Kornimate/medical-research-clean huggingface dataset:
the effects and mechanisms of brief mindfulness meditation and hypnosis for pain

Conditions: Pain; Chronic Pain

Summary: the aim of this study is to determine the effects and mechanisms of 1 x 20-min training in mindfulness meditation and self-hypnosis relative to an inert control. participants will be randomly assigned to condition. the dual primary outcomes will be pre- to post-training changes in current pain intensity and pain unpleasantness. the active treatments are hypothesized to produce greater reductions in pain outcomes than the control. it is also hypothesized that change in mindfulness will be a mediator specific to mindfulness meditation, while change in affect and decentering will be mediators of the hypnosis condition. moderators of response will also be explored.


Eligibility criteria:
inclusion criteria: * must be 18 years of age; * experience chronic or recurrent pain; * have access to a computer, phone or tablet with internet capability; and * be able to read and understand english.
safety and efficacy study of a testosterone eye drop for the treatment of meibomian gland dysfunction

Conditions: Meibomian Gland Dysfunction

Summary: the objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.

meibomian gland secretion plays a crucial role in the health of the ocular surface and function of the tear film. the lipid secreted by the meibomian glands has many crucial roles: 1) to retard evaporation from the preocular surface; 2) lower the surface tension of tears; 3) prevent spill-over of tears from the lid margin; 4) prevent the contamination of the tear film by sebaceous lipids; 5) prevent damage to the skin of the lid margin. in dry eye syndrome, blepharitis, meibomian gland dysfunction, and meibomitis the glands are the central pathophysiology of disease and thus a potential target for therapy.

Eligibility criteria:
inclusion criteria (subjects must): * be ≥ 60 years of age * have a corrected visual acuity of logmar +0.5 (etdrs) * have a documented history of meibomian gland dysfunction * have a tfbut ≤ 5 seconds * have an ocular discomfort score ≥ 1 * have an iop ≤ 25 mmhg at visit 1 in both eyes * report use of and/or desire to use an artificial tears exclusion criteria (subjects may not): * have contraindications to the use of the study medications * have a known allergy or sensitivity to the study medications * have any ocular infections, or active ocular inflammation * have used ocular medications within 24 hours prior to visit 1 * be a current contact lens wearer * require the use of any other ophthalmic medication, other than tear substitutes and study medication provided, for the duration of the trial * have used systemic or topical antihistamines or steroids 48 hours prior to visit 1 or require the use of systemic or topical antihistamines or steroids during the course of the study * have a history of prostate cancer

Keywords: meibomian gland dysfunction dry eye syndrome
treatment of cervical syndrome with physium therapy

Conditions: Cervical Syndrome

Summary: this study aim to investigate the effects of physium therapy for improving pressure pain thresholds (ppts), range of motion,neck disability index, the multidimensional health related quality of life (sf-12) and the multidimensional health related quality of life and pain in patients with mechanical neck pain (np).

fifty-four participants with np will randomly allocated to either an physium therapy (five sessions) or a physical therapy (pt) groups (ten sessions) during two weeks. multimodal pt program included: ultrasound therapy (us), transcutaneous electric nerve stimulation (tens) and massage. visual analogue scale (vas), neck disability index ( ndi), range of motion and (crom), questionnaire sf-12 and ppts in sub-occipital and upper trapezius muscles were measured at baseline, at the end of treatment and at 1 month follow-up. t-tests and a repeated-measures multivariate analysis of variance (rm-manova) were used for vas, crom and ppts, respectively.

Eligibility criteria:
inclusion criteria: * patients of both sexes, * aged between 20 and 60 years, in an * active state of pain and diagnosed with a month of evolution. exclusion criteria: - patients who are pregnant, have pacemaker and those surgically operated cervical spine - - patients who have been treated with myofascial therapy a month earlier.

Keywords: neck pain physical therapy modalities massage manual therapy
young with diabetes type 1 - test of an mhealth app

Conditions: Diabetes Mellitus, Type 1

Summary: a multicenter randomized controlled trial testing the app "young with diabetes"

