Kornimate/medical-research-clean huggingface dataset:
negotiating a quit date or not in online interventions

Conditions: Nicotine Dependence, Cigarettes

Summary: the primary purpose of the current study is to test the effect of providing users of automated web-based smoking cessation interventions with the option of negotiating and re-negotiating the quit date.

web- and mobile phone health behavior change interventions, including smoking cessation programs, offer great promise, but little is known about how such interventions should be designed to increase their efficacy the primary purpose of the current study is to test the effect of providing users of automated web-based smoking cessation interventions with the option of negotiating and re-negotiating the quit date. the investigators propose a 2-arm rct with 1500 adult study participants that all receive a best practices web-based smoking cessation program designed for use on smart phones (web-app). the intervention includes a ten day/session preparation phase (participants continue smoking) as well as a four week post-cessation follow-up phase (14 sessions). the post-cessation phase will only be given to participants that report an initial quit attempt. participants will be randomized to two versions of the intervention: 1) a version that does not provide participants with the option of negotiating the quit day (the preparation phase is fixed to ten days/sessions); or 2) a version that provides the participants with the option of negotiating/re-negotiate the quit day on three occasions. the three occasions are on the first day/session of the intervention, on the fourth day/session of the intervention and on the eleventh day/session of the intervention. the primary outcome is making a quit attempt.

Eligibility criteria:
inclusion criteria: * 18 year or older * being a current smoker * determined to or considering to quit smoking * provide valid e-mail address * provide valid norwegian cell phone number * complete a baseline questionnaire * start using the intervention (pushing the next page button one time or more on the first session provided exclusion criteria: -

Keywords: online intervention e-health negotiating quit date
electrical stimulation improves exercise tolerance in patients with advanced heart failure on continuous dobutamine use

Conditions: Heart Failure; Ventricular Dysfunction, Left

Summary: the purpose of this study is to determine whether neuromuscular electrical stimulation can improve exercise tolerance for patients with heart failure and continuous dobutamine use in a hospital.


Eligibility criteria:
inclusion criteria: * advanced heart failure (stage d - left ventricle ejection fraction \<30%) * new york heart association class iii-iv * standard medical therapy for heart failure management * continuous inotropic infusion exclusion criteria: * unstable angina pectoris * recent (6 months) acute coronary syndrome * arrythmias * chronic renal failure * diabetes mellitus * peripheral vascular diseases * inability to walk
dysbiosis & long covid

Conditions: COVID-19

Summary: the sars-cov-2 virus causes covid-19, which ranges from mild initial symptoms to severe multi-organ dysfunction. while some patients recover to their baseline states, others develop a long covid, or post-acute sequelae of sars-cov-2 (pasc) consisting of symptoms persisting \>2-6 months post-infection. pasc symptoms include post-exertional malaise, fatigue, and heart palpitations as well as incident gi disorders, cognitive dysfunction, and arthritis. based on prevalence/incidence studies, it is estimated that more than 30 million people in the us have ever developed pasc with 10-11% of patients or 11 million people continuing to feel symptoms to the present day10. sars-cov-2 vaccines are only \~32% effective against infection at 4 months post-vaccination11, only 15% effective against the development of pasc12, and only 20% of american adults have received an updated booster as of december 202313. it is therefore imperative that the scientific community make progress in identifying underlying causes of pasc to develop effective treatments. this study will identify microbial metabolites associated with pasc-mediated gut dysbiosis and establish a tractable in vitro model to test t cell-gut epithelium dynamics to develop novel bio-therapeutics for multiple post-viral conditions. this case-control study will collect biospecimens (matched stool \& blood) samples from 400 people with and without long covid (200 participants/group) to understand how covid-induced dysbiosis impacts symptom severity, immune suppression, and gut barrier dysfunction both ex vivo and in vitro.


Eligibility criteria:
inclusion criteria: * age: 18-80 * sex: any * race: any * last covid infection: within past 3 years, pcr- or antigen-confirmed, symptomatic (mild/moderate/severe) * covid vaccination status: any * presence of long covid symptoms (gi, cardiac, pulmonary, neuro, musculoskeletal, and/or psych): 200 with symptoms, 200 w/o symptoms as defined by sbq-lctm. * may or may not be doing routine endoscopy at ucm exclusion criteria: * age \ 80 * last covid infection \>3 years ago (pcr/antigen-confirmed, symptomatic) * currently or within the last 3 months covid+ by nasopharyngeal pcr/antigen test * currently diagnosed with cancer * currently pregnant (cannot take colon biopsy sample; only eligible for survey/blood \& stool collection) * currently on biologic immunomodulatory medications * official diagnosis of irritable bowel disease (ibd) or other chronic gi disorder vulnerable and/or special populations * healthy adult volunteers * pregnant people * ucmc and uchicago employees * staff/faculty
quality of life and voice perception in patients laryngoctomized phonatory wearers

Conditions: Quality of Life; Larynx Cancer

Summary: prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.


