Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of adalimumab in the 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 ii. 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 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). * subjects on permitted oral antibiotic treatment for hs who have not been on a stable dose for at least 28 days prior to the baseline visit. * 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: placebo controlled double blind adalimumab tnf psoriasis hs pioneer ii hidradenitis suppurativa acne inversa boil acne
effect of the sequence of dilatation and lithotripsy on the treatment of choledocholithiasis with ercp

Conditions: Choledocholithiasis; Cholangiopancreatography, Endoscopic Retrograde

Summary: choledocholithiasis is a common and frequently occurring disease in china, accounting for 15.3% \~ 31.7% of the total cholelithiasis.according to its source, can be divided into primary and secondary choledocholithiasis.for large choledocholithiasis, it is difficult to remove all calculi after dilatation of large diameter balloon or mechanical stone following alone.therefore, we used the method of balloon dilation combined with mechanical lithotripsy after est.there are few researches on the sequence of balloon dilation and mechanical lithotripsy at home and abroad, and there is no unified standard. through the ercp balloon expansion of duodenal papilla sphincter and mechanical lithotripsy in the treatment of common bile duct calculi in patients with clinical observation, the balloon expansion and mechanical lithotripsy time order of take stone, stone residues rate and the influence of recent complications such as postoperative pancreatitis, ercp in the treatment of huge stones optimization procedure was formulated.


Eligibility criteria:
inclusion criteria: 1. \>18 years of age 2. for patients with choledocholithiasis found by mrcp and feasible ercp lithotomy, the diameter of calculi ≥1cm should be indicated (number of calculi should be indicated \>5 or\<5) 3. during ercp, the surgeon determined that the calculi should be removed by combining epbd and mechanical lithotripsy, and the calculi could be removed by a single ercp 4. previous cholecystectomy or planned recent cholecystectomy or liver lobectomy can also be included 5. subjects voluntarily participate in this study and sign the informed consent exclusion criteria: 1. coagulation disorders (inr\>1.3) and peripheral blood plate count significantly decreased\<50x10\^9/l 2. preoperative complicated with acute pancreatitis 3. preoperative biliary hemorrhage 4. complicated with severe liver disease and primary sclerosing cholangitis 5. mirizzi syndrome and intrahepatic bile duct stones 6. complicated malignant tumor of hepatobiliary and pancreatic system 7. complicated with obvious stricture of the lower segment of the bile duct 8. intraoperative bile duct duodenal fistula was found 9. previous est or epbd 10. previous history of gastrointestinal reconstruction surgery 11. other ercp contraindications

Keywords: choledocholithiasis cholangiopancreatography, endoscopic retrograde lithotripsy endoscopic papillary balloon dilation
real-world incidence proportion of hepatic toxicity and all adverse drug reactions (adrs) in japanese patients receiving daclatasvir (dcv) trio therapy

Conditions: Hepatitis C

Summary: an observational, postmarketing commitment following the marketing authorization for dcv trio therapy in japan


Eligibility criteria:
inclusion criteria: * patients who are initiating the treatment with dcv trio therapy under the approved indications, dosage, and administration exclusion criteria: * patients who use the dcv trio off label
a study to assess the safety and efficacy of different ad 237 doses in adults with copd

Conditions: COPD

Summary: the purpose of this study is to investigate the efficacy, safety and tolerability of ad 237 in patients with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * diagnosed with copd, with symptoms of cough and chronic sputum production and/or dyspnea. * post-bronchodilator fev1 at no more than 65% and at least 30% of the predicted normal value. * pre-bronchodilator fev1/fvc ratio of less than 70%. * current or ex-smokers with a smoking history of at least 10 pack years. exclusion criteria: * history of asthma, atopy or allergic rhinitis. * other serious respiratory or other medical conditions which may interfere with the outcome of the study.

Keywords: copd coad chronic obstructive pulmonary disease emphysema chronic bronchitis
metabolic parameters 3 months, 9 months, and 2 years after bariatric surgery

Conditions: Obesity; Diabetes; Heart Failure; Insulin Resistance

Summary: an original cohort of 43 patients were recruited for analysis of anthropometrics, metabolic profile, skeletal muscle biopsy, echocardiogram at baseline, 3 months and 9 months post bariatric surgery. while all 43 patients reportedly completed 3 and 9 month evaluations, only 15 patients completed 24 month evaluations due to 28 patients unwilling to return. the overarching purpose appears to have been not only evaluation of weightloss, but normalization of metabolic profile over time.


