Kornimate/medical-research-clean huggingface dataset:
phase 2b study to evaluate the efficacy and safety of isb 830 in adults with moderate to severe atopic dermatitis

Conditions: Moderate to Severe Atopic Dermatitis

Summary: phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of isb 830 in adults with moderate to severe atopic dermatitis. the study will be conducted in 2 parts, with dosing groups 1-4 comprising part 1, and dosing groups 5-6 comprising part 2. all subjects will receive open-label isb 830 after a 16 week blinded treatment period.


Eligibility criteria:
inclusion criteria: * male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis for \>1 year as defined by american academy of dermatology consensus criteria. * atopic dermatitis involvement of ≥10% of body surface area at screening and baseline. * easi score of ≥12 at screening or ≥16 at baseline. * iga score of ≥3 at screening and baseline (on the 0 to 4 iga scale, in which 3 is moderate and 4 is severe) * baseline pruritus numerical rating scale (nrs) score for maximum itch intensity ≥3 over the previous 24 hours. exclusion criteria: * pregnant or lactating women. * prior treatment with isb 830 * treatment with biologics * systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy within 4 weeks of baseline * active chronic or acute infection requiring systemic treatment

Keywords: isb 830, ox40, atopic dermatitis
study to evaluate safety, pharmacokinetics and therapeutic activity of ro6874281 as a combination therapy in participants with unresectable advanced and/or metastatic renal cell carcinoma (rcc)

Conditions: Renal Cell Carcinoma

Summary: this is an open-label, multi-center, randomized, phase 1b, adaptive, clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic activity of ro6874281 in combination with atezolizumab with/without bevacizumab in participants with unresectable advanced and/or metastatic rcc. the study will consist of a dose-escalation part and an extension part.


Eligibility criteria:
inclusion criteria: * unresectable advanced and/or metastatic rcc with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic therapy, including treatment in the adjuvant setting * during dose escalation only, an additional population with unresectable advanced and/or metastatic 2nd line rcc patients is allowed * at least one tumor lesion with location accessible to biopsy per clinical judgment of the treating physician * consent to provide an archival tumor tissue sample (if available) and to undergo baseline and on treatment tumor biopsies for pharmacodynamic biomarker analysis * measurable disease, as defined by recist v1.1. at least one lesion accessible for biopsy * participants with unilateral pleural effusion are eligible if they fulfill both of the following: (a) new york heart association (nyha) class 1; (b) global initiative for obstructive lung disease (gold) test level 1 (forced expiratory volume in 1 second \[fev1\]/ forced vital capacity \[fvc\] less than \[\ =\] 80 percent \[%\] predicted after inhaled bronchodilator) adequate hematological function: neutrophil count of ≥1.5 ≥109 cells/l, platelet count of ≥100,000/≥l, hb ≥9 g/dl (5.6 mmol/l), lymphocytes ≥0.8 ≥109 cells/l. exclusion criteria: * symptomatic or untreated central nervous system (cns) metastases * participants with asymptomatic cns metastases with previous or concomitant brain deficiencies, as defined in the protocol * participants with confirmed bilateral pleural effusion * episode of significant cardiovascular/cerebrovascular acute disease within 6 months prior to cycle 1 day 1 * active or uncontrolled infections * human immunodeficiency virus (hiv) or active hepatitis a, b, c, d and e virus (hav, hbv, hcv, hdv and hev) infection. * major surgery or significant traumatic injury \<28 days prior to cycle 1 day 1 (excluding fine needle biopsies) or anticipation of the need for major surgery during study treatment * serious, non-healing wound; active ulcer; or untreated bone fracture * proteinuria as demonstrated by a urine protein to creatinine ratio (upcr) of \>=1.0 at screening * history of, active or suspicion of autoimmune disease * concurrent use of high dose of systemic steroids. the use of inhaled, topical and ophthalmic steroids is allowed.

