Kornimate/medical-research-clean huggingface dataset:
sensory attention focused exercise in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is 1.) to determine if sensory attention focused exercise is an effective management strategy for parkinson's disease, and 2.) to identify if the benefits are a result of strength gains.

currently, there is no cure for parkinson's disease (pd) and although medication offers symptom reduction, there are many negative side effects associated with medication use. thus, there has been an increased emphasis on exercise interventions for symptom reduction. recent research has shown that both sensory attention focused exercise (safex) and strength training interventions improved disease severity more so than other exercise interventions (such as aerobic, aquatic and no exercise). upon closer examination, safex showed further symptom improvements than the strength training program. thus exists the need to further examine safex using a standardized protocol - a single-blind randomized double-crossover trial - that has been used sparingly in exercise interventions. in addition, the 30-second chair stand has been implemented into the testing protocol, as it has been shown to be a reliable measurement of functional strength for older adults. this test was implemented in order to identify the functional strength gains, if any, that are associated with safex. it is hypothesized that the safex intervention will improve disease symptoms in pd, and that the results will not be due to strength gains.

Eligibility criteria:
inclusion criteria: * diagnosis of pd by a clinician/neurologist * absence of mentation * established medication schedule and dosage exclusion criteria: * mentation * change in medication during period of study * change in exercise level during period of study * inability to complete the exercise program * absence of 5 or more classes, or absence of 3 or more classes in sequence

Keywords: parkinson's disease randomized single-blind crossover trial sensory attention focused exercise
controlled outcome evaluations of a daily physical activity intervention for individuals with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the intervention consists of an individual counseling session, telephone counseling (7 calls), given by a psychologist, and a pedometer. the intervention is based on cognitive behavioral therapy, the diabetes prevention program, the first step program and motivational interviewing. the taxonomy of behavior change techniques is also taken into account. the duration of the intervention is six months. the individual session takes place one week after the baseline measurements, together with the participants' follow-up appointment with their endocrinologist. the individual session takes place at the endocrinology department and is expected to last approximately 30 minutes. in addition to the session, the participants of the intervention group receive a pedometer and a pedometer diary for six months. participants of the intervention group also receive telephone counseling from the psychologist during 24 weeks. they receive a call every two weeks for four weeks and then every four weeks for the next 20 weeks, good for a total of seven counseling calls. the calls are expected to last approximately 20 minutes. the control group has no intervention at all and receive their usual care.


Eligibility criteria:
inclusion criteria: * minimum six months post-diagnosis of type 2 diabetes age between 35 and 75 years * treated by diet alone, oral hypoglycaemic medications, insulin or combination therapy * no documented pa limitations * dutch speaking * having a telephone number
modafinil for the treatment of cocaine dependence - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.

this is a double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.

Eligibility criteria:
inclusion criteria: * participant must have dsm-iv diagnosis of cocaine dependence as determined by scid. * must be seeking treatment for cocaine dependence. * must be able to understand and provide written informed consent. exclusion criteria: * please contact the study site for more information.

Keywords: cocaine dependence
combined immunization of covid-19 inactivated vaccine with qiv and ppv23

Conditions: Safety; Immunogenicity, Vaccine; COVID-19 Vaccines; Influenza Vaccines; Pneumococcal Vaccines

Summary: the main objective of this study was to evaluate the immunogenicity and safety of the booster dose of covid-19 inactivated vaccine and co-immunization with quadrivalent influenza vaccine and 23-valent pneumonia polysaccharide vaccine in people aged 18 years and older. a randomized controlled, open trial design was adopted. the study was conducted with informed consent of the subjects for immunogenicity and safety in the population aged 18 years and older. a total of 3000 healthy subjects were selected, (1)600 healthy subjects were selected for the immunogenicity and safety study of co-immunization, 300 in the adult group (18-59 years old) and 300 in the elderly group (60 years old and above); (2) 2400 healthy subjects were selected for the observational study of the safety of co-immunization, 1200 in the adult group (18-59 years old) and 1200 in the elderly group (60 years old and above ) 1200 people.


Eligibility criteria:
inclusion criteria: * healthy adults 18 years old and older * over 6 months after primary immunization with covid-19 vaccines * can understand and sign the consent * can provide effective personal identification exclusion criteria: * has a history of covid-19 infection * less than 6 months after primary immunization with covid-19 vaccines * already vaccinated with influenza vaccines of that year * vaccinated with pneumococcal vaccines within 5 years * has a history of severe hypersensitivity reaction to vaccines * has uncontrolled seizure or other severe neural system illnesses * has a fever, chronic disease, or acute disease during immunization * gestation period, lactation period, or planning to get pregnant within 3 months * administrated with other drugs under research within 30 days before vaccination * received attenuated vaccines within 14 days before vaccination * received subunit vaccines or inactivated vaccines within 7 days before vaccination * other conditions based on researcher's judgement

Keywords: safety;immunogenecity;combined immunization
rehabilitation outcomes of shoulder function in oral cancer survivors cancer survivors

Conditions: Oral Cancer

Summary: head and neck cancer is prevalent in taiwan, and oral cancer is the most common location. advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. the probability of shoulder dysfunction after neck dissection is as high as 70%. rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.the purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors.

head and neck cancer is prevalent in taiwan, and oral cancer is the most common location. advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. the probability of shoulder dysfunction after neck dissection is as high as 70%. rehabilitation effects on shoulder function for head and neck survivors are needed for further studied. the purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors. we will recruit 60 newly diagnosed oral cancer subjects through the plastic surgeon's referral from april 2018 to march 2020. the participants will be randomized separated into experimental or control group. each group would receive regular physical therapy for shoulder function (i.e., transcutaneous electrical stimulation, shoulder joint range of motion exercise, scapular muscle strengthening training). experimental group would be supplemented by motor control therapy targeting the scapular muscle progressive resistance exercise (exercise plus manual therapy).

Eligibility criteria:
inclusion criteria: * willing to sign the inform consent * sufficiently communicate in the chinese language * be able to follow instructions * newly diagnosed oral cancer * spinal accessory shoulder dysfunction exclusion criteria: * pregnant or breast-feeding woman * cognitively impaired * central nervous disease * distant metastasis or recurrence * a history of shoulder pain or known shoulder pathology * unable to communicate or comprehend the questionnaires

Keywords: oral cancer shoulder dysfunction quality of life motor control strengthening exercise
darvadstrocel for crohn's fistula in the realworld

Conditions: Crohn's Fistula

Summary: background perianal fistula may affect 15-50% of patients with crohn's disease (cd). treatment is complex, requiring a multidisciplinary approach. darvadstrocel (allogeneic mesenchymal cells obtained from lipoaspirates) was approved in 2018 by the european medicines agency and spanish agency of medicines and medical products as a treatment for fistulas in cd. recent european crohn's and colitis organisation (ecco) andspanish working group on crohn's disease and ulcerative colitis (geteccu) guidelines state that darvadstrocel is effective with a favourable safety profile,with a strong level of evidence (level 2).with this study we want to see the real efficacy of darvadstrocel in a spanish population after 6 months of follow-up.

methods: the criteria for the spanish national health system to fund darvadstrocel treatment are: 1)complex fistula in a patient with cd; 2)failure of conventional and anti-tumour necrosis factor treatment; and 3)absence of collection s\>2cm confirmed by pelvic mri scan at the time of surgery. from november 2019 to april 2022, 73 patients were treated with darvadstrocel at 14spanish centres and evaluated clinically and radiologically 6 months after treatment.

Eligibility criteria:
inclusion criteria: * 1)complex fistula in a patient with cd * 2)failure of conventional and anti-tumour necrosis factor treatment * 3)absence of collection s\>2cm confirmed by pelvic mri scan at the time of surgery exclusion criteria: * patients with a diagnosis of rectovaginal fistula, rectal stenosis or severe active proctitis were excluded

Keywords: adipose-derived stem cells cell therapy compassionate use crohn's disease fistula-in-ano
effect of beetroot juice on blood pressure regulation in post menopausal women

Conditions: Postmenopausal Women

Summary: in this study the investigators will test the hypothesis that acute consumption of inorganic nitrate (supplied in concentrated beetroot juice) reduces artery stiffness and resting blood pressure, and lessens the rise in blood pressure during handgrip exercise in postmenopausal women. understanding and improving artery function and blood pressure regulation in women is important because they undergo accelerated arterial stiffening after menopause and have much larger increases in blood pressure when they exercise compared with either premenopausal women or men of similar age.

postmenopausal women have stiff central arteries and exaggerated blood pressure (bp) responses during exercise compared with either premenopausal women or men of similar age. arterial stiffness and exaggerated bp responses to exercise are prognostic for heart wall thickening, future hypertension, adverse cardiovascular events, and mortality. previous studies have reported that acute consumption of nitrate-rich beetroot juice can lower resting and exercising bp responses in older adults. however, these studies included both sexes and did not compare the effects of beetroot juice to a nitrate-depleted placebo (a true control). thus, the potential bp lowering effects of nitrate supplementation per se have not been established in postmenopausal women. the present study examines the acute (single dose) effects of nitrate-rich beetroot juice on resting hemodynamics (peripheral and central bp, arterial wave properties, etc), and physiological responses to handgrip exercise in metabolically healthy post-menopausal women.

Eligibility criteria:
inclusion criteria: * resting systolic blood pressure less than or equal to 160 mmhg * resting diastolic blood pressure less than or equal to 100 mmhg exclusion criteria: * overt cardiovascular, metabolic, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s) * users of any tobacco and/or nicotine products (smokers, chewing tobacco, nicotine-containing patches/gum, smokeless cigarettes) * body mass index greater than 35 * total cholesterol greater than 239 mg/dl * ldl cholesterol greater than 159 mg/dl * fasting blood triglycerides greater than 199 mg/dl * fasting blood glucose greater than 109 mg/dl and hba1c greater than 6.0% * individuals currently taking any of the following medications: 1. blood pressure lowering medication (e.g., beta blockers, ace inhibitors, angiotensin antagonists, calcium channel blockers, diuretics) 2. lipid-lowering medication (e.g., statins) 3. nitrates (e.g. nitroglycerin) for angina 4. phosphodiesterase inhibitors (e.g., viagra) 5. anti-inflammatory drugs * individuals currently taking hormone replacement therapy

Keywords: dietary nitrate supplementation beetroot juice
discovering factors in the clinical trial journey of dementia patients

Conditions: Dementia

Summary: this research aims to collect comprehensive data on the clinical trial experience of dementia patients. its goal is to identify the factors that limit patients' ability to join or complete a trial successfully. clinical trial participation often favors specific demographic groups, and limited research exists on the impact of trial attributes on participation. therefore, this study aims to analyze data from various demographic groups and identify any recurring trends that could provide valuable insights for future dementia patients.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. * participant has a diagnosis of dementia. * willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. exclusion criteria: * pregnant or lactating woman * enrolled in another research study * any mental or medical condition that prevents the patient from giving informed consent or participating in the trial

Keywords: dementia
noninterventional study assessing cognitive function and physical activity in people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.


Eligibility criteria:
inclusion criteria: * patients with relapsing remitting multiple sclerosis (rrms), and treated with betaferon, with the decision for treatment made at the discretion of the attending physician, documented with a prescription of betaferon by the physician * edss 0 - 6 * written informed consent exclusion criteria: * patients who do not meet the local indication criteria for betaferon treatment. * contraindications listed in the local smpcs have to be considered. * patients with a history of severe head trauma. * patients with alcohol and/or drug abuse. * patients with mental retardation. * patients with learning disability.

Keywords: cognition physical activity relapsing remitting multiple sclerosis
adductor canal catheter vs local infiltration of analgesia for total knee arthroplasty

Conditions: Acute Pain; Regional Anesthesia Morbidity

Summary: the study is a prospective randomized controlled trial comparing local infiltration of analgesia in the knee joint and adductor canal catheters for postoperative analgesia following a primary total knee arthroplasty (tka).

the study is a prospective, randomized controlled clinical trial comparing two methods of postoperative analgesia following primary tka. eligible primary tka patients must be asa i - iii and require less than 20 mg oxycodone daily (or its equivalent). exclusion criteria are: allergy to anesthetics, contraindication to regional anesthesia, sensory/ motor disorder involving operative limb, non-english speaking, asa iv or greater, psychiatric or cognitive disorders, incarceration, renal insufficiency with cr \> 2.0 and hepatic failure. when patients agree to participate in the study the following data will be collected by the research staff: asa physical status, age, height, weight, gender, quantitative opiate use, numeric pain score with visual descriptors, paindetect score, womac score and baseline pain management questionnaire. when designated through randomization, local infiltration of analgesia will be placed intraoperatively by the surgeons, per usual protocol and patients in the lia group will receive sham adductor canal catheter. all acc's for both study groups will be placed postoperatively in the pacu. those collecting data will be blinded from identifying patients in the control group, as both groups will have acc placed with same technique. potential risks for each procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity in the form of seizure and cardiac arrest and neuropathy. the preceding are commonly listed though infrequent complications of both procedures. continuous ultrasound will guide the placement of the acc. all adductor canal catheters will remain in for 72 hours. pt from lia group will be discharged home with sham catheter with a saline infusion at 10 ml/hr via an ambulatory pump. patients in acc group will be discharged with continuous adductor canal catheter delivering ropivacaine 0.2% at 10 ml/hr via an ambulatory pump. patients will be called daily for pain diary results. as well as at 6-8 weeks postoperatively to collect paindetect and womac survey.

