Kornimate/medical-research-clean huggingface dataset:
reduction of af ablation induced thrombo-embolic incidence pilot study

Conditions: Paroxysmal Atrial Fibrillation

Summary: the reduce-te pilot study is an international, multicenter, prospective, single arm study to compare the alcath flux extra gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after pulmonary vein isolation to historical data from the literature.


Eligibility criteria:
inclusion criteria: * electrocardiographically documented, symptomatic paroxysmal af. * patients with indication for left atrial ablation of af according to esc guidelines for the management of atrial fibrillation. * anticoagulation according to clinical routine using coumarin derivates with target inr between 2.0 and 3.0 at least 3 weeks prior to the scheduled ablation procedure or novel oral anticoagulants (noacs). * geographically stable for the duration of the study. * willingness and ability to perform written informed consent exclusion criteria: * long standing persistent or persistent af * cha2ds2-vasc score ≥ 5 * prior ischemic stroke or transient ischemic attack * previous pulmonary vein ablation * contraindication for anticoagulation therapy * contraindication for diffusion-weighted mri * claustrophobia * contraindication for transesophageal echocardiography (tee) or intracardiac echocardiography (ice, if tee not possible) * implanted cardiovascular device, including but not limited to an atrial or ventricular pacemaker or defibrillator leads, artificial valves, stents, septal or laa occluders * acute coronary syndrome \< 3 months prior to scheduled ablation * moderate to severe valvular heart disease * la size \> 55 mm (confirming echo at maximum 3 months old) * patients with non-controlled heart failure or patients with current and recent (\< 1 month prior to ablation) heart failure * ejection fraction \< 35% (confirming echo at maximum 3 months old) * conditions that prevent patient's participation in neurocognitive assessment (at physician's discretion) * female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study * any limitation to contractual capability * simultaneous participation in another study * age \< 18 years
phase i, open-label, dose escalation of azd4877 in hematologic malignancies

Conditions: Lymphoma

Summary: the primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called azd4877 based on the side effects experienced by patients that receive azd4877 on a weekly basis in these diseases.


Eligibility criteria:
inclusion criteria: * patients with aml, a certain type of all, nhl and mm * certain types of cancer of the lymph nodes * certain types of leukemias (blood cancers) * disease has or will fail with other treatments * relatively good overall health other than your cancer exclusion criteria: * poor bone marrow function (not producing enough blood cells) * serious heart conditions * poor liver or kidney function

Keywords: phase i cancer lymphoma leukemia myeloma aml all nhl mm
an open-label, dose-escalation study of incb054329 in patients with advanced malignancies

Conditions: Solid Tumors and Hematologic Malignancy

Summary: this was a study of incb054329 given to patients with advanced malignancies that were conducted in three treatment groups. each treatment group had a dose escalation (part 1) and a dose expansion (part 3), two of the treatment groups also had an intra-patient dose titration (part 2).


Eligibility criteria:
key inclusion criteria: * confirmed diagnosis of advanced malignancy: * treatment group a (tga): part 1 and part 2: any advanced solid tumor or lymphoma; part 3: histologically confirmed disease in specific solid tumors and lymphomas * treatment group b (tgb): acute leukemia (part 3 - acute myeloid leukemia \[aml\] only), myelodysplastic syndrome (mds), myelodysplastic /myeloproliferative neoplasms (mds/mpn) and myelofibrosis (mf) * treatment group c (tgc): multiple myeloma * progressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy) * eastern cooperative oncology group (ecog) performance status of 0 or 1 in parts 1 and 2 dose escalation and titration, and 0, 1, 2 in part 3 dose expansion key exclusion criteria: * inadequate hematopoietic, liver, endocrine or renal function * receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug: * \< 6 weeks for mitomycin-c or nitrosoureas * \< 5 half-lives or 14 days, whichever is longer, for any investigational agent (for any indication) * \< 28 days for any antibodies or biological therapies * \< 5 half-lives for all other anticancer medications, or sponsor approval * prior radiotherapy within 2 weeks prior to first dose of study drug * untreated brain or central nervous system (cns) metastases * type 1 diabetes or uncontrolled type 2 diabetes * any sign of clinically significant bleeding

Keywords: solid tumor lymphoma bet bromodomain inhibitor brd diffuse large b-cell lymphoma (dlbcl) burkitt's lymphoma c-myc colorectal cancer non-small cell lung cancer pancreatic adenocarcinoma castration-resistant prostate cancer breast cancer nut midline carcinoma leukemia acute myeloid leukemia (aml) myelodysplastic syndrome (mds) myeloproliferative neoplasms myelofibrosis (mf) multiple myeloma (mm) mds/mpn
effect of local anesthetic on hemodynamic measures during nasal surgery

