Kornimate/medical-research-clean huggingface dataset:
efficacy and tolerability of mud packs therapy in osteoarthritis of the hand

Conditions: Osteoarthritis

Summary: objective to assess both the short-term and the long term effectiveness of spa therapy in patients with primary hand osteoarthritis (oa) in a single blind, prospective controlled, randomized trial.

osteoarthritis is the most common form of joint disease and a major contributor of disability in older people. current treatment of oa include pharmacological and non-pharmacological modalities. spa therapy has a long history in the treatment of oa, but few articles have evaluated the effectiveness of thermal treatment in patients with primary oa of the hands. the aim of this study is to assess the duration of the clinical effectiveness of mud-packs application and mineral bath in patients with primary oa of the hands in a single blind, controlled, randomized trial. our study will follow the patients for a longer period of time (12 months) than was done in previous studies. 60 outpatients will be enrolled; 30 patients will be treated with a combination of daily local mud packs and mineral bath water from the spa centre of fonteverde natural spa resort (san casciano terme, siena, italy) for two weeks; 30 patients will continue regular, routine ambulatory care. patients will be assessed at baseline time, after 2 weeks, after 3, 6, 9 and 12 months following the beginning of the study and will be evaluated by vas for spontaneous pain, dreiser algofunctional index, haq, aims1 and symptomatic drugs consumption.

Eligibility criteria:
inclusion criteria: * patients suffering from osteoarthritis of the hands according to the acr criteria exclusion criteria: * patients suffering from any other rheumatological disease other than osteoarthritis * patients that have been treated with mud-pack therapy and balneotherapy in the last 9 months * contraindications to mud-packs and balneotherapy

Keywords: osteoarthritis hands mud-packs therapy balneotherapy osteoarthritis of the hands
photobiomodulation therapy in exercise capacity assessed by 6mst in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD

Summary: chronic obstructive pulmonary disease (copd) is characterized by dyspnea, as well as musculoskeletal and systemic manifestations. photobiomodulation therapy (pbmt) with use of low-level laser therapy (lllt) and/or light emitting diode therapy (ledt) is an electrophysical intervention that has been found to minimize or delay muscle fatigue. the aim of this study is to evaluate the acute effect of pbmt with combined use of lasers diodes, light emitting diodes (leds), on muscle performance, exercise tolerance and metabolic variables during the 6-minute stepper test (6mst) in patients with copd. twenty-one patients with copd will completed the 6mst protocol over 2 weeks, with 1 session per week. pbmt or placebo (pl) will be performed before each 6mst (17 sites on each lower limb, with a dose of 30 j per site, using a cluster of 12 diodes: 4 × 905 nm super-pulsed laser diodes, 4 × 875 nm infrared leds, and 4 × 640 nm red leds; multi radiance medical™, solon - oh, usa). patients will be randomized into two groups before the test according to the treatment they will receive. assessments will be performed before the start of each protocol. the primary outcomes are oxygen uptake and number of steps, and the secondary outcome are perceived exertion (dyspnea and fatigue in the lower limbs).

all patients will have a diagnosis of copd according to the global initiative for chronic obstructive lung disease (gold) criteria. the patients will be at a stable phase of the disease, indicated by a lack of change in medical therapy (including oral steroids) or an exacerbation of symptoms in the preceding 4 weeks. patients with other known severe chronic diseases, including cardiac, neuromuscular, or orthopedic disorders, will be excluded.

Eligibility criteria:
inclusion criteria: * copd patients * patients are at a stable phase of the disease exclusion criteria: * patients with cardiac diseases * neuromuscular diseases * orthopedic disorders
registry of patients with hypophosphatasia

Conditions: Hypophosphatasia (HPP)

Summary: in this prospective, observational, long term registry patients of all ages with a diagnosis of hypophosphatasia (hpp) are followed at participating sites in multiple countries.

the hpp registry is an observational, prospective, long-term registry designed to collect data on hpp epidemiology, disease history, clinical course, symptoms and burden of disease from patients of all ages who have a diagnosis of hpp. evaluation of safety and effectiveness data in patients with hpp who have/are receiving treatment with asfotase alfa

Eligibility criteria:
inclusion criteria: * male and female participants, of any age, with a confirmed diagnosis of hpp. * participant must have documented alkaline phosphatase (alp) activity below the lower limit of normal for age and sex, or a documented alpl gene mutation. * participant or legal representative is able to read and/or understand the informed consent and study questionnaires in the local language. * signed informed consent and medical records release by the patient or legal representative. patient or patient's parent/legal representative must be willing and able to give written informed consent, and the patient must be willing to give written informed assent, if appropriate and required by local regulations. exclusion criteria: * currently participating in an alexion-sponsored clinical trial. enrollment in the registry will not exclude a patient from enrolling in a future clinical trial.
levator ani muscle avulsion at first birth of mexican women: randomized control trial

