Kornimate/medical-research-clean huggingface dataset:
the effects of animal assisted therapy in outpatient psychiatry clinics

Conditions: Anxiety; Depression; Psychiatric or Mood Diseases or Conditions

Summary: this study will examine whether a session of animal-assisted therapy reduces anxiety levels and improves long-term clinical outcomes of outpatient psychiatric patients in regard to their generalized anxiety disorder (gad-7), patient health questionnaire (phq-9 - depression assessment), three item loneliness scale (til), and mean arterial blood pressure.

previous research regarding the value and benefits of animal-assisted therapy (aat) has often been focused on outcomes within in-patient settings. one project showed that aats may offer a decrease in agitated behaviors and an increase in social interactions in people with dementia. prior research shows a reduction in anxiety when interacting with dogs. these reductions were seen in acutely schizophrenic patients, and general in-patient psychiatric patients. however, prior research has often relied on more obscure assessments that do not offer the validity and reliability seen with the patient health questionnaire (phq-9) and the generalized anxiety disorder scale (gad-7). physiological responses have also been measured and show a reduction in blood pressure, norepinephrine, and epinephrine levels within hospitalized patients interacting with aats. quality of life and happiness have been shown to improve with the presence of animals. loneliness has been shown to decrease amongst older adults interacting with aats once per week. no difference was seen between people interacting with a dog 3 times per week versus once per week, which lends support to the value of a research project where patients may only interact with an aat once per week. other publications regarding aats focused on the theoretical value and discuss how hypothetically the aats may be beneficial to patients and their perceived loneliness, stress, anxiety, interactions with others, and depression. these projects offer strong suggestions on future research projects regarding the value of aat. the prior research is encouraging to the idea that aats may be beneficial in out-patient settings to psychiatrists working with depression and anxiety. given these prior publications, a desire for further evidence and a project validated by commonly used psychiatry assessments is proposed here.

Eligibility criteria:
inclusion criteria: * outpatient psychiatric patients of dr. matt kern who meet the criteria to be diagnosed with major depressive disorder and/or generalized anxiety disorder via patient health questionnaire (phq-9) and/or general anxiety disorder (gad-7) exclusion criteria: * prior history of animal related trauma * participants that require psychiatric hospitalization during the experiment will have their information excluded from analysis * participants who have changes made to any hypertension / blood pressure medications during the experiment will have their blood pressure measurements removed from final analysis

Keywords: animal assisted therapy loneliness depression anxiety
systemic inflammation versus acute pain in total knee arthroplasty (tka)

Conditions: Other Acute Postoperative Pain; Systemic Inflammatory Response Syndrome

Summary: in this study we evaluate if there is a correlation between acute pain and systemic inflammatory markers after total knee arthroplasty (tka).

the correlation between acute pain and systemic inflammatory markers after total knee arthroplasty (tka) is evaluated. level of systemic inflammatory markers (crp and il6) are measured preoperatively and 4 and 24 hours postoperatively. these measurements are correlated to postoperative pain (a detailed assessment of pain at rest and during ambulation). we pole blood-samples collected prospectively (from two data set)

Eligibility criteria:
inclusion criteria: * elective unilateral primary total knee arthroplasty * able to speak and understand danish * able to give informed consent exclusion criteria: * alcohol or medical abuse * allergies to local anesthetics or methylprednisolone * age \< 18 years old * daily use of strong opioids or glucocorticoids * pregnancy or breastfeeding (fertile women) * bilateral / revision arthroplasty * dementia or other cognitive dysfunction * diabetic neuropathy, rheumatoid arthritis, and neurologic or psychiatric diseases potentially influencing pain perception

Keywords: acute postoperative pain systemic inflammation crp il6
efficacy and safety of mp-424, peginterferon alfa-2b and ribavirin in chronic hepatitis c who have not achieved an undetectable hcv rna level with previous interferon based therapy

Conditions: Hepatitis C

Summary: this study will evaluate the efficacy and safety of mp-424 with peginterferon alfa-2b and rbv in patients with (genotype 1) hepatitis c, who did not respond to previous treatment.


Eligibility criteria:
inclusion criteria: * genotype 1, chronic hepatitis c * non-responders (patient who did not respond to previous treatment) * able and willing to follow contraception requirements exclusion criteria: * cirrhosis of the liver or hepatic failure * hepatitis b surface antigen-positive or hiv antibodies-positive * history of, or concurrent hepatocellular carcinoma * history of, or concurrent depression, schizophrenia; or suicide attempt in the past * pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
preemptive and precise intervention for ckd-shpt

Conditions: Hyperparathyroidism; Secondary, Renal

Summary: through multi-center randomized controlled trial studies on preemptive surgical intervention in patients with chronic kidney disease (ckd) - secondary hyperparathyroidism (shpt), to precisely evaluate the safety and effectiveness during perioperative period, and the long-term outcomes by 1-year follow-up. the follow-ups include the evaluation of the overall quality of life, calcium and phosphorus metabolism, hyperparathyroidism level, vitamin d metabolism, bone mineral density, soft tissue and vascular calcification.


