Kornimate/medical-research-clean huggingface dataset:
concomitant radiotherapy and new drugs in metastatic breast cancer

Conditions: Breast Cancer; Radiotherapy; Complications

Summary: the primary objective of the study is to describe the tolerance profile of radiation treatments performed during systemic treatment with new drugs (molecular targeted therapies, immunotherapy, others).

patients suffering from stage iv breast cancer undergoing a systemic treatment including: molecular targeted therapy, conjugated antibodies (adcs), monoclonal antibodies, tyrosine kinase inhibitors (tki), immunotherapy (icis), who are candidates for a radiation treatment (both palliative or curative), after being informed about the study and giving written informed consent, will be considered eligible for this observational study. this study aims to prospectively analyze the tolerance profile of radiation treatments performed during new generation systemic therapy.

Eligibility criteria:
inclusion criteria: * patients suffering from stage iv breast cancer * ongoing systemic treatment including: molecular targeted therapy, conjugated antibodies, monoclonal antibodies, tyrosine kinase inhibitors, immunotherapy (immunocheckpoint inhibitors) * candidates for radiation treatment (both palliative and curative). exclusion criteria: * previous radiation treatment on the same site * absolute contraindications to radiotherapy * systemic treatment administered as part of a clinical trial

Keywords: breast cancer radiotherapy stereotactic radiotherapy (sabr) side effects
registry platform hematologic malignancies (rubin) - extension of tumor registry lymphatic neoplasms

Conditions: Chronic Lymphocytic Leukemia (CLL); Diffuse Large B-cell Lymphoma (DLBCL); Follicular Lymphoma (FL); Mantle Cell Lymphoma (MCL); Marginal Zone Lymphoma (MZL); Waldenström's Macroglobulinemia (WM)

Summary: the purpose of the project is to set up a national, prospective, longitudinal, multicenter registry platform to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with hematological malignancies in germany.

rubin is a national, observational, prospective, longitudinal, multicenter registry platform with the purpose to record information on the antineoplastic treatment of hematological malignancies in germany. it will identify common therapeutic sequences and changes in the treatment of the disease, and will analyse the impact of novel treatments on the outcome of patients in routine care. unmet needs and areas with the potential for improvement in routine care are to be identified. at inclusion, data in patient characteristics, comorbidities, clinical characteristics and previous treatments, if applicable, are collected. during the course of observation data on all systemic treatments, radiotherapies, surgeries, and clinical outcome are documented. health-realted quality of life in patients with hematological malignancies will be evaluated for up to one year.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * confirmed diagnosis of the respective nhl * if patient is alive: signed written informed consent * for patients participating in the pro survey: ic prior to or at day of start of respective line of treatment. * for patients not participating in the pro survey: ic latest eight weeks after start of respective line of treatment. exclusion criteria: * no systemic therapy for respective lymphoid malignancy.

Keywords: non-hodgkin lymphoma (nhl)
covered metallic stents for first-line treatment of benign bile duct strictures

Conditions: Common Bile Duct Stricture

Summary: the current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. this approach necessitates multiple procedures which may extend over one year before the stricture is adequately dilated. the investigators propose a study comparing the standard approach of plastic stenting with the use of newer, fully coated metallic stents which are self-expandable, thereby permitting successful dilation of benign bile duct strictures with fewer procedures.

randomization, as detailed below, is stratified by etiology of the stricture: chronic pancreatitis and postoperative (such as post-liver transplant).

Eligibility criteria:
inclusion criteria: * bismuth type i benign bile duct stricture * objective signs/symptoms related to the stricture exclusion criteria: * suspected malignant etiology for the stricture * prior endotherapy within one year of presentation,except in the following two scenarios: 1) early (\< 30 days) stent placement following liver transplant; 2) in patients with chronic pancreatitis, single plastic stent placed during presenting ercp while evaluating for malignancy * bismuth type ii-iv stricture * proximal common hepatic duct diameter \< 6 mm * intact gallbladder, except in cases where a stent can be deployed \> 1cm below the cystic duct insertion * age \< 18 years, pregnancy, incarceration, inability to provide informed consent * karnofsky score ≤ 40 * inability to pass a guidewire proximal to the stricture * stricture \> 8cm in length * life expectancy \< 1 year * concomitant nonanastomotic biliary strictures or biliary casts

Keywords: stenosis bile duct chronic pancreatitis postoperative post-liver transplant
a study of tirzepatide in overweight and very overweight participants

Conditions: Obesity; Overweight

Summary: the main purpose of this study is to measure the effect of tirzepatide on food intake in participants who are overweight or very overweight. the study will also use imaging to learn more about how tirzepatide affects specific parts of the brain. the effect of tirzepatide on appetite will also be studied. the study will last up to about four months and will include up to 14 visits to the study center.