Eligibility criteria:
inclusion criteria: * patients who will undergo laryngeal demolition surgery, total laryngectomy, who agree to phonatory prosthesis placement * patients who have undergone previous total laryngectomy surgery and intend to undergo placement of phonatory prosthesis. * age \> 18 years * written informed consent exclusion criteria: * patients who have not undergone demolitive surgical treatment by total laryngectomy or who do not accept the placement of phonatory prosthesis. * patients who are unable to complete questionnaires/follow the rehabilitation pathway
non-invasive brain stimulation for gait improvement in patients with spinal cord injury

Conditions: Functional Improvement

Summary: to optimize the functional outcome in early phase of gait rehabilitation in subacute incomplete sci patients using rtms as an additional treatment to physical therapy (e.g. to gait training in lokomat®). using this add-on therapeutic strategy, we expected larger improvement of gait function than with physical therapy alone.

repetitive transcranial magnetic stimulation (rtms) is a noninvasive and painless procedure to modulate cortical excitability of motor areas and induce changes over the descending corticospinal output. this modulation may be useful to promote active recovery of motor function and to obtain functional benefit from gait rehabilitation. through the use of repetitive high-frequency rtms, improvement has been reported in motor and sensory functions measured by american spinal cord injury association (asia) impairment scale (ais), and time to complete a peg-board task in four chronic incomplete cervical sci patients. physical therapy aims to improve function of both undamaged and also, as far as possible, damaged neuronal structures. however, 'reorganization' of neuronal circuits is the target of specific training approaches. therefore, the challenge is to guide cns plasticity in order to optimize the functional outcome for a given individual. hypothesized was that high-frequency rtms coupled with gait training can improve motor recovery in the lower extremities and locomotion in incomplete sci patients to a greater degree than sham stimulation.

Eligibility criteria:
inclusion criteria: 1. had subacute motor incomplete sci (ais-c or d), 2. candidate for gait rehabilitation with lokomat® after cervical or thoracic sci; 3. stable medical treatment at least one week before and during the study; 4. without limitation of passive range of movement in joints 5. agreed to participate after signing a written informed consent form. exclusion criteria: 1. unstable clinical state 2. severe spasticity (mas\>=3) 3. disagreed to sign consent form
comparison of pain sensation during single use of two topical non-steroidal anti-inflammatory drugs (nsaids)

Conditions: Pain

Summary: different case reports are showing that depending on the drug used for eye drops, it might provoke a painful sensation. actually two leading nsaids are used in ophthalmology. this study is intended to provide information about this parameter concerning these two drugs.


Eligibility criteria:
inclusion criteria: * patient over 21 years old * no ocular surface pathology * eligible for cataract surgery exclusion criteria: * any other eye pathology other than cataract

Keywords: pain pain after eyedrops
cd19-cart treatment for all

Conditions: Acute Leukemia

Summary: this study aims to evaluate the safety and efficacy of a novel cd19-cart in the treatment of refractory or recurrent all.

chimeric antigen receptor t cell (cart) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into t cells. this kind of engineered t cells gains the ability to recognize antigen specific tumor cells and initiate the killing process in a hla-independent way. cd19 is the specific cellular marker of b lineage acute leukemia (b-all), thus cd19-cart will be efficient in treating b lineage all. the investigators have constructed two kinds of cd19-cart. one is equipped with a murine cd19 scfv (single-chain variable fragmentt), while the other with a humanized scfv. this study aims to evaluate the safety and efficacy of both murine and humanized cd19-cart in treating refractory or recurrent all.

Eligibility criteria:
inclusion criteria: 1. previously identified as cd19+ all. 2. all patients not eligible for allogeneic sct or relapse after allogeneic sct. 3. expected survival \>12w. 4. creatinine \< 2.5 mg/dl. 5. alanine transaminase (alt)/aspartate aminotransferase (ast) \< 3x normal 6. bilirubin \<2.0 mg/dl 7. voluntary informed consent is given. exclusion criteria: 1. pregnant or lactating women. 2. uncontrolled active infection. 3. active hepatitis b or hepatitis c infection. 4. concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary. 5. previously treatment with any gene therapy products. 6. any uncontrolled active medical disorder that would preclude participation as outlined. 7. hiv infection.
cessation of long term nas vs. keeping on nas among chb patients (cnavk)

