Kornimate/medical-research-clean huggingface dataset:
early discharge after mitral and tricuspid edge-to-edge repair: an assessment of feasibility and safety

Conditions: Mitral Regurgitation; Tricuspid Regurgitation; Mitral Repair; Heart Failure

Summary: mitral regurgitation (mr) and tricuspid regurgitation (tr) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation. these conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities, leaving them with few treatment alternatives. transcatheter edge-to-edge repair (teer) procedures have increasingly been used to improve the severity of both mr and tr, offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk. there is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay. the standard of care in the uk, and particularly in oxford, emphasises fewer investigations before the teer procedure and shorter length of hospital stay. this prospective, observational cohort study will examine the safety and feasibility of this practice.


Eligibility criteria:
inclusion criteria: * aged ≥18 years * accepted by heart team for teer (mitral and/or tricuspid) * willing and able to give informed consent for participation in the study. * regurgitation (mitral and/or tricuspid) grade ≥2+ as assessed by echocardiography * patient is willing and able to attend all follow-up visits exclusion criteria: * patients in whom safety or clinical concerns preclude participation * patient declines to be involved in the study (unwilling to consent to enrolment or deemed by the patient advocate to be unwilling to consent) * patient in whom a toe is contraindicated, or screening toe is unsuccessful * pregnant or planning pregnancy within next 12 months * concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator * patients requiring emergency teer

Keywords: transcatheter edge-to-edge repair mitral teer mitral regurgitation tricuspid regurgitation
evaluation of oral hygiene products in an in situ caries model

Conditions: Dental Caries

Summary: the study will evaluate and compare the potential anti-caries efficacy of a test regimen: placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to remineralize previously demineralized enamel specimens, as measured by surface microhardness recovery (%smhr). this will be a single center, randomized, laboratory analyst blinded, placebo, four treatment, cross-over study in healthy participants. participants will be assessed at baseline and at the beginning and end of each treatment visit to monitor clinical efficacy and safety.


Eligibility criteria:
inclusion criteria: 1. aged between 18 and 85 years inclusive 2. understands and is willing, able and likely to comply with all study procedures and restrictions 3. good general and mental health with, in the opinion of the investigator or medically qualified designee: * no clinically significant and relevant abnormalities in medical history or upon oral examination. * absence of any condition that could affect the participant's safety or well-being or their ability to understand and follow study procedures and requirements 4. currently living in the indianapolis, indiana area and has not had a professional fluoride treatment within 14 days of the first treatment visit 5. currently wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange areas to accommodate two enamel specimens 6. willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods 7. have a salivary flow rate in the range of normal values (un-stimulated whole saliva flow rate ≥ 0.2 milliliter (ml)/minute; gum base stimulated whole saliva flow rate ≥ 0.8 ml/minute). exclusion criteria: 1. pregnant or breast feeding women 2. known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients 3. currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit. 4. taking or have taken a bisphosphonate drug for treatment of osteoporosis. 5. participation in another gskch investigational dental product study within seven days of first study treatment. 6. previous participation in this study. 7. recent history (within the last year) of alcohol or other substance abuse.
retrospective tif study for treatment of gastroesophageal reflux disease (gerd). the retrotif study

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: the purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of transoral incisionless fundoplication (tif) performed with esophyx (brand name) in a broad range of gastroesophageal reflux disease (gerd) patients treated at high volume centers across the united states.

this retrospective, open-label, post-market study evaluates the safety and efficacy of transoral incisionless fundoplication (tif) performed with esophyx (brand name) in a broad range of gastroesophageal reflux disease (gerd) patients treated at high volume centers across the united states, in clinical routine practice, as standard of care.

Eligibility criteria:
inclusion criteria: * age 18-85 years * have undergone the tif procedure within the past 2 years * history of daily proton pump inhibitor (ppi) use for \>6 months * proven gastroesophageal reflux by either endoscopy, ambulatory potential of hydrogen (ph) or moderate to severe symptoms on or off ppis * deteriorated gastroesophageal junction (hill grade ii or iii) * availability for a follow-up visit at 6,12 or 24 months * willingly and cognitively signed informed consent exclusion criteria: * procedure not completed or performed following a non-standardized tif protocol * subjects suffering from other gastrointestinal (gi) conditions such as dyspepsia, celiac disease, irritable bowel syndrome (ibs) or crohn's disease * pregnancy * enrollment in another device or drug study that may confound the results

Keywords: gastroesophageal reflux disease gerd heartburn reflux regurgitation hoarseness cough
compliance with antidepressant medication in treatment of functional dyspepsia

Conditions: Dyspepsia; Compliance; Depression

Summary: the study hypothesis is appropriate clinician-patient communication that provides explanations of the reasons for psychoactive drug prescriptions based on the generation of fd symptoms and the drugs' effects might improve compliance with psychoactive agent regimens among fd patients.

antidepressive agents have been proved to be effective in the treatment of functional dyspepsia (fd) patients. however, one of the factors that limit therapeutic benefit is the poor compliance with prescribed drugs. the possible reasons for lack of compliance include the patient's health beliefs (e.g., that people who took such agents is possibly considered insane in china), lack of knowledge about antidepressants (that they are addictive or can be stopped on recovery), and aversion to side effects. the investigators propose to examine whether different clinician-patient communication methods could affect adherence to antidepressant drugs in functional dyspepsia patients.

