Kornimate/medical-research-clean huggingface dataset:
botulinum toxin-a for hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa; Hidradenitis Suppurativa \(HS\); Hidradenitis Suppurativa, Acne Inversa

Summary: the purpose of this research study is to determine if the medication botulinum toxin-a (btx-a) is effective in treating hidradenitis suppurativa (hs)

hidradenitis suppurativa (hs) is an auto-inflammatory disorder of apocrine sweat glands which results in painful, draining nodules within hair-bearing skin of the axillae, groin, and perineum. there is no consensus for treatment of hs and neither a medical nor surgical cure exists. several case reports show potential efficacy of botulinum toxin-a (btx-a) in inducing remission of hs however, these studies are underpowered. the objective of this study is to determine if botulinum toxin- a induces regression, remission, or relapse of hidradenitis suppurativa lesions.

Eligibility criteria:
inclusion criteria: * subjects with active axillary hidradenitis suppurativa of the same severity bilaterally. regimen * for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation * agreement to forego other treatments for hidradenitis for the duration of the study exclusion criteria: * current use of antibiotics, hormonal therapies, steroids, and/or biologics * presence of cardiac pacemaker * pregnancy or lactation * known neuromuscular disorder * known hyperhidrosis * febrile illness within one month * treatment with another investigational drug or other intervention within three months * patients without active axillary hidradenitis suppurativa

Keywords: hidradenitis suppurativa botulinum toxin-a
the effects of slumbercurve™ following rotator cuff surgery: a randomized control trial

Conditions: Rotator Cuff Tears; Surgery; Pain, Postoperative

Summary: the purpose of this study is to investigate the effects of a novel sleep aid known as slumbercurve™, which serves as an adjustable form of a wedge pillow, on sleep quality and pain management following rotator cuff repair. the researchers hypothesize that slumbercurve™ will significantly improve sleep quality and reduce night-time pain.

poor sleep quality is prevalent among patients undergoing rotator cuff repair surgery, and negatively affects the potential for proper healing. without adequate sleep, the production of anabolic steroids and inflammatory cytokines are diminished. these anabolic steroids and inflammatory cytokines play a key role in postoperative healing, resulting in adequate pain regulation and increased patient satisfaction. therefore adequate sleep quality is important not only for quality of life, but for postoperative healing. a recent systematic review revealed that some studies reported varying degrees in both the time and magnitude of change in return to adequate sleep quality following rotator cuff repair. this study hopes to address this gap in the literature by investigating a novel sleep aid, slumbercurve, and its effect on sleep quality and night-time pain relief. slumbercurve is a class i medical device and is currently advocated to relieve tension and diminish pain in patients undergoing rotator cuff repair surgery. the device provides adjustable elevation of the torso as well as concave positioning, placing the shoulder in a more forward position. this novel sleep aid has the potential to increase sleep quality, and therefore enhance both patient satisfaction and postoperative recovery from rotator cuff repair surgery.

Eligibility criteria:
inclusion criteria: • any male or nonpregnant female aged 18 years or older with a full-thickness rotator cuff tear undergoing rotator cuff repair surgery exclusion criteria: * patients who receive workers' compensation benefits * patients with irreparable tears * patients undergoing revision surgery * patients with concomitant severe glenohumeral arthritis or concurrent adhesive capsulitis * sleep apnea disorder or other diagnosed sleep disorder * neuropsychiatric disease * use of sleep medication * prior shoulder surgery * rotator cuff arthropathy with pseudo paralysis * acute fractures involving the proximal humerus or shoulder girdle
naproxen for the prevention of ho after complex elbow trauma

Conditions: Heterotopic Ossification

Summary: complex elbow fractures can lead to formation of new bone (called heterotopic ossification). this new bone is unwanted and it can restrict motion. this research study is being done to learn more about the effect of the drug naproxen, on unwanted formation of new bone around the elbow as it heals after a fracture. naproxen belongs to a class of drugs called nsaids which stands for non-steroidal anti-inflammatory drugs. several research studies suggest that nsaids such as naproxen can prevent the unwanted formation of new bone around the hip. the effect of nsaids on the formation of bone around the elbow has not been studied as well as it has been studied for their effect on the hip. the drug, naproxen is approved by the us food and drug administration (fda) for sale but ot specifically for the treatment of heterotopic ossification.


