Kornimate/medical-research-clean huggingface dataset:
intralesional injection of methotrexate versus triamcinolone acetonid in treatment of localized psoriasis

Conditions: Localized Psoriasis

Summary: the aim of the present study is to evaluate the efficacy of intralesional injection of methotrexate in comparison with intralesional injection of triamcinolone acetonid in localized psoriasis (body surface area \< 10%) .

study enrolling 30 patients of localized psoriasis. 15 patients received intralesional methotrexate : * taking aseptic condition ,one psoriatic plaque will treated with intralesional injection of methotrexate (25mg /ml) at dosage of 0.1 ml /cm2. * another plaque will treated with intralesional ingection of distilled water as controlled plaque. * patient will receive oral folic acid 5mg tablet every day except the day of injection. other 15 patients received intralesional trimethinolone acetonide: * taking aseptic condition , one plaque will treated with intralesional injection of trimethinolone acetonide (10mg/ml) at dosage of 0.1 ml/ cm2 . * another plaque will treated with intralesional injection of distilled water as controed plaque. * patients will take 6 sessions every 2 weeks for 3 months and will followed up at 2 month and 3 months after treatment .

Eligibility criteria:
inclusion criteria: * patients with localized psoriasis (body surface area\<10%) exclusion criteria: * patient refusal. generalized psoriasis. pregnancy. lactation. immunocompromised patients . patients with history of hypersensitivity to methotrexate. patients with other inflammatory skin disorders. patients with chronic hepatic, renal , pulmonary ,or haematological disorders. patients on treatment for psoriasis .

Keywords: intralesional injection ,methotrexate, localized psoriasis
a trial of shr6508 in secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism

Summary: the study is being conducted to evaluate the tolerability, pharmacokinetics and pharmacodynamics of shr6508 for chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. diagnosed with end stage renal disease receiving stable hemodialysis 3. male or female 4. meet the body mass index standard 5. conform to the asa physical status classification 6. stably use of concomitant medication of other therapies of shpt 7. meet the standard of ipth level, cca and hb exclusion criteria: 1. subjects with a history of malignant tumor 2. subjects with neuropsychiatric diseases 3. subjects with a history of cardiovascular diseases 4. subjects with gastrointestinal diseases 5. subjects with a history of surgery 6. subjects with a history of blood loss 7. subjects with a history of parathyroidectomy or planned during the study 8. subjects with a history of kidney transplant or planned during the study 9. abnormal blood pressure, serum magnesium, serum transaminase, serum albumin, platelet counts. 10. subjects with a treatment history of similar drugs 11. allergic to a drug ingredient or component 12. pregnant or nursing women 13. no birth control during the specified period of time 14. subject with a history of alcohol abuse and drug abuse 15. participated in clinical trials of other drugs (received experimental drugs) 16. the investigators determined that other conditions were inappropriate for participation in this clinical trial
cardiac magnetic resonance imaging and pulmonary perfusion

Conditions: Pulmonary Hypertension

Summary: pulmonary hypertension is a rare severe disease leading to cardiac insufficiency. treatment depends on the severity of the disease. this study evaluates cardiac mri for the assessment of pulmonary hypertension severity and identification of parameters useful for the follow-up in order to adapt the medical treatment to status of the patient. evaluate if cardiac mri can obviate right cardiac catheterization in the follow-up.

thirty patients will be enrolled and followed for 1 year after their inclusion. cardiac mri will be performed at inclusion and at 3 months and 12 months. at the same periods, echocardiography and right heart catheterization will be performed too. morphological and functional parameters will be studied with mri and correlated to invasive parameters and echocardiography too. morphological parameters are: volumes, cardiac cavities areas and ratios and position of the interventricular septum. functional parameters are: ejection fractions of right and left cavities, flow in pulmonary artery, across mitral and tricuspid valves, temporal measurements in the pulmonary artery and auriculoventricular valves. the invasive measurements are considered as the gold standard for this study. the classification of the severity is defined according to the parameters from right cardiac catheterization (4 grades with severity increasing between 1 and 4).