Eligibility criteria:
inclusion criteria: * met the rome iii criteria for fd; * education level no lower than high school; * hospital anxiety and depression scale (hads) score \> 8 respectively; * absence of abnormalities in physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), abdominal ultrasonography and upper gi endoscopy within 6 months; * absence of h. pylori infection exclusion criteria: * known allergy to omeprazole, flupenthixol or melitracen; * any evidence of organic digestive diseases; * reflux-related symptoms only (e.g., retrosternal pain, burning and regurgitation) or predominantly reflux-related symptoms; * severe psychological symptoms that affected life and work; * pregnancy or breastfeeding; * recent myocardial infarction or cardiac arrhythmias; * previous gastric surgery; * use of ppis, psychoactive drugs or other drugs that might affect gastric function within 6 months

Keywords: functional dyspepsia depression compliance
chrononutrition and adolescent weight control

Conditions: Adolescent Obesity; Diet; Weight Loss; Sleep

Summary: comprehensive lifestyle interventions are recommended for the treatment of adolescent obesity; however, evidence suggests that they are not as effective in teens as they are in children and adults. recent evidence supports that shifting the timing of energy intake earlier in the day has led to improved weight loss outcomes among adults with overweight and obesity. given that adolescents traditionally consume the majority of their daily energy intake late in the day (past 5pm), this approach may improve the effectiveness of traditional behavioral weight control interventions in teens. therefore, the primary aim of the proposed research is to pilot a novel adaptation of an evidence-based adolescent weight control intervention in which adolescents will be randomized to consume the majority of their daily energy needs earlier versus later in the day. more specifically, 40 adolescents, ages 13-17, with obesity (bmi\>95% for age and sex) will be randomized to a 16-week evidence-based weight control intervention that has the participant consume \>50 percent of their total energy intake before 3pm (i.e. at breakfast / lunch; bfl) or after 3pm (i.e. dinner; din). assessments will take place at baseline and 16 weeks (post-treatment). the proposed study will test 1) the adherence and feasibility of the bfl vs. din interventions as measured by the average number of days on which daily energy was consumed in accordance with the prescribed eating plan and, secondarily, mean session attendance, 2) if the bfl group will have significantly greater reductions in bmi post-treatment as compared to the din group, 3) if there are differences in sleep duration and quality between groups, and finally, as an exploratory aim, whether there are differences in dietary quality between groups. the proposed research is significant, as it addresses obesity in teens. it is innovative as the timing of meals and snacks have not been manipulated in adolescents in the context of behavioral weight control. moreover, the study will shed light on whether doing so improves sleep and could help to untangle how sleep and weight gain relate in adolescents.


Eligibility criteria:
inclusion criteria: * age 13- 17 years * bmi \> 85th percentile for age and sex * ability to speak, read and write english due to the group format of the intervention * a caregiver who is willing to participate in four separate parent groups with a facilitator * agreement to study participation and random assignment. exclusion criteria: * current involvement in another weight loss program or has lost 10 pounds in the six months prior to enrollment * medical condition that interferes with the prescribed dietary plan or participation in physical activity (e.g. cardiovascular disease, type 1 or 2 diabetes mellitus, or pregnancy) * in treatment for or are diagnosed with a major psychiatric disorder, including an eating disorder, at the time of screening * taking medications that promote weight gain.
the effect of acupuncture on blood pressure and heart rate variability (hrv)

Conditions: Hypertension

Summary: this research is designed to study the effects of needle acupuncture on blood pressure and hrv by stimulating certain acupuncture points and meridians.

outcome measurements include blood pressure and heart rate variability.

Eligibility criteria:
inclusion criteria: * male or female suffering from mild hypertension (systolic bp between 130-165 mmhg, diastolic bp between 90-120 mmhg). exclusion criteria: * individuals with heart, kidney, thyroid disorders, diabetes, chronic disease or illness, neurological diseases, skin or bleeding disorders, * currently taking prescription or otc medications and/or herb/supplements that effect bp or autonomic tone will not be recruited into the study. * in addition, individuals who have a pacemaker and/or are pregnant will not be recruited in the study. a health history questionnaire was used to screen subjects.

