Kornimate/medical-research-clean huggingface dataset:
supportive intervention programs study

Conditions: Fatigue; Nausea and Vomiting; Pain; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage I-IVB Colon Cancer; Stage I-IVB Rectal Cancer

Summary: this randomized clinical trial studies the preliminary efficacy of a yoga skills training (yst) compared to counseling and education (ce) for reducing treatment-related symptoms in patients with colorectal cancer who are receiving chemotherapy. the yst may reduce fatigue, other treatment-related symptoms, and improve the quality of life (qol) of patients with colorectal cancer. it is not yet known whether yst is more effective then ce in reducing these outcomes.

objectives: i. to establish the feasibility of implementing a yst among patients undergoing chemotherapy. this includes the feasibility of implementing yoga in a treatment setting, and patient recruitment, adherence, and retention. ii. to obtain preliminary data on the efficacy of a yst for reducing fatigue among patients undergoing chemotherapy. iii. to obtain exploratory data on the impact of a yst on other treatment-related symptoms (e.g., pain, distress, nausea) and qol. iv. to obtain exploratory data on the impact of a yst on potential psychological (self-efficacy for coping with cancer, response expectancies for symptoms) and physiological (interleukin \[il\]-6 \[il-6\], il-1 receptor antagonist \[il-1ra\], tumor necrosis factor- alpha \[tnf-a\], soluble tnf receptor i \[stnfri\], c-reactive protein \[crp\]) mediators that may explain the impact of the yst on fatigue. outline: patients (n=20) are randomized to 1 of 2 treatment arms. arm i: patients participate in three 15-minute yst sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. patients also receive a compact disc (cd) recording of a 15-minute yst session and are instructed to practice the yst at home 4 times weekly. arm ii: patients participate in three 15-minute ce sessions, comprising empathic attention with an interventionist who allows patients to direct the flow of conversation and provides supportive comments according to standardized procedures. patients also receive cds with recorded information related to coping with colorectal cancer similar in length to the suggested practice time in arm i. the interventions (week 2, week 4, week 6) and assessments (week 0, week 4, week 8) are implemented during visits for chemotherapy (every two weeks).

Eligibility criteria:
inclusion criteria: * signed protocol specific informed consent * are diagnosed with colorectal cancer * recruited within 2 weeks of initiating chemotherapy (including reinitiating chemotherapy after a treatment holiday of greater than or equal to 4 weeks) * able to understand written and spoken english exclusion criteria: * under age 18 (children with colorectal cancer) * unable to read or understand english * vulnerable subjects (except those who are economically or educationally disadvantaged)
efficacy of intrauterine lidocaine and naproxen for pain control with intrauterine device insertion

Conditions: Contraception; Pain

Summary: to compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.

this is a randomized, double-blind, placebo-controlled study with women that will be recruited from our outpatient obstetrics and gynecology clinic. women desiring intrauterine device insertion will be invited to participate. the investigators plan to recruit women desiring intrauterine device insertion into one of four groups: a: placebo/normal saline infusion; b: placebo/lidocaine infusion; c: saline infusion/ naproxen; d: lidocaine infusion/ naproxen.

Eligibility criteria:
inclusion criteria: * deers-eligible reproductive age women (i.e. tricare beneficiaries) * age 18 years and older * desiring paragard or mirena intrauterine device insertion exclusion criteria: * current pregnancy * cervical stenosis * severe medical illness * known allergy or sensitivity to lidocaine or naproxen * peptic ulcer disease * current pelvic inflammatory disease * patients with known renal insufficiency * patients using chronic nsaids or on chronic pain medication * women desiring skyla iud insertion will also be excluded due to infrequency of insertions at wrnmmc

Keywords: naproxen lidocaine intrauterine device iud pain
diabetes visual function supplement study

Conditions: Diabetes Mellitus - Type 1; Diabetes Mellitus - Type 2; Non-proliferative Diabetic Retinopathy

Summary: this study will evaluate the effects of a novel multi-component dietary supplement on the visual function and retinal structure of patients with diabetes with both no diabetic retinopathy and mild to moderate diabetic retinopathy. this is a placebo-controlled trial and neither subjects nor examiners will know if any given subject is taking active supplement or placebo. the hypothesis is that the supplement will improve visual function and retinal structure in subjects on active supplement

adult patients with either type 1 or type 2 diabetes will be enrolled with baseline measurement of visual acuity, contrast sensitivity, color vision, threshold macular perimetry, macular pigment optical density, optical coherence tomography, glycosylated hemoglobin, blood lipids and serum vitamin d status. a multi-component dietary supplement containing ingredients currently available over the counter in the us will be taken for six months and repeat measurements of the above parameters obtained.