Keywords: renal cell carcinoma ro6874281 atezolizumab bevacizumab
the efficiency of anterior repositioning splint for the management of temporomandibular joint dysunction

Conditions: Temporomandibular Joint Disc Displacement

Summary: intra-articular temporomandibular disorders are often related to pain in the area of temporomandibular joint, ear and temple. the aim of the study was to investigate the efficiency of anterior repositioning splints for the management of pain related to temporomandibular joint disc displacement with reduction.

the research material consisted of 112 patients, aged 24 to 45 years, of both genders, who reported to the treatment in consulting room of temporomandibular joint dysfunctions at the jagiellonian university in cracow, between 2014-2016, due to the pain and clicking of temporomandibular joints with comorbid hypertension of masticatory muscles. subjects were examined according to the diagnostic criteria for temporomandibular disorders protocol and after inclusion with painful disc displacement with reduction and masticatory muscle contracture assigned randomly to the study or control group (56 patients in each). in the study group was used the anterior repositioning splint on the lower arch for 20 hour usage per 4 months. in the control group a non-invasive therapy was applied using biostimulation laser in the form of 12 session, performed every second day, on the area of the temporomandibular joints with opened mouth and performing muscles self-exercises with a dominant protrusive position of the mandible. pain intensity was evaluated using verbal numerical rating scale (vnrs) immediately before the treatment and then after 4 and 16 weeks. the obtained data were analyzed using u mann-whitney test (p ≤ 0,005).

Eligibility criteria:
inclusion criteria: 1. unilateral or bilateral presence of clicking, popping and/or snapping noise(s) detected with palpation during opening or closing or lateral or protrusive movements in tmj(s), 2. in the previous 30 days, any tmj noise(s) present with jaw movement or function, 3. unilateral or bilateral pain in the area of temporomandibular joint, 4. presence of masticatory muscles contracture, 5. full dentition or single tooth loss, 6. good general health, 7. positive mandible protrusion test, 8. no contraindications for laser therapy 9. patient consent to be involved in the study. exclusion criteria: 1. partial tooth loss or edentulism, 2. contraindications for laser therapy 3. absence of appropriate symptoms 4. absence of consent to be involved in the study

Keywords: temporomandibular joint disorders disc displacement with reduction anterior repositioning splint
chemotherapy supported by autologous hematopoietic stem cells

Conditions: Ovarian Cancer

Summary: the aim of this project is to use autologous haematopoietic stem cell transfusion support to promote the reconstruction of haematopoietic function after chemotherapy for ovarian cancer. to explore the impact of stored haematopoietic stem cell support therapy on bone marrow protection after conventional chemotherapy for ovarian cancer in order to facilitate its clinical application.

study design:in this prospective, single-center,non-randomised controlled study, patients with ovarian cancer were divided into two groups. the patients in the experimental group received autologous blood transfusion containing hematopoietic stem cells 1 day after conventional chemotherapy, while the control group only received conventional chemotherapy. case selection: patients with primary ovarian cancer,ovarian cancer confirmed by histopathology, and three weeks of platinum-containing regimen chemotherapy. primary end point: 1)incidence and duration of grade 3/4 neutropenia in patients;2)hematopoietic reconstitution time in patients. secondary endpoints: 1)the rate of reduction in chemotherapy dose and postponement of the course for chemotherapy;2) incidence of febrile neutropenia (fn);3)safety of hematopoietic stem cell reinfusion therapy (adverse events). safety assessment: laboratory safety testing, including platelet count,white blood cell and hemoglobin. evaluation of adverse events: infection, neutropenic fever, hypocalcemia,anemia and thrombocytopenia,bone pain, etc.

Eligibility criteria:
inclusion criteria: 1）18-60 years old; 2)there are chemotherapy indicators for ovarian cancer;3)ovarian cancer diagnosed by histopathology;4)recurrent and metastatic ovarian cancer;5)the eastern cooperative oncology group (ecog) performance status score≤1;6)the expected survival time was more than 3 months; 7)pre-menopausal women (post-menopausal women must have been postmenopausal for at least 12 months to be considered infertile), and the serum pregnancy test results are negative;8)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;9)the subjects voluntarily participate in this clinical trial sign an informed consent form and are able to complete the study procedures and follow-up examinations;10)bone marrow function is good,ability to perform stem cell mobilisation and collection. exclusion criteria: 1) patients with bone marrow disease;2)central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology;3)patient has severe cardiac insufficiency;4)previous history of allogeneic stem cell transplantation or organ transplantation;5)patients with active bleeding and autoimmune thrombocytopenic purpura;6)patients with chemotherapy contraindications;7)positive for human immunodeficiency virus (hiv);8)acute or chronic active hepatitis b or hepatitis c infection.

