Kornimate/medical-research-clean huggingface dataset:
intervention effect of shen-based qigong exercise on residual symptoms of schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to observe the intervention effect of shen-based qigong exercise on residual symptoms of schizophrenia.

shen-based qigong exercise is a new kind of health-care qigong exercise based on the theory of traditional chinese medicine, aiming at the characteristics of schizophrenia. in this study, a randomized controlled trial was conducted to observe the rehabilitation effect of this new exercise on residual symptoms of schizophrenic patients. questionnaire, test and other experimental materials were used to evaluate the intervention effect of 12-week shen-based qigong exercise on psychiatric symptoms, cognitive function, quality of life and social function of schizophrenic patients. at the same time, the related physical function and cardiac function indexes were used to evaluate the physical and cardiac rehabilitation effects of the exercise on patients from the aspects of "body" and "heart", so as to verify whether qigong exercise has the effects of adjusting body and heart.

Eligibility criteria:
inclusion criteria: 1. han chinese population 2. age ≥ 18 years 3. education level ≥ 6 years, can fill in the questionnaire independently, have enough audio-visual level to complete the necessary examination 4. assessed by mini 7.0 and satisfied with the diagnostic criteria for schizophrenia based on the diagnostic and statistical manual of mental disorders, fifth edition(dsm-5) 5. patients with schizophrenia residing in the rehabilitation ward, without relapse in the past 6 months 6. residual negative symptoms, with at least one item ≥ 2 on the negative subscale of panss (n1-n7) 7. taking second generation antipsychotics 8. no training history of traditional chinese exercises 9. agreement to participate in the study and willing to give written informed consent exclusion criteria: 1. having severe physical diseases such as cardiovascular, lung, liver, kidney, and hematopoietic diseases 2. satisfied with the diagnostic criteria for other mental disorders based on dsm-5 3. having alcohol or substance abuse/dependence 4. having mental retardation(wais\<70) and/or severe cognitive impairment(mmse\<24) 5. having visual and / or hearing problems, unable to complete the relevant test 6. electroconvulsive or repetitive transcranial magnetic stimulation(rtms) therapy in the past 3 months 7. currently enrolled or participated in other clinical studies in the past 3 months 8. participating in regular exercise training in the past 6 months 9. failure to sign or refuse to sign informed consent
observationa study is a prospective and multi-institutional observational study.

Conditions: Erosive Reflux Disease; Heartburn; Acid Regurgitation

Summary: this observational study is a prospective, multi-institutional non intervention study to examine the prescription patterns, corresponding treatment effects and safety in routine clinical practice for patients prescribed for the treatment of gastroesophageal reflux disease.

the present observational study is designed to check effect and safety for patients who have been prescribed jaqbo for the treatment of erosive gastroesophageal reflux disease.

Eligibility criteria:
inclusion criteria: 1. an adult over 19 years of age 2. a person who voluntarily provides written informed consent exclusion criteria: 1. a pregnant woman or a nursing woman 2. a person who is deemed unsuitable for the subject of the study

Keywords: gerd erd
neoadjuvant treatment in rectal cancer with radiotherapy followed by atezolizumab and bevacizumab (tarzan)

Conditions: Rectal Cancer

Summary: in this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab

38 patients with resectable rectal cancer will be enrolled. all patients will be treated with radiotherapy followed by bevacizumab and atezolizumab.

Eligibility criteria:
inclusion criteria: * signed informed consent * patients age 18 years and older * histologically confirmed adenocarcinoma of the rectum * intermediate risk rectal cancer or low risk distal rectal cancer exclusion criteria: * evidence of metastatic disease * prior radiation therapy for disease under study * prior treatment with cd137 agonists or immune checkpoint blockade therapies * current or recent use of acetylsalicylic acid * history of clinically significant cardiac or pulmonary dysfunction pregnancy or breastfeeding * significant auto-immune disease

Keywords: short term immunotherapy atezolizumab bevacizumab radiotherapy
xylitol adult caries trial (x-act)

Conditions: Dental Caries

Summary: the purpose of the trial is to determine the extent to which daily use of xylitol lozenges reduces the appearance of new caries lesions in adults who tend to experience such lesions (i.e., caries-active adults).

