Kornimate/medical-research-clean huggingface dataset:
suppression of atrial fibrillation with ranolazine after cardiac surgery

Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery

Summary: the objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery

a single center, double blind, prospective, randomized study for patients who are scheduled for elective cardiac surgery (coronary artery bypass graft \[cabg\], or valve or cabg and valve). all patients who meet criteria will be prospectively enrolled in a randomized fashion. patients enrolled will be assigned to receive twice daily identical capsules containing either placebo or ranolazine. study drug will be initiated 2 days before surgery. patients will receive study drug throughout their hospitalization and be kept on it for a full 2 weeks post operatively. patients will be seen in 2 weeks and receive a 30 day follow up contact visit.

Eligibility criteria:
inclusion criteria: * indications for cardiac surgery (cabg, valve surgery or cabg and valve surgery, able to provide informed consent. exclusion criteria: * documented atrial fibrillation within the previous 3 months * ongoing therapy with suppressive antiarrhythmic drugs * patient currently on digoxin * emergent surgery * patient receiving hemodialysis * concomitant use of ketoconazole, diltiazem, verapamil * known tolerance or hypersensitivity to ranolazine * pregnant individuals * maze procedure (is a surgical ablation to treat atrial fibrillation) performed during concurrent cardiac surgery

Keywords: suppress atrial fibrillation heart bypass surgery heart valve surgery
efficacy of "on line" telematic spirometry

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the investigators aim to demonstrate that spirometry performed "on line" with a technician in a remote place from the patient has the same efficacy as the one performed personally. as a previous study the investigators analyzed the inter-observer agreement between two pulmonary function technicians from both centers taking part in the study: san pedro de alcántara hospital (cáceres) and carlos iii hospital (madrid). the main study will be broad (226 patients derivates from primary care to pneumology consultation), prospective, aleatorized, crossed, blind and controlled. the patients will be aleatorized in two groups: 1) personal spirometry: performed in a conventional way; 2) telematic spirometry: performed remotely "on line". the same pulmonary function technician, who will carry out the spirometries personally, will be located in a nearly room. the technician will control the computer office and the spirometer software in the patients's room with another computer. by means of teleconference, the technician will indicate the patient to start the maneuver. after 20 minutes from the end of the first spirometry, the patients will complete the protocol of the following group. the mean values of fvc, fev1 and fev1/fvc, the mean time of spirometry performance, the mean number of spirometric maneuvers performed, are compared between both groups by t proof for paired data. the comparison of the percentage of proofs with non acceptability or reproducibility criteria will be made by x2 test. the analysis will be made blindly. the inter-observer and intra-observer agreement will be evaluated by analysis of intraclass correlation for fvc and fev1 values.


Eligibility criteria:
inclusion criteria: * age between 14 and 70 years. * patients referred for pulmonary consultation from primary care center. exclusion criteria: * psychophysical incapacity to performed spirometry. * informed consent not obtained.

Keywords: copd spirometry telematic spirometry
safety and efficacy study of umbilical cord blood-drived mesenchymal stem cells to promote engraftment of unrelated hematopoietic stem cell transplantation

Conditions: Acute Leukemia

Summary: the purpose of this study is to evaluate the safety and efficacy of promostem (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hmsc/kg in subject for the promotion of an engraftment and prevention of graft rejection and graft-versus-host disease after unrelated hematopoietic stem cell transplantation for children with acute leukemia.

* hematopoietic stem cell transplantation (hsct) is a procedure in which progenitor cells capable of reconstituting normal bone marrow function are administered to a patient. this procedure has been used to treat adults and children with life-threatening hematological malignancies and congenital immunodeficiency disorders. * in hsct, therapeutic goal is an elimination of disease and enrichment of regenerating capacity to achieve engraftments resulting in continued generation of functional blood elements from the engrafted living cells. transplantation of unrelated hematopoietic stem cells originating either from adult bone marrow or from peripheral blood often leads to graft-versus host-disease (gvhd), opportunistic infections and graft failure after transplantation. * in hsct, msc have been used as a therapy for gvhd and other complications. the aim of msc infusions in hsct is to use the cells' immunomodulatory effects to promote engraftment and to reduce the immunological reactions giving rise to gvhd. * there is a growing interest in co-transplantation of msc and hsc to improve the donor outcome in the unrelated hsct condition.

