Kornimate/medical-research-clean huggingface dataset:
can lifestyle changes reverse early-stage alzheimer's disease

Conditions: Alzheimer Disease

Summary: the objective of this study is to determine if comprehensive lifestyle changes may slow, stop, or reverse the progression of early-stage alzheimer's disease.

51 patients who have early alzheimer's disease (moca above 17) in the san francisco bay area were enrolled over time and are randomly assigned to one of two groups. after baseline testing, the first group then receives this lifestyle medicine program for 20 weeks, four hours/day, three days/week (all done virtually via zoom since march 2020 due to covid-19). the second group will not receive the lifestyle program for 20 weeks and will serve as a randomized control group during this phase of the study. both groups will be re-tested after 20 weeks. then, the second group will "cross over" and receive this lifestyle medicine program for 20 weeks and the first group will continue the lifestyle program for 20 additional weeks. after a total of 40 weeks, both groups will be re-tested again and compared. those initially randomly assigned to the control group will receive the intervention for 40 weeks and then be re-tested at that time.

Eligibility criteria:
inclusion criteria: * current diagnosis of mild dementia or mild cognitive impairment due to alzheimer's disease/process (mckhann and albert criteria), with moca score above 17 (i.e., 18 or higher) * willingness and ability to participate in all aspects of the intervention * availability of spouse or caregiver who can provide collateral information and assist with study adherence exclusion criteria: * severe dementia * physical disability that precludes regular exercise * clear evidence for other causes of neurodegeneration or dementia, e.g., severe cerebrovascular disease, parkinson's disease * significant ongoing psychiatric or substance abuse problems

Keywords: mild cognitive impairment
a study to evaluate the safety, tolerability, immunogenicity, and lot consistency of v116 in adults 18 to 49 years of age (v116-004, stride-4)

Conditions: Pneumococcal Disease

Summary: this study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (v116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. the primary study hypothesis is that all 3 lots of v116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (opa) geometric mean titers (gmts) at 30 days postvaccination for all serotypes included in v116.


Eligibility criteria:
the key inclusion and exclusion criteria include but are not limited to the following: inclusion criteria: * has underlying chronic conditions but assessed to be stable as per investigator * has ability to complete electronic vaccine report card (evrc) data collection without assistance as per investigator exclusion criteria: * has a history of invasive pneumococcal disease (ipd) or other culture-positive pneumococcal disease ≤3 years before visit 1 (day 1) * has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease * has a coagulation disorder contraindicating intramuscular vaccination * has a recent illness with fever * has a known malignancy that is progressing or has required active treatment \<3 years before enrollment * is expected to receive any pneumococcal vaccine during the study outside of the protocol * has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥14 days before receipt of study vaccine * is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease * has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine * has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine * has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine
multicenter registry study of aortic valve stenosis in zhejiang elderly（mrs avs）

Conditions: Valvular Heart Disease

Summary: aortic valve stenosis (avs) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. however, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as china etc. because of the slow and progressive nature of avs, symptoms might not be too severe to be diagnosed on time. our retrospective survey (int j cardiol. 2016 nov 25) indicated that severe aortic valve stenosis are very common in china. hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of chinese elderly patients with aortic valve stenosis.


Eligibility criteria:
inclusion criteria: 1. patients over 60 years old meet the following condition moderate or above aortic stenosis as defined by echocardiography: aortic stenosis, moderate or above, or valve area≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient≥20mmhg exclusion criteria: 1. patients cannot be followed up for any reasons. 2. patients in critical condition may be die in one year. 3. patients have been enrolled in this study.
evaluating the risk of cognitive impairment after surgical and transcatheter aortic valve replacement

Conditions: Cardiovascular Disease; Aortic Valve Stenosis; Cognitive Assessments; Valve Surgery; Transcatheter Valve Replacement; Surgical Valve Replacement

Summary: the investigators are conducting a pilot study to compare cognitive outcomes among veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.

the investigators are conducting a pilot study to compare cognitive outcomes in up to 60 veterans with severe aortic valve stenosis who are scheduled to undergo either transcatheter aortic valve replacement (tavr) or surgical aortic valve replacement (savr) at the minneapolis va health care system. participants will be administered a short battery of cognitive tests before and three months after tavr or savr over/up to a two year study period.