Keywords: ovarian cancer conventional chemotherapy blood stem cells autologous blood transfusion
pegfilgrastim and darbepoetin alfa in support of adjuvant chemotherapy for breast cancer

Conditions: Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer

Summary: the main purpose of this study is to see if pegfilgrastim (neulasta) is safe and useful in supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell growth factor, darbepoetin alfa(aranesp) can reduce the need for blood transfusion in chemotherapy recipients.

* patients will receive chemotherapy every 2 weeks for up to 8 cycles (spread out of approximately 16 weeks, total) of treatment. on the day of chemotherapy treatment patients may receive an injection of darbepoetin alfa in addition to chemotherapy if their red blood cell count is below normal levels. * on the day after chemotherapy treatment, patients will receive an injection of pegfilgrastim. there is one pegfilgrastim shot given per treatment cycle, for a total of 8 injections. once the patient has finished chemotherapy and the last of the pegfilgrastim shots, their participation in this trial will be complete. * while on this study the following procedures will be performed: a physical exam will be done every 2 weeks, vital signs will be done every 2 weeks, and blood tests every 2 weeks. * this study also involves a quality of life questionnaire done at the beginning of study treatment, at 2 months, 4 months, 6 months, and 1 year after starting the study treatment. * patients will remain on this study unless they experience unacceptable side effects from any of the treatment drugs.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed breast cancer clinical stage i, ii or iii disease. patients must be deemed of sufficient risk for tumor or recurrence * patients may receive the defined adjuvant chemotherapy treatment either following definitive breast surgery or prior to definitive breast surgery * 18 years of age or older * ecog performance status 0 or 1 * anc \> 1,500/ul * hemoglobin \> 9 g/dl * platelets \> 100,000/ul * total bilirubin less than or equal to uln * ast/alt \< 1.5 x uln * creatinine within normal institutional limits * pt/ptt \< institutional upper limit of normal * lvef \> 50% exclusion criteria: * previous cytotoxic chemotherapy or therapeutic radiation therapy * pregnant or lactating women * receiving any other investigational agents * stage iv breast cancer * history of allergic reactions attributed to compounds of similar chemical or biologic composition to pegfilgrastim or darbepoetin * previous exposure to g-csf or pegfilgrastim or to recombinant erythropoetin-related growth factors. * on antibiotics within 72 hours of registration * patients with immune deficiency who are at increased risk of lethal infections when treated with marrow-suppressive therapy, or hiv-positive patients receiving anti-retroviral therapy * sickle cell disease * known positive antibody response to any erythropoietic agent * known hematologic diseases * known history of hyperviscosity syndrome * patients on lithium * rbc transfusion within past 4 weeks

Keywords: adjuvant chemotherapy g-csf pegfilgrastim darbepoetin alfa
registry of acute coronary syndromes in the lazio region of italy

Conditions: Acute Coronary Syndromes

Summary: the net-sca registry has been designed to document and evaluate the clinical epidemiology and current management of acute coronary syndromes in the lazio region of italy.

lazio is a region of central italy with a resident population of about 5,600,000. the net-sca registry has been designed to document and evaluate the current presentation and clinical management of acute coronary syndromes (acs) in this specific regional area of italy. all consecutive patients with acs admitted to ccu of 15 hospitals of the lazio region will be included in the registry.