Eligibility criteria:
inclusion criteria: * the subjects in this study will represent both male and female patients with clinically severe obesity (bmi \> 40kg/m2 or 35kg/m2 with significant obesity related co-morbidities), who have chosen to undergo elective bariatric surgery. patients are screened through the university of texas houston bariatric surgery center (uthbsc) and are evaluated for bariatric surgery, defined in this study as small pouch gastric bypass with roux-en-y (spgb), or laparoscopic adjustable gastric banding (lagb). adults (\>18)from diverse ethnic backgrounds, with clinically severe obesity, are eligible to be evaluated for bariatric weight loss surgery in the uthbsc. candidates considered for the study are patients who not only fulfill the criteria for weight loss surgery, but also demonstrate a high likelihood of complying with the long-term follow-up that is required for a successful study. patients who have components of the metabolic syndrome (hypertension, diabetes, and dyslipidemia) will be included if these complications do not preclude a safe operation. . exclusion criteria: exclusion criteria include age over 70 years, current history of smoking, coronary artery disease, congestive heart failure, ischemic cardiomyopathy, known peripheral vascular disease, severe psychiatric disease, any medical problem or physical contraindication for surgery (as determined by the physician) and pregnancy. this study will be limited to adults since the safety of gastric bypass surgery has not been shown to be safe in children in large clinical trials -

Keywords: obesity insulin resistance free fatty acids heart failure
internet cognitive behavior therapy (cbt) for body dysmorphic disorder (bdd)

Conditions: Body Dysmorhpic Disorder

Summary: the primary aim is to develop, and test the feasibility, of a novel and protocol-based cognitive behaviour therapy (cbt) treatment for body dysmorphic disorder (bdd) administered via the internet.


Eligibility criteria:
inclusion criteria: * outpatients * male or female -≥ 18 years * currently living in stockholm county * primary diagnosis of bdd according to the dsm-iv-tr * signed informed consent * regular access to a computer with internet access and skills to use the web. exclusion criteria: * psychotropic medication changes within two months prior to the treatment * completed cbt for bdd within the last 12 months * bdd-ybocs \< 12 at psychiatrist visit * other primary axis i diagnosis * current substance dependence * lifetime bipolar disorder or psychosis * suicidal ideation * axis ii diagnosis that could jeopardize treatment participation * other current psychological treatment that could affect bdd symptoms

Keywords: bdd cbt
study of cd07805/47 topical gel in subjects with facial erythema associated with rosacea

Conditions: Rosacea

Summary: a long-term, open-label, non-comparative safety and efficacy study of cd07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.


Eligibility criteria:
inclusion criteria: * male or female who is at least 18 years of age or older. * a clinical diagnosis of facial rosacea. * a clinician erythema assessment (cea) score of ≥3 at screening and at baseline (prior to study drug application). * a patient self assessment (psa) score of ≥3 at screening and at baseline (prior to study drug application). exclusion criteria: * particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia. * current diagnosis of raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, sjögren's syndrome, or depression. * previous refractive eye surgery such as photorefractive keratectomy (prk), laser-assisted sub-epithelial keratectomy (lasek), or laser-assisted in situ keratomileusis (lasik). * current treatment with monoamine oxidase (mao) inhibitors. * current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists. * less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.

Keywords: rosacea
a study of the efficacy and safety of desloratadine (mk-4117) in japanese participants with perennial allergic rhinitis (mk-4117-200)

Conditions: Perennial Allergic Rhinitis

Summary: this is a study to evaluate the efficacy and safety of desloratadine (mk-4117) in japanese participants with perennial allergic rhinitis. the primary hypothesis is that desloratadine is superior to placebo after 2 weeks of treatment with regard to change from baseline in total nasal symptom score among japanese participants with perennial allergic rhinitis.


Eligibility criteria:
inclusion criteria: * diagnosed with perennial allergic rhinitis * outpatient. exclusion criteria: * lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) * coexisting infections or systemic mycosis for which there are no effective antibiotics * asthma complication under treatment * nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed * vasomotor rhinitis or eosinophilic rhinitis * nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug * history of hypersensitivity to antihistamines or study drug * currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months * has started specific desensitization therapy or nonspecific allassotherapy (histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent * severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor * history of malignancy or clinically important hematological disorder * history of severe drug allergy (e.g., anaphylactoid reaction).

