Kornimate/medical-research-clean huggingface dataset:
dronabinol for pain and inflammation in adults living with sickle cell disease

Conditions: Sickle Cell Disease

Summary: this study is designed to address the feasibility of a randomized, double masked, cross-over study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (scd).

the primary hypothesis is that such a study will be feasible as defined by subject adherence to study medication and study procedures and avoidance of other cannabinoid containing substances during the trial period as well as by ability to mask subjects and investigators to treatment assignment secondary hypotheses are: dronabinol will: reduce patient-reported pain interference reduce patient-reported pain scores and change patient-reported pain quality. reduce use of opioid pain medications. improve patient-reported stiffness, nausea and vomiting, sleep, mood, anxiety, and social functioning. reduce markers of inflammation.

Eligibility criteria:
inclusion criteria: * male or female * age ≥18 years, able to understand and sign the informed consent form * clinical diagnosis of scd (hbss, hbsc, hbsβ+; thal, hbsβ0thal, hbs variants) * baseline score of 60 or lower on the ascq-me 7-day pain interference domain * willing to abstain from marijuana, medical and illicit, during study weeks 1 through 6. * for patients currently receiving hydroxyurea and/or l-glutamine, on a stable dose(s) for at least 3 months * for patients currently on a chronic red blood cell transfusion program, on such a program for at least 3 months exclusion criteria: * known intolerance to dronabinol, sesame oil, or marijuana * patients with a diagnosis or medical history of any psychiatric disorder with psychosis * presence of any concomitant medical condition, or use of concomitant medication, that, in the investigator's opinion, may place the subject at increased risk of side effects of dronabinol. * pregnant or nursing women * if a woman capable of becoming pregnant, unwilling to use a medically accepted form of birth control for the duration of study participation. accepted forms include oral contraception or vaginal ring, medroxyprogesterone, contraceptive implants, intrauterine device, or patch, surgical sterilization, total abstinence. we have not included a similar restriction for men as the current fda approval includes no such restriction.
efficacy of vildagliptin versus metformin in poly cystic ovary syndrome

Conditions: Poly Cystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is an endocrine disorder that affects approximately 10-20% of women of reproductive age, management strategies for pcos include lifestyle modifications such as diet and physical activity that are the first-line approach to treatment; however, they are reported to be minimally effective in reducing weight or treating pcos-related symptoms.pharmacological options are also available; however, they are not explicitly approved for pcos treatment as they have been primarily used to treat other conditions such as t2dm


Eligibility criteria:
inclusion criteria: -women diagnosed with pcos according to rotterdam 2003 criteria national institute of health criteria. exclusion criteria: * patients with history of diabetes mellitus (type 1 or 2). * patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months * known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (dpp-4) inhibitors * eating disorders (anorexia, bulimia) or gastrointestinal disorders
magnetic spiderman for preparation of liver donation

Conditions: Liver Transplant; Complications; Surgical Injury

Summary: due to many vascular branches on the supra-hepatic vena cava (shvc) and infra-hepatic vena cava (ihvc), in the whole procedures of preparation of liver donation, preparation of hepatic vena cava (hvc) is the most key and troublesome step. magnetic spiderman (ms) is a novel surgical instrument, designed and created to solve the vital problems of preparation of liver donation's hvc. therefore, the aim of this study is to evaluate the feasibility and security of ms when using it prepare the liver donation's hvc.

from january 1 2020 to june 30 2020, after inclusion and exclusion, donors' livers will be divided to ms group and manual (ma) group. in ms group, ms grips the shvc and ihvc, respectively. ms's magnets are adsorbed on the wall of the basin and ms can pull the hvc accordingly. by changing the position of ms on the wall of the basin, the attending can expose the surgical field that make the operation convenient. in ma group, assistants use vessel forceps to pull the hvc according to the attending's requirements. in both groups, right adrenal vein, phrenic veins and other branches of the hvc are isolated and ligated, then shvc and ihvc where ms's clamps gripped are cut off. after preparation, the shvc and ihvc remain at least 1.5 cm. excess diaphragms are removed. outcomes of two groups are compared.

Eligibility criteria:
inclusion criteria: * all patients receiving donation after cardiac death in the first affiliated hospital, school of medicine, xi'an jiaotong university. exclusion criteria: * patients whose age\ 60 * patients who do not have intact clinical data * patients who are inability to participate in follow-up * patients who undergo split liver transplantation
laparoscopic management of gastrointestinal stromal tumor of stomach

Conditions: Gastric GIST; Submucosal Tumor of Stomach

Summary: gastric gists are rare neoplasms that require excision for cure. although the feasibility of laparoscopic resection of gastric gist less than 2cms has been established, the feasibility, safety and long-term efficacy of these techniques for larger lesions are unclear. investigators hypothesized that laparoscopic resection of gastric gists even for larger lesions is feasible \& results in low perioperative morbidity and an effective long-term control of the disease.

open surgical resection was the standard of treatment until two decades ago, but with advent laparoscopy and experienced gained over the years, the safety \& feasibility of laparoscopic resections of gastric gists has been proven but for tumors less than 2 cm. however, with gain of experience and skill in laparoscopic surgery, many surgeons have reported a safety \& feasibility excision of tumors greater than 5 cm. our current study demonstrates the oncologic safety of the laparoscopic approach even with tumour size range up to 12cm, with efficacy and recurrence rates similar or superior to historical open surgical controls, however, it requires considerable expertise for safe manipulation of the tumour. all these resections were accomplished with minimal morbidity, no perioperative mortality, and short post-operative stay and comparable long term oncological outcomes.

Eligibility criteria:
inclusion criteria: * gastric gist\>2cm size exclusion criteria: * metastatic gist, not fit for ga

Keywords: gastric gists submucosal tumours benign gastric lesions laparoscopic wedge resection
hmgb1 in icu-survivors

Conditions: Sepsis; Cognitive Impairment

Summary: is hmgb1 (high mobility group box 1) elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice? do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged hmgb1 levels in plasma? is there a difference from patients recovering from critical illness without prior sepsis?


Eligibility criteria:
inclusion criteria: * male/female age 18-17 * expected icu-stay more than 24 hours exclusion criteria: * dont understand the language * substance abuse, alcohol or drugs * blind, deaf or suffering from aphasia * ongoing psychiatric illness or psychopharmacological treatment * suffering from dementia och mentally impaired * structured brain damage or meningitis * palliative care * icu-treated for more than 48 hours * transferred from other icu * being treated with ecmo * not having residency in stockholm
cardiogenic shock registry mannheim

Conditions: Cardiogenic Shock

Summary: the study aims to investigate clinically and prognostically relevant parameters in patients with cardiogenic shock within a monocentric observational clinical register.

all consecutive patients with a confirmed cardiogenic shock presenting at the internal intensive care unit (icu) at the university of mannheim are included in the register and followed up during icu stay and after that. data of patients' admission status, cause of cardiogenic shock, baseline parameters and comorbidities are collected. extensive information about echocardiography, electrocardiography and imaging procedures are included in the register. laboratory values, microbiological investigations, organ dysfunction and organ replacement therapies, medication, adverse events, and complications were recorded for several days during the icu stay (days 1, 2, 3, 5, 7, and 8). standard scores for critically ill patients were calculated for the day of admission at the icu if available, and several time points during the icu stay. the register includes information about the mortality during icu stay, 30-day mortality, 6-month mortality and 1-year mortality.

Eligibility criteria:
inclusion criteria: * cardiogenic shock according to current guidelines exclusion criteria: * other forms of shock not primary associated with cardiac dysfunction

Keywords: cardiogenic shock heart failure cardiac arrest shock acute myocardial infarction
recovery time and affecting factors in hemodialysis patients

Conditions: Dialysis; Complications; Life Quality

Summary: patients undergoing hemodialysis (hd) can experience symptoms such as lassitude, pain, muscle cramps, nausea, vomiting, constipation, diarrhea, rash, skin dryness, sleep disorders, and emotional and sexual problems after the treatment. many chronic hd patients do not feel well after the treatment sessions and need some time to recover. this recovery time is defined as the time required to recover from the feelings of lassitude and fatigue.

the recovery time not only decreases the quality of life but also increases the risk of mortality and morbidity. as a prolonged recovery time affects both the patients and the healthcare professionals and caregivers, there has been increased interest on determining the modifiable treatment-related factors in the international literature. the patients are limited in their daily living activities at home and at work during this period and a significant amount of time is therefore required to go back to normal life.

Eligibility criteria:
inclusion criteria: * 18 years or older * being on hd for 4 hours a day on 3 days per week for at least 6 months * no communication problem * volunteering to participate to the study exclusion criteria: * younger than 18 years * shorter being on hd for 4 hours a day on 3 days per week for at least 6 months * have communication problem * not volunteering to participate to the study
retrospective, uncontrolled cohort study on the therapy of chronic megalon

Conditions: Megacolon

Summary: the aim of this retrospective cohort study is to analyze all available data of patients with chronic megacolon in three clinical centers with respect of conservative and surgical therapies.

megacolon may be defined as dilatation of the abdominal colon with a minimum of 9 cm in diameter and the absence of mechanical obstruction. chronic megacolon in adults is an acquired uncommon condition that generally is associated with constipation. it has to be distinguished from other forms of megacolon such as acute toxic megacolon, acute non-toxic megacolon (ogilvie´s-syndrome) and congenital megacolon (hirschsprung disease). regardless of concomitant diseases and causes, most patients with chronic megacolon were treated by laxative measures. less is known about the optimal conservative therapy . if conservative measures fail, there are several surgical options, depending upon anorectal function. however, less in known about the optimal surgical therapy of patients with chronic megacolon. the aim of this retrospective cohort study is to analyze all available data of patients with chronic megacolon in three clinical centers with respect of conservative and surgical therapies.

Eligibility criteria:
inclusion criteria: * chronic megacolon (colon diameter \> 90 mm) exclusion criteria: * toxic megacolon * ogilvie-syndrome * hirschsprung disease * mechanical colorectal obstruction

Keywords: megacolon
a study of ly3108743 in healthy participants and participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to evaluate the safety and tolerability of the study drug known as ly3108743 in healthy participants and in participants with type 2 diabetes. the study will also investigate how ly3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. hormones that control the way sugar is used) in the body, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it. information about any side effects that may occur will be collected. the study is expected to last approximately 7 to 8 weeks for each participant. the study will have up to 3 parts. participants may enroll in only one part.


Eligibility criteria:
inclusion criteria: * must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes * have a body mass index (bmi) of 18.5 to 40.0 kilogram per square meter (kg/m\^2), inclusive, at screening * have normal blood pressure * participants with diabetes must not be taking any anti-hyperglycemic medications with the exception of metformin. if on metformin, participants must be on a stable treatment regimen for at least for 4 weeks prior to screening * participants with diabetes must have a hemoglobin a1c (hba1c) level between 6 to 11%, inclusive, at screening exclusion criteria: * have previously completed or withdrawn from this study * have or used to have health problems or laboratory test results or electrocardiogram (ecg) readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
telemonitoring after surgery to preserve limb function in optimizing mobility in cancer survivors with skeletal metastases

Conditions: Bone Metastases; Cancer Survivor; Metastatic Malignant Neoplasm in the Bone

Summary: this randomized pilot trial studies telemonitoring after surgery to preserve limb function in optimizing mobility in cancer survivors with cancer spread to the bone. the use of mobile devices for telemonitoring may improve the delivery of cost-effective, high-quality, standardized surveillance of cancer survivors.

primary objectives: i. to develop and evaluate the feasibility of a method that enhances surveillance in cancer survivors by using mobile devices in addition to face-to-face visits following surgery for bone metastases. secondary objectives: i. to evaluate how well the face-to-face follow-up format can be adapted to using mobile devices for remote surveillance. ii. limited efficacy testing of the remote surveillance program. iii. to obtain information on acceptability of the mobile surveillance format by patients and clinicians. outline: patients are randomized to 1 of 2 groups. group i (control): patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. patients also undergo a physical activity assessment over 15 minutes. group ii (mobile surveillance): patients undergo standard face-to-face follow up visits as in group i. patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery. after completion of study, patients are followed up at 24-25 weeks.

Eligibility criteria:
inclusion criteria: * have been scheduled for an intramedullary nailing (im) surgery with the department of orthopaedic oncology at university of texas (ut) md anderson cancer center * are able to read and write english 3) are 18 years or older * are willing and able to use a smartphone or tablet comfortably * have access to mobile hot spot, wireless internet, and/or cellular service * must have a caregiver or assistance at home who can assist with collecting physical therapy (pt) measures exclusion: n/a

Keywords: bone metastases intramedullary nailing surgery im physical tasks surveys questionnaires smartphone tablet telemedicine telemonitoring
pharmacokinetic and pharmacodynamic study of th9507, a growth hormone-releasing factor analog, in hiv positive patients

Conditions: HIV

Summary: the primary objective of the study is to determine the pk (tesamorelin) and pd (igf-1) profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated administration once daily for 14 consecutive days. secondary objectives include the evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous injections.


Eligibility criteria:
main inclusion criteria: * male or female, smoker or non-smoker, ≥18 and ≤65 years of age. * hiv-positive with cd4 cell counts \>100 cells/mm3 and viral load \<10 000 copies/ml. * on stable antiretroviral therapy (art) regimen for at least 8 weeks prior to the first study drug administration. * body mass index (bmi) ≥ 20.0 kg/m2. main exclusion criteria: * opportunistic infection or hiv-related disease within 3 months prior to study drug administration. * history of malignancy of any organ or tissue (with the exception of basal cell carcinoma of the skin, in situ carcinoma of the cervix and stable kaposi not having required treatment for the past 6 months). * for male subjects, suspicion of prostate cancer. * for female subjects, history of breast cancer or strong family history (first degree relative) of breast cancer. * known hypopituitarism, history of pituitary tumor/surgery, head irradiation or severe head trauma that had affected the somatotropic axis. * use of any experimental or marketed gh or grf/ghrh products, gh secretagogues, igf-1, or insulin-like growth factor binding protein-3 (igfbp-3) within 6 months prior to study drug administration and throughout the study. * positive pregnancy test at screening.
ucb cimzia pregnancy follow-up study

Conditions: Rheumatoid Arthritis (RA); Crohn's Disease (CD); Psoriatic Arthritis (PsA); Axial Spondyloarthritis and Ankylosing Spondylitis

Summary: the purpose of this observational follow-up study is to collect data systematically on pregnancies and offspring of women who become pregnant while participating in a certolizumab pegol (czp) study or whose pregnancies have otherwise been reported to ucb due to potential czp exposure during pregnancy.


