Kornimate/medical-research-clean huggingface dataset:
weekly paclitaxel and trastuzumab in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. however, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. the present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in her2+ patients.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic breast cancer overexpressing her2 * pretreatment with anthracycline in either the adjuvant or palliative setting. * her2 positivity was defined as 2+ or 3+ overexpression using the dako herceptest, confirmed by fluorescence in-situ hybridization (fish) if 2+. * informed consent exclusion criteria: * more than 1 chemotherapy for advanced disease * taxane or trastuzumab pretreatment * brain metastases * eastern cooperative oncology group (ecog) performance status \>1 * pregnancy or lactation, childbearing potential without reliable contraception * clinically significant cardiac disease, * neutrophils \<1500/µl, platelets \<75,000/µl * total bilirubin and creatinine \>1.5 × the upper limit of normal
prospective, multicenter non interventional study to evaluate adherence to betaferon over a 2 years period

Conditions: Multiple Sclerosis

Summary: the aim of the seplus study is to evaluate the patients characteristics associated with adherence to betaferon over a 24-month follow up period after the initiation of betaferon in the betaplus program


Eligibility criteria:
inclusion criteria: * male or female \>/= 18 years old * outpatient with a confirmed diagnosis of recurrent-remittent multiple sclerosis or patients at high risk of developing multiple sclerosis after a first demyelinating clinical event * patient who initiated betaferon as described by smpc less than 2 months ago. the decision of physician is clearly separated from the decision to include the patient in the study * treatment naïve patients before the initiation of betaferon * or patients having interrupted betaferon for more than 6 months before to start again * or patients receiving a disease modifying drug (dmd) other than betaferon * patient with edss score \< 4 * patients approved and signed an inform consent and approved the collect of their data exclusion criteria: * contraindications and warning of the respective summary of product characteristics

Keywords: multiple sclerosis betaplus program recurrent/remittent multiple sclerosis patients adherence to treatment regimen
simultaneous integrated boost technique in breast cancer radiotherapy

Conditions: Breast Cancer; Radiotherapy Side Effect

Summary: adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer. simultaneous integrated boost (sib) techniques have been shown to provide more conformal treatment plans than conventional sequential boost, in addition, sib enables a reduction in the overall treatment time by 1 week compared to conventional boost techniques. the proposed study is aimed at evaluating radiation-induced toxicity in patients treated with breast-conserving surgery in combination with radiotherapy using sib technique.


Eligibility criteria:
inclusion criteria: * invasive breast cancer or ductal carcinoma in situ * breast conserving surgery * complete tumor resection * treatment with adjuvant radiotherapy of the breast * indication for boost irradiation * given informed consent exclusion criteria: * incomplete tumor resection * mastectomy * distant metastases at diagnosis * unable to give informed consent
trial regarding the acceptability of audiotape intimate partner violence (ipv) screening

Conditions: Domestic Violence

Summary: the purpose of this study is to compare the safety, acceptability and ease of the administration of two screening methods, a pen and paper questionnaire and an audiotape with headsets, for screening for intimate partner violence in a pediatric emergency department (ed).

intimate partner violence (ipv) is a significant health problem, affecting 2 - 4 million women each year. over half of the homes in which women are abused contain children, with 3.3 - 10 million children witnessing ipv each year. in 1998, the american academy of pediatrics (aap) issued guidelines stating that "identifying and intervening on behalf of battered women may be one of the most effective means of preventing child abuse," and recommending that pediatricians perform routine ipv screening. because of the substantial number of families seen in the emergency department (ed), this setting could provide an important site in which to implement universal screening. exactly how to implement screening in this busy environment is unclear. one possible approach involves the use of an audiotape with a headset with a prerecorded screening questionnaire that prompts the respondent to circle "yes" or "no" answers on an otherwise blank sheet of paper. this method of screening has the potential benefits of: * providing a more private method of screening; * improving screening of women who cannot read well; * enhancing the rate of screening by removing the burden of screening from providers. comparison: female caregivers in a pediatric ed will be randomized to answering domestic violence (dv) screening questions either via pen and paper or via audiotape. after answering these screening questions, all women will be asked standardized questions about the acceptability, safety and ease of use of the method to which they are randomized.

Eligibility criteria:
inclusion criteria: * older than 18 or an emancipated minor exclusion criteria: * child undergoing acute resuscitation * other adults in the room

Keywords: domestic violence screening emergency department
stair instead of elevator use at work: cardiovascular primary preventive effects on hospital employees.