Conditions: Trauma

Summary: levator ani muscle (lam) avulsion occurs in 13-36% of women having their first birth. these damages by palpation and ultrasound of the pelvic floor can be detected. avulsion of the lam results in decreased muscle strength of the pelvic floor, enlarge the genital hiatus and promotes pelvic organ prolapse. the perineal muscle training is a proposal to combine the perineal massage with pelvic floor exercises in order to prepare the lam in the last weeks before delivery, to withstand stretching which will be submitted during childbirth. no studies in the world that have explored the effect of the perineal muscle training on the avulsion of mea. objective: to quantify the proportion of primiparous that result with avulsion of lam after their first birth among those performing perineal muscle training from week 33 of gestation and those with usual prenatal care.

this study will be performed in 228 primiparous. previous informed consent they will be randomized in two groups: 1) perineal muscle training and 2) usual prenatal care. pelvic floor will be evaluated before and after childbirth clinically and ultrasonographilly. the outcome variables will be: 1) avulsion lam diagnosed by palpation and 2-3d pelvic floor ultrasound, 2) symptoms of pelvic floor dysfunction identified with standardized and validated spanish pfdi-20 questionnaire, 3) changes dimension of the genital hiatus and perineal body, 4) accomplishment of perineal muscle training. demographic variables (marital status, occupation, level of education, age, weeks of gestation, weight, height, bmi, religion, pathologies) and variables related to childbirth (weeks of gestation duration of the second period, use of analgesia, variety of position, episiotomy, forceps. dystocia, who attended the birth, weight and head circumference of the newborn, tearing report and who repairs the last one.

Eligibility criteria:
inclusion criteria: 1. future primiparous over 18 who have single fetus, without contraindications to take delivery. primigesta omit the term since in the study patients who have had previous pregnancies that are not related to damage to the pelvic floor as will be accepted: abortions, ectopic or molar. 2. with or without symptoms of pelvic floor dysfunction (assessed with pfdi-20 questionnaire). 3. have 33 weeks gestation to start participating, so the invitation must be made before this gestational age as mentioned above. 4. physical and mental ability to understand and perform the maneuvers used in the study. exclusion criteria: 1. any contraindication to labor, this feature can appear at any time during pregnancy, including during labor. 2. physical or mental inability to perform the maneuvers used in the study. 3. avulsion of mea detected before birth. 4. agree not participate in the study. 5. previous pregnancies older than 20 weeks gestation resolved abdominally.

Keywords: levator ani avulsion perineal muscle training pelvic floor ultrasound
compensatory sweating after unilateral sympathectomy on the dominant side or bilateral sequential sympathectomy

Conditions: Hyperhidrosis Primary Focal Palms

Summary: the standard treatment for palmar hyperhidrosis is bilateral sequential thoracic sympathectomy. high rates of compensatory sweating due to the surgical procedure are described in the literature. in the search for a reduction in this side effect, it is possible that unilateral sympathectomy in the dominant side obtains acceptable results and leads to less compensatory sweating with improvement of the quality of life. the aim of this study it to compare the intensity of compensatory sweating due to the standard treatment, that is, bilateral sequential videothoracoscopic sympathectomy in relation to unilateral thoracic sympathectomy on the dominant side.


Eligibility criteria:
inclusion criteria: * body mass index equal to or less than 28; * exclusive palmar hyperhidrosis or palmar hyperhidrosis associated with axillary and / or plantar hyperhidrosis; exclusion criteria: * being sinister (or left-handed); * craneo-f acial or generalized hyperhidrosis; * coagulopathies; * previous thoracic surgery; * other comorbidities such as cardiological, metabolic, infectious or neoplastic diseases; * pregnancy;

Keywords: hyperhidrosis sympathectomy sweating
cognitive remediation for first episode of psychosis patients

Conditions: Psychosis

Summary: this study aims to look at the effectiveness of a combination of cognitive remediation and social cognition training to improve cognition and functioning when compared to cognitive remediation alone. the target population will be those who are experiencing their first episode of psychosis.

a first episode of psychosis is defined as the first experience of positive symptoms, such as hallucinations and delusions, and the behaviour that accompanies it. this is associated with problems in many areas of cognition; the ability to acquire knowledge and understanding. these cognitive symptoms have been found to have a large impact on daily functioning (e.g. accessing education or employment and maintaining relationships) and cannot effectively be treated with medication. cognitive remediation (cr) is a therapy that aims to improve cognition and, through generalisation of this, improve daily functioning and quality of life. although it is an area of deficit, social cognition, the ability to perceive and understand emotional states, is often not targeted in cognitive remediation. however, interventions which have focused on providing social cognition training (sct) alongside cr have shown large improvements in daily functioning. this study aims to look at the effectiveness of a combination of cr and sct to improve cognition and functioning when compared to cr alone. the target population will be those who are experiencing their first episode of psychosis. participants will be recruited from an early intervention in psychosis service which is an nhs service set up to provide rapid treatment for those experiencing psychosis. participants will take part in a ten week cr or cr+sct intervention which will consist of spending 90 minutes a week in a small group setting working through a series of computer games which aim to improve cognition. interviews and questionnaires regarding daily functioning, cognition, quality of life and symptoms will be used before and after the intervention. participants will be asked to attend follow-up interviews 6 months after the intervention has ended to complete the measures again to see if any beneficial effects have lasted.

Eligibility criteria:
inclusion criteria: * non-affective psychosis * premorbid iq of over 70 * a service user of the early intervention service * aged 18 or over (up to the age of 35 which is the limit for the early intervention service) * psychiatrically stable enough to attend to completion (no hospitalisations or medication changes in last 4 weeks) exclusion criteria: * active substance dependency * history of severe head injury

Keywords: cognitive remediation social cognition training first episode psychosis schizophrenia
ocular surface immune response in dry eye disease

Conditions: Dry Eye Disease

Summary: in vivo confocal microscopy (ivcm) is a sensitive imaging tool for detecting dry eye-associated subclinical inflammation. studies have previously shown that ivcm provides an in vivo metric to measure inflammatory changes in the central cornea. the objective of the current study is to assess inflammatory response changes in the peripheral cornea and the conjunctiva by analyzing epithelial immune cell density and morphology in these areas and then correlating the ivcm findings to clinical signs and symptoms to establish novel objective imaging biomarkers.


Eligibility criteria:
for dry eye disease participants inclusion criteria: * age \>18 * ability to consent to study * symptoms of dry eye disease for at least 6 months, such foreign body sensation, burning, stinging, light sensitivity * positive vital dye staining of the cornea * at least one of the following objective signs: (schirmer i \<10 mm at 5 minutes), decreased (\<0.2 mm) tear meniscus, decreased tear breakup time (tbut) of \<10 seconds, positive vital dye staining of the conjunctiva for age-match controls inclusion criteria: * between the ages of 18-89 * the ability to provide informed consent for study inclusion * clear, healthy cornea * normal tear meniscus (\> 0.3 mm) for dry eye disease participants exclusion criteria: * history of contact lens wear in the past 3 months * history of ocular surgery in the past 6 months * active ocular allergies * history of ocular infection in the past 3 months * history of diabetes * history of topical or systemic anti-inflammatory therapy in the past 1 month for age-match controls exclusion criteria: * history of ocular or eyelid surgery within the past 12 months * history of herpetic or other infectious keratitis or other inflammatory eye disease * history of any other acute ocular disease * current use of topical medications (not including artificial tears) * current use of contact lenses * history of ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy * history of cancer elsewhere in the body which is currently under systemic chemotherapy * current glaucoma disease requiring use of glaucoma drops * history of diabetes mellitus * current diagnosis of dry eye disease

Keywords: dry eye
allogen-li treatment of spinal stenosis

Conditions: Low Back Pain

Summary: in this pilot study, investigators will test the efficacy of allogen-li, an allograft derived from amniotic fluid, injected into the epidural space at the level of spinal stenosis as an anti-inflammatory treatment to relieve back and leg pain symptoms in patients with spinal stenosis and/or disc herniation. the patients will be followed for 12 weeks. the effect of this treatment will be examined by patient reported changes in pain and disability utilizing validated outcome measures, and mri imaging evaluating changes in contrast enhancement and t2 signal related to that reflect inflammation and degeneration.

allogen-li contains multiple factors that may serve to ameliorate the detrimental effects of osteorarthritis and degenerative disc disease. anti-inflammatory components include inhibitors of matrix metalloproteins and pro-inflammatory cytokines, growth factors and interleukins. the product has low immunogenicity and is hypo-osmotic.2 placental tissues, including amniotic fluid, amniotic membrane and chorion are regulated as human cell and tissue products (hctp) by the fda. this regulation allows clinicians to use the allograft materials for human injection. allogen-li is derived from placental tissues obtained from carefully screened healthy mothers at the time of scheduled cesarean section. the mothers have agreed to donate the tissues, which would otherwise be discarded. the experimental treatment would entail an injection of one dose of allogen-li and marcaine into the epidural space under ct guidance, in an identical manner to traditional epidural steroid /marcaine injections.