Eligibility criteria:
inclusion criteria: 1. subjects aged 18 years or greater 2. operative treatment of one of the following injuries * an elbow dislocation with or without associated fractures * an olecranon fracture-dislocation, but not simple olecranon fractures * a distal humerus fracture exclusion criteria: 1. an existing diagnosis of one of the following conditions * injury to the central nervous system, thorax, or abdomen precluding the immediate use of non-steroidal anti-inflammatory medications * fracture of any long bone since non-steroidal anti-inflammatory medications may increase the risk of nonunion * history of gastritis, peptic ulcer disease, or upper gastrointestinal bleeding * impaired renal function (creatinine \> 2.0), hypovolemia, heart failure, high blood pressure ( \> 160/90), fluid retention, asthma, liver dysfunction (bilirubin \> 2.0), or a coagulation disorder * allergy to non-steroidal anti-inflammatory medications * asthma, nasal polyps, urticaria, and hypotension associated with the use of nsaids * considerable dehydration 2. pregnant or breast-feeding women 3. concomitant use of one of the following drugs: * aspirin * other naproxen products (ec-naprosyn, anaprox, anaprox ds, naprosyn suspension, aleve) * methotrexate * diuretics (thiazides / furosemide) * ace-inhibitors (captopril, enalapril, ramipril etc.) * beta-blockers (propanolol etc.) * probenecid (for gout or hyperuricemia) * h2-blockers, sucralfate and intensive antacid therapy * lithium * anticoagulants / warfarin (coumadin, waran, jantoven etc.) * sulfonamides * anticonvulsant medication (peganone, mesantoin, cerebyx, dilantin, etc.)

Keywords: complex elbow trauma prevention complication naproxen nsaids
influence of hospital volume on mortality and short-term postoperative outcomes in uncomplex general surgery in switzerland

Conditions: Cholecystolithiasis; Cholecystitis; Inguinal Hernia; Femoral Hernia; Umbilical Hernia; Appendicitis

Summary: the effect of centralisation measures on the operative outcomes after any type of surgery in switzerland has not been highlighted yet. this study aims to investigate the influence of the annual case-specific hospital volume on uncomplex general surgery. the four operations investigated are appendectomy, cholecystectomy, umbilical hernia repair, and inguinal/femoral hernia repair.


Eligibility criteria:
inclusion criteria: * all patients with appendicectomy for appendicitis, cholecystectomy for cholecystolithiasis and/or cholecystitis , umbilical hernia repair, or inguinal and/or femoral hernia repair exclusion criteria: * incomplete case documentation * age under 20 years * other hospitals than general or surgical hospitals * no index operation
injectable extended-release buprenorphine (xr-b) in a correctional setting: qualitative interviews

Conditions: Opioid Use Disorder; Criminal Justice; Treatment Adherence and Compliance

Summary: this qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (xr-b), to treat individuals with opioid use disorder (oud) within a correctional setting. the research aims to understand if xr-b can be a feasible and effective alternative to the standard daily treatment and to identify which groups within the prison population may benefit the most from this treatment. in-depth interviews are conducted with incarcerated individuals and relevant stakeholders.


Eligibility criteria:
incarcerated individuals, inclusion criteria: * english speaking * over the age of 18 * diagnosed with opioid use disorder incarcerated individuals, exclusion criteria: - diagnosed with "severe, persistent, mental illness (spmi)" rationale for exclusion: these individuals suffer from severe mental health disease and therefore warrant greater protection, have greater risk for coercion, and offer insights to severe co-diagnosis treatment that, while important, remain outside the scope of general mat implementation. organizational stakeholders, inclusion criteria: - employed or contracted by rhode island department of corrections (for organizational staff interviews) and involved with the medication for addiction treatment (mat) program organizational stakeholders, exclusion criteria: - if not permitted by their organizational union to participate

Keywords: addiction criminal justice medications for opioid use disorder
applicability of the ottawa ankle rules

Conditions: Ankle Fracture; Ankle Sprain

Summary: the aim of this prospective study was to compare outcomes in patients handled by emergency physician according to oar versus by an orthopedic resident. 92 consecutive patients with ankle injuries attending our emergency department were divided in two groups. the study group comprised 32 patients who arrived during the morning shift and were examined by an emergency physician according to oar. patients discharged without an x-ray were followed in the clinic or by telephone communication. the control group constituted 60 patients who were examined during the evening and night shifts by orthopedic residents unaware of this study.

objective. ankle and midfoot injuries are common orthopedic complaints, both in general medicine and orthopedic practice. the percentage of fractures among these injuries is small, however many will undergo x-ray. ottawa ankle rules (oar) are clinical guidelines for determining whether to use radiography in such cases. the aim of this prospective study was to compare outcomes in patients handled by emergency physician according to oar versus by an orthopedic resident. also, we validated the applicability of oar in an emergency department in our country. methods. 92 consecutive patients with ankle injuries attending our emergency department were divided in two groups. the study group comprised 32 patients who arrived during the morning shift and were examined by an emergency physician according to oar. patients discharged without an x-ray were followed in the clinic or by telephone communication. the control group constituted 60 patients who were examined during the evening and night shifts by orthopedic residents unaware of this study.

Eligibility criteria:
inclusion criteria: * ankle trauma exclusion criteria: * unwilling to participate
study evaluating the efficacy and safety of etanercept and acitretin in korean patient with moderate to severe psoriasis

Conditions: Moderate to Severe Psoriasis

Summary: to compare the efficacy of etn 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of etn 25 mg twice weekly plus acitretin 10mg bid at week 24 in subjects with moderate to severe psoriasis.


Eligibility criteria:
inclusion criteria: * active, moderate to severe psoriasis defined by the following criteria: clinically stable, plaque psoriasis involving more than 10% body surface area (bsa) or pasi 10. * in the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: methotrexate (mtx), cyclosporine, and psoralen plus ultraviolet a radiation (puva) therapy. * negative urine pregnancy test before the first dose of study drug in all female patients exclusion criteria: * evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. * any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes. * prior exposure to tnf inhibitors including etn. prior exposure to efalizumab (raptiva®) and alefacept (amevive®) is also prohibited.

Keywords: etanercept acitretin psoriasis
adjuvant radiation in aortic valvuloplasty - arava

Conditions: Aortic Valve Stenosis

Summary: this study will examine the effect of external beam radiation therapy in the prevention of restenosis following successful balloon aortic valvuloplasty in severe, symptomatic aortic stenosis.


Eligibility criteria:
inclusion criteria: * severe aortic stenosis * nyha class 2-4 chf symptoms * age \> 75 * euroscore \> 7 * prohibitively high risk for aortic valve replacement surgery as designated by a cardiac surgeon
methyl-donor nutrient supplementation and methylation profile in lupus patients with obesity

Conditions: Overweight and Obesity; Lupus Erythematosus

Summary: dietary supplementation with methyl donors has been demonstrated to increase dna methylation in leucocytes whereas a limited dietary intake of methyl donors was associated with dna hypomethylation. considering sle disease, previously study showed that high doses of vitamin b6 and folate were associated with less severe sle. furthermore, some evidences reported a relatively high incidence of decreased serum b12 levels in rheumatic patients. this led to the suggestion that diets rich in methyl group donors could have beneficial effects on sle.


Eligibility criteria:
inclusion criteria: * sle diagnosis * female * in pre-menopausal period * aged between 18 to 45 years * patients that meet the classification criteria according to systemic lupus international collaborating clinics classification criteria (slicc) * patients with sledai score ≤ 4 on systemic lupus erythematosus disease activity index 2000 (sledai-2k) * under prednisone treatment at a dosage \<10 mg/day * under treatment with chloroquine at a stable dose * bmi \> 18,5 kg/m2 exclusion criteria: * current infection * diabetes * arterial hypertension * smokers * pregnancy * anticoagulants use * methotrexate use * other autoimmune diseases * current vitamin b12 or/and folic acid supplementation
a randomized, open-label, comparative, parallel-group, multicenter study of sparc1507

Conditions: Advanced Biliary Tract Cancer

Summary: an open label study to determine the efficacy and safety of sparc1507

subjects with advanced biliary tract carcinoma meeting the eligibility criteria will be randomized in this study.

Eligibility criteria:
inclusion criteria: * evidence of advanced/metastatic biliary tract cancer * male or female ≥ 18 years old * participants must have measurable disease according to recist * ecog performance status ≤ 1 exclusion criteria: * known hypersensitivity to trial treatments, or their excipients * prior history of treatment with any taxane therapy * cardiovascular disorders as per investigator's discretion * the subject has received radiation therapy
effect of electroacupuncture on pain threshold

Conditions: Pain

Summary: this study is designed to evaluate whether or not electroacupuncture can have an effect on the pain threshold of the subject, as compared to sham treatment.

this study is utilized to evaluate the what effectiveness electroacupuncture has on pain threshold as compared to sham. the outcome measurement utilized will be a digital algometer. the electroacupuncture treatment will consist of a total of four electroacupuncture treatments stimulating acupuncture points li4 and li11, and will be given on the same upper extremity tested by the algometer. the algometer measurements will occur alone on the first week, prior to the treatments on the second and third week, and the final reading alone on the fourth week.

