Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of adalimumab in treatment of hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa (HS)

Summary: a study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (hs).

the clinical trial identifier is pioneer i. the purpose of this study is to evaluate the safety of adalimumab and to determine how well it works in the treatment of adults with moderate to severe hs. hs is a chronic skin disease that creates red, swollen, painful bumps which can break open to combine and form tunnels in the skin and scars. sometimes these bumps can heal themselves quickly and sometimes they will become much worse and create sores that heal with multiple combined scars, or areas that do not heal. in this study, approximately 300 adults will be enrolled at treatment centers worldwide. subject participation in this study will be up to 50 weeks. there will be a screening period, which will last from 7 to 30 days, and a study treatment period of up to 36 weeks. study visits occur at screening, baseline, and weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32 and 36 (or sooner if subject leaves the study before week 36). the study is divided into two treatment periods. the first period (period a) will last 12 weeks and the second period (period b) will last up to 24 weeks.

Eligibility criteria:
inclusion criteria: * adults must have a diagnosis of hs for at least 1 year prior to baseline. * hs lesions must be present in at least two distinct anatomical areas, one of which must be at least hurley stage ii or hurley stage iii. * subject must have stable hs for at least 60 days prior to screening visit and at baseline visit. * subject must have experienced an inadequate response to at least a 90-day treatment of oral antibiotics for treatment of hs. * subject must have a total an count of greater than or equal to 3 at baseline. exclusion criteria: * subject was previously treated with adalimumab or another anti-tumor necrosis factor (anti-tnf) therapy (e.g., infliximab or etanercept). * subject received any oral antibiotic treatment for hs within 28 days prior to baseline. * subject received oral concomitant analgesics (including opioids) for hs-related pain within 14 days prior to baseline visit. * if entering the study on concomitant oral analgesics for non-hs related pain: * subject on opioid analgesics within 14 days prior to baseline visit; * subject not on a stable dose of non-opioid oral analgesics for at least 14 days prior to the baseline visit ("as needed" is not considered a stable dose).

Keywords: acne psoriasis hidradenitis suppurativa tnf hs pioneer i acne inversa boil placebo controlled double blind adalimumab
accuracy and predictive values for colorectal cancer of quantitative fit in symptomatic patients in primary care

Conditions: Colorectal Cancer

Summary: the aim of this study is to determine accuracy and predictive values for colorectal cancer of a faecal quantitative immunochemical test (fit) in unselected symptomatic patients presenting in primary care. main reference test will be linkage to a nationwide colorectal cancer registry.

this is a nationwide multi-centre study in primary care, sweden. patients from the age of 40 years and above presenting in primary care with symptoms associated with colorectal cancer prompting their gp to take actions are eligible. consenting patients will fill out a short form on symptoms during last 4 weeks. they will provide 2 faecal samples from 2 different days. samples will be analysed at any of three laboratories within 5 days using quikread go® (aidian oy). the analytical working range is 10-200 µg hb/g faeces. the outcome will be reported as the concentration of first test (fit 1) and highest concentration of two tests (fit max). the outcome of the study fit will remain within the study and gps must request a separate fobt for clinical purposes. reference test will be linkage to the swedish colorectal cancer registry (with in practice complete coverage) after at most 2 years for all patients. accuracy and predictive values will be determined and roc-curves analysed. some patients included in the study will be referred for colonoscopy for clinical reasons, and the outcome of fit in relation to colonoscopy findings will be reported for this group as well.

Eligibility criteria:
inclusion criteria: patients presenting in primary care with symptoms associated with colorectal cancer prompting their gp to take actions are eligible. exclusion criteria: referral for bowel examination for other reasons than symptoms. not able to understand the instructions for participation.

Keywords: quantitative faecal immunochemical test, symptomatic, primary care
use of atropine in tredmill stress testing

Conditions: Chest Pain

Summary: the aim of this study is to evaluate the safety and feasibility of atropine added during treadmill stress testing in patients with chronotropic incompetence or poor exercise capacity. our hypothesis is that we can increase heart rate by using atropin in these patients, so we will achieve more conclusive results.


