Kornimate/medical-research-clean huggingface dataset:
autonomic and cardiovascular recovery after the acute use of resveratrol in overweight and obesity individuals

Conditions: Polyphenols; Cardiovascular Diseases; Autonomic Nervous System

Summary: the aim of this study is to understand the importance of resveratrol supplementation as a possible adjuvant in improving the metabolic profile and cardiovascular autonomic recovery of individuals with overweight and grade i obesity, reducing the incidence of diseases associated with obesity and the costs in primary, secondary and tertiary care.

food is a strong ally in improving the metabolic state in overweight, obesity and prevention of associated diseases, working on weight loss and ingestion of anti-inflammatory, anti-oxidant and cardioprotective substances, among these substances, we highlight the polyphenols. resveratrol or 3,5,4-trihydroxystilbene is a polyphenol studied since 1976, a phytoalexin synthesized in the skin of the grape, which is increased when exposed to stresses such as ultraviolet radiation, enhancing the antioxidant and cardioprotective characteristics.this study aims to evaluate the cardiovascular autonomic recovery and the metabolic profile with the acute effect of resveratrol extract after submaximal aerobic exercises in individuals with overweight and grade i obesity.heart rate variation (hrv) is considered the most trivial method for analyzing the behavior of autonomic efferents (parasympathetic and sympathetic) on the heart. hrv recovery after exercise has been widely used as a method of analyzing ans adaptation (vagal recovery) under various conditions.healthy, physically active individuals with good health characteristics have a rapid recovery of hrv after exercise, indicating good adaptability and a lower risk for cardiovascular diseases. meanwhile, changes hrv patterns provide a sensitive and early indicator of health impairments. the monitoring of these data is necessary, as they act as markers of emerging risk for the development of complications associated with cncds and risks of future injuries. in this context, the present project will make it possible to verify the effect of the acute use of resveratrol on the metabolic profile and on the autonomic and cardiovascular recovery of individuals with overweight and obesity grade i.

Eligibility criteria:
inclusion criteria: - individuals with overweight and obesity grade i exclusion criteria: * cardiorespiratory disorders * neurological disorders * skeletal muscle injury * known impairments that prevent the subject from performing the procedures.

Keywords: resveratrol cardiovascular diseases autonomic nervous system
a multi-center, international prospective follow up study

Conditions: Benign Prostatic Hyperplasia (BPH)

Summary: the study objective is to assess the safety and efficacy of itind three to five years following treatment.

this study will recruit patients who participated in the mt-03 study in the itind arm to assess the safety and efficacy of the itind procedure at three to five years following treatment as demonstrated by reduction of symptoms measured by ipss and qol and improvement of functional parameters as measured by peak urinary flow and pvr. sexual and erectile function will also be assessed alongside the incidence of any related late occurring adverse events.

Eligibility criteria:
inclusion criteria: 1. subject signed informed consent form (icf) 2. subject who had participated in the mt-03 study in the itind arm 3. subject able to comply with the study protocol. exclusion criteria: 1. any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study 2. patients that are known to have had undergone an alternative surgical procedure for bph during mt-03 study.
erector spinae block for spine surgery

Conditions: Lumbar Radiculopathy

Summary: this study is to determine whether or not the addition of liposomal bupivacaine in an esp block will have long term benefits for patients undergoing lumbar spinal fusion surgery. given previous studies found long term benefits from liposomal bupivacaine, the hypothesis is that patients will have decreased opioid usage and improved pain scores when compared to a standard esp block with plain 0.25% bupivacaine.

this will be a double blind prospective randomized control trial comparing liposomal bupivacaine with plain bupivacaine in their effectiveness in esp blocks in lumbar spinal fusion surgery. patients scheduled for a lumbar spinal fusion procedure will be identified at the time of the scheduled surgery. the endpoints of this study include: the primary objective is to compare the amount of postoperative intravenous opioid consumption among two study groups for the first 72 hours: patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and esp block with liposomal bupivacaine + 0.25% bupivacaine and patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and esp block with 0.25% bupivacaine the secondary objectives include: compare the severity of pain at rest at specific timepoints postoperatively. compare general quality of recovery via qor-15 at 48 hours, 72 hours and then at routine follow up visits occurring 2 weeks, 6 weeks, and 12 weeks postoperatively. measure rate of postoperative nausea/vomiting in pacu. measure time to ambulation. compare analgesia satisfaction score at time of discharge. measure hospital length of stay.

