Kornimate/medical-research-clean huggingface dataset:
inpatient group acceptance and commitment therapy (act) for psychosis spectrum disorder

Conditions: Psychotic Disorders; Acceptance and Commitment Therapy; Psychotherapy, Group; Inpatients

Summary: the pilot study that will serve as the basis for the larger project - a multicenter randomized controlled single-blinded trial (rct) will focus on testing the feasibility and efficacy of an inpatient group act treatment program and its effects on symptom severity and patient satisfaction in patients with psychosis spectrum disorder. the act-specific treatment program for inpatients with psychosis spectrum disorder is designed to enable patients to deal with their disease in an accepting manner over the long term, to promote self-determined and positive attitudes toward treatment and support options, and thus to reduce rehospitalization rates.

inpatient hospitalization is an important time to provide patients with psychosis spectrum disorder with skills to better manage symptoms and improve functioning after discharge. the long-term goal is to reduce the negative consequences of these disorders and to have a lasting positive impact on the course of the disease. against this background, the aim of a larger-scale future study project is to evaluate a specific act-based four-week treatment program providing inpatient group therapy interventions for patients with psychosis spectrum disorder. the act-specific treatment program is designed to enable patients to deal with their disease in an accepting manner over the long term, to promote self-determined and positive attitudes toward treatment and support options, and thus to reduce rehospitalization rates. the pilot study will focus on testing the feasibility and efficacy of the inpatient group act treatment program and its effects on symptom severity and patient satisfaction in patients with psychosis spectrum disorder. here, treatment will include a high-frequency four-week inpatient act group therapy program with a focus on the core act process of mindfulness in addition to standard inpatient treatment. within the scope of the survey, possible side effects of the intervention will also be recorded and mapped by conducting qualitative individual interviews and documenting serious adverse events.

Eligibility criteria:
inclusion criteria: * patients with psychosis spectrum disorder with the following diagnoses according to the diagnostic and statistical manual diploma in social medicine 5 ("schizophrenia spectrum and other psychotic disorders"): * schizophrenia * schizophreniform disorder * schizoaffective disorder * delusional disorder * brief psychotic disorder * psychotic disorder due to another disorder * substance-induced/medication-induced psychotic disorder * depressive episode with psychotic symptoms * manic or bipolar episode with psychotic symptoms exclusion criteria: * patients decline to participate in the treatment program * language or intellectual abilities insufficient for study participation

Keywords: mindfulness acceptance and commitment therapy psychotherapy, group inpatients psychotic disorders
treatment of wounds with a new adhesive foam dressing

Conditions: Wounds and Injuries; Burns

Summary: this study will look at whether elect, a new adhesive foam dressing, can offer an alternative to traditional wound care methods. patients will be treated with elect for 14 days. data relating to wound healing, the performance of the dressing and the opinion of the doctor will be collected. the hypothesis of this study is that the elect foam adhesive dressing is 'fit for purpose' and will be effective at treating a variety of wounds.


Eligibility criteria:
inclusion criteria 1. participants must be ≥1 years old 2. males and females (females must not be pregnant and must use contraception if of child bearing potential) 3. participant must have a partial thickness burn, acute or chronic wound that would benefit from the application of an advanced wound dressing to help facilitate moist wound healing 4. presence of a suitable wound which can be treated with the available sizes of the elect adhesive foam dressing (7.5cm x 7.5cm, 12.5cm x 12.5cm, 15cm x 15cm and 17.5cm x 17.5cm) 5. participant is under the direct observation of the investigator for the duration of the study (i.e the participant's wound must not be treated by another clinician throughout the duration of the study). 6. the participant or the participant's legal representative is able to understand and is willing to consent to the study. exclusion criteria 1. participants with a known history of poor compliance with treatment (including if the participant has a known , diagnosed emotional or neurological condition such as mental disorders/illnesses, mental retardation, drug or alcohol abuse, that would pre-empt their ability to understand and consent) 2. participants who are unable to understand the aims and objectives of the study. 3. participant is a prisoner. 4. participants with a known sensitivity to any of the constituents of the evaluation products, including polyester, polyurethane, and acrylic adhesive 5. participants with facial wounds as the reference wound 6. participants with confirmed or suspected clinically infected reference wounds (unless wounds are being treated per standard protocol for wound infection) 7. participant is likely to undergo foreseeable definitive surgery within 2 weeks from screening 8. participants where a reference wound cannot be treated in isolation from other wounds 9. participants who have participated in this evaluation previously and closed/100% healed, or have been withdrawn from the study, or any previous studies 10. participant who are employees of smith \& nephew group companies