Eligibility criteria:
inclusion criteria: * patients with chest pain without evidence of ischemia eligible for exercise test. * age\> 18 years old exclusion criteria: absolute: * patients with lbbb * unstable angina * recent myocardial infarction * un controlled arrythmia * congestive heart faliure * severe symptomatic valvular heart disease * acute pulmonary embolism * acute perimyocarditis * acute aortic dissection relative: * lt main stenosis * severe hypertention (systolic\> 200 mmhg; diastolic \> 100 mmhg) * cardiomyopathy * obstructiove abnormalities * psychiatric disorders * high degree av block

Keywords: chest pain low work capacity rate incompetence
autologous bone marrow derived mesenchymal stromal cells transplantation(bm-msc) for kienbock's disease

Conditions: Kienböck's Disease

Summary: kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is usually progressive without treatment. cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells are the best candidates for this kind of treatment. this study examined lunate core decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal cells for its treatment potential. bone decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal/stem cell will be done in 30 patients with kienböck disease. the patients will be followed at 2weeks, 3months, 6m and 12 months after implantation. the spss(v16) software will be used for data analysis.

kienböck's disease is characterized by avascular necrosis of the lunate wrist there is probably no single cause of avascular necrosis of the lunate. its origin may involve multiple factors, such as the blood supply (arteries), the blood drainage (veins), and skeletal variations. current treatments are: at the early phase only observation. in the more advanced phases surgical techniques such as bone decompression. a potential therapeutic strategy would be cell therapy, a source of such cells with a regenerative potential could be mesenchymal stem cells (mscs). the investigators will evaluate safety and efficacy of implantation of autologous bm-msc (bone marrow-derived mesenchymal stromal cell) in 30 patients with kienböck's disease in combination with bone decompression surgery. these patients will be followed up and data will be analyzed with spss(v16).

Eligibility criteria:
inclusion criteria: * kienböck's disease without response to conservative treatment (physical and medical) for over 6 months * both genders * visual analogue scale of 4 or higher * hematological and biochemical analysis with no significant alterations that contraindicates intervention * the patient is able to understand the nature of the study * informed written consent of the patient exclusion criteria: * age over 65 or under 18 or legally dependent * infection signs or positive serology for hiv, hepatitis and syphilis * allergy to gentamicin, or to bovine, cattle or horse serum * pregnancy or lactating * pregnancy or breast-feeding * neoplasia * immunosuppression * participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study * other conditions that may, according to medical criteria, discourage participation in the study

Keywords: autologous cell therapy kienböck's disease bone marrow derived mesenchymal stromal/stem cell
prevention of residual low back pain after percutaneous kyphosis(pkp) using posterior branch block of spinal nerve

Conditions: Osteoporotic Fracture

Summary: the purpose of this study was to block the posterior branch of lumbar spinal nerve during pkp operation and compare it with the patients without spinal nerve block, so as to verify the effect of posterior branch block of spinal nerve in relieving short-term and long-term residual low back pain after operation.

patients older than 60 years old who underwent percutaneous kyphosis(pkp) surgery for osteoporotic fractures were randomly divided into two groups. the lumbar spinal nerve branch was blocked with betamethasone and ropivacaine in the experimental group during pkp operation, while the lumbar spinal nerve branch block was not performed in the control group during pkp operation. the low back pain was evaluated at 1 week, 2 weeks, 1 month, 3 months and 6 months after operation using visual analogue pain score(vas)scale.so as to compare the effect of lumbar spinal nerve block on residual pain after pkp.

Eligibility criteria:
inclusion criteria: * osteoporotic fracture * acute vertebral compression fracture (within 2 weeks) * fracture level lower thant6 exclusion criteria: * other types of fractures * patients younger than 60 years of age, * with other disease (metabolic bone disease, metastasis, uncor- rectable coagulopathy, spinal infection, severe cardiopulmonary comorbidity, cognitive disorders etc)

Keywords: percutaneous kyphoplasty（pkp） nerve block posterior branch of spinal nerve
a follow-up comparison of active versus passive manual therapy in patients with low back pain

Conditions: Low Back Pain; Manual Therapy; Education

Summary: to determine if there is any carry over difference between the type of education provided about common treatment techniques for patients with low back pain. this will be looked at right after treatment and when patients return on their second visit after they do a common exercise program for a few days.

prior clinical trials have shown that patients respond differently to different explanations about interventions performed. a recent randomized clinical trial demonstrated that a 10-minute manual therapy treatment (prone lumbar posterior to anterior mobilization (pa's) with a neuroplasticity vs. traditional biomechanical explanation) produced an immediate, significant improvement in straight leg raise (slr) and pain for patients with chronic low back pain. however, there is a need to examine whether there is any carry over (48-96 hours) or if utilizing a home exercise program (hep), aimed at increasing the various sensory process applied in the clinic, produces any carry over. this will be looked at in patients with who are provided different explanations about common back treatment techniques to see if there will be any change in pain rating or back and leg movement.

