Kornimate/medical-research-clean huggingface dataset:
does atrial fibrillation (af) termination without additional ablation influence outcome?

Conditions: Atrial Fibrillation

Summary: this prospective study aims to investigate if termination of atrial fibrillation (af) after pulmonary vein antrum isolation (pvai) without additional ablation of non-pv triggers, in long-standing persistent (lsp) af, is enough to ensure long-term success.

background: af is a heterogeneous arrhythmia. at its simplest, it is triggered by rapidly firing foci around pulmonary veins (pv) and can be cured by isolation of pv alone. evidences suggest that when high frequency of atrial activation is maintained for relatively longer period (as in persistent or long-standing af), ion channel remodeling changes the electrophysiologic substrate and lead to af permanence. therefore, pvai alone, as anticipated, demonstrates to have limited success rate in persistent and lsp af and additional ablations beyond pvai involving substrate modification are advocated by many experts in electrophysiology. however, there is yet no consensus on the ablation strategy for long-standing af. it is still not clear whether af termination during ablation could be considered as an ablation endpoint or not, as earlier studies have reported results that are at variance with each other. some studies have suggested that termination of af during ablation is associated with reduced recurrence of arrhythmia while others detected no association of af termination with long-term maintenance of sinus rhythm (sr) in persistent or lsp-af.therefore this study aims to examine ablation outcomes in lsp-af patients with af termination with or without additional ablation of extra-pv triggers. hypothesis: af termination does not eliminate the need for additional ablations in achieving long-term ablation success in lsp-af.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. lsp-af patients experiencing af termination during ablation 3. ability to understand and provide signed informed consent exclusion criteria: 1. previous left atrial catheter ablation or maze procedure in left atrium 2. reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc

Keywords: lspaf af termination pvai nonpv triggers long-standing persistent
heart-health promotion

Conditions: Heart Diseases

Summary: the researchers intend to use the expanded health belief model in enhancing heart-health preventive behaviors among high school female students

the study intervention will be derived from the expanded health belief model which includes adhering to healthy diet, encouraging healthy weight, nutrition, and physical activity stress management, and smoking cessation and smoking avoidance.

Eligibility criteria:
inclusion criteria: * high school female students who do not experience any psychiatric-mental disorder exclusion criteria: * high school female students who experience any psychiatric-mental disorder

Keywords: expanded health belief model, heart-health-preventive behaviors, high school female students
study of allogeneic bone marrow transplantation following cyclophosphamide and radiotherapy in patients with myelodysplastic syndrome and acute leukemia related to fanconi's anemia

Conditions: Fanconi's Anemia; Myelodysplastic Syndromes; Leukemia, Nonlymphocytic, Acute; Leukemia, Lymphocytic, Acute

Summary: objectives: i. determine the effectiveness of moderate dose cyclophosphamide and radiotherapy in terms of improving survival and reducing the morbidity following allogeneic bone marrow transplantation in patients with myelodysplastic syndrome and acute leukemia related to fanconi's anemia.

protocol outline: patients receive cyclophosphamide iv over 1-2 hours on day -6 through -3 and total body radiotherapy on day -1. patients undergo allogeneic bone marrow transplantation on day 0.

Eligibility criteria:
* diagnosis of fanconi's anemia with the family history and typical phenotype including: short stature hypoplastic radii skin pigmentation renal anomalies chromosomal fragility * evidence of fanconi's myelodysplastic syndrome bone marrow dysplasia of all 3 marrow cell lines and clonal cytogenetic abnormalities demonstrable in marrow cells * first complete remission following therapy for fanconi's acute leukemia allowed * must have related histocompatible donor no evidence of excessive in vitro chromosome fragility typical of fanconi's anemia normal cbc and bone marrow

Keywords: fanconi's anemia acute leukemia acute lymphocytic leukemia acute myeloid leukemia acute undifferentiated leukemia adult acute lymphoblastic leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia adult acute myeloid leukemia in remission aplastic anemia childhood acute lymphoblastic leukemia childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia childhood acute myeloid leukemia in remission de novo myelodysplastic syndrome hematologic disorders hematopoietic/lymphoid cancer leukemia myelodysplastic syndrome oncologic disorders previously treated myelodysplastic syndrome rare disease secondary myelodysplastic syndrome
effect of fermented prunus mume vinegar on improvement of fatigue

Conditions: Fatigue

Summary: the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of fermented prunus mume vinega on improvement of fatigue in adults for 8 weeks.

previous studies have indicated that fermented prunus mume vinega may have the ability to improve fatigue. therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of tfermented prunus mume vinega on improvement of fatigue in adults; the safety of the compound are also evaluate. the investigators examine fatigue severity scale, lactate, creatinine kinase, urinary malondialdehyde at baseline, as well as after 4 and 8 weeks of intervention. sixty adults were administered either 600 mg of fermented prunus mume vinega or a placebo each day for 8 weeks;