Eligibility criteria:
inclusion criteria: 1. patient age 2\~19 years old with plan to have unrelated hematopoietic stem cell transplantation with acute leukemia 2. patient never has an experience of hematopoietic stem cell transplantation 3. patient must have an acute leukemia with a complete remission. 4. patients must have an ecog 0\~2. 5. no moderate or sever organ dysfunction : ejection fraction \> 45%; creatinine \<2.0 mg/ml; serum bilirubin \< 2 mg/ml; ast/alt \< 200 iu/l. 6. patient must not have an transplantation with different source of hematopoietic stem cell such as bone marrow and cord blood. 7. patient must not have an infection needed an administration of non-oral antibiotics. 8. no active severe infection derived form virus or fungus. 9. each patient / patient's guardian must sign written informed consent. exclusion criteria: 1. patient has previously received hematopoietic stem cell transplantation. 2. patient plans to have a related hematopoietic stem cell transplantation. 3. patient has a severe internal disease. 4. patient has enrolled another clinical trial study within last 4 weeks.

Keywords: mesenchymal stem cells allogeneic transplantation engraftment gvhd childhood unrelated hsct
hamate hook removal, microscrew internal fixation and plaster fixation for the treatment of hamate hook fractures

Conditions: Fractures, Bone

Summary: to compare the effects of hamate hook removal, microscrew internal fixation and plaster fixation on fracture healing, work, life, and exercise recovery in patients with hamate hook fractures by retrospective case analysis.

hamate hook fractures are rare, and mainly occur during sports activities. its projection is often obscured by other carpal bone in conventional x-ray plain films, so hamate hook fractures are the most easily missed injury in hand surgery. as the incidence of such fractures is too small, it brings some difficulties in the clinical choice of correct and effective treatment. currently, treatment programs of hamate hook fractures also are not consistent.

Eligibility criteria:
inclusion criteria: * hamate hook fractures finally diagnosed by x-ray and ct scan at the wrist position holding a cup and the carpal canal position (appendix 2) * unilateral hamate hook fractures * irrespective of age and sex exclusion criteria: * incomplete follow-up data
a study of subcutaneous (sc) tocilizumab (roactemra/actemra) in participants with active rheumatoid arthritis (ra) and inadequate response to disease-modifying anti-rheumatic drugs (dmards)

Conditions: Rheumatoid Arthritis

Summary: this phase iiib, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of sc tocilizumab (roactemra/actemra) in monotherapy or in combination with methotrexate or other non-biologic dmards in participants with active ra who are naive to tocilizumab. participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly (qw) for 24 weeks.


Eligibility criteria:
inclusion criteria: * active ra according to the revised acr (1987) criteria or eular/acr (2010) criteria * moderate to severe ra with a das28-esr score \>3.2 points * inadequate response and/or intolerance to mtx or other non-biologic dmards and/or where mtx or other non-biologic dmards are inappropriate * oral corticosteroids (less than or equal to \[\ /=\] 4 weeks prior to baseline * permitted non-biologic dmards allowed if at stable dose for \>/=4 weeks prior to baseline * receiving treatment on an outpatient basis, not including tocilizumab * agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline * rheumatic autoimmune disease other than ra * functional class iv as defined by the acr classification of functional status in rheumatoid arthritis * diagnosis of juvenile idiopathic arthritis or juvenile ra and/or ra before the age of 16 * prior history of or current inflammatory joint disease other than ra * exposure to tocilizumab or any other biologic dmards at any time prior to baseline * treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening * intra-articular or parenteral corticosteroids within 4 weeks prior to baseline * history of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies * evidence of serious concomitant disease or disorder * known active current or history of recurrent infection * any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening * active tuberculosis requiring treatment within the previous 3 years * positive for hepatitis b or hepatitis c * history of or current active primary or secondary immunodeficiency * pregnant or lactating women * neuropathies or other conditions that might interfere with pain evaluation * inadequate hematologic, renal, or liver function
osteocalcin level in gingival clavicular fluid during canine retraction in periodontal compromised patients