Eligibility criteria:
inclusion criteria: * adults aged greater than or equal to 18 years old and less than or equal to 85 years old. * patients who are scheduled to undergo lumbar spinal surgery (1-2 level) and willing and able to provide informed consent. exclusion criteria: * patients with a history of chronic opioid use for \> 3 months including but not limited to fentanyl, morphine, oxycodone, methadone. * patients with known allergy or intolerance to any drug used in the study including local anesthetics and total intravenous anesthesia medications. * patients with a history of alcohol or drug abuse. * patients with a history of intolerance of nonsteroidal anti-inflammatory drugs.-patients with hepatic insufficiency. * patients with renal insufficiency. * patients who are pregnant. * patients with american society of anesthesiologists physical status of 4 or greater. * patients on immunosuppressive therapy. pregnant patients.
evaluation of hearing aid benefit

Conditions: Hearing Loss, Sensorineural

Summary: the present study will investigate the benefit of hearing aids for speech intelligibility (in both quiet and noisy environments) compared to the unaided condition. participants will include adults with moderate to moderately severe hearing impairment. the participants will complete laboratory-based speech intelligibility assessments with binaural hearing aids and without hearing aids.


Eligibility criteria:
inclusion criteria: * moderate to moderately severe sensorineural hearing loss * willingness to wear custom hearing instruments during the study. * age-normal cognition * ability to attend on-site study visits.
telerehabilitation in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) is a compressive peripheral neuropathy characterized by pain, tingling sensation and paresthesia in the territory of the median nerve. these symptoms cause significant functional impairment that affects patients' quality of life. pain neuroscience education (pne) combined with therapeutic exercise (te) has shown good results in patients with chronic pain, but the effects of this multimodal treatment via telerehabilitation have not been studied in patients with cts. telerehabilitation has demonstrated clinical and functional outcomes as effective as face-to-face interventions, being a good alternative to improve accessibility to rehabilitation care in a context of pandemic and social distancing. the purpose of this study is to provide coordinated, patient-centered care by implementing a telerehabilitation model for patients with severe cts. the objective of this study was to compare the effectiveness of a multimodal therapy program (te plus pne) versus a unimodal treatment (te) in patients with cts. a randomized controlled trial, simple-blind and multicenter study will be conducted. patients will be randomly assigned to the multimodal treatment group (te plus pne) or to the unimodal treatment group (te). at admission, an investigator blinded to treatment assignment will conduct data collection. the measurements will be the following outcomes: a) pain catastrophizing scale; b) tampa scale for kinesiophobia-11; c) numerical rating scale (nrs); d) boston carpal tunnel questionnaire; e) hospital anxiety and depression scale; f) quality of life, using the eq-5d instrument; g) patient's global impression of change; h) katz diagram; these evaluations will be performed again at week 6 and 12.


Eligibility criteria:
inclusion criteria: * over 20 years of age, severe cts medical diagnosis, duration of symptoms for more than three months, access to a smartphone with internet, and acceptance to participate in the study. exclusion criteria: * inability to understand instructions, non-controlled mental health pathology, cognitive problems and previous surgery in the upper limb.

Keywords: pain disability education exercise
osteopuncture for osteoarthritis-associated knee pain & disability

Conditions: Osteoarthritis

Summary: the purpose of this study is to investigate the feasibility, effectiveness, and duration of treatment response of periosteal electro-acupuncture (osteopuncture) for osteoarthritis (oa)-associated chronic knee pain.

knee osteoarthritis (oa) is painful in 6.8% of men and 11.4% of women age 63-93, with over 20 million americans affected nationwide, and may lead to a variety of untoward consequences including limitations in physical function, postural instability, sleep disturbance, psychosocial disability, and substantial utilization of health care resources. while oral analgesics represent the mainstay of treatment for chronic pain associated with knee oa, non-responders with limiting comorbidities may have few therapeutic alternatives. the aims of this research study are to (1) reduce pain severity and disability in community-dwelling older adults with oa-associated chronic knee pain using periosteal electroacupuncture (osteopuncture), and (2) improve the physical performance, psychosocial function, sleep, and appetite of these individuals. 88 older adults with persistent knee pain and x-ray evidence of oa, no other rheumatologic disorders, no history of knee surgery, and no prominent pain in sites other than the knee(s) will be randomized to receive either osteopuncture or control osteopuncture once a week for 6 weeks. all outcome measures for pain and disability, as well as physical performance, psychosocial function, sleep, and appetite, will be collected pre-treatment, at the completion of the 6-week protocol, and 3 months later.

Eligibility criteria:
inclusion criteria: * radiographic evidence of knee oa on a standing ap x-ray * bilateral knee pain for at least 3 months with pain of at least moderate intensity every day or almost every day exclusion criteria: * non-ambulatory, or severely impaired mobility (i.e., require the use of a walker) * folstein mini-mental state examination score of less than 24 * severe visual or hearing impairment * knee pain due to factors other than oa, e.g. rheumatoid or psoriatic arthritis, gout, pseudogout, metastatic cancer * significant pain in parts of the body other than the knee or acute knee pain * a large knee effusion or severe mechanical instability of the knee * history of corticosteroid injection in the affected knee(s) during the preceding 3 months * history of hyaluronic acid injection in the affected knee(s) during the preceding 3 months * acute or terminal illness * immune suppression * anticoagulation therapy * presence of a pacemaker * prior acupuncture treatment

Keywords: knee pain acupuncture /acupressure alternative medicine analgesia arthritis therapy chronic pain functional ability
the effect of local intraoperative steroid administration on post-acdf dysphagia

Conditions: Swallowing Function

Summary: few methods were available to determine which muscle groups are associated with pd in details in previous investigations. local steroid administration has shown some effects on pd in a large number meta-analysis. in this study, we aimed to conduct a prospective randomized-double blinded study to exam the efficacy and the safety of the local steroid administration on acdf patients by using high resolution impedance manometry in patients receiving acdf.

postoperative dysphagia (pd) is the most common complication after anterior cervical discectomy and fusion (acdf). however, few methods were available to determine which muscle groups are associated with pd in details in previous investigations. local steroid administration has shown some effects on pd in a large number meta-analysis. in this study, we aimed to conduct a prospective randomized-double blinded study to exam the efficacy and the safety of the local steroid administration on acdf patients, and the also apply the high resolution impedance manometry (hrim) on patients receiving acdf for better delineation of the swallowing function. pressure-flow analysis (pfa), derives pharyngeal pressure flow variables obtained from hrim were used to analyze the mechanisms of pd.

Eligibility criteria:
inclusion criteria: * patients undergoing elective anterior cervical spine surgery exclusion criteria: * patients receiving spine surgery not at the first time * patients with head and neck cancer * patients receiving other surgeries at head and neck region * patients had previous swallowing difficulty history
the effectiveness of different doses of hyaluronic acid injections in knee osteoarthritis.

Conditions: Knee Osteoarthritis

Summary: the aim of this prospective, randomized, controlled multi-centre study is to compare the effectiveness and safety of three and five injections of standard linear hyaluronic acid (ha) versus single ha injection in terms of pain intensity and functional status in patients with knee osteoarthritis.

osteoarthritis (oa) is the most common form of chronic joint disease. a treatment option for patients diagnosed with knee osteoarthritis is intra-articular hyaluronic acid therapy. in this prospective, randomized controlled, single blind, interventional study, a total of 90 patients with stage 2-3 knee osteoarthritis according to the kellgren lawrence classification who meet the eligibility criteria will be enrolled in the study. eligible participants will be randomly assigned to one of the three groups using computer-generated random numbers. in the first group, 2 ml linearly linked 20 mg 1.0% hyaluronic acid injection in 5 sessions, in the second group 2 ml linearly linked 32 mg 1.6% hyaluronic acid injection in 3 sessions and in the third group 2.4 ml linearly linked 48 mg 2.0% hyaluronic acid injection in a single sessions will be applied. participants are going to evaluate before injection, at the 1-month follow-up, at the 3-month follow-up and 6-month follow-up using the visual analog scale (vas) scores for pain during activity, at rest, and at night, with the western ontario and mcmaster universities osteoarthritis index (womac) change in pain, stiffness and physical function score, the change in the timed up and go test (tug) time and the change in the patient's daily activities with the numerical global patient assessment scale.

Eligibility criteria:
inclusion criteria: * unilateral or bilateral symptomatic knee pain for at least three months * presence of kellgren-lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs * functional ambulation scale stage 4-5 * being able to attend injection and control examinations exclusion criteria: * intra-articular knee injection within the last six months * history of severe trauma to the knee within the past six months * concomitant severe meniscus or ligament injury, surgery applied to the knee area * presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee. * having a bleeding disorder and / or using warfarin * kellgren-lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs * presence of cardiac or systemic disease that may affect exercise * the presence of neurological disease and psychiatric disease such as parkinson's disease, stroke history that may affect balance * body mass index ≥35 kg / m² * allergy to hyaluranic acid products

Keywords: knee osteoarthritis linear hyaluronic acid
study of xl228 in subjects with chronic myeloid leukemia or philadelphia-chromosome-positive acute lymphocytic leukemia

Conditions: Chronic Myeloid Leukemia; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Summary: the purpose of this study is to determine the safest dose of the bcr-abl inhibitor xl228, how often it should be taken, and how well people with leukemia tolerate xl228.


Eligibility criteria:
inclusion criteria: 1. the subject has a confirmed pathologic diagnosis as evidenced by the presence of the bcr-abl translocation \[t(9;22)\] by fluorescence in situ hybridization (fish), cytogenetics, or quantitative polymerase chain reaction (qpcr) of one of the following: 1. cml * chronic phase (cp) * accelerated phase (ap) * blast phase (bp) or 2. ph+ all 2. the subject has one of the following: * known t315i abl mutation * known resistance to or intolerance of imatinib and dasatinib * at least one prior anti-leukemia therapy, including, but not limited to, interferon, imatinib, or dasatinib 3. the subject is at least 18 years old. 4. the subject has an eastern cooperative oncology group (ecog) performance status ≤2. 5. the subject has adequate organ function. 6. the subject is capable of understanding and complying with the protocol and has signed the informed consent document. 7. sexually active subjects must use an accepted method of contraception during the course of the study. 8. female subjects of childbearing potential must have a negative pregnancy test at enrollment. exclusion criteria: 1. the subject has received interferon, imatinib, or dasatinib within 7 days of the first dose of xl228. 2. the subject has received an investigational agent or radiotherapy within 28 days of the first dose of xl228. 3. the subject has received immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus for graft-versus-host disease \[gvhd\]) within 28 days prior to the first dose of xl228. 4. the subject has not recovered to national cancer institute (nci) common terminology criteria for adverse events (ctcae) v3.0 grade ≤1 from toxicities related to peripheral stem cell or bone marrow transplant. 5. the subject has not recovered to ctcae v3.0 grade ≤1 from adverse events (aes) due to investigational drugs or other medications. 6. the subject has known allergy or hypersensitivity to any component of the investigational drug product. 7. the subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 8. the subject is pregnant or breastfeeding. 9. the subject is known to be positive for the human immunodeficiency virus (hiv). 10. the subject has an inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee.

Keywords: myeloid leukemia lymphocytic leukemia ph+ all
study of colal-pred® in the treatment of moderate acute ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called colal-pred®, is useful in the treatment of ulcerative colitis.

ulcerative colitis is a disease that causes inflammation of the large bowel, causing fever, diarrhoea, dehydration and other symptoms. standard treatment for ulcerative colitis includes general medical treatments such as fluid and salt replacement and attention to diet. anti-inflammatory medicines such as steroids (e.g. prednisolone) and aminosalicylates (e.g. mesalazine) are the main drug treatments. this study will investigate whether colal-pred®, a novel dosage form of a prednisolone ester, is safe and effective in the treatment of ulcerative colitis, compared with the standard treatment (conventional prednisolone) and also to determine which dose which will work best for future patients.

Eligibility criteria:
inclusion criteria: * endoscopically confirmed diagnosis of ulcerative colitis * score of 6-10 on the disease activity index (dai) * moderate to severe mucosal appearance exclusion criteria: * previous colonic surgery * other treatments for ulcerative colitis that have not been stabilised * clinically significant diabetes, heart failure, unstable angina, cirrhosis, renal failure * history of tuberculosis

Keywords: ulcerative colitis
hiit following breast cancer chemotherapy

Conditions: Breast Cancer

Summary: chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. however, breast cancer survivors have a higher risk of cardiovascular disease (cvd) due to chemotherapy than adults without cancer. cardiovascular rehabilitation can be an effective strategy to decrease the incidence of cvd and its risk factors in this population. the proposed study may help to examine the effect and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.


Eligibility criteria:
inclusion criteria: * female patients based on biological sex * 18 to 85 years of age * diagnosis of primary, invasive, non-metastatic, stages i-iii breast cancer * completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 18 months prior to study enrollment. adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, serms, serds, ais), cdk4/6 inhibitors, parp inhibitors, her2 targeted agents, immunotherapy, and bisphosphonates are allowed within 6 months of study enrollment and during study participation * absence of contraindications to exercise or to participate in study * study clinician approval exclusion criteria: * do not meet inclusion criteria * scheduled to receive surgery or radiation therapy during the intervention period * any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent) * lymphedema stage ≥2 prior to study enrollment * are pregnant * current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)