Conditions: Heart Rate; Blood Pressure; Blood Loss During Surgery; Surgical Field

Summary: 1% lidocaine with 1:100,000 to 1:200,000 of epinephrine is routinely injected into the nasal mucosa during nasal surgery to reduce patient blood loss and improve the surgical field and visibility. typically 1% lidocaine with 1:100,000 of epinephrine is used in nasal surgery. however, 1 % lidocaine with 1:200,000 (which is a more dilute solution of epinephrine) is also used. this latter dose theoretically should have a lesser effect on cardiac stimulation which increases the heart rate and blood pressure at the time of surgery. the nasal mucosa has excellent absorbing ability which is great for the application of drugs but there is concern for systemic absorption and side effects. potential serious side effects can occur with local injection such as hypertension, tachycardia, and cardiac arrhythmias. these side effects occur mainly through the absorption of epinephrine. it is the goal of this study to see if a weaker concentration of epinephrine (1:200,000) can maintain a good surgical field with a decrease in hemodynamic side effects.

objective- to evaluate the effect of 1% lidocaine with 1:200,000 of epinephrine on hemodynamic measures and bleeding in the surgical field in patients undergoing nasal surgery compared to 1% lidocaine with 1:100,000. recruitment plan- patients undergoing general anesthetic for nasal surgery (septoplasty or sinus surgery) will be asked to participate in this study. all patients undergoing nasal surgery are injected with local anesthetic into the nasal mucosa after induction of general anesthetic. those patients who agree to participate in the study will be randomized into 2 groups (injection either 1 % lidocaine with 1:100,000 or 1:200,000 of epinephrine). procedures 1. patients will be put to sleep following standard general anesthetic protocol 2. patients will be injected with either 1% lidocaine with 1:100,000 or 1% lidocaine with 1:200,000 into the nasal mucosa 3. after injection the following will be measured every 15 minutes for the first hour to evaluate effectiveness of the local anesthetic. 1. heart rate 2. blood pressure 3. routine ecg monitoring 4. map (mean arterial pressure) 5. surgical field, degree of bleeding. alternatives- subjects can refuse to participate in the study. if subjects refuse to participate in the study they will still be injected with 1% lidocaine with 1:200,000 of epinephrine which is standard of care data analysis- data will be compiled and statistical analysis will be made using prism software.

Eligibility criteria:
inclusion criteria: * any patient between the ages of 16-75 who is scheduled to undergo routine nasal surgery. exclusion criteria: * allergy to lidocaine, * recent mi, * recent stroke, * uncontrolled hypertension, * arrhythmias, * congestive heart failure.
effects of erector spinae plane block method used in pain management in heart surgery on vascular diameters

Conditions: Coronary Artery Disease; Erector Spinae Plane Block; Bypass Extremity Graft

Summary: off-pump coronary artery bypass grafting (opcabg) is a bypass method performed on the working heart. pain is a frequently seen side effect experienced following this surgery. erector spinae plane block is our analgesia method that the investigators routinely perform prior to the surgery to overcome this problem. in this method, analgesic medication is given via a needle in between the two superficial muscle groups (erector spinae muscles) located in participants back. the investigators believe this method not only provides pain relief, but also is beneficial (dilating) on the vessels that will be used for bypassing the clogged vessels during the surgery. the investigators aimed to measure some parameters in this routine procedure before and after performing the analgesic method with an ultrasound (imaging with sound waves).


Eligibility criteria:
inclusion criteria: * patients who are aged between 18-75, * asa iii * patients who are undergoing off pump coronary artery bypass grafting surgery exclusion criteria: * patients who are allergic to planned-medications, * those with previous cardiac surgery, * patients undergoing emergency surgery, * uncontrolled diabetes mellitus, * chronic opioid or opioid receptor agonist users, * those with pre-operative neuropathies, psychiatric diseases, * non-communicable patients and * those who refuse to participate

Keywords: cardiac anesthesia sympathectomy off-pump coroner artery by-pass surgery
digital otoscope versus education and feedback for otitis media in young children

Conditions: Otitis Media; Antimicrobial Stewardship

Summary: randomized controlled trial involving 40 pediatric primary care clinicians with high rates of diagnosing and treating middle ear infections. ten enrolled clinicians will be randomly assigned to each of 4 arms for a three-month trial: 1) personalized education and feedback about proper ear infection diagnosis; 2) use of a digital otoscope; 3) both education and feedback plus use of a digital otoscope; 4) control (no intervention).

randomized controlled trial involving 40 pediatric primary care clinicians with rates of otitis media diagnosis and antibiotic prescribing in the top quartile of the entire clinician population of the pediatric physicians' organization at children's over the previous 12 months who consent to enroll in the trial after direct outreach from the study team. ten enrolled clinicians will be randomly assigned to each of 4 arms for a three-month intervention period: 1) personalized education and feedback about proper otitis media diagnosis following criteria from the american academy of pediatrics; 2) use of the wispr digital otoscope; 3) both education and feedback plus use of the wispr digital otoscope; 4) control (no intervention).