Conditions: Cardiovascular Diseases

Summary: this is an intervention study which evaluates the cardiovascular primary preventive effects of using stairs instead of elevators at the worksite during a 12-weeks period. we hypothesize that stair-climbing during working hours can meet the daily amount of physical activity recommended by current public health guidelines.


Eligibility criteria:
inclusion criteria: * age \> 18 years * no or little stair-use at work (\< 5 stories/day) * sedentary lifestyle exclusion criteria: * positive answers to the health screening physical activity readiness questionnaire (par-q) * part-time employment \< 80% * absence of more than 2 weeks during the intervention period * intention to begin a weight control program * medication changes which may influence blood pressure, lipid or glucose metabolism
thinking in speech for children with autism

Conditions: Autism Spectrum Disorder; Speech

Summary: this study examines a cognitive therapy for autistic children, thinking in speech. thinking in speech helps children with autism independently cope with everyday events that cause stress, by developing their ability to use "inner speech".

the purpose of this study is to examine the effectiveness of thinking in speech (tis) in teaching children to identify when they are experiencing a problem and learn to ask for help appropriately. participants. participants will be 20 verbal children, aged 7-11, who have been diagnosed with autism or related neurocognitive disorders. therapists will be experienced and certified speech-language pathologists (slps) who will be trained to use tis for this grant, investigators will develop a standardized training program that can be administered to community slps. training will consist of background reading and discussions, analysis of past therapy sessions, and practice sessions with individualized feedback provided by a trainer. training will focus on developing the child's ability to ask for help. asking for help requires a complex combinations of executive functions and being able to adopt the perspective of another person. training sessions will be recorded for use in further training development and enhancements. a five-week training program is anticipated. procedure: both training and therapy will be delivered remotely. the therapists will plan to conduct sixteen 30-minute remote therapy sessions over 8 weeks - the actual time frame will depend on the health and scheduling demands of the therapists and children. all tis sessions will be video-recorded. children will be randomly assigned to either receive therapy immediately or to be placed on a 10-week wait-list after which they will receive therapy.

Eligibility criteria:
inclusion criteria: * verbal language ability as reported by the caregiver * ages 7-11 * prior autism or related neurocognitive diagnosis * child proficient in english * caregiver proficient in english * residing in pennsylvania * access to internet at home exclusion criteria: * history of major child mental illness (e.g., bipolar, schizophrenia, psychosis) * child visual and/or hearing impairment that interferes with his/her ability to participate in therapy
the effect of treatment with umbilical cord blood platelet lysate on diabetic foot ulcers

Conditions: Diabetic Foot

Summary: application of autologous platelet rich plasma (prp) has been a major breakthrough for the treatment of diabetic foot ulcers, as it provides the necessary growth factors which enhance tissue healing. human umbilical cord blood platelet lysate (ucb-pl) contains a supraphysiological concentration of growth factors. the aim of the study is to evaluate the efficacy of umbilical cord blood platelet lysate (ucb-pl) gel for the treatment of diabetic foot ulcer.

110 patients with diabetic foot ulcer will be randomized to receive ucb-pl gel or regular dressing with normal saline. the diabetic foot ulcers will be first debrided to remove any necrotic and infected tissues or hyperkeratotic skin. afterward, the wound area will be cleaned thoroughly with normal saline. ulcer length, width and surface will be measured before any study procedure. the ucb-pl gel in the treatment group and the dressing with normal saline in the control group will be applied in the ulcer, and then a few layers of sterile gauze, and non-compressible bandage will be used to cover the wound/ulcer area. this will be repeated every three days for one month. after the fist one month of treatment, the patients will be followed up for a period of 20 weeks post-treatment. care and management efforts will be provided at each visit included cleansing and assessing of the wound, obtaining an interim wound history, including information regarding adverse events, concomitant medications and other aspects of care since the last visit. ulcers will be photographed at two weeks, at four weeks, at two months, at four months and at six months.

Eligibility criteria:
inclusion criteria: * age\>18 years old * patients with diabetic foot ulcer, foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces) * ulcer with area(length x width) measurement\<30 cm2 * non-infected ulcers exclusion criteria: * pregnacy * venous ulcers * clinical signs and symptoms of infection * exposure of bone, muscle, ligaments, or tendons and the presence of tunneling
g-csf in the treatment of toxic epidermal necrolysis

Conditions: Stevens - Johnson Syndrome

Summary: neuponet aims to evaluate interest of g-csf in the treatment of toxic epidermal necrolysis. this is a prospective randomized controlled trial. patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of g-csf during 5 consecutive days) or in a placebo group. patients will be randomized at admission and will be followed until 3 months after discharge.