Keywords: acupuncture, high blood pressure, hrv
study on pressure ulcers prevention with mepilex® border sacrum dressing in scheduled cardiovascular surgery

Conditions: Pressure Ulcers; Prevention; Skin Ulcer; Ulcer

Summary: the study is a randomised controlled trial of patients admitted for a scheduled cardiac surgery at the clermont-ferrand hospital. patients meeting the study inclusion criteria will be allocated to either the control group that will receive pressure ulcer prevention standard care or the intervention group that will receive pressure ulcer prevention standard care plus have a mepilex® border dressing applied to their sacrum.

the main objective of this research is to evaluate the impact of mepilex border® dressing applied in addition to standard pressure ulcer prevention protocol, in a french hospital setting, in at-risk patients in a cardiovascular surgery unit with full hospitalisation including block operation and icu. hypothesis: patients treated with mepilex® border dressings will have a lower incidence rate of sacral pressure ulcer development than patients receiving standard care.

Eligibility criteria:
inclusion criteria: * subject over 18 years of age, * subject programmed to benefit from cardiac surgery with sternotomy, * subject capable and willing to comply with the protocol and willing to give his written consent, * subject affiliated to a social security system exclusion criteria: * subject with a skin lesion in the sacral area upon admission, * subject admitted for emergency cardiovascular surgery (unscheduled subject), * subject admitted for heart transplant surgery, * subject participating in another clinical study or in a period of exclusion from a study previous, * subject with a linguistic or psychological disability to sign informed consent, * subject refusing to give written consent, * subject deprived of liberty by administrative or judicial decision, under guardianship or curatorship.
the effects of smartphone addiction on pinch strength, muscle stiffness, and hand/wrist function in young adults

Conditions: Smartphone Addiction

Summary: smartphones have become an indispensable part of daily life, and their increasing use has raised concerns about various health effects, including musculoskeletal symptoms. repetitive movements of the thumb and hand muscles can lead to issues such as tendinosis, myofascial pain syndrome, and a decrease in pinch strength. studies have shown that musculoskeletal symptoms related to smartphone use are common among young adults and university students. additionally, an increase in device size may place greater strain on the wrist and finger muscles. repetitive movements can cause stiffness changes in the thumb muscles, and the relationship between these changes and pinch strength is considered an important research topic. in this study, we aimed to investigate the effects of smartphone addiction on pinch strength, muscle stiffness, hand/wrist pain, and function in young adults.

this study was designed as a cross-sectional study. volunteers eligible to participate were first screened based on the results of the smartphone addiction scale-short version (sas-sv), and they were divided into two groups as smartphone addiction and non-smartphone addiction, with a cutoff score of 31 for males and 33 for females. subsequently, the determination of dominant hand was performed. all assessments were conducted on the participants' dominant extremity. the assessments were carried out in the following order: patient-rated wrist/hand evaluation questionnaire (prwhe), the finkelstein test, muscle stiffness measurement, and finally, pinch strength assessment, as it was considered to potentially cause fatigue. all assessments were conducted by expert physiotherapists within a total duration of 30 minutes, and participants were not followed up afterward, nor recieved any intervention.

Eligibility criteria:
inclusion criteria: * willing to participate in the study * have been using a smartphone for more than one year * aged between 18 and 25 years * send 25 or more text messages or emails per day * spend more than 2 hours browsing the internet and/or play games for more than one hour a day exclusion criteria: * having radiating/radicular pain in the upper extremity * having neck pain * congenital deformities in the upper extremity and neck * a history of diagnosed neurological, rheumatic, musculoskeletal, or cardiovascular diseases * having previously undergone surgery on the neck and/or upper extremity * having been diagnosed with de quervain's disease or tendinopathy in the hand/hand wrist muscles before

Keywords: smartphone behavior addictive muscle stiffness musculoskeletal pain
safety, tolerability, and pharmacokinetics of pti-808, pti-801, and pti-428 combination therapy in subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the study is a randomized, double-blind, placebo-controlled, study that will be conducted at multiple centers in subjects with cystic fibrosis (cf) who are either homozygous for the f508del mutation or heterozygous with at least copy of the f508del mutation.

study pti-808-02 will enroll up to approximately 32 subjects. subjects in the first cohort will receive pti-808 and pti-801. following completion of cohort 1, initiation of enrollment into subsequent cohorts will be based upon review and approval by the safety review committee (src).

