Kornimate/medical-research-clean huggingface dataset:
transplant and addiction project (tap) - 1

Conditions: End Stage Liver Disease; End Stage Renal Disease; Substance-Related Disorders

Summary: the purpose of this study is to test a novel distance-based (telephone) intervention to help transplant candidates with current or recent substance abuse to stay "clean and sober" both prior and following transplant surgery.

participants who need a liver or renal transplant and who are ineligible due to current or recent (past 6 months) alcohol and/or other drug abuse are being recruited from the transplant programs at st. luke's-roosevelt hospital center (renal), columbia presbyterian hospital (renal/liver) and virginia commonwealth university medical center (liver). baseline and follow-up computer-assisted assessments and structured clinical interviews along with collection of biological samples (urine, hair) will occur in the transplant clinics; however, phone counseling sessions originate at st. luke's. participants are randomly assigned to one of two treatments: (1) usual care (no phone counseling) or (2) usual care + counseling. the telephone counseling sessions are designed to help participants become motivated to remain abstinent and improve other health behaviors such as sleep or stress management.

Eligibility criteria:
inclusion criteria: * end stage liver or renal disease * having used drugs or alcohol during the past 6 months * turned down for transplant due to current or recent substance use * access to telephone exclusion criteria: * psychotic or other unstable serious psychiatric disorders that preclude full, active participation * moderate to severe hepatic encephalopathy * non-english speaking

Keywords: end stage liver disease end stage renal disease substance-related disorders
neuropsychological indicators of scd progression

Conditions: Biomarkers; Cognitive Assessment; Cognitive Decline; Neurocognitive Disorders; Neurodegenerative Diseases; Subjective Cognitive Decline

Summary: some patients with subjective cognitive decline (scd) progress to neurocognitive disorders (ncd), whereas others remain stable; however, the neuropsychological determinants of this progression have not been identified. the investigators objective was to examine baseline neuropsychological indicators that could discriminate between people in whom the scd progressed to a mild or major ncd and people in whom the scd remained stable. the investigators retrospectively included patients consulting for scd at a university medical center's memory center (amiens, france) and who had undergone three or more neuropsychological assessments at least 6 months apart. the relationship between domain-specific scores and the global cognitive score (gcs, as a function of final status (stable scd vs. progression toward a mild or major ncd)) was examined using a generalized linear mixed model.


Eligibility criteria:
inclusion criteria: * patients who had been referred to the memory center at amiens university medical center (amiens, france). * patients who had undergone three neuropsychological assessments at least 6 months apart, from 2005 * patients who met the criteria for scd. exclusion criteria: * patients who didn't meet the criteria for scd

Keywords: biomarkers cognitive assessment cognitive decline neurocognitive disorders neurodegenerative diseases neuropsychological assessment risk of progression subjective cognitive decline
reduction of post-operative endodontic pain

Conditions: Post Operative Endodontic Pain

Summary: to determine the effect of intraligamentary injection of lornoxicam on the intensity of post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.

sixty qualified samples (initial estimate which will be come more accurate after the pilot study on 6 patients) will be divided randomly in three groups which all of them will have an inferior alveolar injection and before the beginning of the treatment the primary group will receive an injection of 0.4 ml ( 0.2 ml in mesio buccal and 0.2 ml in disto buccal) of lornoxicam and the second group will be injected with 0.4 ml of normal saline( 0.2 ml in mesio buccal and 0.2 ml in disto buccal) ,in third group we will only pretend the injection but actually there is no substance injected ,making the patient believe that there was an injection . then the patients' pain will be evaluated with visual analogue scale analysis (vas) 0-170 mm in time intervals of 6, 12, 24 and 48 hours after the treatment.

