Kornimate/medical-research-clean huggingface dataset:
pradaxa (dabigatran etexilate) 150 mg/q.d. in patients with moderate renal impairment after hip or knee replacement surgery

Conditions: Arthroplasty, Replacement; Thromboembolism

Summary: an observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of pradaxa in patients with renal impairment


Eligibility criteria:
inclusion criteria: patients of 18 years of age or above with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing elective total hip replacement surgery who consent in writing to their participation in this observational study exclusion criteria: all patients who should not be treated with pradaxa 150 mg according to the european summary of product characteristics (spc): severe renal impairment (creatinine clearance \ 2 upper limit of normal (uln); hepatic impairment or liver disease expected to have any impact on survival, anaesthesia with post-operative indwelling epidural catheters, hypersensitivity to dabigatran etexilate or to any of the excipients, active clinically significant bleeding, organic lesion at risk of bleeding, spontaneous or pharmacological impairment of haemostasis, concomitant treatment with quinidine, protehetic heart valve requiring anticoagulant treatment
mental and cognitive health and physical activity in the perioperative breast cancer setting

Conditions: Breast Cancer; Breast Neoplasms; Cancer, Breast; Cancer of the Breast

Summary: this study evaluates the complex relationships between mental health, cognitive function, and physical activity before surgery in patients with stage i-iii breast cancer. most patients with breast cancer experience declines in their mental health, with up to two-thirds of patients reporting symptoms of depression and anxiety. cancer-related cognitive decline is even more prevalent; 75% of patients with breast cancer report varying degree of loss in mental acuity throughout their cancer experience. both mental and cognitive health declines are pervasive, lasting anywhere from 5 years to decades after treatment completion. not only are these declines detrimental to patients' quality of life, but they also increase the risk of cancer-related mortality. maintaining sufficient levels of physical activity (pa) is important to both prevent breast cancer and improve health post-diagnosis. pa improves anxiety and depressive symptoms during and after treatment. early intervention with pa prior to or during cancer treatment, or prehabilitation, can avoid or reduce the severity of treatment-related side effects, hospital length of stay, surgical complications, and care costs. information gained in this study may help researchers learn more about the right time during treatment for delivering lifestyle programs to improve mental and cognitive health.


Eligibility criteria:
eligibility criteria patients: * a physician-confirmed diagnosis of breast cancer (stage i-iii) * female over the age of 18 * scheduled to receive curative-intent breast surgery and chemotherapy (neoadjuvant or adjuvant) * able to understand and willing to sign an institutional review board (irb)-approved informed consent document. given documented mental and cognitive health declines after both neoadjuvant and adjuvant treatment regimens, the investigators are including both patient populations in this exploratory study. patients of all baseline anxiety, depression, cognitive function, and physical activity levels are eligible to participate. eligibility criteria stakeholders: * healthcare personnel with a staked interest in patient care during chemotherapy, including but not limited to surgical oncologists, medical oncologists, physical and occupational therapists, nurses, patient navigators, dietitians, and exercise physiologists * able to understand and willing to sign an irb-approved informed consent document

Keywords: breast cancer physical activity prehabilitation cognition stakeholder needs implementation science
efficacy of a mouthwash containing propolis

Conditions: Gingivitis; Periodontitis; Plaque; Inflammation

Summary: characterization of green propolis and development of mouthwash containing propolis to control plaque and gingivitis. a phase i.

chemical characterization of propolis by hplc (high-performance liquid chromatography), antimicrobial testing against pathogens and cariogenic. studies in vitro on anti-inflammatory activity, cytotoxicity tests of green propolis.

Eligibility criteria:
inclusion criteria: * age ranging from 18 to 60 years * minimum of 20 natural teeth * mean plaque index (pi)of at least 1.5 * an average gingival index (gi), at least less than 1.0. exclusion criteria: * individuals with orthodontic appliances or removable dentures, * individuals whit tumors of soft tissue or hard mouth, and advanced periodontal disease, * indivuduals whit antibiotic therapy 2 weeks prior to study initiation, or with known hypersensitivity propolis are also excluded.

Keywords: clinical trial mouthwash propolis plaque gingivitis compliance
monitoring of vital signs during skin-to-skin holding by mothers of their preterm babies

Conditions: Other Preterm Infants

Summary: this observational study aims to monitor the vital sign changes in both mother and baby that occur during kangaroo care in preterm infants and to investigate any potential correlations between maternal measurement values and those of the infant. the purpose of this observational study is to look for a method to track the earliest responses that could, theoretically, be considered as 'social responses' in hopes of providing developmental interventions earlier to at-risk infants.

the goal of this observational study is to identify any signs of early "social response" in order to be able to assist infants that lack this response with early neurobehavioral modifications.