Eligibility criteria:
inclusion criteria: * admission to ccu for acs exclusion criteria: * acs due to major extracardiac causes (i.e. traumatic)

Keywords: acute coronary syndrome
use of sitagliptin for stress hyperglycemia or mild diabetes following cardiac surgery

Conditions: Diabetes Mellitus, Type 2; Hyperglycemia

Summary: this is a randomized controlled trial to determine the safety and efficacy of sitagliptin in patients with stress hyperglycemia or mild diabetes following cardiac surgery. patients will receive sitagliptin or placebo. sitagliptin may be of particular use in this patient population due to the effects on hepatic glucose production (a major feature of sh), safety (lack of contra-indications for heart failure or renal failure and no hypoglycemia), and tolerability. the secondary objective of this study is to determine whether the management of patients with persistent insulin requirements following cardiac surgery differs among patients with stress hyperglycemia or mild diabetes.


Eligibility criteria:
inclusion criteria: * either of the following: mild diabetes mellitus or stress hyperglycemia * and: * cardiac surgery * insulin requirement between 8-30 units subcutaneous on post-op day 3 or later off pressors, off enteral feeding, extubated or glucose \>150 mg/dl at least twice in a 24 hour period (\>4 hours apart) and otherwise not requiring basal insulin exclusion criteria: * use of pressors, mechanical ventilation, or enteral or parenteral feeding within previous 12 hours * glucocorticoids in doses exceeding the equivalent of prednisone 10 mg/day within the previous 48 hours * left ventricular assist device * percutaneous or laparoscopic surgery * end stage renal disease * end stage liver disease * history of pancreatitis * type 1 diabetes * pregnancy * unable to give consent in english * no phone * prisoners * less than 18 years of age
comparison of svf-gel filling and co2 fractional laser on atrophic acne scar treatment

Conditions: Autologous Fat Graft Harvesting, SVF-gel Preparation and Filling; CO2 Fractional Laser Treatment by Using Acupulse Device

Summary: background adipose extracellular matrix/stromal vascular fraction gel（svf-gel）, which contains adipose-derived stem cells, endothelial cells, smooth muscle cells, pericytes, and other cell components. objective to determine the efficacy and safety of svf-gel for treating acne scars and to compare the results with co2 fractional laser. methods seventeen patients with moderate to severe acne scars were treated with svf-gel filling and co2 fractional laser through a 24-week, randomized split-face study. one randomly assigned half side of each patient's received one svf-gel filling treatment and the other side by two co2 fractional laser treatment once one months. clinical improvement was assessed by two blinded investigators with echelle d'evaluation clinique des cicatrices d'acne (ecca) scale, visia and antaro-3d detection.

this study was designed as a 24-week, prospective, randomized split-face protocol that compared clinical courses between two facial sides either receiving svf-gel injection or co2 fractional laser for acne scars. at the initial presentation, the evaluation of the severity of acne scar by echelle d'evaluation clinique des cicatrices d'acne (ecca) scale (table1), visia and antera 3d analysis for all enrolled patients. then, each facial side of every patient was randomly assigned into either svf-gel injection or co2 fractional laser treatment side. a random allocation sequence was created using computer-based random number generators to assign the treatment modality of each side. randomization codes were secured in a safe until all data analyses were finished. each patient was received svf-gel injection for just one time on one half face, co2 fractional laser treatment for two consecutive sessions at 8-week intervals on the other half face, with a follow-up visit at 16 weeks after the final co2 fractional laser treatment. evaluations of each treatment sessions were performed after 1 week, 2 months of every treatment. two dermatologists evaluating the severities of acne scars were blinded to the assignment. at patients' each evaluation visit, photographic assessments by dermatologists, visia and antera 3d analysis and patients' subjective assessments were conducted.

Eligibility criteria:
inclusion criteria: * acne scar patients with severity of moderate to severe by ecca scale evaluation. * all the subjects were not allowed to use any systemic, topical, or light-based acne scar treatment during the course of this study. exclusion criteria: * pregnancy, mental illness. * intake of oral isotretinoin within 3 months * application of the other chemical peeling and light-based treatments within 8 weeks
study to assess the safety and efficacy of viltolarsen in ambulant boys with dmd (racer53-x)

Conditions: Duchenne Muscular Dystrophy

Summary: this is a phase 3, multi-center, open-label extension study in ambulant boys with dmd who have completed the 48-week treatment period of either viltolarsen or placebo in study ns-065/ncnp-01-301.

this phase 3 study is a multi-center, open-label extension study in ambulant boys with dmd who have completed the 48-week treatment period of either viltolarsen or placebo in study ns-065/ncnp-01-301. patients will receive viltolarsen administered iv at weekly doses of 80 mg/kg. study ns-065/ncnp-01-302 will be comprised of a 96-week treatment period.