Eligibility criteria:
inclusion criteria: * severe aortic stenosis (ava: 1 cm2 and/or mean gradient =or \> 40 mmhg and/or peak velocity \> 4 m/s) * scheduled to undergo either surgical or transcatheter aortic valve replacement at the minneapolis va health care system exclusion criteria: * severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures) * unable or unwilling to provide informed consent
effect of milnacipran on pain processing and functional magnetic resonance imaging (fmri) activation patterns in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia defined by 1990 american college of rheumatology (acr) criteria * visual analog pain score between 40 and 90 mm * right-hand dominance exclusion criteria: * suicidal risk * substance abuse * pulmonary dysfunction * renal impairment * active cardiac disease * autoimmune disease * uncontrolled narrow-angle glaucoma * active liver disease * cancer * active peptic ulcer disease or a history of inflammatory bowel disease or celiac sprue * unstable endocrine disease * prostatic enlargement

Keywords: fibromyalgia milnacipran forest laboratories
biofeedback in pediatric inflammatory bowel disease

Conditions: IBD

Summary: this prospective, randomized, longitudinal, controlled project will occur in two phases. phase 1 is the pre-diagnosis data collection for treatment-naïve participants who are referred for a diagnostic endoscopy/colonoscopy due to suspicion of ibd. phase 2 (rct) is only for patients who are diagnosed with ibd. these patients will be randomized to receive biofeedback intervention daily for 8 weeks or no biofeedback intervention. all participants will receive physician directed standard of care treatment.

the inflammatory bowel diseases (ibd), which include crohn's disease (cd) and ulcerative colitis (uc), affects 3 million americans. in approximately 25-30% of patients, onset of these chronic diseases occurs prior to the age of 20. despite medical advances in new therapies, the clinical remission rate on biologics is less than 50% and a significant number of patients will lose response to anti-tnf therapy over time. in addition, patients that require a change in therapy will have a lower response rate to a different biologic. additional therapies and mechanisms that affect disease activity need to be investigated to identify complimentary treatments that can further impact remission rates without increasing side effects such as lymphoma. environmental factors, such as stressor exposure, can exacerbate mucosal inflammation. patients with ibd report a lower quality of life, as well as increased anxiety and depression. psychological interventions may improve disease activity. this study will test, using a randomized clinical trial (rct) design, whether biofeedback intervention will attenuate disease activity. if efficacious, this study will provide a rationale for establishing biofeedback as a complimentary therapy to standard of care to ameliorate stress-induced increases in chronic inflammation.

Eligibility criteria:
inclusion criteria: the inclusion criteria for phase 1 are: 1. age 8-17 years 2. referred for a diagnostic colonoscopy with strong clinical concern for ibd 3. live within a 2 hour drive of nch there is one additional inclusion criterion for phase 2: 1. patients have been diagnosed with ibd exclusion criteria: 1. participants are excluded if they have a comorbid chronic illness, perianal disease, current corticosteroid treatment, taking antibiotics within the last 3 months, psychological disorders that they are undergoing treatment or taking medication for at that time, or undergoing psychological treatments such as cognitive behavioral therapy, mindfulness, or biofeedback therapy at the time of enrollment. 2. age and language are limited by the demands of the study (questionnaire completion)

Keywords: biofeedback pediatric
evaluation of a self-care toolkit in surgical breast cancer patients

Conditions: Anxiety; Pain; Nausea; Fatigue; Sleep Disturbance

Summary: this randomized controlled trial (rct) in newly-diagnosed breast cancer patients seeks to determine the effectiveness of a self-care toolkit on specific symptoms associated with surgery as compared to a standard care group.

the main research questions focus on whether the toolkit provides short-term benefits on symptoms associated with surgery (i.e., pain, anxiety, nausea) and whether it impacts emotional distress and other symptoms (i.e., pain, fatigue, sleep disturbance, global health, quality of life) at a two-week post-operative time point. this study will be conducted at san antonio military medical center (sammc) in active duty, veteran, and military dependent women newly diagnosed with breast cancer for whom surgery (e.g., lumpectomy or mastectomy) is the initial treatment option. one to two weeks prior to surgery, women diagnosed with breast cancer at sammc oncology department will be invited to participate in this study. those who meet criteria and agree to participate will be enrolled on-study and randomly assigned to either the surgical toolkit group or standard care group. during the pre-operative period, women in the intervention group will be asked to read through the manual, listen to each of the 8 audiofiles at least once but as many times as desired, and to wear the acupressure wristbands during surgery. women randomized to the standard care group will not receive an intervention prior to surgery but will receive the toolkit at study completion. the rationale for providing women in the standard care group with the toolkit at their post-operative visit is that the skills of breathing, meditation, and guided imagery might be potentially beneficial for them to use during their subsequent treatment or a future surgery. additionally, qualitative interviews will be conducted in a cohort of women from the intervention group, at a two-week post-operative time point to assess their impressions and satisfaction with the toolkit; questions will focus on whether the individual used each of the toolkit's components, frequency of use, how she would rate the product's attributes (e.g., ease of use, clarity of instructions, quality rating, helpfulness), and perceptions about the helpfulness and usefulness of learned mind-body skills.