Eligibility criteria:
inclusion criteria: * inborn at mount sinai * gestational age between 30 0/7 weeks and 34 6/7 weeks gestation * only one infant of a multiple gestation * plan by family to do kangaroo care during nicu stay exclusion criteria: * outborn infants * gestational age less that 29 6/7 weeks or greater than 35 0/7 weeks * other infants of multiple gestation (see inclusion criteria) * any major congenital anomalies * sepsis and/or any other serious clinical complication precluding kangaroo care

Keywords: preterm kangaroo care skin-to-skin vital sign heart rate respiratory rate oxygen saturation
a pilot study for the efficacy and safety of tacrolimus in the treatment of refractory lupus nephritis

Conditions: Lupus Nephritis

Summary: the purpose of this protocol is to determine whether tacrolimus and prednisolone are effective and safe in the treatment of the cyclophosphamide-resistant, refractory diffuse proliferative lupus nephritis


Eligibility criteria:
inclusion criteria: * biopsy-proven lupus nephritis who class iv , iv+v * previously treated by three times over of i.v. cyclophosphamide or 6 months more duration of immunosuppressive treatments (azathioprine, mmf, cyclophosphamide p.o.) for the lupus nephritis * spot urine protein creatinine raio \> 1.0 * rbc \> 5 /hpf on microscopic examination of urine exclusion criteria: * previous treatment of cyclosporine a or tacrolimus * serum creatinine lever : over 300 mmol/dl * allergy to the macrolide antibiotics * other systemic organ damage
effects of connective tissue manipulation versus stretching exercises in primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the study will be a randomized clinical trial in which the effect of connective tissue manipulation will be compared with the effect of stretching exercises on pain and severity of symptoms in primary dysmenorrhea. inclusion criteria will include nulliparous females in the age range of 18-25 years old. exclusion criteria will be women with irregular menses (\ 35 days), systemic and gynecological diseases (gastrointestinal, autoimmune, psychiatric diseases, endometriosis, pelvic inflammatory diseases), pregnant women, previous pelvic surgery, traumatic injury. the participants will be allocated to two groups, group a and b. group a will receive connective tissue manipulation on sacral, lumbar, lower thoracic and anterior pelvic regions with the patient in sitting and supine positions. group b will receive active stretching exercise regime including forward, backward ad side trunk bending, heel raise, half squatting, knee to chest, hamstring stretching, calf stretching and abdominal contractions.

the study will be a randomized clinical trial in which the effect of connective tissue manipulation will be compared with the effect of stretching exercises on pain and severity of symptoms in primary dysmenorrhea. inclusion criteria will include nulliparous females in the age range of 18-25 years old. exclusion criteria will be women with irregular menses (\ 35 days), systemic and gynecological diseases (gastrointestinal, autoimmune, psychiatric diseases, endometriosis, pelvic inflammatory diseases), pregnant women, previous pelvic surgery, traumatic injury. the participants will be allocated to two groups, group a and b. group a will receive connective tissue manipulation on sacral, lumbar, lower thoracic and anterior pelvic regions with the patient in sitting and supine positions. group b will receive active stretching exercise regime including forward, backward ad side trunk bending, heel raise, half squatting, knee to chest, hamstring stretching, calf stretching and abdominal contractions. all the participants will be informed about the manner of research and will be asked to sign the consent form after they are willing to participate in the study. walidd score and dysmenorrhea severity scoring will be used to determine and assess the dysmenorrhea pain and severity. treatment sessions will be conducted for 8 weeks, 3 times in a week and each session will be carried out for 20 minutes. at the end of two months, subjects will be assessed for their two menstrual cycles. spss 21 will be used for data analysis. after checking normality of data appropriate tests will be applied.

Eligibility criteria:
inclusion criteria: * nulliparous women • age range of 18 to 25 years exclusion criteria: * women with irregular menses (\ 35 days) * systemic and gynecological diseases * pregnant women * women taking contraceptive pills * traumatic injuries * previous pelvic surgery

Keywords: primary dysmenorrhea connective tissue manipulation stretching
retrospective study of germ cell tumors of the central nervous system

Conditions: Germ Cell Tumor of CNS

Summary: retrospectively analyzing the epidemiological and clinical characteristics, treatment, recurrence, prognosis and prognostic factors of the germ-cell tumors of central nervous system in a single center.

clinical data of patients with germ-cell tumors of central nervous system who were treated in the department of neuro-oncology, sanbo brain hospital capital medical university between january 2007 and december 2022 were retrospectively collected, and the epidemiological and clinical characteristics, treatment, recurrence, prognosis and prognostic factors of the disease were analyzed.