young people with diabetes type 1, their parents and health care providers have participated in developing the mhealth app "young with diabetes". the aim of the app is to support young people to self-manage their diabetes type 1. a test group of 70 young people with diabetes type 1 test the app for 12 months as a supplement to standard care and the control group receives standard care only. at baseline and after 2, 7 and 12 months hba1c, problem areas in diabetes, perceived competences in diabetes and health care climate are measured.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * 14 to 22 years old * followed at one of the six diabetes departments/centers 1. pediatric and adolescent department, nordsjællands hospital, hillerød 2. department of cardiology, nephrology and endocrinology, nordsjællands hospital, hillerød 3. pediatric and adolescent department, herlev hospital 4. steno diabetes center, gentofte 5. pediatric department, roskilde hospital 6. department of endocrinology, køge hospital * have an ios or android smartphone * last measured hba1c before sending out recruiting letters: 64 mmol/mol or more (if the last measured hba1c is older than 6 months at time of baseline visit a new hba1c is measured and has to be at least 64 mmol/mol before the participant kan be randomized) * mean of the three last measured hba1c before sending out recruiting letters: 58 mmol/mol or more (if the third last hba1c is older than 18 months at time of baseline visit a new hba1c is measured and has to be at least 64 mmol/mol before the participant kan be randomized) exclusion criteria: * a psychical or psychiatric disorder that enables them to use the app * participates in other diabetes interventions * sees a psychologist or psychiatrist * have participated in developing the app young with diabetes

Keywords: diabetes type 1 transition telemedicine mhealth app youth self-management
implementing 3-step workout for life in home health

Conditions: Frailty; Disability or Chronic Disease Leading to Disablement

Summary: the purpose of this project is to study how to adapt and implement the 3-step workout for life program in a local home health agency. a series of learning cycles will be conducted to adjust the treatment dose and delivery mode. the specific aim is to evaluate the implementation-related clinical and patient outcomes.

medicare beneficiaries admitted to home health agencies are often in frail status with decreased muscle strength and difficulty in performing activities of daily living. the purpose of the proposed research is to study how to adapt and implement the 3-step workout for life program by the physical therapy and occupational therapy practitioners in a local home health agency. a series of learning cycles will be conducted to adjust the treatment dose and delivery mode, so that the program can be implemented at low cost but remains effective in improving self-care ability for medicare beneficiaries. the specific aim is to evaluate the implementation-related clinical and patient outcomes.

Eligibility criteria:
inclusion criteria: * is a medicare beneficiary * admitted to the partnered home health agency * show or experience muscle weakness * demonstrate functional limitation on at least one of the oasis self-care items exclusion criteria: * has an acute fracture with surgical or weight-bearing restrictions * has elective joint replacement surgery * has a lower extremity amputation * is receiving active treatment for cancer diagnosis * has on-going dialysis treatment * had acute cardiac surgery * with acute stroke or neurologic disorder that limits motor movements * in terminal stages of congestive heart failure * has been referred to hospice care * has severe cognitive deficits limiting verbal communication * has significant medical complications that preclude safe participation in resistance exercise
evaluation of robotic arm rehabilitation in stroke patients

Conditions: Stroke

Summary: the purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.

a robotic exercise device has been developed(mit-manus)capable of providing therapy to the arm for patients with weakness due to stroke. the randomized trial will compare conventional care, planar robot intervention and an intervention of planar and vertical robot training among patients with chronic, stable deficits. we will evaluate motor outcomes, effectiveness, cost, patient satisfaction and quality of life. the study will determine the efficacy of upper extremity robot therapy compared to supervised self-administered exercise therapy in patients with deficits due to stroke.

Eligibility criteria:
inclusion criteria: * subjects must have a clinically, defined, unilateral, hemiparetic stroke with radiologic exclusion of other diagnoses * stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients * a grade 3 or lower in manual muscle test in the hemiparetic elbow flexion and shoulder abduction exclusion criteria: * subjects unable to give informed consent * serious complicating medical illness * contracture or orthopedic problems limiting the range of joint movement in the study arm * visual loss * stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients * botox treatment within 3 months of enrollment
cognitive enhancement program in improving cognitive function in breast cancer survivors

Conditions: Breast Cancer; Cancer Survivor; Cognitive/Functional Effects

Summary: this randomized clinical trial studies cognitive enhancement program in improving cognitive function in breast cancer survivors. a cognitive enhancement program may help improve cognitive function in breast cancer survivors and may help doctors plan better treatment for cognitive decline.

primary objectives: i. to improve cognition of women who have had breast cancer and exhibit cognitive decline through a cognitive enhancement program. outline: participants are randomized to 1 of 2 arms. arm i (cognitive enhancement program): participants are randomized to 1 of 2 arms. arm ia (lumosity): participants complete lumosity cognitive exercises. lumosity cognitive exercises are online video game-based activities that are designed to practice various cognitive skills including processing speed, attention, memory and executive function. participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. participants also complete relaxation exercises (guided imagery, progressive muscle relaxation, and/or autogenics) at least 10 minutes a day for 6 weeks and compensatory strategies (the use of external devices such as a notebook, day planner, or smartphone for cuing, reminding, and organizing; the use of memory strategies such as repetition, paraphrasing, and active listening; and the use of executive strategies such as self-talk for planning and attention orientation) as much as possible. arm ib (active journaling): participants complete active journal cognitive exercises. active journaling requires participants to keep a written diary or journal where she discusses what her thoughts and feelings about various events with a focus on describing the meaning of the activities and experiences, particularly new things that were learned. active journaling is a method of practicing various cognitive skills including communication, organization, memory and executive function. participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. participants also complete relaxation exercises and compensatory strategies as in arm ia. arm ii (lumosity only): participants complete lumosity cognitive exercises as in arm ia.

Eligibility criteria:
inclusion criteria: * previous diagnosis of breast cancer * received chemotherapy treatment for breast cancer diagnosis * chemotherapy-free for at least one year exclusion criteria: * history of learning disability, head trauma, neurologic disorder or significant psychiatric condition * significant medical condition (e.g. diabetes) unrelated to cancer diagnosis * magnetic resonance imaging (mri) contraindications (e.g. metallic biomedical implants) * pregnancy
the oral cavity as a source of febrile neutropenia

Conditions: Febrile Neutropenia; Solid Tumors; Dental Infection; Oral Infection

Summary: febrile neutropenia (fn) is a clinically important adverse effect of myelosuppressive chemotherapy. if patients present with fn, attention is focussed on well-recognized sites of origin of infection: the airways, urinary tracts, and skin. however, infections can be only documented clinically in about two-third of febrile episodes, whereas a causative microbial pathogen cannot be identified in the majority (\>70%) of cases. pre-treatment oral evaluation aimed to identify and eliminate oral/dental foci is only routinely used in patients at high risk for oral complications (i.e. head and neck cancer patients and stem cell transplantation recipients). however, any patient treated with myelosuppressive chemotherapy, be it for cure or palliation, is at risk of developing infection in and/or originating from the oral cavity. nevertheless, in these patients dental screening is somewhat randomly employed at the oncologist's discretion. more insight into the pre-treatment oral condition and its potential role in fn is mandatory, particularly considering the growing numbers of older patients retaining their natural dentition and the increase of dental diseases and cancer incidence with age. in addition, oral diseases may aggravate chemotherapy-induced oral mucositis (om). om is associated with an inflammatory response, which together with ulcerations providing a portal of entry for bacteria, can result in fn and systemic inflammatory syndrome (sirs) and/or sepsis. evidence suggests that microorganisms are involved in the pathobiology of om, but no longitudinal studies using open-end sequencing are available. furthermore, comparing bacteria identified in blood cultures in febrile patients with those of the oral cavity will expand the knowledge on the role of the oral cavity as a potential source of bacteremia. the investigators expect that the results will provide a scientific base for subsequent intervention studies on the efficacy of dental screening and elimination of foci, and other interventions aimed at modifying the oral environment before and during chemotherapy.


Eligibility criteria:
inclusion criteria: * diagnosed with a solid cancer, lymphoma or multiple myeloma * planned treatment with myelosuppressive chemotherapy with fn risk of 10%-20% (with or without targeted therapies or hormonal therapy) * willing and able to give written informed consent * age 18 or older * presence of (partial) natural dentition and/or dental implants exclusion criteria: * patients unable to give written informed consent * patients \<18 years * prior irradiation to the head and neck * edentulous patients

Keywords: myelosuppressive chemotherapy febrile neutropenia solid tumors dental infection oral infection
implementation of pedometer for monitoring step count pre and post lumbar esi for radicular pain

Conditions: Chronic Low Back Pain

Summary: our aim is to assess usability and compliance of a wireless pedometer for monitoring step count after a lumbar epidural steroid injection for the treatment of radicular pain in low back pain patients. our main hypothesis is to demonstrate pedometer measured step count can be used to measure efficacy of pain interventions.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * patients receiving lumbar epidural steroid injections as pain management to be scheduled at least one week away (-2 days/1 month). * patients who are able to understand how the fitbit instrument works and are willing to consent to the study. * patient who used web-based communication frequently, e.g. email. * patients who can speak, understand, and write in english. * prior mri or an appointment to obtain an mri prior to the procedure. exclusion criteria: * workers' compensation cases. * patient does not have a computer at home. * non-ambulatory patients. * patients who have received a lumbar epidural steroid injection in the past 6 months. * nursing or pregnant women.
effects of a mediterranean style diet on vascular health in type 2 diabetes

Conditions: Type 2 Diabetes; Coronary Heart Disease

Summary: in this study we will compare the effects of a mediterranean diet, high in fruit and vegetables with the more conventional diet recommended for diabetes therapy (a high carbohydrate, low fat diet) on glycaemic and lipid control and on markers of inflammation, in people with newly diagnosed type 2 diabetes. the hypothesis is that, over a six-month intervention period, a hvm diet will be more effective than a conventional hclf diet in improving glycaemic and lipid control, and in reducing markers of vascular inflammation in people with type 2 diabetes.