Eligibility criteria:
inclusion criteria: * those who complain of fatigue for more than 1 month * fatigue severity scale 3 points or more exclusion criteria: * chronic hepatitis b or c infection * being treated for hypothyroidism or hyperthyroidism * more than twice the normal upper limit of creatinine * liver enzyme value is more than twice the normal upper limit * uncontrolled diabetes (over 160 mg / dl of fasting blood sugar) * uncontrolled hypertension (more than 160/100 mmhg, measured after 10 minutes of stability in subjects) or those with heart disease, such as angina or myocardial infarction * taking medications that affect fatigue within the past 1 month (psychiatric drugs such as chinese medicine, soy drugs, depression, beta-blockers, steroids, hormones, etc.). however, intermittent medication due to sleep disorders is excluded. * a history of gastrointestinal resection or complain of severe gastrointestinal symptoms such as heartburn and indigestion * already have participated in or plan to participate in another drug clinical trial * alcohol abusers * pregnant, lactating or have a pregnancy plan during the clinical trial period * allergic reactions to fermented prunus mume vinegar * a person deemed inappropriate by the researcher for other reasons
photobiomodulation effect on vulvovaginal atrophy in postmenopausal women.

Conditions: Vulvovaginal Atrophy

Summary: menopause is a physiological event and is defined as the loss of ovarian follicular activity, with consequent permanent cessation of menstrual cycles. its diagnosis is made retrospectively after 12 months of amenorrhea, with no pathological cause involved. this period is marked by several changes in the female organism, mainly the genitourinary syndrome (gus), which is a collection of signs and symptoms resulting from the state of hypoestrogenism. almost half of postmenopausal women will experience symptoms of gus, with vaginal dryness being the most prevalent, followed by dyspareunia and vulvovaginal irritation. the aim of the study is to evaluate the effect of photobiomodulation with red led (ligth emitting diode) on the symptoms of vulvovaginal atrophy in postmenopausal women. a randomized and controlled clinical trial will be developed, which will include postmenopausal women with signs and symptoms of vulvovaginal atrophy. participants will be allocated into two groups: those who will undergo photobiomodulation with intravaginal led, and those who will receive vaginal cream with estriol. objective and subjective improvement of atrophy will be assessed using the vaginal health index and the visual analog scale, respectively. vaginal ph, cell maturation index and changes in sexual function through the female sexual function index questionnaire will also be assessed. the variables will be analyzed at the time of admission, in one and three months after the intervention.


Eligibility criteria:
inclusion criteria: * postmenopausal women (amenorrhea for less than 12 months); * presence one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation and vaginal burning); * vaginal heath index ≤ 15 (signs of atrophy); * normal cytopathology of uterine cervix in the last year. exclusion criteria: * previous or current history of gynecological neoplasia; * who used hormonal or non-hormonal treatment for vulvovaginal symptoms of menopause; * current or recent genitourinary lesions or infectious processes in the genitourinary tract (last month); * current or recent (last month) systemic treatment with antifungals, antibiotics or corticosteroids; * presence of genital prolapse; * presence of contraindications to the use of vaginal estrogen (current, previous or suspected diagnosis of breast cancer, malignant estrogen-dependent tumors, uninvestigated uterine bleeding, untreated endometrial hyperplasia, deep venous thrombosis and current or previous pulmonary thromboembolism, known thrombophilia, recent or active arterial disease, acute liver disease, porphyria, use of drugs that may interact with estriol and hypersensitivity to the components of the vaginal cream formula).

Keywords: genitourinary syndrome led light emitting diode vulvovaginal atrophy menopause climacteric photobiomodulation
maximal strength training following hip fracture surgery: impact on muscle mass, balance, walking efficiency and bone density

Conditions: Rehabilitation

Summary: one group will receive today's standard rehabilitation program following hip fracture surgery. the intervention group will have maximal strength training incorporated in their program. it consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over 4 sets for leg press and abduction resistance exercise at \~85% of maximal strength is carried out. muscle strength, balance and bone density will be compared between the groups following the 8-week rehabilitation period. the feasibility of the intervention for the patient group will be evaluated based on compliance with training program and possible adverse events related to the operated hip.