Eligibility criteria:
inclusion criteria: * toxic epidermal necrolysis with scorten 1 to 5 at admission exclusion criteria: * toxic epidermal necrolysis with scorten 6 or 7 at admission * hypercoagulable state * cardiac or peripheral arterial disease * active malignancy * myelodysplastic syndrome or hematological malignancy * fructose intolerance * pregnancy * patient refusal
pain education and therapeutic exercise for fibromyalgia

Conditions: Fibromyalgia

Summary: fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and psychological problems. the european league againts rheumatism (eular) described an algorithm how to treat step by step these patients. the objective of this trial is to evaluate if patient education plus therapeutic exercise is more effective in pain intensity, fatigue, function, strength, pain threshold, anxiety, depression, quality of life, quality of sleep, kinesiophobia, pain coping and biochemical and genetic markers and compared to therapeutic exercise. for this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). the investigators included patients diagnosed of fibromyalgia according to the american college of rheumatology (acr). patients included are randomized into 2 groups one receive education of pain neurophysiology plus exercise therapy and the other only exercise therapy. groups receive 3 treatment sessions a week over 10 weeks. the variables are measured at the beginning and end of treatment. and also some variables are measured before and after each session.


Eligibility criteria:
inclusion criteria: * diagnosed medically with fibromyalgia * diagnosed according to the american college of rheumatology criteria * agreement to attend to treatment sessions exclusion criteria: * any kind of contraindications for physical activity * other kind of diseases that could limit the intervention * previous surgery last year * medication modifications in the last 3 months

Keywords: fibromyalgia therapeutic exercise physiotherapy
improving diagnosis and treatment of metastatic advanced prostate cancer

Conditions: Advanced Prostate Carcinoma

Summary: the aim of this study is to provide clinical evidence to determine if whole body magnetic resonance imaging (wbmri) with a novel technique called diffusion-weighted imaging (dwi) can improve current treatment for apc patients, allowing for early identification of disease progression or treatment response, hence facilitating clinical decision-making and leading to improvement in patient care. the idt study includes two retrospective analyses and a single centre prospective observational study for apc patients.

metastatic advanced prostate cancer occurs when cancer spreads from the prostate to other parts of the body (bones, lymph nodes or other organs), with bones being the commonest site of spread in prostate cancer. these cancer growths are called metastases. apc metastases are diverse (heterogeneous) in their growth pattern, such that not all metastases will respond to the same treatment.

Eligibility criteria:
inclusion criteria: retrospective study a baseline wbmri scans in metastatic apc patients acquired up to 8 weeks prior to the initiation of a new line of therapy. retrospective study b paired wbmri scans in metastatic apc patients at baseline within 8 weeks prior to treatment and at 12 ± 3 weeks after systemic treatment prospective study c written informed consent. age ≥18 years. advanced prostate cancer patients with indication for systemic anti-cancer therapy to be enrolled in a clinical study. participants must have a baseline wbmri and ct-guided bone marrow biopsy. exclusion criteria: prospective study c patient is claustrophobic. contraindications to mri examination (e.g., cardiac pacemakers, cochlear implants).
ticagrelor monotherapy after 3 months in the patients treated with new generation sirolimus stent for acute coronary syndrome (tico study)

Conditions: Acute Coronary Syndrome

Summary: to compare the clinical outcomes of dual antiplatelet therapy with aspirin and ticagrelor vs. ticagrelor monotherapy at 3 months after pci in patients with acute coronary syndrome.


