Kornimate/medical-research-clean huggingface dataset:
quality of life study breakthrough cancer pain treated in radiation oncology services with palliative intent

Conditions: Breakthrough Pain

Summary: in the context of radiotherapy, control of breakthrough pain represents a special challenge. patients undergoing radiotherapy may experience different situations of pain that may be due to the need to remain immobilized during radiotherapy session, the need to wear an immobilization mask (head and neck cancer), the odynophagia caused by mucositis, defecation after the development of proctitis, or sudden pain during the night causing sleep disturbances. in a survey conducted in radiation oncology services more than half of patients treated with radiotherapy experienced pain, and 39% of patients reported that their pain was not treated properly. this situation may increase the patient's anxiety, dissatisfaction with treatment, affect their quality of life and can even come to refuse radiotherapy treatment. this post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in radiotherapy services in spanish hospitals.


Eligibility criteria:
inclusion criteria: * patients \> 18 years * cancer patients * patients attended in radiation oncology consultations with palliative intent * life expectancy \> 6 months * written informed consent * patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by davies algorithm exclusion criteria: * untreated patients with opioids for baseline pain * patients who are not opioid tolerant * serious psychiatric disorder or any disease or condition that prevents the collection of data * patients with evidence of opioid addiction or history of drug or alcohol abuse

Keywords: breakthrough cancer pain quality of life radiotherapy
the continuation of erlotinib

Conditions: Non-small Cell Lung Cancer

Summary: newly developed or progressive brain metastasis during erlotinib treatment is considered progressive disease requiring change of treatment regimens despite no progression in extracranial lesions. given that there is a dissociation in terms of response to erlotinib between brain and extracranial sites, we intend to conduct this pilot study to determine whether the continuation of erlotinib treatment can prolong the progression free interval of extracranial lesions as long as cranial lesion is controlled separately by conventional treatment modalities such as surgical resection, stereotactic radiosurgery, and whole brain radiotherapy.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically proven non small cell lung cancer 2. new developed or progression of brain lesions among patients with good control of extracranial lesions to erlotinib 3. patients who are receiving erlotinib as salvage therapy 4. at least one unidimensionally measurable lesion with a diameter \> 10mm using brain mri 5. at least on unidimensionally measurable or evaluable lesion 6. male or female patients aged \>18 years 7. ecog performance status 0-2 8. adequate hematologic function 9. adequate renal function 10. adequate hepatic function exclusion criteria 1. leptomeningeal metastases 2. acute severe infection requiring antibiotic therapy 3. significant cardiovascular disease 4. uncontrolled dm 5. severe ophthalmologic disease

Keywords: non-small cell lung cancer erlotinib brain metastasis
improving pregnancy outcomes with intermittent preventive treatment in africa

Conditions: Pregnancy; Malaria in Pregnancy; Malaria

Summary: this study evaluates the efficacy and safety of monthly intermittent preventive treatment using dihydroartemisinin piperaquine (dp) alone or in combination with azithromycin (az) compared to sulphadoxine-pyrimethamine (sp) for the prevention of malaria in pregnant women in the second and third trimester.

intermittent preventive treatment with sulphadoxine-pyrimethamine (iptp-sp) is one of the pillars of malaria prevention in pregnancy in sub-saharan africa, in addition to prompt case management and use of long lasting insecticide treated bednets. however, mounting resistance to sp by plasmodium falciparum increasing renders iptp-sp ineffective. two exploratory trials in uganda and kenya demonstrated that iptp with dp was superior to iptp-sp for the prevention of malaria infection in pregnancy. however, neither study was adequately powered to look at adverse birth outcomes. this study is a confirmatory efficacy trial in malawi, tanzania and kenya to determine the efficacy and safety of iptp with dp alone or in combination with az. this will be a 3-arm trial, superiority, partial blinded, placebo controlled, randomized trial comparing iptp with sp, versus iptp with dp alone, and iptp with dp+az with the following hypotheses: * iptp with dp is superior to iptp with sp in preventing adverse pregnancy outcomes. * the combination of dp with az further reduces adverse pregnancy outcomes compared to iptp with dp alone.

Eligibility criteria:
inclusion criteria: * pregnant women between 16-28 weeks' gestation * viable singleton pregnancy * resident of the study area * willing to adhere to scheduled and unscheduled study visit procedures * willing to deliver in a study clinic or hospital * provide written informed consent exclusion criteria: * multiple pregnancies (i.e. twin/triplets) * hiv-positive * known heart ailment * severe malformations or non-viable pregnancy if observed by ultrasound * history of receiving iptp-sp during this current pregnancy * unable to give consent * known allergy or contraindication to any of the study drugs

Keywords: malaria in pregnancy intermittent preventive treatment iptp
comparison of oral 30 % dextrose and iv midazolam sedation during mri in neonates

Conditions: Epilepsy; Trauma; Metabolic Disease

Summary: the purpose of this study is to demonstrate the effectiveness of oral glucose administration during mri for imaging of newborns and compare with midazolam sedation.

motion artefacts affect the quality of mri and in order to overcome this problem procedures are performed under sedation or general anaesthesia. the safety profile of these methods for newborns is unclear. alternative non-pharmacological interventions are changeable and might be time consuming. oral glucose/sucrose administration has been the most frequently studied non-pharmacologic intervention in term and preterm neonates during painful procedures. in this study investigators aimed to compare oral 30% glucose and intravenous midazolam their efficiency on sedation during mri.

Eligibility criteria:
inclusion criteria: * neonates requiring mr imaging for diagnosis exclusion criteria: * patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations

Keywords: newborn mri oral 30% glucose
elemental formula in neonates post small bowel resection: improved weaning from total parenteral nutrition?

Conditions: Short Bowel Syndrome

Summary: in neonates with recent small bowel resection or congenital bowel anomalies (gastroschisis or omphalocele), does an elemental formula as compared to a partially hydrolyzed formula allowed the infant to wean off total parenteral nutrition (tpn) earlier?

neonates with short bowel syndrome (sbs) due to recent small bowel resection or congenital bowel anomalies (gastroschisis or omphalocele) can have inability to adequately digest and absorb enteral feedings resulting in prolonged parenteral nutrition (pn) dependence for nutrition and growth. prolonged pn dependence can result in parenteral nutrition associated liver disease (pnald) and intestinal failure requiring small bowel or small bowel/liver transplantation for survival. after bowel resection, the bowel has an ability to compensate for significant loss by going through a process called intestinal adaptation. enteral feeding is the key factor for initiating and maintaining the adaptation of the intestine. whole protein formulas or partially hydrolyzed formulas provide either the full protein or dipeptides/tripeptides respectively, and are thought to confer the best benefit in inducing intestinal adaptation and increasing paracrine stimulation. however, in small studies of adults and children with sbs,an amino acid based (elemental) formula demonstrated improved feeding tolerance and ability to wean off tpn. in a small study, babies fed breast milk or elemental formula appeared to have shorter duration of tpn. this is a randomized, blinded clinical trial to determine if elemental formula, elecare® (vs. partially hydrolyzed formula, pregestimil®) is better tolerated and allows a higher proportion of neonates with small bowel resection or congenital bowel anomalies to successfully wean off tpn.

Eligibility criteria:
inclusion criteria: * term or pre-term neonates with either surgical resection of the small bowel or congenital bowel anomalies (gastroschisis, omphalocele) unable to tolerate 90kcal/kg/day of enteral feedings by 1 month of age exclusion criteria: * term or preterm neonates with nec totalis, * inborn errors of metabolism, or * known or suspected congenital syndromes

Keywords: short bowel syndrome elemental formula partially hydrolyzed formula enteral feeding tpn dependency intestinal adaptation tpn cholestasis
prognostic values of chest/abdominal wall varices and spider nevi in patients with liver cirrhosis

Conditions: Liver Cirrhosis

Summary: chest/abdominal wall varices and spider nevi are two common presenting signs of liver cirrhosis. their prognostic values remain unclear.


Eligibility criteria:
inclusion criteria: 1. liver cirrhosis. 2. consecutive admission. 3. permitted to physical examinations. 4. informed consents. exclusion criteria: 1. non-cirrhotic portal hypertension. 2. malignancy. 3. uncontrolled infection. 4. severe chronic diseases. 5. poor patient compliance.

Keywords: liver cirrhosis
study of allogeneic adipose-derived mesenchymal stem cells for non-covid-19 acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome; Ards

Summary: this is a phase 2 randomized study to assess the safety and efficacy of covi-msc in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to covid-19 infection.

this is a phase 2, randomized controlled, multicenter study to assess the safety and efficacy of covi-msc in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to covid-19 infection. subjects will be randomized 2:1 to receive covi-msc or placebo. covi-msc or placebo will be administered intravenously on day 0, day 2, and day 4.

Eligibility criteria:
inclusion criteria: * negative for sars-cov-2 infection as determined by an approved polymerase chain reaction (pcr) or an approved antigen test of any specimen * hospitalized with non-covid-19-induced ards (any severity) with a pao2/fio2 (pf ratio) ≤ 300 * requires oxygen supplementation at screening * willing to follow contraception guidelines exclusion criteria: * current standard of care treatments for ards appear to be working and the subject is clinically improving * a previous stem cell infusion unrelated to this trial * pregnant or breast feeding or planning for either during the study * suspected uncontrolled active bacterial, fungal, viral, or other infection * history of a splenectomy, lung transplant or lung lobectomy * concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable) * expected survival or time to withdrawal of life-sustaining treatments expected to be \< 7 days

Keywords: ards
safety and efficacy study of a 10% intravenous immune globulin solution in subjects with primary immunodeficiency disorders

Conditions: Primary Immunodeficiency Diseases (PID); Immune Thrombocytopenic Purpura (ITP); Kawasaki Syndrome

Summary: the purpose of this study is to assess the safety and efficacy of immune globulin intravenous (human), 10% (igiv 10%) in subjects with primary immunodeficiency disorders.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration * diagnosis of a pid disorder as defined by world health organization criteria for which the subject has been receiving a regimen of igiv infusions every 21 to 28 days over a period of at least 4 months pre-study at a dose of 300-600 mg/kg body weight * subjects \> 24 months of age * a negative serum pregnancy test for any female subject who is of childbearing potential. exclusion criteria: * subjects sero-positive at enrollment for one or more of the following: hepatitis b surface antigen (hbsag), antibodies to hepatitis c virus (hcv), antibodies to human immunodeficiency virus (hiv) types 1 or 2 * subjects with levels of alanine amino transferase (alt) and aspartate amino transferase (ast) \> 2.5 times the upper limit of normal for the testing laboratory. an ast \> 2.5 times the upper limit of normal is allowable, if the alt does not exceed the upper limit of the reference range for the testing laboratory * subjects with neutropenia (defined as an anc \>= 1,000/mm3) * subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender * subjects with malignancy or a history of malignancy * subjects who received any blood or blood product exposure other than an igiv and/or immune serum globulin (isg) preparation within the 6 months prior to study entry * subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following igiv and/or isg infusions * subjects with selective complete iga deficiency * subjects with moderate levels of anti-iga antibodies (\>150), or subjects with lower anti-iga antibodies who are naive to igiv treatment. (subjects with lower levels of iga antibodies, whom the investigators know to have tolerated iga containing igiv preparations in the past, may be included if the investigator is comfortable with this) * subjects receiving antibiotic therapy for the treatment of infection within 30 days prior to enrollment * subjects who receive prophylactic antibiotics as part of their care regimen * subjects participating in another clinical study involving an investigational product or device within 30 days prior to study entry

Keywords: pid immunodeficiency immune thrombocytopenic purpura (itp) kawasaki syndrome
oral versus topical antibiotics for chronic rhinosinusitis exacerbations

Conditions: Chronic Rhinosinusitis

Summary: the purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (crs) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily intranasal antibiotic irrigations. the two treatments will be compared to see if there is any difference in patient outcomes. this will help guide treatment strategies for patients with crs in the future.

see brief summary.

Eligibility criteria:
inclusion criteria: 1. adults (age ≥ 18). 2. diagnosis of crs. 3. worsening sinonasal symptoms. 4. previous bilateral endoscopic sinus surgery (ess) (including maxillary antrostomy and anterior ethmoidectomy). 5. english speaking. 6. open sinuses (open middle meatus bilaterally; determined on endoscopy). 7. positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen antibiotic regimens. exclusion criteria: 1. patients \< 18 years of age. 2. treatment with systemic or topical antibiotics within the last 1 month. 3. pregnant women. 4. non-english speaking persons. 5. systemically ill at initial visit necessitating treatment prior to culture data. 6. allergies to chosen susceptible antibiotics. 7. sinonasal culture with less than 1+ growth. 8. multiple organisms grown on culture that are not sensitive to a single antibiotic. 9. patients with ciliary function disorders (cystic fibrosis, kartagener's syndrome, ciliary dyskinesia). 10. patients with immunodeficiencies.
can the origin of sperm affect embryo ploidy in patients with severe male factor infertility?

Conditions: Male Infertility

Summary: there is evidence indicating that sperm plays a role in determining blastocyst ploidy status. in our study, we aim to compare the outcomes of preimplantation genetic testing for aneuploidy (pgt-a) and the subsequent clinical outcomes following transfers of euploid embryos. this comparison will be conducted between cases where ejaculated sperm and cases where testicular sperm were used for intracytoplasmic sperm injection (icsi), specifically focusing on severe male factor infertility patients.


Eligibility criteria:
inclusion criteria: * cases planned to have icsi pgt-a cycles * males diagnosed as severe male factor infertility * normo responder female partners exclusion criteria: * leukocytospermia * presence of varicocele. * known genetic abnormality * use of sperm or oocyte donors * use of gestational carrier * presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection * any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Keywords: icsi male infertility pgt-a tese
effects of footstrike transition on tibial stress fracture risk

Conditions: Tibial Stress Fracture

Summary: biomechanical literature suggests that runners who utilize a mid or forefoot strike pattern may suffer from a reduced incidence of chronic injuries compared to a rearfoot strike. this investigation examined the effects of a 10-week footstrike transition intervention on tibial stress fracture risk in runners.


Eligibility criteria:
inclusion criteria: * recreational runner * 3-years minimum of running experience * injury free for 12-months exclusion criteria: * injury at baseline
psychosocial determinants of nutrient intake in girls

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to better understand the determinants of nutrient intake in black and white adolescent girls and to examine the effects of nutrient intake and eating behaviors on obesity, a significant risk factor for cvd.

background: studies have documented the importance of eating behavior as a modifiable risk factor for the development of obesity and cardiovascular disease (cvd). the burden of obesity and cvd is not equally distributed in the population; women from ethnic minority populations are particularly likely to be obese and to have higher rates of cvd and stroke than white women. design narrative: the study determines the extent to which psychological and familial factors contribute to nutrient intake in black and white girls, beyond the well-established effects of ethnicity and socioeconomic factors. specifically, the aims of the project are the following: 1) to provide a detailed developmental description of eating behaviors and nutrient intake in black and white girls and to examine the "clustering" of certain eating behaviors (e.g., skipping meals and snacking) into eating patterns; 2) to determine the clinical significance of eating behaviors and eating patterns by examining their contribution to nutrient intake and the development of obesity; 3) to examine the role of psychological and familial factors as determinants of eating behaviors, eating patterns, nutrient intake, and obesity in black and white girls. capitalizing upon the availability of extensive data collected prospectively among an exceptionally well-maintained cohort of 2,379 black and white females over a 12-year period (from ages 9-10 to ages 21-23), the study applies innovative analytic procedures to further the scientific understanding of the determinants of nutrient intake and eating behaviors in adolescent girls. participants were assessed annually for ten years as part of the national heart, lung and blood institute growth and health study (nghs) with measurements of anthropometry, food intake, eating and weight related attitudes and behaviors and family cohesion. parents also provided information about weight, eating, and family environment at two assessments. in a subsequent study with the same sample, structured clinical interviews were conducted to determine history of psychiatric disorders and risk factors for eating disorders. adult weight was also measured.

Eligibility criteria:
no eligibility criteria
maintaining optimal trauma outcomes: resilience in the midst of a ransomware attack

Conditions: Trauma; Electronic Health Record

Summary: retrospective review of de-identified hospital emergency room and trauma registry data and operating room case logs from april 9th through june 9th, 2016, 2017 examining outcomes as affected by a ransomware attack in a level i trauma center

on april 9, 2017, erie county medical center, western new york's sole level i trauma center was under cyberattack. the perpetrators utilized ransomware that gained access to the hospital's web server and encrypted hospital data, forcing a system-wide downtime for nearly 2 months. electronic medical records, imaging, and interdepartmental communication were severely affected, forcing the hospital to temporarily return to pre-emr era operations. we examined the impact of this cyber disaster on the outcomes of trauma care. retrospective review of de-identified hospital emergency room and trauma registry data and operating room case logs from april 9th through june 9th, 2016, 2017, and 2018. baseline characteristics of study cohort for each period will be examined using the chi-square test for categorical variables and the student's t-test for continuous variables that are normally distributed. this was an exempt study in our institution.

Eligibility criteria:
inclusion criteria: * all trauma patient admissions that were seen through the ecmc trauma center from april to june 2016 and april to june 2017 * adult patients \>13 years old exclusion criteria: -patients who came through the emergency department that were not categorized as trauma patients