Eligibility criteria:
inclusion criteria: * age over 65, hip fracture surgery exclusion criteria: * copd, heart failure, dementia
ejaculatory abstinence in iui cycles

Conditions: Infertility; Spermatozoa; Reproductive Disorder

Summary: intrauterine insemination (iui) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. the aim of this study was to report the effect of ejaculatory abstinence on sperm dna fragmentation and pregnancy rates in iui cycles, as well as the correlation between the two.

intrauterine insemination (iui) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. the fact that iui is less expensive, less invasive, and easier to perform than other assisted reproductive techniques makes it the first-line treatment option in infertility treatments. several studies have been published over the past few years examining the relationship between sperm dna fragmentation and iui outcome. the optimal period for ejaculatory abstinence before the semen sample is a controversial issue in the literature. there are only two retrospective studies examining the relationship between the ejaculatory abstinence period and pregnancy rates after iui. several studies suggested performing iui with sperm samples obtained in a shorter abstinence period than recommended by who. however, there isn't enough research on this issue in the literature. moreover, there is no specific prospective clinical research examining the relationship of ejaculatory abstinence period and sperm dna fragmentation in iui cycles. the aim of this study was to report the effect of ejaculatory abstinence on sperm dna fragmentation and pregnancy rates in iui cycles, as well as the correlation between the two

Eligibility criteria:
inclusion criteria: * infertility for more than 12 months * diagnosed as unexplained infertility * female age between 20 and 40 years * regular menstrual cycles * mid-luteal progesterone levels of \>3 ng/ml * basal fsh \ 1ng/ml * body mass index (bmi) 19-35 kg/m2 * no pelvic pathology documented by transvaginal ultrasound and bilateral tubal patency diagnosed by hysterosalpingography * normal semen parameters according to who criteria exclusion criteria: * any endocrine and pelvic pathology * pcos (polycystic ovarian syndrome) * known endometriosis history * prior pelvic surgery * persistent ovarian cysts.

Keywords: intrauterine insemination ejaculatory abstinence sperm dna fragmentation tunel assay
examining patterns in the involvement of gastric bypass patients in clinical studies

Conditions: Gastric Bypass; Weight Loss Surgery

Summary: clinical trial participation has historically been heavily biased toward specific demographics. several people will be invited to enroll in this study so that it may collect a variety of data about gastric bypass clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. the information collected from this study can be used to improve patient experience and outcomes for future patients and an opportunity to contribute to the advancement of medical knowledge and treatments for gastric bypass.


Eligibility criteria:
inclusion criteria: * age 18 years and older * diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention * capable of giving signed informed consent. exclusion criteria: * ecog score of 4 * ineligible for gastric bypass surgery * pregnant women or women actively seeking to become pregnant.

Keywords: gastric bypass weight loss surgery
an observational study in children with cln2 batten disease

Conditions: Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)

Summary: this is a prospective, longitudinal natural history study to document the progression of ocular manifestations of cln2 disease among a community-dwelling population of pediatric participants affected by this disease.

cln2 is a rare disease with limited available ocular natural history data. while current standard of care slows motor degeneration, it is not known to treat the ocular manifestations of disease. this study is planned to document, through prospective data collection, ocular disease progression in children with a clinical presentation consistent with cln2 batten disease undergoing current standard of care for their condition. no investigational product is administered in this observational study.

Eligibility criteria:
inclusion criteria: a participant is eligible to be included in the study only if all of the following criteria apply: 1. his or her legal guardian(s) is(are) willing and able to provide them written, signed informed consent. 2. has documented diagnosis of cln2 disease due to tpp1 deficiency, or has a relative clinically diagnosed with cln2 with the same mutation as the participant 3. is currently receiving biweekly ert treatment with cerliponase alfa exclusion criteria: a participant is excluded from the study if any of the following criteria apply: 1. has had prior treatment with an adeno-associated virus-based aav gene therapy 2. is currently participating in a clinical trial of investigational product for the treatment of cln2 disease

Keywords: cln2, batten disease
characterization of adalimumab concentrations in pediatric patients with inflammatory rheumatic disease with and without methotrexate

Conditions: Rheumatic Diseases

Summary: this study is to assess standardized adalimumab (ada) concentrations in pediatric inflammatory rheumatic diseases (pird) patients treated with ada for ≥ 12 weeks with and without concomitant methotrexate (mtx) therapy and to assess peak and trough ada concentrations in ada naïve patients after first ada administration with and without mtx (pre-phase).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of a juvenile idiopathic arthritis (jia), uveitis or chronic recurrent multifocal osteomyelitis (crmo) * medical indication for initiation of ada treatment or established ada therapy for ≥ 12 weeks * exclusion of chronic infections * no parallel treatment with other biologic medications * available patient history since ada start * no pregnancy * ability to comply with the entire study protocol * willingness to participate with signed informed consent exclusion criteria: * other rheumatic inflammatory diseases * age \ 18 years * pird patients and parents with cognitive impairments preventing to understand study requirements * additional severe chronic disease (kidney failure, liver insufficiency), malignancies or prior chemotherapy