Eligibility criteria:
inclusion criteria: * diabetes mellitus diagnosed at least 5 years * age greater than or equal to 18 years * english speaker exclusion criteria: * proliferative diabetic retinopathy or severe non-proliferative retinopathy * clinically significant macular edema * corrected visual acuity less than 20/30 in either eye * diagnosis of other serious eye disease (glaucoma, age-related maculopathy) * less than 18 years old * non-english speaker * no known allergy or sensitivity to any supplement ingredients

Keywords: diabetes diabetic retinopathy nutritional supplements visual function macular pigment macular threshold sensitivity contrast sensitivity color vision optical coherence tomography
efficacy and safety of cold versus hot snare polypectomy for removal of 4-10 mm pedunculated colorectal polyps

Conditions: Colorectal Polyps

Summary: this was a non-inferiority randomized controlled trial designed to compare the efficacy and safety of cold versus hot snare polypectomy for the removal of 4-10 mm pedunculated colorectal polyps. the primary outcome was delayed postpolypectomy bleeding. the secondary outcomes included immediate postpolypectomy bleeding, procedure time, en bloc resection, complete histologic resection, use of haemostatic clips and perforation rate.


Eligibility criteria:
inclusion criteria: 1. 18-80 years old, male and female 2. proposed colonoscopy and colonoscopy detection of at least one 4-10 mm pedunculated colorectal polyp exclusion criteria: 1. contraindication to colonoscopy or polypectomy 2. use of antiplatelet or anticoagulant drugs within 1 week before polypectomy 3. alarming signs and symptoms of colorectal cancer (blood in stool, black stool, unexplained anaemia and weight loss, abdominal mass, positive rectal examination; or imaging and laboratory tests highly suspicious for colorectal cancer) or endoscopic manifestations of polyps highly suspicious for high-grade intraepithelial neoplasia or carcinoma 4. comorbidity with inflammatory bowel disease, colonic polyposis, or active gastrointestinal bleeding 5. inadequate bowel preparation 6. pregnant or lactating women 7. failure to sign the informed consent form 8. patients deemed ineligible by investigators to enrol in the trial
a long-term survival analysis of different surgical method in early hepatocellular carcinoma

Conditions: Long-term Effects of Cancer Treatment

Summary: the investigators established three prospective cohorts of patients with bclc stage 0-a hcc, based on different surgical approaches (open, laparoscopic and robotic). after 5 years of follow-up, the investigators used propensity score matching (psm) to reduce selection bias and then compared the long-term oncological outcomes of the three different surgical approaches, which might provide high-level evidence in non-randomized observational studies.

in this study, three prospective cohorts of patients with bclc stage 0-a hcc, underwent complete liver resection using different surgical approaches (olr, llr, and ralr), were established. after adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (psm) analysis.

Eligibility criteria:
inclusion criteria: * all hcc patients in bclc stage 0-a underwent liver resection in hepatic surgery center, tongji hospital, tongji medical college, huazhong university of science and technology. the inclusion criteria were as follows: 14- 75 years old exclusion criteria: * with any history of malignant tumors; with treatment of ablation, tace or tki history before liver resection.
assessing patient confidence in biologic medications

Conditions: Psoriasis

Summary: in dermatology, biologic medications are used to treat conditions such as moderate-to-severe psoriasis. these medications generally function to decrease inflammation or disrupt the inflammatory cycle. examples of biologic medications commonly used in dermatology include tumor necrosis factor-alpha (tnf-alpha), blockers/inhibitors (etanercept, infliximab, certolizumab pegol, golimumab), interleukin 12/23 blockers (ustekinumab) and interleukin 17a blockers (secukinumab, ixekizumab). due to biologic medication's efficacy and safety profiles, they have revolutionized dermatology and the general medical field. however, patients may be apprehensive about choosing a biologic medication for a variety of reasons. these include hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media. many patients are not aware that clinical trial evidence for biologics exist, and instead may rely on anecdotal evidence in choosing to take these medications. because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. physicians must be able to ascertain from where the fear originates and how it can be countered. by understanding what kind of information will allow patients to be confident in their decision to take a biologic, dermatologists can improve outcomes and initiate use of this drug. furthermore, reducing fear of side effects or adverse events may improve adherence to treatment and may improve treatment outcomes. the investigators propose this study with the goal of learning whether patients are more confident in the potential success of biologic medications in treating their psoriasis after being presented with clinical trial evidence, anecdotal evidence, or both.