Conditions: Periodontal Diseases

Summary: osteocalcin levels can be measured gingival crevicular fluid (gcf). changes in osteocalcin levels can provide important information about the status of bone metabolism and bone remodeling. the levels of this markers in gcf can provide information about the status of bone remodeling in the surrounding bone tissue in periodontal affected teeth.

osteocalcin levels can be measured using a blood test or by analyzing the levels of osteocalcin in urine or saliva. changes in osteocalcin levels can provide important information about the status of bone metabolism and bone remodeling. osteocalcin has been found to be present in gingival crevicular fluid (gcf), along with other bone metabolism markers such as alkaline phosphatase and tartrate-resistant acid phosphatase. the levels of these markers in gcf can provide information about the status of bone remodeling in the surrounding bone tissue. orthodontic tooth movement is influenced by the remodelling ability of surrounding bone and soft tissue, such as pdl and gingiva. bone remodelling occurs in coordination, requiring coupling of bone formation after resorption. orthodontic force induces an aseptic inflammatory response, involving cytokines and chemokines. . increased levels of osteocalcin in body fluids indicate abnormal bone turnover activity.

Eligibility criteria:
inclusion criteria: * adult female patients who were seeking for orthodontic treatment with controlled previous chronic periodontitis. * pocket depth of more than 5 mm before receiving non-surgical periodontal treatment or/and pocket depth of less than 4 mm after periodontal therapy. * sever to very sever irregularity of mandibular anterior arch according to little's irregularity index ranging from 7 to 10 mm with acceptable oral hygiene. * all the permanent dentition excluding third molars should be present. * no systemic disease or history of prolonged use of medication interfering with tooth movement as corticosteroids. exclusion criteria: * previous orthodontic treatment. * patients with aggressive periodontitis or any smoking habits. * pregnant or lactating female patients were excluded.

Keywords: osteocalsin periodontal compromised teeth canine retraction
quality of life in patients that undergo j pouch or side to end coloanal anastomosis for rectal cancer

Conditions: Rectal Cancer

Summary: the investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a j pouch.

the side to end anastomosis has become popular in recent years as it is technically simple to construct. the difference between the baker type(side to end) of anastomosis and the j pouch, is that no formal pouch is constructed in the side to end. it has one staple line and the anastomosis. the investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a j pouch.

Eligibility criteria:
inclusion criteria: 1. patients with distal rectal cancers who will be having an abdominal proctocolectomy with a low colorectal anastomosis within 4 cm of the dentate line or a coloanal anastomosis will be candidates for this study. 2. no evidence of distant metastatsis - exclusion criteria: stage iv rectal cancer 1. history of radiation to the pelvis ( eg. for uterine or prostatic cancer) 2. evidence of synchronus or metachronus disease 3. h/o dementia 4. prisoners 5. women who are pregnant 6. history of previous right colectomy 7. history of inflammatory bowel disease -

Keywords: j pouch colorectal rectal cancer coloplasty
association between lifetime physical activity and exercise and the development of wild-type transthyretin amyloid cardiomyopathy

Conditions: Amyloid Cardiomyopathy; Wild Type ATTR Amyloidosis

Summary: the aim of this study is to investigate the association between increased lifetime physical activity and the development of wild-type transthyretin amyloid cardiomyopathy.

