Kornimate/medical-research-clean huggingface dataset:
the efficacy and safety of abraxane combined with epirubicin as neoadjuvant chemotherapy in breast cancer

Conditions: Breast Cancer

Summary: some studies have demonstrated the efficacy of abraxane in treating breast cancer in both adjuvant and metastatic settings. few data is available on abraxane in neoadjuvant treatment for breast cancer. the aim of this project is to evaluate tailored primary systemic therapy with weekly abraxane (125mg/m2) combined with q3week epirubicin (100mg/m2) in early operable (stage of t2-4n0-3m0) breast cancer. this study will be an open label non randomized, single arm, single center study.

the hypothesis is that tailored neoadjuvant chemotherapy with 4 cycles of pe(weekly abraxane 125mg/m2, q3week epirubicin 100mg/m2, 21day/cycle) is feasible and achieves high response rates. it is proposed that 50 patients will be enrolled in this study. the target population is women with early breast cancer (stage of t2-4n0-3m0) who are eligible for primary systemic therapy. the primary objective of the trial is to determine the overall response rate. secondary endpoints will include response rates in axillary lymph nodes, safety and tolerability and the rate of breast conservation.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent 2. women and men at least 18 years of age or older. 3. pathological confirmation of breast cancer 4. tumor stage(tnm): t2-4n0-3m0 5. no evidence of distant metastasis 6. adequate bone marrow, hepatic, and renal function 7. measurable disease as per recist criteria 8. karnofsky≥70 9. laboratory criteria: plt≥100\*109/l wbc≥4000/mm3 hgb≥10g/dl alt and ast\<2\*uln exclusion criteria: 1. presence of metastatic disease. 2. inflammatory breast cancer. 3. bilateral breast cancer. 4. previous chemotherapy or hormonal therapy for current breast neoplasm. 5. other malignant tumors (concurrent or previous). 6. pregnant woman. 7. hypersensitive to any drug in abraxane or epirubicin regimen or any ingredient of abraxane or epirubicin. 8. any severe systemic disease contraindicating chemotherapy.

Keywords: neoadjuvant chemotherapy abraxane epirubicin
a study of biib022 in combination with paclitaxel and carboplatin in subjects with non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to determine whether biib022, paclitaxel and carboplatin are effective in the treatment of treatment-naive, stage iiib/iv non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * age \>/= 18 years old * treatment-naive stage iiib/iv non-small cell lung cancer * ecog performance status 0 or 1 exclusion criteria: * history of another primary cancer within 3 years * any prior or concurrent investigational or standard therapy for treatment of nsclc * prior anti-igf-1r therapy * unstable diabetes

Keywords: biib022 stage iv taxol stage iiib carboplatin paclitaxel non small cell lung cancer treatment naive anti igf1r nsclc open label igf1r paraplatin cytotoxic mitotic inhibitor taxane alkylating agent
a study on the pharmacokinetics and safety of valcyte (valganciclovir) in pediatric heart transplant recipients less than 4 months of age

Conditions: Cytomegalovirus Infections, Heart Transplantation

Summary: this open label study will assess the pharmacokinetics and the safety and tolerability of valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients \< 4 months of age.


Eligibility criteria:
inclusion criteria: * males and females, 0 to \< 4 months (\< 125 days) of age at the time of the last pk assessment in this study * parent or guardian of the patient is willing and able to give written informed consent * patient has received a first heart transplant * patient is at risk of developing cytomegalovirus (cmv) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of cmv * adequate hematological and renal function * able to tolerate oral medication (any appropriate form of tube feeding is acceptable) exclusion criteria: * allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past * severe, uncontrolled, clinically abnormal diarrhea * liver enzyme elevation of more than five times the upper limit of normal for ast (sgot) or alt (sgpt) * patient requires use of any protocol prohibited concomitant medications * patient has previously participated in this clinical trial
effectiveness of a digital application for adolescents with mild to moderate anxiety

Conditions: Anxiety; Anxiety and Fear; Adolescent - Emotional Problem

Summary: the goal of this randomized controlled trial is to investigate the effectiveness of a new therapist-guided rule based intervention in bergen municipality, child and family help center. do they have a decrease in anxiety symptoms following the intervention? do they have an increase in functional level following the intervention? researchers will compare the therapist-guided rule based intervention with treatment as usual for adolescents with mild to moderate anxiety. participants will use the intervention, which is based on cbt, for 8 weeks.

modi is a mobile application and consists of a training program for adolescents with anxiety problems. anxiety is one of the most common mental disorders. the anxiety symptoms usually have an age of onset in adolescence. for many, these anxiety symptoms persist into adulthood, and lead to reduced quality of life and functional impairment. the goal is to prevent anxiety disorders, comorbid disorders and loss of function as a result of the anxiety symptoms. this study wants to investigate the effectiveness of a digital intervention in a randomized controlled trial. the study will recruit n = 128 young people aged 13-16 who will be randomized to either a therapist-guided, rule-based chatbot intervention or treatment as usual in the child and family help center in bergen municipality. the study will examine the clinical effects of the new intervention compared to treatment as usual

Eligibility criteria:
inclusion criteria: * ages 13-16 * resides in bergen * completed rcads-25 * reports "yes" to both questions: * do you have anxiety symptoms? do you often feel stressed, scared, worried, or feel it in your body (e.g., stomach pain, heart palpitations, breathing problems, sweating, dizziness)? * do anxiety symptoms prevent you from doing things you want or need to do (e.g., meeting new people, giving presentations at school, going to sleepovers, going to the shopping center)? or do you spend so much time worrying that it affects your daily life? can read norwegian exclusion criteria: * currently receiving other psychological treatment * immediate need for other psychological treatment, such as severe depression, suicide risk, ocd, psychosis/substance abuse issues, autism spectrum disorder * anxiety is largely related to bullying * extensive school absence of more than 50% in the last three months

Keywords: digital health digital interventions cognitive behavior therapy adolescent anxiety
zinc supplementation of imipramine therapy

Conditions: Major Depression

Summary: examination of the effect of zinc supplementation on imipramine therapy in major depression.

a placebo-controlled, double blind study of zinc supplementation in imipramine therapy was conducted in sixty, depressed patients fulfilling the dsm-iv criteria for major depression without psychotic symptoms. after a one week washout period, patients were randomized into two groups treated with imipramine and receiving once daily either placebo (n=30) or zinc supplementation (n=30) for 12 weeks.

Eligibility criteria:
inclusion criteria: * patients with fulfilled dsm-iv criteria for moderate or severe depressive episode * one week washout period without any pharmacotherapy exclusion criteria: * psychotic symptoms

Keywords: depression antidepressant treatment zinc placebo
pulmonary tuberculosis sequelae in patients with copd

Conditions: Copd; Tuberculosis; Quality of Life

Summary: it is known that there is a complex relationship between tuberculosis and copd. post-tuberculosis airway disease or copd associated with tuberculosis occurs in a significant portion of tuberculosis patients. however, it was observed that mortality rates and exacerbation rates of copd patients with tuberculosis sequel were higher. however, the effect of tuberculosis sequela on functional outcomes in copd patients has not been investigated in the studies. the aim of this study is to determine whether the previous tuberculosis sequelae has a functional effect on patients with copd.

this research is planned as a cross-sectional study. it will start within one week following the approval of the ethics committee and will be completed within one year. the universe of the study is s.b.ü. dr. suat seren chest diseases and surgery training and research hospital consists of patients who apply to pulmonary rehabilitation outpatient clinic. participants will consist of two different groups: copd patients with tuberculosis and copd patients without tuberculosis. the voluntary principle will be taken into account in participating in the research. within the scope of the evaluation; demographic and clinical information of the people who will participate in the study will be recorded, and thorax ct and pft examinations performed within the polyclinic service within the last 1 month will be evaluated. saint george respiratory questionaire (sgrq), 6-minute walk test (6mwt), medical research council dyspnea scale (mrc), copd assessment test (cat) will be applied to the patients. regarding the illness histories, the number of hospitalizations and emergency admissions in the last 1 year will be recorded. detailed tuberculosis anamneses will also be taken from patients with tuberculosis sequelae.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * being over 18 years old * having thorax ct in the last 1 month * having pft examination performed in the last 1 month exclusion criteria: * being in a copd attack * the patient has additional pulmonary comorbidity such as lung ca, bronchiectasis, lung fibrosis.

Keywords: copd tuberculosis exercise capacity quality of life
efficacy and tolerance of formula 609613 37 in acneic patients

Conditions: Acne

Summary: acne affects most adolescents and young adults with varying severity and presentation. for early or localized forms, the first-line treatment is usually local. the available treatments often lead to local irritation, particularly during the first few weeks of use. this is why creams containing exfoliating agents have long been used in acne, as they are considered to allow a faster disappearance of superficial lesions. the objective of this 6-month double-blind study is to demonstrate in 100 acneic patients the interest of an anti-acne face cream as an adjunct to and in addition to a 5% benzoyl peroxide gel.

the study is conducted in accordance with the protocol and the legislative and regulatory provisions in force (after obtaining authorization of the french health authorities and the favorable opinion of the ethics committee). regarding the statistical analysis, two different analysis are performed: * descriptive analysis: quantitative variables are described by the mean and standard deviation and qualitative variables by the raw number of each modality and the corresponding percentage. * comparative analysis: for quantitative variables, inter-group comparisons are made by a student's t-test or a non parametric mann-whitney test if necessary. for qualitative variables, comparisons are made using a chi-square test, if the expected number of participants is less than 5, fischer's exact test on a 4-box contingency tables is used. a significant level of p \<0.05 is considered as significant. a double-data entry is carried out then a comparison of the two databases is performed. finally internal and external consistency tests are planned. missing data are described and possibly analyzed.

Eligibility criteria:
inclusion criteria: * acneic facial skin * between 20 and 50 non-inflammatory lesions on the face * between 10 and 40 superficial inflammatory lesions on the face * no local acneic treatment in the previous 15 days * no treatment with isotretinoin in the previous 3 months * agreeing to apply only the study products exclusion criteria: * less than 20 or more than 50 non-inflammatory lesions on the face * less than 10 or more than 40 superficial inflammatory lesions on the face * prescription of a local acne treatment for less than 15 days * prescription of an antibiotic treatment for less than 1 month * prescription of an isotretinoin treatment for less than 3 months * changing toiletries and hygiene products regularly

Keywords: acne lipohydroxyacid salicylic acid benzoyl peroxide dermocosmetic
the use of mentoring to promote well-being for female smart members

Conditions: Harassment, Non-Sexual; Harassment, Sexual; Bullying, Workplace; Mental Stress; Work-Related Condition; Work-related Injury; Work Related Stress

Summary: women are highly underrepresented in the construction skilled trades. in addition to facing the industry's well-known physical risks, women are subjected to discrimination, harassment, and skills under-utilization. as a result, tradeswomen have increased risk for injury, stress-related health effects, and high attrition rates from apprenticeship programs, thus perpetuating their minority status. mentoring is a well-established technique for learning technical and personal navigation skills in new or challenging social environments. the investigators propose development and dissemination of a mentorship program through local unions of the international association of sheet metal, air, rail and transportation workers (smart), and evaluating its success in reducing women's injury and work stress, while improving retention.

journey-level workers will be trained on effective mentoring techniques, and matched to approximately 100 women apprentices within participating local unions. mentees will be followed for two years within the mentorship program, with another 100 women apprentices in locals not receiving the mentorship training similarly followed as controls. the impact of participation in mentoring programs will be measured through apprentices' experience of stress, coping mechanisms, safety climate, and retention in the apprenticeship programs. specifically, the investigators propose to: aim 1: develop a mentorship training program for journey-level sheet metal workers to assist women apprentices in navigating the challenges faced by women in trades aim 2: disseminate the training and assist locals in developing effective mentorship programs aim 3: evaluate the effectiveness of the mentoring programs specified in aims 1 and 2 aim 4: disseminate the best practices for supporting women apprentices in the skilled trades.

Eligibility criteria:
inclusion criteria: * all mentors must be journey-level sheet metal workers that are members of the smart (international association of sheet metal, air, rail, and transportation workers) union. all mentees and control apprentices must be apprentice-level sheet metal workers that are members of the smart union, and identify as woman. exclusion criteria: * no exclusions will be made on the basis of sex, race, ethnicity, age, disability or religion for mentors, mentees, and control apprentices. no exclusions will be made on the basis of gender for mentors. for mentees and control apprentices, those that do not identify as a woman will be excluded.
the optimization of conditioning regimen for hla matched hsct in saa

Conditions: Severe Aplastic Anemia

Summary: hematopoietic stem cell transplantation (hsct) from a human leukocyte antigen (hla) -matched donor is an effective option for severe aplastic anemia (saa), but there is no standardized and recommended conditioning regimen. the occurrence of mixed chimerism after transplantation is associated with secondary graft failure and poor failure-free survival. previous studies have shown that fludarabine (flu)/ cyclophosphamide (cy)/ antithymocyte globulin (antithymocyte globulin), atg) and cy/atg conditioning regimens had higher rates of mixed chimerism and poorer failure-free survival. a small cohort study has suggested that adding busulfan to flu/cy/atg or cy/atg can reduce the incidence of mixed chimerism and improve failure-free survival. this study was a prospective, multicenter, randomized controlled trial to compare the efficacy and safety of different conditioning regimens in the treatment of severe aplastic anemia (saa) after hematopoietic stem cell transplantation (hsct) from hla-identical sibling or unrelated donor.


Eligibility criteria:
inclusion criteria: 1. diagnosed as saa/vsaa 2. indication for hematopoietic stem cell transplantation 3. available hla matched sibling or unrelated donor 4. no active infection 5. no serious organ damage: liver and kidney function (alt and ast \< 2.5 times normal value, normal renal function, no cardiac insufficiency) 6. signed informed consent 7. high risk factors of mixed chimerism, at least one of the following 1. age \< 18 years old 2. ferritin level ≥2500ng/ml before transplantation exclusion criteria: 1. age \> 50 years old 2. ecog≥3 3. active infections that were difficult to control 4. severe liver and kidney dysfunction 5. mental illness 6. not signing the informed consent 7. pregnant or lactating women 8. any condition considered by the investigators to be unsuitable for enrollment

Keywords: hla matched donor transplantation
efficacy study in allergic rhinitis patients after intranasal administration of azd8848

Conditions: Allergic Rhinitis

Summary: the primary purpose of this study is to investigate effect, tolerability and safety of different dosing regimens of azd8848 administered intranasally to seasonal allergic rhinitis patients out of season in an allergen challenge model.

a double-blind, placebo controlled, randomised, parallel group phase iia study to investigate the efficacy, tolerability, and safety of different dosing regimens of azd8848 administered intranasally to seasonal allergic rhinitis patients out of pollen season in a nasal allergen challenge model

Eligibility criteria:
inclusion criteria: * seasonal allergic rhinitis patients out of pollen season * have a history and presence of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test) * patients with need of treatment for their nasal symptoms during the pollen season exclusion criteria: * symptomatic perennial allergic or non-allergic rhinitis * family history of autoimmune disease a history of asthma

Keywords: azd8848 allergic rhinitis efficacy tolerability safety nasal symptoms
non-interventional comparison of sedatives on weaning from mechanical ventilation in intensive care patients

Conditions: Critical Illness

Summary: the purpose of this study is to determine whether the use of different sedatives affect the weaning process from mechanical ventilation in intensive care patients.

traditionally patients with ongoing mechanical ventilation have been sedated to assure absence of pain, anxiety and to provide comfort. unfortunately this approach might have negative consequences such as prolonged time for mechanical ventilation, length of stay in the icu and hospital. in this study, the investigators would like to investigate (in an exploratory way due to the non-interventional setup) whether weaning from mechanical ventilation will be affected by the choice of sedatives - including dexmedetomidine, midazolam and propofol. this study also aims at investigating how the choice of primary sedative will affect delirium/anxiety, need of other medications (sedatives, analgesics, anti-psychotics), quality of life after icu and the presence of post-traumatic stress disorder. in addition, the investigators aim at receiving information from the caregivers on their icu experience, as recent data imply that not only the icu patient but also the caregiver suffer from ptsd after the icu stay.

Eligibility criteria:
inclusion criteria: * admitted to a general icu ward * ≥ 18years * intubated and mechanically ventilated for at least 24 hours * need of light to moderate sedation (corresponding to rass 0 - (-3) or maas 2-3) * sedated with dexmedetomidine, midazolam and/or propofol * good knowledge in swedish language * signed informed consent exclusion criteria: * lack of fulfilling prescribed sedation regime * estimated high risk of death during the study period, according to investigator (roughly equal to estimated mortality rate (emr) \> 80% ) * tracheotomy * change in sedative drugs since the "fit for weaning" time point * use of other alpha-2 agonists (clonidine) during icu stay * positive pregnancy test or currently lactating/ known pregnancy or lactation * participation in other study involving use of a pharmacologically active compound * patients with limitations in therapy * otherwise unable to fulfill the study, according to investigator's opinion

Keywords: weaning mechanical ventilation dexmedetomidine propofol midazolam
the effectiveness of a care bundle to prevent postpartum hemorrhage after cesarean delivery

Conditions: Cesarean Delivery

Summary: delays in the detection or inconsistent use of effective interventions of postpartum hemorrhage can result in complications or death. we designed a cluster-randomized trial to assess a multi-component strategy for the detection and treatment of postpartum hemorrhage after cesarean delivery.


Eligibility criteria:
inclusion criteria: * hospital level 1. public hospitals 2. there are more than 100 cesarean deliveries per year * patient level 1. cesarean delivery 2. sign informed consent exclusion criteria: * hospital level 1. data verification information cannot be provided * pregnant woman level 1. no blood routine results within 2 weeks before surgery

Keywords: postpartum hemorrhage cesarean delivery randomized trial detection treatment
early versus delayed oral liquids and soft food after elective ceasarean section

Conditions: Prevent Postopertive Nausea and Vomiting

Summary: to compare the safety of early versus delayed oral feeding after uncomplicated cesarean section under spinal anesthesia

cesarean section is one of most common surgical procedures saving both for mother and newborn when medically indicated .traditionally patients are not given fluids or food afer abdominal surgery until bowel function return as evidenced by bowel sounds passage of flatus or stool or feeling of hunger the rationale of this practice is to prevent postoperative nausea , vomiting, distension and other complications

Eligibility criteria:
inclusion criteria: * previous 1,2,3 cs uncomplicated elective cs singletone pregnancy spinal anesthesia exclusion criteria: * women with medical disorder htn, dm history of bowel surgery or intraoprative complication contraindication to spinal anesthesia
impact of weight loss induced by bariatric surgery or nutritional management on sexual function in men with severe obesity

Conditions: Obesity; Bariatric Surgery Candidate

Summary: study of the impact of weight loss induced by surgery (interventional group) or optimal nutritional management (control group) on sexual function in men with severe obesity


Eligibility criteria:
inclusion criteria: * severe obesity with bmi\> 25 kg / m2 exclusion criteria: * patient having undergone sterilization

Keywords: fertility bariatric surgery