Kornimate/medical-research-clean huggingface dataset:
diabetes smoking cessation incentives study

Conditions: Smoking Cessation; Diabetes Type 2

Summary: the purpose of this study is to evaluate the feasibility of contingency management on improving smoking cessation among individuals with type 2 diabetes.

type 2 diabetes (t2dm) and cigarette smoking are major causes of morbidity and mortality in us, and research indicates there is a complex relationship between these two risk factors. smoking cessation is recommended as a standard treatment of diabetes by the american diabetes association; however, patients with t2dm and their providers are often inundated with other challenging lifestyle changes and disease management. due to the complex relationship between diabetes and smoking and the large number of competing lifestyle changes recommended at diagnosis, smokers with t2dm may benefit from a contingency management (cm) program that incentivizes cessation. providing patients tangible rewards to reinforce positive behaviors such as smoking abstinence has been proven effective in substance abuse programs, smoking cessation among pregnant women unwilling or unable to quit, and other population subgroups. in this cruk2 study the investigators aim to test and further explore the potential effectiveness of financial incentives contingent upon proof of quitting smoking. the investigators will gather diabetes-related contextual factors associated with participation in the program and smoking cessation.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * earn a score \> 4 on realm indicating \> 6th grade english literacy level * willing to quit smoking 7 days from their first visit * have an expired co level \>8 ppm suggestive of current smoking at baseline * currently smoking \> 5 cigarettes per day * willing and able to attend 6 study visits exclusion criteria: * unable to demonstrate use of or unwilling to use the remote co monitor and phone app

Keywords: financial incentives contingency management
disease control and safety in patients with relapsing remitting multiple sclerosis (rrms) switching from natalizumab to fingolimod

Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)

Summary: this study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

patient were screened, signed an informed consent at visit 1, at the 2nd visit, all patient received a baseline infusion of natalizumub and subsequently randomized to one of 3 treatment arms. at the randomization visit, the washout phase started, and eligible patients were randomized 1:1:1 to one of three treatment groups: * 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod, * 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod, or * 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod.

Eligibility criteria:
inclusion criteria: patients must: * have relapsing remitting multiple sclerosis * have been on treatment with natalizumab for at least 6 months prior to screening and discontinuation is an option. exclusion criteria: patients with: * history of chronic immune disease * crohn's disease * certain cancers * uncontrolled diabetes * certain eye disorders * negative for varicella-zoster virus igg antibodies * certain hepatic conditions * low white blood cell count * on certain immunosuppressive medications or heart medications * resting heart rate less than 45 bpm. * certain heart conditions or certain lung conditions * inability to undergo mri scans other protocol-defined inclusion/exclusion criteria may apply

Keywords: relapsing remitting multiple sclerosis multiple sclerosis (ms) safety tolerability health outcomes fingolimod disease control mri
clinical study for assessment of the efficacy of gabapentin (carbatin and neurontin) in patients with neuropathy pain

Conditions: Neuropathy; Pain

Summary: the purpose of this study is to assess the efficacy of gabapentin (carbatin \& neurontin) in patients with neuropathy pain.


Eligibility criteria:
inclusion criteria: * subjects who have been diagnosed the disease of neuropathy pain arising from diabetic peripheral neuropathy, postherpetic neuralgia, traumatic/surgical nerve injury, incomplete spinal cord injury, or trigeminal neuralgia and if they have a mean weekly pain score of at least 4 on the 100-mm visual analog scale (vas) of the short-form mcgill pain questionnaire (sf-mpq) completed a screening / baseline period before randomization. additional disease-specific inclusion criteria are listed in table 1. * subjects must be 20 years of age or older. exclusion criteria: * subjects who are pregnant, lactating or of childbearing potential not using effective contraceptives. * subjects who have a clinically significant or unstable medical or psychiatric condition. * subjects who are known of hypersensitivity to gabapentin. * serum creatinine \> 1.5 times the upper limit of normal * subjects who have received nerve blocks or acupuncture for pain relief within four weeks before a screening / baseline period. * subjects who have the presence of chronic pain other than the target pain being studied (unless the chronic pain is in a different body region than the target pain and its intensity is not greater than that of the target pain). * subjects who have received nondrug therapies or any special procedures for the relief of the target pain within two weeks before a baseline visit. * subjects who are using the following agents within 30 days prior to screening: antidepressants, opioids, other anticonvulsants, local anaesthetic injections or any investigational drug.
landmarc study: a study with focus on aorta ascendens

