Kornimate/medical-research-clean huggingface dataset:
surgical approach for acute external thrombosed hemorrhoidal disease

Conditions: Hemorrhoids External Thrombosed

Summary: acute external thrombosed hemorrhoidal disease (aethh) is one of the emergent complications of hemorrhoidal disease that results in pain and loss of work force. although surgical excision is recommended in the treatment of aethh in the guidelines of the american society of colorectal surgeons (ascrs) and the european society of coloproctology (escp), the level of evidence is low and it is emphasized that additional studies are needed. therefore, the investigators aimed to compare the efficacy of surgical excision with medical treatment in the treatment of aethh.

hemorrhoids are normal anatomical structures and are divided into internal and external according to the dentate line. external hemorrhoids distal to the dentate line, unlike internal hemorrhoids, are covered with squamous epithelium (anoderm), have somatic innervation, and are highly sensitive to pain. while internal hemorrhoidal disease causes symptoms such as painless bleeding, mucosal prolapse, soiling, and itching, external hemorrhoids do not cause clinical findings unless thrombosed. acute constipation or excessive straining are held responsible for acute external thrombosed hemorrhoidal disease (aethd). it appears as a painful, firm, purple-colored mass in the anoderm, and the main symptom is anal pain. the severity of pain increases in the first 24-48 hours after the formation of the thrombosed pack and reaches its peak. the pain is quite severe in the first 72-96 hours. afterwards, with the resorption of the thrombosis, the severity of the pain decreases and the disease heals, leaving a skin tag behind. aethd can be treated with surgical excision or conservative approaches. conservative treatment includes a warm water sitz bath, analgesics, anti-inflammatory drugs. also, phlebotonic drugs can be added. in the ascrs and escp guidelines, early surgical excision is recommended for patients with acute external thrombosed hemorrhoidal disease in the first 72-96 hours (low quality evidence 2c). guidelines highlight the lack of controlled studies of aethd treatment . in this study, the investigators aimed to compare early surgical excision with conservative treatment in terms of pain control and recurrence in the treatment of aethd.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18-70 who present with isolated external thrombosed hemorrhoids * patients with the onset of the complaint before 96 hours exclusion criteria: patients under the age of 18 and patients over the age of 70 * mentally retarded patients * pregnant patients * patients with concomitant proctological disorders (anal fissure, anal fistula, anal abscess, etc.) those with a history of proctology surgery * patients with grade 3-4 internal hemorrhoids * patients using anticoagulant drugs * patients whose complaint has passed 96 hours after onset
safety and efficacy of intravitreal injection of human retinal progenitor cells in adults with retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: this study evaluates the changes in visual function at 12 months following a single injection of human retinal progenitor cells compared to sham treated controls in a cohort of adult subjects with rp.

there is no effective treatment for rp; once photoreceptors are lost, they do not regenerate. the rate of deterioration of vision varies from person to person, with most people with rp legally blind by age 40. preclinical studies demonstrated that transplantation of retinal progenitor cells into the eye can result in both photoreceptor replacement and significant slowing of host photoreceptor loss. thus, the primary goal of this therapy is to preserve, and potentially improve, vision by intervening in the disease at a time when dystrophic host photoreceptors can be protected and reactivated. based on the demonstration of acceptable safety and tolerability in a phase 1/2a study, this phase 2b study is designed as a controlled comparison of the changes in visual function and functional vision in subjects who receive a single jcell injection in comparison to a comparable sham-treated control group of subjects with rp.

Eligibility criteria:
inclusion criteria: clinical diagnosis of rp confirmed by erg and willing to consent to mutation typing, if not already done best corrected visual acuity (bcva) 20/80 or worse and no worse than 20/800 adequate organ function and negative infectious disease screen female of childbearing potential must have negative pregnancy test and be willing to use medically accepted methods of contraception throughout the study exclusion criteria: eye disease other than rp that impairs visual function pseudo-rp, cancer-associated retinopathies history of malignancy or other end-stage organ disease, or any chronic disease requiring continuous treatment with system steroids, anticoagulants or immunosuppressive agents known allergy to penicillin or streptomycin treatment with corticosteroids or any investigational or neuroprotectant therapy within 90 days of enrollment cataract surgery within 3 months prior to enrollment
european study of opioid induced constipation

Conditions: Opioid-Induced Constipation

Summary: constipation is common (40-90%) in advanced cancer patients , and has a significant negative impact on quality of life. the aetiology of constipation is often multifactorial in advanced cancer patients. however, it is well recognised that opioid analgesics are a common cause of constipation in this group. the prevalence of opioid-induced constipation (oic) is stated to be 40-70%, although a recent large study reported an even higher figure. oic has been reported to exceed pain in terms of distress caused, and studies have found that some patients choose to reduce or discontinue opioid medication in order to attempt to better control constipation. moreover, oic is associated with a variety of physical (gastrointestinal, systemic), psychological and social problems.