Eligibility criteria:
inclusion criteria: * patients ≥ 19 years old * patients who received new generation sirolimus-eluting (osiro®) stent implantation for treating acs * patients without significant clinical events such as mi, stent thrombosis or revascularization until 3 months after pci * provision of informed consent exclusion criteria: * age \> 80 years * increased risk of bleeding, anemia, thrombocytopenia * a need for oral anticoagulation therapy * pregnant women or women with potential childbearing * life expectancy \< 1 year * patients who treated with strong cyp3a4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, or atazanavir) * patients who had history of intracranial hemorrhage * moderate to severe hepatic dysfunction * increased risk of bradycardia-related symptom (guidance and reference)
surgical procedures for advanced tumor disease. a prospective study evaluating quality of life

Conditions: Advanced Cancer

Summary: patients in a known palliative setting and with localized symptoms due to tumor growth will be evaluated for their quality of life before and after a surgical intervention (primary endpoint). medical outcome in terms of length of stay in hospital, length of stay on a intensive care unit, complications, reinterventions will be recorded (secondary endpoints). the investigators will also observe patients with conservative treatment.

what is the impact on quality of life by operations in symptomatic advanced tumor disease ? after informed consent patients in known palliative situations and with localized symptoms due to tumor growth will be enrolled in our study. the investigators will assess quality of life with the eortc qlq c30-questionnaire and collect data about the disease an the actual state of the patients. by the time of discharge out of hospital the investigators will hand out the questionnaire again and the investigators will collect data regarding the therapies, operations, complications, reinterventions, time spent on a intensive care unit, time spent in hospital. the questionnaire will be completed after 4 and 12 weeks as well.

Eligibility criteria:
inclusion criteria: * informed consent * tumor patients within a known palliative situation, patients do know about the absence of a curative treatment * patients are symptomatic because of localized tumor growth * patients having an operation for symptom relief or treated without surgery exclusion criteria: * patients with an only intraoperatively seen palliative tumor disease * debulking operations, prophylactic operations for prevention of symptoms, operations for venous access (an exception will be made for enteric bypass operations in patients with a yet preserved passage) * dementia, age ≤ 18, barrier of speech

Keywords: palliation quality of life surgery surgery; palliative lifestyle
a subjective evaluation of inflow pain associated with the use of an experimental solution for peritoneal dialysis

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to evaluate the inflow pain using an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (esrd) in peritoneal dialysis (pd) patients.


Eligibility criteria:
inclusion criteria: * patients who have given written informed consent after the nature of the study has been explained. * patients who are at least 18 years of age. * patients who have been treated with pd using specific solutions for at least 30 days before the screening visit. * patients who experience pain on infusion based on medical judgement. exclusion criteria: * patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before to screening visit. * patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit. * patients who are participating in another study that requires ethics committee approval. non-interventional studies are permitted. * patients who have received an investigational product within 30 days preceding the screening visit. * patients who are pregnant or lactating. (nb: female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study). * patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.
pain sensitivity during puberty

Conditions: Pain

Summary: aim 1- to examine the differences in pain sensitivity between adolescents at early vs. mid pubertal status aim 2- to determine the relationships between sex hormone levels and pain sensitivity exploratory aim 1- to determine the effect of pubertal maturation on pain sensitivity exploratory aim 2- to identify parameters related to who will develop chronic pain during puberty hypothesis 1- adolescents in early pubertal status will have higher pain ratings and lower pain modulation capabilities compared to adolescents in mid puberal status. hypothesis 2- pain sensitivity will be associated with sex hormone levels. exploratory hypothesis 1- as adolescents mature, they will have a decrease in pain sensitivity to experimental pain which will be related to changes in sex hormone levels. exploratory hypothesis 2- female adolescents with greater pain sensitivity, lower testosterone levels and with a family history of pain would be at a higher risk to develop chronic pain

at baseline, participants will complete a 2.5-hours study session. in the study session, psychophysical assessments of thermal and pressure stimuli will be performed and sex hormone levels will be analyzed. in addition, demographic, social, pubertal maturation, behavioral and psychological factors will be collected via questionnaires. in the optional follow-up portion, participants can complete short surveys every 3 months and/or return for study visits after 6 months and/or after every year depending on the participant's availability. the study visits will include the same procedures as the baseline study visit. additional surveys regarding new symptoms of pain will be completed. in some cases, participants will meet a pediatric physician who will determine if they meet the criteria for any pain syndrome (for research purposes only).

Eligibility criteria:
inclusion criteria 1. healthy males and females 2. 9-16 years old 3. english speakers exclusion criteria participants will not be enrolled if any of the following criteria exist and based on the investigator discretion: 1. pregnancy 2. chronic pain or frequent headaches (\>5 headache /month) 3. psychiatric or neurological disorders 4. lack of sensation in the testable limb 5. disorders associated with pubertal maturation or usage of contraceptive pills that affect sex hormone levels 6. regular use of pain medications (e.g., opioids, antidepressants).

Keywords: pain puberty