Eligibility criteria:
inclusion criteria: * adults over the age of 18 * patients presenting at pt with a primary complaint of lbp * lbp being present for 6 months or more * fluent in english * willing to participate in the study. exclusion criteria: * under age 18 * not able to read/understand the english language * prisoners * no medical issues precluding physical therapy treatment (red flags) * no medical precautions to the use of manual therapy (metal, skin lesions, etc.) * prior spine surgery * unable to lay prone for the treatment

Keywords: low back pain manual therapy education neuroplasticiy
corneal endothelial changes following pediatric cataract surgery with iol implantation

Conditions: Congenital Cataract Surgery; IOL Implantation; Change in Corneal Endothelial Cell Morphology

Summary: cataract surgery is known to cause loss of corneal endothelial cells. in adults, it is reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs following cataract surgery. however, no data is available regarding endothelial changes after cataract surgery with iol implantation in pediatric eyes. the aim of this study is to prospectively observe changes in endothelial cell density, coefficient of variation and hexagonality following cataract surgery with iol implantation in pediatric eyes.


Eligibility criteria:
inclusion criteria: * eyes undergoing pediatric cataract surgery with iol implantation at iladevi cataract \& iol research center, ahmedabad, india. * children older than 4 years undergoing cataract surgery with iol implantation were included. exclusion criteria: * exclusion criteria were as follows: eyes with traumatic or subluxated cataract and inability to get preoperative specular. intraoperatively, sulcus fixated iols, and eyes with no iol implantation were excluded.

Keywords: corneal endothelium congenital cataract surgery iol implantation
pharmacokinetics of malathion gel 0.5% and malathion 0.5% lotion (ovide) in patients with head lice

Conditions: Pediculosis

Summary: in this study, 24 adult patients with head lice will be treated with a topical malathion head lice treatment; 12 patients will be treated with a novel product, malathion gel, 0.5%, and other 12 patients will be treated with ovide lotion 0.5% marketed by taro pharmaceuticals usa, inc. the primary objective of this study is to compare the blood level exposure of malathion 0.5% gel to that of the ovide lotion 0.5%.

a randomized, single-dose, parallel group, comparative pk study. patients will be randomly assigned in 1:1 ratio to the study products. twenty four (24) consenting patients, age 18 years and older, who meet inclusion/exclusion criteria will be enrolled in this study. 12 patients will be treated with malathion gel, 0.5% and other 12 patients will be treated with ovide lotion 0.5%. the study will be single centre and conducted only in india. the primary objective of this study is to compare the systemic exposure of malathion 0.5% gel manufactured by taro pharmaceuticals usa, inc. to that of the ovide lotion 0.5%, currently marketed by taro pharmaceutical usa, inc., in adult patients with head lice. the secondary objective is to determine the link between the exposure and cholinesterase activity.

Eligibility criteria:
inclusion criteria: * male or non-pregnant female * patients 18 years of age or older and healthy presenting with pediculosis capitis * the patient must be willing to consent to the patient's treatment with malathion gel 0.5% or ovide lotion 0.5% and for blood drawings before and after medication administration. exclusion criteria: * individuals with history of irritation or sensitivity to pediculicides or hair care products * individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, or sponsor, will interfere with the evaluation. * individuals previously treated with a pediculicide within 4 weeks of the study. * individuals who exhibit potential signs and symptoms of cholinesterase inhibition. * patients currently receiving sulfonamide antibiotics or ivermectin.

Keywords: head lice
helmet cpap versus hfnc in covid-19

Conditions: COVID; Acute Hypoxemic Respiratory Failure

Summary: we aim to investigate whether the use of continuous positive airway pressure using a helmet device (helmet cpap) will increase the number of days alive and free of ventilator within 28 days compared to the use of a high flow nasal cannula (hfnc) in patients admitted to helsingborg hospital, sweden, suffering from covid-19 and an acute hypoxic respiratory failure.

a detailed description can be found in the study protocol published in trials in dec 2020: tverring, j., åkesson, a. \& nielsen, n. helmet continuous positive airway pressure versus high-flow nasal cannula in covid-19: a pragmatic randomised clinical trial (covid helmet). trials 21, 994 (2020). https://doi.org/10.1186/s13063-020-04863-5