this european study follows on from a united kingdom study, and aims to confirm findings of the previous study in a larger, more heterogeneous sample: it also aims to explore additional strategies to manage oic. moreover, the study aims to identify differences in perception of normal bowel habit / constipation, and differences in oic management in the different european countries. previous studies suggest that there are cultural differences in people's beliefs about constipation / normal bowel function. the aim of the project is to investigate oic in a real world / heterogenous group of european patients with cancer.

Eligibility criteria:
inclusion criteria: * age 18 years or over * diagnosis of cancer * diagnosis of cancer pain or cancer treatment-related pain * taking regular opioids for at least one week (i.e. opioid for mild to moderate pain / "weak" opioid; or opioid for moderate to severe pain / "strong" opioid) exclusion criteria: * unable to provide consent * unable to complete questionnaire
endoscopic gastric reduction for weight management

Conditions: Obesity

Summary: the proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. the investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves durability of the procedure.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 30 and 40 * age \>18 and ≤50 * stable weight for 3 months (within 5% of bmi) * normal basic labs (cbc, chemistry profile, creatinine) * negative pregnancy test for females \>18 or ≤ 50 exclusion criteria: * diabetes * unstable coronary artery disease * heart failure * cardiac arrhythmia * cardiac valvular disease * obstructive of interstitial lung disease * females of child-bearing age \>18 or ≤ 50 who are pregnant or lactating * mallampati score of 4 * asa 3 or above * previous gastric surgery * ulcer disease * gastroparesis, * \> 5 cm hiatal hernia * congenital anomalies of the gi tract * currently on or prescribed a medication known to affect weight within 3 months of study entry.

Keywords: obesity weight loss gastric reduction (volume) bmi 30-40
urodynamic effects of uk-369,003 in men with lower urinary tract symptoms

Conditions: Prostatic Hyperplasia

Summary: this is a pilot study to generate hypotheses about the urodynamic effects of uk-369,003 in men with lower urinary tract symptoms.


Eligibility criteria:
inclusion criteria: * male subjects, aged 40 years and above, with documented luts with an international prostate symptom score (ipss) ≥13. * clinical diagnosis of bph * qmax 5 to 15 ml/sec with a voided volume of ≥150 ml * urodynamically defined bladder outlet obstruction exclusion criteria: * prostate cancer * post-void residual urine volume \>200 ml * documented uti * history of relevant urological surgery
fampridine pregnancy exposure registry

Conditions: Multiple Sclerosis; Pregnancy

Summary: this is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged-release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy.

there are no mandatory physician visits. the registry will collect pregnancy outcome data from the participants health care provider during the prenatal follow up (6-7 months gestation), pregnancy outcome (4 weeks after estimated delivery date) and finally the pediatric follow up (at 4 weeks and 12 weeks post birth).

Eligibility criteria:
key inclusion criteria: * documentation that the patient was exposed to prolonged-release fampridine since the first day of her last menstrual period (lmp) prior to conception or at any time during pregnancy. (if exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure.) * the outcome of the pregnancy must not be known at the time of report. key exclusion criteria: * none note: other protocol defined inclusion/exclusion criteria may apply.
safety and tolerability of levetiracetam intravenous 15 minute infusion in subjects suffering from partial onset seizures

Conditions: Epilepsy

Summary: subjects receiving lev as adjunctive therapy to 1 or 2 other aeds for partial onset seizures and subjects who are temporarily unable to take oral lev, may require alternative routes of administration. the purpose of this trial was to evaluate the safety and tolerability of 1000 to 3000 mg/day lev administered as a 15-min iv infusion b.i.d. after switching from the same oral dose.


Eligibility criteria:
inclusion criteria: * adult * in- or out-subjects suffering from partial onset seizures according to the ilae classification of epileptic seizures; * intake of levetiracetam as an adjunctive antiepileptic oral treatment in addition to one or two antiepileptic drugs (aed). exclusion criteria: * had problems of venous accessibility; * showed safety issues related to the administration of one of the concomitant aeds requiring medical intervention; * clinically significant ecg/lab abnormalities; * administered vigabatrine; * administered felbamate for less than 18 months; * had contraindication to any component of the study medication treatment as iv formulation or known allergic reaction to or intolerance of pyrrolidone derivatives.

Keywords: levetiracetam keppra
study on magnetic field therapy to improve quality of sleep and reduction of chronic spine pain

Conditions: Back Pain; Neck Pain; Sleep Initiation and Maintenance Disorders

Summary: hypthothesis: the researchers hypothesize that application of active magnetic therapy vs. sham utilized while individuals sleep can reduce neuropathic pain in the spine and improve the quality of sleep. the null hypothesis is that treatment of subjects with spine pain with exposure to permanent/static magnetic fields has no measurable effect on neuropathic pain scores or quality of sleep scores.

design: this is a double-blind, randomized, placebo-controlled study which will consist of two treatment groups. treated subjects will receive a permanent/static magnetic sleeping pad with a nominal strength of less than 1000 gauss. control subjects will receive physically identical sleeping pad with a nominal surface field strength of 0 gauss (placebo). the magnets will be contained in a standard mattress pad and subjects will sleep on the pad. the primary outcome measures will be quality of sleep as well as the daily vas scores. these are subjective. there will be objective assessment by the quantification of autonomic nervous system (ans) strengths of the parasympathetic and sympathetic effects from this non-invasive digital study using spectral analysis. individuals will be evaluated at onset of study and at end of study to look at specifics of range of motion, spasm, radiculitis, etc. scores will be kept on a monthly basis as well as repeat of ans testing each month. at the end of the study, individuals will return all forms, be reevaluated by dr. weintraub and also will be asked questions regarding pgic for bias, etc. additionally heart rate and systolic and diastolic bp readings at rest and with challenge of standing will be recorded at baseline and each visit to determine if there is an anti-hypertensive effect from sleeping on magnetic device. a reduction of 3 mm hg improves stroke and cardiac risk by a minimum of 4%. no new anti-hypertensive medications will be allowed.

Eligibility criteria:
inclusion criteria: * female or male subjects age 18-80. * capable of understanding and complying with study protocols. * chronic cervical, thoracic or lumbar pain for at least six months. * sleep difficulties and/or insomnia exclusion criteria: * unable to understand informed consent (mental retardation, psychosis, communicative impairment). * cardiac pacemaker or other mechanical internal devices. * tumor in the spine/history of malignancy. * pregnancy. * prior spine surgery

Keywords: neck pain/lumbar pain/magnets/sleep deficiency/ insomnia/
epcoritamab in chronic lymphocytic leukemia and richter syndrome

Conditions: Leukemia, Chronic Lymphocytic; Richter Syndrome

Summary: this correlative study aims to understand the pharmacodynamic effects and clonal dynamics in response to epcoritamab by obtaining and analyzing lymph node, bone marrow, and blood samples from subjects enrolled in gct3013-03 trial sponsored by genmab at nih. samples will be collected before and at multiple time points during treatment with epcoritamab. national heart, lung, and blood institute (nhlbi) investigators are experienced in testing samples treated with bsab2,3 including epcoritamab in an ongoing pre-clinical collaboration with genmab. addressing the objectives of this correlative study will advance the science and clinical application of epcoritamab specifically as well as t-cell engaging bsab in general as an emerging class of immunotherapy for cancer. the study is enrolling by invitation only.

study description: subjects enrolled in gct3013-03, a phase 1b/2 study of epcoritamab in r/r cll and rs, at the national institutes of health (nih) clinical center (cc) will be invited to simultaneously participate in this companion correlative study. subjects will undergo percutaneous lymph node coreneedle biopsies, bone marrow biopsies, lymphapheresis, and blood draws for pharmacodynamic evaluation of tumor and immune cells in affected tissue sites and blood before and during treatment with epcoritamab. objectives: primary objective: -assess the pharmacodynamic effects of epcoritamab in the tumor microenvironment. secondary objectives: * assess the pharmacodynamic effects of epcoritamab in blood * investigate clonal dynamics during treatment with epcoritamab exploratory objective: -evaluate pharmacodynamic and predictive biomarkers endpoints: primary endpoint: -immunophenotype and transcriptome of t cells and tumor cells in lymph node and bone marrow secondary endpoints: * immunophenotype and transcriptome of t cells and tumor cells in peripheral blood * dna sequencing of tumor cells exploratory endpoints: -tests include, but are not limited to single cell multiomics, bulk lymph node transcriptome cytokine analysis

Eligibility criteria:
* inclusion criteria: in order to be eligible to participate in this study, an individual must meet all of the following criteria: * must be undergoing screening for gct3013-03 * stated willingness to comply with all study procedures and availability for the duration of the study * ability of subject to understand and the willingness to sign a written informed consent document. exclusion criteria: none

Keywords: epcoritamab, pharmacodynamic, tumor microenvironment, clonal dynamics, biomarker
evaluating fracture risk assessment tools (frax) from different regions in central south chinese postmenopausal women

Conditions: Osteoporosis Fracture

Summary: we evaluated fracture risk assessment tools (fraxs) from different regions in chinese postmenopausal women.

this cross-sectional study recruited 264 postmenopausal women aged ≥50 years in september 2017. basic information, general condition, history of illness, family history, and clinical risk factors were evaluated via a questionnaire. all subjects underwent a bone mineral density examination of the femur and lumbar spine and thoracolumbar spinal x-ray. the 10-year major osteoporotic fracture (mof) and hip fracture (hf) risks were calculated using fraxs from mainland china, hong kong, taiwan, and asia-america. all data were analyzed using spss 17.0. sensitivity, specificity, and likelihood ratio were used to compare the effectiveness of each frax.

Eligibility criteria:
inclusion criteria: * postmenopausal women aged ≥50 years were randomly selected from community centers in changsha city, hunan province, china in september 2017. menopause was defined as the absence of menstrual cycles for at least one year. all subjects were noninstitutionalized and in good health. exclusion criteria: * the criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs.

Keywords: frax osteoporosis chinese population
auricular acupuncture as part of multimodal analgesia after lower leg fracture

Conditions: Pain, Postoperative; Fracture, Ankle; Pilon Fracture of Tibia; Foot Fracture

Summary: the purpose is to find out if incorporation of an intraoperative electro auricular acupuncture protocol when added to a standard multimodal analgesic regimen for patients undergoing surgery to repair lower leg fracture under spinal anesthesia will help reduce postoperative opioid use.


Eligibility criteria:
inclusion criteria: 1. patient ages 18-64 2. american society of anesthesiology physical status i, ii or iii 3. inpatients scheduled to undergo ankle orif at harris health system ben taub hospital exclusion criteria: 1. renal dysfunction (serum cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications 2. allergy to any of the standard anesthetic agents 3. patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder) 4. patient or surgeon refusal
systemic therapy and cognitive behavioral therapy for social anxiety disorders

Conditions: Social Anxiety Disorder

Summary: goals of the study: systemic therapy was approved in 2008 by the scientific advisory board on psychotherapy (wissenschaftlicher beirat psychotherapie: wbp) for a variety of disorders which, at the time, did not include anxiety disorders. according to the 2007 joint methods paper of the wbp and the mutual federal committee (gemeinsamen bundesausschuss: g-ba), there must be three randomized-controlled trials (rct) for anxiety disorders. these studies are available now but lack explicit details about the clinical significance of the reductions they show in social anxiety symptoms. this project is funded by the german association for systemic therapy, counseling and family therapy (deutsche gesellschaft für systemische therapie, beratung und familientherapie: dgsf). study design: the study is planned as a mono-centric, balanced pilot rct. it investigates the feasibility of an rct comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders (sad) in 32 patients.


Eligibility criteria:
inclusion criteria: * social anxiety disorder (skid: icd-diagnosis: f40.1, liebowitz social anxiety scale \> 30); * agreement to participate in the study and to be randomized into the two treatment groups exclusion criteria: * acute drug or alcohol intoxication or dependency * anorexia with bmi \< 14 * psychotic disorder * severe physical diseases
large abdominal hernia repair with surgimend 3.0

Conditions: Hernia

Summary: the rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%. the purpose of this study is to evaluate the rate of hernia recurrence at one year following repair with surgimend 3.0, an fda-cleared novel biologic mesh, the hypothesis being that such rate will be less than 20% at one year, representing a 50% reduction over the historic rate of 40%.


Eligibility criteria:
inclusion criteria: all three of the following criteria must be present for enrollment into the study: * large abdominal hernia * inability to close the fascia primarily * contra-indication for the use of synthetic mesh * age \> 18 years exclusion criteria: * use of surgimend 3.0 to simply reinforce a complete closure of the fascia performed either primarily or sequentially or by component separation technique * inability to close the skin over the surgimend 3.0

Keywords: repair of a large hernia with surgimend 3.0, a biologic mesh
nebulized lidocaine to prevent cough at emergence from anesthesia

Conditions: Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat

Summary: our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.

our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation. this randomized controlled study will compare the effect of lidocaine and placebo nebulization in the immediate pre operative period in order to evaluate the effectiveness in reducing post extubation cough and sore throat.

Eligibility criteria:
inclusion criteria: * age\>18 years * asa status i or ii exclusion criteria: * unexpected difficult laryngoscopy * surgery\>3 hours