Kornimate/medical-research-clean huggingface dataset:
moving on - an rct to test physical therapy education

Conditions: Breast Cancer

Summary: the purpose of this study is to test the acceptability, feasibility and explore the possible effects of an early physical therapy education intervention for breast cancer survivors.

this study uses a randomized controlled and longitudinal study design. we will compare two groups - an intervention group and a control group - to test the effects of an early physical therapy education intervention for breast cancer survivors who are candidates for breast cancer surgery. because of the nature of the intervention (patient early education with 1:1 discussion of educational materials) we will be unable to introduce blinding of the participant as well as the staff.

Eligibility criteria:
inclusion criteria: * newly diagnosed with unilateral breast cancer * candidate for breast cancer surgery as first line of cancer treatment * undergo breast cancer surgery at brigham and woman's hospital, boston, massachusetts * female * english speaking * greater than or equal to 21 years old exclusion criteria: * previous history of breast cancer and/or recurrent/metastatic disease * receiving neoadjuvant chemotherapy treatment * bilateral breast cancer * history of shoulder impairments or severe upper quarter scarring * pregnancy * central nervous system damage * dementia * history of other previous cancers (except non-melanoma skin) * systemic medical conditions (e.g.: fibromyalgia, rheumatoid arthritis, etc.) * amputation of either upper extremity
the effects of tranexamic acid on joint inflammation and cartilage health in anterior cruciate ligament injured patients

Conditions: Anterior Cruciate Ligament Reconstruction

Summary: patients who tear their acl are at high risk for developing arthritis (post-traumatic osteoarthritis-ptoa) just 10 years later. joint bleeding and inflammation contribute to deterioration of joint health. this study will determine whether treatment with tranexamic acid (txa), an fda approved medication that reduces bleeding right after acl injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of ptoa.


Eligibility criteria:
inclusion criteria: * age 18-30 years * within 4 days of unilateral acl injury * presence of effusion/hemarthrosis. exclusion criteria: * inflammatory arthritis, radiographic osteoarthritis (k-l grade 2 or higher), gout/ pseudogout * systemic or acute illness requiring medications * concomitant knee injury aside from meniscus tear and mcl tear not requiring surgery * prior surgery to either knee * prior injury to either knee requiring crutches * history of thromboembolic disease * current use of combination hormonal contraception * chronic nsaid use * cortisone injection to either knee within the prior 3 months * not indicated for or unable to undergo aclr within 3 months of injury
ascend: a clinical trial to evaluate the safety and effectiveness of via disc np, a supplement for degenerated intervertebral discs

Conditions: Degenerative Disc Disease; Disc Degeneration; Lumbar Discogenic Pain

Summary: via disc np is an off-the-shelf minimally processed human nucleus pulposus tissue allograft intended to supplement degenerated intervertebral discs. the study is a randomized, double-blind, sham-controlled, multi-center study in participants with symptomatic lumbar intervertebral disc degeneration (\> 6 months) and unresponsive to conservative therapy for at least 3 months. participants will be randomized on a 1:1 basis to receive either a single via disc np intradiscal injection at 1 or 2 levels or a sham procedure at 1 or 2 levels.


Eligibility criteria:
key inclusion criteria: 1. age 22 to 85 years old 2. diagnosis of early to moderate ddd, modified pfirrmann grade 3-7 3. chronic axial midline low-back pain with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care 4. positive hip flexion test as confirmed with the neurologic exam indicating positive provocation with sustained hip flexion at the time of screening 5. demonstrated intolerance to sitting for more than 30 minutes at a time based on self-report or assessed by a qualified healthcare professional at the screening visit 6. low-back pain severity score of ≥ 40 to ≤ 90 mm on the vas at the time of screening 7. odi score of ≥ 40 to ≤ 80 at the time of screening key exclusion criteria: 1. contraindication to mri for any reason 2. contraindications to the proposed sedation/anesthetic protocol 3. symptomatic involvement of more than two lumbar discs 4. fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc(s) 5. grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or type iii modic changes around the target disc 6. clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology 7. clinical suspicion of facet pain as primary pain generator 8. women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study. pregnancy is confirmed by: * a positive pregnancy test during the screening visit * self-reported pregnancy 9. women of childbearing potential (wocbp) who are not using a reliable form of contraception (as determined by the investigator)