Eligibility criteria:
inclusion criteria (all of the following): 1. age ≥ 18 years 2. sars-cov-2 found in the upper or lower respiratory tract by pcr during the current disease episode 3. peripheral oxygen saturation (spo2) \< 92 % despite conventional low-flow oxygen therapy of at least 6 l /min for at least 15 min 4. a decision to initiate hfnc or helmet cpap by the attending ward physician 5. the patient has given written informed consent to participate. exclusion criteria (any of the following): 1. need for direct admission to the intensive care unit for mechanical ventilation 2. unconsciousness or drowsiness 3. pneumothorax 4. carbon dioxide pressure (pco2) \> 6 kpa in venous blood gas (vbg) 5. underlying chronic obstructive pulmonary disease stage iii-iv 6. a decision not to participate 7. inability to comprehend the study content and give informed consent
the bioavailability of a spray dried dispersion solid dose formulation of pf-06260414 relative to a suspension formulation

Conditions: Healthy

Summary: the current study will investigate the relative bioavailability of a spray dried dispersion solid dose formulation of pf 06260414 administered as a single oral dose of 30 mg of pf 06260414 relative to a single oral dose of 30 mg of pf 06260414 administered as a nanosuspension under fasted or fed conditions in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * any condition possibly affecting drug absorption (eg, gastrectomy)

Keywords: chronic obstructive pulmonary disease
evaluation of rumination, frailty and tanatophobia in cancer patients over 65 years of age

Conditions: Cancer; Death; Rumination; Frailty

Summary: the aim of this study is to evaluate tanatophobia and rumination in individuals over 65 years of age receiving cancer chemotherapy and to determine the related factors.

no studies were found in the literature evaluating the relationship between frailty and lack of social support with tanatophobia and rumination. the aim of this study is to evaluate tanatophobia and rumination in individuals over 65 years of age receiving cancer chemotherapy and to determine the related factors.

Eligibility criteria:
inclusion criteria: * 65 years or older * conscious and no communication problems * being literate * willing to participate in our study voluntarily * cancer patient receiving active chemotherapy treatment exclusion criteria: * not being willing to participate in the research * serious life-threatening condition (critical illness, intensive care unit stay, acute complication) * dementia, alzheimer's, cognitive dysfunction * major psychiatric illness

Keywords: cancer tanatophobia rumination fraility elderly
effect of salba & flax on postprandial glycemia and subjective satiety

Conditions: Hyperglycemia, Postprandial

Summary: the purpose of this study is to determine whether drinks containing salvia hispanica l (salba) or flax lower postprandial blood glucose levels and improve appetite in healthy individuals.

dietary fibre has been implicated in improving many risk factors associated with type 2 diabetes and cardiovascular disease (cvd). however, on average, norther americans consume less than half of the recommended amount set by health agencies. it has been proposed that the health benefits of dietary fibre may be attritbuted to rheological characteristics such as viscosity. salvia hispanica l (salba) and flax are nutritionally similar. the primary objective of this research trial is to study the effects of salba and flax on postprandial glycemia and appetite in healthy individuals.

Eligibility criteria:
inclusion criteria: * bmi less than 35 kg/m\^2 exclusion criteria: * known history of liver or kidney disease, diabetes, hypertension, stroke, or myocardial infarctions, thyroid disease, gastrointestinal disease, or aids * subjects using medications or natural health products

Keywords: postprandial glycemia subjective appetite salba flax
study to evaluate initiation of stalevo in early wearing-off

Conditions: Parkinson's Disease

Summary: an open, non-randomised, multinational, multicentre direct switch study in levodopa-treated parkinson's disease patients suffering from early wearing-off in parkinson's disease. the study will consist of 2 consecutive periods: screening period and study treatment period. duration of the study will be up to 8 weeks for each subject. the study treatment dosage will be determined by the subject's current, separately administered standard levodopa/ddci treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be switched to an equivalent dose of stalevo® without changing the number of doses per day. the levodopa daily dose during stalevo® treatment may be adjusted according to the study subject's clinical response.

see 'brief summary'.

Eligibility criteria:
inclusion criteria: * subjects with idiopathic parkinson's disease and early wearing-off symptoms treated with standard levodopa/ddci treatment * age \>35 - years * hoehn and yahr stage 1-3 performed during the 'on'-stage * at least 1 symptom identified by woq-9 * dosing frequency of 3-4 doses of standard-release levodopa/ddci (maximum total daily dose of 600 mg of levodopa) exclusion criteria: * atypical or symptomatic parkinson's disease * unpredictable off-periods * any peak-dose dyskinesia. 'off'-state dystonia is allowed * use of any rescue medications to treat symptoms of 'off'-state. 1 dose of soluble levodopa/ddci is allowed. * concomitant treatment with non-selective monoamine oxidase (mao) inhibitor or simultaneous use of higher than recommended doses of mao-a and mao-b inhibitors (selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine.