Kornimate/medical-research-clean huggingface dataset:
evaluation of yoga for substance use risk factors in a school setting

Conditions: Adolescent Development

Summary: this study will evaluate the efficacy of yoga taught during school to positively influence risk and protective factors of substance use and the initiation and severity of substance use. the study hypothesis is that, compared to a control group participating in regular physical education classes, subjects who participate in 32 yoga sessions across an academic year will improve in negative internalizing behaviors and self-regulatory skills that are known risk and protective factors for substance use. this study will also test the hypothesis that the yoga intervention will reduce both severity of substance use and the degree of substance use initiation.

the long-term, programmatic goal of this research is to advance prevention of addictive behaviors especially substance use in normal adolescent psychological development. the overall goal of this proposal is to pilot test a novel, preventive intervention for adolescent substance use. more specifically, it will evaluate the efficacy of yoga taught during school to positively influence risk and protective factors of substance use and the initiation and severity of substance use. this study involves a group randomized, controlled trial of yoga compared to physical education-as-usual for one school year, with a 6-month and 1-year follow-up, in order to accomplish the following specific aims: specific aim 1 - to evaluate the efficacy of a school-based yoga program for reducing negative internalizing behaviors (negative mood, perceived stress, impulsivity) which are risk factors for adolescent substance use. specific aim 2 - to evaluate the efficacy of this yoga program for promoting self-regulatory skills as protective factors against substance use in adolescence. specific aim 3 - to conduct a preliminary evaluation of the efficacy of this yoga program for reducing substance use initiation and severity of use.

Eligibility criteria:
inclusion criteria: * registered for physical education class

Keywords: mental health substance use substance use initiation education mind body therapies yoga meditation adolescent adolescence child children middle school
physostigmine after general anesthesia

Conditions: Postoperative Nausea and Vomiting; Anesthesia Recovery Period

Summary: recovery after general anaesthesia is often prolonged in the elderly. this group is particularly exposed to post-operative confusion. this has negative personal consequences as well as consequences for the postoperative care for these patients. the hypothesis is that physostigmine will decrease the amount of time in the post-anaesthesia care unit (pacu ), the postoperative amount of pain and shivering and finally post-operative confusion.

the researchers wish to investigate the use of physostigmine in the elderly patients (age \> 60 yrs, asa i-iii) in the postoperative recovery-phase after general anesthesia. apart from the beneficial effects for the patient, the lessened amount of time in the pacu will release caregiving resources and thereby increase the efficacy of the pacu.

Eligibility criteria:
inclusion criteria: * scheduled for surgical acute or elective operation * general anesthesia. * asa physical status i-iii * age \> 60 years exclusion criteria: * asthma and chronic pulmonary diseases * glaucoma * diabetics * any history of neurological and psychiatric disorder * parkinson's disease * disorders of the gastrointestinal and urogenital tracts

Keywords: pacu physostigmine recovery postanesthesia nursing wakefulness general anesthesia general anesthetics postoperative period
progesterone and second trimester bleeding

Conditions: Antepartum Bleeding; Preterm Birth

Summary: working hypothesis and aims: to investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding. the participants will be allocated through randomization to a study or control group. women in the study group will receive micronized progesterone 200 mg (utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. both women and medical staff will be blinded to group allocation. treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.


Eligibility criteria:
inclusion criteria: * viable pregnancy * gestational age between 13 to 26 weeks * vaginal bleeding from uterine origin * singleton pregnancy * normal clotting tests * hemodynamically stable woman exclusion criteria: * water leak * signs of preterm labor * fetal malformations incompatible with life * uterine malformations and other maternal conditions, i.e. liver disease, breast cancer, active thromboembolic state * past preterm birth

Keywords: second trimester vaginal bleeding late abortion preterm birth progesterone
a study to evaluate safety, pk, pd and efficacy of azd5492, a t cell-engaging antibody targeting cd20 in subjects with r/r b-cell malignancies.

Conditions: B-cell Malignancies

Summary: this is a phase i/ii study designed to evaluate if experimental t cell engaging antibody targeting cd20 azd5492 is safe, tolerable and efficacious in participants with relapsed or refractory b-cell malignancies.


Eligibility criteria:
inclusion criteria: * ≥18 years of age; * histologically documented cd20+ mature b-cell neoplasm * large b-cell lymphoma * follicular lymphoma * mantle cell lymphoma * chronic lymphocytic leukemia * small lymphocytic lymphoma * relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy; * ecog performance status of ≤ 2 (\< 2 in eu countries). the above is a summary, other inclusion criteria details may apply. exclusion criteria: * any neoplasm histology not specified in the ic section; * active cns involvement in lymphoma; * cns pathology including but not limited to any history of seizure disorder/epilepsy; * prior allogeneic hsct within 180 days, prior autologous hsct within 90 days, or cell therapy within 90 days of start of therapy; * history of grade ≥ 3 crs or grade ≥ 3 icans; * active and uncontrolled infections; * unresolved aes ≥2 grade due to prior anticancer therapies, with some exceptions the above is a summary, other exclusion criteria details may apply.

Keywords: cd20 cd8 t cell engager tcr azd5492 relapsed, refractory b-cell malignancies cll, chronic lymphocytic leukemia sll, small lymphocytic lymphoma mcl, mantle cell lymphoma lbcl, large b-cell lymphoma fl, follicular lymphoma titanium tce
interpersonal therapy-based treatment to prevent postpartum depression in adolescent mothers

Conditions: Depression

Summary: this study will aim to prevent postpartum depression in pregnant teenagers through an interpersonal therapy-based program.

postpartum depression is believed to be one of the most common complications after pregnancy. this type of depression often occurs within the first year after the baby is born and is most likely caused by dramatic changes in hormone levels after pregnancy. pregnant teenagers are even more at risk for experiencing complications throughout pregnancy and parenting difficulties after delivery. minimal research has been done on preventive ways to reduce postpartum depression in teenagers. therefore, this study will evaluate the effectiveness of an interpersonal therapy-based program at preventing postpartum depression in financially disadvantaged pregnant teenagers. participants will first undergo a 15-minute interview about their background and emotions. participants will undergo a second interview and then be randomly assigned to receive either interpersonal therapy-based treatment or standard care. participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. participants assigned to receive standard care will focus more on the health issues associated with pregnancy and postpartum. both groups will attend weekly 1-hour sessions for 5 weeks. homework may be assigned to review topics discussed, and all participants will receive the book baby basics. following treatment, participants will meet with researchers again when they are 34 to 36 weeks pregnant; in the hospital after the baby is born; and 6, 12, and 24 weeks after the baby is born.

Eligibility criteria:
inclusion criteria: * less than 24 weeks pregnant * not currently being treated for depression * speaks and reads english fluently exclusion criteria: * currently receiving mental health services from a health care provider * meets dsm-iv criteria for an affective disorder, substance use disorder, or psychosis

Keywords: adolescents depression, postpartum
optimizing post-operative recovery in bariatric patients with obstructive sleep apnea undergoing outpatient surgery: a comparison of sugammadex and neostigmine

Conditions: Anesthesia

Summary: this study assesses the efficacy of sugammadex against neostigmine for hastening recovery from neuromuscular blockade and optimizing pulmonary function in obese patients with obstructive sleep apnea presenting for outpatient surgery. both drugs are used in anesthesiology to reverse neuromuscular blockade that is given in the setting of inducing and maintaining general anesthesia.


Eligibility criteria:
inclusion criteria: * obese (body mass index \[bmi\] \>30 kg/m2) * diagnosis of obstructive sleep apnea (osa) (with or without continuous positive airway pressure \[cpap\] use) * scheduled for surgery requiring general anesthesia and neuromuscular blockade exclusion criteria: * history of hepatic, renal, or cardiovascular and/or cerebrovascular dysfunction * history of difficult tracheal intubation * history of adverse reaction to anesthesia * history of adverse reaction to rocuronium, sugammadex, and/or neostigmine/glycopyrrolate
family meals on prescription- a randomized controlled trial

Conditions: Obesity, Childhood; Hypertension; Metabolic Syndrome; Dietary Habits

Summary: "matkassen - effekten av tre månaders intensiv kostintervention hos barn med fetma/ family meals on prescription.- a randomized controlled trial : the aim of the study was to explore a novel approach for the treatment of obesity in children and adolescents through an intensive dietary intervention, consisting of receiving a weekly bag of groceries and recipes for five family meals at a reduced price for three months. data concerning dietary patterns and food habits, weight, bmi and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients' one year follow up appointment at the clinics.

children between the age of 5-15 years receiving treatment for obesity at the pediatric clinics in varberg and kungsbacka were offered to participate in the trial. the study population was divided into two arms including 60 patients in each arm: * in the first arm the patients received care consistent with regional guidelines. * in the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months. data concerning dietary patterns and food habits, weight, bmi and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients' one year follow up appointment at the clinics.

Eligibility criteria:
inclusion criteria: * children between the ages of 5 to 15 * attending the paediatric obesity clinics in kungsbacka or varberg exclusion criteria: * younger than 5 or older than 15
evaluate the efficacy and safety of saxagliptin in combination with metformin ir compared to saxagliptin monotherapy and to metformin ir monotherapy in drug naive chinese subjects with type 2 diabetes who have inadequate glycaemic control

Conditions: Type 2 Diabetes Mellitus

Summary: a multicenter, randomized, double-blind, active-controlled, phase 3 trial to evaluate the efficacy and safety of saxagliptin in combination with metformin ir as initial therapy compared to saxagliptin monotherapy and to metformin ir monotherapy in subjects with type 2 diabetes who have inadequate glycaemic control

allocation: randomized endpoint classification: efficacy/safety study intervention model: parallel assignment masking: double blind primary purpose: treatment

Eligibility criteria:
inclusion criteria: 1. subjects with type 2 diabetes mellitus; 2. hba1c ≥8% but ≤12%; 3.fasting c-peptide ≥1.0 ng/ml; 4. subject will be drug naïve; 5. body mass index ≤40 kg/m2. exclusion criteria: 1. symptoms of poorly controlled diabetes; 2. chronic or repeated intermittent corticosteroid treatment ; 3. calculated creatinine clearance \ 132.6 μmol/l (\>1.5 mg/dl) for men, \>123.8 μmol/l (\>1.4 mg/dl) for women; 4. creatine kinase ≥3x uln; 5.abnormal tsh value at screening will be further evaluated by free t4, subjects with an abnormal free t4 will be excluded; 6. history of administration of any antihyperglycaemic therapy for a total of 28 days or for more than three consecutive days or a total of seven non-consecutive days during the eight weeks prior to screening; 7. current treatment with a strong cyp3a4/5 inhibitor; 8. prior treatment with saxagliptin or any dpp-4 inhibitor; 9. significant or history of cardiovascular disease, renal disease, psychiatric disorders, immunocompromised individuals, hemoglobinopathies, liver disease, pancreatitis.

Keywords: type 2 diabetes mellitus, dipeptidyl-peptidase 4 inhibitors, saxagliptin, metformin, endocrine system diseases
assessment of sleep disturbance as a biomarker of disease activity in a military population with posttraumatic stress disorder

Conditions: Post-traumatic Stress Disorder

Summary: post-traumatic stress disorder (ptsd) is a public health problem due to both its chronic nature and the low response rate to conventional therapies. sleep disorders are the first cause of complaint in patients with ptsd due to night awakenings, difficulty to fall asleep and nightmares. according to a part of the scientific community, replicative traumatic nightmares represent ptsd's basis mechanism. traumatic nightmares generate disabling symptoms such as anxiety reactions, while maintaining the symptoms by depriving the individual of good quality sleep. traumatic nightmares may thus be a sign of ptsd seriousness and chronicity, although their physiological basis remain poorly known. in the military population, which is highly exposed to psychological traumatism, ptsd prevalence is very high and is associated with severe intensity patterns, a very high frequency of replicative nightmares and a low response to conventional therapies.


Eligibility criteria:
inclusion criteria: * military or former military * age between 18 and 65 years old * ptsd group : with a ptsd diagnosis * control group : without any sleep, psychiatric or neurologic pathology exclusion criteria: * diagnosis of progressive psychiatric pathology prior to the traumatic event responsible for ptsd * sleep pathology prior to the traumatic event responsible for ptsd * neurological pathology or severe head injury within the last 3 years
bispectral index and patient state index during general anesthesia with remimazolam

Conditions: Remimazolam; Anesthesia, General; Hypnotics and Sedatives; Thyroid Disease; Breast Diseases; Parathyroid Diseases

Summary: the aim of this study is to compare the bispectral index (bis) and patient state index (psi) during general anesthesia using remimazolam. the infusion rate of remimazolam is 6-12mg/kg/h during induction of anesthesia and 1-2mg/kg/h during maintenance of anesthesia. to calculate the fraction, the sum of times when bis\<60 and psi \<50 will be divided by the time from the loss of consciousness during induction of anesthesia to fully awake during emergence. we will compare the fraction of bis \<60 and the fraction of psi \<50 to find if there is some difference between the two depth of anesthesia monitoring devices during remimazolam anesthesia.


Eligibility criteria:
inclusion criteria: * patients ≥ 19 years need general anesthesia * american society of anesthesiologists (asa) classification i, ii * written informed consent exclusion criteria: * american society of anesthesiologists (asa) classification iii, iv, v * bmi \> 40kg/m\^2 * past medical history of anaphylactic reaction to remimazolam, remifentanil, or other benzodiazepines. * administration of anxiolytics, antipsychotics, rifampicin, succinylcholine, neostigmine, flumazenil, and cyclosporin within the past 24 hours * benzodiazepine user (e.g. for seizure control) * transfer to intensive care unit after surgery

Keywords: patient state index bispectral index electroencephalography
hypertonic saline solution to prevent acute kidney injury after heart transplantation

Conditions: Heart Transplantation; Acute Kidney Injury

Summary: the goal of this study is to evaluate if hypertonic saline solution can prevent or attenuate acute kidney injury after heart transplantation in the early postoperative phase.

acute kidney injury (aki) is a frequent complication immediately after heart transplantation (ht), with incidence rates between 40-70%. several factors contribute to this complication, such as hypervolemia, hyperactivation of renin-angiotensin-aldosterone system (rass) and low cardiac output. hypertonic saline solution (hss) can reduce diuretic resistance, increase urinary output and improve renal function in hypervolemic status such as acute heart failure. therefore, the investigators hypothesized that the use of hss could prevent or attenuate aki after heart transplantation in the early postoperative phase. the investigators aim to randomize 74 patients to receive 150 ml of hss 3,5% or placebo (saline solution 0,9%) twice daily for 3 days after ht. renal function, right ventricular echocardiographic parameters and pulmonary artery catheter parameters will be assessed. patients will be followed-up until 30 days, or death.

Eligibility criteria:
inclusion criteria: * hospitalized patients submitted to orthotopic heart transplantation (ht) exclusion criteria: * requirement of renal replacement therapy at the time of ht * requirement of extracorporeal membrane oxygenation (ecmo) before or immediately after ht * severe peri-operative mechanical complications * double transplant (e.g. heart-kidney or heart-lung) * hypernatremia (na ≥ 145) * severe hyponatremia (na ≤ 120)
the use of ultrasonic coagulating shears compared to monopolar electrocautery in open gastric cancer surgery

Conditions: Stomach Cancer; Gastrectomy; Ultrasonic Coagulating Shears

Summary: ultrasonic coagulating shears are made for performing for cutting and hemostasis at once during operation. it was proved that a laparoscopic gastric resection showed significantly shorter operative time and less work load distribution, and more stability of bleeding than before an introduction of ultrasonic coagulating shears . in an open gastric cancer surgery, ultrasonic coagulating shears have been often used for lymph node dissection or cutting of small vessels in some hospitals in korea. however its usefulness or effectiveness has not been fully proved. there was only one report about using ultrasonic coagulating shears in open gastrectomy. the report contained small number of subjects and surgical procedures were different from the investigators. the investigators expect to reduce operative time and blood loss with ultrasonic coagulating shears. ultrasonic coagulating shears will also enable us to dissect lymph node with closure of lymphatics. this may reduce the amount of drainage fluid from peritoneal cavity and shorten the removal time of a drain, which will also shorten the hospital stay. the objective of this study is to evaluate the safety and benefit of ultrasonic coagulating shears in open gastrectomy including usefulness and effectiveness by a randomized controlled, prospective study.


Eligibility criteria:
inclusion criteria: * patients with the diagnosis of gastric cancer * the patient who agrees to participate in this study by signing the informed consent form exclusion criteria: * the patient who refuse to participate in this study * have simultaneously other cancer * underwent cancer therapy at past time * have bleeding disorder, coagulation disorder, chronic disease (e.g.heart failure, cardiovascular disease, active hepatitis) * have a previous upper gastrointestinal surgery

Keywords: ultrasonic coagulating shears in gastrectomy
sunitinib plus prednisone in patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy

Conditions: Prostatic Neoplasms

Summary: this study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. this is a second-line study.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate. * progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant). * progressive disease based on psa progression, recist, or positive bone scan. * ecog 0 or 1. exclusion criteria: * prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting. * chemotherapy within 3 weeks. * impending complications from bone metastases. * ongoing urinary obstruction. * cardiac dysfunction, qtc \>470 msec. * cns involvement.

Keywords: docetaxel-refractory mcrpc second-line treatment with sunitinib and prednisone