Eligibility criteria:
inclusion criteria: * diagnosed with psoriasis (icd-9: 696.1) * age 18-80 exclusion criteria: * individuals younger than 18 (line of questioning necessary for the study may be beyond understanding in this age group) * currently or previously managed with a biologic medication

Keywords: decision making
64cu-sar-bispsma positron emission tomography: a phase 3 study of participants with biochemical recurrence of prostate cancer

Conditions: Prostate Cancer; Prostate Cancer Patients With Detectable PSA Following Prostatectomy; Prostate Cancer Recurrent; Prostate Cancer Patients Who Have Brachytherapy Seed Implant; Prostate Cancer Patients Treated by Radiotherapy; Cryotherapy

Summary: the aim for this study is to investigate the ability of 64cu-sar-bispsma pet/ct to detect recurrence of prostate cancer


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age. 2. signed informed consent. 3. life expectancy ≥ 6 months as determined by the investigator. 4. histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy. 5. participant potentially eligible for salvage therapy with curative intent. 6. psa level after definitive therapy: 1. post-radical prostatectomy: detectable or rising psa that is ≥ 0.2 ng/ml with a confirmatory psa ≥ 0.2 ng/ml (per aua recommendation) or 2. post-radiation therapy, cryotherapy, or brachytherapy: increase in psa level that is elevated by ≥ 2 ng/ml above the nadir (per astro-phoenix consensus definition). 7. participant willing to undergo biopsy of a 64cu-sar-bispsma pet-positive lesion for histological confirmation of pc, where this is safe and feasible. 8. an eastern cooperative oncology performance status of 0-2. exclusion criteria: 1. participants who received investigational agent within 5 biological half-lives prior to day 1. 2. participants administered any high energy (\>300 kev) gamma-emitting radioisotope within 5 physical half-lives prior to day 1. 3. previous systemic therapy for pc (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy). 4. ongoing treatment or treatment within 6 months of day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for pc. 5. known or expected hypersensitivity to 64cu-sar-bispsma or any of its components. 6. any serious medical condition or extenuating circumstance (including receiving the investigational product or not capable of having a pet scan) which the investigator feels may interfere with the procedures or evaluations of the study.

Keywords: prostate cancer prostate biochemical recurrence
hepcidin and glucose metabolism

Conditions: Iron Deficiency Anemia of Pregnancy; Iron Metabolism Disorders; Glucose Intolerance; Gestational Diabetes

Summary: gestational diabetes mellitus (gdm), defined as hyperglycemia with blood glucose values above normal but below those diagnostic of dm, and iron deficiency (id) with or without anemia (ida) are common during pregnancy. both disease patterns are associated with an increased risk of complications during pregnancy and at delivery and may have a variety of negative effects on different aspects of child development. thus, gdm and id/ida during pregnancy should be prevented. whether iron supplementation with high oral doses acutely increases hepcidin during pregnancy, and whether this acute iron-induced increase in hepcidin decreases insulin sensitivity, is uncertain.


Eligibility criteria:
inclusion criteria: * week of pregnancy 24-28 * pre-pregnancy bmi \<27.5kg/m2 * singleton pregnancy * hb \> 8.0 g/dl willing to either: * not take any iron supplements for 14 days (however, participants will receive a similar amount of total iron during the 4 study days that they would normally receive over 14 days) or * to take the multivitamin "burgerstein schwangerschaft and stillzeit" supplements over the 14 days (contains 30 mg iron) exclusion criteria: * iron infusion within the past 6 months * severely anemic hb\<8.0g/dl * acute or chronic disease * long-term medication * medical problems known to affect iron homeostasis * smoking
achieving self-directed integrated cancer aftercare (asica) in melanoma

Conditions: Melanoma

Summary: the asica study is looking at how the uk national health service (nhs) might use technology in the future to more effectively support people who have been treated for melanoma.

all patients who have been treated for melanoma are advised to regularly examine their own skin (total-skin-self-examinations; tsse) but research has found that many people are not shown how to do this effectively. we are investigating whether a digital app we have developed (asica) can help people with melanoma to use a hand-held tablet computer to do more regular and effective tsse, and whether this would lead to earlier detection of recurrent and new primary melanomas. the asica app also uses the internet to enable people to electronically communicate the findings of their tsse to a specialist nurse. all those who consent to take part in the study will be randomly allocated into one of two groups. one group will use the asica app in addition to their normal follow-up, the other group will continue to attend their routine melanoma follow-up only. participants will be recruited from two uk sites - nhs grampian and cambridge university hospitals.