Eligibility criteria:
inclusion criteria: * pediatric primary care clinicians from the pediatric physicians' organization at children's with an otitis media treatment index for the previous 12 months in the top quartile of all pediatric physicians' organization at children's clinicians with at least 100 qualifying encounters in the year exclusion criteria: * currently using any digital otoscope * more than one other clinician from the same practice participating in the trial
group cognitive behavioural family intervention (cbfi) for people with schizophrenia and their families

Conditions: Schizophrenia; Psychosis

Summary: cognitive behavioural family intervention (cbfi) is a brief psychosocial intervention that incorporates the model of cognitive behavioural therapy (cbt) into the family context. it builds upon the current trend of family interventions/psychoeducation with refocusing on the cognitive model within the family interpersonal relationship. existing literature indicates that cbfi may be effective in improving positive and negative symptoms of people diagnosed with schizophrenia immediately following the programme. this mixed-method is to evaluate the feasibility and effectiveness of a cbfi programme for people with schizophrenia and their families in a local context. the findings may accumulate more evidence that cbfi is a brief and effective psychosocial intervention that is adapted to hong kong clinical settings.


Eligibility criteria:
inclusion criteria: service users * diagnosis of schizophrenia-spectrum disorders, based on clinical judgement by the treating clinicians * aged 18-65 * able to communicate in cantonese family caregivers * aged above 18 * living with service users * able to communicate in cantonese * nominated by the service users exclusion criteria: service users * having co-morbidity of learning disability * organic/neurological conditions * substance misuse disorder family caregivers * having active psychiatric conditions * looking after more than one family member suffering from chronic physical or mental illnesses

Keywords: schizophrenia psychosis family intervention cognitive behavioural therapy cbt
efficacy of a digital biofeedback system for home-based rehabilitation after total joint replacement

Conditions: Hip Osteoarthritis; Knee Osteoarthritis

Summary: the study was designed to assess the efficacy of a home-based rehabilitation program using a digital kinematic biofeedback system after total hip or knee replacement. this is a single-arm prospective study. patients will be enrolled pre-operatively and will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery. this program will consist of rehabilitation sessions performed independently by the patient at under remote monitoring from a physical therapist. outcomes will be measured at baseline, 4 weeks into the rehabilitation program and at the end of the program. the primary outcome is the change in patient performance measure through the timed-up-and-go (tug) test in comparison with the pre-operative score. secondary outcomes will be measured in terms of: a) patient reported outcomes (hip or knee osteoarthritis outcome score) and b) range of motion of the relevant joint (hip or knee).


Eligibility criteria:
inclusion criteria: * clinical and imaging evidence of hip/knee osteoarthritis * indication for total hip/knee replacement according to the patient´s orthopedic surgeon * ability to walk unaided, with unilateral or bilateral support * availability of a carer to assist the patient after surgery exclusion criteria: * patients admitted for revision of total hip/knee replacement * contralateral hip or knee osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program * aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process * respiratory, cardiac, metabolic or other condition incompatible with at least 30 minutes of light to moderate physical activity * major medical complications occurring after surgery that prevent the discharge of the patient within 10 days after the surgery * other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program * blind and/or illiterate patients
acute exercise and energy balance regulation: effect of intensity

Conditions: Obesity

Summary: physical activity is mainly considered and use for its impact on energy expenditure in the treatment of obesity, and less is known concerning its indirect effects on energy intake. the aim of this work is to clarify the impact of an acute bout of exercise, depending on its intensity (high versus low), on the following energy intake and nutrient utilization, in obese and non-obese boys and men.

20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean) will complete a sub-maximal test on a ergo cycle to draw their linear relationship between vo2 and fc. then they will enter a metabolic chamber three times, for 24 hours each. a first session will be considered as sedentary, and volunteers will remain inactive. during the second and third session, they will have to complete a cycling test generating an energy expenditure of 400 kcal, once at low intensity (40%vo2max) and once at high intensity (70% vo2max). those three sessions will be realized in a randomized order with an interval of at least 7 days and urinary collection over the 24hours will be done during all the sessions. at the beginning of the protocol, blood samples will be taken, body composition assessed by dxa and adiposity location evaluated by mnr.

Eligibility criteria:
inclusion criteria: * male * adults between 18 to 30 years old and adolescents between 12 and 15 years old * body mass index : * lean adults : 20 \<bmi\< 25 kg.m² * obese adults : 30\<bmi\<38 kg.m² * lean adolescents: bmi \<90th percentile * obese adolescents: bmi\>97th percentile * affiliated to national health insurance * subject giving his written informed consent * subject considered as normal after clinical examination and medical questionnaire. exclusion criteria: * chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments * refusal to be registered on the national volunteers data file * being in exclusion on the national volunteers data file * practising intensive physical exercise * heavy consumer of alcohol or/and tobacco * previous medical and/or surgery judged by the investigator as incompatible with this study

Keywords: obesity acute exercise intensity of exercise energy balance regulation appetite
acupuncture for residual insomnia associated with major depressive disorder

Conditions: Insomnia; Depression

Summary: the purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment on residual insomnia in major depressive patients.

this is a randomized single-blinded controlled trial. patients will be randomly assigned to one of the three groups. one is the traditional acupuncture treatment group, one is the non-traditional acupuncture treatment group and the other is an acupuncture-like placebo treatment. patients will be put into groups and then compared. the chance of getting into each group is 1:1:1, i.e. equal chance.

Eligibility criteria:
inclusion criteria: * willing to give informed consent; * hong kong resident; * age 18-65 years; * previous dsm-iv major depressive disorder as confirmed with the structured clinical interview for dsm-iv; * hamilton depression rating scale scores of 18 or below for at screening and baseline visit; * a chief complaint of insomnia; * able to comply with the trial protocol. exclusion criteria: * any symptoms suggestive of specific sleep disorders, including loud snoring, periodic leg movement, parasomnia; * a diagnosis of sleep apnea or periodic limb movement disorder (plmd) as assessed by overnight polysomnography (psg); * presence of suicidal risk; * previous history of schizophrenia, other psychotic disorders, and bipolar disorder; * pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception; * infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe.

Keywords: insomnia depression electroacupuncture acupuncture randomized clinical trial traditional chinese medicine
to evaluate a phase ia/ib clinical study of eg017 in patients with advanced breast cancer.

Conditions: Breast Cancer

Summary: to evaluate the safety, tolerability, pharmacokinetics and efficacy of eg017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer.

the major aims of the study are to define the safety profile of this new drug, and to determine a recommended.

Eligibility criteria:
inclusion criteria: 1. female, 18-75 years old; 2. expected survival ≥ 12 weeks; 3. subjects with ecog score of physical state 0\~1; 4. histologically confirmed recurrent or metastatic advanced breast cancer; exclusion criteria: 1. those who have had a severe allergic reaction to any drug or its components in this study in the past; 2. present with primary central nervous system (cns) malignancies; subjects with cns metastasis who have failed local treatment (except asymptomatic bms, or symptomatic bms with complete remission of symptoms ≥ 2 weeks after treatment for bms); 3. has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period; 4. gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:
cukurova university faculty of medicine non-interventional clinical research institutional ethics committe

Conditions: Menopause; Sleep; Fatigue; Therapeutic Touch

Summary: this research was carried out to determine the effect of therapeutic touch on sleep quality and fatigue in menopausal women.

methods: this randomized controlled experimental study was conducted with 48 (24 in the intervention group and 24 in the control group) women who sought treatment in the gynecological outpatient clinic of a public hospital. according to the study procedure, while the intervention group received therapeutic touch, the control group received sham therapeutic touch for 10 minutes a day for five consecutive days. data were collected through the personal information form, the pittsburgh sleep quality index, and the piper fatigue scale. results: the median post-test total sleep quality score was significantly lower in the intervention group than in the control group (p=0.010). however, the mean total fatigue scores did not differ significantly between the groups (p=0.917). conclusions: the results of this study showed that therapeutic touch was effective in improving sleep quality, but it did not affect fatigue in menopausal women.

Eligibility criteria:
inclusion criteria: the study included women who agreed to participate in the study, lived in the city center, were at least literate, were in the natural premenopausal (irregular menstrual cycle within the last three months), perimenopausal (amenorrhea for 3-11 months or increased irregular menstruation), or postmenopausal (amenorrhea for more than 12 months) periods, were open to communication and cooperation, and could speak turkish. exclusion criteria: the women who received hormone replacement treatment, used drugs for sleep problems and depression, were diagnosed with a medical psychiatric disease, and had sensitivity or problems about touching were excluded.

Keywords: menopause sleep fatigue therapeutic touch