Conditions: Aortic Diseases; Aortic Aneurysm; Aortic Dissection; Aortic Aneurysm, Thoracic; Aortic Dilatation; Aortic Elongation

Summary: rationale: aortic diameter is currently used as a gold standard in international guidelines for prediction of aorta pathology (aortic aneurysm and aortic dissection). however, aortic diameter has proven to be insufficiently accurate for making decisions about well-timed preventive interventions. the landmarc study will take place in line with the fibaa-bank ('correlatie tussen cardiovasculaire fibroseringsgraad en aorta elongatie, dilatatie en atria dilatatie (fibaa-bank): een biobank \& databank onderzoek met focus op aorta en atria' (metc-number 2022-3164)), and aims to reveal the undiscovered relationship between wss (wall shear stress) values and aortic strain. in combination with data from the fibaa-bank, the landmarc study will provide more accurate information for future risk stratification models for cardiovascular pathology (with focus on aortic disease). objectives: primary objective: indication of the association between wss (peak wss and wss gradient) (through 4d-flow mr and ct) and aortic strain. secondary objective: indication of the association between (hemo)dynamic processes within the body (aortic elongation/aortic strain) and (patho-)physiological changes (degree of cardiovascular tissue fibrosis).


Eligibility criteria:
inclusion criteria: * 18 years and older * able to understand the trial and provide informed consent * patients who have participated in the fibaa-bank exclusion criteria: * patients with abnormal congenital cardiothoracic anatomy, with exception of presence of a bicuspid aortic valve * patients with history of chemotherapy, or radiotherapy within thoracic region * patients with an age \>80 years * patients with a weight \>120 kg * patients with a contra-indication for mri according to the mumc+ odin protocol nr. 004952 * patients with impaired renal function (gfr \<30)
prediction of outcomes following total knee replacement- pilot

Conditions: Osteoarthritis, Knee; Knee Replacement

Summary: this study seeks to examine multiple risk factors as predictors of pain and function following total knee arthroplasty (tka). risk factors will be measured pre-surgically using psychophysical testing procedures, multimodal evaluation of sleep, standardized questionnaires. additionally, this study will collect pilot data on a brief mindfulness-based cognitive-behavioral treatment that may help to improve long-term tka outcomes. the pilot study compared tka patients that received brief mindfulness-based cognitive behavioral therapy (mbcbt) to the treatment-as-usual (tau) group from the parent study.

the present study seeks to collect pilot data on a brief mindfulness-based cognitive-behavioral treatment to determine the feasibility of this intervention and its potential benefits. the study includes 6 total contacts, 1 visit before surgery and 3 after surgery, and 2 phone calls. the last visit will be about 6 months after surgery. the study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold. the research takes place at the brigham \& women's pain management center, 850 boylston st, chestnut hill.

Eligibility criteria:
inclusion criteria: 1. age 45 or older, 2. meet the american college of rheumatology criteria for knee oa, 3. scheduled to undergo total knee arthroplasty, 4. facility with the english language that is adequate to complete study procedures exclusion criteria: 1. cognitive impairment preventing completion of study assessment procedures. 2. myocardial infarction within the past 12 months. 3. presence of severe raynaud's or severe neuropathy, 4. active vasculitis or severe peripheral vascular disease, 5. current infection, 6. use of oral steroids, 7. recent history of substance abuse or dependence, 8. known anemia

Keywords: cbt
hepatitis c positive organ to recipient hepatitis c negative longitudinal transplant study

Conditions: Liver Transplant; Complications; Hepatitis C

Summary: compare wait list mortality and time to liver, heart or kidney transplant for registrants listed to consider allografts from hepatitis c virus (hcv) nucleic amplification testing (nat)+ donors versus those who are not . the umbrella protocol has been set up to include heart and kidney transplant recipients.

the research project will take place within each transplant center and can be incorporated into routine pre- and post-transplant care (i.e., no extra visits are needed). enrolling in this study will enable patients to accept offers of hcv nat+ livers, in addition to the regular waitlist. all other transplant eligibility criteria have to be met per routine care. the multi-site project will establish a biorepository and prospective data collection with the goal of obtaining more generalizable results than single-center studies alone can. patients who enroll in the study but receive an hcv- organ instead, will be (data collection only) as part of the study. aims are to evaluate sustained virologic response (svr) rates post-transplant with direct acting anti-viral (daa) therapy, as well as long-term patient and graft outcomes. evaluate the financial impact of timely transplant and daa therapy compared to traditional wait time health care expenditure. create a blood and tissue biorepository for future evaluation of hcv nat+ allografts and their outcomes

