Kornimate/medical-research-clean huggingface dataset:
study for elderly (≥ 65 years) patients with classical hodgkin lymphoma undergoing cga at diagnosis

Conditions: Classical Hodgkin Lymphoma

Summary: the aim of the study is to develop a prognostic index for elderly patients with newly diagnosed chl starting from a prospective observational study of consecutive cases registered after the completion of the comprehensive geriatric assessment (cga)

the aim of the study is to develop a prognostic index for elderly patients with newly diagnosed chl starting from a prospective observational study of consecutive cases registered after the completion of the comprehensive geriatric assessment (cga) prospective data collection study of a consecutive series of newly diagnosed elderly chl patients undergoing cga before any therapy with the use of adl, iadl and cirs-g. patients who will be considered not eligible to receive treatment or to be given only palliative therapy after cga assessment are eligible for the study. patients will be screened and restaged according to clinical practice instrumental and laboratory assessments timing and type of examinations.

Eligibility criteria:
inclusion criteria: 1. diagnosis of classical hodgkin lymphoma 2. age ≥ 65 year 3. evaluation of comprehensive geriatric assessment at baseline 4. signed informed consent 5. previously untreated patients exclusion criteria: none

Keywords: hodgkin elderly patients cga
fast track appendectomy for suppurative appendicitis

Conditions: Suppurative Appendicitis

Summary: the literature has reported that fast track surgery can be safely applied to children undergoing appendectomy for acute appendicitis. there is no current evidence regarding the application of same day discharge protocol in children with intra-operative findings of suppurative appendicitis. the current standard of care for patients who present with intra-operative findings of suppurative appendicitis includes post-operative admission and treatment with intravenous antibiotics. patients are discharged home once they have met the following discharge criteria: temperature less than 38.5 degrees celsius, pain control with oral pain medication, and tolerating a liquid diet. given the evidence in the literature that has shown that same day discharge of patients with acute appendicitis is safe and effective, we propose that fast track surgery protocol can be safely applied to patients with intraoperative findings of suppurative appendicitis. we hypothesize that this will result in a decreased postoperative length of stay, without an increase in 30-day complication rate.


Eligibility criteria:
inclusion criteria: * pediatric patients aged 5-18 * diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800. * intraoperative findings of suppurative appendicitis exclusion criteria: * pregnancy * complex medical history not appropriate for same day discharge

Keywords: suppurative appendicitis, appendicitis, pediatric
spectrum of serum sodium disturbances in patients with non-sellar/suprasellar supratentorial tumors

Conditions: Supratentorial Brain Tumor

Summary: this study was designed to quantify the incidence of hyponatremia in patients of supratentorial/supra-sellar lesions and observe their effect on neurological morbidity and mortality.

disorders of sodium and water balance are one of the commonly encountered problems while managing patients with neurological diseases. managing such problems are challenging because the pathophysiology behind these disorders are complex and poorly understood and treatment of the injured brain itself can contribute to, and complicate the diagnosis of sodium disorders. serum sodium disturbance can manifest as hypernatremia or hyponatremia. hypernatremia usually occurs in the diabetes insipidus syndrome, whereas hyponatremia develops as a syndrome of inappropriate secretion of antidiuretic hormone (siadh) or cerebral salt-wasting syndrome (csws). because of the cerebral effects of hyponatremia, neurosurgical patients are at increased risk of complications including severe cerebral edema, mental status changes, seizures, vasospasm, and death. though the problem of hyponatremia has been addressed in patients with different brain pathologies, this has not been studied in patients with non-sellar/suprasellar supratentorial tumors. this study was envisioned to quantify the incidence and magnitude of hyponatremia in this patient population and their subsequent neurological morbidity and mortality.

Eligibility criteria:
inclusion criteria: patients undergoing surgical management for supratentorial/suprasellar tumors. exclusion criteria: glasgow coma score (gcs) \<4.

Keywords: hyponatremia dysnatremia neurosurgery neurointensive care
a study of zw171 in participants with advanced or metastatic mesothelin-expressing cancers

Conditions: Mesothelin-expressing Advanced Cancers

Summary: this study is being done to find out if zw171 is safe and can treat participants with advanced (locally advanced \[inoperable\] and/or metastatic) mesothelin-expressing cancers.

part 1 of the study will evaluate the safety and tolerability of zw171. part 2 of the study will evaluate the anti-tumor activity of zw171 while continuing to evaluate the safety and tolerability.

Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable) and/or metastatic disease. cancers that are refractory to all available standard of care (soc) treatment, cancers for which no soc treatment is available, or the participant cannot tolerate or refuses soc therapy. * an eastern cooperative oncology group (ecog) performance status score of 0 or 1. * adequate cardiac left ventricular function, as defined by left ventricular ejection fraction ≥ 50% as determined by either echocardiogram or multigated acquisition scan. * adequate organ function. exclusion criteria: * known additional malignancy that is progressing or that has required active treatment. * undergone prior allogenic tissue (e.g., hematopoietic stem cell) or solid organ transplantation within the last 5 years. * ongoing, clinically significant toxicity (grade ≥ 2) associated with prior cancer therapies, with the exception of alopecia. * advanced/metastatic, symptomatic, visceral spread, at risk of life-threatening complications in the short-term (including participants with massive uncontrolled effusion \[pleural, pericardial\], pulmonary lymphangitis, active unresolved bowel obstruction, massive ascites \[requiring paracentesis \>2 times within 2 weeks prior to the first dose\], and over 50% liver involvement). * acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of participants with gilbert's syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment). * active or recurrent clinically significant autoimmune disease requiring systemic high-dose corticosteroids or immunosuppressive drugs.

Keywords: advanced or metastatic cancers adc antibody drug conjugate
evaluating the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder (bpd)

Conditions: Borderline Personality Disorder

Summary: this study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.


Eligibility criteria:
inclusion criteria: * participants, who completed the last treatment visit of the previous double-blind brexpiprazole bpd trial and who, in the opinion of the investigator, could potentially benefit from administration of brexpiprazole for the treatment of bpd. * male or female outpatients, ages 18 to 65 years, inclusive, at the time of informed consent of the previous double-blind brexpiprazole bpd trial. exclusion criteria: * sexually active males or females of childbearing potential (focbp) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of imp. male participants must also agree not to donate sperm from trial screening/baseline through 30 days after the last dose of investigational medicinal product (imp). * women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving imp. * participants who participated in a clinical trial within 90 days prior to screening/baseline (with the exception of a previous brexpiprazole double-blind bpd trial) or who participated in more than 2 clinical trials within a year prior to screening/baseline. * participants who develop a medically significant abnormality.
implementation of a population health chronic disease management program

Conditions: Diabetes Mellitus; Cardiovascular Diseases; Hypertension

Summary: a pilot program was created by the network's primary care leadership team at massachusetts general hospital. a population health management program was implemented for chronic disease management. the investigators evaluated quality of care process and outcome measures over the first six months of the program and compared practices assigned a central population health coordinator to those not assigned this support.

a pilot program was created by the network's primary care leadership team at massachusetts general hospital. they hired and allocated 4 population health coordinators (phcs) as part of a pilot project to centralize population health management efforts to improve quality of care for chronic disease management. the network did not have sufficient resources to implement a phc in all of the 18 network practices. so the program's team invited practice leaders to participate and the phcs were allocated by program's leadership team based on a variety of factors including responses from the practice leader, baseline quality scores, size of the practice, nature of the practice (health center vs not), and location of the practice (on campus or community based). these decisions were made in a way that sought to equitably distribute available phc resources within the practice network as a way to get network buy-in and maximize the impact of the program, both for practices with and without phcs. in this study, the investigators evaluated quality of care process and outcome measures over the first six months of the chronic disease management program. the investigators hypothesized that practices assigned a central phc would have greater performance increases in quality measures compared to practices that were not assigned a phc.

Eligibility criteria:
inclusion criteria: * diabetes mellitus (type 1 or type 2), or cardiovascular disease (including coronary artery disease, peripheral vascular disease, and cerebrovascular disease), or hypertension * breast cancer: women 50-74 years of age * cervical cancer: women 21-64 years of age * colorectal cancer: men or women 52-75 years of age exclusion criteria: * patients not connected with a specific network physician or practice * patients who switched between phc and non-phc practices during the follow-up period * breast: bilateral mastectomy * cervical: total hysterectomy colorectal: total colectomy
an efficacy and safety study of transdermal therapeutic system (tts)-fentanyl in severe chronic low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of transdermal therapeutic system (tts)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in severe (very serious, life threatening) chronic (lasting a long time) low back pain in thai participants.