transthyretin amyloidosis is considered to be the most common cause of cardiac amyloidosis, with an increasing diagnosis rate over the last decade. though once considered to be a rare disease, recent data suggest it is underappreciated as a common cause of cardiac diseases and syndromes such as left ventricular hypertrophy, aortic stenosis, and heart failure with preserved ejection fraction, especially in the elderly. wild-type transthyretin amyloidosis, which is associated with ageing, is currently considered to be the most frequent form of amyloidosis worldwide, and is dominated by cardiac symptoms. other than male gender and advanced age, risk factors for the development of wild-type transthyretin amyloid cardiomyopathy (wtattr-cm) are largely unknown. there is rising empirical observation that patients with wtattr-cm frequently have a substantial history of athletic activity, which might contribute to the manifestation of the disease. this study aims to create evidence of a correlation between increased lifetime physical activity and the development of wtattr-cm. furthermore, the investigators aim to explore the association between certain sport disciplines and disease development.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of wtattr-cm including sequencing of the ttr gene; or hf; or healthy proband without a diagnosis of heart disease 2. initial diagnosis of respective cardiac disease (wtattr-cm, hf) after the 6th decade of life; or no cardiac disease (healthy control) 3. willingness and ability to provide signed informed consent form (icf) 4. age \> 60 years exclusion criteria: 1. history of severe chronic illness limiting the ability to perform physical activity during the 3rd to 6th decade 2. a diagnosis of dementia or cognitive impairment 3. any other reason resulting in the inability to perform the questionnaire and/or interview 4. known disease-causing variant (pathogenic or likely-pathogenic) in the ttr gene
impact of treatment of periodontis on endothelial function in patients with obstructive sleep apnea

Conditions: Cardiovascular Disease in Obstructive Sleep Apnea

Summary: evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in patients with chronic periodontitis and severe obstructive sleep apnea treated by cpap. patients with and without chronic periodontitis will be treated by cpap for 20 weeks. at v2 (10 weeks), endothelial dysfunction will be assessed by the reactive hyperemia- peripheral artery tone index. the endothelial dysfunction of the patients will be also assessed at v3 (20 weeks) after periodontitis treatment for the group of patients with chronic periodontitis.

at v2, patients with periodontitis will have full-mouth intensive removal of denatl plaque biofilms with the use of scaling and root planing. the add-on effect of the periodontitis treatment on endothelial dysfunction will be assessed ten weeks later (v3) in comparison with v2 by taking into account with the effect of 10 weeks of cpap in the control group with severe osa but not periodontitis.

Eligibility criteria:
inclusion criteria: * severe osa defined by an apnea hypopnea index \> or = 30 per hour * with or without chronic parodontitis exclusion criteria: * non equilibrated diabetes * obesity (bmi \> or = 40) * active smoker (\> 1 pack per day (20 cigarettes)) * pregnancy * antibiotics within the preceding three months * prophylactic antibiotherapy required for the parodontitis treatment * acute parodontitis or all parontal pathology requiring immediate therapy * less than 10 teeth

Keywords: obstructive sleep apnea endothelial dysfunction periodontitis
pelvic floor symptoms after bilateral sacrospinous fixation

Conditions: Pelvic Organ Prolapse

Summary: this study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage iv.


Eligibility criteria:
inclusion criteria: * age 18 and above * pelvic organ prolapse ics-popq stage iv, with or without uterus * signed informed consent exclusion criteria: * gynecologic surgery in the three past months before planned surgery * history of prolapse surgery * participation in another study * need to simultaneously perform other surgical procedures (i.e. rectopexy) * ongoing chemotherapy of treatment with immunosuppressant drugs
suprapubic single-incision laparoscopic appendectomy versus conventional appendectomy: a randomized controlled trial

Conditions: Complications

Summary: conventional laparoscopic appendectomy(cla) is the current standard treatment. to obtain additional benefits such as a better cosmetic outcome, the investigators developed a surgical option termed suprapubic single-incision laparoscopic appendectomy (ssila), which creates a non-visible scar, that was preliminarily shown to be feasible and safe in our previous retrospective studies to further evaluate the feasibility, safety and cosmetic results of this innovative approach, the investigators compared the outcomes of ssila and cla by performing a randomized controlled trial.