Eligibility criteria:
inclusion criteria: * 1) chronic kidney disease stage 3-5d patients aged ≥18 years; * 2) the diagnosis is consistent with ckd-metabolic bone disease and shpt after evaluation by a kidney specialist; * 3) sustained blood immunoreactive parathyroid hormone level of \> 300ng/ml, and had received drug treatment; * 4) persistent hypercalcemia and/or hyperphosphatemia that is not responding to medication; * 5) imaging suggested evidence of at least one parathyroid nodular hyperplasia; * 6) signed the informed consent. exclusion criteria: * 1) age \<18 years old; * 2) patients with dialysis duration \< 3 months, or with other unstable dialysis state; * 3) kidney transplant patients; * 4) who is considered inappropriate to participate in this study after evaluation by the supervising physician.
comparison of hypertonic saline and mannitol on brain relaxation during supratentorial tumors resection

Conditions: Brain Tumor - Metastatic; Brain Tumor, Adult: Glioblastoma

Summary: hyperosmotic agents are used to decrease intracranial pressure. the aim of the study is to compare the effects of continuous 3% hypertonic saline (hs), bolus hs and 20% mannitol on intraoperative brain relaxation in patients with raised intracranial pressure during surgery for supratentorial tumors.

after obtaining approval from the ethics committee and informed consent, a total of 90 patients aged 18-70 years, conscious (gcs\>13) and american society of anesthesiologists (asa) class i-iii, who had intracranial shift \>0.5 cm or glioblastoma multiforme or metastatic tumor and who were scheduled for supratentorial mass resection under elective conditions, will be included in the present prospective, randomized, double-blind and placebo-controlled study. patients with heart failure, kidney insufficiency, diabetes insipidus, electrolyte imbalance and who are unconscious will be excluded from the study. the patients will randomized into 3 groups: group 1: %3 hs bolus 3 ml.kg-1 group 2: %3 hs infusion 20 ml/h group 3: %20 mannitol 0,6 gr.kg-1 after head fixation, all patients will be administered with hs or mannitol (over 20 minutes). arterial blood gas (abg) analysis (cobas b 221 blood gas analyzer, roche®, basel, switzerland) will be made at 30 minute,2,4,6,8. hours. blood sodium, potassium, chlorine, base excess, lactate levels and blood osmolarity will be recorded in each time intervals. the brain relaxation scale will be recorded at the time of dura opening.

Eligibility criteria:
inclusion criteria: * elective supratentorial tumor resection * glioblastoma multiforme * metastatic tumor * intracranial shift \>0.5 cm * gcs\>13 exclusion criteria: * renal failure * heart failure * electrolyte imbalance

Keywords: hypertonic saline, mannitol, supratentorial brain tumor
assessing and promoting resilience in patients with adult congenital heart disease

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to evaluate the feasibility and preliminary efficacy of the promoting resilience in stress management (prism) intervention in patients with adult congenital heart disease.

after consent is obtained, eligible patients (moderate or complex achd, stages b, c, or d) will complete the baseline study measures assessment and be randomized to receive prism or usual care (anticipated n=86, 43 per group). patients in the intervention group will participate in the six prism sessions over 3 months. at 3 months following enrollment, patients in both groups will again complete study measures. we will define feasibility as a) the proportion of eligible patients who enroll and b) the proportion of patients who complete the intervention among those randomized to intervention. we will define preliminary efficacy as the change in mean resilience from baseline to 3 months after randomization between those randomized to intervention and usual care. exploratory analyses will examine prism's impact on patient-centered outcomes of quality of life, symptoms of anxiety and depression, and perceived competence for health care.

Eligibility criteria:
inclusion criteria: * adults with moderate or complex achd, stages b, c, or d as defined by the 2018 achd guidelines * receive care in our health system exclusion criteria: * diagnosis of another life-limiting illness * inability to participate in study activities independently and in english

Keywords: resilience adult congenital heart disease stress management advance care planning
pilot study to evaluate a novel gastric space occupying device

Conditions: Obesity

Summary: this will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. no formal hypothesis testing will be conducted.