Keywords: wound burns acute chronic foam adhesive dressing
effectiveness of a home-based, self-administered exercise program for hands in patients with systemic sclerosis

Conditions: Systemic Sclerosis; Scleroderma; Hand Rheumatism; Rehabilitation

Summary: systemic sclerosis (ssc) is a heterogeneous autoimmune disease characterized by fibrosis of the skin and internal organs. hand involvement is one of the most observed musculoskeletal involvements in patients with ssc, which can impact on general health, quality of life, and psychological status. hand exercise programs can help patients to improve not only hand function but also general health status; nevertheless, further randomized control trials (rcts) are needed to clarify its effect. hence, the investigators aimed to investigate the effectiveness of home-based, self-administered exercise program for hands in patients with ssc and demonstrate the improvements in general health status.

the current study was designed as a single-blind, prospective, randomized controlled, comparative study with a 2-month follow-up period, conducted in a rheumatology outpatient clinic of a university hospital, between july 2016-june 2019. female patients with ssc who fulfilled the 2013 acr/eular classification criteria for systemic sclerosis were included in the study. patients with neurological disorders, arthritis, myositis, amputation of fingers, serious contracture resisting handgrip, and history of undergoing hand surgery were excluded from the study. patients were enrolled in the study after they signed the written informed consent. following the assessment of patients in terms of eligibility, patients were randomized into an exercise and a control group. the computerized block randomization method was used to randomize subjects into groups. both groups were informed about systemic sclerosis and they received the printed materials that include recommendations such as avoiding cold and trauma. the treatment group participated in a single hand exercise training (isometric hand exercise and self-administered stretching) applied by a physiatrist. they additionally received the printable instructions for exercises. compliance was assessed by a checklist, which included all information on how to exercise and how many times to do them. the investigators aimed to investigate the impact of hand exercise program on hand function and demonstrate its influence on health status, quality of life, and psychological status of patients with ssc.

Eligibility criteria:
inclusion criteria: - female systemic sclerosis patients who fulfilled the 2013 acr/eular classification criteria for systemic sclerosis exclusion criteria: * patients with neurological disorders, * arthritis, * myositis, * amputation of fingers, * serious contracture resisting hand grip * history of undergoing hand surgery

Keywords: systemic sclerosis scleroderma hand rehabilitation exercise therapy self-management
effectiveness of multisensoral nature-based intervention in hospitalized children during venous blood sampling

Conditions: Anxiety; Fear; Pain; Satisfaction

Summary: this randomized controlled trial (rct) study aims to evaluate the effectiveness of multisensoral nature-based intervention compare to standard care in relieving anxiety, fear and pain in hospitalized child aged 5 to 9 years and parent's anxiety and satisfaction during venous blood sampling. the assessment uses different measures to assess child's anxiety, fear, pain and parent's anxiety and satisfaction during venous blood sampling.

the rct study aims to evaluate the effectiveness of multisensoral nature-based intervention compare to standard care in relieving anxiety, fear and pain in hospitalized child aged 5 to 9 years and parent's anxiety and satisfaction during venous blood sampling. the intervention includes a multi-sensory nature experience using natural materials and a virtually created natural environment. the study will include children and parents in the intervention group (n=53, receiving the multisensoral nature-based intervention) and children and parents in the control group (n=53, receiving usual care). the children's blood sampling will be videotaped. the assessment uses different measures assess to child's anxiety (mypas = the modified yale preoperative anxiety scale), child's fear (cfc = children fear scale), child's pain (fas = facial affective scale), parent's anxiety (stay-y1 = the state-trait anxiety inventory) and satisfaction (vas = visual analogue scale) during venous blood sampling. in addition, heart rate (hr) measurement are used to assess the child's anxiety, fear and pain. the data will be analysed using statistical methods.

Eligibility criteria:
inclusion criteria: 1. the child is aged between 5 and 9 years old 2. the child has a long-term illness (such as diabetes or rheumatism) 3. the child has previous experience of venous blood sampling 4. the child's level of development is age-appropriate (such as, the child is cared for at home or in day care/day nursery or attends school in the same level as the other children) 5. child and parent understand and speak the finnish language exclusion criteria: 1. the child has a diagnosis of abnormal neurological development (such as, a child has difficulty understanding spoken language or expressing emotions) 2. the child has chronic pain that has lasted more than 3 months and requires strong painkillers (opiates). 3. the child undergoes an examination or treatment during a check-up at the outpatient clinic that requires medical treatment similar to anesthesia 4. the child is taking a sedative medication.