Conditions: Chronic Hepatitis B

Summary: to identify the collected cases who can stop nas safely with satisfactory clinical outcome including sustain viral remission and hbsag clearance among chronic hepatitis b(chb) patients.

nucleos(t)ides analogues(nas) is a safe and effective treatment among chronic hepatitis b(chb) patients with excellent tolerance. entecavir or tenofovir mono therapy has been shown to achieve inhibition of hbv replication in almost all adherent patients. however, hbsag loss rate is low even after long-term nas treatment. recent studies indicated that cessation of nas treatment could increase hbsag clearance rate. identifying the collected cases who can stop nas safely with satisfactory clinical outcome including sustain viral remission and hbsag clearance is very important.

Eligibility criteria:
inclusion criteria: 1. hbsag positive, hbeag negative, antibody to hbeag-positive; 2. stable administration of anti-hbv neucleos(t)ides analogue mono therapy for at least more than one and a half year; 3. demonstration of undetectable hbv dna on three occasions, each at least 6 months apart, which is consistent with the apasl stopping rule; 4. patients read, understand the consent form, and signed the study consent. exclusion criteria: 1. patient with other liver diseases; 2. patient with concurrent hepatitis viruses or hiv infection; 3. patients are reluctant to stop their anti-hbv treatment.
spinal cord stimulator implant study

Conditions: Back Pain

Summary: this study is for patients who have been approved by their doctors and insurance companies to receive spinal cord stimulator implants. the goal of this study is to investigate if pain and disability is improved in patients with an implant in combination with coping skills training. these patients are compared with those with an implant that receive chronic education information and those with an implant that are in the control group and receive no additional training or information.

this study tests the hypotheses that a pain coping skills program in combination with an scs implant can improve short- and long-term outcomes in self-efficacy for coping with chronic pain, physical disability, psychological distress, and pain intensity. participants are patients who have been approved by their doctors and insurance companies to receive the spinal cord stimulator trial. after patients have been approved, they can be enrolled in this study. after completing a baseline evaluation, patients are randomized into (1)six individual pain coping skills training sessions(relaxations techniques, communication skills, goal setting), (2) six individual chronic pain education sessions (discussion approach to etiology and treatment of chronic pain and information on spinal cord stimulator implants, or (3) treatment as usual (no study intervention). participants are evaluated prior to or shortly after their surgery, at post treatment, at 6 month follow-up and at 12 month follow-up. all participants continue their routine medical care throughout the study.

Eligibility criteria:
inclusion criteria * daily back pain for 6 months or more * approved by physician and psychologist for implant * ability to read and write english * at least 18 years old exclusion criteria: * pending litigation * not approved for implant

Keywords: chronic back pain spinal cord stimulator implant
bioavailability study of (buspar) buspirone hcl tablets under fasting conditions

Conditions: To Determine Bioequivalence Under Fasting Conditions

Summary: to compare the single-dose bioavailability of par and bristol-myers squibb buspirone hcl tablets

to compare the single-dose bioavailability of par and bristol-myers squibb (buspar) 15 mg buspirone hcl tablets under fasting conditions, following administration of a 30 mg dose

Eligibility criteria:
inclusion criteria: * healthy male volunteers, 18-45 years of age * weighing at least 60 kg, who are within 10% of their ideal weights (table of "desirable weights of adults", metropolitan life insurance company, 1983) * physical examination and laboratory tests of hematologic, hepatic and renal functions * medically healthy subjects with clinically normal laboratory profiles will be enrolled in the study exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease * the presence of alcoholism or drug abuse within the past year * hypersensitivity or idiosyncratic reaction to buspirone hcl * subjects who have been receiving monoamine oxidase inhibitors * subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study * subjects who, through completion of the study, would have donated in excess of 500 ml blood in 14 days, or 500-750 ml of blood in 14 days (unless approved by principal investigator, 1000 ml blood in 90 days, 1250 ml blood in 120 days, 1500 ml blood in 180 days, 2000 ml blood in 270 days, 2500 ml blood in 1 year * subjects who have participated in another clinical trial within 28 days of study start

Keywords: bioequivalence buspirone hcl fasting
reperfusion time in st segment elevation myocardial infarction (stemi)

Conditions: Myocardial Infarction

Summary: reperfusion delay in stemi has been shown to be excessive in our community. in order to improve delay a fast track (direct transfer in catheterization laboratory) has been implemented. the present study aims at evaluating the benefits of this procedure.

reperfusion delay in stemi has been shown to be excessive in our community. admission in emergency room and waiting for transfer to catheterization laboratory seems to be the principal source of delay. in order to improve delays a fast track (direct transfer in catheterization laboratory) has been implemented for patients being diagnosed with stemi by emergency physician out of hospital. the present study aims at evaluating the benefits of this procedure.