Eligibility criteria:
inclusion criteria: * have stable body weight for the past 1 month prior to screening * have a body mass index (bmi) between 27 to 50 kilograms per meter squared (kg/m²), inclusive at screening * willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff * women must not be pregnant or breastfeeding exclusion criteria: * have undergone or plan to undergo gastric bypass or bariatric surgery * have claustrophobia or have ferromagnetic implants that can interfere with completion of fmri measurements * have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study * unwilling to comply with smoking and alcohol restrictions during the study * have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening * have a diagnosis of type 2 diabetes
myelogen: germline testing for predisposition to myeloid malignancies

Conditions: Myeloid Malignancy; Myeloid Malignancies; Blood Cancer; Blood Cancers

Summary: this research study is evaluating the feasibility of conducting cancer genetic testing using healthy skin cells among participants with a diagnosis of a blood cancer. additionally, investigators will evaluate how often participants with blood cancers are found to have risk for cancer based on family genes.

the purpose of this prospective, non-randomized, non-therapeutic, single arm study is to determine the feasibility and benefit of performing genetic testing for all participants with a blood cancer diagnosis regardless of clinical suspicion. research study procedures include screening for eligibility, in-clinic visits, questionnaires, and skin punch biopsies. participants will receive germline genetic testing with a comprehensive hereditary cancer gene panel. it is expected that about 200 individuals with blood cancer will take part in this research study.

Eligibility criteria:
inclusion criteria: * age of 18 years or older * participants must have histologically confirmed myeloid malignancy or bone marrow failure within the last 6 months prior to screening. * ability to understand and provide a signed and completed consent document in english or spanish. exclusion criteria: * patients with who cannot safely undergo skin biopsy as adjudicated by the study team. * patients who have previously undergone germline genetic testing for predisposition to myeloid malignancies

Keywords: myeloid malignancy myeloid malignancies blood cancer blood cancers
effectiveness of backside massage and lamaze breathing on labour outcome among primigravida

Conditions: Labor Pain

Summary: the study aims to investigate the effects of a combination of lamaze breathing exercises and backside massage on the labor experiences of primigravidae in pakistan. labour pain, if left unaddressed, can lead to abnormal labor, hence the importance of effective pain management techniques. lamaze breathing techniques are non-pharmacological methods aimed at psychologically and physically preparing mothers for drug-free childbirth. backside massage therapy is another non-invasive intervention that can help to reduce pain and anxiety during labor. the study will involve a randomized controlled trial with two groups: an intervention group receiving backside massage and lamaze breathing along with standard labor care, and a control group receiving only standard labor care. primigravidae between 26 to 34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal departments. eligible participants will be randomly allocated to either group to minimize bias. the backside massage therapy intervention will be administered by trained massage therapists. outcome measures include level of labor pain and anxiety levels, maternal stress hormone levels (adrenocorticotropic hormone, cortisol, and oxytocin), maternal vital signs, fetal heart rate, labor duration, apgar scores, and maternal satisfaction and self-efficacy. the sample size of 90 participants (45 in each group) has been determined to achieve a 95% power level with a 5% error rate, accounting for a 20% attrition rate. data analysis will employ mixed-effect regression models, time series analyses, paired t-tests, or equivalent non-parametric tests to assess between-group and within-group outcome measures. the study aims to provide valuable insights into the efficacy of combining lamaze breathing exercises and backside massage therapy as complementary interventions for managing labor pain and anxiety among primigravidae in pakistan, potentially reducing the need for medically unnecessary cesarean sections and improving maternal and neonatal outcomes.


Eligibility criteria:
inclusion criteria: * primigravidae * age 20-35 years old * gestational age of 37-41 weeks * first stage of labour * singleton pregnancy * cephalic presentation * regular contractions * cervical dilatation of at least 6 cm * minimum of three contractions every 10 minutes * contraction intensity of at least moderate * contraction duration between 30 seconds and 60 seconds exclusion criteria: * diagnosis of underlying chronic diseases (e.g., cardiovascular disease, kidney disease, diabetes, asthma, mental health disorders, epilepsy or seizure) * pregnancy-related diseases (e.g., gestational diabetes, preeclampsia, cephalo-pelvic disproportion, polyhydramnios or oligohydramnios, deep venous thrombosis) * pregnancy complications (e.g., placenta praevia, antepartum haemorrhage, fetal distress, administration of analgesics)
vitamin d levels and vitamin d education in geriatric patients

Conditions: Vitamin D Insufficiency; Vitamin D Deficiency

Summary: vitamin d is important to maintain good health. although it is found in foods and vitamins, many people still have low vitamin d levels. one purpose of this study is to describe vitamin d levels from patients at the university of colorado seniors clinic. another goal of the study is to find out if education by a pharmacist can increase vitamin d levels in patients who have low vitamin d levels.


Eligibility criteria:
inclusion criteria: * patient at the university of colorado hospital seniors clinic with an appointment in december 2005 or january 2006 * age 65-89 years exclusion criteria: * history of dementia or memory loss * severe illness or life expectancy less than 6 months * assistance with medications from an assisted living facility * history of celiac sprue, crohn's disease, or chronic pancreatitis * high calcium levels, high parathyroid hormone levels, low phosphorus levels, or very high vitamin d levels * taking prescription vitamin d

Keywords: vitamin d deficiency geriatric patients
blys and ifn in sle

Conditions: Systemic Lupus Erythematosus

Summary: this protocol tests whether changes in blys or ifn can be detected in a normal immune response to a vaccine and, if so, whether the response differs between those with lupus and healthy controls.


Eligibility criteria:
inclusion criteria: * acr lupus criteria * 18\<age\<65 exclusion criteria: * chronic infection or cancer * pregnancy
evident, occult and no demonstrated usi and uds findings in women with ≥stage ii cystocele

Conditions: Urodynamic Stress Incontinence in Severe Cystocele Women

Summary: prevalence rates of urodynamic urinary incontinence (usi) subtypes and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage ii cystocele are important for clinical consultation, especially for occult usi. misdiagnosis of occult usi before cystocele repair might lead to occurrence of de novo stress urinary incontinence after cystocele repair. thus, the aim of this study was to elucidate the above findings and between-group associations.

between november 2011 and january 2017, medical records of all women with ≥stage ii cystocele who underwent urodynamic studies in a medical center were reviewed. anova test and post-hoc testing with bonferroni's correction were used for statistical analysis. usi is noted during filling cystometry and is defined as the involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction. the recruited patients with cystocele were classified into three groups (i.e.,evident usi, occult usi and no demonstrated usi) according to pad weight results before and after prolapse reduction.

Eligibility criteria:
inclusion criteria: 1. age \>20y/o 2. cystocele \> stage ii 3. complete urodynamic study exclusion criteria: 1. pregnancy 2. urinary tract infection 3. previous pelvic reconstruction surgery

Keywords: cystocele urodynamic stress incontinence pad test urodynamic study
the post-marketing safety and immunogenicity research of speeda® rabies vaccine for human use

Conditions: Rabies Vaccine Allergy; Vaccination Adverse Event; Anti-D Antibodies

Summary: the objective of this study was to achieve the post-marketing safety and immunogenicity research of speeda® rabies vaccine for human use from chengda bio

the aim of the research is to compare the two immune procedures. the investigators plan to enroll 10500 participants signed the informed consent who separately inject by zagreb or essen procedure.

Eligibility criteria:
inclusion criteria: * parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed * participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months * participant body temperature ≤ 37.0℃ * participant without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup) exclusion criteria: * three-level exposure * known allergy to any constituent of the vaccine * reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction * known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth * participation in any other interventional clinical trial * an acute illness with or without fever (temperature \> 37.0℃) in the latest week preceding enrollment in the trial * inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study * reported clearly the infection of the upper respiratory tract with 6 months clinical manifestation of metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
the step home trial: utilising physical activity data in the acute post-operative setting

Conditions: Surgery; Enhanced Recovery; Technology

Summary: this is an observational study, which aims to assess how physical activity levels following surgical procedures correlate with patient recovery and length of hospital stay, as well as the utility of this physical activity data to the postoperative surgical team. surgical teams frequently enquire about their patients' physical activity levels on postoperative ward rounds. although this information is often provided anecdotally by nursing staff and junior doctors, there are no objective data made available to the clinician. such data has the potential to supplement other observations (e.g. heart rate, blood pressure, temperature) to help gain an impression of a patient's recovery and physical status, this in turn could provide evidence to help facilitate early discharge as well as to predict medium to longterm outcomes. advances in wearable technology allow the investigators to collect detailed information with regard to activity with minimal disruption. recent literature has shown that these wristworn sensors can feasibly be worn in hospital pre and postoperatively, with evidence of a correlation between the amount of steps taken postoperatively and the length of hospital stay. this study will provide further evidence for the usability and utility of wearable sensors in the inpatient surgical setting. it will provide supporting evidence for surgeons to confidently analyse and assess patients in hospital, allowing for safe and expedient discharge home as well as identify highrisk patients who are likely to require extra support and surveillance in the community setting.


Eligibility criteria:
inclusion criteria: * undergoing elective surgical operative procedure exclusion criteria: * unable to mobilise independently have medical condition characterized by movement disorder e.g. parkinson's disease unable to understand and complete the sf-36 (unless interpreter present) or lack capacity to consent psychological disorder aged less than 18
hbv vaccination in hiv-infected adults

Conditions: Hepatitis B Vaccination, HIV

Summary: the finding of isolated hepatitis b core antibody (isolated hbc) in absent of recent active hepatitis could cause by several scenarios, including false positive, remote infection without viremia, and occult infection with low viremia. hepatitis b virus (hbv) vaccine booster could be a great prevention strategy for those who do not have hbv viremia. there is no standard consensus for management of this issue especially among hiv infected population. in addition, prior studies revealed that hiv-infected individuals had lower immunologic response to hbv vaccine than general population. this study intends to compare the immune response and safety of 4- versus 3-standard dose of hepatitis b virus vaccination in hiv-infected adults who has isolated hbc. the immunologic response will be evaluated after the participants receive vaccination.

* a randomized controlled trial to evaluate differences in immunogenicity and safety of the two hepatitis b vaccination regimens, including the percentage of responders, high-level responders, anamnestic response, geometric mean titers of anti-hbs antibody, adverse events and predictive factors associated with vaccine responsiveness * after participant enrollment, data on baseline characteristics, time since hiv diagnosis, cd4 counts, hiv viral load, antiretroviral treatment regimen and duration will be collected, then the participants will be randomized into 2 groups to receive either 3- or 4-standard doses (20 mcg per dose) of hbv vaccination, and follow-up blood test for anti-hbs titers at multiple pre-specified time points to evaluate outcomes

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * on combination antiretroviral therapy (cart) * cd4 ≥ 200 cell/mm3 for ≥ 1 year * hiv viral load \< 20 copies/ml for ≥ 1 year * isolated anti-hbc ab (negative hbsag, anti-hbs ab) and negative anti-hcv at screening exclusion criteria: * pregnancy * previous hbv vaccination * intolerance to any component of hbv vaccine * transaminitis in the past 3 months (≥ 5 unl) * ongoing opportunistic infection (oi) * active malignancy, with current chemotherapy or radiotherapy * systemic steroid therapy (≥ 0.5 mg/kg/day) or any immunomodulating therapy in the last 6 months * other immunocompromised disorders (e.g. solid organ transplant) * asplenism * renal insufficiency (crcl ≤ 30 ml/min) * decompensated cirrhosis (child-pugh c)

Keywords: hbv vaccination, hiv, isolated anti-hbc
potential predictive biomarkers in patients undergoing first-line chemotherapy for metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer; Chemotherapy Effect; Biomarker

Summary: chemoresistance remains an obstacle in treating people with metastatic colorectal cancer (mcrc). studying samples of blood and tumor tissue in the laboratory from patients with mcrc receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. it may also help doctors predict how patients will respond to treatment. in this study, we aimed to evaluate biomarkers in chemotherapy regimens for first-line chemotherapy for mcrc.


Eligibility criteria:
inclusion criteria histologically confirmed metastatic colorectal cancer unresectable metastatic disease must be confirmed histologically if \> 2 years since primary diagnosis measurable metastatic disease \> 1 cm by spiral ct scan or \> 2 cm by other methods scheduled to receive first-line chemotherapy for metastatic disease chemotherapy must include fluorouracil, capecitabine, irinotecan hydrochloride, or oxaliplatin exclusion criteria inadequate or unusable tissue as the only tissue available brain metastases or meningeal disease contraindication to chemotherapy pregnant or nursing other severe pathology that is likely to worsen during therapy dementia or severely impaired mental condition geographical or psychological reasons that would preclude treatment