Eligibility criteria:
inclusion criteria: * adults patients with pulmonary hypertension without specific treatment at inclusion * etiologies include chronic embolic disease, systemic fibrosis, gougerot sjogren, drug induced hypertension, primary hypertension. * informed consent * affiliated to medical insurance. exclusion criteria: * left cardiac disease responsible for pulmonary hypertension, congenital cardiopathies * pulmonary functional tests with important impairment (decrease in tpcmore than 30%, decrease in vems more than 30% * child * pregnancy * contraindications to mri * without informed consent * without insurance

Keywords: pulmonary arterial hypertension cardiac mri (magnetic resonance imaging) severity prognosis
efficacy and safety study in the prevention of antibiotic-associated diarrhea (aad) and clostridium difficile-associated diarrhea (cdad) in hospitalized adult patients exposed to nosocomial infection

Conditions: Antibiotic-Associated Diarrhea; Clostridium Difficile-Associated Diarrhea

Summary: the purpose of this study is to evaluate the efficacy and safety of bio-k+ cl-1285 in the prevention of antibiotic-associated diarrhea (aad) and clostridum difficile-associated diarrhea (cdad) in hospitalized patients exposed to nosocomial infection.


Eligibility criteria:
inclusion criteria: * antibiotic therapy for a minimum of 3 days and a maximum of 14 days * expected to remain hospitalized for a minimum of 5 days * patients who have received less than 36 hours of antibiotic therapy * negative pregnancy test at screening * obtained his/her informed consent after verbal and written information * patients having a telephone available (mobile, work, home) * patients having a fridge at home exclusion criteria: * pregnant or breastfeeding women * patients presenting with active diarrhea (3 or more liquid stools per 24 hour period). * patients with a history of daily consumption of probiotics, fermented milk and/or yogurt; * patients known to have shown a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. non-medicinal ingredients: cellulose, hypromellose, magnesium stearate (vegetal source), ascorbic acid, colloidal silicon dioxide) * patients presenting with an active, non-controlled intestinal disease such as crohn's disease or ulcerative colitis; * a previous documented c. difficile infection \< 3 months prior to study initiation ; * ostomized patients, parenteral nutrition users * patients with an immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, acquired immune deficiency syndrome (aids)) * ongoing or recent use of antibiotic therapy in the 30 days prior to the study product first administration. * patients with planned administration of antibiotics other than broad spectrum penicillin, cephalosporin or clindamycin for the treatment of an infection; * patients with concomitant participation in another clinical trial; * patients who are not likely to comply with study requirements

Keywords: probiotic antibiotic-associated diarrhea (aad) prevention clostridium difficile-associated diarrhea (cdad)prevention
cidofovir in treating patients with stage ib, stage ii, stage iii, or stage iva cervical cancer who are receiving chemotherapy and radiation therapy

Conditions: Cervical Cancer; Precancerous Condition

Summary: rationale: drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. radiation therapy uses high-energy x-rays to kill tumor cells. drugs such as cidofovir may make tumor cells more sensitive to radiation therapy. giving cidofovir together with radiation therapy and chemotherapy may kill more tumor cells. purpose: this phase i trial is studying the side effects and best dose of cidofovir in treating patients with stage ib, stage ii, stage iii, or stage iva cervical cancer who are receiving chemotherapy together with radiation therapy.

objectives: primary * determine the maximum tolerated dose of cidofovir when given as a radiosensitizer in patients with stage ib-iva cervical cancer undergoing concurrent chemoradiotherapy. secondary * evaluate the influence of treatment on the expression of mrna codons in hpv oncoproteins e6 and e7. * determine the rate of local control. outline: this is a dose-escalation study of cidofovir. patients receive cidofovir iv weekly for 2 weeks prior to beginning radiotherapy and then once biweekly during radiotherapy. patients undergo external pelvic radiotherapy for 5 weeks. beginning ≤ 2 weeks later, patients undergo utero-vaginal brachytherapy. some patients may also undergo a second course of external radiotherapy to the parametrium and/or lymph nodes ≤ 3 days after brachytherapy. patients also receive concurrent carboplatin iv once weekly during external radiotherapy and brachytherapy. biological expression of hpv oncoproteins e6 and e7 is analyzed during treatment.

Eligibility criteria:
disease characteristics: * diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix * stage ib2 (\> 4 cm), ii, iii, or iva disease * no lumbo-aortic metastasis * initial tumor must be hpv-positive patient characteristics: * who performance status 0-1 * life expectancy \> 3 months * anc \> 2,000/mm\^3 * platelet count \> 100,000/mm\^3 * hemoglobin ≥ 9 g/dl * transaminases \< 1.5 times upper limit of normal (uln) * alkaline phosphatase \< 1.5 times uln * bilirubin \< 1.5 times uln * creatinine \< 1.5 times uln * creatinine clearance ≥ 55 ml/min * proteinuria \< 2 g/l * not pregnant * negative pregnancy test * no renal disease * no concurrent active infection * no prior or concurrent psychiatric illness * no history of cancer except for basal cell carcinoma * no other active infection or serious illness that would prevent the patient from receiving study treatment * no known psychological, familial, social, or geographic reason that would preclude clinical monitoring prior concurrent therapy: * no prior radiotherapy or chemotherapy * more than 30 days since prior experimental drugs

Keywords: human papilloma virus infection cervical squamous cell carcinoma cervical adenocarcinoma stage ib cervical cancer stage ii cervical cancer stage iii cervical cancer stage iva cervical cancer
mothers in motion program to prevent weight gain in wic mothers (mim)

Conditions: Overweight; Obesity

Summary: mothers in motion will draw on the successes of the pilot intervention of the same name and will promote healthy lifestyle behavior changes (eating more fruits and vegetables, increasing physical activity, dealing with stress) in low-income wic mothers of young children. the intervention group's weight change (difference between the initial enrollment and 3 months post intervention) will differ from the control group's weight change by an average of at least 2.8 pounds.

mothers in motion will draw on the successes of the pilot intervention of the same name and will promote healthy lifestyle behavior changes (eating more fruits and vegetables, increasing physical activity, dealing with stress) in low-income wic mothers of young children. both treatment groups will receive usual wic care (nutrition counseling and similar services). the control group will receive generic printed health and nutrition materials to read at their own pace if they wish. the intervention group will watch the culturally sensitive dvd chapters according to a study calendar, complete action plan worksheets, and call in to peer support group teleconferences to discuss the dvd chapter contents. the teleconferences will be led by moderators trained in motivational interviewing (mi) and group facilitation. participants will complete phone interviews and provide body weight measurements at baseline (t1), immediately after (t2) and 3 months after (t3) the intervention time period. t3 body weight will be the primary outcome.

Eligibility criteria:
inclusion criteria: * african american or white * fluent in english * 18-39 years old * at least 6 weeks postpartum * body mass index (bmi) between 25.0 and 39.9 * willing to provide address and up to 3 working phone numbers * willing to update their contact information monthly * willing to participate in the project for 9 months * willing to make 3 additional trips to wic clinics for weight measures * working dvd player at home and access to a working phone. exclusion criteria: * pregnant * mim pilot study participation * plan to become pregnant or relocate to a location outside of study area during the trial * self-reported type 1 or 2 diabetes * unable to walk more than 1 block without resting or shortness of breath.

Keywords: intervention
suitability of dce-mri for detection of vascular changes after vbt

Conditions: Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus

Summary: this is a pilot study of dce mr imaging to detect vascular changes in the vagina during and after radiotherapy n patients receiving adjuvant brachytherapyfor cervical or endometrial cancer.