Keywords: degenerative disc disease lumbar discogenic pain
preventing inadvertent hypothermia in patients undergoing major spinal surgery

Conditions: Hypothermia Following Anesthesia; Neurosurgery; Scoliosis; Kyphosis; Forced Air Warming; Major Spinal Fusion

Summary: background major spinal surgery tend to be lengthy with an increased risk of hypothermia. a quality improvement project of patients undergoing major spinal surgery showed that 67 % were hypothermic at the beginning of surgery. several patients expressed a feeling of coldness at the arrival of the operating theatre. aim to evaluate if bairhuggers full access underbody blanket can prevent hypothermia at initiation if used as prewarming and intraoperative warming compared to the results from the local quality improvement project. in addition we aim to explore patients´ experiences of comfort in relation to their temperature. method temperature of patients undergoing major spinal surgery (n=30) will be assessed at arrival to the theatre, after insertion of bladder catheter, at the start and end of surgery using a bladder temperature. the patients´ experiences of comfort will be evaluated with a 5 point likert at the arrival to the operating theatre and after ten minutes of active prewarming with bairhuggers full access underbody blanket. preoperatively ten randomly chosen patients will be observed and later interviewed in order to obtain further information regarding their experiences of comfort in relation to their temperature. conclusion and perspectives by increasing the investigators knowledge on bairhuggers full access underbody blanket and its effects in preventing hypothermia as well as gaining insight to patients´ experiences of comfort in relation to temperature, the investigators anticipate to improve pre-anesthetic care and minimize risk factors associated with hypothermia for patients undergoing major spinal surgery.


Eligibility criteria:
inclusion criteria: * patients for elective major spinal surgery * patients ≥ 14 years * danish language exclusion criteria: * patients\> 110 kg * patients with a temperature \> 37.5 ° c * patients with a temperature ≤ 35 ° c * cognitive impairment to such an extent that the patient does not understand the purpose of, nor is able to cooperate, with the project
diagnostic evaluation of sarcopenia in elderly patients

Conditions: Sarcopenia

Summary: sarcopenia is a generalized progressive skeletal muscle disorder that represents a related physiological vulnerability that is associated with or increases the likelihood of adverse outcomes, including falls, fractures, physical disability and death. the parameters used to assess sarcopenia in clinical practice have limited use due to their custody. in this perspective, this study proposes or develops a tool for the diagnosis of having sarcopenia with a specific boa and a sensitive boa. low cost and useful. elderly patients (n = 403) from the geriatrics outpatient clinic of hospital das clínicas, faculty of medicine, university of são paulo will be selected this study was of clinical importance, due to sarcopenia and a relevant factor, and could lead to consequences and poor prognosis in patients with gold, and it was not a method of clinical practice to properly endorse body composition in this population.

sarcopenia is a progressive and generalized skeletal muscle disorder that represents an age-related physiological vulnerability that is associated with an increased likelihood of adverse outcomes, including falls, fractures, physical disability and mortality. the parameters used to assess sarcopenia in clinical practice have limited use due to its cost. in this perspective, this study proposes the development of a tool for the diagnosis of having sarcopenia with good specificity and good sensitivity and of low cost and useful. elderly patients (n = 403) from the geriatrics outpatient clinic of hospital das clínicas, faculty of medicine, university of são paulo will be selected. after signing the informed consent, sarcopenia will be assessed using the reference method (dxa) and anthropometry. the data obtained by the methods are treated statistically to obtain correlation and thus a new tool for the evaluation of sarcopenia patients in the elderly can be developed. this study is of clinical importance, as sarcopenia is a relevant factor and can lead to consequences and poor prognosis in elderly patients, and there is no low-cost method in clinical practice to properly assess body composition in this population.

Eligibility criteria:
inclusion criteria: * age ≥ 60 years * sign free and informed consent; * demonstrate interest, conditions and availability to participate in all procedures included in the study protocol; exclusion criteria: * refusal to participate; * patients who have not undergone cognitive testing; * physical amputation; * patients undergoing interventional treatment for sarcopenia;

Keywords: body composition sarcopenia elderly
evaluation of the aspheric restor iol after routine cataract extraction

Conditions: Cataract

Summary: the purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric restor multifocal intraocular lens (iol) and compare it to a historical control group of patients implanted bilaterally with the spherical restor multifocal

the purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric restor multifocal intraocular lens (iol) and compare it to a historical control group of patients implanted bilaterally with the spherical restor multifocal.