Eligibility criteria:
inclusion criteria: * normal healthy subjects exclusion criteria: * hypertension * heart disease * pregnancy * no spinal manipulation or other treatment or medication that could effect pain threshold

Keywords: asymptomatic normals
vst-1001 (dilute fluorescein) for lymphatic mapping & localization of lymph nodes in patients with breast cancer

Conditions: Breast Cancer

Summary: the purpose of this phase 1 portion of this clinical research study is to find out what dose of dilute fluorescein is needed for a surgeon to best see important lymph nodes that need to be removed during surgery (a standard of care surgery referred to as a sentinel lymph node biopsy procedure) in patients diagnosed with breast cancer. the purpose of the phase 2 portion of this clinical research study is to find out if giving dilute fluorescein sodium in combination with a radiotracer (a drug that is radioactive) can help surgeons localize the lymph nodes that need to be removed in patients diagnosed by breast cancer.

the study is a single center prospective, non randomized, single arm, open label, single dose vst-1001 study for lymphatic mapping and localization of lymph nodes draining a primary tumor site in patients with clinically node negative breast cancer. this study evaluates the combined modality technique of investigational vst-1001 with companion medical devices (replacing the blue dye) and 99mtc-labeled sulfur colloid for concordance in lymphatic mapping and localization of lymph nodes in patients who are undergoing a sentinel lymph node biopsy (slnb) surgical procedure. this purpose of the phase i study is to determine a safe and effective recommended dose of vst-1001 for intraoperative lymphatic mapping and localization of lymph nodes draining a breast tumor. the purpose of the phase ii study is to further evaluate the phase i study recommended dose of vst-1001 and to evaluate its ability to provide intraoperative visualization of the lymphatic system and lymph nodes draining the primary tumor in patients diagnosed with breast cancer.

Eligibility criteria:
inclusion criteria: * diagnosis of primary breast cancer. * diagnosed with invasive adenocarcinoma, or dcis for which a slnb is the recommended standard of care, or breast cancer with all of the following conditions met: * fna results positive for cancer cells * positive clinical breast examination * mammography and/or us and/or mri abnormality(ies) consistent with malignancy. * n0 and m0 at the time of study entry. * ecog 0, 1, or 2 exclusion criteria: * a tumor with direct extension to the chest wall and/or to the skin. * diffuse tumors or multiple malignant tumors in the breast. * prior breast malignancy of the ipsilateral breast. * patient currently receiving or had prior treatment for the currently diagnosed breast cancer. * medical conditions and/or prior surgical procedures that have the potential to substantially alter the lymphatic drainage pattern from the primary tumor to the lymph node basin. * inability to localize 1 or 2 lymph node drainage basin(s) via lymphatic mapping.

Keywords: sentinel lymph node biopsy breast cancer lymphatic mapping
single ascending dose study of medi1341 in healthy volunteers

Conditions: Parkinson's Disease

Summary: this is a study of single ascending intravenous doses of medi1341 or placebo in up to 48 healthy volunteers, aged 18 to 65 years. the study will include up to 6 planned cohorts; each cohort will comprise 8 participants. each participant will receive a single 60 minute intravenous infusion of medi1341 or placebo and will undergo scheduled assessments over a period of 13 weeks. the main aim of the study is to assess the safety and tolerability of single doses of medi1341 in healthy volunteers.

this is a randomized, double-blind, placebo-controlled study of single ascending intravenous doses of medi1341 in male and nonfertile female healthy volunteers, aged 18 to 65 years. the study will include up to 6 planned cohorts; each cohort will comprise 8 participants. within each cohort, 6 participants will be randomized to receive medi1341 and 2 will be randomized to receive placebo. a safety review committee will review data from each cohort before progression to the next higher dose cohort occurs. on day 1, each randomized participant will receive a single 60 minute intravenous infusion of medi1341 or placebo and will undergo scheduled safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments. additional study assessments will occur on days 2, 4, 8, 15, 22, 29, 43, 57, and 92.

Eligibility criteria:
inclusion criteria: * participants must be healthy, with no clinically significant abnormality identified on the medical or laboratory evaluation at screening * participants must weigh ≥50 kg and must have a body mass index between 18 and 32 kg/m\^2, inclusive * participants must have a 12-lead electrocardiogram recorded at screening that is normal for the appropriate age group and shows no abnormalities that will compromise safety in this study * participants must have no clinically significant findings on the clinical neurological examinations at screening and at baseline or on the ophthalmic examination at screening. exclusion criteria: * nicotine use within 6 months before screening * considered to be at a high risk of developing a stroke * significant medical history of dizziness, blackouts, fainting, or vaso-vagal attacks * history of any significant ophthalmic disorder, including congenital, genetic or acquired conditions affecting the retina or choroid * history of severe allergy or history of hypersensitivity to immunizations or immunoglobulins * history of any significant psychiatric disorder * history of alcohol abuse * history of cancer within 5 years of screening * history of drug abuse * any contraindication to lumbar puncture * any clinically significant abnormality in ecg rhythm, conduction or morphology * positive serologic findings at screening for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen, or hepatitis c virus antibodies * use of prescription or non-prescription drugs * for female participants, a positive serum or urine pregnancy test result at screening

Keywords: healthy volunteers safety tolerability pharmacokinetics pharmacodynamics immunogenicity