Kornimate/medical-research-clean huggingface dataset:
study evaluating som230 in patients with metastatic carcinoid tumors

Conditions: Carcinoid Tumors

Summary: study evaluating som230 in patients with metastatic carcinoid tumors


Eligibility criteria:
inclusion criteria: * patients with biopsy-proven metastatic carcinoid tumors * patients with at least one measurable lesion (excluding bone) * patients must be considered inadequately controlled while on sandostatin lar therapy based on the symptoms of carcinoid syndrome (diarrhea and/or flushing) as defined as experiencing a minimum average of at least four bowel movements per day or a minimum average of at least two episodes of flushing per day exclusion criteria: * patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study * patients who have undergone major recent surgery / surgical therapy for any cause within 1 month * patients on any cytotoxic chemotherapy or interferon therapy within the last 2 months * patients with uncontrolled diabetes mellitus * patients who had received radiotherapy for any reason within the last 4 weeks must have recovered from any side effects of radiotherapy * patients who have congestive heart failure unstable angina, cardiac arrhythmia or a history of acute myocardial infarction within the three months preceding enrollment * patients with chronic liver disease * female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. * history of immunocompromise, including a positive hiv test result * patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving som230 * patients who have given a blood donation (of 400 ml or more) within 2 months before receiving som230 * patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing * patients with additional active malignant disease within the last five years

Keywords: som230 sandostatin carcinoid syndrome
impact of morning symptoms in clinical control of chronic obstructive pulmonary disease (copd)

Conditions: COPD

Summary: observational study to know the impact of morning symptoms in clinical control of copd patients. 1200 patients will be included by general practitioners (gps) and pneumologists. objective: establish if there are differences in the impact of copd on daily activities and morning symptoms measured through questionnaires of daily life activity (capacity of daily living during the morning (cdlm), global chest symptoms questionnaire (gcsq))


Eligibility criteria:
inclusion criteria: * patient has signed informed consent form * patients of both sexes,\> 40 years. * patients diagnosed with copd according to global consensus on the definition, classification and management of the disease (gold) criteria: * post-bronchodilator forced expiratory volume in 1 s (fev1) / forced vital capacity (fvc) \<70% * post-bronchodilator fev1 \<80% (stage ii, iii and iv) exclusion criteria: * participating in an epidemiological study or clinical trial * patient with other respiratory disease than copd (eg bronchial asthma, cystic fibrosis, severe bronchiectasis, restrictive lung disease, cancer, etc.). * patients with mild copd: fev1\> 80%

Keywords: morning symptoms copd
comparison of ketoprofen gel to placebo in mechanical low back pain

Conditions: Low Back Pain

Summary: mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. although parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs and paracetamol are used commonly in these patients, application of analgesics in gel forms might be an reasonable alternative to these drugs with fewer adverse effects.

mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs (nsaid) and paracetamol are used commonly in these patients. however, these drugs are not out of adverse effects and can not be used in some patients with diverse comorbidities. gel forms of nsaids are used commonly in the outpatient clinics and shown to be effective in these patients by a cochrane meta-analysis. however, there is no data on the effect of gel forms of analgesics in ed. the application of analgesics in gel forms might be a reasonable alternative to the paranteral drugs with fewer adverse effects. the present study aimed to reveal the effect of ketoprofen gel in patients presented with low back pain to emergency department.

Eligibility criteria:
inclusion criteria: * mechanical low back pain exclusion criteria: * under 18 years old * over 65 years old * pain less than 40 mm in visual analogue scale * allergy to the study drug * drug or alcohol addiction * pregnancy and lactation

Keywords: ketoprofen gel low back pain emergency department
the experience of caregivers of children with down syndrome

Conditions: Down Syndrome

Summary: this study will explore how caregivers adjust to having a child with down syndrome. primary caregivers 18 years of age and older of a child with down syndrome may be eligible for this study. participants complete a 20- to 30-minute survey that explores the subject s thoughts and feelings about being a caregiver to a child with down syndrome. questions explore the impact on the subject of being a caregiver for a child with down syndrome, the subject s uncertainties related to the child s condition and goals for the child related to social skills, behavior, learning and education, physical and mental health, independence, and other goals. it also asks questions about the caregiver, the family and the child with down syndrome. ...

the proposed study aims to explore the relationships between perceived uncertainty, hope and adaptation in caregivers of children with down syndrome (ds). there are often uncertainties surrounding the prognosis of ds which extend into various aspects of the child s life. in addition to the possibility of chronic medical conditions associated with the syndrome, there is also uncertainty related to the level of independence and cognitive, social and behavioral functioning that the child will achieve. it is not fully understood how caregivers adapt to having a child with ds in light of the uncertainty and the particular challenges associated with this condition. while a high level of perceived uncertainty may be seen as a threat to adaptation, there is also evidence that caregivers may find benefits in uncertainty. literature suggests that a person s level of hope influences how the perceived uncertainty is appraised and that hope is also related to the process of adaptation. there is no research that systematically explores the relationship between perceived uncertainty, hope, and adaptation. this study s conceptual framework is based on lazarus \& folkman s transactional model of stress and coping and is also informed by snyder s conceptualization of hope and mishel s theory of perceived uncertainty in illness. a cross-sectional research design will quantitatively explore the relationships between perceived uncertainty, hope, and adaptation. in addition, an open-ended section will be included to qualitatively describe the focus of caregivers hope for their child and how the focus of hope relates to the degree of hope. participants will be recruited from ds support groups, website postings, listservs, and clinic patient lists. they will have the option of completing either a paper or online version of the survey, or completing the survey by phone. the main outcome variable is psychological adaptation to being a care giver for a child with ds.

Eligibility criteria:
* inclusion criteria: participants will be men and women ages 18 or older who are the primary caregivers of a child with down syndrome. the parent may be a biological or adoptive parent or other primary caregiver and the child must reside with the primary caregiver. exclusion criteria: none

Keywords: parents down syndrome hope uncertainty adaptation ds survey
initial assessment of the feasibility and efficacy of a scalable digital cbt for generalized anxiety and associated health behaviors in a cardiovascular disease population

Conditions: Anxiety Disorders; Cardiovascular Diseases; Anxiety; Health Behavior

Summary: the treatment of generalized anxiety disorder (gad) in an accessible manner represents an unmet need for those with cardiovascular disease (cvd), given that patients with cvd experience numerous barriers for in-person treatment engagement. the research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (n=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute cvd events and clinical levels of gad symptoms to dcbt or a waitlist (control) condition, using a 1.5:1 allocation (dcbt:control).

the treatment of generalized anxiety disorder (gad) in an accessible manner represents an unmet need for those with cardiovascular disease (cvd), given that patients with cvd experience numerous barriers for in-person treatment engagement. a recent large-scale efficacy trial of digital cognitive behavior therapy (dcbt) for gad demonstrated significant benefit relative to waitlist control with a large effect size. the research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention, followed by (2) recruitment and randomization of 90 individuals with a history of acute cvd events and clinical levels of gad symptoms to dcbt or a waitlist (control) condition, using a 1.5:1 allocation (dcbt:control). assessments will occur at week 0 (baseline), week 3, week 6, and week 10 (post-treatment).

Eligibility criteria:
inclusion criteria: * experienced an acute cvd event (i.e., myocardial infarction, stroke/transient ischemic attack, cardiac arrest, unstable angina, congestive heart failure with hospitalization; exclusion of coronary heart disease, atrial fibrillation, and other arrhythmias) * clinical levels of gad symptoms as operationalized by a score of ≥10 on the gad-7 * age 18 or older. * individuals must be in the post-acute phase of their cvd; this is operationalized as \> 2 months post an acute cardiac event. exclusion criteria: * non-english speaker/literate * no access to a digital device * severely vision impaired * severe cognitive impairment * pending acute surgery or with a life prognosis of fewer than 6 months * the presence \[by self-report\] of schizophrenia, psychosis, bipolar disorder, seizure disorder, or current substance use disorder other than nicotine * initiation or change of psychotropic medication dosage within the past 4 weeks * received cbt for anxiety in last 3 months
the gut microbiome in flt3- al undergoing allo-hsct with or without sorafenib maintenance

Conditions: Acute Leukemia; Allogeneic Hematopoietic Stem Cell Transplantation

Summary: this prospective trial investigates the effect of sorafenib maintenance therapy in flt3 negative acute leukemia patients after allo-hsct in terms of gut microbiome.

acute leukemia is a heterogeneous group of clonal diseases. leukemia relapse remains the main cause of treatment failure, including the patients undergoing allogeneic hematopoietic stem cell transplantation (allo-hsct). sorafenib, an inhibitor of multiple kinases including flt3, has shown promising activity in flt3-itd-positive aml. the investigator's previous studies demonstrated that sorafenib maintenance post-transplantation could improve the outcomes of flt3-itd positive aml patients, which was associated with sorafenib enhancing the graft-versus-leukemia (gvl) effect. recent studies have shown that sorafenib is also effective in patients with flt3-negative acute leukemia. the investigator's previous exploratory study found that salvage therapy such as sorafenib combined with chemotherapy and donor lymphocyte infusion could significantly improve the cr rate and survival in patients with recurrent flt3-negative acute leukemia after allo-hsc. more and more studies have shown that sorafenib and allo-hsct have synergistic gvl effect. some studies have demonstrated that gut microbiome is associated with graft-versus-host-disease (gvhd) and gvl. however, the exact mechanism of sorafenib enhancing the gvl effect and the influence of gut microbiome on sorafenib maintenance after allo-hsct in flt3 negative acute leukemia patients remain unknown.

Eligibility criteria:
inclusion criteria: * flt3 negative acute leukemia * allo-hsct recipients exclusion criteria: * intolerance to sorafenib pretransplantation * cardiac dysfunction (particularly congestive heart failure) * hepatic abnormalities (bilirubin ≥ 3 mg/dl, aminotransferase\> 2 times the upper limit of normal) * renal dysfunction (creatinine clearance rate \< 30 ml/min) * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (according to the investigators' decision)

Keywords: hematopoietic stem cell transplantation gut microbiome sorafenib acute leukemia
grazoprevir (mk-5172) with peg-interferon and ribavirin in participants with chronic genotype 2 or 3 hepatitis c (mk-5172-012)

Conditions: Hepatitis C, Chronic

Summary: this study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (mk-5172) when administered concomitantly with peg-interferon alfa-2b (peg-ifn) and ribavirin (rbv) to treatment-naïve participants with chronic genotype 2 (gt2) or genotype 3 (gt3) hepatitis c virus (hcv) infections.


Eligibility criteria:
inclusion criteria: * body weight ≥ 88 lbs and ≤ 275 lbs * documented chronic hepatitis c (chc) gt2 or gt3 infection * no known cirrhosis * agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug * chest x-ray within the last 6 months * eye exam within the last 6 months exclusion criteria: * known to be human immunodeficiency virus (hiv) positive or co-infected with active hepatitis b virus (positive for hepatitis b surface antigen) * prior approved or investigational treatment for hepatitis c * evidence of hepatocellular carcinoma * diabetic and/or high blood pressure with clinically significant eye exam findings * pre-existing psychiatric condition * clinical diagnosis of abuse of certain substances within specified timeframes * known medical condition that could interfere with participation * active or suspected cancer within the last 5 years * female who is pregnant, breastfeeding, or expecting to conceive or donate eggs * male who is planning to impregnate partner or donate sperm * male with a pregnant female partner * chronic hepatitis not caused by hcv
real-world evidence study on cystistat

Conditions: Interstitial Cystitis and Bladder Pain Syndrome

Summary: this study will be conducted with the aim of ensuring the continued acceptability of the benefit-risk ratio and confirming the safety and performance of the device throughout its expected lifetime. cystistat is supplied as a 50 ml solution containing 40 mg of sodium hyaluronate. it is indicated for the temporary replacement of the gag layer in the bladder.

real-world evidence observational studies are considered as an expedient tool to reflect the use of a product under real life conditions.

Eligibility criteria:
inclusion criteria: * first prescription of cystistat according to instructions for use. * female patients of any ethnic origin with clinical diagnosis of interstitial cystitis (ic)/bladder pain syndrome (bps). if in accordance with routine clinical practice at the site, essic diagnostic criteria will be used. * age: 18 years and older. * at least 6 months duration of bladder pain/discomfort symptom(s), e.g. constant bladder pain/discomfort or bladder pain/discomfort when voiding or as a burning sensation between voids as the bladder fills with urine. * at least one accompanying intermittent or persistent lower urinary tract symptom, such as urinary frequency, urgency, or nocturia during the previous 6 months. * bladder pain/ interstitial cystitis symptom score (bpic-ss) \> 18 prior to first treatment. * written informed consent. exclusion criteria: * known hypersensitivity reactions to sodium hyaluronate. * pregnancy / planned pregnancy or breastfeeding during the course of this nis. * known history of any gag substitution therapy within the last 2 years. * known history of fulguration or resection of hunner's lesions. * known diagnosis of recurrent urinary tract infection or overactive bladder. * any other conditions or diseases that can cause similar symptoms, using information from medical history, physical examination findings, laboratory studies (e.g., urine bacterial culture), and other previously performed procedures (e.g., urodynamics, cystoscopy, laparoscopy, radiological studies). * patients are not able to fulfil study requirements according to physician's opinion.
accessibility to new drugs versus soc in sweden

Conditions: Anticoagulation

Summary: the healthcare system in sweden is publicly funded and aims to provide equal access to care irrespective of socioeconomic status. this includes ensuring equity in drug treatment. socioeconomic disparities have been shown to influence patient management and health outcomes in certain swedish populations. the swedish board of health and welfare has stated that the prescription of new drugs, which are more expensive than generic standard of care drugs, might be influenced by patients' socioeconomic status. to evaluate the association between socioeconomic factors and use of a doac (rivaroxaban, dabigatran, or apixaban) or standard of care (warfarin) in patients with nvaf in sweden.


Eligibility criteria:
inclusion criteria: * patients aged ≥18 years in sweden with a diagnosis of nvaf (identified using international classification of diseases, version 10 \[icd-10\]) codes in the national patient register) between 1 december 2011 and 31 december 2014 and with a first dispensed prescription for either a doac or warfarin following their nvaf diagnosis. exclusion criteria: * patients with a dispensed prescription for a doac or warfarin prior to the index date (the date of first doac/warfarin purchase designated the index date) * patients with a dispensed prescription for more than one anticoagulant at index date. * patients with valvular atrial fibrillation
supplementary postoperative parenteral nutrition for head and neck cancer patients

Conditions: Head and Neck Neoplasm

Summary: the purpose of the study is to examine whether postoperative nutrition with endeavours of 100% coverage of the patient's estimated energy and protein needs, can reduce the incidence of postoperative complications.


Eligibility criteria:
inclusion criteria: * patients who completed head and neck cancer surgery and got a feeding tube perioperatively * patients of legal age * patients who can understand and read scandinavian languages exclusion criteria: * patients with allergy to components in parenteral nutrition * patients where it is impossible to give parenteral nutrition

Keywords: supplementary parenteral nutrition postoperative nutrition postoperative complications
soft drink, milk and obesity in chilean children

Conditions: Obesity

Summary: the primary aim of this randomized controlled trial is to evaluate the effects of replacing habitual consumption of sugar-sweetened soft drinks with milk over 16 weeks.

the prevalence of obesity has risen dramatically among children in the u.s. and throughout the world since the 1960s. many factors are thought to have contributed to the epidemic of pediatric obesity. one factor that has received increasing attention is consumption of sugar-sweetened beverages. feeding studies suggest physiological mechanisms by which sugar in liquid form may be less satiating than other foods. an observational study found total energy consumption to be greater among children who consume sugar-sweetened beverages compared to non-consumes. short-term interventional studies report increasing energy intake and body weight in subjects given sugar-sweetened beverages compared to non-caloric beverages. our preliminary data found that the risk for becoming obese increased by about 60% in middle school children for every additional serving per day of sugar-sweetened beverage consumed. the purpose of the present study is to conduct a 16-week clinical trial involving 96 children ages 8 to 10 years in chile, a developing nation characterized as undergoing a "nutrition transition." the subjects, selected for current sugar-sweetened soft drink consumption, will be randomly assigned to intervention or control groups. the intervention group will be encouraged to substitute milk products for soft-drinks; to facilitate this dietary change, a variety of milk products will be delivered to subjects' homes on a weekly basis. clinical endpoints include changes in dietary quality, body weight, adiposity by dexa-scan and measures of calcium homeostasis.

Eligibility criteria:
inclusion criteria: * male or female, age 8 to 10 years * tanner stage i * bmi between 85th and 95th percentiles for age and gender * consuming at least 2 servings/day of sugar-sweetened beverages * willingness to consume milk instead of sugar-sweetened beverages for 16 weeks * able to read spanish and accurately complete dietary assessments exclusion criteria: * presence of a serious underlying medical condition * taking any medication that affects body weight * history of lactose intolerance or milk protein allergies * history of an eating disorder

Keywords: obesity, beverages, weight loss, body mass index, diet
haic plus lenvatinib vs haic plus sorafenib for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (haic) compared with lenvatinib combined with haic in patients with advanced hepatocellular carcinoma (hcc)


Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage c * eastern cooperative oncology group performance status of 0 to 2 * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: * platelet count ≥ 75,000/μl * hemoglobin ≥ 8.5 g/dl * total bilirubin ≤ 30mmol/l * serum albumin ≥ 30 g/l * asl and ast ≤ 5 x upper limit of normal * serum creatinine ≤ 1.5 x upper limit of normal * inr ≤ 1.5 or pt/aptt within normal limits * absolute neutrophil count (anc) \>1,500/mm3 * ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma hepatic artery infusion chemotherapy sorafenib lenvatinib