Eligibility criteria:
recipient inclusion criteria: 1. adult patients \> or = 18 years of age 2. actively listed for liver transplant (lt) or simultaneous liver and kidney (slk) 3. current hcv nat- status 4. review by multi-disciplinary transplant team that patient is appropriate for listing for hcv nat+ liver offers recipient exclusion criteria: 1. unwilling to consent to post transplant daa therapy 2. hepatitis b virus (hbv) viremia donor inclusion criteria: 1. hcv nat+ 2. deceased donor organs 3. hbv cab donors will be considered on a case by case basis based on specific recipient factors and plan for post-transplant prophylaxis donor exclusion criteria: 1. bilirubin \>3 2. positive nucleotide testing for hbv 3. radiographic, laboratory or other clinical evidence of portal hypertension 4. fibrosis on pre-procurement liver biopsy fibrosis \> f1 or fibroscan \>7 (if both are done and discordant, use biopsy to determine eligibility
evaluation of a novel nasal conformer in pediatric patients

Conditions: Cleft Lip; Nasal Surgical Procedures

Summary: this study compares the current commercially available nasal conformer available for use in cleft lip repair and nasal scar release to a novel, anatomically shaped conformer based upon typical nasal airspace shape. this will follow patients using both of these types of splints during the post-operative healing process with one group starting with the standard splint and then moving to the anatomic conformer and the second group beginning with the anatomic and them moving to the standard conformer. this study will evaluate the patient experience and outcomes of the 2 types of conformers, looking at the discomfort, device dislodgements, ease of use and occurrence of complications such as skin irritation and rashes or skin breakdown.


Eligibility criteria:
inclusion criteria: * patient's undergoing primary cleft lip repair or release of nasal scarring exclusion criteria: * patient or parents declined participation postoperative nasal stenting is judged clinically inappropriate
radiation therapy after lumpectomy in treating women with ductal carcinoma in situ or invasive breast cancer

Conditions: Breast Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells. purpose: phase ii trial to study the effectiveness of radiation therapy during surgery followed by whole-breast radiation therapy in treating women who have undergone lumpectomy for ductal carcinoma in situ or invasive breast cancer

objectives: * determine the effect of intraoperative radiotherapy boost to the tumor bed on acute complications after lumpectomy (before whole breast irradiation) in women with ductal carcinoma in situ or invasive adenocarcinoma of the breast. * determine the local recurrence rates in patients treated with this regimen. * determine the cosmetic outcome in patients treated with this regimen. outline: patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity. postoperatively, patients undergo external beam radiotherapy to the entire breast 5 days a week for 5-6 weeks. patients are followed at 1 month and then every 3 months for 2 years. projected accrual: a total of 25 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * histologically confirmed ductal carcinoma in situ or invasive adenocarcinoma of the breast * primary tumor classified as t1, t2, or t3 * candidate for breast-conserving surgery * must have undergone lumpectomy with negative margins or minimal margin involvement * currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection * no evidence of metastatic disease * hormone receptor status: * not specified patient characteristics: age * adult sex * female menopausal status * not specified performance status * ecog 0-2 life expectancy * not specified hematopoietic * wbc greater than 3,500/mm\^3 * granulocyte count greater than 1,500/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic * not specified renal * not specified other * not pregnant * no other malignancies within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer * prior contralateral breast cancer allowed if curatively treated more than 5 years previously * no severe psychiatric or medical illness prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * no prior radiotherapy to the involved breast surgery * see disease characteristics

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer ductal breast carcinoma in situ breast cancer in situ
effect of physical training in patients with heart failure caused by chemotherapy for cancer treatment

Conditions: Insufficiency;Cardiac; Cancer; Cardiotoxicity; Heart Failure

Summary: new therapies for cancer increased patient survival, but led to the recognition of adverse effects associated with cancer treatment, such as the use of chemotherapy. cardiotoxicity is the most significant adverse effect, which affect the functional capacity and quality of life and is associated with high morbidity and mortality, regardless of the oncological prognosis. one of the manifestations of cardiotoxicity is ventricular dysfunction that can lead to heart failure. neuro humoral hyperactivation with increased sympathetic nerve activity is a typical manifestation of heart failure and is associated with worse prognosis. studies have shown that physical training significantly reduces sympathetic nerve activity in addition to improving muscle blood flow, reversing effects on skeletal muscle and improving quality of life. the hypothesis is that physical training may reduce sympathetic nerve activity and vasoconstrictor status in patients with heart failure caused by anthracyclines, as well as improving baroreflex and chemoreflex sensibility, mechanoreflex and metaborreflex control and skeletal myopathy.