Eligibility criteria:
inclusion criteria: 1. age between 21-64 years 2. bmi 27-40 kg/m2 3. no history of weight reduction of more than 5% of total body weight in the past 6 months exclusion criteria: 1. have unstable angina, myocardial infarction within the past year, or heart disease classified within the new york heart association's class iii or iv functional capacity; 2. be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure; 3. be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months; 4. have type 1 diabetes or type 2 diabetes requiring oral medications or insulin; 5. history or symptoms of thyroid disease which is not controlled by medication; 6. have severe renal, hepatic, pulmonary disease or cancer; 7. past history of gastrointestinal surgery (excluding uncomplicated appendectomy); 8. have a history of adhesive peritonitis; 9. history or symptoms of esophageal and/or gastric varices; 10. have history or congenital or acquired gi anomalies (e.g. atresias, stricture, and /or diverticula); 11. history or symptoms of inflammatory bowel disease, such as chron's disease; 12. history of/ signs and /or symptoms of duodenal or gastric ulcer; 13. have gastroparesis; 14. pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential); 15. currently using pharmaceutical agents for weight loss;
medtronic adapta, versa and sensia new3 post approval study

Conditions: Arrhythmia; Bradycardia

Summary: the primary purpose of this study is to assess the long term reliability of the medtronic adapta®/sensia™/versa™ platform of devices. this study is required by fda as a condition of approval of new3 devices. patients will be followed for 5 years after implant. this study utilizes data collected from the system longevity study (sls).

the rate of device malfunctions will be determined and a comparison to historical controls will be done.

Eligibility criteria:
inclusion criteria: * subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's irb/mec/reb. and one of the following must also apply: * subjects indicated for implant or within six months post-implant of a medtronic market-released lead connected to a medtronic adapta®, sensia™, or versa™ ipg. the medtronic lead must be used for pacing, sensing or defibrillation application. * subjects who participated in a qualifying study (ide) of a medtronic cardiac therapy product and: 1) have a medtronic adapta®, sensia™, or versa™ ipg 2)product is market-released 3) complete implant and follow-up data, including product-related adverse events are available and 4) subject of appropriate legal guardian authorizes release of subject study data to sls * subjects implanted with a medtronic adapta®, sensia™, or versa™ ipg and medtronic capsure epi leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. exclusion criteria: * subjects who are, or will be inaccessible for follow-up at a sls center * subjects with exclusion criteria required by local law (emea only) * subjects receiving an implant of a medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant * subjects implanted with a medtronic device whose predetermined enrollment limit for that specific product has been exceeded

Keywords: pacemaker
hypofractionated radiation therapy for patients with breast cancer receiving regional nodal irradiation

Conditions: Breast Cancer

Summary: the primary objective of this study is to document lymphedema rates in patients requiring regional nodal irradiation (rni) who receive hypofractionated radiation as compared to conventional radiation.

participants with stage ii or stage iii node-positive breast cancer, or t3n0 node-negative will receive hypofractionated radiation for 4 weeks. we hypothesize that patients receiving a shorter course of radiation will have reduced lymphedema. lymphedema is diagnosed when the patient's arm circumference measures 10% or more as compared to pre-treatment (baseline) arm circumference measurement. secondary endpoints will address the effectiveness, quality of life, and side effect profile of a shortened course of treatment.

Eligibility criteria:
inclusion criteria: * karnofsky performance status 50% - 100% * diagnosis of stage ii or iii node-positive breast cancer (note: stages include: t4a-cnany, t3n1, txn2.) or t3n0 node-negative breast cancer. * for patients with txn1 disease, one of the following criteria must be met: grade 3; ≤ 45 years of age at time of screening for this study; extensive lymphovascular space invasion (lvsi); 3 lymph nodes positive; hormone-negative disease; positive lymph nodes after chemotherapy; or extracapsular extension * prior surgery and chemotherapy allowed, no prior radiation to the target area (breast or chest and nodes). note: radiation should occur 3-12 weeks after last chemotherapy or surgery, whichever comes last. * women of child-bearing potential (wocp) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. exclusion criteria: * diagnosis of inflammatory breast cancer * previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more) * diagnosis of scleroderma * diagnosis of lupus * diagnosis of active dermatomyositis * diagnosis of metastatic disease * pregnant or nursing
hypotension prediction index in postoperative surgical patients

Conditions: Surgery

Summary: pacu-hpi study evaluates the use of a hemodynamic monitor in the post-anesthetic recovery room on patients undergoing colorectal, hepatobiliary, and vascular surgery, to determine the feasibility of recruiting this surgical population.

postoperative vascular complications, including myocardial infarction (mi), myocardial injury after noncardiac surgery (mins), stroke, and death occur in up to 18% of surgical patients.1 hypotension is a frequent occurrence in the postoperative period and can increase the risk of postoperative vascular complications.2 therefore, accurate prediction of postoperative hypotension can identify patients at risk for postoperative vascular complications who would benefit from early intervention. the investigators propose a feasibility study to determine the accuracy of the hypotension prediction index (hpi) parameter of the hemosphere monitor and acumen iq sensor (edwards lifesciences, irvine, ca) to predict postoperative hypotension in surgical patients.

Eligibility criteria:
inclusion criteria: 1. patient ≥45 years old 2. will undergo open colorectal, hepatobiliary, or vascular surgery; 3. is expected to have an arterial cannula inserted intraoperatively; 4. has an anticipated stay in pacu for at least 2 hours; 5. able to provide written informed consent exclusion criteria: 1. planned admission to icu; 2. refusal to participate; 3. previously enrolled in the study
the effects of dehydration on the performance of judoka

Conditions: Dehydration

Summary: dehydration is a common phenomenon in judo that can lead to negative performance such as a decline in strength, a decline in anaerobic performance, a reduced body fluid balance, glycogen depletion and worsened psychological parameters. therefore, we want to simulate several judo combats and look at the performances whether they change during a competition day. we also want to see if the results are different in a dehydrated versus euhydrated state.


Eligibility criteria:
inclusion criteria: * judoka * minimum 18 years * men and women * only dehydration: sauna, warm bath, sweat suit exclusion criteria: * injured * sick * not underaged (18 years)
a proof-of-concept trial to evaluate the safety and efficacy of ub-421 plus chidamide in changing hiv reservoirs

Conditions: HIV-1 Infection

Summary: this is a phase ii proof-of-concept trial study to assess the safety and efficacy of ub-421 monotherapy plus chidamide in changing the latent hiv reservoir among art-treated hiv-1 adults with stably viral suppression who undergo art interruption.


Eligibility criteria:
inclusion criteria: 1. hiv-1 sero-positive, with documented hiv-1 infection by official, signed, written history 2. male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 20 years or older. 3. no breastfeeding or pregnancy for women. 4. have been receiving art for more than 3 years by screening visit 1 (sv1). 5. both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception 6. subjects must sign the informed consent before undergoing any study procedures. exclusion criteria: 1. subjects with active systemic infections, except for hiv-1 2. any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug. 3. current receiving treatment regimen for hepatitis b, hepatitis c or latent tuberculosis 4. any alcohol or illicit drug use 5. receipt of any other investigational study agent(s) within 90 days before sv2. 6. currently on the treatment for diabetes.
systematic review and meta-analysis on dcb vs. poba in de-novo femoropopliteal disease

Conditions: Peripheral Arterial Disease; Intermittent Claudication

Summary: restenosis is still an issue after endovascular revascularization for femoropopliteal occlusive disease. one approach to reduce the rates of restenosis and reintervention is local application of paclitaxel with drug-coated balloon angioplasty. the purpose is to conduct a systematic review and meta-analysis of randomized-controlled trials comparing on drug-coated balloon angioplasty (dcb) vs. plain old balloon angioplasty (poba) in de-novo femoropopliteal disease.

peripheral arterial disease is the third leading entity of atherosclerosis. the femoropopliteal segment is affected in most patients. endovascular revascularisation is one possible treatment option, but high rates of restenosis, especially in complex lesions, are a limiting factor. bare-metal stents failed to show a long-term superiority in a cochrane systematic review. another approach to prevent restenosis is local delivery of an antiproliferative drug (e.g. paclitaxel) via drug-coated balloon angioplasty. new studies did report their results since the publication of earlier meta-analyses. it's time for an up-to-date systematic review. prior systematic reviews did not address risk of bias nor did they take differences in treatment strategy despite the used balloon catheter into consideration.some previous reviews did compare results from different points in time, e.g. analysis of 6 months' results together with 24 months' results.

Eligibility criteria:
inclusion criteria: * randomized controlled trials * dcb vs. poba * focus on de-novo femoropopliteal lesions * registration in a clinical trials registry * available study protocol (either in clinical trial registry or published) exclusion criteria: * non-randomized controlled trials * focus on below-the-knee interventions * focus on iliac artery interventions * focus on treatment of critical limb ischemia * focus on treatment of in-stent restenosis * usage of additional devices except for bare-metal stent (e.g. atherectomy)

Keywords: drug-coated balloon angioplasty angioplasty plain old balloon angioplasty peripheral arterial disease intermittent claudication systematic review meta-analysis paclitaxel