Kornimate/medical-research-clean huggingface dataset:
comparison of otezla to sfa-002 to placebo in plaque psoriasis patients

Conditions: Psoriasis (PsO)

Summary: the goal of this clinical trial\] is to learn if sfa002 can treat mild, moderate and severe plaque psoriasis as good or better than otezla, compared to placebo in adult and pediatric patients. the main questions it aims to answer are: how much does oral sfa002 treatment improve plaque psoriasis measured at different timepoints, 12 weeks, 24 weeks and 52 weeks of treatment. how much does oral otezla (apremilast) improve plaque psoriasis measured at different timepoints, 12 weeks, 24 weeks and 52 weeks of treatment. these treatments will be compared to placebo, a look-alike substance that contains no drug. participants will be randomly placed into 3 groups to receive either sfa002, or oral apremilast or placebo for the duration of the trial. patients that do not respond to apremilast or placebo treatment in 12 weeks will be offered the opportunity to take sfa002 for the remainder of the study. there may be a higher burden for participants in this study compared to usual standard of care. participants will attend regular visits per routine clinical practice. the effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.


Eligibility criteria:
inclusion criteria:- 1. candidates for systemic therapy with mild to moderate chronic plaque psoriasis (pso) (with or without psoriatic arthritis) at screening and baseline for at least 6 months prior to baseline defined as: 2. body surface area (bsa) \>= 10% and \ = 12; and static physician global assessment (spga) = 3 (moderate) based on a 5-point scale (0 to 4) - exclusion criteria: 1. participant has any form of pso other than chronic plaque pso (e.g., pustular pso, palmoplantar pustulosis, acrodermatitis of hallopeau, erythrodermic, or guttate pso). 2. history of current drug-induced pso or a drug-induced exacerbation of pre-existing psoriasis. 3. history of active ongoing inflammatory skin diseases other than pso and psoriatic arthritis that could interfere with the assessment of pso (e.g., hyperkeratotic eczema). 4. prior exposure to sfa002 or apremilast. -

Keywords: otezla apremilast mild psoriasis
a study of the effect of polyphenon e (green tea extract) on breast cancer progression

Conditions: Breast Cancer

Summary: to see if an extract of green tea can affect certain markers of breast cancer and breast cancer progression in women with a recent biopsy positive for cancer and who are scheduled for surgery.

to evaluate the short-term effects of a daily dose of polyphenon e administered during the interval between breast biopsy and surgery in women with recently diagnosed breast cancer. endpoints will be changes in serum and tissue biomarkers related to progression of cancer. the effect of polyphenon e on tumor cell c-met expression and phosphorylation is the primary objective. secondary objectives include the effects on the other tissue and serum biomarkers. evaluation of the safety and tolerability of polyphenon e in this subject population is another objective. 1.1 determine the effects of polyphenon e on tumor cell c-met expression and phosphorylation levels in patients with breast cancer 1.2 determine the effects of polyphenon e on pi-3k activation in patients with breast cancer 1.3 determine the effects of polyphenon e on mapk activation in patients with breast cancer 1.4 determine the effects of polyphenon e on expression levels of other proteins involved in motility and invasion such as rho gtpases and extracellular proteinases in patients with breast cancer 1.5 determine the effects of polyphenon e on markers of angiogenesis in patients with breast cancer 1.6 determine the effects of polyphenon e on other serum markers: c-reactive protein (crp), insulin-like growth factor i (igf-i), insulin-like growth factor binding protein 3 (igfbp-3) and hepatocyte growth factor hgf 1.7 evaluate the safety and tolerability of polyphenon e in this subject population

Eligibility criteria:
inclusion criteria: * definitive biopsy demonstrating primary breast cancer * residual breast cancer requiring additional surgical resection * stage i, ii or iii disease * patient has ability to give signed informed consent * normal hepatic and renal function (creatinine\<1.5, transaminases \<1.5 times upper limit of normal). * ecog performance status of 0 or 1. * age ≥ 21 years and less than 75 exclusion criteria: * prior hormonal or surgical therapy for breast cancer * abnormal liver function test * liver or kidney problems that would interfere with metabolism of study drug * any condition that would hamper informed consent or ability to comply with study protocol * participation in another research study in the last three months * known malignancy at any site other than breast * recent consumption of green tea (5 or more cups per day, within one week prior to biopsy) * allergy or intolerance to any component of green tea * inability or refusal to comply with definitive surgical therapy

Keywords: breast cancer egcg polyphenon e c-met vegf hgf
effect of 25-hydroxyvitamin d and a structured exercise program on dialysis patients

Conditions: End Stage Kidney Disease

Summary: this study aims to examine the effect of 25 hydroxyvitamin d supplementation and a structured exercise program on the exercise capacity and quality of life of haemodialysis patients with 25 hydroxyvitamin d insufficiency.