the investigators included patients\> 18 years, left ventricular ejection fraction \<= 0.55, functional class (nyha) i-iii, under medical treatment for heart failure. patients with coronary artery disease, moderate to severe valve disease, positive chagas serology, inability to participate in an exercise program are excluded. primary outcome: muscle sympathetic nerve activity secondary outcome: arterial baroreflex sensitivity, peripheral chemorreflex sensitivity, mecanic and muscuclar metaborreflex control, ubiquitin proteasome system activity. patients were divided into 2 groups-trained (n = 10) and non-trained (n = 10). patients in the trained group will complete 16 weeks of aerobic training. evaluation of cardiac function, functional capacity, quality of life and biochemical evaluation (troponin, hs-crp and bnp). for muscle evaluation will be performed biopsy of the vastus lateralis muscle

Eligibility criteria:
inclusion criteria: * age 18 years old * funcional class i-iii (nyha) * ejection fraction \< o,55 * treated for heart failure exclusion criteria: * coronary artery disease * moderate to major valve disease * positive serology for chagas * inability to perform physical exercises

Keywords: autonomic dysfunction baroreflex control ergorreflex control muscle myopaty
safety and efficacy study of an a1-adenosine receptor agonist to slow heart rate in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study is designed to evaluate the safety of dti-0009 in patients with atrial fibrillation and to find the dose of dti-0009 that lowers heart rates in patients with atrial fibrillation with rapid ventricular response.


Eligibility criteria:
inclusion criteria * primary diagnosis of atrial fibrillation with rapid ventricular response of any duration as documented by an ecg exclusion criteria * presence of other significant cardiac disease or history of significant neurological, hepatic,cardiovascular, renal, gastrointestinal, thyroid, respiratory, rheumatologic, or hematologic disease or impairment that in the investigator's judgment is serious enough to preclude the patient from safely participating in the study
ketamine for analgesia after cesarean section

Conditions: Cesarean Section; Postoperative Pain

Summary: in this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.

in this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia. the patients were randomized in two groups: * group ketamine: these patients recieved 0.25 mg/kg of ketamin intravenously 5 minutes after the spinal anesthesia. * group placebo: recieved 20 ml of normal saline solution intravenously 5 minutes after the spinal puncture. the investigators recorded intra demographic, intraoperative and post operative data. the main outcome was the analgesic score: the visual analog scale (vas). dynamic vas was also monitored at 24 hours post operatively.

Eligibility criteria:
inclusion criteria: * full term pregnant adult patients * monofetal pregnancy * scheduled for urgent or elective cesarean section under spinal anesthesia exclusion criteria: * necessity of general anesthesia during the procedure * post partum hemorrage
weight change with controlled ankle movement (cam) boot use

Conditions: Ankle Injuries; Foot Injuries and Disorders; Body Weight Changes

Summary: the purpose of the study is to determine if patients wearing a cam boot have a change in weight compared to patients who wear a cam boot and are provided nutritional guidelines and perform upper body exercises.

the study objectives include: 1) determine if patients wearing a cam (controlled ankle movement) boot have a change in weight compared to patients who wear a cam boot and are provided nutritional guidelines at the time the cam is dispensed and perform upper body exercises through the treatment period. 2) determine, if weight is gained or lost, the average amount gained/lost over the treatment period. 3) to qualitatively explore if the intervention helped to prevent gain weight during post-operative recovery when cam boot is used

Eligibility criteria:
inclusion criteria: * age greater or equal to 18 years * participants with foot or ankle injury who are prescribed a cam boot as standard of care * participants willing to have height and weight measured at the time of enrollment and final visit * participant is able to provide voluntary, written consent * fluent in written and spoken english * participant in the opinion of the principal investigator, is able to understand the clinical investigation exclusion criteria: * age less than 18 years * pregnant women * participants with vertigo or other balance issues * participants unable to provide informed consent * participants with foot or ankle injury who will not be wearing a cam boot * participants unable/unwilling to perform upper body exercises and follow nutrition recommendations

Keywords: controlled ankle movement cam boot