Keywords: children nature-based intervention venipuncture
the effectiveness of walking in patients with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: expected results: finding from this evidence-based study ought to clarify the effectiveness of walking intervention for patients with sle, and provide reference for future nursing strategies to improve disease adaptability.

background and purpose: walking exercise may be grateful in strengthening the cardiopulmonary function, regulating the joint flexbility, relieving the pain and the disturbance of sleep, all of which can further improve the quality of life among the patients with chronic diseases. nevertheless, the information regarding the effect of walking exercise amongst systemic lupus erythematosus (sle) subjects is still obscure. this study aimed to the influence of quality of life and sleep after the implementation of walking exercise among such groups. uses the psychometric evaluation of the chinese version of the pittsburgh sleep qualityindex、systemic lupus erythematosus-specific quality of life questionnaire and systemic lupus disease activity of lupus erythematosus disease activity score and taiwanese depression questionnaire to evaluate the effectiveness of the intervention of walking exercise on systemic lupus erythematosus. methods: through the quasi-experimental study design, the investigators intend to recruit the sle patients from a hospital in taiwan between 2021-2022. the main intervention is composed of home walking, which contained walking guidance and telephone consultation. after that, the investigators apply the structured questionnaires and existing data to collect performance indicators, covering the chinese version of pittsburgh sleep qualityindex, systemic lupus erythematosus-specific quality of life questionnaire, systemic lupus disease activity of lupus erythematosus disease activity score, and taiwanese depression questionnaire. the effects of walking exercise is determined by the generalized estimation equations(gee) .

Eligibility criteria:
inclusion criteria: * patients with fulfilled the american college of rheumatology 1997 criteria for sle exclusion criteria: * .patients with cardiovascular disease * limited motion, such as bed-ridden, femur head necrosis * were pregnant, or had a depressive disorder,

Keywords: quality of sleep quality of life walking
role of metabolites in nicotine dependence (1) - 1

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to determine the effects of cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.

the purpose of this study was to determine the effects of a metabolite of nicotine, cotinine, on tobacco withdrawal symptoms. cotinine has been shown to have psychoactive effects that are similar as well as different from those of nicotine, however, little research has been conducted examining the role cotinine plays in nicotine addiction. this study compared the effects of cotinine with the nicotine patch, and a combination thereof on tobacco withdrawal symptoms. the results showed that cotinine antagonizes the beneficial effects of the nicotine patch in reducing withdrawal symptoms.

Eligibility criteria:
inclusion criteria: male or female subjects, aged 21-45 yrs inclusive, with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. subject must be in good health as verified by medical history, screening exam, and screening laboratory tests. subject must provide written informed consent to participate in the study and be motivated to stop smoking for a short term. exclusion criteria: history of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, peptic ulcer disease or any other medical condition which the physician or investigator deems inappropriate for participation, insulin-dependent diabetes; pregnant or lactating or not using adequate birth control methods; requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history; chronic use of systemic steroids or antihistamines; skin sensitivity which would preclude use of a transdermal system; abuse of alcohol or any other recreational or prescription drug; use of any other tobacco products, including smokeless tobacco and nicotine products; previous use of transdermal nicotine system; inability to fulfill all scheduled visits and examination procedures throughout the study period.

Keywords: nicotine dependence
micra av transcatheter pacing system post-approval registry

Conditions: Bradycardia

Summary: medtronic is sponsoring the micra av registry using the micra av system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release. the micra av registry is conducted within medtronic's product surveillance registry (psr) platform.

the micra av registry is a global, prospective, observational, multi-site registry. patients enrolled in the micra av registry will be prospectively followed for a minimum of 3 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent). enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all micra av system follow-up patient visits are to be reported. therefore, if more frequent scheduled visits occur per a provider's routine clinical care practice, those visits are reported. the total estimated registry duration is 4.5 years

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient is intended to receive or be treated with a micra av transcatheter pacing system and must be enrolled prior to the implant procedure exclusion criteria: * patient who is, or is expected to be inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
epidermal growth factor receptor (egfr) status based gefitinib neoadjuvant therapy in non small cell lung cancer (nsclc)

Conditions: Non Small Cell Lung Cancer

Summary: this study aims to investigate the efficacy and safety of gefitinib as neoadjuvant therapy in stage iiia nsclc patients.


Eligibility criteria:
inclusion criteria: * patients pathological diagnosed with nsclc,with egfr sensitive mutation; * stage iiia patients with technical operable disease evaluated by image and lab results; * patients without chemotherapy or targeted-therapy before; * inform consent. exclusion criteria: * patients with malignant tumor other than lung cancer; * patients with other diseases such as cardiovascular disease that may hamper follow up; * patients that may not coordinate well,judged by researcher.