Eligibility criteria:
inclusion criteria: * subject must have an age-related cataract in both eyes. * 40 years of age or older. * patient must desire cataract extraction. * expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries. * willing and able to comply with scheduled visits and other study procedures exclusion criteria: * preoperative ocular pathology potentially affecting visual acuity. * keratometric astigmatism exceeding 1.50 diopters. * planned postoperative refraction for mono-vision. * uncontrolled diabetes. * use of any systemic or topical drug known to interfere with visual performance. * contact lens use during the active treatment portion of the trial. * any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis. * pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control. * any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results. * participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial. * intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye. * other ocular surgery at the time of the cataract extraction.

Keywords: cataract cataract extraction intraocular lens age related
outcome of endodontic retreatment in one or two visits

Conditions: Endodontic Disease; Endodontically Treated Teeth; Root Canal Infection

Summary: this study is a prospective randomized controlled study of patients who come to the university and non-surgical root canal retreatment is considered as the election of choice in presence of periapical disease. the aim is to evaluate the success rate of non-surgical retreatment performed in one compared to two visit treatment up to 10 years of follow-up. the null hypothesis is that there will be no statistically significant differences in rates of success, when performing root canal non-surgical retreatment in one or two visits.


Eligibility criteria:
inclusion criteria: * patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form. * understands and is willing to comply with all study procedures and restrictions. * not presence of clinically significant and relevant abnormalities of clinical history or oral examination. * retreatment cases due to an endodontic failure. * diagnosis of apical periodontitis. * single or bi-radicular teeth. exclusion criteria: * general: patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities. * specific: root resorption, root fractures, impossibility of restoration and cases were secondary root canal treatment is not the treatment of choice.

Keywords: primary root canal treatment secondary root canal treatment periapical healing outcome
a study to assess the efficacy and safety of 20, 40, and 80mg of sildenafil three times a day in the treatment of pulmonary arterial hypertension

Conditions: Hypertension, Pulmonary

Summary: to evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day \[tid\]) on exercise capacity, as measured by the 6-minute walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. to investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (pk) parameters.


Eligibility criteria:
inclusion criteria: included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmhg and a pulmonary artery wedge pressure of less than or equal to 15 mmhg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-minute walk test distance of 100 m to 450 m. exclusion criteria: subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, hiv, chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects with significant (ie \> 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days; subjects with pulmonary hypertension secondary to any other etiology other than those specified in the inclusion criteria.
improving access to chiropractic care in community health centers

Conditions: Lower Back Pain

Summary: the goal of this study is to evaluate the feasibility of new implementation strategies designed to increase the number of primary care providers (pcps) referrals to chiropractic care for lower back pain (lbp) in underserved populations. the investigators plan to pilot the strategies in three qualified community health centers (chcs) and compare the number of lbp patients who receive referrals before and after implementation. the implementation strategies involve pcp, patient, and organizational interventions. patients presenting with lbp will be provided educational materials that focus on the safety and effectiveness of chiropractic care as an evidence-based treatment for lbp. materials will be available in chc common areas and may be sent to patients by their pcp via patient portal. pcps will participate in interactive lunch seminars to allow for inter-professional learning for pcps. they will also participate in a survey regarding their attitudes and beliefs relating to chiropractic care. currently, many pcps cannot make chiropractic care referrals in the electronic health record (ehr). the investigators plan to add this option, or make it easier if the referral is already available. this multi-level, multi-component approach will last two months, and will be rolled out sequentially in three clinics using a stepped-wedge design. the ordering of clinics will be random. the primary outcome is the proportion of patients with lbp who received a referral to chiropractic care before and after the intervention. secondary outcomes include referral to any non-pharmacologic treatment, use of imaging, and prescribed medications.