Eligibility criteria:
inclusion criteria: * clinically or pathologically diagnosed as germ cell tumor of the central nervous system. * have received antitumor therapy. * patients who were clinically diagnosed based on neuroimaging characteristics and response to radiotherapy or chemotherapy were allowed for enrollment. exclusion criteria: * patients with missing key information such as tumor location, surgical, chemotherapy and radiotherapy data, and post-treatment evaluation.
a study to observe real-life allocation of antipsychotics in acute inpatient management of schizophrenia

Conditions: Schizophrenia

Summary: reconnect-s alpha is a multicentre study to observe the management of schizophrenic patients who are hospitalized due to an acutely agitated psychotic episode. the patients should be managed according to normal clinical practice until discharge time. data will be collected by review of medical records of the hospitalisation prior the study visit. during the study the patients will conduct one visit on the day of their discharge after hospitalisation due to an acutely agitated psychotic episode. on the study visit data on demographics, diagnosis and medical history will be recorded. data on antipsychotic and concomitant medication will be collected by review of medical records.

reconnect-s alpha: a non-interventional study to observe real-life allocation of antipsychotics in the acute inpatient management of schizophrenia

Eligibility criteria:
inclusion criteria: * male or female patients, * 18 years or older, * meeting the diagnostic criteria for schizophrenia stated in the diagnostic and statistical manual of mental disorders, * meeting 4th edition (dsm-iv) criteria hospitalization due to an acutely agitated psychotic episode. exclusion criteria: * patient in acutely agitated state upon discharge from the hospital, * current participation in any clinical trial, * previous enrolment in the present nis.

Keywords: antipsychotics schizophrenia acute inpatient
interactive e-health database for the identification of potential interactions among drugs prescribed to ckd patient

Conditions: Renal Insufficiency, Chronic

Summary: the aim of the current project is the development and implementation of an e-health database of drug interactions (drug-drug, drug-food, drug-alcohol and drug-herbal products interaction) to ckd patients in order to achieve a holistic approach to patient care and personalized medicine. the study will be conducted in the university of ioannina (cooperation between the department of nephrology and the laboratory of physiology). data will be collected form 150 ckd patients (stages 1-5 pre-dialysis, undergoing dialysis, kidney transplantation). sixty patients will be selected for the pilot study which will include blood and urine tests and specific polymorphism analysis (pharmacogenetic tests). pilot implementation of the e-health database will be undertaken by health professionals of the department of nephrology (university hospital of ioannina) to test the system in realistic setting (usability, efficiency and efficacy) in order to make the necessary changes prior to full scale deployment.


Eligibility criteria:
inclusion criteria: * age\>18 years * ckd diagnosis according to kdoqi guidelines * absence of active malignancy * absence of decompensated heart failure new york heart association (nyha) iv * absence of liver cirrhosis * patient's consent exclusion criteria: * age\<18 years * active malignancy * decompensated heart failure nyha iv * liver cirrhosis * patient's refusal to participate in the study

Keywords: drug interactions polymorphism, genetic pharmacogenetics databases, pharmaceutical
effect of reoperation for recurrence after open umbilical hernia repair

Conditions: Umbilical Hernia

Summary: background operation for small umbilical hernias is one of the most common surgical procedures, but the best surgical technique, including the choice of suture or mesh remains unknown. it is well known that using non-absorbable sutures in closure of the abdomen, diminishes the risk of incisional hernias and wound healing problems.it has also been found that the use of resorbable suture in fixation of the mesh in lichtesteins procedure leads to greater risk of recurrence of the hernia. furthermore, it has been stated in smaller studies, that the use of the mesh in open operation for a small umbilical hernia has lower risk of recurrence (approx. 1-3%) than sutured repair (10-12 %). however, the scientific literature is deficient, with few patients. the purpose of this study is to describe reoperation rate of recurrence after small umbilical hernias, depending on choice of sutures in both regular repair and in mesh repair. hypothesis: sutured repair with non-absorbable suture has lower recurrence rates than with other types of sutures, whereas mesh repair has even lower recurrence rates in small umbilical hernia repairs.

national prospective registry study with data from the danish ventral hernia database (dvhd) and the national patient register (lpr) in patients undergoing open to umbilical or epigastric hernia repair during the period 1 january 2007 to 31 december 2010. apart from operator-registered perioperative data from dvhd, operations can be characterized with different types of sutures, choice of mesh and other relevant information, with possible impact on long-term outcome after surgery, including recurrence. there will be used frequency analyzes and kaplan meyer statistics, supplemented by multivariate cox regression analysis, as well as non-parametric statistics. eligibility criteria: open mesh or sutured repair for small umbilical hernias from 1th of january 2007 to 31th of december 2010. outcome measures: reoperation as a surrogate for recurrence.