Keywords: non small cell lung cancer gefitinib neoadjuvant therapy
comparison between two methods of throat swabbing

Conditions: Pharyngitis

Summary: throat swabbing is an important instrument in the diagnosis of strep pharyngitis and sometimes the main argument for antibiotic treatment. there is no firm knowledge about an appropriate method of the swabbing for receiving maximal sensitivity. we hypothesize that accurate swabbing from the pus will increase the sensitivity of the swabbing as compared to free swabbing. in order to check this hypothesis we will compare two swabs from the same throat. one that will be taken by a physician specifically from the pass and the second will be taken by a nurse as she used to do it. an increase of 10% of positive results will be accepted as a significant advantage.


Eligibility criteria:
inclusion criteria: * patients with sore throat, classified 2-3 according to cantor's criteria exclusion criteria: * patients on antibiotic treatment * suspected carriers of streptococcus
gore viabahn endoprosthesis peripheral vascular disease study

Conditions: Peripheral Vascular Diseases

Summary: to evaluate the performance of the gore viabahn® endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (sfa) occlusive disease in long lesions.

this is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups.

Eligibility criteria:
inclusion criteria: * lifestyle-limiting claudication or rest pain. * subject (or their legal guardian) has read, understood and provided written informed consent. * at least 21 years of age. * quality of life questionnaires completed. * noninvasive lower extremity arterial studies within 45-days prior to study procedure. * if applicable, staged ipsilateral vascular procedure ≥ 14-days prior to study procedure. * if applicable, vascular treatment on non-study leg for bilateral claudication ≥ 14-days prior to study procedure. * male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test. * projected life expectancy of greater than three years. * the ability to comply with protocol. * angiographic and lesion requirements meets protocol criteria. exclusion criteria: * untreated flow-limiting aortoiliac occlusive disease. * any previous stenting or surgery in the target vessel. * subjects with arterial lesions requiring treatment with device diameters other than 6, 7, or 8 mm. * severe ipsilateral common femoral/profunda disease requiring surgical intervention. * femoral or popliteal aneurysm. * non-atherosclerotic disease resulting in occlusion. * tibial artery disease requiring treatment. * prior ipsilateral femoral artery bypass. * severe medical comorbidities. * popliteal artery vascular access at any time during procedure. * antegrade and retrograde vascular access on the same common femoral artery at the time of the sfa intervention. * serum creatinine \> 2.5 mg/dl within 45 days prior to study procedure. * major distal amputation. * septicemia. * any previously known coagulation disorder. * morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion). * contraindication to anticoagulation or antiplatelet therapy. * known allergies to stent/stent-graft components. * history of prior life-threatening reaction to contrast agent. * currently participating in another clinical research trial. * current peritoneal or hemodialysis.
a phase 2a study of modified vaccinia virus to treat sorafenib-naïve advanced liver cancer

Conditions: Hepatocellular Carinoma

Summary: this study is to determine how effectively jx-594 (pexa-vec) will prolong life in patients with advanced hepatocellular carcinoma (hcc) who have not been previously treated with sorafenib, and the safe administration of jx-594 in five weekly iv infusions.

this was a phase 2a, two-staged, single-arm, open-label study in sorafenib-naïve patients with advanced hcc. patients received 5 weekly iv infusions of pexa-vec and could have continued to receive iv infusions of pexa-vec every 3 weeks until progressive disease (pd).

Eligibility criteria:
key inclusion criteria: * histologic or cytologic confirmation of advanced primary hepatocellular carcinoma (hcc) * measurable tumor (at least one tumor with ≥1 cm ld of contrast-enhancement during the arterial phase on ct scanning) * ecog performance status 0, 1 or 2 * child-pugh class a; or child-pugh class b7 without clinically significant ascites * platelet count ≥50,000 plts/mm3 * wbc count ≥2,000 cells/mm3 and ≤50,000 cells/mm3 * hemoglobin ≥10 g/dl * adequate liver function key exclusion criteria: * received sorafenib as previous treatment for hcc for more than 14 days * history of severe exfoliative skin condition (e.g., eczema or atopic dermatitis requiring systemic therapy for \> 4 weeks) * prior treatment with jx-594 * known significant immunodeficiency due to underlying illness (e.g. hiv/aids) and/or medication * severe or unstable cardiac disease * viable cns malignancy associated with clinical symptoms * pregnant or nursing an infant * significant bleeding event within the last 12 months.

Keywords: liver cancer hcc first line hcc pexa-vec jx-594