this is an open label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time) study conducted to assess the efficacy and safety of tts-fentanyl in thai participants with chronic low back pain. all participants start treatment with 12.5 micrograms (µg) per hour patch. the patches will be replaced every 3 days. on day 3, and every 3 days thereafter, the tts-fentanyl dose increases will be considered based on rescue medication consumption and pain assessment. no increase in tts-fentanyl dose will be performed within the 72-hour dosing interval. the duration of the treatment will be 30 days. primary efficacy assessment will be pain control rated by participants. assessment time points will be at day 0 (baseline), on day 15 and day 30 (trial end). at the end of study, global preference on efficacy, side effects and overall satisfaction will also be rated by investigator and participants. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: -chronic low back pain with moderate to severe pain at least 3 months -participants needed to be treated with strong opioid and haven't been treated with strong opioid in the past -participants who still had moderate to severe pain (visual analog scale \[vas\] \>= 4), which was not adequately controlled by weak opioids such as tramadol or codeine at optimal doses (at least 120 milligram \[mg\] per day for tramadol or 200 mg per day for codeine) for at least 7 consecutive days -participants who failed from other treatments such as operation or lack of efficacy of current treatment -participant who has signed the informed consent form exclusion criteria: -skin disease that prevent the use of the transdermal system or which could affect the absorption of fentanyl or local tolerability -history or suspicion of alcohol or drug abuse within the past 5 years -history of cardiac, nervous system or respiratory disease which in the investigator's judgment precludes participation in the study because of the potential for respiratory depression -concomitant use of non steroidal anti-inflammatory drugs (nsaids), cyclooxygenase - 2 (cox-2), muscle relaxant, topical analgesic during the previous week (unless on stable drug dose for at least 1 month before study entry) -pregnancy or breast-feeding female; female participants of childbearing potential without adequate contraception

Keywords: low back pain tts-fentanyl durogesic
studying gene expression in tissue samples from young patients with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is looking at gene expression in tissue samples from young patients with acute myeloid leukemia.

objectives: * examine mrna from pediatric patients with acute myeloid leukemia with 11q23 translocations by reverse transcriptase-pcr to quantify expression of evi1 splice variants. outline: cryopreserved mrna from diagnostic samples is analyzed for gene expression by reverse transcriptase-pcr.

Eligibility criteria:
disease characteristics: * diagnosis of pediatric acute myeloid leukemia with 11q23 abnormalities patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: childhood acute myeloid leukemia/other myeloid malignancies
tiotropium handihaler vs. tiotropium respimat in copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to determine if tiotropium respimat will result in better ventilation distribution of the lung in copd participants quantified by hyperpolarized xemri. this study is designed to simulate the real-life clinical setting where patients receive one-time instruction on the inhaler use.


Eligibility criteria:
inclusion criteria: 1. outpatients of either gender, age \> 40. 2. willing and able to give informed consent and adhere to visit/protocol schedules. (consent must be given before any study procedures are performed) 3. women of childbearing potential must have a negative urine pregnancy test. this will be confirmed before participation in this investigational protocol. 4. clinical diagnosis of copd confirmed by post-bronchodilator spirometry demonstrating fev1/fvc \< 0.70 in all gold stages (http://www.goldcopd.org/). 5. patients who are tiotropium naïve or whose tiotropium can be withheld for 2 weeks before screening visit/visit 1 exclusion criteria: 6. upper respiratory tract infection within 6 weeks (in this case, we will re-screen the patient after 6 weeks) 7. 24/7 oxygen use 8. previous history of pneumothorax 9. evidence of interstitial, occupational or chronic infectious lung disease by imaging studies 10. for women of child bearing potential, positive pregnancy test. 11. major chronic illnesses which in the judgement of the study physician would interfere with participation in the study 12. history of claustrophobia
evaluation of topical lidocaine spray as adjuvant to upper gastrointestinal endoscopy in children

Conditions: Dyspepsia; Malabsorption Syndrome; Gastroesophageal Reflux Disease; Abdominal Pain

Summary: there is some controversy in the medical literature regarding the effectiveness of topical lidocaine in children as an adjuvant drug to upper gastrointestinal endoscopy. in children, deep sedation and general anesthesia are often used to sedate children submitting to this procedure. propofol is an anesthetic drug increasingly popular in this situation, but this drug can only be used with an anesthesiologist in brazil. its main side effects include hypotension, respiratory depression and local pain. lidocaine is frequently used as premedication, and the rationale is that lowering patient discomfort could lower the required dose to achieve the endoscopy and reduce potential side effects. nevertheless, some patients perceive this medication as uncomfortable. this study aims to compare sedative drug doses between patients who were given either placebo or topical lidocaine.

this study is a randomized double-blind placebo-controlled clinical trial. primary outcome: propofol doses required to achieve adequate sedation. population: children submitting to upper digestive endoscopy, weight \> 30 kg and age between 8 and 18 years. exclusion criteria: neurological disorders, psychiatric disorders, specific contra-indication to either lidocaine or propofol. estimated sample: 160 patients. placebo: tannic acid 0.5%

Eligibility criteria:
inclusion criteria: * children and adolescents submitting to upper digestive endoscopy with weight above 30 kg and age between 8 and 18 years exclusion criteria: * neurological disorders * psychiatric disorders * specific contra-indication to lidocaine * specific contra-indication to propofol

Keywords: endoscopy, gastrointestinal lidocaine propofol child adolescent
double-blind, randomized, placebo-controlled, multi-center phase 3 study to evaluate the efficacy and safety of fostamatinib in covid-19 subjects

Conditions: Covid19; SARS (Severe Acute Respiratory Syndrome); SARS Pneumonia; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; Pneumonia; Pneumonia, Viral

Summary: the study is a double-blind, randomized, placebo-controlled, multi-center, phase 3 study to evaluate the efficacy and safety of fostamatinib in covid-19 subjects.

the primary objective of this study is: to evaluate the efficacy of fostamatinib when used in combination with standard of care (soc) in subjects hospitalized with covid- 19 and requiring oxygen supplementation, as measured by days on oxygen.

Eligibility criteria:
inclusion criteria: * ≥18 years of age at screening. * the subject or a legally authorized representative has provided written informed consent. * hospitalized covid-19 subjects without respiratory failure who are either not receiving any oxygen therapy or are receiving supplemental oxygen via mask or nasal prongs. * male or non-pregnant, non-lactating female subjects with sars-cov-2 infection documented by a hospital approved diagnostic test (eg, a food and drug administration authorized test in the us) within 7 days prior to randomization. exclusion criteria: * pregnant or lactating female of childbearing potential. * use of extracorporeal membrane oxygenation (ecmo). * uncontrolled hypertension (systolic blood pressure \[bp\] ≥160 mmhg and/or diastolic bp ≥100 mmhg), unstable angina, congestive heart failure of new york heart association classification iii or iv, serious cardiac arrhythmia requiring treatment at screening. * history of myocardial infarction within 1 month prior to screening.

Keywords: covid19 sars-associated coronavirus pneumonia pneumonia, viral
cognitive-behavioral therapy for adults with adhd: a qualitative study

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this is a qualitative study of participants who have taken part in a randomized controlled trial (rct) of a new treatment protocol based on cognitive-behavioral therapy for adults with attention deficit/hyperactivity disorder predominantly inattentive presentation. the purpose of the qualitative study is to explore participant perceptions of taking part in the rct to further develop and improve the new treatment protocol.


Eligibility criteria:
inclusion criteria: * principal diagnosis of adhd inattentive presentation * 18 years of age or older * if on medication, it needs to be well-established since three months, and * prior psycho-educational intervention exclusion criteria: * intellectual impairment * substance use disorder * difficulties in adherence to medical or other treatment * social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or * simultaneous psychological treatment
robotic versus abdominal surgery for endometrial cancer

Conditions: Endometrial Neoplasms

Summary: this study is intended to explore differences in oncologic and surgical safety between robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial cancer.

hypothesis: robotic assisted laparoscopy (ral)is equal in terms of oncologic and surgical safety as conventional abdominal surgery (as) for high risk endometrial cancer (ec). methods: women with high risk ec (defined as high grade endometrial, clear cell or serous) are randomized to either ral or as. both groups will undergo complete surgical staging (hysterectomy, bilateral salpingoophorectomy, pelvic and paraaortal lymphadenectomy) primary endpoint: number of harvested lymph nodes per station secondary endpoints: recurrences up to 3 year after surgery. lymphatic side-effects, quality of life, cost, surgical morbidity.

Eligibility criteria:
inclusion criteria: * 18-75 years of age * high risk endometrial cancer exclusion criteria: * who performance\>1 * severe comorbidity, asa\>3 * unable to understand information
sugars-sweetened commercial beverages on short-term food intake

Conditions: Obesity

Summary: the purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when compared to cola, a fruit drink and a water control in normal weight and overweight/obese 9-14 year old boys and girls. it is hypothesized that 1% chocolate milk will increase meal time satiation to a greater extent than other sugars-sweetened commercially available beverages. food intake will be measured 60 minutes after the consumption of 350 ml of water, fruit drink, cola or 1% chocolate milk.


Eligibility criteria:
inclusion criteria: * healthy boys and girls 9-14 years of age, stable weight, born at full term, normal birth weight exclusion criteria: * restricted diet, taking medications that affect food intake, significant learning, behavioral or emotional problems, food allergies to test treatments

Keywords: prevention