Eligibility criteria:
inclusion criteria for chcs: * be a chc in the boston area with primary care * agree to participate in study inclusion criteria for pcps: * work at a participating chc * be an md, doctor of osteopathy (do), nurse practitioner (np), or physician assistant (pa) inclusion criteria for patients with lbp: * has pcp at participating chc * has lbp diagnosis * is 18 years of age or older exclusion criteria for chcs: * there are no exclusion criteria exclusion criteria for pcps: * there are no exclusion criteria exclusion criteria for patients with lbp: * there are no exclusion criteria for adult patients with lbp

Keywords: chiropractic care primary care provider chiropractor referrals chronic pain non-pharmacologic treatment community health centers
polycystic ovary syndrome (pcos) - effect of physical exercise and electroacupuncture

Conditions: Polycystic Ovary Syndrome

Summary: hypothesis: the overall hypothesis is that women with pcos, both obese and non-obese, have larger adipocytes, altered metabolism and signs of inflammation in adipose tissue and that these changes are associated with high sympathetic nerve activity, hyperandrogenism hyperinsulinaemia, insulin resistance with progression to type ii diabetes and cardiovascular disease (cvd) as well as psychological distress and reduced quality of life. physical exercise and electro-acupuncture decrease high concentrations of androgens, induce regulare menstrual pattern, inhibits high sympathetic activity and restore the pcos induced disturbances.

primary outcome: changes in androgen concentrations and menstrual pattern secondary outcome: changes in sympathetic nerve activity, uterus peristalsis, ovarian morphology, adipose tissue related variables, insulin sensitivity, coagulation factors and health related quality of life and symptoms of anxiety and depression.

Eligibility criteria:
inclusion criteria: * to get the diagnosis polycystic ovary syndrome (pcos), ultrasonography should reveal at least 1 ovary with pco according to the rotterdam diagnostic criteria as well as one of the following two symptoms: 1. anovulation/oligoovulation defined as ≥ 35 days during the last year 2. clinical signs of hyperandrogenism (hirsutism, acne) exclusion criteria: * cardiovascular disease * diabetes mellitus * other endocrine disease (congenital adrenal hyperplasia, androgen producing tumour, cushing's syndrome) * estrogen/gestagen treatment during the last 3 months * breast-feeding the last 6 months * antiandrogen treatment the last 3 months

Keywords: androgens menstrual pattern insulin resistance adipocytes obesity stress muscle sympathetic nerve activity psychological distress and quality of life
study of subcutaneous immune globulin in patients requiring igg replacement therapy (japan study)

Conditions: Primary Immune Deficiency

Summary: the objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (scig; igpro20) in subjects with primary immunodeficiency (pid). in addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with igpro20.


Eligibility criteria:
inclusion criteria: * diagnosis of pid with hypo- or agammaglobulinemia requiring igg replacement therapy * intravenous igg (ivig) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent * written informed consent exclusion criteria: * newly diagnosed pid, i.e., subjects who have not previously received immunoglobulin replacement therapy * ongoing serious bacterial infections (sbis: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening * ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-hodgkin's lymphoma, and immunodeficiency with thymoma * allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening * pregnancy or nursing mother * a positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (hiv-1), hiv-2, hepatitis c virus, or hepatitis b virus * participation in a study with other investigational product during this study and within 3 months prior to screening * subjects who donated blood (200 ml within one month or 400 ml within 3 months prior to screening), or planning to donate blood during the study

Keywords: immune globulin subcutaneous scig primary immunodeficiency pid
early versus delayed pneumococcal vaccination in hiv

Conditions: Pneumococcal Infections

Summary: the purpose of this study is to determine whether people who are hiv-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. the study will also compare the effectiveness of polysaccharide and heptavalent vaccines.

a multicentre, randomized controlled trial using a two factorial design. eighty patients will be randomly assigned to receive either pneumovax (or pneumo23 according to standard use at site) or heptavalent pneumococcal conjugate vaccine (prevnar) prior to reconstitution of the immune system or will have immunization delayed until their cd4 count is greater than 200 cells/mm3 after the introduction of antiretroviral therapy. randomization will be stratified by study centre. variable block sizes will be used to try to prevent study personnel from guessing the next allocation. random allocation lists will be generated by computer.

Eligibility criteria:
inclusion criteria: * hiv-positive * between 18 and 65 years of age * have a cd4 cell count below 200 cells/mm3 * willing to begin/change antiretroviral therapy * willing and able to provide informed consent exclusion criteria: * pregnant or breastfeeding * have had previous pneumococcal vaccination * have had occurrence of pneumococcal infection (brain, blood or lung infections) in past 5 years * have hypersensitivity to components of either vaccine * have acute feverish illness at the time of vaccination * have had splenectomy (removal of the spleen) * have received treatment with ivig within the last 6 months

Keywords: hiv hiv infections