assessments will include a battery of neuropsychological tests, questionnaires, blood samples, and magnetic resonance imaging (mri). the main objectives of the study are to investigate: 1. changes in cognitive functions over the course of treatment with icis. 2. possible associations between changes in cognitive function and immune markers during and following ici treatment. 3. possible associations between changes in cognitive function and changes in brain morphology. 4. changes over time in other possible adverse effects of ici treatment, including psychological distress, sleep disturbances, and fatigue.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of melanoma and scheduled for ici treatment at aarhus university hospital (auh), denmark. the healthy control group will consist of an age- and gender- matched sample of participants. exclusion criteria: * previous treatment with immunotherapy * neurodegenerative diseases (dementia etc.) * substance abuse * known progressive psychiatric diseases (e.g., schizophrenia) * other confirmed diagnoses with underlying cognitive impairment * insufficient danish proficiency

Keywords: immune checkpoint inhibitors melanoma cancer-related symptoms cognitive dysfunction
muscle synergies during gait in children with cerebral palsy undergoing robot-assisted gait therapy

Conditions: Cerebral Palsy

Summary: this is a single-arm longitudinal study for children with cerebral palsy with gait impairments that involves robot-assisted gait training (rgt) and includes pre and post-data collection visits. the study aims to evaluate changes in muscle synergies in children with cerebral palsy (cp) in response to rgt. additionally, the study aims to investigate the relationship between muscle synergies and the clinical outcomes of rgt.

participants will be assessed 2 times - before and after training with the robot. all the testing and training sessions will be carried out at spaulding rehabilitation hospital and will include: clinical tests: * a test to evaluate gross motor function * a test to assess walking speed * a test to assess endurance muscle activity tests: * a test to derive detailed measures of how well participant walk using a camera-based motion capture system. * special sensors (called electromyographic - emg - sensors) will be used to determine when and how muscles are recruited to generate movements. training with the robot: study participants will undergo 18 sessions of robot-assisted gait training for 18 time the training sessions will be carried out by trained study staff. the robot will assist study participants to walk. each training session will last about 1 hour.

Eligibility criteria:
inclusion criteria: * diagnosis of spastic cerebral palsy * 6 to 18 years of age * gross motor function (gmfcs) level i, ii, iii or iv * femoral length \< size of robotic exoskeleton used for gait training (femur length between 210-350mm) * ability to communicate pain or discomfort exclusion criteria: * recent use of lokomat within the last 3 months * contraindication to robotic-assisted gait training such us thromboembolic disease, progressive neurologic disorder, cardiovascular or pulmonary contraindications, aggressive behaviors, severe cognitive deficits, bone instabilities, fractures, osteoporosis) * skin ulcers in trunk or lower limbs * hip, knee, ankle arthrodesis

Keywords: cerebral palsy robotics gait rehabilitation
lipid lowering in patients with statin intolerance

Conditions: Hyperlipidemia; Coronary Artery Disease

Summary: this study will attempt to further validate a clinical treatment plan to lower ldl values using non-prescription supplements combined with a lifestyle change and education program which could represent an alternative approach to improve compliance in group of people who are unable to take traditional medication to lower cholesterol.

up to 70 participants will be randomized into 2 groups. each shall have similar total and ldl cholesterol values obtained prior to the study. study group 1 will participate in the change of heart program (an intensive program to make therapeutic lifestyle changes) and take a placebo pill. study group 2 will also participate in change of heart. group 2 will be provided an over the counter supplement consisting of red rice yeast 2.4-3.6 gms day) blood work consisting of a lipid panel, cardiac crp, cpk, liver function panel and tsh will be obtained prior to study, and at 12 and 26 wks. questionnaires will be administered regarding quality of life indexes, and ancillary symptom relief (i.e. degree of arthritis discomfort, generalized weakness) before, 12 and 26 weeks. after the change of heart program ends (12 weeks), participants will continue on study medication for a total of 6 months. a final questionnaire and final blood work will be obtained at 6 months, and at that point, medications can be discontinued.