Eligibility criteria:
inclusion criteria: * healthy (asa i, ii); * patients with first or second mandibular molars who need endodontic treatment; * vital tooth without a history of past endodontic treatment; * patients with clinical evidence of irreversible pulpits with moderate to severe pain; * patients without pre apical lesion and periodontal ligament enlargement more than 0.75-1mm on the x-ray images; * patients in the age group of 18-65 years old exclusion criteria: * pregnant or nursing; * necrotic tooth; * patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or nsaids; * people who have a history of acute peptic ulcer, during the past 12 months; * people who have bleeding problems or have been taking anticoagulant drugs over the past month; * patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs.

Keywords: in the patients with symptomatic irreversible pulpitis
skin efficacy testing of astrion products

Conditions: Skin Pigment; Skin Red

Summary: this project aims to conduct safety and efficacy tests on the skin for the ingestion of astrion vitality capsules, containing a. membranaceus and c. asiatica roots, and the topical application of astrion vitality cream. the goal is to develop health and skincare products that regulate physiological functions, promote overall wellness, and enhance skin beauty.


Eligibility criteria:
inclusion criteria: * subjects aged ≥18 years. exclusion criteria: * non-voluntary participants. * subjects diagnosed with skin diseases, cirrhosis, or chronic renal failure by a -physician. * individuals with known allergies to cosmetics, drugs, or food. * pregnant or breastfeeding women. * individuals taking medication for chronic diseases. * subjects who, within 12 weeks prior to the test, have undergone laser facial treatments, chemical peels, or experienced prolonged sun exposure (more than 3 hours of direct sunlight in a week). * students taught by the investigator. * individuals unwilling to allow the publication of photos of the experimental results.
effect of ectoin® inhalation solution on subjects with mild bronchial asthma

Conditions: Asthma

Summary: in this single center, dose finding, safety study the effect of inhaled ectoin® inhalation solution will be investigated in subjects with mild bronchial asthma. this dose-finding study will estimate the minimum effective dose and will assess the safe dosage, in terms of the quantity given to patients. the results will be compared to baseline measurements. the results regarding sputum measurements will be compared to measurements after placebo administration.

based on the anti-inflammatory effects of inhaled ectoin® shown in previous animal studies, this trial aims to investigate the effects in terms of a reduction of the unspecific bronchial hyperresponsiveness (bhr) to methacholine challenge test on subjects with mild bronchial asthma. in addition, measurements of exhaled nitric oxide level as an indicator of bronchial inflammation will be investigated. this study will focus primarily on safety and dose finding in 12 to 18 subjects with mild bronchial asthma. after a screening visit, subjects will be treated with placebo, followed by increasing doses of ectoin® (low, medium and high dose). all doses of ectoin® inhalation solution and placebo will be administered for 5 - 7 days.

Eligibility criteria:
inclusion criteria: * adults (18 - 65 years) * fev1 ≥ 80% of predicted for patient's normal value pre bronchodilator (according to european coal and steel community reference values) * positive methacholine challenge test (pd20 ≤ 0.5 mg) * a general practitioner or consultant diagnosed mild bronchial asthma * non or ex smoker (for more than 6 months, pack years (py) ≤ 5) exclusion criteria: * pregnant or lactating females * participation in another clinical study in the previous month * severe concomitant disease which may have an impact on the study participation * hypersensibility against ectoin® * patients who have had treatment with live attenuated vaccinations within 14 days prior to screening visit (inactivated influenza vaccination is acceptable, provided it is not administered within 7 days prior to screening visit). * other respiratory diseases (e.g. chronic obstructive pulmonary disease (copd), cystic fibrosis, alpha-1-antitrypsin deficiency, sarcoidosis, bronchiectasis, allergic alveolitis, tuberculosis, etc.) * upper and lower airway respiratory infection within 4 weeks prior to study start

Keywords: asthma ectoin ectoine feno metacholin sraw
unilateral versus bilateral endoscopic lung volume reduction a comparative case study

Conditions: Pulmonary Emphysema

Summary: patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral elvr with complete lobe closure in comparison with incomplete bilateral treatment.

patient enrolment and data acquisition is to be carried out on a prospective basis. it is planned to enrol a total of 20 patients with bilateral heterogeneous pulmonary emphysema. all patients will undergo treatment at one study centre in heidelberg. patients will be considered for both unilateral and bilateral treatment with intrabronchial valves (ibv) on the basis of their emphysema distribution. patients will be randomised to two treatment arms. 10 patients receive unilateral or bilateral treatment in each case.