Keywords: rhinitis allergic rhinitis nose diseases respiratory tract diseases immune system diseases cholinergic antagonists cholinergic agents neurotransmitter agents histamine h1 antagonists, non-sedating histamine h1 antagonists histamine antagonists histamine agents
effect on vascular calcification of replacing warfarin by rivaroxaban with or without vitk2 in hemodialysis patients

Conditions: Vascular Calcification

Summary: this study examines patients on chronic hemodialysis with non-valvular atrial fibrillation, who have a cha2ds2-vasc score of ≥ 2 and therefore are candidates for or already receive a vitamin k antagonist. the first question is whether replacement of the vitamin k antagonist by rivaroxaban is able to slow progression of vascular calcification. the second question is whether addition of vitamin k2 to rivaroxaban can further slow down or even halt the progression of vascular calcification.

the present study targets dialysis patients with non-valvular atrial fibrillation requiring treatment with vitamin k antagonists. it addresses the question whether replacement of the vitamin k antagonist by rivaroxaban is able to slow progression of vascular calcification (vc). the second research question is whether addition of vitamin k2 to rivaroxaban can further beneficially affect the progression of vc. two non-invasive methods are used to evaluate the impact of interventions on the progression of vc: i.e. coronary artery calcification (cac) and pulse wave velocity (pwv) measurements. the detection of cac is predictive for the presence of obstructive coronary artery disease and future coronary events. vc and stiffening of the central elastic-type arteries are independent predictors of cardiovascular morbidity and mortality in hemodialysis patients.

Eligibility criteria:
inclusion criteria: * end stage renal failure treated with chronic hemodialysis * atrial fibrillation * cha2ds2-vasc score ≥ 2 * ability to provide informed consent exclusion criteria: * known intestinal malabsorption or inability to take oral medication * inability to stop co-medication that causes major interactions with rivaroxaban (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, rifampicin, phenytoin, carbamazepine, phenobarbital or st john's wort) * investigator's assessment that the subject's life expectancy is less than 1 year * prosthetic mechanical heart valve * contraindication for anticoagulation * liver dysfunction child-pugh grade b-c * pregnancy, breastfeeding, inadequate contraception * incompliance with medication and scheduled investigations

Keywords: vascular calcification hemodialysis rivaroxaban vitamin k2
dosimetric limitation of pelvic bone and peritoneal space in rectal cancer patients during chemoradiotherapy

Conditions: Rectal Cancer

Summary: this project first retrospectively analyzes the intestinal dose indicators related to the concurrent radiotherapy and chemotherapy of rectal cancer and gastrointestinal toxicity, and the pelvic dose indicators related to hematological toxicity, and then prospectively conducts radiotherapy based on the dose indicators most closely related to toxicity. the dose is limited when the plan is made to reduce the gastrointestinal and hematological toxicity of rectal cancer with concurrent radiotherapy and chemotherapy.


Eligibility criteria:
inclusion criteria: 1. patients with rectal adenocarcinoma 2. clinical staged t3/4 or any node-positive disease 3. age of 18-75 years 4. karnofsky performance status \> 80 5. adequate bone marrow reserve, renal and hepatic functions 6. without previous antitumoural chemotherapy 7. no evidence of metastatic disease 8. written informed consent before randomization 9. ugt1a1's genotype of 6/6 or 6/7 exclusion criteria: 1. clinical staged i or iv 2. age of \ 75 years 3. karnofsky performance status \< 80 4. previous pelvis radiotherapy 5. previous antitumoural chemotherapy 6. clinically significant internal disease 7. refuse to write informed consent before randomization 8. ugt1a1's genotype of 7/7
guided self-help for families with an overweight child

Conditions: Obesity

Summary: the purpose of this study is to evaluate whether a home based program can teach parents and moderately overweight kids who are of 8-12 years old with a bmi% between 85-97%, how to manage their child's weight. the study uses manuals and involves a short visit to the clinic every other week.

an estimated 4-5 million children between the ages of 6-17 in the united states are obese. children who are obese are at an increased risk for many negative health consequences in childhood and in adulthood. in addition, these children are at an increased risk for psychosocial consequences in childhood and adolescence, including poor self-esteem, teasing, verbal abuse and social isolation. guided self-help offers an opportunity to provide empirically based programs to a larger amount of the target population. once such treatment methods are available, it is possible that the guided self-help treatment for childhood obesity can be disseminated to primary care practitioners, psychologists, nurses, and health educators. ultimately, the goal of this application is to develop a treatment protocol that can be used by clinics and lay health professionals to intervene with children who are overweight and their parents.