Eligibility criteria:
inclusion criteria: * age 40-85 * american society of anesthesiologists (asa) physical status (ps) 1-3. • undergoing unilateral, primary, total knee arthroplasty * english as native language exclusion criteria: * patient refusal * history of opioid dependence * contraindication to peripheral nerve block • pre-existing significant neuropathy

Keywords: adductor canal catheter arthroplasty, replacement, knee local infiltration of analgesia
assessment of response before, during and after neoadjuvant chemoradiotherapy in rectal cancer patients

Conditions: Adenocarcinoma; Rectal Neoplasms

Summary: rectal cancer is a frequent but curable malignancy in the western world. the golden standard in treating these patients consists of neoadjuvant chemoradiotherapy (crt) followed by extensive surgery regardless of tumor response. the main question is whether extensive surgery can be avoided holding in mind that already a significant amount of patients reach a pathological complete response after radiochemotherapy. the goal of this study is dual. first of all, the investigators want to investigate the value of dw-mri and 18fdg-pet in the assessment of response after neoadjuvant crt in 100 patients with rectal cancer, to select those patients eligible for less invasive surgery. in the same patient group, the investigators will examine the biomarker potential of molecular characteristics of the tumor in blood and tissue. using both molecular and radiological findings, the investigators want to predict pathological response after chemoradiotherapy and to select patients who may benefit from treatment adjustments during chemoradiotherapy.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age. * patient's body weight is ≤ 120 kg. * histologically proven and evaluable (according to recist criteria) adenocarcinoma of the rectum (tumour \<15 cm from the anal verge), staged t3-4 n0 and t1-4n1-2. * who ps ≤ 2 * adequate bone marrow, hepatic and renal function (assessed within 14 days prior to study entry): * hemoglobin \>10.0 g/dl, * absolute neutrophil count \> 1.5 x 109/l, * platelet count \> 100 x 109/l, * presence of adequate contraception in fertile patients. adequate methods of contraception are: intra-uterine device, hormonal contraception, condom use with spermicide. * written informed consent must be given according to ich/gcp and national/local regulations. exclusion criteria: * evidence of distant metastases. * prior chemotherapy or radiotherapy for rectal cancer. * pregnant or breastfeeding women. * significant impairment of intestinal resorption (e.g. chronic diarrhea, inflammatory bowel disease). * known allergies to intravenous contrast agents. * contra-indications for magnetic resonance imaging (metal implants, claustrophobia, etc. ). * previous or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and non-melanoma skin cancer. * history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake. * presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Keywords: staged t3-4 n0 and t1-4n1-2 adenocarcinoma of the rectum rectum
clinical outcomes and costs of 4-week versus 6-week bloodwork for patients on hemodialysis

Conditions: End Stage Renal Disease

Summary: the objective of this quality improvement study was to determine the effect of an institution-wide switch of routine bloodwork from four-week intervals to six-week intervals on the achievement of anemia and chronic kidney disease-mineral and bone disorder (ckd-mbd) targets for patients on chronic hemodialysis.

rationale \& objective: routine bloodwork for patients on hemodialysis has both financial and opportunity costs, but there is little data on how the frequency of measurement affects patient outcomes. our objective was to determine the effect of changing from routine bloodwork at four-week intervals to six-week intervals on the achievement of anemia and chronic kidney disease-mineral and bone disorder (ckd-mbd) targets. study design: retrospective interrupted time series from june 1, 2012 to december 31, 2015. setting \& participants: tertiary hospital in ontario, canada, that provides hemodialysis to 350-400 adult patients. quality improvement activities: institution-wide switch of routine bloodwork from four-week intervals to six-week intervals on march 24, 2014. outcomes: proportion of patients who achieved recommended hemoglobin and phosphate targets. in a 252-day sub-analysis, we also calculated the cost-savings attributable to a change in laboratory testing frequency for hemoglobin, ferritin, iron saturation, calcium, and phosphate. analytical approach: statistical process control to analyze variation in the clinical outcomes.

Eligibility criteria:
inclusion criteria: * all patients who received chronic hemodialysis at the kingston health sciences center regional hemodialysis program exclusion criteria: * none