Eligibility criteria:
inclusion criteria: 1. baseline cholesterol - ldl more than 160 with one risk factor or ldl more than 130 with 2 or more risk factors for developing coronary artery disease (smoker, age \>40, male, family history, diabetes, obesity) utilizing atp iii guidelines 2. have had a statin prescribed by a doctor for high cholesterol, and have stopped medication because of side effects 3. ability to exercise without physical restrictions 4. ability to attend 12 week consecutive change of heart sessions 5. not taking any cholesterol lowering medication for at least 1 month prior to initiation of trial. not taking red yeast rice for at least 1 month prior. exclusion criteria: 1. any active cardiac problem including chest pain, angina, shortness of breath with minimal activity, or unstable angina/acute coronary syndrome within one year 2. known intolerance to one of the study drugs 3. physical limitation preventing aerobic exercise program, such as severe arthritis, peripheral vascular disease, congestive heart failure, or symptom limiting pulmonary disease 4. uncontrolled hypertension (defined as sbp\>180 mmhg or dbp \> 100mmhg. 5. heart attack, bypass surgery, or angioplasty/stent within 1 year of study 6. triglyceride level more than 400 mg/dl

Keywords: statin intolerance hyperlipidemia lifestyle changes red yeast rice
serial body composition change for risk prediction and nutritional guide in treating patients with sepsis

Conditions: Sepsis

Summary: to explore whether serial changes of data in body composition of patients with sepsis can help clinician to monitor prognosis.

the investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). the body composition data (of day 1, 3, 8) of the patients in the intervention group will be given to the dietitians for adjusting the diet formula according to the patient's body composition.the patients in control group also will undergo bio-electrical impedance analysis (bia) assessment, but not disclosed to the dietitian. the diet formula will be adjusted on the discretion of the dietitian caring for the septic patients based on clinical judgement.

Eligibility criteria:
inclusion criteria: 1. icu patient 2. clinical diagnosis of sepsis exclusion criteria: 1. expired within 3-days

Keywords: sepsis body composition nutritional intervention
comparison of the effects of lidocaine and articaine used for buccal infiltration and supplemental palatinal infiltration anesthesia in teeth with irreversible pulpitis

Conditions: Fist and Second Molars With ırreversible Pulpitis

Summary: objective: the aim of this study was to compare the effects of articaine or lidocaine in buccal infiltration or palatal infiltration in addition to buccal infiltration in maxillary first or second molars with irreversible pulpitis. method: among the patients who applied to akdeniz university faculty of dentistry endodontic clinic for the treatment of maxillary molars with irreversible pulpitis, 80 volunteers who met the criteria were included in the study. eighty patients were divided into 4 groups (n = 20). 1. group buccal infiltration with 4% articaine containing 1:100,000 epinephrine, 2. group buccal infiltration with 2% lidocaine containing 80,000 epinephrine, 3. group buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine, 4.group buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine. pain during the endodontic procedure was determined and recorded according to the heft parker visual analog scale.


Eligibility criteria:
inclusion criteria: 1. the patient must be a healthy individual between the ages of 18 and 65 who is classified as asa i and ii. 2. no allergy to local anesthetic substances to be used in the study 3. upper maxillary molars with irreversible pulpitis whose vitality has been proven by pulp tests, with no radiolucency at the root tip 4. not having used any painkillers, antibiotics, antidepressants and sedative drugs in the last 12 hours 5. being capable of understanding the pain scale exclusion criteria: 1. allergy to local anesthetics 2. failure to respond to the cold test and electric pulp test performed on the relevant tooth 3. radiolucent lesion in the apical part of the relevant tooth on periapical radiography 4. no vital tissue is encountered when the pulp chamber is opened

Keywords: articaine, lidocaine, irreversible pulpitis, infiltration anesthesia
a study of e7050 administered orally to patients with advanced solid tumors

Conditions: Solid Tumors

Summary: the purpose of this study is to determine the maximum tolerated dose (mtd), safety, pharmacokinetics (pk), pharmacodynamics (pd) and anti-tumor activity of e7050 when administered orally twice daily to patients with advanced solid tumors.

phase i, open-label, dose-escalation study to determine the maximum tolerated dose (mtd) of e7050 given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.

Eligibility criteria:
inclusion criteria: 1. subjects with a histological or cytological diagnosis of solid tumors or gastric cancer. 2. subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available. 3. subjects with adequate organ function. 4. patients who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug. 5. subjects with performance status (ps) 0-1 established by eastern cooperative oncology group (ecog). exclusion criteria: 1. subjects who have brain metastases with clinical symptoms or which requires treatment. 2. subjects with the serious complications or disease history. 3. subjects who cannot take oral medication. 4. subjects who need continuous use of drugs or foods that strongly inhibit or induce cyp3a4/5 or cyp2d6 during the study period. 5. female subjects who are pregnant or breast-feeding.