Eligibility criteria:
inclusion criteria: * child between the ages of 8 \& 12 * an moderately overweight child with a bmi% between 85-97% * child has a parent willing to participate * child has a parent who can read english at a minimum of a 6th grade level * family who is willing to commit to treatment attendance and attendance at all assessments. exclusion criteria: * child psychiatric disorder diagnoses (based on parent report) * child diagnoses of a serious current physical disease (such as diabetes) * child who is taking medications that may impact their weight * child with physical difficulties that limit the ability to exercise * child with an active eating disorder * child and parent will be moving out of the san diego county before study completion * child and/or parent has a modified diet due to religious or socially conscious reasons (such as vegan, vegetarian)

Keywords: obesity guided self help treatment treatment method overweight overweight children and parents families with overweight child efficacy body mass index weight
exploratory study of breast cancer with aby025

Conditions: Breast Cancer

Summary: the aim is to study if breast cancer metastases accumulate the newly developed her2 binding molecule 111-in-aby025 and if that shows whether the metastases express her2.


Eligibility criteria:
inclusion criteria: * female age \>20 years * one or more known metastases localizations exclusion criteria: * other critical disease than breast cancer * age ≤ 20 years

Keywords: breast cancer diagnostics her2 imaging metastases spect imaging of metastases
correlation study between the classification of arthrogenic motor inhibition (ami) and clinical assessment after acl rupture

Conditions: ACL - Anterior Cruciate Ligament Rupture

Summary: the goal of this interventional study is to measure medial vastus inhibition and associate it with ami classification in patients with acl rupture. the main question it aims to answer is: is there a correlation between ami classification and clinical assessment after acl rupture ? participants will undergo surface emg and myotonometry.


Eligibility criteria:
inclusion criteria: * patient, male or female, aged ≥ 18 years and \< 45 years * patient with an acl rupture confirmed by mri * patient with an acl rupture ≤ 30 days old * french speaking patient who does not object to the use of his/her data exclusion criteria: * patient with previous ipsi or contralateral knee injury/surgery * patient with multi-ligament injury * pregnant or breastfeeding woman
pilot study of vitamin d screening use in peripheral arterial disease patient over maximum distance walking

Conditions: Peripheral Arterial Disease

Summary: the prevalence of peripheral arterial disease (pad) is greater than 15%. pad is associated with an increased risk of cardiovascular death, coronary heart disease and stroke, with a mortality rate of 5% per year. most clinical evidence supports the idea that having normal vitamin d reduces cardiovascular risk. the data suggests that normalizing vitamin d levels would have a significant impact on public health, reduce costs and help control the incidence and prevalence of cardiovascular disease. there is also a plausible physiological theory, supported by numerous observational studies, that vitamin d supplementation should be effective in improving cardiovascular outcomes, such as blood pressure, arterial stiffness, atherosclerosis, endothelial function, and clinical events. the investigators hypothesize that routine screening for vitamin d deficiency and supplementation in case of hypovitaminosis d is effective for improving the maximum walking distance after 12 weeks of treatment in stage 2 pad patients .

at admission eligible patients are proposed to participate. written consent is signed after complete oral and written explanation of the protocol is signed. vitamin d level will be assessed : patients without vitamin d deficiency will be excluded. the influence of vitamin d supplementation on the evolution of walking distance in 12 weeks will be studied by comparing the spontaneous evolution of this walking distance, in not supplemented patients (period 1 ), and the evolution under treatment with vitamin d (period 2, afer 3 months ). the spontaneous evolution of the walking distance will be evaluated by the difference in walking distance observed between the beginning and the end of the first period (3 months) . the evolution of walking distance under vitamin d treatment will be evaluated by the difference in walking distance between between the beginning and the end of the second period (3 months). the duration of participation for a subject is equal to 6 months (2 periods of 3 months )

Eligibility criteria:
inclusion criteria: * patients presenting a peripheral arterial disease (stage 2) * affiliation to the french national healthcare system * french speaking patients exclusion criteria: * pregnancy * inability to understand the study goal * patients protected by decision of law

Keywords: peripheral artery disease vitamin d