Kornimate/medical-research-clean huggingface dataset:
stress management for cancer patients: how well does it work? (c2h-d)

Conditions: Mood; Stress, Psychological

Summary: psychological interventions for cancer patients have been tested and found to reduce stress and improve quality of life. these interventions have been tested at academic medical centers but have not been available for use by community mental health professionals. one such intervention is the biobehavioral intervention (bbi), developed by professor barbara l. andersen and colleagues at ohio state (osu). current funding has enabled the investigators to train mental health professionals from across the country to deliver the bbi at their institution. recently diagnosed cancer patients who are participating in the bbi group at these institutions may participate in a research study completing self report measures asking about psychological and behavioral outcomes (for example, mood, stress, diet and physical activity). the investigators hypothesize that individuals participating in the intervention will report improvements in outcomes, such as reduced stress and improved mood, reduced symptoms of the disease and treatment, etc., after completing the intervention and continue to report these improvements up to 6 months after the group ends. osu will coordinate this data collection project but information about participating sites is listed in http://clinicaltrials.gov.


Eligibility criteria:
inclusion criteria: * recent initial diagnosis of cancer without metastatic disease * able to speak/read english exclusion criteria: those with concurrent diagnoses of * organic brain syndrome * dementia * mental retardation * non-english speaking * significant sensory deficit * severe mental illness (e.g., schizophrenia, psychotic disorder)

Keywords: stress management coping skills recently diagnosed cancer patients intervention, psychological
combined bilateral uterine artery ligation and bakri balloon during cesarean section

Conditions: Placenta Previa

Summary: this study will be performed to compare the effectiveness of routine bakri balloon tamponade and bilateral uterine artery ligation during cesarean section in patients with placenta previa

intraoperative methods to control profuse bleeding during cesarean section in patients with placenta previa include uterine packing, balloon tamponade, uterine compression sutures, arterial ligation, uterine artery embolization, and hysterectomy.

Eligibility criteria:
inclusion criteria: * women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures exclusion criteria: * patients with the high possibility of morbid adherent placenta * those presented with severe antepartum hemorrhage * patients with cardiac, hepatic, renal, or thromboembolic disease; * patient refuses to consent
intercostal cryoanalgesia for acute pain after vats lung resection

Conditions: Thoracic Surgery; Video-Assisted; Cryotherapy Effect; Paravertebral Block

Summary: intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. the aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute thoracic pain after vats lung resection surgery.

vats lung resection is associated with a high incidence of moderate to severe acute thoracic pain. in the postoperative period, optimal analgesia may facilitate recovery, lead to higher patient satisfaction, and lower postoperative complications. regional analgesia techniques are usually recommended for vats, and the paravertebral block is often used. however, the duration of the paravertebral block is short (6 to 24 hours), and prolongation of the effect requires the placement of a paravertebral catheter and local anesthetic infusion into the paravertebral space. at our institution, patients with vats lung resections are often discharged home 24-48 hours after surgery. intercostal cryoanalgesia has an onset of about 12 hours, which coincides with the weaning of the single-injection paravertebral block. analgesia is usually prolonged over several weeks, does not require catheter placement, and is not associated with hemodynamic side effects. these characteristics may allow rapid recovery and safe home discharge after vats lung resection. the aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute thoracic pain after vats lung resection surgery.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective anatomical pulmonary resection (anatomical segmentectomy, lobectomy or bilobectomy) by vats for lung cancer * american society of anesthesiologists (asa) score 1-3 exclusion criteria: * contraindication to the paravertebral block (coagulopathy, discontinuous paravertebral space, impossible thoracoscopic visualization of the paravertebral space) * contraindication to intercostal cryoanalgesia (cold urticaria, cryoglobulinemia) * epidural analgesia preferred (high risk of thoracotomy, marginal lung function) * surgical criteria (conversion to thoracotomy, non anatomical wedge resection) * known allergy to acetaminophen, celecoxib, sulfa or both hydromorphone and morphine * preoperative thoracic or shoulder pain on the operated side * history of thoracic surgery on the operated site * regular use of opioids or medication with effects against neuropathic pain (tricyclics, gabapentinoids, duloxetine, venlafaxine) * inability to understand pain scales or to communicate clearly despite adequate teaching * contraindication to non-steroidal anti-inflammatory drugs (renal filtration rate \< 60 ml/min, active gastric ulcer) * pregnancy * patient refusal to participate
effects of denture-related stomatitis on blood pressure in denture wearers

Conditions: Denture Stomatitis

Summary: the aim of this study is to evaluate the influence of presence of oral fungal infection, which leads to denture-related stomatitis, on blood pressure, endothelial function and immune cell phenotype in patients wearing dentures.


Eligibility criteria:
inclusion criteria: * patients with dental prostheses used for at least 6 months, * substantial portion of the oral mucosa covered by dental prosthesis. exclusion criteria: * acute inflammatory disorders other than denture-related stomatitis, neoplastic disease relapses or chemotherapy courses less than 5 years before the enrolment, * antibiotics in less than 4 weeks before the enrolment, * anti-inflammatory drugs (steroids and non-steroidal, excluding aspirin in doses less than 80 mg) in less than 2 months before the enrolment, * history of myocardial infarction, acute coronary incident or vascular inflammation in 5 weeks or less before the enrolment, * chronic haematological disorders and immunodeficiencies less than 5 weeks before the enrolment, * major medication changes less than 5 weeks before the enrolment or during study.

Keywords: denture stomatitis dentures denture wearers
exergaming to increase physical activity in overweight/obese children and adolescents

Conditions: Obesity

Summary: the primary purpose of this study is to examine the effects of regular exergaming for 8 weeks in 24 overweight/obese children and adolescents (10-17 years) on maximal aerobic fitness (vo2max) and physical activity levels measured before and after (8 weeks) intervention period, and in addition at follow-up (12 weeks). we also wish to investigate the effects on markers of cardio metabolic health and body composition, measured at baseline, 8 weeks and 12 weeks follow-up. also, the participants gaming frequency will be registered throughout the 8 week period, as well as during the follow-up between 8 and 12 weeks. aim of this study is to investigate if access to this game can provide health benefits for overweight/obese children and adolescents.


Eligibility criteria:
inclusion criteria: * defined as overweight/obese for age and sex * able to ride a bike for up to 60 minutes exclusion criteria: * known cardiovascular disease * taking beta-blockers or anti-arrhythmic drugs * other diseases that restrict them from doing high-intensity training

Keywords: exercise therapy physical fitness gaming child healthy lifestyle fitness testing
study to evaluate meningococcal serogroups a,c,w-135,y conjugate vaccine when given as 1 dose to healthy subjects aged 18-25 years

Conditions: Infections, Meningococcal

Summary: the purpose of this study is to evaluate the safety, reactogenicity, immunogenicity and persistence up to three years after administration of one dose of the menacwy conjugate vaccine when given to young adults aged 18-25 years.

administration of the candidate vaccine or of the active control (mencevax™ acwy) will be done in an open manner. the study consists of a vaccination phase during which subjects receive one vaccine dose (gsk's menacwy conjugate vaccine or mencevax™ acwy vaccine) and 3 years of follow-up. there are in total 7 visits to the doctor: before and 2, 7 and 30 days after vaccination (vaccination phase) as well as 12, 24 and 36 months after vaccination (follow-up phase). 7 blood samples are taken: one at each visit.

Eligibility criteria:
inclusion criteria: * healthy male or female between, and including, 18 and 25 years of age at the time of vaccination. * written informed consent obtained. * subject with previously completed routine childhood vaccinations to the best of his/her knowledge. * female subjects should be of non-childbearing potential, or abstinent, or using an adequate contraception. exclusion criteria: * previous vaccination against or history of or exposure within previous 12 months to, meningococcal serogroup a, c, w-135 or y disease. * administration of a tetanus vaccine within 6 months before study vaccination. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of any neurologic disorders or seizures. * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * history of chronic alcohol consumption and/or drug abuse
iron absorption in haiti

Conditions: Iron Deficiency

Summary: the government of haiti plans to introduce a flour fortification program. the aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. for this purpose, iron absorption from wheat flour using different iron compounds will be investigated.


Eligibility criteria:
mother-child pairs will be recruited! inclusion criteria for mothers : * women of reproductive age (18 to 45 years) * generally healthy * consenting to study participation exclusion criteria for mothers : * pregnancy or lactation * weight \>65 kg * chronic illnesses which may influence iron absorption * severe anemia (hb\<10 g/dl) inclusion criteria for children: * age 4 years +/- 12 months * generally healthy exclusion criteria for children : * severe anemia (hb\<10 g/dl) * weight for height \< -2 z scores (wasting) * height of age \< -2 z score (stunting) furthermore, the following exclusion criteria apply to both mothers and children : * chronic illnesses or medication which may influence iron absorption (will be judged by investigator) * consumption of vitamin or mineral supplement (unless they agree to discontinue using them two weeks before beginning of the study until the las visit) * allergies or intolerances relevant to the test meal (gluten) * blood donation or major blood losses during the 2 months prior to the study * illness during the 4 weeks prior to the study (will be judged by investigator)
the role of narrowband ultraviolet b exposure in the maintenance of vitamin d levels during winter