Eligibility criteria:
inclusion criteria: * age \> 40 inhomogeneous emphysema fev1 between 20-40% dlco between 20-40% 6mwt \> 150 m exclusion criteria: * pregnant homogeneous disease fev1 \< 20%

Keywords: endoscopic lung volume reduction emphysema copd patients with bilateral heterogeneous pulmonary emphysema
implementation of online mindfulness-based stress reduction tailored for people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this project aims to implement and investigate a mindfulness-based stress reduction (mbsr) in people with multiple sclerosis (pwms). the main objective is to implement mbsr intervention for pwms in a major tertiary care clinic for pwms. we will iteratively refine the intervention as required based on stakeholder feedback and any other emergent contextual findings. participants will be asked to take part in an 8-week mbsr course and report changes in anxiety, depression, quality of life, emotional regulation, self-compassion, mindfulness, and health services use.


Eligibility criteria:
inclusion criteria: 1. age \>18 years \</= 60 years 2. diagnosis of ms or related condition (clinically isolated syndrome, neuromyelitis optica spectrum disorder, chronic inflammatory demyelinating neuropathy) 3. able to understand spoken and written english 4. willing to take part in an mbsr course exclusion criteria: 1. cognitive impairment (\<26 on the montreal cognitive assessment) 2. severe active mental health impairment (psychosis, suicidality) 3. medical instability (terminal/life threatening inter-current illness)

Keywords: mindfulness
effects of community occupational therapy in older patients with dementia and their caregivers.

Conditions: Community Occupational Therapy; Dementia Patients; Primary Caregivers of Dementia Patients

Summary: the purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers.

1. objective to determine the effects of community occupational therapy on the daily performance of older patients with mild to moderate dementia and the sense of competence of their primary caregivers. 2. methods 1. design: a randomized controlled single-blind design is used with 3 measurement moments. we measure at baseline (before start of ot intervention), after 6 weeks (the effect measurement)and after 3 months after baseline (follow-up measurement). 2. patients: 135 patients and their primary caregivers are needed to determine effects on the primary outcome measures of this intervention, with a power of 80% and alpha = 0.05/3. this power calculation is based on the outcomes of a pilot study (graff, et al., 2003). 3. intervention: 5 weeks client-centered community occupational therapy directed at both patients and primary caregivers using an ot guideline.the control group receives no ot intervention, but usual care. 4. main outcome measures are: assessment of motor and process skills, interview in deterioration of daily activities in dementia (iddd)and sense of competence questionnaire (scq) 5. analysis: analyses of covariance on intention-to-treat basis (last observation carried forward (lcof))will be used to determine the effects of community ot on the daily performance of older patients with dementia and the sense of competence of their primary caregivers. also secondary patients'and caregivers' health outcomes will be analyzed by analyses of covariance on intention-to-treat basis. 6. cost-effectiveness: the costs of this ot intervention will also be determined and a cost-effectiveness analysis will be carried out. 3)results: results at baseline, at 6 weeks and at 3 months follow-up on primary outcome measures and on patients' and caregivers' secondary health outcomes and also the cost effectiveness of this intervention, will be analyzed and described in international publications.