Eligibility criteria:
inclusion criteria: * adult (≥18) * patients treated for stage 0-2c cutaneous melanoma within the preceding 24 months exclusion criteria: * stage 3 and 4 melanoma. * previous local recurrence of melanoma within last 24 months. * patients who are unable to consent and/or complete questionnaires (e.g. due to cognitive or language issues). * patients who are blind or visually impaired.
neural and antidepressant effects of propofol

Conditions: Treatment Resistant Depression

Summary: this study will compare the antidepressant effects of propofol at two different doses while measuring potential treatment-related biomarkers.

aim 1: compare the clinical antidepressant effects of high-dose versus low-dose propofol. aim 2: characterize the dose-dependent effects of propofol on brain function and gene expression

Eligibility criteria:
inclusion criteria: age 18-55 years diagnosis of major depressive disorder or bipolar disorder current moderate-to-severe depressive episode episode duration more than 2 months and less than 5 years failure of at least 2 adequate antidepressant medication trials within the past 2 years 16-item quick inventory of depressive symptomatology, self-rated (qids) \> 10 24-item hamilton depression rating scale (hdrs) \> 18 exclusion criteria: contraindication to propofol, egg lecithin, soybean oil, or other study drugs lifetime history of a serious suicide attempt(gvion and levi-belz, 2018) recent suicidal behavior(past 3 months) body mass index \> 40 kg/m2 daily use of benzodiazepine, opioid, ace inhibitor, or arb medication symptomatic coronary artery disease or heart failure poorly controlled hypertension or diabetes abnormal kidney or liver function pregnant or breast feeding traumatic brain injury or significant neurologic signs (past year) substance use disorder, moderate-to-severe(past 3 months) obsessive compulsive disorder (past month) post-traumatic stress disorder (past month) schizophrenia-spectrum disorder (lifetime) neurocognitive disorder (past year) personality disorder as a current focus of treatment ect within the past 3months inappropriate for ect, or poor response to ect within the past 5 years incompetent to provide consent
optimizing transcranial direct current stimulation for motor recovery from hemiparesis

Conditions: Stroke; Cerebrovascular Accident

Summary: this study will compare the effectiveness of different polarities of transcranial direct current stimulation paired with intensive motor training in recovery of upper extremity function in individuals with severe post-stroke hemiparesis. the hypothesis is that more severely impaired individuals will derive greater benefit from anodal stimulation of the ipsilesional hemisphere or cathodal stimulation of the contralesional hemisphere than dual stimulation (anodal applied to the ipsilesional hemisphere and cathodal applied to the contralesional hemisphere.)

this study has 2 aims: 1) determine which transcranial direct current stimulation (tdcs) electrode configuration is most effective in combination with motor training to promote motor recovery from severe post-stroke hemiparesis; and 2) begin to clarify the extent to which baseline transcranial magnetic stimulation (tms) measures predict response to tdcs, as well as the effects of tdcs paired with motor training on tms measures of motor cortical organization. to accomplish these aims, the investigators will recruit 36 human subjects with severe post-stroke hemiparesis and assign each subject to 1 of 4 tdcs conditions (anodal excitatory ipsilesional; cathodal inhibitory contralesional; a combination of anodal excitatory ipsilesional during cathodal inhibitory contralesional; or sham). each subject will undergo a 20-minute stimulation session once a day for 10 days over a 2-week period. each session will be followed by 3 hours of intensive, task-oriented upper extremity motor training. outcome measures for this study include tms motor cortical maps and standardized tests of motor performance. the investigators hypothesize that all groups will show improvement in all measures; however, both the anodal excitatory ipsilesional group and the cathodal inhibitory contralesional group will show significantly greater improvement compared with the other 2 groups. the investigators will also find evidence clarifying whether the presence or absence of motor-evoked potentials (meps) has predictive value regarding which tdcs configuration would be most effective for a particular subject.

Eligibility criteria:
inclusion criteria: * chronic stroke patients * single stroke * chronic (more than 12 months after from stroke) * at least 18 years old, but there is no upper age range for this project. * participants not able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°. exclusion criteria: * history of head injury with loss of consciousness, seizure, severe alcohol or drug abuse, psychiatric illness * within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery * cognitive deficit severe enough to preclude informed consent * positive pregnancy test or being of childbearing age and not using appropriate contraception * participants with history of untreated depression.

Keywords: motor recovery neuroplasticity chronic human noninvasive brain stimulation neuromodulation