Eligibility criteria:
inclusion criteria: * mesh or non-mesh umbilical hernia repair hernia defect size max. 2 cm. exclusion criteria: * bigger defect than 2 cm. laparoscopic repair

Keywords: umbilical hernia repair recurrence choice of suture mesh mesh/non-mesh
scalp sampling for fetal surveillance

Conditions: Fetal Hypoxia

Summary: the purpose of this study is to compare lactate and total acid-base status in fetal scalp blood with lactate and total acid-base status in maternal blood and amniotic fluids to provide information on how lactate and base deficit correlates with scalp samples. furthermore, the investigators want to study whether angiogenic factors in fluids above may be a possible marker of asphyxia during labor.


Eligibility criteria:
inclusion criteria: * all deliveries eligible for fetal blood sampling exclusion criteria: * non swedish speaking * those who decline to participate in the study

Keywords: hypoxia fetal blood sampling lactate ph base deficit angiogenic factors suspected fetal hypoxia
efficacy of different ablation strategies for controlling atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study involves treatment for atrial fibrillation (af)-the most common heart condition in the us-where the upper chambers of the heart beat very fast and in a disorganized manner. this can be felt as palpitations, tiredness, shortness of breath and passing out, plus can lead to stroke, damage to the heart muscle and a shorter life span. study participants will receive a common treatment for atrial fibrillation called radiofrequency ablation (rfa), where small lesions or "burns" are made inside the heart to cut off the abnormal impulses that cause af. the purpose of this study is to compare the effectiveness of three different common ablation strategies in patients with persistent or permanent af. subjects will be randomized (like drawing straws) to be treated with one of the three strategies to see if there is a difference in how well atrial fibrillation is controlled after treatment.

in most cases, af originates where the pulmonary veins (pv) enter the left upper chamber of the heart, known as the left atrium (la). common to the procedure in each arm of the study is pulmonary vein isolation (pvi) or ablation of tissue around the pulmonary vein entrances. after pvi, the procedure continues with ablation in other areas of the la where similar abnormal impulses are found. the three strategies for continuing with ablation after pvi are described in the "arms" section below.

Eligibility criteria:
inclusion criteria: * all patients of age ≥ 30 years, undergoing their first ablation procedure that meet acc / aha defined criteria for persistent or permanent af will be eligible to participate in the study. this includes patients with a history of af episodes lasting at least 7 days or requiring at least 2 cardioversions. exclusion criteria: 1. patients with paroxysmal af (self-terminating episodes lasting \< 7 day) 2. patients who have had a previous af ablation procedure 3. pregnancy 4. failure to obtain informed consent 5. less than 30 years old

Keywords: atrial fibrillation a-fib af persistent permanent pulmonary vein isolation ablation
comparion of erector spinae plane block and quadratus lumborum block in laparoskopic cholecystectomy

Conditions: Postoperative Pain; Anesthesia, Local

Summary: erector spinae plane block is a newly defined regional anesthesia technique. its use for many indications has been identified by case reports in the literature. as the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic.quadratus lumborum block (qlb) type 2 is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and qlb in laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * elective laparoscopic cholecystectomy, asa status 1-2 exclusion criteria: * patient refusal contraindications to regional anesthesia known allergy to local anesthetics bleeding diathesis use of any anti-coagulants inability to provide informed consent severe kidney or liver disease inability to operate pca system patient with psychiatric disorders
lgbt internet based smoking treatment - 1

Conditions: Tobacco Use Disorder

Summary: the overall goals of this line of research are to develop and evaluate innovative treatments for lesbian, gay, bisexual, and transgender (lgbt) cigarette smokers and to understand the processes related to smoking and relapse in this previously unstudied population of smokers. in this study, participants are randomly assigned to one of two internet-based smoking cessation treatments: 1) a self-help intervention tailored lgbt smokers plus social support plus email-based counseling, or 2) a standard self-help condition alone, similar to other general smoking cessation treatments. before starting the program, participants will complete measures of smoking, nicotine dependence, depression diagnosis, demographics, mood, motivation to change, and alcohol use. smoking status will be determined at 1, 3, 6, and 12 months following the start of treatment. data will be analyzed to compare the quit rates of the two internet-based treatment groups. also, we will complete exploratory analyses to determine those variables that best predict quitting for lgbt smokers.


Eligibility criteria:
must identify as a lesbian, gay male, bisexual male or female or a transgender individual. must smoke most days during the preceding month. must have a valid email address.

Keywords: smoking tobacco