Eligibility criteria:
inclusion criteria: * aged 65 years or older * mild to moderate dementia (mmse 10-24) * living in the community at maximum of 50 kilometers from the memory clinic * having an informal primary caregiver who was involved in the care for the patient at least once a week exclusion criteria: * depression: score \> 12 on the geriatric depression scale * severe behavioral or psychological symptoms in dementia (bpsd) judged by a geriatrician * severe illnesses, judged by a geriatrician * no ot goals, determined by the researcher or research assistant * caregivers having severe illnesses

Keywords: elderly/aged occupational therapy daily activities caregivers sense of competence
serum ferritin in ckd patients serum ferritin

Conditions: Chronic Kidney Diseases

Summary: variability of serum ferritin in ckd patients and how these variables may affect the treatment decisions with iron supplements

serum ferritin has a wide range variability in ckd patients this makes the use of serum ferritin as an indicator of iron deficiency is limited and mostly ckd is secondary to inflammation so serum ferritin as ferritin is an acute phase reactants so it will be very high in ckd patients ,

Eligibility criteria:
inclusion criteria: * all ckd patients stage 3 to 5 not on dialysis exclusion criteria: * inflammatory chronic diseases ida autoimmune disorders liver diseases malignancy infections
cx3cr1+t cell predict immunotherapy efficacy

Conditions: Non-small Cell Lung Cancer

Summary: this study aimed to evaluate the correlation between the proportion of flow-sorted cx3cr1+t cells in peripheral blood and the cx3cr1+t-specific gene signature and the efficacy of immunotherapy.

the status and abundance of t cells vary across tumor microenvironments (tmes) may fundamentally influence response to immunotherapy in non-small cell lung cancer. cx3cr1+ cd8+ t cells showed high migration in and were enriched in the blood, whose amplification is strongly associated with response to anti-pd-1 therapy and better survival. however, the prediction performance of cx3cr1+ t features and characteristics has not been fully validated. this study intends to conduct a clinical trial based on cx3cr1+ cd8+t cell in peripheral blood to verify the association of proportion and specific transcriptome signature of cx3cr1+t cell in immunotherapy efficacy prediction. with the help of recist 1.1 criteria, the investigators evaluate the clinical response after prescribed cycles of treatment to explore the correlation between peripheral blood markers and immunotherapy efficacy. to develop a low cost, robust and accurate prototype prediction model for nsclc patients who take anti-pd-1 drugs is investigators final translational purpose.

Eligibility criteria:
inclusion criteria: 1. at least 18 years old; 2. diagnosed as non-small cell lung cancer by biopsy before treatment; 3. prepare to receive pd(l)1 inhibitor monotherapy or combined chemotherapy and antivascular drugs; 4. lesion imaging can be measured and evaluated by recist1.1 standard; 5. life expectancy exceeds 3 months; 6. ecog score 0-2; 7. the newly io treated patients did not receive immunotherapy, chemoradiotherapy before participate in the trial; 8. sign informed consent and be willing to provide 5ml of peripheral blood for research exclusion criteria: 1. genetic test showed egfr and alk mutations; 2. patients with other co-morbidities that may affect their follow-up and short-term survival; 3. patients with any history of antitumor therapy; 4. patients with a history of other systemic tumors; 5. the ineligible participants assessed by the researchers
influence of triflusal on cognitive functions in healthy subjects

Conditions: Healthy

Summary: the purpose of this study is to investigate the effects of the enos activating agent triflusal on episodic memory and cognitive functions in healthy participants.

randomised, placebo controlled, double blind, cross-over design primary study outcomes are: performance in picturial and verbal memory tasks. main secondary outcomes are: performance in working memory and cognitive tasks and influence on mood, depression and anxiety and motivation. once daily oral administration of placebo mannitol for 7 days in a cross-over trial with a washout period of at least 14 days between the two periods. each participant will take triflusal as well as placebo

Eligibility criteria:
inclusion criteria: * healthy * male or female * normotensive * bmi between 20 and 27 kg/m2 * aged between 18 and 40 years * native or fluent german-speaking * caucasian * female practicing safe contraception exclusion criteria: * acute or chronic psychiatric or somatic disorder * any contraindication against aspirin or other nsaids * history of coagulation disease * history of gastrointestinal disease * laboratory exclusion criteria: values of blood count, blood chemistry and coagulation status outside normal range * pathological ecg * pregnancy, breast-feeding
patient centered results for uterine fibroids