Keywords: cancer gastrointestinal cancer
obstructive sleep apnea in scleroderma and pulmonary involvement

Conditions: Scleroderma, Systemic; Sleep Apnea, Obstructive; Pulmonary Disease

Summary: scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. obstructive sleep apnea (osa) may also be seen in scleroderma. less is known regarding the prevalence of osa in scleroderma and its association with pulmonary involvement.

scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. osa may also be seen in scleroderma. less is known regarding the prevalence of obstructive sleep apnea in scleroderma and its association with pulmonary involvement. the investigators would like to address the prevalence of osa in patients with scleroderma, using overnight cardiorespiratory polygraphy. other comorbidities and pulmonary findings on computer tomography (ct) as well as lung function tests will be evaluated. the investigators plan to include 60 patients.

Eligibility criteria:
inclusion criteria: * known scleroderma diagnosis * must be able to give informed consent exclusion criteria: * serious neurological and/or psychiatric disease

Keywords: scleroderma sleep apnea pulmonary disease
efficacy and safety of insuman basal/comb/rapid in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: - to evaluate the decrease of hb a1c ≥ 1% after 6 month treatment in patients with type 2 diabetes mellitus (t2dm) uncontrolled on oral antidiabetics (oads) secondary objectives: * to evaluate the percentage of patients with hb a1c \< 7.5%, * to evaluate the rate of hypoglycaemia (symptomatic, severe) * to evaluate the middle dose of insulin per product - insuman basal, insuman comb, insuman rapid after 6 month treatment * to evaluate the change in fasting plasma glucose (fpg) after 6 month treatment * to assess the overall safety * to evaluate the efficacy of education courses in diabetes schools (% of correct answers after second test compare to the testing of the initial level)

6 months

Eligibility criteria:
inclusion criteria : * t2dm patients uncontrolled by maximum tolerated dose of 1-2 oads * males and female \> 18 years * hba1c \> 7.5% * patients with abilities of self-monitoring of diabetes, managing of patient's diary, ability to obtain education in diabetes school, completion of questionnaire * it is expected that the patient will remain on a stable dose of oads within 6 months of treatment exclusion criteria : * type 1 diabetes * current temporary insulin therapy (gestational diabetes, pancreas cancer, surgery, clinical trial) * any clinically significant acute major organ or systemic diseases making interpretation of the evaluation results difficult * patient planning a pregnancy now or in the next 6 months * the patient is participating in another clinical study now or in the last 28 days prior to visit 1 * the patient is a drug user (currently or in the past) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
safety and effectiveness study of insulin glargine (lantus) initiation and titration in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: percentage of patients achieving glycosylated hemoglobin (hba1c) \< 7% with no severe or nocturnal hypoglycemic episodes at 6 months secondary objectives: * glycosylated hemoglobin (hba1c) change from baseline to 6 months * insulin glargine dose at 3 and 6 months * hypoglycemic episodes (all types)


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of type 2 diabetes for more than 6 months * patients treated with oral antidiabetics (oads monotherapy or combination) with an hba1c \>7% and \ 7% and \<10% or treated with nph insulin who have experienced severe and/or nocturnal hypoglycemia in the last 6 months. * ability to perform smbs and insulin self-titration under the physicians guidance. * body mass index (bmi) \>21 kg/ m2. * signature of informed consent. exclusion criteria: * hospitalized patients. * pregnant women or with the intention of becoming pregnant. * unexplained weight loss of more than 10% in the last 6 months. * women with child bearing potential not using effective contraceptive methods. * women in breast feeding period. * patients on chronic treatment with systemic corticosteroids or protease inhibitors. * history of drug or alcohol abuse. * diabetic retinopathy with surgical treatment in 3 months previous to study entry or patients that could require surgical treatment in the following 6 months to study entry. * major systemic disease clinically important that would interfere with implementation or interpretation of the study, at the discretion of the investigator. * renal failure known as creatinine \> 1.4 mg/dl in women and \> 1.5 mg/dl in men. * known hypersensitivity to glargine or any of its excipients. * patients with history of hospitalization due to cardiovascular event, cardiovascular procedure in the past 6 months. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
pecs ii block versus surgeon infiltration for open subpectoral biceps tenodesis

Conditions: Tendonitis

Summary: a phase iv, randomized, single-blind, single-center study measuring the effects of pecs ii block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid utilization in participants who undergo open subpectoral tenodesis.