Eligibility criteria:
inclusion criteria: * diagnosis of stemi exclusion criteria: * on site resuscitated patients

Keywords: stemi st elevation myocardial infarction
effect of beta-glucan on cholesterol lowering

Conditions: Hypercholesterolemia

Summary: the primary aim of this study is to determine whether the cholesterol-lowering efficacy of barley b- glucan varied as function of molecular weight (mw) and the total daily amount consumed. our second aim is to investigate the mechanism responsible for the action, specifically, whether β-glucan lowers circulating cholesterol concentration via inhibiting cholesterol absorption and synthesis. thirdly, we aim to determine if any gene-diet interactions are associated with cholesterol lowering by barley β-glucan. in addition, we aim to investigate the alteration of the gut microbiota after β-glucan consumption and the correlation between the altered gut microbiota and cardiovascular disease risk factors.

this study consists of four dietary phases which are separated by \>28 days wash-out period. during the treatment phase, participants will be provided with all meals for the 35 day period. breakfast meals will be consumed under the supervision of the research staff and lunch, dinner and snacks will be provided to take home in take-out packaging. while subjects are on the wash-out period they will return to their normal diet. the meals are on a 7 day rotating schedule that reflect an average canadian diet. changes in blood lipids, body weight, and waist circumference will be measured during each treatment phase. cholesterol absorption and synthesis will be examined by stable isotope method. single nucleotide polymorphisms (snps), rs3808607 of gene cyp7a1and rs429358 and rs7412 will be determined bytaqman® snp genotyping assay following the manufacturer's protocol. fecal samples will be collected at the end of each intervention phase and will be subjected to illumina sequencing of 16s rrna genes.

Eligibility criteria:
inclusion criteria: * bmi 20-40 kg/m2 * fasting cholesterol levels of 5.0-8.0 mmol/l * fasting serum ldl cholesterol levels of 2.7-5.0 mmol/l exclusion criteria: * pregnant or lactating * taking lipid lowering medication or nutritional supplements that affect blood lipids * dietary restrictions which would affect consuming the study diet for 5-wk for four study phases. * not deemed healthy by study physician

Keywords: beta-glucan barley molecular weight viscosity cholesterol stable isotope gene-nutrient interaction gut microbiota
vocal cord movement assessment using airway ultrasound.

Conditions: Vocal Cord Movement Assessment by Airway Ultrasound

Summary: total of 100 patients are included in this is a prospective observational study to evaluate the role of airway ultrasound (usg) in assessing vocal cord mobility in patients undergoing thyroid surgery. patients will be scanned preoperatively by airway ultrasound which will be compared to post operative ultrasound scans.

all 100 patients between age groups of 15-70 years, will be scanned pre-operatively to see vocal cord mobility as a reference value. a proper acoustic window is mandatory for optimal visualization of laryngeal structures. visibility of false vocal cords, true vocal cords and arytenoids will be given one point each for one side, maximal score will be 6. according to points the acoustic window scoring for glottis aperture will be graded as fair, when both false vocal cords are visible (score1-2), along with false cord when both arytenoids are visible scored good (score3-4) and if single or both true vocal cords are visible then scored as very good(score5-6). after the surgery the same patient will be scanned again for vocal cord mobility at 4hours of extubation . any change in mobility will be recorded. if any change will be observed, direct laryngoscopy (dl) will be done to confirm the diagnosis. any complication in the post-operative period will be recorded.

Eligibility criteria:
inclusion criteria: * patients undergoing thyroid surgery between specified age limits. exclusion criteria: * retro sternal goiters.
osteopathic treatment in adult patients with cystic fibrosis

Conditions: Cystic Fibrosis; Back Pain; Neck Pain; Chest Pain

Summary: to study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis

to compare the impact of osteopathic treatment to a placebo of osteopathic treatment and to usual care on pain at 6 months in adult patient with cystic fibrosis localized to chest, cervical, dorsal neck or back.

Eligibility criteria:
inclusion criteria : * diagnosis of cystic fibrosis ( positive sweat test and / or presence of 2 disease causing mutations in the cftr gene * age \> 18 years * patient with chronic chest , neck or back pain * written informed consent * with health insurance exclusion criteria : * regular follow-up by an osteopathic physician in the previous 3 months * patients awaiting lung transplantation * history of lung transplantation * pregnancy * understanding disorders preventing the patient to apply the study * participation in another clinical interventional study protocol

Keywords: complementary and alternative medicine osteopathic treatment