dental caries incidence is higher in adults than children. recent recommendations from both the centers for disease control and an nih consensus development conference on dental caries call for clinical trials of caries prevention methods in caries-active adults. little is known about the effectiveness of caries prevention methods in adults, and virtually no information exists with respect to prevention among adults who are at elevated risk for developing caries lesions. this application describes a clinical trial of an intervention to prevent dental caries in caries-active adults that is responsive to the cdc and consensus conference recommendations. the xylitol for adult caries trial (x-act) is a three-year, multi-center, randomized, placebo-controlled, double-blind study to determine the effectiveness of xylitol lozenges in reducing the incidence of coronal and root caries in caries-active adults. the intervention is the daily use of xylitol lozenges. participants will be 750 adults (ages 25-75) with current or recent caries lesions who are dental school patients at one of three clinical centers in chapel hill, nc, birmingham, al, and san antonio tx. these clinical centers offer diverse populations with substantial proportions of minority populations that enhance the generalizability of the findings. the study chair is located at the university of north carolina-chapel hill, and the data coordinating center is at the kaiser permanente center for health research in portland, or. this intervention is being tested because it represents a potentially effective caries prevention method with a high likelihood of adoption by dental practitioners as an "add on" caries preventive method for their caries-active patients. the potential for adoption of the intervention is an important consideration because current data suggest that caries-active adults are underexposed to caries-preventive treatment in dental practices. if effective, the intervention also holds potential as a public health measure.

Eligibility criteria:
inclusion criteria: * age 25-80 * at least one caries lesion in year prior to enrollment * at least 12 teeth without crowns * no allergies to xylitol or aspartame * anticipate remaining in area for 3 years exclusion criteria: * 10 or more caries lesions in year prior to enrollment * currently receiving long-term antibiotic therapy * history of head and neck radiation
cardiac outcome measures in children with muscular dystrophy

Conditions: Duchenne Muscular Dystrophy; Becker Muscular Dystrophy; Limb Girdle Muscular Dystrophy

Summary: the purpose of the research study is to evaluate different cardiac measures that are obtained by echocardiographic tests in patients with muscular dystrophy.

the research study will include 50 participants aged 8 to 18 years old (before 18th birthday) with duchenne, becker, or autosomal recessive limb-girdle (specifically: lgmd 2c-2f and 2i) muscular dystrophies. participants will be seen in one of five cooperative international neuromuscular research group (cinrg) centers located in the united states. all study assessments will be completed in the same day and include reviewing past medical and surgical history, collecting vital signs, collecting cardiac measures through echocardiographic tests.

Eligibility criteria:
inclusion criteria: * participants must be between the ages of 8 and 18 years old * confirmed diagnosis of muscular dystrophy (dmd, bmd, or lgmd 2c-2f and 2i) exclusion criteria: * investigator assessment of inability to comply with protocol * history of a congenital cardiac defect or other cardiac disease unrelated to muscular dystrophy

Keywords: cardiac muscular dystrophy prospective pediatric echocardiogram
the effect of standardized enteral nutrition on critically ill patients

Conditions: Critically Ill

Summary: the goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.

as investigators all know, the nutrition status in critically ill patients is associated with the prognosis of these patients. and it has been confirmed that early enteral nutrition results in better outcome. however,some epidemiological investigation reported that in most intensive care unit, the phenomenon of delayed feeding or under feeding are not uncommon. in 2007, a study reported that the percentage of early enteral nutrition within 48h is 64%, based on mechanical ventilated patients in 208 intensive care unit nationally. other study indicated that the calorie supported by the enteral nutrition only constitute 50% of the target calorie. several studies have showed that the application of a standard enteral nutrition protocol could result in an improvement in the delivery of enteral feedings to patients. however, there is no such study in china.the goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.

Eligibility criteria:
inclusion criteria: * critically ill patients who is expected the length of icu stay for more than 3 days exclusion criteria: * patients who can obtain enough calorie through independent oral feeding. patients aged less than 18 years. patients who are pregnant or breastfeeding. patients who are burned. patients with malignant tumor terminal stages of diseases

Keywords: critically ill, intensive care, enteral nutrition
a phase iii open-label extension study of gabapentin as adjunctive therapy in japanese pediatric patients with partial seizures

Conditions: Epilepsies, Partial

Summary: examine the safety and efficacy of gabapentin as adjunctive therapy in japanese pediatric patients with partial seizures


Eligibility criteria:
inclusion criteria: * completion of study a9451162 (nct00603473) exclusion criteria: * seizures related to drugs or acute medical illness * history of any serious medical or psychiatric disorder
toxicity substudy of evaluation of subcutaneous proleukin in a randomised international trial (esprit): toxil-2 substudy

Conditions: HIV Infections

Summary: this substudy is an open-label, randomised study comparing the uptake of recombinant interleukin-2 (ril-2) in hiv-1 infected individuals receiving different combinations of antiemetics and analgesic agents during ril-2 dosing in esprit. the design is a factorial one with 4 arms. all patients will receive regular ibuprofen and paracetamol from days 1-6 of the ril-2 dosing cycle; in addition, patients will be randomised to receive one of two antiemetic combinations, i.e. ondansetron or metoclopramide with or without low dose codeine phosphate as an additional analgesic agent.

the research is a randomised open-label substudy of esprit. the substudy is exploring whether the amount of ril-2 taken during a dosing cycle of ril-2 can be increased through controlling the predictable side-effects of ril-2 better. this is a four arm study with a factorial design; patients will be randomised to one of four arms. each arm consists of different combinations of adjunctive agents. each patient will receive paracetamol and ibuprofen prophylactically throughout the cycle, the other adjunctive agents prescribed will vary according to which arm the patient is randomised to, but the antiemetic used will be either ondansetron or metoclopramide with or without low dose codeine phosphate as an additional analgesic agent. the primary end-point is the percentage of planned ril-2 actually taken during the cycle. secondary end-points include safety, side-effects of ril-2 and the adjunctive agents, cd4+ t-cell changes and quality of life measures.