Eligibility criteria:
inclusion criteria: 1. patient has completed the ns-065/ncnp-01-301 study; 2. patient's parent(s) or legal guardian(s) has (have) provided written informed consent and health insurance portability and accountability act authorization, where applicable, prior to any study-related procedures; patients will be asked to give written or verbal assent according to local requirements; 3. patient and parent(s)/guardian(s) are willing and able to comply with scheduled visits, investigational product (ip) administration plan, and study procedures. exclusion criteria: 1. patient had an adverse event in study ns-065/ncnp-01-301 that, in the opinion of the investigator and/or the sponsor, precludes safe use of viltolarsen for the patient in this study; 2. patient had a treatment which was made for the purpose of dystrophin or dystrophin-related protein induction after completion of study ns-065/ncnp-01-301; 3. patient took any other investigational drug(s) during or after completion of study ns-065/ncnp-01-301; 4. patient is judged by the investigator and/or the sponsor not to be appropriate to participate in the extension study for any reason.
capillary-venous paired data collection

Conditions: Oncology

Summary: capillary-venous paired data collection.

an iterative data collection study to continuously assess the performance of our entia liberty device with cancer patients. our device enables a full blood count from a finger prick sample. the participants enrolled in the study will attend the study site for their routine venepuncture blood test. once enrolled, they will have a finger prick test obtained by a healthcare professional (trained member of the clinical research team) to be tested on an entia liberty device. within 4 hours of that same participant's routine venepuncture, a small amount of blood from the venepuncture will be also tested on a second entia liberty device in the laboratory. all the results from the capillary finger prick liberty test, routine venepuncture blood test (gold standard reference method) and the venous blood liberty test will be compared against each other to regularly assess that the improvements made on the measurement system of the device is sufficient.

Eligibility criteria:
inclusion criteria: * age \>18 years old at the time of study entry * currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle of treatment * scheduled to be undergoing routine venous laboratory blood tests as part of standard of care * can provide written informed consent exclusion criteria: * history of haematological malignancy * inadequate use and understanding of the english language, requiring a translator
phase ii pilot study of cladribine (2-chlorodeoxyadenosine; 2-cda) for early stage primary sclerosing cholangitis

Conditions: Cholangitis, Sclerosing

Summary: objectives: i. evaluate the effects of cladribine (2-chlorodeoxyadenosine; 2-cda) on biochemical, radiologic, and histologic parameters in patients with early stage primary sclerosing cholangitis.

protocol outline: patients are treated with subcutaneous injections of cladribine (2-chlorodeoxyadenosine; 2-cda) for 5 consecutive days every month for 3 months.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- stage i-iii primary sclerosing cholangitis radiologically and pathologically documented no concomitant liver disease, e.g.: * viral hepatitis * autoimmune hepatitis * primary biliary cirrhosis * cirrhosis * portal hypertension or associated complications * jaundice caused by dominant stricture --prior/concurrent therapy-- no concurrent immunosuppressives --patient characteristics-- hematopoietic: * absolute neutrophil count at least 2500/mm3 * platelet count at least 100,000/mm3 * hemoglobin at least 10 g/dl other: * no active infection * no fistula abscess * no active inflammatory bowel disease * quiescent disease allowed, including: chronic ulcerative colitis crohn's disease * no other significant immunologic disorder * no active malignancy * no active alcohol or drug abuse * no pregnant or nursing women * effective contraception required of fertile patients endoscopic retrograde cholangiopancreatography within 36 months prior to registration liver biopsy within 12 months prior to registration

Keywords: gastrointestinal disorders primary sclerosing cholangitis rare disease