Eligibility criteria:
inclusion criteria: * 18+ years of age * women treated at sammc oncology clinic or crdamc oncology clinic for newly-diagnosed breast cancer for whom surgery (e.g., lumpectomy or mastectomy) is the initial treatment option exclusion criteria: * women receiving chemotherapy, radiation or hormone therapy as first line treatment for breast cancer (i.e., any of these treatment options prior to surgery) * severe hearing-impairment (i.e., that would interfere with ability to hear the toolkit audiofiles)

Keywords: anxiety pain nausea fatigue sleep disturbance breast cancer surgery
psa treatment with hokt3γ1 (ala-ala)

Conditions: Arthritis, Psoriatic

Summary: hokt3gamma1 (ala-ala) is a man-made antibody that is commonly used to prevent organ rejection. the purpose of this study is to determine whether hokt3gamma1 (ala-ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine.

psoriatic arthritis is a form of inflammatory arthritis that affects approximately 7% of people who have psoriasis. treatment typically include drugs such as methotrexate, azathioprine, and etanercept, which suppress the immune system in a nonspecific fashion in an attempt to control the immune responses causing the disease. in some severe cases of psoriatic arthritis, these drugs cannot adequately control the disease, often requiring patients to undergo continuous treatment to prevent or combat disease activity. hokt3gamma1 (ala-ala) is a genetically engineered monoclonal antibody directed against the cd3 antigen on t cells. hokt3gamma1 (ala-ala) specifically targets immune cells that are actively involved in destructive immune responses, such as those that cause psoriatic arthritis. in a small pilot study of eight people with psoriatic arthritis who received a 2-week course of hokt3gamma1 (ala-ala), the drug appeared safe and caused no serious side effects. this study will test the safety and efficacy of hokt3gamma1 (ala-ala) in alleviating symptoms in psoriatic arthritis patients. this study will last 2 years. individuals with psoriatic arthritis who are receiving methotrexate or azathioprine therapy and have active disease are eligible to participate. participants will be randomly assigned to receive hokt3gamma1 (ala-ala) or placebo. participants will receive a 5-day treatment with the drug or placebo every month for the first 4 months of the study. there will be 5 study visits over 2 years to assess the safety and effectiveness of hokt3gamma1 (ala-ala) and to evaluate laboratory measures related to the underlying immune problems that cause psoriatic arthritis.

Eligibility criteria:
inclusion criteria: * diagnosis of psoriatic arthritis. participants do not need to have concurrent psoriasis to participate in the study; * active inflammation in 3 or more joints; * currently receiving ongoing therapy with methotrexate or azathioprine; and * willing to use acceptable forms of contraception. exclusion criteria: * active infection with hiv, hepatitis c virus, or hepatitis b virus; * uncompensated heart failure or a recent myocardial infarction (heart attack) within the 6 months prior to study entry; * certain other serious illnesses or cancers; * participation in another clinical trial within the 6 weeks prior to study entry; or * pregnant or breastfeeding.

Keywords: psoriatic arthritis arthritis psoriasis psoriatic psa
efficacy and safety of s-adenosyl-l-methionine in treatment of chronic hepatitis b patients with cholestasis

Conditions: Hepatitis B; Cholestasis

Summary: this is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.

evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety

Eligibility criteria:
inclusion criteria: 1. from 18-65 years old 2. diagnosed as hepatitis b, previous has hbv or hbsag(+)\>6 months, and now hbsag or hbv dna(+) 3. with intrahepatic cholestasis: meet easl 2009 diagnoses criteria alp\>1.5uln and ggt\>3uln or stb\>2uln exclusion criteria: 1. liver mass, liver carcinoma 2. liver failure 3. non-hepatic diseases caused jaundice 4. obstructive jaundice

Keywords: hepatitis b cholestasis
circulating tumor dna and immunophenotyping as potential biomarkers with regional nodal irradiation for breast cancer