Eligibility criteria:
inclusion criteria: * cohorts 1,2 and 4: a confirmed diagnosis of cf with the f508del/f508del cftr genotype on record, along with clinical findings consistent with cf such as chronic sinopulmonary disease or gastrointestinal/nutritional abnormalities * cohort 3 only: confirmed diagnosis of cf with at least one copy of the f508del cftr mutation on record, along with clinical findings consistent with cf, such as chronic sinopulmonary disease or gastrointestinal / nutritional abnormalities * forced expiratory volume in 1 second (fev1) 40-90% predicted, inclusive * non-smoker and non-tobacco user for a minimum of 30 days prior to screening * cohort 3 only: a sweat chloride value of ≥60 mmol/l based on quantitative pilocarpine iontophoresis (as documented in the subject's medical record or as confirmed at the screening visit) exclusion criteria: * currently taking or has taken a cftr modulator within 30 days prior to initial dose of study drugs * participation in another clinical trial or treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to study day 1 * history of cancer within the past 5 years * history of organ transplantation * hospitalization, sinopulmonary infection, cf exacerbation, or other clinically significant infection or illness (as determined by the investigator) requiring an increase or addition of medication, such as antibiotics or corticosteroids, within 14 days of day 1 * initiation of any new chronic therapy (e.g., ibuprofen, hypertonic saline, azithromycin, pulmozyme®, cayston®, tobi®) or any change in chronic therapy (excluding pancreatic enzyme replacement therapy) within 28 days prior to day 1 * history or current evidence of alcohol or drug abuse or dependence within 12 months of screening as determined by the investigator * pregnant or nursing women
brain lesions following endovascular and surgical treatment of unruptured intracranial aneurysms

Conditions: Unruptured Intracranial Aneurysms

Summary: the purpose of this study is to determine the incidence and impact of brain lesions in mri after coiling and clipping of unruptured intracranial aneurysms on clinical and neurological outcome of patients.

silent ischemic lesions after treatment of unruptured intracranial aneurysm (uia) might alter patients' clinical and neurological outcome. furthermore silent brain lesions are not well documented after endovascular and surgical treatment of unruptured intracranial aneurysms. therefore, the investigators investigate the incidence and influence of treatment-related ischemic lesions in magnetic resonance / diffusion-weighted-imaging after endovascular and surgical treatment of uia.

Eligibility criteria:
inclusion criteria: * diagnosis and treatment of unruptured intracranial aneurysm * age ≥ 18 yrs * written informed consent by patients prior to study participation * willingness to participate in follow-up exclusion criteria: * ruptured intracranial aneurysm * contraindication for mri * participation in an intervention-/amg-study

Keywords: treatment of
benefit of 3-d planning in total hip replacement. a prospective randomized study

Conditions: Hip Injuries; Surgery; Prosthesis User

Summary: in this prospective randomized four-armed study the investigators aim to compare wheter 3-d planning, which necessitates preoperative ct acquisition and sophisticated planning together with engineers, results in measurable benefits in terms of objective and subjective outcome values in a collective of patients undergoing primary total hip replacement. hypothesis: 1. when compared to 2-d planning, 3-d planning of a thr results in better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants. 2. when compared to a non-anatomical stem, an anatomical stem allows better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants.

patients sent to our outpatient clinic for eventual primary thr are informed about this study and written patient information given to them. when patients decide to undergo primary total hip replacement, patient's questions with respect to this study are discussed in the outpatient clinic and patients willing to participate included. block randomization using closed envelopes for age categories 40-50, 50-60, 60-70 years will be conducted to assign the participant to one of the four study arms. patients will be blinded for the type of stem and method of planning. investigators are blined in terms of methods of planning. in terms of stem design, investigators can not be blinded since their visibility on x-ray does not allow it. the preoperative investigation includes routine investigation and an additional ct scan plus evaluation of the "university of california at los angeles" (ucla) activity level and "short form health 36" (sf-36) score. the same applies for the postoperative investigation and 3 months. the follow-up visits at 1, 5 and 10 years are routine investigations with additional ucla and sf-36 scores.

Eligibility criteria:
inclusion criteria: * patients aged 40-70 years scheduled for primary thr * signed written informed consent. exclusion criteria: * charnley class b and c * asa score \>2 * pregnancy * gross hip deformity making complex hip reconstruction (greater trochanter advancement, acetabular augmentation, femoral osteotomy, use of cemented or revision stem) necessary * immature patients and patients incompetent to judge
tki258 in subjects with refractory or relapsed multiple myeloma

Conditions: Multiple Myeloma

Summary: the primary objective of this study is to determine the maximum tolerated dose (mtd), dose limiting toxicity (dlt), and safety profile of chir-258 when administered to subjects with refractory or relapsed multiple myeloma (mm).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple myeloma * evidence of relapsed or refractory disease exclusion criteria: * intracranial disease or epidural disease * clinically significant cardiac disease * diabetes mellitus

Keywords: refractory multiple myeloma or relapsed multiple myeloma