Eligibility criteria:
inclusion criteria: * must be 18 years of age. * must have histologically confirmed carcinoma of the cervix, carcinoma or carcinosarcoma of the uterus. * subjects are receiving intracavitary brachytherapy. * ecog performance status of 0-2. * creatinine clearance 30. exclusion criteria: * subjects with an inability to tolerate mr imaging (i.e. claustrphobia) * study subjects who have contraindication to mri scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants. * patients who do not speak or read english.
efficacy and safety of hs-10374 compared to placebo in adults with active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this study has been designed to explore the clinical efficacy and safety of hs-10374 in the treatment of active psoriatic arthritis. additionally, this study is to find the optimal dosing for the future clinical development of hs-10374.


Eligibility criteria:
inclusion criteria: 1. male or female subjects between the ages of 18-75 years. 2. has a history of psoriatic arthritis (psa) for at least 6 months, and meets the classification criteria for psoriatic arthritis (caspar) at screening. 3. active arthritis as shown ≥ 3 swollen joints (66 joints) and ≥ 3 tender joints (68 joints) at both screening and baseline. 4. active plague psoriatic skin lesion or documented history of plague psoriatic at screening. 5. hs-crp ≥ 3mg/l at screening. 6. subjects either (i) do not have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 tnf-inhibitor (tnfi-experienced). exclusion criteria: 1. non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis), with the exception of nail psoriasis, which is allowed. 2. other autoimmune or autoinflammatory condition ( ie, rheumatoid arthritis, systemic lupus erythematous, gout), with the exception of inflammatory bowel disease and/or autoimmune uveitis being inactive at least 12 months before the screening, as assessed by the investigator. 3. active fibromyalgia syndrome 4. recent history of active infection, chronic infection history or risk of serious infection.

Keywords: psoriatic arthritis
intradermal tozinameran for patients with immune-mediated dermatologic diseases

Conditions: Bullous Dermatoses; Psoriasis; COVID-19 Vaccines

Summary: this is a randomised controlled trial conducted to prove that the immunological performance of intradermal tozinameran (i.e., pfizer-biontech covid-19 vaccine) is no worse than the standard intramuscular route in patients with immune-mediated dermatologic diseases. the side effects profile and disease activity post-vaccination will also be assessed.

the standard intramuscular tozinameran is widely used as a covid-19 vaccine booster dose, although the fractionated-dose intradermal route of the vaccine has emerged as a dose-sparing and cost-effective alternative. however, before implementing the intradermal vaccine in patients with immune-mediated dermatologic diseases, its immunogenicity should be confirmed, as many of them use long-term immunosuppressive medications, which may alter their immune responses to the vaccine. this prospective open-labelled single-blinded randomised-controlled parallel-grouped non-inferiority trial aims to determine non-inferiority in the immunogenicity of fractionated-dose intradermal tozinameran in comparison with the standard intramuscular tozinameran as the fourth covid-19 vaccine dose in patients with immune-mediated dermatologic diseases and compare vaccine-related adverse effects between the two.

Eligibility criteria:
inclusion criteria: 1. aged equal to or more than 18 years 2. diagnosed with psoriasis or autoimmune bullous diseases 3. completed two-doses of the primary vaccine series and the third booster dose lasted for more than three months 4. agree to receive the fourth covid-19 vaccine dose as tozinameran exclusion criteria: 1. history of previous covid-19 infection 2. positive result of covid-19 rapid antigen test (tested upon recruitment prior to vaccination) 3. uncontrolled disease activity 4. non-dermatologic immune-mediated diseases 5. congenital or acquired immunodeficiency syndrome 6. cancer 7. pregnant women 8. allergy to components of tozinameran 9. inability to give written informed consent to participate in the study

Keywords: covid-19 vaccine immunogenicity autoimmune bullous diseases psoriasis
arterial hypertension in men in the warmia and masuria region

Conditions: Arterial Hypertension

Summary: the primary aim of the study is to define the prevalence of arterial hypertension and risk factors of its development in an unselected group of polish men from the region of warmia and mazury, considered as one of the most unprivileged in terms of social and employment status in poland. polish men life expectancy at birth is 74 years and is lower as polish women life expectancy at birth by 8 years. the difference in western europe is 5 years. prom aims to investigate the prevalence of arterial hypertension as well as to increase the interest in its prevention and treatment in men from the region.

increased arterial blood pressure (ht) in chronic conditions is a major risk factor of cardiovascular morbidity and premature mortality. ht is diagnosed in 30-45% of global adult population and this number is still growing. the primary aim of the study is to define the prevalence of arterial hypertension and risk factors of its development in an unselected group of polish men from the region of warmia and mazury, considered as one of the most unprivileged in terms of social and employment status in poland. polish men life expectancy at birth is 74 years and is lower as polish women life expectancy at birth by 8 years. the difference in western europe is 5 years (79 male vs. 84 female) (https://www.statista.com/statistics/274514/life-expectancy-in-europe/). the study protocol is approved by the ethics committee of the regional medical chamber of warmia and mazury in poland. the study are conducted according to the good clinical practice guidelines. each participant signs an informed consent and be coded with unique id. as a pivotal part of the prom project, arterial blood pressure have to be measured in agreement with the esh/esc guidelines in randomly selected male subjects. participants will complete coded and standardized questionnaire and received a referral for free blood and urine tests. in serum will be tested: glucose, creatinine and lipid profile; microalbuminuria and creatinine were measured in urine, urinary albumin-to-creatinine ratio (uacr) will be calculated. estimated glomerular filtration rate (egfr) will be calculated according to the mdrd formula. 1-2 ml of serum will be frozen at -80c degree. results of analyses will be saved by indexing with id code only, personal data with individual ids will be saved in additional file. all hard copy will be archived in secure room with coded electronic key. the investigators plan to repeat the measurements in 5 years in follow-up study. prom aims to investigate the prevalence of arterial hypertension as well as to increase the interest in its prevention and treatment in men from the region.

Eligibility criteria:
inclusion criteria: * male exclusion criteria: * female

Keywords: arterial hypertension male health warmia-masuria region
study to assess efficacy and safety of pt009 compared to pt005, pt008, and symbicort® turbuhaler® on lung function over 24-weeks in subjects with moderate to very severe copd

Conditions: Chronic Obstructive Pulmonary Disorder

Summary: this is a phase iii randomized, double-blind, parallel group, multi-center, 24-week lung function study with bff mdi (320/9.6 μg and 160/9.6 μg) compared to ff mdi 9.6 μg, bd mdi 320 μg, and open-label symbicort® tbh (200/6 μg) administered bid.

this is a phase iii randomized, double-blind, parallel group, multi-center, 24-week lung function study with bff mdi (320/9.6 μg and 160/9.6 μg) compared to ff mdi 9.6 μg, bd mdi 320 μg, and open-label symbicort® tbh (200/6 μg) administered bid. subjects will undergo a 1- to 4-week screening period. subjects who successfully complete the screening period will be to one of the following five treatment groups:bff mdi 320/9.6 μg bid (n=660), bff mdi 160/9.6 μg bid, ff mdi 9.6 μg bid, bd mdi 320 μg bid, symbicort®, tbh 400/12 μg bid. following randomization, subjects will enter the treatment period and undergo additional treatment visits over 24 weeks.

Eligibility criteria:
inclusion criteria: 1. give their signed written informed consent to participate 2. are at least 40 years of age and no older than 80 years 3. copd patients who are symptomatic 4. must be receiving one or more inhaled bronchodilators as maintenance therapy exclusion criteria: 1. current diagnosis of asthma, 2. copd due to α1-antitrypsin deficiency 3. known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, pulmonary resection or lung volume reduction surgery during the past 6 months 4. long-term-oxygen therapy (≥ 12 hours a day).

Keywords: copd