Keywords: pharmacokinetics pharmacodynamics adalimumab methotrexate drug-drug interaction trough ada concentration peak ada concentration pediatric inflammatory rheumatic diseases
neoadjuvant chemotherapy for pancreatic cancer followed by gs and gnp

Conditions: Pancreatic Adenocarcinoma

Summary: the effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. however it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best.

gemcitabine plus s-1 versus gemcitabine plus nab-paclitaxel

Eligibility criteria:
inclusion criteria: elective pancreatectomy for pancreatic cancer exclusion criteria: a previous cancer surgery a body weight loss of \>10% during the 6 months before surgery the presence of distant metastases seriously impaired function of vital organs because of respiratory, renal, or heart disease.

Keywords: neoadjuvant
estimation of therapeutic effect of mdcure on patients with chronic lower back pain

Conditions: Back Pain Lower Back Chronic

Summary: this study will assess the therapeutic effect of mdcure® device. mdcure® is an fda class 1 listed medical device, produced to iso-13485 standards, that delivers extremely low intensity (nano tesla; 10-9) and low frequencies (1-100 hertz) electromagnetic fields (emf) intended to reduce muscular aches and pains particularly of the lower back. assessing the reduction of lower back pain. half of participants will receive the mdcure device, while the other half will receive a mock device.


Eligibility criteria:
inclusion criteria: * men and women aged 18-75 * patients with chronic lower back for more then 3 month * patients who scored over 21% and below 60% in the oswestry questionnaire exclusion criteria: * a neurological deficient in lower limbs * patients who scored more than 60% on the oswestry questionnaire. * patients who underwent surgical intervention in spine including metal implant in lower back * patients diagnosed with cancer * patients with any type of vertebral fracture * patients who received steroid injection less then a month prior to starting the experiment * patients treated with steroids as a preventive treatment on a regular basis * patients using narcotic drugs for over a six month period or cannabis or any other sort of narcotic drug for over a six month period prior to their enrollment in the study * pregnant women
ecgi in patients with persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: to determine the values and limitations of ecgi in guiding ablation and risk stratification in patients with persistent atrial fibrillation.

the patient population will include symptomatic persistent af patients (n=50). the total of fifty patients will be studied to determine: * the values and limitations of ecgi in identifying atrial fibrillation (af) triggers, af initiators and af perpetuators as targets sites for catheter ablations in patients with persistent af. * the mechanisms of residual atrial tachycardia/flutter (res-at/afl) after af substrate ablations by targeting complex fractionated atrial electrograms (cfae). * if there is a relationship between primary cfae sites and driver sites or other distinct patterns from the ecgi mapping system. * the rate of af termination to sinus rhythm after ablation at target sites identified by ecgi

Eligibility criteria:
inclusion criteria: * patients are diagnosed as persistent af. persistent af was defined as continuous af from 7 days to 12 months and long- lasting af beyond twelve months. * patients who are symptomatic * patients who are willing to sign consent and be followed post procedure in an out- patient arrhythmia clinic exclusion criteria: * patients under 18 years or over 85 years of age. * patients with chronic alcoholism. * recent myocardial infarction within one month of the study. * significant debilitating diseases or a terminal disease. * patients with documented left atrial thrombus. * medical or mental conditions precluding a long-term follow-up.
conventionally fractionated adaptive radiation therapy of bladder cancer an individualized approach

Conditions: Muscle-Invasive Bladder Carcinoma

Summary: this is a single-arm, prospective, phase ii, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle invasive bladder cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (imrt).


Eligibility criteria:
inclusion criteria: 1. histologically proven bladder cancer 2. urothelial carcinoma 3. age ≥ 18 years 4. stage t1b-t4an0m0 5. tur-b and pet-ct or ct of thorax/abdomen/pelvis within 8 weeks prior to inclusion 6. suitable for radiotherapy 7. ecog/who performance status 0-2 8. written informed consent 9. for cohort b, participant's must have normal organ and marrow function as defined below: * leukocytes ≥2,500/mcl * absolute neutrophil count ≥1,500/mcl * platelets ≥100,000/mcl * hemoglobin ≥9 g/dl * total bilirubin ≤ 1,5 uln * ast(sgot)/alt(sgpt) ≤3 × uln * alkaline phosphatase ≤2.5 × uln * creatinine clearance \<25 ml/min we recommend avoiding cisplatin for participants with creatinine clearance \<50 ml/min. * inr and aptt £1.5 uln exclusion criteria: 1. prior pelvic radiation therapy 2. inability to comply with the protocol 3. presence of a hip prothesis 4. grade 2 or greater baseline diarrhea 5. uncontrolled inflammatory bowel disease (ulcerative colitis or crohn's disease)