Eligibility criteria:
inclusion criteria: patients participating in esprit and randomised to the ril-2 arm, who: 1. are not at cd4+ t-cell target for the protocol 2. have not received ril-2 for \> 2 months 3. have reported both gi upset and constitutional side-effects as one of the reasons for either dose modifying in prior cycles or unwillingness to receive further ril-2 4. are considered by the investigator as medically safe to receive further dosing with ril-2 5. are willing to receive further dosing with ril-2 at the dose specified by the investigator 6. are willing to sign informed consent to participate in the substudy exclusion criteria: 1. all exclusions for the receipt of ril-2 on esprit 2. known allergy to non-steroidal anti-inflammatory drugs (nsaids), opiates, 5ht-3 (serotonin-3) inhibitors, anti-dopaminergic antiemetics, or any other components of the proposed adjunct regimens. 3. use of other nsaids (cyclooxygenase-2 \[cox-2\] inhibitors, corticosteroids) or opiate analgesics within two weeks of ril-2 dosing. use of low dose aspirin as a cardio-protective agent is allowed.

Keywords: ril-2-toxicity interleukin-2 therapy hiv toxicity substudy of esprit
corevitas atopic dermatitis registry: a study of post approval drug safety and effectiveness

Conditions: Atopic Dermatitis

Summary: this prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for patients with atopic dermatitis under the care of a licensed dermatologist or qualified physician extender. secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices. condition or disease : atopic dermatitis

the objective of the corevitas atopic dermatitis (ad) registry is to create a national cohort of patients with atopic dermatitis. data collected will be used to extensively evaluate the effectiveness and safety of medications used to treat atopic dermatitis. this will be done through the standardized collection of patient-reported outcomes (pro) and clinician-reported outcomes (clinro), and the prevalence and incidence of comorbidities and adverse events, medication utilization patterns, and patient productivity measures.

Eligibility criteria:
inclusion criteria has been diagnosed with ad by a dermatologist or qualified dermatology provider. 2) is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted. 3) willing and able to provide consent for participation in the registry. 4) willing and able to provide personal information (full legal name, sex, date of birth, home address zip/postal code, and email address or phone number at a minimum) if required based on registry location and applicable laws and regulations. 5) has been prescribed a new enrollment eligible medication. a new therapy is a medication that the subject has never taken before. 1. at the time of registry enrollment or 2. within 12 months prior to registry enrollment exclusion criteria: 1)is participating or planning to participate in a blinded clinical trial for an ad drug. follow-up criteria registry follow-up data collection should be done at the time of routine clinical encounters approximately every 6 months. routine or standard of care clinical encounters may occur in between two registry visits, but the data collected in the follow-up forms should cover the time period since the last registry visit. for planning purposes, each follow-up visit is anchored to the date of the last eligible registry visit. a follow-up visit is eligible for payment if 150 days have passed since the last visit submission. a follow-up visit is not eligible for payment if conducted less than 150 days since the last registry visits except when the early follow-up visit criteria are satisfied. early follow-up criteria a registry follow-up visit should be conducted whenever a patient is prescribed or receiving the first dose of a new eligible medication even if less than 150 days have passed since the last registry visit. when the early follow-up criteria are met, the next anticipated registry visit is calculated from the date of the early follow-up visit.
reliability and validity of the turkish version of the laval

Conditions: Obesity; Quality of Life

Summary: the study is a turkish validity and reliability study of the laval questionnaire.

the study was planned as a student's master thesis. the whole study was carried out by us. all evaluations were completed. all analyses were completed. it is an observational study. it is a survey study.the study data were entered retrospectively. research i̇zmir bayraklı district health directorate no. 1 healthy life centre (1 october 2021 - 15 november 2021) and gaziemir municipality (15 november 2021 - 15 march 2022) was conducted. dokuz eylül university ethics committee accepted the study on 22.12.2021 with the decision number 2021/38-08. people with body mass index ≥ 30 kg/m2 and who met the inclusion/exclusion criteria were included in the study. in addition to the laval questionnaire, the sf-12 general health quality of life questionnaire and the obese-specific quality of life scale were used. for the adaptation of the turkish version of the questionnaire, first, language validity was ensured by back translation method.