Conditions: Vitamin D Deficiency

Summary: the investigators investigated the ability of narrowband ultraviolet b (nbuvb) treatment in the maintenance of vitamin d levels achieved during the summer in finland. the investigators randomized 37 subjects into groups of 17 and 18 subjects. the other group received 2 standard erythema doses (sed) nbuvb exposure every other week until week 24, and serum 25(oh)d levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. the control group was not illuminated and serum samples were analyzed correspondingly. punch biopsies were taken at the onset and at week 14 for cyp27a1 and cyp27b1 enzyme expression level analyses.

the investigators investigated the ability of narrowband ultraviolet b (nbuvb) treatment in the maintenance of vitamin d levels achieved during the summer in finland. the investigators randomized 37 subjects into groups of 17 and 18 subjects. the other group received 2 standard erythema doses (sed) nbuvb exposure every other week until week 24, and serum 25(oh)d levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. the control group was not illuminated and serum samples were analyzed correspondingly. 6mm punch biopsies were taken at the onset and at week 14 for cyp27a1 and cyp27b1 enzyme expression level analyses.

Eligibility criteria:
inclusion criteria: * age over 18 * fitzpacker's skin type ii-iv exclusion criteria: * age under 18 * diseases that inhibit vitamin d metabolism or absorption * fitzpacker's skin type i * history of skin cancer * vitamin d substitution 1 month before baseline or during study * sun holidays 1 month before baseline or during study

Keywords: calcidiol 25(oh)d nbuvb cyp27a1 cyp27b1 vitamin d
effect of a nursing program for patients with cystic fibrosis on disease management

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the effect of a nursing program in patients with cystic fibrosis.

all patients living with cystic fibrosis will be asked by questionnaire before (november 2014) and after (september 2016) the implementation of the program about their satisfaction with treatment, trust in the cf-team, adherence, self-efficacy, treatment burden and quality of life.

Eligibility criteria:
inclusion criteria: * cystic fibrosis exclusion criteria: * none
evaluating the impact of a new complement to physiotherapy intervention for positional torticollis in infants

Conditions: Torticollis

Summary: children with a torticollis are usually referred for physiotherapy where they are evaluated, and given exercises as well as education to treat the condition. this study is being done in order to compare 2 methods of sharing information with parents of children with torticollis.

160 children of less than 6 months of age will be recruited for the study and divided in 2 groups. children of both groups will receive the same physiotherapy evaluation and exercises but parents will receive information handouts with one of two different types of illustrations and written instructions for home exercises.

Eligibility criteria:
inclusion criteria: * aged newborn to 6 months at initial visit in physiotherapy, * a diagnosis of pt made by a physician, * at least 37 weeks of gestational age at delivery exclusion criteria: * congenital muscular torticollis with fibrosis (confirmed diagnosis): because this is a rare condition that has a different rate of recovery, * presence of craniosynostosis (confirmed diagnosis made by a neurosurgeon), * apgar score of less than 7 at 5 minutes, * prescription of a tubular orthosis for torticollis (tot) collar or botox intervention for the torticollis, * confirmed diagnosis of syndrome or neurological condition.

Keywords: congenital muscular torticollis
transanal total mesorectal excision versus laparoscopic tme for rectal cancer

Conditions: Rectal Neoplasms

Summary: to investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.

natural orifice transluminal endoscopic surgery (notes) give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. experience with transanal minimal invasive surgery(tamis) for rectal cancer show that such notes procedures are feasible and safe. and also, lots of experimental studies and small case series reporting the feasibility of transanal anterior resection with single incision laparoscopic surgery(sils) port or other devices. however any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function, sexual function, qof) are missing. this study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive total mesentery excision for rectal cancer.

Eligibility criteria:
inclusion criteria: * biopsy-proven adenocarcinoma of the rectum * eligible to undergo conventional laparoscopic low anterior resection or transanal hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma * node negative (n0), t1 (high risk features), t2 and t3 rectal cancer on pelvic mri * closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic mri * rectal cancer located 3-10 cm from the anal verge exclusion criteria: * metastasis * obstructing rectal cancer * synchronous colon cancer * t4 rectal cancer not treated preoperatively with full-course chemoradiation * pregnant or breast-feeding * receiving any other study agents * fecal incontinence * history of prior colorectal cancer * history of inflammatory bowel disease * history of pelvic radiation * bmi \> 40 * large uterine fibroids * uncontrolled intercurrent illness

Keywords: rectal cancer laparoscopic tatme tme
soy isoflavonates versus placebo on quality of life in menopausal women

Conditions: Menopause; Menopausal Women; Soy Isoflavone Effect; Quality of Life

Summary: within the context of the proposed research study, the effect of soy isoflavonoid supplements on the quality of life and coagulation of menopausal women. it has been observed that menopause, as a physiological process, is associated with alterations in the physical, mental and sexual quality of life, making the use of hormone replacement therapy necessary; however, hormone therapy is associated with hypercoagulability, since it has been seen that women have higher levels of thrombogenic microvesicles such as: platelets with a greater probability of causing blood clotting were more likely to present a greater amount of white matter hyperintensities, which appear in the mri scan.

the following study is aimed at clarifying the effects of soy isoflavonate supplements on the quality of life and markers of hypercoagulability in menopausal women. the reasons for conducting this research arise from the concern of minimizing side effects such as hypercoagulation caused by hormone replacement therapy, which is intended to be replaced with soy isoflavonates to evaluate its efficacy.