Eligibility criteria:
inclusion criteria: 1. patients between 18 and 75 years of age 2. patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis exclusion criteria: 1. patients younger than 18 and older than 75; 2. patients with a history of chronic pain that have used opioids for pain management for 3 months or longer; 3. patients who are allergic to oxycodone; 4. patients with diagnosed or self-reported cognitive dysfunction; 5. patients with a history of neurologic disorder that can interfere with pain sensation; 6. patients with a history of drug or recorded alcohol abuse; 7. patients who are unable to understand or follow instructions; 8. patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease; 9. patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures; 10. patients with a bmi over 45; 11. any patient that the investigators feel cannot comply with all study related procedures; 12. nyu langone health students, residents, faculty or staff members.
deep neuromuscular blockade on postoperative pain

Conditions: Neuromuscular Blockade

Summary: this study aims to investigate the impact of varying degrees of neuromuscular blockade on postoperative pain in pediatric patients aged over 2 months to under 7 years undergoing laparoscopic surgery under general anesthesia.


Eligibility criteria:
inclusion criteria: * pediatric patients aged over 2 months to under 7 years scheduled for laparoscopic surgery under general anesthesia. * american society of anesthesiologists (asa) physical status classification i, ii, or iii. exclusion criteria: * patients undergoing emergency surgery. * patients with chronic pain or currently taking analgesics for chronic pain. * known hypersensitivity to general anesthetic agents or analgesics. * patients with underlying cardiovascular disease. * patients with neuromuscular disorders. * any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the study.
study to evaluate 13 c isotope ratio measurement for urea cycle capacity assessment

Conditions: Urea Cycle Disorders

Summary: in this short-term study a method for the evaluation of the metabolic competency of the urea cycle in vivo will be assessed. in order to monitor the efficacy of new treatment options for patients with urea cycle disorders and to monitor the severity of the disease, a reliable and safe quantitative method for the measurement of the urea cycle flux is required. urea synthesis will be evaluated by administering sodium \[1-13c\]-acetate and measuring subsequent incorporation of \[13c\] label from na-acetate into urea in healthy volunteers and asymptomatic subjects genetically disposed to urea cycle disorders.


Eligibility criteria:
inclusion criteria: * group 1 + 2: healthy subjects * group 3: healthy asymptomatic subjects genetically disposed to urea cycle disorders * all: age 18 to 50 years (adult) * written informed consent exclusion criteria: * presence of acute infection * participation in other clinical trials within 30 days prior to inclusion * severe coagulopathy * severe systemic or chronic disease * pregnancy or lactation

Keywords: isotope ratio measurement urea cycle 13c acetate healthy adults
comparison between two endoscopic treatments of bleeding internal hemorrhoids:band ligation and electrocoagulation probe

Conditions: Hemorrhoids

Summary: the purpose of this study is to determine which treatment, band ligation (placing rubber bands around the hemorrhoids) or bicap electrocoagulation (using electricity to cauterize) is safer and more effective endoscopic treatment for bleeding internal hemorrhoids.


Eligibility criteria:
inclusion criteria: 1. grade ii or iii internal hemorrhoids with chronic rectal bleeding, which failed at least 8 weeks of intensive medical therapy. 2. age over 18 years 3. a life expectancy of at least 24 months 4. a signed written informed consent exclusion criteria: 1. the patient was uncooperative or could not return for routine outpatient follow-up 2. severe or end-stage co-morbid illness 3. prior endoscopic or surgical treatment of hemorrhoids within the past 6 months 4. ongoing need for anticoagulation therapy or high doses of aspirin or non-steroidal antiinflammatory agents 5. presence of severe rectal pain 6. recently thrombosed internal or external hemorrhoids 7. anal stricture,fissure, fistula,or abscess 8. rectal carcinoma or bleeding distal colonic polyp 9. rectal varices 10. acute or chronic colitis 11. rectal prolapse 12. radiation telangiectasia of the rectum 13. prothrombin time \>3 seconds over control 14. platelet count \<75,000

Keywords: internal hemorrhoids rubber band ligation bipolar coagulation