Eligibility criteria:
inclusion criteria: 1. low back pain of \> 4-5 weeks but \< 6-7 months 2. evidence of at least mild lumbar stenosis /disc herniation on mri 3. failure of conservative therapy to include physical therapy and pharmacotherapy 4. patient is at least 18 years of age 5. patient is willing to be blinded to treatment until after the 12 week post injection visit 6. patient is willing and able to review and sign the study informed consent form exclusion criteria: 1. no evidence of lumbar stenosis or disc herniation on mri 2. patient has had prior lumbar surgery at any level 3. patient has received epidural steroid injection in the past 6 months 4. patient currently receives systemic steroids for another medical condition 5. patient is pregnant 6. patient has systemic infection at the proposed injection site 7. patient has a systemic malignancy 8. current therapy with any immunosuppressive medication 9. history of solid organ or hematologic transplantation 10 history of autoimmune disorder 11. patient has known allergy to lidocaine, marcaine or steroid 12. devices and conditions that are contraindications for mri examination (routinely screened before all mri examinations). 13. patient is on anticoagulant medications (other than asa). 14. patient has egfr of \<40 15. patient has known chronic kidney disease

Keywords: disc herniation spinal stenosis
best therapy for patients with neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: a prospective observational study containing three arms comprising different therapeutic measures to treat patients with neuroendocrine tumors in advanced stages. the therapy arms include local ablative therapy such as tace or sirt, surgery and rfa with peptide receptor radiotherapy.

study design: prospective observational study comparing ablative measures as tace or sirt with surgery/rfa and with peptide receptor radio-therapy in patients with advanced well-differentiated neuroendocrine tumors with lymph node or distant metastases (n1, m1) prospective evaluation primary end points: time to progression secondary end points: survival, quality of life (eortc-qlq30), weight, time of hospitalization, karnofsky index) non-randomized cohort study number of patients needed in all groups: 70 per group, 210 overall evaluation of response to therapy every 3-6 months by imaging, clinical status, weight, quality of life, karnofsky-index cross-over allowed if therapy changes

Eligibility criteria:
inclusion criteria: * biopsy-proven neuroendocrine tumor (who class i-ii, tnm grading 1-2) * advanced disease with lymph node or distant metastases (n1, m1) undergoing cytoreduction by surgery/local ablative therapy or peptide receptor radiotherapy * curative intent of all therapies possible exclusion criteria: * undifferentiated neuroendocrine carcinoma (who class iii, tnm grading 3) * secondary tumor * advanced carcinoid heart disease requiring surgery

Keywords: neuroendocrine tumors transcatheter arterial chemoembolization selective internal radiotherapy surgery radio-frequency ablation peptide-receptor radiotherapy progression-free survival quality of life overall survival weight time of hospitalization
study to assess adverse events and change in disease activity when oral abbv-932 is added to antidepressant therapies in adult participants with generalized anxiety disorder

Conditions: Generalized Anxiety Disorder (GAD)

Summary: generalized anxiety disorder (gad) is usually treated with antidepressant therapy (adt); however, sometimes adts alone are not enough to adequately treat gad. the purpose of this study is to assess how safe and effective abbv-932 is when added to the antidepressant therapies in adult participants with gad who have had an inadequate response adts. abbv-932 is an investigational drug being developed for the adjunctive treatment of gad. participants will be randomly assigned to receive abbv-932 or placebo in addition to their currently prescribed adts. there is 1 in 3 chance of participants assigned to placebo. approximately 315 adult participants with gad and inadequate response to adts will be enrolled in approximately 50 sites in the united states and puerto rico. participants will receive oral capsules of abbv-932 or matching placebo in addition to their prescribed adt for 6 weeks and then will be followed for an additional 4 week follow-up period. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of mental disorders, fifth edition, text revision (dsm-5-tr) criteria for generalized anxiety disorder (gad) confirmed by the mini international neuropsychiatric interview (mini). * currently taking one of the food and drug administration (fda) approved antidepressant therapies (adt) for gad (i.e., escitalopram, paroxetine, duloxetine, or venlafaxine er) with an inadequate response to an adequate dose (per label) and duration (\>= 8 weeks) as verified by a baseline hamilton anxiety rating scale (ham-a) total score \>= 20 and clinical global impression of severity scale (cgi-s gad) \>= 4. exclusion criteria: * have a montgomery-åsberg depression rating scale (madrs) score \>= 20. * new diagnosis or exacerbation of major depression in the last 6 months.

Keywords: legato - (gad) generalized anxiety disorder (gad) abbv-932
study to evaluate safety, tolerability and immunogenicity of a bedside mixing combination of two adjuvanted influenza vaccines

Conditions: Influenza

Summary: this trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.


Eligibility criteria:
inclusion criteria: * healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment exclusion criteria: * serious medical conditions * allergies to vaccine components, including but not limited to egg/chicken products * reduced immune function * recent use of immunosuppressive therapy * recent use of influenza vaccine

Keywords: influenza vaccine adjuvants flu