Eligibility criteria:
inclusion criteria: * acute appendicitis or interval appendicitis * informed consent exclusion criteria: * diagnosis of appendicitis was not clinically established (symptoms attributable to urinary or gynecological problems) * history of cirrhosis and coagulation disorders * suspected or proven malignancy * contraindication to general anesthesia (severe cardiac and/or pulmonary disease) * inability to give informed consent(severe mental disease) * pregnancy * bmi\>30kg/m2 * generalized peritonitis

Keywords: appendicitis appendectomy single-incision
a self-management program to prevent falls in people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this project's overall aim is to develop, deliver, and evaluate feasibility of a fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. the program will use a comprehensive intervention approach to address a variety of fall risk factors, and utilise self-management strategies. specific aims are to 1. develop a fall prevention program, that addresses diverse fall risk factors and utilises self-management strategies, for ambulatory and non-ambulatory people with multiple sclerosis using a co-design process. 2. to examine feasibility, acceptability, fidelity, and potential outcome of the online, co-designed self-management fall prevention intervention for ambulatory and non-ambulatory people with multiple sclerosis, and to examine feasibility of the recruitment process, the data collection procedures, and the outcome measures.

falls among people with multiple sclerosis (pwms) are common and associated with injuries, fear of falling and low health-related quality of life. considerations of behavioural, environmental, psychological and physical influences (including ambulation status) are needed to meet fall prevention needs for pwms. thus, using a codesign process involving key stakeholders a novel online self-management fall prevention intervention will be created specifically for ambulatory and non-ambulatory pwms. the feasibility, acceptability, fidelity and outcome of this complex intervention will be explored. findings will inform a future full-scale randomised controlled trial. a mixed-method design will be used. forty-eight pwms, stratified for ambulation level, will be randomised to control (n=24) or intervention (n=24). both groups will receive a brochure about fall risk factors and fall prevention. the intervention is group-based (eight pwms in each group); will be delivered online; and involve six, 2-hour weekly sessions and a booster session 8 weeks after the sixth session. each intervention group will be led by a trained facilitator. data collection will be performed at baseline, and after seven and 18 weeks. outcome measures will capture data on fall prevention behaviours, fear of falling, falls self-efficacy, social and everyday activities, perceived impact of ms and number of falls. feasibility of recruitment process, data collection procedures, outcome measures, and delivery, and intervention acceptability, fidelity and outcomes will be evaluated. both quantitative and qualitative methods will be used.

Eligibility criteria:
inclusion criteria: * community-dwelling adults aged ≥ 18 years * diagnosed with multiple sclerosis * able to independently transfer from bed to wheelchair with or without aids but without assistance of another person * able to understand and communicate in swedish * able to use and access to technical devices for online meetings i.e., computers or tablets with internet access

Keywords: feasibility studies accidental falls self-management complex intervention group-based online intervention short message service
pharmacokinetics of atazanavir/ritonavir in hiv-1 infected pregnant women

Conditions: HIV Infection

Summary: to determine what dosing regimen of atazanavir (atv) / ritonavir (rtv) produces adequate drug exposure during pregnancy compared to drug exposure in historical data in human immunodeficiency virus (hiv) infected participants.


Eligibility criteria:
inclusion criteria: * hiv-infected pregnant women * \> 18 years of age * between week 12 and 32 gestation * cd4 \> 200 cells/mm³ * treatment-naive with hiv rna \> 400 c/ml, on haart with hiv rna \ 400 c/ml

Keywords: hiv-1 infected pregnant women, either treatment naive or on atv/rtv combined with zdv/3tc