chronic inflammation affecting both small and large blood vessels is an important factor increasing the risk of heart disease in people with type 2 diabetes. good markers present in the blood are now available to detect this inflammatory state. recent evidence suggests that a mediterranean-type diet, high in plant foods and with monounsaturated fat from olive oil has beneficial effects on blood vessels as well as on blood glucose and blood lipid control. in this study we will compare the effects of a mediterranean diet, high in fruit and vegetables with the more conventional diet recommended for diabetes therapy (a high carbohydrate, low fat diet). twenty-four people with type 2 diabetes will be randomised to one of these diets and followed for six months. at the end of this time, the effect of the diets on markers for inflammation will be compared.

Eligibility criteria:
inclusion criteria: -english speaking people with newly diagnosed type 2 diabetes (within 3-12 months of diagnosis) who are attending the alfred hospital, diabetes education outpatient clinic. exclusion criteria: * age \ 75 years; * body mass index (bmi) \ 37 kg/m2; * on corticosteroid or insulin therapy; * presence of established renal and/or liver disease (serum creatinine more than 0.12 mmol/l/albumin excretion rate greater than 300 µg per minute or alt more than twice the upper limit of normal respectively).

Keywords: dietary intervention
hydeal-d® application for promoting the restoration of sexual function in the postpartum period

Conditions: Vagina; Anomaly; Puerperium; Disease; Sexual Dysfunction

Summary: during postpartum and lactation, vaginal epithelium tends to have an impaired degree of hydration and lubrication. this may lead to vaginal dryness, burning sensation dyspareunia or itching, which negatively affect the sexual function of puerperal women. this study aimed to evaluate the efficacy of hydeal-d® vaginal gel (hyalogyn®, fidia farmaceutici, abano terme, italy) application on promoting the restoration of sexual function in the postpartum period.


Eligibility criteria:
inclusion criteria: * women from 18 to 40 years old; * women in the puerperium period (after vaginal delivery or cesarean section); * women that are breast-feeding, that are not breast-feeding or that are breast-feeding partially; exclusion criteria: * allergy to hyaluronic acid gel; * women non-italian speaking; * women with signs of vaginal infection; * women with a history of cancer of any site with recent genital bleeding of unknown origin; and patients with acute hepatopathy, embolic disorders, severe primary disease of kidney; * women who are attending or have attended other clinical trials within previous two weeks; * women with mental disorder and no insight

Keywords: puerperium
injection of autologous bone marrow aspirate in patients with degenerative disc disease.

Conditions: Lumbar Disc Disease

Summary: lumbar discectomy and injection of purified cellular bone marrow concentrate or lumbar discectomy only

in order to find a regenerative treatment for back pain from ddd, cell based therapies have become of increasing interest. recent clinical studies have shown promising improvement in pain and disc hydration, thus indicating a regenerative effect. the use of mesenchymal stem cells for regeneration of degenerated connective tissue of mesenchymal origin has proven efficient in multiple recent studies. however, the acquisition of mesenchymal stem cells (msc) is always an extensive procedure requiring either enzymatic or genetic manipulation of acquired tissues. thus, the use of these mscs is highly controversial and raises concerns in terms of patient safety. one of the most commonly used sources for mscs is bone marrow tissue. even when not manipulated, these tissues already contain a significant amount of mesenchymal stem cells and growth factors. therefore, they are used for regenerative treatments of multiple degenerative musculoskeletal diseases. this is an exploratory pilot study which aims to compare patient outcomes between two treatments approaches for ddd that are currently being used in clinic. while micro- discectomy is the standard of care for ddd, micro-discectomies with autologous bone marrow cell injections have been used in clinic in the past year. the goal of this study is to determine if the bone marrow injection group is superior compared to the control group (state of the art micro-discectomies) in enhancing degenerative disc recovery and improving or preventing back pain.

Eligibility criteria:
inclusion criteria: 1. male or female patients ≥18 years of age 2. radiologically (mri) confirmed diagnosis degenerative disc disease of the lumbar spine and/or lumbar disc herniation 3. unresponsive to conservative/non-operative treatment for \>3 months 4. psychosocial, mental and physical ability to understand and to adhere to this protocol, especially adhering to the visit schedule follow-ups, and observe treatment plan 5. signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial study-related procedures exclusion criteria: 1. pregnant or breastfeeding patients 2. active malignancy 3. active chronic or acute infection 4. autoimmune disorder that impacts the lumbar spine (ankylosing spondylitis, lupus eg.) 5. acute episode or major mental illness 6. major cognitive impairment causing to inability to understand informed consent

Keywords: sciatica lumbar disc herniation discectomy