Conditions: Breast Cancer

Summary: this study will assess how radiation affects the patterns of circulating tumor deoxyribonucleic acid (ctdna) and immune cells (t cells) during radiation treatment in patients with breast cancer. by better understanding how radiation therapy affects these markers (characteristic that is measured to see how well the body responds to a treatment for a disease) in the blood, researchers may better customize treatments for patients with breast cancer in the future.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * histologically confirmed primary or recurrent non-metastatic invasive breast cancer with plans for adjuvant post-lumpectomy or post-mastectomy radiation therapy at the mayo clinic and indications for regional nodal irradiation. * or patients undergoing curative intent irradiation for oligometastatic breast cancer (=\< 3 sites of metastases) is permitted * willingness to provide informed consent and expresses understanding of this protocol and its requirements, risks, and discomforts * patients with non-metastatic breast cancer must have completed their final breast surgery including re-excision of margins for invasive cancer and ductal carcinoma in situ (dcis) or chemotherapy within 90 days prior to registration but no sooner than 21 days prior to the initiation of radiation therapy (rt). * bilateral breast cancer is permitted * positive or close margins is allowed exclusion criteria: * other active malignancy =\< 2 years prior to registration (exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix) * pregnancy or lactation * inability on the part of the patient to understand the informed consent to be compliant with the protocol
sexual function of trans women after vaginoplasty

Conditions: Gender Dysphoria Vaginoplasty Sexuality

Summary: genital feminine affirming surgery may be an important step for transgender women. vaginoplasty consists in the creation of external female genitalia and an operational vaginal cavity, and thus responds to major functional and aesthetic issues. different techniques are available: inversion of penile skin flap for creation of the vulva. the vaginal cavity may come from scrotal skin graft, sigmoid segment, small intestine, or peritoneal flap. vaginoplasty has a major place in the the transgender woman pathway, but the specific evaluation of long-term sexuality has not been explored so far. multicentric (lyon, fr - lille, fr - limoges, fr), prospective, observational study patients who underwent vaginoplasty or revision vaginoplasty. main objective: to assess sexuality after sex reassignment surgery in transgender women.


Eligibility criteria:
inclusion criteria: * \> 18 years old * underwent vaginoplasty or revision in lyon south hospital, lille university hospital, limoges university hospital, between january 2007 and december 2019 * penile inversion vaginoplasty with scrotal skin graft exclusion criteria: * \< 18 years old * vaginoplasty other than scrotal skin graft : intestinal segment or peritoneal flap

Keywords: genital gender affirming surgery gender dysphoria transwomen vaginoplasty sexuality satisfaction
cholecystectomy blunt dissection

Conditions: Laparoscopic Cholecystectomy

Summary: day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of calot´s. 5mm suction irrigation blunt dissection starting from the gallbladder fundus is another option. the aim is to test the hypothesis that with 5mm suction irrigation blunt dissection technique a better same day discharge and a shorter operative time can be achieved.

after initiation of general anaesthesia patients are randomized either to conventional(cautery) or 5mm suction irrigation blunt dissection group. the patients and recovery room personnel are blinded to the operative technique used.

Eligibility criteria:
inclusion criteria: * asa i-ii * bmi under 35 * normal liver enzymes * no bile duct dilatation in ultrasound * cholecystolithiasis exclusion criteria: * nsaid allergy * previous upper gi-surgery * common bile duct stones in preoperative imaging * history of severe acute pancreatitis

Keywords: cholecystolithiasis cholelithiasis gallstones biliary tract diseases digestive system diseases gallbladder diseases calculi pathological conditions, anatomical
progressive resistance training versus relaxation for breast cancer patients during chemotherapy: biological mechanisms and effects on fatigue and quality of life

Conditions: Breast Cancer; Cancer-related Fatigue

Summary: the purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and quality of life in breast cancer patients during chemotherapy. to determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (jacobsen method).


Eligibility criteria:
inclusion criteria: * breast cancer patient after lumpectomy or mastectomy, stage i-iii * adjuvant chemotherapy * bmi at least 18 exclusion criteria: * contraindication for exercise * radiotherapy during intervention period
a study of a potential mechanisms of spinal manipulation in the treatment of low back pain

Conditions: Low Back Pain

Summary: the purpose of this study was to determine the immediate effect of 3 common physical therapy interventions for people experiencing low back pain on the perception of thermal pain. additionally, the investigators wished to determine the influence of psychological factors related to fear and anxiety on their findings and to determine whether the effects of the individual interventions were local (specific to the area of application) or global (influenced regions away from the area of application).


Eligibility criteria:
inclusion criteria: * ages eighteen to sixty * currently experiencing low back pain or currently not experiencing low back pain and have not had an episode for the prior six months exclusion criteria: * non-english speaking * systemic medical conditions (e.g. diabetes, hypertension) * current use of psychiatric medication * pregnancy * signs and symptoms indicative of nerve root compression (reflex change, myotomal weakness, or sensation change) * history of surgery to the low back

Keywords: low back pain spinal manipulation central sensitization manual therapy