Conditions: Fibroids, Uterine

Summary: the overall goal of this project is to better enable patients with uterine fibroids (uf) to make informed decisions about treatment options by leveraging the highest possible evidence of healthcare quality. the foundation of this project will be a multi-site, prospective registry of a diverse group of women who have undergone either medical or surgical treatment for uf. specifically, the investigators are interested in: comparing management options for symptom relief; comparing management options for preserving reproductive function; and comparing effectiveness among different subpopulations, including consideration of patient needs and preferences of treatment options.

compare uf will enroll approximately 10,000 subjects across 9 clinical enrolling centers in the us. we anticipate recruitment to last approximately 24 months. sites will consent interested patients and have them complete a patient contact information form to be used to contact the patient for telephone interviews. following informed consent, the site will collect clinical information and several patient-reported outcomes scales, including the uterine fibroid symptom quality of life questionnaire (ufs-qol), the menopausal rating scale, and the eq-5d, a standardized measure of general health outcomes. in year 01 of this study, among patients receiving a procedure to treat their uf, 1000 will be asked to provide two blood samples: the first at time of enrollment (before the procedure) and the second at 12 months after the procedure. samples will be evaluated for ovarian reserve via a blood assay measurement of anti-mullerian hormone. additionally, for patients who have a procedure to treat their uf, they will have a routine clinic follow-up visit, sometime between 6 - 12 weeks post procedure. additional clinical data will be collected at this time. for patients who are treated medically, there will be no further study-related clinic visits. follow-up will occur exclusively by telephone. all consented patients will complete telephone interviews at approximately 12, 24, and 36 months following the initial procedure. it is anticipated that patients enrolled during the first study year will complete a maximum of three years of follow-up. however, if additional funds become available, the investigators plan to extend the follow-up of enrolled patients to five years.

Eligibility criteria:
inclusion criteria: * diagnosis of uf by imaging or pathology report within 2 years of enrollment initiation. * menstrual period within 12 months exclusion criteria: * post-menopausal * men * 55 years old or older
short-course antimicrobial therapy for paediatric respiratory infections

Conditions: Community-acquired Pneumonia

Summary: randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.


Eligibility criteria:
inclusion criteria: children aged 6 months to 10 years presenting with cap will be eligible. cap will be defined if all of the four following numeric criteria are met: 1. fever (\>37.5 c axillary, \> 37.7 c oral, or \>38 c rectal) recorded in the ed or at home in the 48h prior to presentation; 2. any one of: 1. tachypnoea on exam (\>60 bpm for age \ 50 bpm for 1-2 y of age, \>40 bpm for 2-4 y of age, and \>30 bpm for \>4 y of age); 2. cough on exam or by history; 3. increased work of breathing on exam; or 4. auscultatory findings (focal crackles, bronchial breathing, etc.) consistent with pneumonia; 3. infiltrates on chest radiograph consistent with bacterial cap as judged by the ed physician; and 4. the attending ed physician diagnoses the child with primary cap. (children treated with systemic steroids in the ed will be presumed to have primary asthma exacerbation with possible infection and therefore will not meet inclusion criteria.) participants must be well enough to be treated as outpatients (discharged home by the ed physician, adequate volume status, able to tolerate oral medication, oxygen saturation \> 90%, no evidence of impending respiratory failure), and have no evidence of empyaema or necrotizing pneumonia on chest radiograph. exclusion criteria: children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease, history of repeated aspiration or velopharyngeal incompetence, malignancy, conditions requiring treatment with immune suppressants, primary immunodeficiency, advanced hiv infection, prolonged admissions (\>48 h) to hospital within the past 2 months, pneumonia previously diagnosed within the past month, lung abscess diagnosed within the past six months, receipt of \> 24 hours of beta-lactam antibiotic therapy already received at presentation to the ed, receipt of at least a 5 day course of amoxicillin \< 72h prior to presenting to the ed, receipt of an intravenous cephalosporin or azithromycin in the ed, or suspected allergy to penicillin. children will not be eligible to participate more than once.

Keywords: antibiotic stewardship non-inferiority randomized controlled trial