Eligibility criteria:
inclusion criteria: * submission of a signed and dated informed consent form. * declared willingness to comply with all study procedures and availability for the duration of the study. * can read and write * female, age 45 to 65 years * female with more than 1 year of amenorrhea. * no hormone replacement therapy or herbal medications in the 6 months prior to the investigation. * ability to take oral medication and willing to comply with the \<study intervention regimen. * agreement to comply with lifestyle considerations for the duration of the study. * have a smartphone-type cell phone * residence in francisco morazán exclusion criteria: * patient does not sign informed consent * patient does not wish to participate * history of thrombo embolism * history of cardiovascular disease * presence of estrogen-dependent neoplasm * presence of abnormal genital bleeding * uncontrolled metabolic diseases * smoking and drinking habits * use of anticoagulant or acetylsalicylic acid * known allergic reactions to soy isoflavonate components * history of thrombophilias such as: antithrombin deficiency, protein c deficiency, protein s deficiency, factor v leiden, prothrombin g20210a, hyperhomocysteinemia, antiphospholipid syndrome, acquired activated protein c resistance.

Keywords: menopause menopausal women soy isoflavone effect quality of life
a study designed to determine if the drugs albuterol (salbutamol) and fluticasone have an effect on the pharmacokinetics of the investigational product technosphere® insulin inhalation powder in healthy volunteers

Conditions: Diabetes Mellitus; Healthy Subjects

Summary: this study will investigate the effects of inhaled albuterol \& fluticasone on one dose of ti inhalation powder. a total of 12 eligible subjects will be enrolled.


Eligibility criteria:
inclusion criteria: subjects must have a fasting blood glucose (bg) level of less than 6.1 mmol/l fev1/ fvc = lln tlc = 80% predicted dlco (unc) = 80% predicted (miller) no significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of = 12% and = 200 ml in fev1 or fvc) at screening fev1 = 80% (nhanes iii predicted exclusion criteria: history of diabetes mellitus previous exposure to any inhaled insulin product any known pulmonary disease or inability to perform pft maneuvers meeting recommended american thoracic society (ats) standards of acceptability and repeatability criteria respiratory tract infection within 8 weeks prior to screening/visit 1 major organ system diseases including seizures, heart failure, uncontrolled hypertension, aneurysm, cancer within the past 5 years, liver disease, anemia or autoimmune disorder clinically significant abnormalities on screening laboratory evaluation female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period or not practicing adequate birth control unable and/or unlikely to comprehend how to use the investigational device in this study or to follow study instructions

Keywords: healthy males or females subjects
autologous bone marrow-derived mononuclear cells for acute spinal cord injury

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to evaluate the safety and effectiveness of intrathecal transplantation of autologous bone marrow-derived mononuclear cells for the treatment of traumatic acute spinal cord injury. spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). early treatment is the key to improve the prognosis, however, the majority of clinic trails nowadays are focusing on sub-acute or chronic phase because it takes 4-6 weeks to expand the autologous stem cells. in this study, the investigators will treat patients with acute spinal cord injury with autologous bone marrow-derived mononuclear cells and compare with the control group.


Eligibility criteria:
inclusion criteria: * patients aged between 18 and 60 years * traumatic spinal cord injury * asia impairment scale a-d * the injury must be within two weeks * patients submitted written informed consent exclusion criteria: * traumatic spinal cord injury with brain injury or peripheral nerve injury * patients with severe multiple injuries and unstable vital signs * non-traumatic spinal cord injury caused by spinal tumors, hematoma, myelitis, etc. * patients with central spinal cord injury * patients with a completely transected spinal cord * patients with fever or acute infection * ongoing infectious disease, such as tuberculosis, hiv, hepatitis, syphilis, etc. * patients with anemia, coagulopathy, and other known blood system diseases * patients with malignant tumour * patients with neurodegenerative diseases, or any neuropathies * patients with ankylosing spondylitis * patients with a previous history of spinal surgery * patients who are pregnant or possibly pregnant * patients with psychiatric, addictive or any other mental disorders that can not give a truly informed consent * patients who are participating in other clinical trials