Eligibility criteria:
inclusion criteria: * pregnancy is identified while the patient is participating in an interventional or noninterventional certolizumab pegol (czp) study conducted by ucb, or a development partner, regardless of phase or treatment arm (ie, commercial or investigational, placebo or comparator treatment), or whose pregnancies were spontaneously reported to ucb due to potential czp exposure during pregnancy * sufficient information to classify the pregnancy as prospective or retrospective is available * full initial reporter (ie, woman or healthcare provider (hcp)) contact information reported to allow for follow-up (name, address, telephone number/email address) and contact information for at least 1 applicable hcp if initial contact is the woman * consent to participate is provided exclusion criteria: * pregnancies in which the resulting infant is over 1 year of age at the time of informed consent will not be eligible to participate in the study

Keywords: cimzia® czp pregnancy follow up study autoimmune diseases pregnancy outcomes major congenital malformations birth outcomes malformation birth defect
hypertensive and normal pregnancy--calcium metabolism and renin-angiotensin - scor in hypertension

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Eclampsia; Pre-Eclampsia

Summary: to study calcium metabolism and the renin-angiotensin system in hypertensive and normal pregnancy.

background: beginning in fiscal year 1975, the multidisciplinary scor examined causes, consequences, and treatments of human hypertension. a central theme was the renal basis for human hypertension. the subproject on calcium metabolism and the renin-angiotensin system in hypertensive and normal pregnancy began in december, 1990. design narrative: a longitudinal study was performed on normal pregnant women and women with chronic hypertension who had a high incidence of superimposed preeclampsia. in a previous study, the investigators had demonstrated that preeclampsia was associated with reduced urinary excretion of calcium and with lower plasma renin activity (pra) compared with normal pregnancy. the goal of the investigators was to identify the metabolic and cellular basis for these alterations in calcium homeostasis and in the renin angiotensin system. they tested two hypotheses. the first hypothesis was that diminished placental and/or renal production of 1,25-dihydroxyvitamin d, leading to lower serum calcium, higher parathyroid hormone, and increased renal tubular reabsorption of calcium, was the metabolic basis for hypocalciuria in preeclampsia. the second hypothesis was that lower pra in preeclampsia was due to systemic and renal vasoconstriction with hypertension and diminished natriuresis. serial measurements of 1,25-dihydroxyvitamin d, parathyroid hormone, serum ionized calcium, pra, estradiol and progesterone, and urinary calcium and electrolytes were obtained, particularly at the onset of preeclampsia. acute renal hemodynamic studies were also performed in women with preeclampsia and in gestational age matched normals. the studies investigated the relationships among glomerular filtration rate, renal blood flow, parathyroid hormone, vitamin d, atrial natriuretic factor, renin, estradiol and progesterone, and sodium and calcium excretion during infusion of inulin and pah with either saline or calcium chloride. intracellular free calcium concentration in platelets and lymphocytes of pregnant women participating in longitudinal and acute renal hemodynamic studies were also measured. basal and stimulated (with angiotensin ii, ionomycin and thrombin), intracellular free calcium concentrations were compared in normal and hypertensive pregnant women and correlated with calcium regulatory hormones, plasma renin activity and hypertension. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
validate the dosimetric parameters that correlate with acute hematologic toxicity (ht) in patients with rectal cancer

Conditions: Rectal Neoplasm

Summary: the purpose of this study is to validate the dosimetric parameters that correlate with acute hematologic toxicity (ht) in patients with rectal cancer treated with neoadjuvant chemoradiotherapy.

the investigators' ongoing retrospective study investigated the clinical and dosimetric parameter (dosimetry of pelvic bone marrow) which relate with acute hematologic toxicity in patient with rectal cancer treated with neoadjuvant chemoradiotherapy. in order to validate the dosimetric limitation of pelvic bone marrow in decreasing the intensity of ht, the investigators want to conduct a study to observe the acute ht without assigning any specific interventions to the subjects of the study, who will receive the standard treatment according to the multidisciplinary team's (mdt) decision and patient choice. therefore, this study's type is observational.

Eligibility criteria:
inclusion criteria: * rectal cancer * receive neoadjuvant chemoradiotherapy exclusion criteria: * hematological system disorders

Keywords: radiotherapy hematologic toxicity pelvic bone marrow