Eligibility criteria:
inclusion criteria: 1. stable on dialysis for at least 3 months 2. able to obtain informed consent 3. medically stable 4. dialysis adequacy at target for small solute clearance (ie kt/v\>1.2 or urea reduction ratio\>65%) 5. serum 25-hydroxyvitamin d levels less than 75nmol/l at baseline exclusion criteria: 1. limb amputation 2. impaired cognition 3. impaired vision 4. haemoglobin concentration \< 110g/l 5. change in erythropoiesis stimulating agent dose over the last 2 months 6. unable or unwilling to comply with exercise program

Keywords: chronic kidney failure 25 hydroxyvitamin d falls exercise quadriceps strength
safety and efficacy study of ravulizumab in adults with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: the primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gmg).


Eligibility criteria:
inclusion criteria: 1. diagnosed with myasthenia gravis at least 6 months (180 days) prior to the date of the screening visit as confirmed by specific criteria. 2. myasthenia gravis foundation of america clinical classification class ii to iv at screening. 3. mg-adl profile must be ≥ 6 at screening and randomization (day 1). 4. vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (n meningitidis). exclusion criteria: medical conditions 1. any active or untreated thymoma. history of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening. 2. history of thymectomy within the 12 months prior to screening. 3. history of n meningitidis infection. 4. use of the following within the time period specified below: * iv immunoglobulin within 4 weeks of randomization * use of plasma exchange within 4 weeks of randomization * use of rituximab within 6 months of screening 5. participants who have received previous treatment with complement inhibitors (for example, eculizumab).
treatment of aggressive behavior and post-traumatic stress disorder

Conditions: Aggressive Behavior; Post-Traumatic Stress Disorder

Summary: street children and children of vulnerable families in conflict or former conflict regions are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. the narrative exposure therapy for violent offenders (netvo) aims to reduce both ptsd symptoms and aggressive behavior. it helps the children to anchor fearful experiences and positive emotions linked to violent behaviour in the past. additionally, visions for the future are developed in order to foster successful reintegration into society.


Eligibility criteria:
inclusion criteria: * positive emotions concerning aggressive behavior derived from expert interviews with higher scores of the appetitive aggression scale (aas) * children are part of an aid program for reintegration into society exclusion criteria: * current substance dependance or use of antipsychotic drugs * chronically ill children

Keywords: aggressive behavior appetitive aggression post-traumatic stress disorder
a clinical trial of an inactivated quadrivalent influenza vaccine in chinese children aged 3 to 8 years

Conditions: Influenza

Summary: routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. for those aged 6 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. for those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in china. the study is a prospective, open-labelcomparison of the immunogenicity and reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in subjects of 3-8 years old withdifferent history of influenza vaccination.

subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.blood samples were obtained from children at 3 time points-before receiptof dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeksafter dose 2. hemagglutination inhibition (hai) antibody titers to the a/h3n2,a/h1n1, and b antigens included in the vaccine were measured at each timepoint

Eligibility criteria:
inclusion criteria: * aged 3-8 years old * healthy subjects judged from medical history and clinical examination * subjects themselves or their guardians able to understand and sign theinformed consent * subjects themselves or their guardians can and will comply with therequirements of the protocol * subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (doses need not have been received duringsame or consecutive seasons); subjects have not received infuenzavaccine before enrollment * subjects with temperature \<=37.0°c on axillary setting exclusion criteria: * any prior administration of other research medicine/vaccine in last 30 days * any prior administration of influenza vaccine in last 6 month * any prior administration of immunodepressant or corticosteroids in last 3 months * any prior administration of blood products in last 3 months * any prior administration of any attenuated live vaccine in last 14 days * any prior administration of subunit or inactivated vaccines in last 7 days * subject who developed guillain-barre syndrome post influenza vaccination * subject who is allergic to any ingredient of the vaccine * subject with acute febrile illness or infectious disease * thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection * subject with damaged or low immune function which has already beenknown * subject with congenital heart disease or other birth defects unsuitable for vaccination. * subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections. * any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol

Keywords: safety immunogenicity quadrivalent influenza vaccine
are pediatric patients' dental anxiety levels affected by covid -19 clinical conditions?

Conditions: Anxiety, Dental

Summary: changes in the dental office environment during the pandemic may affect the children's dental anxiety. this double-blind, randomized, controlled clinical study aimed to assess children's dental anxiety focusing on changes in the dental office environment with the child drawing: hospital (cd: h) picture test.the results showed that most children exhibited positive or very positive behavior and were not significantly affected by changes in the dental environment or clinical attire. the evaluations from the psychiatrist and dentist using cd: h were highly consistent.

the study involved 120 children aged 5-7 years. all patients and their parents were informed about the purpose and method of the study before the study and signed informed consent forms. children's behaviors and attitudes before the dental exam were assessed using the frankl behavioral scale. the children were then divided into two groups:the pandemic clinical conditions (pcc) group, who were examined in an isolated dental office with special attire, and the conventional clinical conditions (ccc) group, who were examined in a standard dental office with typical clinical attire. after the exam, the children were asked to draw a picture, which was then evaluated by a pediatric dentist and child psychiatrist using cd: h. the results showed that most children exhibited positive or very positive behavior and were not significantly affected by changes in the dental environment or clinical attire. the evaluations from the psychiatrist and dentist using cd: h were highly consistent. in conclusion, the changes in the dental office and clinical attire during the pandemic did not significantly impact children's anxiety levels.

Eligibility criteria:
inclusion criteria: healthy children children between 5-7 years old no prior dentistry experience children willing to draw picture exclusion criteria: children who had mental or physical disabilities children \< 5 years old, previous dentist experience who refused to draw picture

Keywords: anxiety,child
allogeneic tumor cell vaccination in patients with solid tumors

Conditions: Metastatic Solid Tumors

Summary: the goal of this study is to apply allogeneic tumor cell vaccination for immunotherapy in patients with micro-metastatic disease and/or in patients at high risk disease progression. the present study will use allogeneic tumor cell lines for tumor cell vaccines that share mhc determinants with the patient aiming to overcome possible restriction of antigen presentation.


Eligibility criteria:
inclusion criteria: * patients with measurable metastatic disease or disease resistant to chemotherapy or with minimal residual disease at high risk to relapse. exclusion criteria: * karnofsky less than 60%. unrelated condition requiring the use of any cytotoxic agents or immunosuppressive agents which may interfere with optimal immune response.

Keywords: tumor cell vaccine
the situation of re-infection of helicobacter pylori after successful eradication

Conditions: Helicobacter Pylori

Summary: the patients who accept the quadruple eradication program of the helicobacter pylori and success to eradicate helicobacter pylori will be followed-up to observe the situation of re-infection of helicobacter pylori.

the patients with helicobacter pylori accepted he quadruple eradication program of the helicobacter pylori.they will be followed-up from 1 year to 5 years to observe the situation of re-infection of helicobacter pylori.the rate of the re-infection will be described by frequency and percentage.

Eligibility criteria:
inclusion criteria: * patients, aged between 18 and 70 years old, with positive h. pylori infection that was not eradicated by previous therapies are included. the h. pylori infection is confirmed by the positive rapid urease test or 13c-breath test. exclusion criteria: * patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of ppi, nsaid or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. patients previously treated with h. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Keywords: re-infection
levitra (vardenafil, bay38-9456) partner satisfaction study ii

Conditions: Sexual Dysfunction; Male Erectile Dysfunction

Summary: this trial is to provide additional important information on the impact of the treatment of the man its ed with vardenafil on partnership. this study is being run at up to 50 study centers in europe and south africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and their female partner's sexual quality of life. many men experience occasional erectile problems during their lives. however, when this becomes a continued problem, it can affect both the man and his female partner. the causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. this study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether treating a man its erectile dysfunction with vardenafil will improve his female partner its sexual quality of life. the second part (week 12) of the study (educational program) a subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an educational program concerning ed in the from of a dvd.


Eligibility criteria:
inclusion criteria: * males 18 to 64 years * males with ed for more than six months, according to the nih consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance) * stable heterosexual relationship for more than 6 months * the subject must make at least four attempts at sexual intercourse * documented, dated, written informed consent inclusion criteria partner * females 18 years, and older * stable, heterosexual relationship for more than 6 months with male ed subject * documented, dated, written informed consent * motivated to support treatment for male partner's ed * absence of significant sexual dysfunction as assessed by the total score on the fsfi16 \> 23.55 exclusion criteria: * any unstable medical condition or substance abuse disorder that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study * subjects who are taking nitrates or nitric oxide donors * subjects who are taking the following inhibitors of cytochrome p 450 cyp 3a4: very potent hiv protease inhibitors (ritonavir, indinavir), the anti-mycotic agents traconazole and ketoconazole (topical forms are allowed) or erythromycin * known hypersensitivity to vardenafil * presence of significant penile anatomical abnormalities (e.g. penile fibrosis or peyronie's disease) * history of retinitis pigmentosa * unstable angina pectoris * severe chronic or acute liver disease * premature ejaculator (defined as ielt \< 2 minutes) * subjects who were taking alpha blockers * lost of vision of one eye because of naion exclusion criteria partner * presence of sexual dysfunction as assessed by the fsfi16 \< 23.55 * any unstable medical condition or substance abuse disorder that, in the opinion of the investigator, is likely to affect the partner's ability to complete the study or precludes the partner's participation in the study
palmitoylethanolamide and polydatin in pediatric irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: this will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to study the efficacy and safety of co-micronised palmithoylethanolamide/polydatin in pediatric patients (\> 10 years) with irritable bowel syndrome (ibs)

the study will include a 2-week screening period, and a 12-week placebo-controlled treatment period . after the screening phase, eligible patients will be randomly assigned to either co-micronised form palmithoylethanolamide/polydatin 200 mg/20 mg, or the equivalent placebo (without the active treatment, replaced by equal amount of microcrystalline cellulose), three times a day, in a 1:1 ratio, for 12 weeks. study visits were conducted every 4 weeks during the treatment period. all the subjects will be blindly allocated by means of scratch cards to one of the two treatment groups according to a computer-generated randomisation list provided by our statistician. a validated program will be used by an independent statistician to generate a randomisation list with blocks, block size = 4, pre-allocated to centres. patients and study investigators will be blinded to the randomisation codes. the codes will be kept confidential until the end of the study when the randomisation code will be broken after the database lock. after the screening visit and at the end of treatment all subjects will undergo intestinal permeability test and fecal calprotectin assay. calprotectin assay will be performed using a commercially available enzyme-linked immunosorbent assay test (calprest eurospital, trieste, italy). according to the manufacturer, calprotectin levels exceeding 100 mg/kg were considered positive. intestinal permeability will be evaluated using a liquid chromatography/mass spectrometry method previously published . all subjects will undergo a formal clinical assessment and will be further phenotyped using validated questionnaires. number of bowel movements per day and/or week and bowel habit characteristics, will be assessed by the bristol stool scale. the protocol will be approved by an independent ethics committee and conducted according to the declaration of helsinki and the principles of good clinical practice. the trial will be registered in a public registry. the primary outcome will be the change in the abdominal pain symptoms (frequency and severity) according to validated score from baseline to the end of the treatment period. secondary outcome will be modifications of intestinal permeability and fecal caprotectine.

Eligibility criteria:
inclusion criteria: * positive diagnosis of all ibs subtypes, * negative fecal calprotectine * nagative anti-transglutaminasi antibodies exclusion criteria: * current use of nonsteroidal anti-infl ammatory drugs, corticosteroids and mast cell stabilisers * use of topical or systemic antibiotics in the last month, * continuous use of stimulant laxatives, * major abdominal surgery, inflammatory bowel disease, infectious diarrhoea, allergic diseases and other organic or psychiatric disorders.
long-term safety and tolerability of tri476 (oxcarbazepine) in children with inadequately controlled partial onset seizures

Conditions: Partial Onset Seizures

Summary: this study is designed to provide long term safety data of tri476 in children with inadequately-controlled partial seizures. this study is conducted in patients who complete the core study ctri476b1301. blinding is maintained during the transition and dose adjustment phase of the extension study. all patients are treated with tri476 from the dose adjustment phase onwards. the purpose of study is to confirm that tri476 as adjunctive therapy is safe.


Eligibility criteria:
inclusion criteria: * patients who completed the double-blind treatment phase of the core study (b1301). * a parent/legal guardian must be present and give written consent for all patients enrolled in this trial. patients consent must be obtained using assent document according to patients age. * females of childbearing potential must have a negative pregnancy test at week 8 in the core study b1301. exclusion criteria: * patients with medical ineligibility to enter the extension, as assessed by the investigator at each site. * patients who participated in the core study, but did not complete it (prematurely discontinued) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: seizures oxcarbazepine child