Eligibility criteria:
inclusion criteria: * volunteering, being literate * age ≥ 18 and age ≤ 75 * body mass index (bmi) ≥ 30 kg/m2 * ability to follow instructions to fill out questionnaires. exclusion criteria: * affected by psychiatric illness

Keywords: obesity quality of life validity and reliability
a mhealth behavioral cancer pain protocol for medically underserved communities

Conditions: Breast Cancer

Summary: the purpose of this study is two-fold. first, the investigator will develop a low-literacy mobile pain coping skills training (mpcst) protocol for cancer patients with pain (i.e., therapist manual, patient manual including handouts, and the smartphone materials) as well as a beta version of the basic smartphone components with the assistance of experts in the field. next, an iterative development design using focus groups with women who have breast cancer and pain accrued from medically underserved areas will be used to refine the developed mpcst protocol and basic smart phone components. the protocol-designed to reduce cancer pain and disability in patients with low literacy in medically underserved areas-will be delivered via tele-video conferencing sessions in the community clinic. the smartphone tools (e.g., simple text messages, images, and preloaded intervention content) will allow the intervention to extend into the patients' homes. the second study purpose is to pilot test the feasibility, acceptability, and efficacy of the developed protocol. the investigator will also obtain an estimate of the effect size of the developed protocol to decrease pain. focus group data will be managed and evaluated in a systematic format using a grounded theory approach. data analyses for the pilot testing period of the study will be assessed by examining accrual, attrition, and adherence to the intervention. simple t-tests will be used to examine pre- to post-intervention differences in pain and the other outcomes of interest. there are minimal risk or safety issues related to this study.


Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer within the last three years * being \>21 years old, * having a life expectancy of at least 12 months, * having 1 clinical pain ratings of \>3 gathered as part of their routine clinic visits exclusion criteria: * metastases to the brain, * presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff, * current or past (\<6 months) engagement in pcst for cancer.

Keywords: pain coping mhealth breast cancer
polycystic kidney disease data repository

Conditions: Polycystic Kidney Disease

Summary: autosomal dominant polycystic kidney disease (pkd) is the most common inherited kidney disease, affecting more than 400,000 people in the u.s. and 5 million people worldwide. pkd is the 4th most common cause of kidney failure requiring dialysis and/or transplantation. over half of all pkd patients develop kidney failure by age 60 years, although age of onset of kidney disease varies widely, even among members of the same family. despite the fact this is a relatively common problem, relatively few patients have been studied for a sufficient period of time to fully understand how patients are affected over the course of their lifetime. the reason for creating this repository is to collect information about pkd so that the investigators may fully understand its complications, including high blood pressure, heart attack, and stroke. this information may also aid in the development of improved treatment strategies.

visit #1: * an initial detailed history, physical examination, and laboratory evaluation * an extensive family history of pkd will be obtained from the patient. follow-up study visits: - patients will return to the outpatient facility for detailed follow-up examinations every other year after visit 1.

Eligibility criteria:
inclusion criteria: * any person, age 18 or older, with previously diagnosed adpkd is eligible to participate. exclusion criteria: * inability to provide informed consent.

Keywords: pkd
thymoglobulin versus alemtuzumab versus daclizumab in living donor renal transplantation

Conditions: End-Stage Renal Disease; Living Donors

Summary: the purpose of this study is to observe in a randomized prospective study the effectiveness and toxicity of thymoglobulin vs. campath-1h used for induction therapy in recipients of living donor (ld) kidneys, compared with the investigators standard treatment protocol of zenapax® and maintenance immunosuppression.

to observe in a randomized prospective pilot study the effectiveness and toxicity of thymoglobulin vs. campath-1h used for induction therapy in recipients of living donor (ld) kidneys, compared with our standard treatment protocol of zenapax® and maintenance immunosuppression (vide infra). to determine the effect different antibody induction regimen on the lymphoid cell subsets of the immune system in kidney allograft recipients peripheral blood and bone marrow aspirates will be tested at surgery before transplantation and at intervals post operatively. to treat renal transplant patients successfully in the absence of long-term calcineurin inhibition to determine if there are beneficial effects on the prevention of chronic allograft nephropathy.

Eligibility criteria:
inclusion criteria: * age \>14 years * weight \>40 kg * primary renal allograft:living related (non hla identical) and unrelated donor * negative standard cross match for t-cells * signed and dated consent form exclusion criteria: * patient has previously received or is receiving an organ transplant other than kidney * patient has received a kidney transplant from a non-heart beating donor * patient has received an abo incompatible donor kidney * recipient or donor is seropositive for human immunodeficiency virus (hiv) * patient has a current malignancy or a history of malignancy

Keywords: esrd